chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lymph node pain, Lymphadenopathy, Malaise, Musculoskeletal stiffness
Clinical narrative: I began having severe left arm pain, down to my hand, four hours after the vaccination.  This pain subsided after a number of hours.  I began to experience moderate discomfort in my left shoulder, upper arm, armpit and pectoral muscle area, which made sleeping uncomfortable.  The next day, March 6, I experienced moderate malaise, continued pain as described above, and increasing pain and a feeling of swelling or fullness in my armpit and pectoral area.  It felt like the armpit lymph node and the sentinel lymph nodes on the front of my left shoulder were swollen and irritated.  On Saturday March 7 and Sunday, March 8, I experienced no malaise, but the feeling of fullness and painful lymph nodes increased.  On Sunday afternoon, at about 4 PM, I removed my blouse and saw that was looked like a large bruise had formed on my left breast and a paler bruise appearing discoloration was under my arm.  the feeling of fullness in my lymph nodes and armpit had subsided, but still remained to a certain extent.  When I got up at 6:30 AM on March 9, I observed that what had appeared bruise like had become quite red.  The discolored area was smaller, but the underside of my breast had a red somewhat lumpy appearing rash like skin effect. This rash does not itch.  I still have a feeling of fullness in my armpit and my shoulder and pectoral muscles are stiff and moderately sore, with normal range of motion.  Otherwise, I feel well, with no fever or pain or rash anywhere else.  I feel fairly normal, except for some concern over this side effect
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Rash, Swelling
Clinical narrative: I began having severe left arm pain, down to my hand, four hours after the vaccination.  This pain subsided after a number of hours.  I began to experience moderate discomfort in my left shoulder, upper arm, armpit and pectoral muscle area, which made sleeping uncomfortable.  The next day, March 6, I experienced moderate malaise, continued pain as described above, and increasing pain and a feeling of swelling or fullness in my armpit and pectoral area.  It felt like the armpit lymph node and the sentinel lymph nodes on the front of my left shoulder were swollen and irritated.  On Saturday March 7 and Sunday, March 8, I experienced no malaise, but the feeling of fullness and painful lymph nodes increased.  On Sunday afternoon, at about 4 PM, I removed my blouse and saw that was looked like a large bruise had formed on my left breast and a paler bruise appearing discoloration was under my arm.  the feeling of fullness in my lymph nodes and armpit had subsided, but still remained to a certain extent.  When I got up at 6:30 AM on March 9, I observed that what had appeared bruise like had become quite red.  The discolored area was smaller, but the underside of my breast had a red somewhat lumpy appearing rash like skin effect. This rash does not itch.  I still have a feeling of fullness in my armpit and my shoulder and pectoral muscles are stiff and moderately sore, with normal range of motion.  Otherwise, I feel well, with no fever or pain or rash anywhere else.  I feel fairly normal, except for some concern over this side effect
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site swelled up, began to itch, and turned red.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Malaise, Pain in extremity
Clinical narrative: Patient developed headache and general malaise evening of vaccination. The next day she developed severe left arm and shoulder pain and had difficulty moving her left shoulder. The pain and ROM has improved but not resolved and she is still unable to lay on left shoulder or lift Left arm above her head.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: other people are having problems with Shingrix as well, pain; This case was reported by a consumer via call center representative and described the occurrence of pain in an unspecified number of patients 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not applicable for this report. The reporter stated that she had a friend and they told her that other people were having problems with Shingrix as well, pain and they do not know if they should have dose 2. The reporter had no other information. This case has been linked to US2019207617, reported by the same reporter.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Influenza A; Ineffectiveness of flu vaccine; Initial information received on 02-Mar-2020 regarding an unsolicited valid serious case received from a consumer/non-health care professional.  This case involves a patient (of unknown demographics) who was diagnosed with influenza A (Influenza), while he/she received vaccine INFLUENZA VACCINE [Flu vaccine].  Medical history, concomitant, medical treatment, vaccination and family history were not provided.   