chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site haematoma, Injection site inflammation, Injection site oedema, Injection site pain
Clinical narrative: Tendinitis; Injection site edema; Incorrect administration site/ patient thinks that as Shingrix was injected four inches below the shoulder line, the injection could have missed the deltoid muscle and went straight to the bone.; Bruising/Hematoma at injection site/ experienced bruising at the injection site; Bruising/Hematoma at injection site/ experienced bruising at the injection site; Injection site pain; This case was reported by a physician via call center representative and described the occurrence of injection site bruising in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2019, the patient received the 1st dose of Shingrix. On 12th August 2019, less than a day after receiving Shingrix, the patient experienced injection site bruising, injection site hematoma, injection site pain and vaccine administered at inappropriate site. On 21st January 2020, the patient experienced injection site inflammation and injection site edema. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the injection site bruising and injection site hematoma were resolved with sequelae and the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site inflammation, injection site edema and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site bruising, injection site hematoma, injection site pain, injection site inflammation and injection site edema to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced bruising at the injection site for 1 to 2 days that later turned into a hematoma. The patient also experienced pain at the injection site (left shoulder) that was ongoing at time of reporting. As a measure, the patient received physical therapy, pain medication and consulted a pain specialist. Three weeks before reporting the patient had a shoulder magnetic resonance imaging that showed tendinitis and edema at the injection site. The patient thought that as Shingrix was injected four inches below the shoulder line, the injection might have missed the deltoid muscle and went straight to the bone. The reporter consented to follow up. This is 1 of the 2 cases, reported by same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Magnetic resonance imaging abnormal, Product administered at inappropriate site, Tendonitis
Clinical narrative: Tendinitis; Injection site edema; Incorrect administration site/ patient thinks that as Shingrix was injected four inches below the shoulder line, the injection could have missed the deltoid muscle and went straight to the bone.; Bruising/Hematoma at injection site/ experienced bruising at the injection site; Bruising/Hematoma at injection site/ experienced bruising at the injection site; Injection site pain; This case was reported by a physician via call center representative and described the occurrence of injection site bruising in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2019, the patient received the 1st dose of Shingrix. On 12th August 2019, less than a day after receiving Shingrix, the patient experienced injection site bruising, injection site hematoma, injection site pain and vaccine administered at inappropriate site. On 21st January 2020, the patient experienced injection site inflammation and injection site edema. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the injection site bruising and injection site hematoma were resolved with sequelae and the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site inflammation, injection site edema and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site bruising, injection site hematoma, injection site pain, injection site inflammation and injection site edema to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced bruising at the injection site for 1 to 2 days that later turned into a hematoma. The patient also experienced pain at the injection site (left shoulder) that was ongoing at time of reporting. As a measure, the patient received physical therapy, pain medication and consulted a pain specialist. Three weeks before reporting the patient had a shoulder magnetic resonance imaging that showed tendinitis and edema at the injection site. The patient thought that as Shingrix was injected four inches below the shoulder line, the injection might have missed the deltoid muscle and went straight to the bone. The reporter consented to follow up. This is 1 of the 2 cases, reported by same reporter.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Injection site induration, Injection site warmth, Mobility decreased
Clinical narrative: her arm burned; Stiff; she could not move the arm/ still can't lift things with that arm; Sore/ soreness; Swelling; injection site is warm and hard; injection site is hard; she is very tired; This case was reported by a consumer via call center representative and described the occurrence of pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in her forties) and shingles (had shingles in December 2019).   On 9th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th February 2020, 10 hrs after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced pain and swelling. On 10th February 2020, the patient experienced burning sensation, limbs stiffness and mobility decreased. In February 2020, the patient experienced injection site warmth, injection site induration and tiredness. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the pain, swelling, burning sensation and limbs stiffness were recovering/resolving and the outcome of the mobility decreased was not recovered/not resolved and the outcome of the injection site warmth, injection site induration and tiredness were unknown.   It was unknown if the reporter considered the pain, swelling, burning sensation, limbs stiffness, mobility decreased, injection site warmth, injection site induration and tiredness to be related to Shingrix.  Additional details were reported as follows: The patient had the Shingles twice in the last five years. The patient received vaccine in unknown arm at around noon. She stated that she felt fine until 10 PM that evening and that she started to have soreness and swelling that came on really fast. She took some Tylenol and Ibuprofen and that she went to bed and when she woke up her arm burned and she was not able move the arm. The patient stated that her arm did not burn as much at time of reporting but she was still stiff and sore and still can not lift things with that arm. The patient also experienced injection site warmth  and injection site  hardness and she felt very tired. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain, Swelling
Clinical narrative: her arm burned; Stiff; she could not move the arm/ still can't lift things with that arm; Sore/ soreness; Swelling; injection site is warm and hard; injection site is hard; she is very tired; This case was reported by a consumer via call center representative and described the occurrence of pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in her forties) and shingles (had shingles in December 2019).   On 9th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th February 2020, 10 hrs after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced pain and swelling. On 10th February 2020, the patient experienced burning sensation, limbs stiffness and mobility decreased. In February 2020, the patient experienced injection site warmth, injection site induration and tiredness. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the pain, swelling, burning sensation and limbs stiffness were recovering/resolving and the outcome of the mobility decreased was not recovered/not resolved and the outcome of the injection site warmth, injection site induration and tiredness were unknown.   It was unknown if the reporter considered the pain, swelling, burning sensation, limbs stiffness, mobility decreased, injection site warmth, injection site induration and tiredness to be related to Shingrix.  Additional details were reported as follows: The patient had the Shingles twice in the last five years. The patient received vaccine in unknown arm at around noon. She stated that she felt fine until 10 PM that evening and that she started to have soreness and swelling that came on really fast. She took some Tylenol and Ibuprofen and that she went to bed and when she woke up her arm burned and she was not able move the arm. The patient stated that her arm did not burn as much at time of reporting but she was still stiff and sore and still can not lift things with that arm. The patient also experienced injection site warmth  and injection site  hardness and she felt very tired. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Immediate post-injection reaction
Clinical narrative: chills; tired; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 22nd January 2022) for prophylaxis.   On 2nd November 2019, the patient received the 1st dose of Shingrix. On 2nd November 2019, immediately after receiving Shingrix, the patient experienced chills and tiredness. On an unknown date, the outcome of the chills and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and since receipt had chills almost every day and was feeling tired.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches; Fever; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced general body pain and fever. On an unknown date, the outcome of the general body pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had body ache and fever.  The reporter asked how long would side effects usually last. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: developed urticaria; This case was reported by a physician via call center representative and described the occurrence of urticaria in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced urticaria. On an unknown date, the outcome of the urticaria was unknown.   It was unknown if the reporter considered the urticaria to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received 1st dose and experienced urticaria. This case has been linked with case US2020026104, reported for same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: rash all over her body; hives on the upper torso of her body; This case was reported by a other health professional via call center representative and described the occurrence of generalized rash in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2021) for prophylaxis.   On 28th August 2019, the patient received the 1st dose of Shingrix. On 29th August 2019, 1 days after receiving Shingrix, the patient experienced generalized rash and hives. On an unknown date, the outcome of the generalized rash and hives were resolved with sequelae.   It was unknown if the reporter considered the generalized rash and hives to be related to Shingrix.  Additional details were received as follows: Approximately 24 hours after receiving Shingrix, the patient experienced rash all over her body, with hives on the upper torso of her body. The reporter consented to follow up.
