chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: a 6 months old female patient was not administered DTap-IPV portion of Pentacel and she only received ActHIB portion diluted by sterile water from another manufacture diluent, no AE; Initial information received on 15-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a six month old female patient who received a 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: UJ148ABA and Exp. Date: 03-Feb-2021) via an intramuscular route in an unknown administration site for prophylactic vaccination on 20-Jun-2020, where DTap-IPV portion of vaccine was not administered and the Act-HIB portion was administered by diluted with sterile water from another manufacture's diluent from Merck (product preparation issue).  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS B VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination.  It was an actual medication error case 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 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: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received first dose of Menactra at age 12, received second dose at age 14, no AE; Initial information received on 15-Jun-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional (office staff).  This case involves a 14 year old female patient who received first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and Exp. Date not reported) via an unknown route in an unknown administration site for prophylactic vaccination at age 12 and second dose at age 14, on 09-Jul-2015 and 22-Jun-2017 respectively (inappropriate schedule of product administration).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was an actual medication error case due to inappropriate schedule of 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 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.  There will be no information available on the batch number for this case.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Periarthritis, Shoulder injury related to vaccine administration
Clinical narrative: Shoulder injury related to vaccine administration. Developed frozen shoulder within 24 hrs after vaccine administration.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Headache, Immobile, Oedema peripheral
Clinical narrative: I had a swollen, red, hot deltoid the evening of the injection.  It went into my entire arm down into my hand with massive edema, hot to touch, extreme pain , immobility, headache, chills, NO fever, but, the edema which was 70 percent larger than the other arm lasted 5 days.  It started to recede on day 6.  I have startling photos that I would like to send with this report.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: I had a swollen, red, hot deltoid the evening of the injection.  It went into my entire arm down into my hand with massive edema, hot to touch, extreme pain , immobility, headache, chills, NO fever, but, the edema which was 70 percent larger than the other arm lasted 5 days.  It started to recede on day 6.  I have startling photos that I would like to send with this report.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Rash, Rash erythematous
Clinical narrative: Prior to administration of Rabies immunization #2, the donor reported a reaction to her first Rabies immunization, received on 06/07/2020.  Donor noticed "red bumps" (i.e., a rash) on her inner right thigh on 06/08/2020.  the rash was approximately 3" x 3".  Rash resolved on its own by 06/09/2020.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Blood glucose normal, Loss of consciousness, Pallor
Clinical narrative: Patient was given vaccines in office at 2:30pm. After all vaccinations were administered patient became weak and pale in color and passed out. Within one minute of patient passing out he regained consciousness and was speaking. Physician was notified and blood pressure and blood sugar were checked. Blood sugar 95 and Blood pressure 92/48. Water and a cool compress was given. Patient was in the office for 30 minutes and monitored until he regained color and strength and blood pressure returned to normal 92/58. Educated to call or follow up as needed.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Blood pressure increased, Condition aggravated, Dyspnoea
Clinical narrative: MD diagnosed as serum sickness.  She had hives on the inside of legs.  She has prickly sensation on lower extremities, severe pain in lower back, hips, right shoulder, knees and ankles.  Following that, her blood pressure went up extremely high.  She had trouble breathing.  There was an increase in acid reflux.  Due to Covid 19, she didn't realize that they were all related to Shingrix.  She tried Benadryl, amongst other things, and it made it slightly better.  When she went into the cold, all of her side effects were heightened.  She didn't get to the doctor until the first week of May.  She was having trouble all during that time.  When she saw the doctor, she said her breathing was bad, so she was prescribed Prednisone, and the MD gave her a sample of Triamcinolone.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Gastrooesophageal reflux disease, Musculoskeletal pain, Paraesthesia, Serum sickness, Temperature intolerance