On an unknown date, patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [Flu vaccine] (lot number not reported, of unknown Expiration date) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (3 days ago), the patient was diagnosed with serious influenza A (Influenza ) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. It was reported that it was an ineffectiveness of flu vaccine (vaccination failure). These events  were assessed as medically significant.  Laboratory data was not provided.  Final diagnosis was influenza.   It was not reported if the patient received any corrective treatment.  The outcome of the event was not reported at the time of report.   Information on the batch number was requested.; Sender's Comments: This case concerns patient (of unknown demographics) who was diagnosed with influenza A virus infection after and despite administration with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown.The patient's past history, medical condition at time of vaccination and lab test ruling out predisposing etiologies were not reported. Based upon the reported information, the role of the suspect vaccine and a case of vaccination failure cannot be assessed.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injected limb mobility decreased, Injection site erythema, Injection site pain, Pruritus
Clinical narrative: 2/21/20 Client reports upper left arm at injection site very sore, redness size of baseball.  Motion somewhat limited due to pain.  Also red, raised rash to torso, mainly back, and bilateral legs.  Approximately 20 spots.  Itching intense, then subsides.  Also describes Right-sided temporal headache- also comes and goes.  Symptoms began 2weeks following injection.  Client denies fever.  Referred to HealthCare Provider.   3/6/20-Client again phoned- same symptoms exist- subside for 2-3 days at a time, then return.  No change in appearance of rash per client.  Again, referred to Health Care Provider.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: 2/21/20 Client reports upper left arm at injection site very sore, redness size of baseball.  Motion somewhat limited due to pain.  Also red, raised rash to torso, mainly back, and bilateral legs.  Approximately 20 spots.  Itching intense, then subsides.  Also describes Right-sided temporal headache- also comes and goes.  Symptoms began 2weeks following injection.  Client denies fever.  Referred to HealthCare Provider.   3/6/20-Client again phoned- same symptoms exist- subside for 2-3 days at a time, then return.  No change in appearance of rash per client.  Again, referred to Health Care Provider.
Age: 0.75
Sex: F
Vaccine: FLU4, HEP
Symptoms: Pyrexia
Clinical narrative: Fever to 104.0 2 days after receiving immunizations. No other symptoms.
Sex: F
Vaccine: UNK
Symptoms: Continuous positive airway pressure, Respiratory distress
Clinical narrative: About 30 minutes after injection of Hep B, patient went into respiratory distress and needed IV fluids, oxygen, and seapap treatment.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral, Dizziness, Ear discomfort, Fatigue, Feeling abnormal
Clinical narrative: Right ear fullness Right ear hearing loss Extreme dizziness Brain fog Vertigo Lightheadedness Fatigue
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging, Vertigo
Clinical narrative: Right ear fullness Right ear hearing loss Extreme dizziness Brain fog Vertigo Lightheadedness Fatigue
Age: 25.0
Sex: M
Vaccine: DTAP, HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was supposed to receive Tdap, but was given Dtap; patient is not having adverse events
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Flushing, Injection site reaction, Rash erythematous
Clinical narrative: Red rash at injection site, feeling flush in the face intermittently, fatigue
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site urticaria, Injection site warmth
Clinical narrative: Induration at the site on March 7th 2020, hot to the touch that spread to hives that began this morning, March 9th 2020, on the right thigh.  Given Prednisolone 10ml and Benadryl 5 ml at 10 am this morning MArch 9th 2020. No wheezing noted by provider.
Age: 74.0
Sex: U
Vaccine: UNK
Symptoms: Erythema, Pain, Skin wound
Clinical narrative: Box 17 - Shingrix   When I started experienced broken skin. Looked like skin was flipped open with a small red dot in the center. Very painful, as if I was being bitten. Washed the areas with an antiseptic, then applied Neosporin. Eventually area disappeared.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood glucose normal, Fatigue, Headache
Clinical narrative: Severe reaction...joint aches and pains, Headache, extreme fatigue. In bed for 1 day, felt affects  for 3 more days. 2nd of 2 shots in series.  !!Had started to check blood sugar 2 weeks prior as recommended by doctor for suspected reactive hypoglycemia. Fasting blood sugar for the prior two weeks was 98 +- 2.  First day after Shingrex shot, fasting blood sugar was 85, 2nd day was 90, third day was 95, 4th day was normal at 98. This is a very surprising side affect not noted in the mfr literature so thought I would report this in your system.