Age: 40.0
Sex: F
Vaccine: FLU4, TD
Symptoms: Injection site erythema, Injection site rash, Neuralgia, Pain, X-ray
Clinical narrative: Red mark/rash around injection site and pain with movement of left arm. Pt unsure if she received the DT or Tdap. Pt was examined and treated by her PCP for cervical nerve radiating pain with gabapentin for her symptoms the day following administration of the vaccine.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Fever of 99.8. Sore knees.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Blood immunoglobulin A, Blood immunoglobulin G, Full blood count, Henoch-Schonlein purpura, Metabolic function test
Clinical narrative: Symptoms consistent with Henoch Schonlein Purpura
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Urine analysis
Clinical narrative: Symptoms consistent with Henoch Schonlein Purpura
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash covering my body
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Chest pain, Feeling hot, Hyperhidrosis, Pain in extremity
Clinical narrative: ON 10/18/2019- PATIENT DESCRIBED CHEST PAIN THAT INCREASED IN SEVERITY AS TIME WENT ON. THIS WAS ACCOMPANIED BY ARM PAIN AND A SENSATION OF WARMTH/SWEATING.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear infection, Headache, Sinus congestion, Tinnitus
Clinical narrative: headaches a few days after the vaccine and continuing 3-4 times weekly, sinus congestion, ear infection, constant ringing in ears since receiving vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness from shoulder to elbow that lasted 3 weeks.  Did not hurt or itch.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Eye discharge, Eye swelling, Ocular hyperaemia, Rash
Clinical narrative: Pt. had her 1 yr immunization on 1/28/20. And came to clinic on 2/13/20 with red swollen eye with drainage and a rash. Provider feels it could be a adverse reaction to the MMR.  Rash and other nonspecific skin eruption (ICD-782.1) (ICD10-R21)    Assessment: mac red rash than blanches white on abd , chest and back; had MMR on Jan 28; will recheck on tuesday Eye drainage (ICD-379.93) (ICD10-H57.89)    Assessment: conjunctiva are clear; eyelids appear swollen with increased redness; had MMR Jan 28 so this could be the reaction we see to it ; will recheck Tuesday Pt. came to appt. on Thursday Feb 20th. No rash today no red swollen eye today either.
Age: 69.0
Sex: F
Vaccine: FLU4, TTOX, VARZOS
Symptoms: Computerised tomogram head, Facial pain, Magnetic resonance imaging brain, Trigeminal neuralgia
Clinical narrative: On 12/11/2019 I developed severe facial pain later diagnosed as Trigeminal Neuralgia of the 5th trigeminal nerve.  My neurologist gave me OXcarbazepine and Gabapentin which has stopped the pain
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Underdose
Clinical narrative: no symptoms; adult patient inadvertently received a pediatric dose; This spontaneous report was received from a medical assistant and refers to a 40-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.  On 06-FEB-2020, the patient was inadvertently vaccinated with a pediatric dose (0.5 mL) of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot# R031055, expiration date: 04-JUN-2021) (route of administration and frequency were not provided) for prophylaxis as a first dose in immunization series instead of an adult dose (1.0 mL). No confusion was reported, it was a medication error. No symptoms were reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Nausea, Pallor, Vomiting
Clinical narrative: became pale; nausea; vomited; This spontaneous report was received from a medical assistant referring to a 4-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-FEB-2020, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose, frequency, dosing schedule were not reported) via subcutaneous route (lot # S017265 and expiration date 01-DEC-2020) which was reconstituted with sterile diluent (lot # R020229 and expiration date 08-NOV-2020) for prophylaxis. Other suspect therapies included: On 10-FEB-2020, the patient was vaccinated with diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (QUADRACEL) (strength, dose, route, dosing schedule, lot # and expiration date were not reported) for prophylaxis. On 10-FEB-2020, after administration of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD), the patient became pale, had nausea and vomited. The patient went to the emergency room for observation and she was treated with epinephrine (EPIPEN). On 11-FEB-2020, the outcome of the events were recovered. The causality assessment between the suspect therapy and the events were not reported.