Clinical narrative: MD diagnosed as serum sickness.  She had hives on the inside of legs.  She has prickly sensation on lower extremities, severe pain in lower back, hips, right shoulder, knees and ankles.  Following that, her blood pressure went up extremely high.  She had trouble breathing.  There was an increase in acid reflux.  Due to Covid 19, she didn't realize that they were all related to Shingrix.  She tried Benadryl, amongst other things, and it made it slightly better.  When she went into the cold, all of her side effects were heightened.  She didn't get to the doctor until the first week of May.  She was having trouble all during that time.  When she saw the doctor, she said her breathing was bad, so she was prescribed Prednisone, and the MD gave her a sample of Triamcinolone.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: MD diagnosed as serum sickness.  She had hives on the inside of legs.  She has prickly sensation on lower extremities, severe pain in lower back, hips, right shoulder, knees and ankles.  Following that, her blood pressure went up extremely high.  She had trouble breathing.  There was an increase in acid reflux.  Due to Covid 19, she didn't realize that they were all related to Shingrix.  She tried Benadryl, amongst other things, and it made it slightly better.  When she went into the cold, all of her side effects were heightened.  She didn't get to the doctor until the first week of May.  She was having trouble all during that time.  When she saw the doctor, she said her breathing was bad, so she was prescribed Prednisone, and the MD gave her a sample of Triamcinolone.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: She developed rashes on the skinfold of her lower breast. It was also happened on her first Shingrix Vaccine.
Age: 9.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: On 6/11, developed local swelling and redness at injection site. (L deltoid) On 6/13, developed 2 vesicles in the center of swelling and redness at injection site. On 6/15, developed mild scattered erythematous papular lesions on face, trunk, extremities - Lesions not pruritic / itchy or painful On 6/15, ID team was consulted and patient was started on IV Acyclovir 10mg/kg q8hrs - As of 6/17, rash is stable, if not improving
Age: 9.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Liver function test increased, Polymerase chain reaction, Rash papular, Varicella virus test
Clinical narrative: On 6/11, developed local swelling and redness at injection site. (L deltoid) On 6/13, developed 2 vesicles in the center of swelling and redness at injection site. On 6/15, developed mild scattered erythematous papular lesions on face, trunk, extremities - Lesions not pruritic / itchy or painful On 6/15, ID team was consulted and patient was started on IV Acyclovir 10mg/kg q8hrs - As of 6/17, rash is stable, if not improving
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash, Streptococcus test negative
Clinical narrative: Mother reports rash beginning evening after vaccinations administered.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood gases, Blood glucose increased, Diabetic ketoacidosis, Intensive care, Metabolic function test
Clinical narrative: Patient presented to the office on 3/31 with increased respiratory rate and was found to have an elevated blood sugar of 450.  He was diagnosed with diabetic keto acidosis and admitted to the intensive care unit.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Respiratory rate increased
Clinical narrative: Patient presented to the office on 3/31 with increased respiratory rate and was found to have an elevated blood sugar of 450.  He was diagnosed with diabetic keto acidosis and admitted to the intensive care unit.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site reaction, Rash macular
Clinical narrative: Legs are very red and splotchy after her vaccines today  6/17/2020 @ 4:12 PM
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Administration site swelling, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Redness, swelling, tenderness to admin site with low grade fever
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Pelvic pain
Clinical narrative: 6/16/2020, 8:00 PM sore at injection site 6/17/2020, pre-dawn hours  sore at pelvis and knees, headache 6/17/2020, 9:00 AM chills
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Dysstasia, Gait disturbance, Muscular weakness
Clinical narrative: Mom reports that child show signs of muscle weakness, unable to stand up properly, walking with uneven gait, happened about 4x this morning but has resolved
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Computerised tomogram head, Electrocardiogram, Headache, Laboratory test
Clinical narrative: Mother reports on 06/17/2020 around 1240 p.m. she got a call that her daughter was passing out, was pale,  had chills, and had a headache. Daughter was getting her nails done at the time. This was about 2 hours after the vaccine was administered.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness, Pallor, Urine analysis, Vaccination complication
Clinical narrative: Mother reports on 06/17/2020 around 1240 p.m. she got a call that her daughter was passing out, was pale,  had chills, and had a headache. Daughter was getting her nails done at the time. This was about 2 hours after the vaccine was administered.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Lethargy, Myalgia, Pyrexia
Clinical narrative: shivering, muscle aches, skin sensitivity, mild fever (99.3F), lethargy, pain at injection site. Resolved in 24 hrs.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensitive skin
Clinical narrative: shivering, muscle aches, skin sensitivity, mild fever (99.3F), lethargy, pain at injection site. Resolved in 24 hrs.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Pruritus, Skin warm
Clinical narrative: Patient's face is red and warm, actually looks like Shingles. She said is a little painful and itchy too.