Age: 1.83
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC13, RV5
Symptoms: Wrong product administered
Clinical narrative: I administered the incorrect vaccine at 4:40 PM on 04/03/2020. I administered Hepatitis A in the left thigh. The right vaccine that was supposed to be administered was Hepatitis B. The parents of the patient were informed by staff. Parents of the patient agreed to have Hepatitis B administered. Staff then proceeded to administer
Sex: M
Vaccine: HEP, HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Titer for Hepatitis B-borderline per laboratory/ low titer; This spontaneous report as received from a medical student refers to a 15-year-old male patient. The patient had seasonal allergies. The patient had no pertinent medical history, drug reactions or allergies and concomitant therapies.  On 21-NOV-2004, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not reported) for childhood immunization. On 21-DEC-2004, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown). On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 5/0.5 microgram/ml, as third dose, intramuscularly (dose, lot # and expiration date were not reported) for childhood immunization.  On 21-FEB-2020, the patient had titers drawn to check for hepatitis B immunity and the laboratory results were "borderline" (also reported as low titer). The patient did not seek medical attention.  The outcome of the event was reported as not recovered. The relatedness between the event and the suspect vaccines was not proceeded.
Sex: U
Vaccine: HEPA, HIBV, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects; patient was administered an improperly stored dose of either VAQTA, PEDVAX HIB, or GARDASIL9; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. This report concerns 1 patient and 2 combination products.  On 12-JAN-2020, the patient was vaccinated with an improperly stored dose of either hepatitis a vaccine, inactivated (VAQTA) lot # S010727, expiration date 26-JUL-2020, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S006471, expiration date 22-JAN-2022 or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621926, expiration date 28-NOV-2021 (doses and routes of administration were not reported) all for prophylaxis. There was no adverse event reported. The vaccines experienced temperature excursion of 34.9 degrees F (F) for 7 minutes and 48.2 F for 5 hours. There was no previous temperature excursion reported. The digital data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea
Clinical narrative: difficulty breathing; This case was reported by a consumer and described the occurrence of difficulty breathing in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced difficulty breathing. On an unknown date, the outcome of the difficulty breathing was not recovered/not resolved.   It was unknown if the reporter considered the difficulty breathing 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 difficulty in breathing. The reporter asked would this go away or did need to see doctor.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: severe intermittent pain in the left arm from injection site deltoid; severe intermittent pain in the left arm from injection site deltoid to wrist; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date 7th November 2021) for prophylaxis.   On 28th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm and wrist pain. On an unknown date, the outcome of the pain in arm and wrist pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and wrist pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The patient experienced severe intermittent pain in the left arm from injection site deltoid to wrist for 6 months and till the time of reporting experiencing it. The reporter did not consent to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Lethargy, Pyrexia
Clinical narrative: fever of 100.7 degrees; no apetite; lethargic; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female 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 fever, appetite absent and lethargy. On an unknown date, the outcome of the fever, appetite absent and lethargy were recovered/resolved.   It was unknown if the reporter considered the fever, appetite absent and lethargy to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received her 1st dose of Shingrix and experienced a fever of 100.7 degrees. The reporter did not consent to follow up. The outcome of events was reported as recovered/resolved with sequel, but in database it was mentioned as recovered/resolved, so kept as reported in database.      Lab Comments: On an unknown date lab test was performed.
Age: 63.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: erythema, warmth, and hive
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Loss of personal independence in daily activities, Pain
Clinical narrative: Flu like, severely limited my activities, achy body,  headache, very sore arm, exhaustion continues till today. Some days are better than others.  This is extreme.  When I had my first oral herpes outbreak some 20 years ago it was very extreme as well. My dentist said he had never seen anything like my outbreak.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Flu like, severely limited my activities, achy body,  headache, very sore arm, exhaustion continues till today. Some days are better than others.  This is extreme.  When I had my first oral herpes outbreak some 20 years ago it was very extreme as well. My dentist said he had never seen anything like my outbreak.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Delirium, Dysgraphia, Impaired driving ability, Mobility decreased, Muscular weakness
Clinical narrative: pt called the next day stated that she was "delirious" last night, had a fever of "102",  Her right arm  is so weak that she cant "lift it".  She stated that she wrote things down  last night "that she cant even read this morning".  She stated that she canceled all her appt for today, (3-6) because she "cant drive due to her weak arm".