Sex: U
Vaccine: MENB
Symptoms: Erythema
Clinical narrative: Upper right arm erythema on 28May2019 to 05Jun2019; This is a spontaneous report from a contactable physician. A patient of unknown age and gender received on an unknown date meningococcal group b rlp2086 (TRUMENBA, Lot# 18-002303, Exp. Date 31Jan2020) at 0.5 ml single for immunization. Medical history and concomitant medications were not reported. At study visit (day 8), on 28May2019, the patient experienced upper right arm erythema that recovered on 05Jun2019.
Sex: U
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Experienced severe redness that lasted 1 week; This is a spontaneous report from a contactable pharmacist via Pfizer Sales Representative, who reported events for two patients. This is one of the two reports.  A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date at single dose for immunisation .The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced severe redness that lasted 1 week; event is non-serious and recovered on an unknown date. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020076486 same reporter/drug, different patient
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Had pain at the injection site for about 2 months; This is a spontaneous report from a contactable pharmacist via Pfizer Sales Representative, who reported events for two patients. This is one of the two reports. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date at single dose for immunisation .The patient medical history and concomitant medications were not reported. On an unspecified date the patient had pain at the injection site for about 2 months; event is non-serious and recovered on an unknown date. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020076440 same reporter/drug, different patient
Age: 61.0
Sex: M
Vaccine: FLU4, FLUX, FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: On 1/30 pt said he was having issues-with numb legs. On 2/3 pt said he woke up with no feeling at all in legs. He was taken to hospital. He said he was given a spinal tap The result of the spinal tap showed Guillain-Barre Syndrome. The patient was given a 5day IV of Ig and remained in hospital until 2/13. He was then transferred to rehab center for further therapy. When I last spoke to him 2/17/20 he was still in rehab center
Age: 61.0
Sex: M
Vaccine: FLU4, FLUX, FLU4
Symptoms: Guillain-Barre syndrome, Laboratory test, Lumbar puncture, Musculoskeletal disorder
Clinical narrative: On 1/30 pt said he was having issues-with numb legs. On 2/3 pt said he woke up with no feeling at all in legs. He was taken to hospital. He said he was given a spinal tap The result of the spinal tap showed Guillain-Barre Syndrome. The patient was given a 5day IV of Ig and remained in hospital until 2/13. He was then transferred to rehab center for further therapy. When I last spoke to him 2/17/20 he was still in rehab center
Age: 61.0
Sex: M
Vaccine: FLU4, FLUX, FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: On 1/30 pt said he was having issues-with numb legs. On 2/3 pt said he woke up with no feeling at all in legs. He was taken to hospital. He said he was given a spinal tap The result of the spinal tap showed Guillain-Barre Syndrome. The patient was given a 5day IV of Ig and remained in hospital until 2/13. He was then transferred to rehab center for further therapy. When I last spoke to him 2/17/20 he was still in rehab center
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Rash, Skin warm, Swelling
Clinical narrative: Rash & localized reaction - red, swollen, warm
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patients arm swelled up near the elbow, away from site of injection. Arm was sore but no sharp pain. Patient went to urgent care and was Prescribed an antibiotic/cephalexin and benadryl as prophylaxis.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Ear pain, Fatigue, Headache, Injection site pain
Clinical narrative: Muscle pain, nausea, fever, pain at injection site, chills, fever, headache, earache, extreme fatigue which have lasted over 24 hours.  Sleep and Tylenol used
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Muscle pain, nausea, fever, pain at injection site, chills, fever, headache, earache, extreme fatigue which have lasted over 24 hours.  Sleep and Tylenol used
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased
Clinical narrative: Patient states that she awoke about 6:30am the following morning (11-14-18) and could not lift her head off the pillow.  She was lying on her side and could not move her body it seemed.  It took her "a little bit" to roll onto her back in bed.  She yelled for her grandson to help her get up and into the living room.  She said it took all his strength to get her up and into the living room where she sat in her recliner.  She reports it wasn't until about 9am that she could begin to move and control her body.  It steadily improved and she had no more side effects of any kind by lunchtime and has had no adverse effects since then.  She was in the office today for her Annual Wellness Visit and reported the events to me from 2018.