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Intussusception, Irritability, Ultrasound abdomen abnormal
Clinical narrative: Patient presented with increased fussiness and episode of blood in stool, found on ultrasound to have intussusception
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Crying, Pyrexia, Screaming
Clinical narrative: About 1.5 hours after my child's PCV vaccination he was inconsolably crying/screaming  for 8+ hours.  He developed a fever of 101.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Inflammation, Pyrexia, Rash
Clinical narrative: Fever appeared 6 days after vaccination, starting with extremely low grade and eventually reaching 101.5 degrees F after two days.  Fever broke after 3 days.  Then rash appeared on torso, followed by rash on limbs and face.  Rash lasted 5 days.  Also diarrhea for 24 hours after the fever broke while rash was inflamed.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Chills and shivering Jun 10, 1:00 and 14:00  Headache Jun 10, 9:00
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Irritability, Mucous stools
Clinical narrative: gross blood and mucous in stool, fussiness beginning afternoon after receiving vaccines. No treatment Self-Resolved after 72 hrs.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Blepharospasm, Snoring, Syncope, Unresponsive to stimuli
Clinical narrative: In kitchen with Dad suddenly collapsed to the ground making a snoring noise. Not responsive for 10 minutes. Eyes twitching no other body movements. Body no stiff. No warm. Taken to ED by Ambulance. Observed in ED overnight.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Asthenia, Confusional state, Coordination abnormal, Pain
Clinical narrative: Pharmacy administered 2nd dose Shingrix patient 24 hrs Later developed severe whole Body aches, weakness, aphasia, discoordingaiton - Entire episode Lasted 7 days.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood pressure decreased, Dysphagia, Hyperventilation, Pallor, Skin burning sensation
Clinical narrative: Received MCV4 + MenB. About 1-2 hours later had "burning under his skin", difficulty swallowing, + Hyperventilating. Went to Urgent Care - gave Benadryl 25 mg - seemed better but about 1 hr later became pale + BP dropped - ER BP in ER 86/56. Given IV fluids, Pepcid, decadron + IV Benadryl A few hours later he felt better and was discharged home
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site reaction, Pruritus, Rash macular, Tenderness
Clinical narrative: Blotchy, redness @ site of injection that spread to larger area on arm above elbow. Mild itching and soreness with pressure.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Deafness neurosensory, Herpes zoster, Oral disorder
Clinical narrative: bilateral, intermittent tinnitus/tinnitus of both ears; Sensorineural hearing loss; hearing  loss; oral lesion on each side of the buccal mucosa and tongue; the time of her injection she developed a rash on the right posterior shoulder; This case was reported by a lawyer and described the occurrence of tinnitus in a patient who received Herpes zoster (Shingrix) for shingle.   The initial information was received on 12 June 2020 via medical records (case now medically confirmed). As per medical on dated 02 May 2019, the patient had blistery type rash in patches on back with some scabbing and also healing papular rash In the front of her chest on the right) noted. The patient complaint a sore on her back for about 1 week. The patient states area burns and hurts. The patient was positive for rash (on back). The assessment was Herpes zoster without complication. As per medical on dated 15 July 2019, the patient stated she had an episode of shingles back in May on her back and was treated with Valtrex at the emergency center. She did complete the new shingles vaccine. As per medical on dated 06 February 2020, The patient diagnosis included tinnitus of both ears and Sensorineural hearing loss (SNHL) of both ears. The patient had hearing loss. In 2018 the patient was seen by physician for acute sialadenitis. The patient presented for evaluation of tinnitus. She had this for the past 10 months following her last shingle vaccine (Shingrix) one day after the injection. She then also developed some oral lesion on each side of the buccal mucosa and tongue. At the time of her injection she developed a rash on the right posterior shoulder. The tinnitus was bilateral and was intermittent, the sound changes from high pitched to a pumping noise and was not pulsatile.; Reporter's Comments: .