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: pt called the next day stated that she was "delirious" last night, had a fever of "102",  Her right arm  is so weak that she cant "lift it".  She stated that she wrote things down  last night "that she cant even read this morning".  She stated that she canceled all her appt for today, (3-6) because she "cant drive due to her weak arm".
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Hives appeared on my neck. I took Diphenhydramine for 2x a day for three days until rash was gone.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin, Eye pain, Influenza like illness, Rash
Clinical narrative: DEVELOPED EXPECTED FLU LIKE SYMPTOMS DAY AFTER RECEIVING VACCINE, THEN DEVELOPED PAIN BEHIND BOTH EYES AND RASH TO HANDS AND ARMS DEVELOPED ON 3RD DAY AFTER RECEIVING VACCINE--SAW DERMATOLOGIST WHO BIOPSIED RASH AND STATES COULD BE SHINGRIX REACTION
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin, Eye pain, Influenza, Ocular discomfort, Ocular hyperaemia
Clinical narrative: DEVELOPED EXPECTED FLU LIKE SYMPTOMS DAY AFTER RECEIVING VACCINE, THEN DEVELOPED PAIN BEHIND BOTH EYES AND RASH TO HANDS AND ARMS DEVELOPED ON 3RD DAY AFTER RECEIVING VACCINE--SAW DERMATOLOGIST WHO BIOPSIED RASH AND STATES COULD BE SHINGRIX REACTION
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Photophobia, Rash
Clinical narrative: DEVELOPED EXPECTED FLU LIKE SYMPTOMS DAY AFTER RECEIVING VACCINE, THEN DEVELOPED PAIN BEHIND BOTH EYES AND RASH TO HANDS AND ARMS DEVELOPED ON 3RD DAY AFTER RECEIVING VACCINE--SAW DERMATOLOGIST WHO BIOPSIED RASH AND STATES COULD BE SHINGRIX REACTION
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin, Eye pain, Influenza like illness, Rash
Clinical narrative: First regular flu symptoms for 36 hours post injection. On 3/2/20 I noticed a small bump on the tip of my Lt thumb Over the day I had several more bumps show up This progressed with the RT hand getting bumps on top of bumps, markedly worse in looks yet pain from the bumps that presented on fingers, finger tips, joints of on hand/finger worse 3/3/20 -3/5/20 light sensitivity heightened worked in dark office with low level lighting 3/2/20 through current, whites of eyes bloodshot and eyes hurt in their socket (best way to describe it) eyelids feel heavy, eyes feel like I haven't had sleep, yet I have.  3/6/20 stayed home from work 3/7/20 it was now on my wrist, as well and several on my face 3/8/20 now also on the back of my right arm (tricept area)  3/9/20 sought medical advice on what to do to find out what it is from the Dermatologist. Dr. is pretty sure it is relational to the Shingrix yet some of these symptons a-typical to what he has seen.  He biopsied two spots today.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin, Eye pain, Influenza, Ocular discomfort, Ocular hyperaemia
Clinical narrative: First regular flu symptoms for 36 hours post injection. On 3/2/20 I noticed a small bump on the tip of my Lt thumb Over the day I had several more bumps show up This progressed with the RT hand getting bumps on top of bumps, markedly worse in looks yet pain from the bumps that presented on fingers, finger tips, joints of on hand/finger worse 3/3/20 -3/5/20 light sensitivity heightened worked in dark office with low level lighting 3/2/20 through current, whites of eyes bloodshot and eyes hurt in their socket (best way to describe it) eyelids feel heavy, eyes feel like I haven't had sleep, yet I have.  3/6/20 stayed home from work 3/7/20 it was now on my wrist, as well and several on my face 3/8/20 now also on the back of my right arm (tricept area)  3/9/20 sought medical advice on what to do to find out what it is from the Dermatologist. Dr. is pretty sure it is relational to the Shingrix yet some of these symptons a-typical to what he has seen.  He biopsied two spots today.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Photophobia, Rash