Sex: F
Vaccine: UNK
Symptoms: Chest discomfort, Cough, Drug eruption, Drug interaction, Injection site erythema
Clinical narrative: a cough; chest tightness; drug rash; a red ring around the injection site; patient believed there was a drug interaction with the PNEUMOVAX 23 and her TRESIBA; This spontaneous report as received from a physician via field employee refers to a 76-year-old female patient. The patient's concurrent condition included diabetes mellitus. No information regarding the patient's medical history or allergies was provided.  On 08-JAN-2020 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S033516, expiration date 29-JUN-2021 (dose, frequency, and route of administration were not reported) for prophylaxis. Other suspect therapies included insulin degludec (TRESIBA) (dose, frequency, route of administration and indication were not reported). On 16-JAN-2020, the patient experienced a drug rash, a red ring around the injection site for the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), a cough and chest tightness. On 24-JAN-2020, the patient was seen in the office and all symptoms had resolved. Physician informed field employee that the patient believed there was a drug interaction with the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and her insulin degludec (TRESIBA). No treatment was given for the adverse events.  The outcome of a drug rash, a red ring around the injection site, a cough, chest tightness and drug interaction was reported as recovered/resolved. The causality assessment between the events and the suspect therapy was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Deafness unilateral, Ear discomfort, Hypoacusis, Sudden hearing loss
Clinical narrative: Sudden idiopathic hearing loss of the right ear; Sensorineural hearing loss, unilateral, right ear, with restricted hearing on the contralateral side/Tinnitus; Information was received from a lawyer regarding a case in litigation, referring to a female patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 22-FEB-2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dosage schedule, lot number and expiration date were not reported). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered hearing loss along with pressure and tinnitus. Plaintiff was diagnosed with sudden idiopathic hearing loss of the right ear and sensorineural hearing loss, unilateral, right ear, with restricted hearing on the contralateral side. As a direct and proximate result, Plaintiffs symptoms have resulted in physical limitations not present prior to using Merck's product. Plaintiff also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition, sustained serious, progressive, severe, incurable and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of sudden hearing loss and deafness neurosensory was considered as not recovered. The reporter considered sudden hearing loss and deafness neurosensory to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, sudden hearing loss and deafness neurosensory were considered to be medically significant events.
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Sudden idiopathic hearing loss of the right ear; Sensorineural hearing loss, unilateral, right ear, with restricted hearing on the contralateral side/Tinnitus; Information was received from a lawyer regarding a case in litigation, referring to a female patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 22-FEB-2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dosage schedule, lot number and expiration date were not reported). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered hearing loss along with pressure and tinnitus. Plaintiff was diagnosed with sudden idiopathic hearing loss of the right ear and sensorineural hearing loss, unilateral, right ear, with restricted hearing on the contralateral side. As a direct and proximate result, Plaintiffs symptoms have resulted in physical limitations not present prior to using Merck's product. Plaintiff also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition, sustained serious, progressive, severe, incurable and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of sudden hearing loss and deafness neurosensory was considered as not recovered. The reporter considered sudden hearing loss and deafness neurosensory to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, sudden hearing loss and deafness neurosensory were considered to be medically significant events.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Adverse drug reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was recovered/resolved.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacy women received dose of Shingrix and had problem  with the dose and  had to go to bed for a couple of days.  The follow up consent was granted. This case has been linked with case US2020025224, reported by same reporter