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash papular, Rash vesicular, Scab
Clinical narrative: bilateral, intermittent tinnitus/tinnitus of both ears; Sensorineural hearing loss; hearing  loss; oral lesion on each side of the buccal mucosa and tongue; the time of her injection she developed a rash on the right posterior shoulder; This case was reported by a lawyer and described the occurrence of tinnitus in a patient who received Herpes zoster (Shingrix) for shingle.   The initial information was received on 12 June 2020 via medical records (case now medically confirmed). As per medical on dated 02 May 2019, the patient had blistery type rash in patches on back with some scabbing and also healing papular rash In the front of her chest on the right) noted. The patient complaint a sore on her back for about 1 week. The patient states area burns and hurts. The patient was positive for rash (on back). The assessment was Herpes zoster without complication. As per medical on dated 15 July 2019, the patient stated she had an episode of shingles back in May on her back and was treated with Valtrex at the emergency center. She did complete the new shingles vaccine. As per medical on dated 06 February 2020, The patient diagnosis included tinnitus of both ears and Sensorineural hearing loss (SNHL) of both ears. The patient had hearing loss. In 2018 the patient was seen by physician for acute sialadenitis. The patient presented for evaluation of tinnitus. She had this for the past 10 months following her last shingle vaccine (Shingrix) one day after the injection. She then also developed some oral lesion on each side of the buccal mucosa and tongue. At the time of her injection she developed a rash on the right posterior shoulder. The tinnitus was bilateral and was intermittent, the sound changes from high pitched to a pumping noise and was not pulsatile.; Reporter's Comments: .
Sex: F
Vaccine: VARZOS
Symptoms: Sialoadenitis, Skin ulcer, Tinnitus
Clinical narrative: bilateral, intermittent tinnitus/tinnitus of both ears; Sensorineural hearing loss; hearing  loss; oral lesion on each side of the buccal mucosa and tongue; the time of her injection she developed a rash on the right posterior shoulder; This case was reported by a lawyer and described the occurrence of tinnitus in a patient who received Herpes zoster (Shingrix) for shingle.   The initial information was received on 12 June 2020 via medical records (case now medically confirmed). As per medical on dated 02 May 2019, the patient had blistery type rash in patches on back with some scabbing and also healing papular rash In the front of her chest on the right) noted. The patient complaint a sore on her back for about 1 week. The patient states area burns and hurts. The patient was positive for rash (on back). The assessment was Herpes zoster without complication. As per medical on dated 15 July 2019, the patient stated she had an episode of shingles back in May on her back and was treated with Valtrex at the emergency center. She did complete the new shingles vaccine. As per medical on dated 06 February 2020, The patient diagnosis included tinnitus of both ears and Sensorineural hearing loss (SNHL) of both ears. The patient had hearing loss. In 2018 the patient was seen by physician for acute sialadenitis. The patient presented for evaluation of tinnitus. She had this for the past 10 months following her last shingle vaccine (Shingrix) one day after the injection. She then also developed some oral lesion on each side of the buccal mucosa and tongue. At the time of her injection she developed a rash on the right posterior shoulder. The tinnitus was bilateral and was intermittent, the sound changes from high pitched to a pumping noise and was not pulsatile.; Reporter's Comments: .