Clinical narrative: First regular flu symptoms for 36 hours post injection. On 3/2/20 I noticed a small bump on the tip of my Lt thumb Over the day I had several more bumps show up This progressed with the RT hand getting bumps on top of bumps, markedly worse in looks yet pain from the bumps that presented on fingers, finger tips, joints of on hand/finger worse 3/3/20 -3/5/20 light sensitivity heightened worked in dark office with low level lighting 3/2/20 through current, whites of eyes bloodshot and eyes hurt in their socket (best way to describe it) eyelids feel heavy, eyes feel like I haven't had sleep, yet I have.  3/6/20 stayed home from work 3/7/20 it was now on my wrist, as well and several on my face 3/8/20 now also on the back of my right arm (tricept area)  3/9/20 sought medical advice on what to do to find out what it is from the Dermatologist. Dr. is pretty sure it is relational to the Shingrix yet some of these symptons a-typical to what he has seen.  He biopsied two spots today.
Age: 40.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Erythema, Influenza like illness, Lymphadenopathy, Odynophagia, Pustule
Clinical narrative: Reports had "flu like symptoms" following first dose of MMR given on 2/5/2020.  1/2 hour after administration of 2nd doses given on 3/6/2020 developed redness to face, neck, upper chest and back.  Went to ED for eval.  Reports she developed rash/hives to face, neck, torso, scalp, upper arms.  Hives have spread to upper thigh and peri area.  Describes rash as "itchy" and painful.  Provider also noted swollen glands at paricervical region, described rash as macular, papular, with some pustules.  Painful to swallow.  Throat slightly injected.  Slight swelling of submanibular glands.  Has been using OTC Benardryl gel caps every 4 hours since Friday without relief of symptoms and hydrocortisone cream to hives.Denied SOB. or trouble breathing.  Employee is afebrile.  on 3/9/2020 was given scripts for Medrol dose pack and Atarax for itching.  Was given another VIS sheet for MMR and highlighted area on page 2 stating that hives, rash and swollen glands can develop following vaccine administration.  Advised by CNP not to have the MMR vaccine in future.  Will recheck with provider on 3/7/2020 to ensure hives are improving.
Age: 40.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Rash, Rash macular, Rash papular, Rash pruritic, Salivary gland enlargement
Clinical narrative: Reports had "flu like symptoms" following first dose of MMR given on 2/5/2020.  1/2 hour after administration of 2nd doses given on 3/6/2020 developed redness to face, neck, upper chest and back.  Went to ED for eval.  Reports she developed rash/hives to face, neck, torso, scalp, upper arms.  Hives have spread to upper thigh and peri area.  Describes rash as "itchy" and painful.  Provider also noted swollen glands at paricervical region, described rash as macular, papular, with some pustules.  Painful to swallow.  Throat slightly injected.  Slight swelling of submanibular glands.  Has been using OTC Benardryl gel caps every 4 hours since Friday without relief of symptoms and hydrocortisone cream to hives.Denied SOB. or trouble breathing.  Employee is afebrile.  on 3/9/2020 was given scripts for Medrol dose pack and Atarax for itching.  Was given another VIS sheet for MMR and highlighted area on page 2 stating that hives, rash and swollen glands can develop following vaccine administration.  Advised by CNP not to have the MMR vaccine in future.  Will recheck with provider on 3/7/2020 to ensure hives are improving.