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: 4 year old female patient received expired vaccine, no AE; Initial information received on 12-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 4 years old female patient who received a 0.5 mL expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] for prophylactic vaccination (lot C5366AA and expiry date: 07-Feb-2020) via an unknown route in the right deltoid, on 12-Feb-2020.  Medical history, medical treatment, vaccination and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: dose of Pentacel that was administered after being reconstituted with sterile water/no AE; Initial information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an eight month male old patient who was vaccinated with a third dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (frequency: once, lot UJ060AAA, expiry date 14-Oct-2020) via an intramuscular route in the left thigh for prophylactic vaccination on 21-Jan-2020.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It is an actual medication error case due to wrong solution used in drug reconstitution. It was reported that a dose of Pentacel was administered after being reconstituted with sterile water.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying
Clinical narrative: Inconsolable Crying; Initial information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2020SA041917 (same reporter).  This case involves a female patient (age not reported) who experienced inconsolable crying (crying), while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) on 30-Jan-2020  On 30-Jan-2020, the patient received a second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ148ARA and 03-Feb-2021) via intramuscular route in the left thigh for prophylactic vaccination.  On an unknown date, the patient developed a non-serious inconsolable crying (crying) (Unknown latency), following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  No lab data was reported.  Final diagnosis was crying.   It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a patient was given fluzone high dose on 28-Oct-2019 and 12-Feb-2020; Initial information received on 12-Feb-2020 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves 83 years old female patient who received an extra dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] on 28-oct-2019 and 12-feb-2020 (Extra dose administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Oct-2019, the patient received first dose of the INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE prefilled syringe with an unknown batch number via unknown route in unknown administration site for prophylactic vaccination. On 12-Feb-2020, the patient received a second dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE  prefilled syringe(lot UJ307AA and expiration date 29-Jun-2020) via intramuscular route in the right deltoid for prophylactic vaccination.   It was an actual medication error case due to extra dose administered.  Since, patient received the annual vaccine frequently).   At the time of the report, no adverse events were reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Myalgia, Skin reaction, Swelling
Clinical narrative: SKIN REACTION: BLISTERS, REDNESS, MUSCLE PAIN/TENDERNESS, SWELLING, REDNESS INITIALLY SELF TREATED WITH IBUPROFEN AND RETURNED TO THE PHARMACY THE FOLLOWING DAY, PHARMACIST RECOMMENDED GOING TO THE LOCAL CLINIC TO BE SEEN.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Peripheral swelling, Skin discolouration
Clinical narrative: 12 days after vaccine pt developed blisters/swelling on 3 fingers of left hand that turned black then spread to other hand a few weeks later. Pt also developed shingles a few weeks after vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Blood test, Chest X-ray, Erythema, Herpes zoster
Clinical narrative: 12 days after vaccine pt developed blisters/swelling on 3 fingers of left hand that turned black then spread to other hand a few weeks later. Pt also developed shingles a few weeks after vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Skin discolouration, Swelling
Clinical narrative: 12 days after vaccine pt developed blisters/swelling on 3 fingers of left hand that turned black then spread to other hand a few weeks later. Pt also developed shingles a few weeks after vaccination.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Autonomic nervous system imbalance, Orthostatic hypotension, Postural orthostatic tachycardia syndrome
Clinical narrative: Orthostatic hypotension, dysautonomia symptoms, POTS symptoms
Age: 64.0
Sex: M
Vaccine: FLU4, HIBV, MENB, MNQ, PPV
Symptoms: Wrong product administered
Clinical narrative: Vaccine administration error by the nurse. Surgeon explicitly ordered "Prevnar 13" but nurse administered Pneumovax 23.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Decreased appetite, Gait disturbance, Myalgia
Clinical narrative: Severe muscle pain - neck, back, buttocks, thigh Weakness Could not walk for one day, could not eat a full meal for 4 days
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Chills, Pain, Pain in extremity, Painful respiration
Clinical narrative: 02/19/2020 BOTTOM OF FEET HURT, BODY ACHING, CHILLS/SHIVERING. TEETH CHATTERING. SLEPT WITH HEATING PAD ALL NIGHT. 02/20/2020 BOTTOM FEET CONTINUE TO HURT, BODY ACHING ALL OVER (FEELS LIKE WAS BEAT WITH A BALL BAT), HURTS TO TAKE DEEP BREATH (ACHE NOT DIFFICULTY BREATHING), BACK HURTS THE WORST.  400MG. IBUPROFEN TAKEN. TOLD TO CALL PCP. PCP STATES BODY'S NORMAL REACTION TO VACCINE, TAKE IBUPROFEN FOR THE ACHES AND PAINS   TOOK ANOTHER IBUPROFEN AND ALL SYMPTOMS GONE BY 10:30 a.m.