Age: 75.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Erythema, Pain
Clinical narrative: the area started itching; redness around the injection covering 3 inches of area; also associated with swelling; warmth to touch; her arm started aching; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of erythema (Refer case id US2020AMR097280).   On 5th June 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 5th June 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 6th June 2020, the patient experienced injection site erythema, injection site swelling and injection site warmth. On 7th June 2020, the patient experienced injection site itching. On an unknown date, the outcome of the pain in arm, injection site swelling and injection site warmth were recovering/resolving and the outcome of the injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site erythema, injection site swelling, injection site warmth and injection site itching to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine and started aching arm and it increased next day covering upper middle part of the arm..  Next day after vaccination she noticed redness around the injection covering 3 inches of area. Redness was also associated with swelling and warmth to touch.  The redness was still present like it was. The swelling and warm to touch has decreased but it was still present. Two days after receiving vaccination, the area started itching, and it was still present. Consented to follow up. This case has been linked with case US2020AMR097280, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR097280:same patient
Age: 75.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: the area started itching; redness around the injection covering 3 inches of area; also associated with swelling; warmth to touch; her arm started aching; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of erythema (Refer case id US2020AMR097280).   On 5th June 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 5th June 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 6th June 2020, the patient experienced injection site erythema, injection site swelling and injection site warmth. On 7th June 2020, the patient experienced injection site itching. On an unknown date, the outcome of the pain in arm, injection site swelling and injection site warmth were recovering/resolving and the outcome of the injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site erythema, injection site swelling, injection site warmth and injection site itching to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine and started aching arm and it increased next day covering upper middle part of the arm..  Next day after vaccination she noticed redness around the injection covering 3 inches of area. Redness was also associated with swelling and warmth to touch.  The redness was still present like it was. The swelling and warm to touch has decreased but it was still present. Two days after receiving vaccination, the area started itching, and it was still present. Consented to follow up. This case has been linked with case US2020AMR097280, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR097280:same patient
Age: 0.58
Sex: M
Vaccine: IPV
Symptoms: Disorientation, Glassy eyes, Irritability, Ocular hyperaemia, Pyrexia
Clinical narrative: My son received the IPOL vaccine on 6/3/20.  In less than 24 hours after the vaccine was administered he developed red blotchy hives on his chest, sides, under arms, back, and chin.  He had a fever of 102.  For the next few days he wasn't himself.  He was very irritable, glassy/red eyes (he looked high/disoriented) and slightly warm.  On 6/7 he developed a rash on his back, belly, and neck.