Age: 40.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Urticaria
Clinical narrative: Reports had "flu like symptoms" following first dose of MMR given on 2/5/2020.  1/2 hour after administration of 2nd doses given on 3/6/2020 developed redness to face, neck, upper chest and back.  Went to ED for eval.  Reports she developed rash/hives to face, neck, torso, scalp, upper arms.  Hives have spread to upper thigh and peri area.  Describes rash as "itchy" and painful.  Provider also noted swollen glands at paricervical region, described rash as macular, papular, with some pustules.  Painful to swallow.  Throat slightly injected.  Slight swelling of submanibular glands.  Has been using OTC Benardryl gel caps every 4 hours since Friday without relief of symptoms and hydrocortisone cream to hives.Denied SOB. or trouble breathing.  Employee is afebrile.  on 3/9/2020 was given scripts for Medrol dose pack and Atarax for itching.  Was given another VIS sheet for MMR and highlighted area on page 2 stating that hives, rash and swollen glands can develop following vaccine administration.  Advised by CNP not to have the MMR vaccine in future.  Will recheck with provider on 3/7/2020 to ensure hives are improving.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Patient states she developed a sore arm with swelling 1 day after the administration.  She has since developed an area of redness measuring 10.5 cm X 5.7 cm.  Redness is just below the injection site.  Redness is tender, without warmth or streaking.
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: vaccine given 9:30am 3/5/20 at pediatrics, 7 am on 3/6/20 patient woke up with a 102 degree fever. fever remained 102 throughout the day. 3/7/20 he woke up with a fever still at 102. at around 7:30 am he vomited.  he threw up again one more time that day as well as having diarrhea several times throughout the day. 3/8/20 fever up to 103.5 and still has diarrhea. also, vomited one in the morning. took patient to the urgent care at 2:15pm for evaluation where they concluded he was having a vaccine reaction.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus, Rash, Scab
Clinical narrative: red blisters (fluid-filled)  all over the forehead, eyelid,both sides of the face. Back of ears and some on neck. Rashes neck, torso, hips. Started itching around 2nd week. Start of 4th weekSEVERE itching at night,  face and wherever rashes all over the body. Scabs in the face are still visible since the start of 2nd week after vaccination. NEVER had any reaction from the OLD Shingle vaccine at the age of 60.       NOTE: PATIENT FILLING THIS OUT NOT DOCTOR OR FACILITY
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; the patient was inadvertently administered a dose of GARDASIL 9; This spontaneous report was received from a nurse practitioner (also reported as nurse prescriber), referring to a 40-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.      On 05-MAR-2020, the patient was inadvertently vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as prophylaxis (strength, dosage regimen, route of administration, and anatomical location were not reported; and lot number R022533 has been verified to be valid, expiration date reported and validated as 12-NOV-2019) (expired product administered). No additional adverse event.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain, Rash
Clinical narrative: I'm having a reaction. It's near the injection site / It's a large red; It's a large red and a sore spot; plus the headache; painful rash; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 58-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st February 2020, the patient received the 2nd dose of Shingles vaccine. In February 2020, less than a week after receiving Shingles vaccine, the patient experienced erythema, pain, headache and painful rash. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the erythema, pain, headache and painful rash were not recovered/not resolved.   It was unknown if the reporter considered the erythema, pain, headache and painful rash to be related to Shingles vaccine.  Additional details were received as follows: The patient stated that after vaccination experienced large red and sore spot near the injection site but over to the side and to the right. The patient also had headache. The patient asked what to do with Advil as Advil was touching the pain.
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Abdominal pain upper, Chills, Condition aggravated, Feeling of body temperature change
Clinical narrative: real bad stomach pain in lower Abdominal area /real bad lower abdominal pain; hot and cold; Chilks; irritable bowel syndrome aggravation; Stomach pain; This case was reported by a consumer via call center representative and described the occurrence of lower abdominal pain in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included irritable bowel syndrome.   On 19th February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced lower abdominal pain, feeling hot and cold, chills, irritable bowel syndrome aggravated and stomach pain. On an unknown date, the outcome of the lower abdominal pain, feeling hot and cold, chills, irritable bowel syndrome aggravated and stomach pain were unknown.   It was unknown if the reporter considered the lower abdominal pain, feeling hot and cold, chills, irritable bowel syndrome aggravated and stomach pain to be related to Shingrix.  Additional details were received as follows: The patient experienced real bad stomach pain in lower Abdominal area hot and cold and chills. The patient asked what are the side effects of the shingles vaccine. The patient was referred to the healthcare professional.