Age: 56.0
Sex: M
Vaccine: UNK
Symptoms: Muscular weakness, Vaccination site pain
Clinical narrative: Right arm at point of vaccinated severe pain and weakness
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Patient came to pharmacy and said that she had received the pneumovax vaccine at our pharmacy and after getting it, complained of soreness, pain, hot, and red. Patient had told this information to the doctor who told patient to come into pharmacy and have pharmacy complete VAERS form.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Chills, Crying, Hyperhidrosis
Clinical narrative: I had immediate shoulder pain at the site of injection that I still have, plus swelling.  about 12 hours after the injection my entire body started to hurt so badly I could only lay in bed.  Every joint, bone and muscle hurt so bad I spent several hours crying on 2/19/2020.  My fever got as high as 103 degrees about 4pm on 2/19/2020. I alternated bewtween shivering and sweating. I took advil for the pain and fever.  The pain stayed constant.  My fever has varied from 103 to 100.   Today my full hurts about 80% less than yesterday and my temperature is 100.  I had the same reaction after my first dose, but I also got a flu shot and the nurse told me the reaction was from the flu shot.  She was mistaken.  I can't remember ever having a fever this high in. my entire life, except for the day after I got the first dose of this shingles vaccine.  It's 2/2/2020 and I can still barely life the right arm where I got the shot.  But symptons are subsiding
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: I had immediate shoulder pain at the site of injection that I still have, plus swelling.  about 12 hours after the injection my entire body started to hurt so badly I could only lay in bed.  Every joint, bone and muscle hurt so bad I spent several hours crying on 2/19/2020.  My fever got as high as 103 degrees about 4pm on 2/19/2020. I alternated bewtween shivering and sweating. I took advil for the pain and fever.  The pain stayed constant.  My fever has varied from 103 to 100.   Today my full hurts about 80% less than yesterday and my temperature is 100.  I had the same reaction after my first dose, but I also got a flu shot and the nurse told me the reaction was from the flu shot.  She was mistaken.  I can't remember ever having a fever this high in. my entire life, except for the day after I got the first dose of this shingles vaccine.  It's 2/2/2020 and I can still barely life the right arm where I got the shot.  But symptons are subsiding
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: I had immediate shoulder pain at the site of injection that I still have, plus swelling.  about 12 hours after the injection my entire body started to hurt so badly I could only lay in bed.  Every joint, bone and muscle hurt so bad I spent several hours crying on 2/19/2020.  My fever got as high as 103 degrees about 4pm on 2/19/2020. I alternated bewtween shivering and sweating. I took advil for the pain and fever.  The pain stayed constant.  My fever has varied from 103 to 100.   Today my full hurts about 80% less than yesterday and my temperature is 100.  I had the same reaction after my first dose, but I also got a flu shot and the nurse told me the reaction was from the flu shot.  She was mistaken.  I can't remember ever having a fever this high in. my entire life, except for the day after I got the first dose of this shingles vaccine.  It's 2/2/2020 and I can still barely life the right arm where I got the shot.  But symptons are subsiding
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: Cool compresses, juice and water given, graham crackers given. Vitals checked, doctor made aware.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: pt had significant redness at the sight of injection and went to see physician. timeline is unclear since patient reported only 18 days after the shot
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient came in for a Well child exam on 2/20/2020 and was given 1 year old immunizations (Hep A, Prevnar13, MMRV, Varivax) at 10:30 AM by our medical assistant. Medical Assistant was notified at 11:00 AM. Medical Assistant called manufacturer MERCK (case number 01495615 spoke to RN from Medical Team) at 11:10 AM and reported the event. Event was also reported to RN from Immunization Registry.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Rash erythematous, Rash macular