Age: 0.58
Sex: M
Vaccine: IPV
Symptoms: Rash, Rash macular, Skin warm, Urticaria
Clinical narrative: My son received the IPOL vaccine on 6/3/20.  In less than 24 hours after the vaccine was administered he developed red blotchy hives on his chest, sides, under arms, back, and chin.  He had a fever of 102.  For the next few days he wasn't himself.  He was very irritable, glassy/red eyes (he looked high/disoriented) and slightly warm.  On 6/7 he developed a rash on his back, belly, and neck.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: shingles rash that caused severe pain; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. In or around December of 2007, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. In or around December of 2009, the pt was diagnosed with Shingles, which lasted several weeks and caused severe pain; the shingles rash continued to occur approximately every six months. As a direct and proximate result of the company's defective zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the company's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Outcome of the event was not provided and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered rash to be a disabling event
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms.; on 6/12/2020 a patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drug, concurrent conditions and previous drug reactions or allergies were not reported.      On 12-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, subcutaneously administered, lot number S031496, which has been verified to be a valid one, and expiration date reported and validated as 07-OCT-2021 (dosage schedule and frequency were not reported) as prophylaxis (product storage error). The vaccine was reconstitued with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot number reported and validated as T000494, expiration date on 06-JUL-2022). It was exposed to a temperature between 6 degrees Fahrenheit (F) to 14 degrees F for a timeframe of 15 minutes and another one between 15 degrees F to 46 degrees F for a timeframe of 29 hours and 15 minutes. There was no previous temperature excursion. Digital data logger was involved. The patient experienced no symptoms (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer concerning a patient of unknown age and gender.  The patient's concurrent conditions and medical history were not provided.  On or about 19-DEC-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (Lot #, dose and route were not provided) for the long-term prevention of shingles and zoster-related conditions.   On an unknown date, ("reported as subsequent to patient's zoster vaccine live (ZOSTAVAX) vaccination"), the patient was treated at local hospital for shingles and was hospitalized.  It was reported that as a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; Rotateq with an expiration date of 6/2/2020 was administered to the patient on 6/15/2020; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not reported.  On 15-JUN-2020, the patient received expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered orally, lot number R025116, expiration date 02-JUN-2020 (expired product administered) (strength, dose, and frequency were not reported). No adverse effects were reported.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site swelling, Skin reaction
Clinical narrative: Developed localized skin reaction - redness and swelling noted approximately 4x3in in size on right  deltoid.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Left arm pain and swelling at injection site (immediate, lasting 7 days) Fatigue, aches (whole body), chills, headaches, (starting 5 hours later, lasting 8 days) Sore throat and some nasal congestion (48 hours later, lasting 6 days) Low fever 99.5 - 100.7 (96 hrs later, lasting 4 days)
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Left arm pain and swelling at injection site (immediate, lasting 7 days) Fatigue, aches (whole body), chills, headaches, (starting 5 hours later, lasting 8 days) Sore throat and some nasal congestion (48 hours later, lasting 6 days) Low fever 99.5 - 100.7 (96 hrs later, lasting 4 days)
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Left arm pain and swelling at injection site (immediate, lasting 7 days) Fatigue, aches (whole body), chills, headaches, (starting 5 hours later, lasting 8 days) Sore throat and some nasal congestion (48 hours later, lasting 6 days) Low fever 99.5 - 100.7 (96 hrs later, lasting 4 days)
Age: 1.58
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: broke out in hives all over. head to toe. with severe itching and fever. mom gave benadryl ( diphenhydramine) 2.5ml x 2 doses and tylenol (acetaminophen) 5ml x 1 dose
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: About 2 hours after I received the vaccination, I noticed that my shoulder was extremely stiff and painful. I could not raise my arm without severe pain. There was swelling and redness from my shoulder to my elbow. My left arm is about twice its normal size and very hot to the touch.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling, Skin warm
Clinical narrative: About 2 hours after I received the vaccination, I noticed that my shoulder was extremely stiff and painful. I could not raise my arm without severe pain. There was swelling and redness from my shoulder to my elbow. My left arm is about twice its normal size and very hot to the touch.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Activated partial thromboplastin time, C-reactive protein increased, Erythema multiforme, Full blood count, Hypoxia
Clinical narrative: BEGAN 6/10/20 EVENING WITH HIVES. NEXT MORNING STARTED ON BENADRYL AND ZYRTEC. RASH PROGRESSED, DIAGNOSED WITH ERYTHEMA MULTIFORME ON 6/12/20. HOSPITALIZED 6/12/20 FOR HYPOXIA, FEVER AND RASH.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Prothrombin time, Pyrexia, Rash, SARS-CoV-2 test negative, Urticaria
Clinical narrative: BEGAN 6/10/20 EVENING WITH HIVES. NEXT MORNING STARTED ON BENADRYL AND ZYRTEC. RASH PROGRESSED, DIAGNOSED WITH ERYTHEMA MULTIFORME ON 6/12/20. HOSPITALIZED 6/12/20 FOR HYPOXIA, FEVER AND RASH.