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Irritable bowel syndrome
Clinical narrative: real bad stomach pain in lower Abdominal area /real bad lower abdominal pain; hot and cold; Chilks; irritable bowel syndrome aggravation; Stomach pain; This case was reported by a consumer via call center representative and described the occurrence of lower abdominal pain in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included irritable bowel syndrome.   On 19th February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced lower abdominal pain, feeling hot and cold, chills, irritable bowel syndrome aggravated and stomach pain. On an unknown date, the outcome of the lower abdominal pain, feeling hot and cold, chills, irritable bowel syndrome aggravated and stomach pain were unknown.   It was unknown if the reporter considered the lower abdominal pain, feeling hot and cold, chills, irritable bowel syndrome aggravated and stomach pain to be related to Shingrix.  Additional details were received as follows: The patient experienced real bad stomach pain in lower Abdominal area hot and cold and chills. The patient asked what are the side effects of the shingles vaccine. The patient was referred to the healthcare professional.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: bump warm sore; bump warm; bump sore; extra dose/ 3rd dose in a 2 dose series; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 3FJ59, expiry date 27th January 2021) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were received as follows: The age at vaccination was not reported. The patient received 3 doses of Shingrix, which led to extra dose administered. The reporter consented to follow up. HCP did not have the full details at the time of the call.   Follow up information received from pharmacist on 24th February 2020: The patient's demographic details were updated. On 25th October 2018, the patient received the 3rd dose of Shingrix via intramuscular .5 ml.  On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site warmth, injection site pain. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site pain to be related to Shingrix.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular, Rash pruritic
Clinical narrative: extreme itching; Red spots throughout his body; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2019, the patient received the 1st dose of Shingrix. In January 2020, 3 weeks after receiving Shingrix and an unknown time after starting Sarna Lotion, the patient experienced itchy rash and red spotty rash. The patient was treated with camphor, menthol (Sarna Lotion). On an unknown date, the outcome of the itchy rash and red spotty rash were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash and red spotty rash to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of the Shingrix vaccine and three weeks later started to experienced extreme itching with red spots throughout his body. The patient applied Sarna lotion which did not help much, He was sawby an allergist who gave him an oral medication unknown name and also that had not helped him.. The patient was scheduled to get his allergy testing done. The patient continues to experienced extreme itch thought out his body with red spots.  The pateint had tried a medicated soap and also that had not helped him. The follow up consent was granted.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: received Fluzone booster injection 02/28/2020 at 750AM. IM Rt lateralis vastus. At noon mom notes red bumps posterior Neck which also involved Rt lateral abdominal, Rt thigh.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Cough, Productive cough, Wheezing
Clinical narrative: PATIENT WAS IN OFFICE WITH MOM TODAY FOR HIS 5 YEAR WELL EXAM. HE RECEIVED TWO VACCINES MMR AND QUADRACEL (IPV/DTAP), IN HIS LEFT THIGH. HE LEFT THE OFFICE AND ON HIS WAY OUT THE DOOR HE STARTED TO COUGH. MOM LEFT OFFICE AND WITHIN 10 MINUTES SHE CALLED OUT OFFICE AND SAID HE WAS STARTING TO COUGH MORE , HAD A TIGHT WHEEZE AND SAID HIS MOUTH FELT LIKE HE HAD PHLEGM IN THE BACK OF HIS THROAT. MOM GAVE HIM 1/2 TAB OF BENADRYL.  WE SUGESTED MOM TO COME BACK TO OFFICE, WEGAVE HIM AN ALBUTEROL TREATMENT AND 12.5 MLS OF PREDNISONE. MD LISTENED TO LUNGS AND HE WAS CLEAR AND WAS DISCHARGED.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness
Clinical narrative: Flue like symptoms for 48 hours, diarrhea as well.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Unbearable arm pain. Patient was injected into the same arm that was recently fractured. Pt went to the hospital due to the pain.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Migraine with aura, Photophobia
Clinical narrative: SHINGLE SYMPTOMS WRAPPING AROUND RIGHT TRUNK, OCULAR MIGRAINE EPISODES CONTINUING EVERY 2-3 DAYS TILL PRESENT, LIGHT SESITIVITY IN RIGHT EYE
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema
Clinical narrative: the second dose ofGARDASIL9 "not intramuscular and was given at the top of her shoulder ahnost parallel bra strap; redness at the injection site; This spontaneous report was received from a registered nurse and refers to a 32-year-old female patient. The patient's concurrent conditions included allergy to acetaminophen (+) oxycodone hydrochloride (PERCOCET), ibuprofen and pseudoephedrine hydrochloride (SUDAFED). The patient's historical drug included acetaminophen (+) oxycodone hydrochloride (PERCOCET), ibuprofen (manufacturer unknown) and pseudoephedrine hydrochloride (SUDAFED). It was reported that the patient did not have any concomitant medications or pertinent medical history.  On 03-DEC-2019, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), injection, (strength, route of administration, lot # and expiration date were not reported) for prophylaxis.  On 13-FEB-2020, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R028386, expiration date 27-APR-2021. The patient received a second dose of the vaccine not intramuscularly and it was given at the top of her shoulder almost parallel bra strap. On 14-FEB-2020, the patient contacted the office to report redness at the injection site. She sought medical attention to see the nurse however no treatment was given. The outcome of injection site erythema was reported as recovering.  The causality assessment was not provided.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; lhe patient was administered an improperly stored dose of PNEUMOVAX; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies or medical history provided.   On 26-FEB-2020, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, lot # S028601, expiration date 02-JUN-2021 (strength, dose, frequency, route of administration, were not reported) for prophylaxis. No additional adverse event was reported.  Since unknown date in September 2019, there were the multiple temperature excursion above 9 degrees Celsius, for a time frame of 30 hours. There was no previous temperature excursion. The digital data logger was involved.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; pharmacist reports improperly stored PNEUMOVAX 23 was administered to a patient.; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.      On 04-MAR-2020, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vial for injection as prophylaxis (strength, dosage regimen, route of administration, and anatomical location were not reported; and lot number R031812 has been verified to be valid, expiration date reported and validated as 26-SEP-2020) (product storage error). No additional adverse effects reported.  The temperature excursion reporter was: 70 degrees Fahrenheit for 24 hours. No previous temperature excursions. A data logger was used.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: four month did not receive HIB part of Pentacel injection, No AE; Initial information was  received on 02-Mar-2020 regarding an unsolicited valid non-serious case received from the other  healthcare professional.  This case involves a four month old female patient who did not receive HIB part of Pentacel injection, while adminstration with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)) for Immunisation.  On 24-Feb-2020, the patient received a second dose of 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]  (frequency once, lot number UJ058ABA and expiration date 13-Oct-2020) but did not receive HIB part, via an unknown route in the left thigh for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of report, 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 and Module VI of the 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: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: medical assistant misunderstood and gave Adacel to the child by mistake instead of his mother, no AE; medical assistant mistakenly gave adacel to 4 month old infant, no AE; Initial information was received on 02-Mar-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a four month old male patient to whom the medical assistant by mistake administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6401AA, expiry date-05-Nov-2021, prefilled syringes) via intramuscular route in the left fasciitis lateralis for prophylactic vaccination on 02-Mar-2020 instead of his mother (Wrong patient received product and Product administered to patient of inappropriate age).   Medical history, past medical treatment, vaccination and family history were not provided.  On 02-Mar-2020, the patient received a dose of concomitant vaccinations which included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong patient received product and inappropriate age at vaccine administration.  At the time of report, 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.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient of age range of 59 to 62 received Fluzone High-Dose, no AE; patient of age range of 59 to 62 received Fluzone High-Dose, no AE; Initial information was received on 03-Mar-2020 regarding an unsolicited valid non-serious case from a consumer.  This case is linked to cases 2020SA059559 and 2020SA059571 (same reporter).  This case involves a patient (age range of 59 to 62) (gender unknown) who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination in the last October to November.  Medical history, medical treatment, vaccination and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.   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.  Information on the batch number was requested.