Clinical narrative: red splotchy rash
Age: 20.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site reaction, Rash maculo-papular
Clinical narrative: Patient had circular erythema around the injection site measuring approximately 5cm in diameteter with erythematous maculopapular lesions and erythematous papules on an erythematous base that started near the injection site and spread down the left arm, across the torso, up the neck and face, over the arm, and to the waistline within hours. Rash described as pruritic.  Patient denied any anaphylactic symptoms. There was no fever, SOB, chest pain. The patient denied any history of skin conditions, recent infections, chronic health issues. Pulse was 63 beats per minute, no tachypnea. Normal heart sounds and lung sounds on exam. No purulent discharge or ulceration at the injection site. No open lesions, vesicles, or ulcers on the skin other than expected scab at small pox vaccine injection site. There were no enlarged axillary or cervical lymph nodes. Rash thought to be consistent with generalized allergic reaction vs generalized vaccinia. Patient treated with antihistamine and given return precautions for any signs of anaphylaxis. Will follow up within 24 hours.
Age: 20.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Patient had circular erythema around the injection site measuring approximately 5cm in diameteter with erythematous maculopapular lesions and erythematous papules on an erythematous base that started near the injection site and spread down the left arm, across the torso, up the neck and face, over the arm, and to the waistline within hours. Rash described as pruritic.  Patient denied any anaphylactic symptoms. There was no fever, SOB, chest pain. The patient denied any history of skin conditions, recent infections, chronic health issues. Pulse was 63 beats per minute, no tachypnea. Normal heart sounds and lung sounds on exam. No purulent discharge or ulceration at the injection site. No open lesions, vesicles, or ulcers on the skin other than expected scab at small pox vaccine injection site. There were no enlarged axillary or cervical lymph nodes. Rash thought to be consistent with generalized allergic reaction vs generalized vaccinia. Patient treated with antihistamine and given return precautions for any signs of anaphylaxis. Will follow up within 24 hours.
Age: 10.0
Sex: F
Vaccine: IPV
Symptoms: Loss of consciousness, Pallor, Vomiting
Clinical narrative: Patient in today with dad for a polio vaccine. After giving the vaccine, dad and patient started walking towards check out and patient became pale. We sat her down in a chair and she vomited 4 times. Took patient back to exam room and she passed out against dad- did not hit head, did not have any injuries, no seizing, came to in seconds. Her BP at 8:19am was 69/33 (right arm), BP at 8:30am was 94/58. Gave small sips of apple juice and patient started feeling better, left with dad.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Nausea, Sneezing
Clinical narrative: fatigue, sneezing for a couple of days and then she has severe nausea and headaches
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient described having redness and bumps around injection site. No swelling or bruising reported. Patient stated she does not have itch. Advised using hydrocortisone cream to relieve.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Chills, Decreased appetite, Headache
Clinical narrative: 2x2.5 inch hard hot red area and pain at injection site, temperature of 100.2, mild headache, severe chills, no appetite and general weakness. Day spent on sofa or in bed. Tylenol taken. Ice to arm.  On 02/19/2020 at 0700 felt much better with the exception of injection sire. As of today the site is slowly getting better.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 2x2.5 inch hard hot red area and pain at injection site, temperature of 100.2, mild headache, severe chills, no appetite and general weakness. Day spent on sofa or in bed. Tylenol taken. Ice to arm.  On 02/19/2020 at 0700 felt much better with the exception of injection sire. As of today the site is slowly getting better.
Age: 56.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Back pain, Dyspnoea
Clinical narrative: Difficulty breathing and back pain approximately 5 minutes after administration