Age: 1.17
Sex: M
Vaccine: UNK
Symptoms: Injection site swelling, Pyrexia, Vomiting
Clinical narrative: He got shots in both legs(2) one leg is swollen. He was running fever last night . Also throwing up.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, MNQ, PNC13, RV5
Symptoms: Wrong product administered
Clinical narrative: Pt came in for 2 month Well Child visit.  2month immunizations were given. As MA was putting in vaccines into our computer to she realized that Menveo was given instead of HIB vaccine.  Provider called the pts mother and explained what had happened.  It was recommended by the provider for the patient to come back in 1 week for HIB vaccine to stay on track.  Mother understood all of this.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash to chest, abdomen, and forearms noted yesterday. Client stopped in the office this morning to show staff. She is going to see healthcare provider today.
Age: 1.17
Sex: F
Vaccine: MMR
Symptoms: Measles post vaccine, Rash
Clinical narrative: Measles rash, non-contagious  no treatment required
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Musculoskeletal pain, Pain, Paraesthesia, Somnolence
Clinical narrative: PATIENT RECEIVED DOSE #2 SHINGRIX THE EVENING OF 6/17/20.  LATER THAT EVENING THE PATIENT REPORTED HAVING DINNER AND THEN FEELING SO TIRED THAT HE WENT TO SLEEP FOR 3 HOURS.  THE PATIENT DEVELOPED BODY ACHES IN THE MORNING (6/18) BUT STILL REPORTED TO WORK.  HIS TEMPERATURE WAS TAKEN AT WORK AND HE WAS AFEBRILE.   HE REPORTS SHOULDER SORENESS AND A TINGLING SENSATION IN HIS HANDS.  HE STATED THAT HE HAS HAD "STRANGE" REACTIONS TO VACCINES AND MEDICATIONS (IBUPROFEN) IN THE PAST.  PATIENT CONCERNED THAT THESE SYMPTOMS COULD BE COVID RELATED BUT DOES NOT REPORT ANY OTHER SYMPTOMS ASSOCIATE WITH COVID.  ON 6/18/20 AT 10:30 AM WHEN THE PATIENT CALLED THE PHARMACY TO REPORT THIS ADVERSE EVENT, HIS FATIGUE AND BODY ACHES HAD SIGNIFICANTLY SUBSIDED, BUT NOT COMPLETELY.  WILL FOLLOWUP WITH PATIENT VIA PHONE CALL TOMORROW 6/19/20.
Age: 5.0
Sex: U
Vaccine: HEPA
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives on legs, started at injection site.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: received a dose of ROTATEQ following temperature excursions; no other adverse effects; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. No concurrent condition, medical history or concomitant therapy was reported.   On an unknown date, the patient was vaccinated with a 2 ml dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R033256 with expiration date of 23-JUN-2020; strength and route were not reported) following temperature excursions (product storage error), for prophylaxis. The vaccines were exposed to the highest temperature of above 47 degrees Fahrenheit (F)/ 9 degrees Celsius (C) (8.5 C) for 30 minutes. Previous temperature excursion included highest temperature above 47 F/9C (12.1 C) for 42 hours, above 47 F/9C (8.5 C) for 1 hour and above 47 F/9C (8.7 C) for 30 minutes. A data logger was involved. No other adverse effects were reported.
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; the patient was administered an improperly stored dose of VAQTA; This initial spontaneous report was received from a registered nurse and 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 one patient and one combination product.  On 22-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # S032055, expiration date: 09-NOV-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. The administered vaccine experienced a temperature excursion of 12.1 degrees Celsius for 16 hours and 11 minutes. The digital data logger was involved in regards the temperature excursion details. No previous temperature excursion had occurred. No additional adverse event information was provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032055; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; the patient was administered an improperly stored dose of VAQTA; This initial spontaneous report was received from a registered nurse and 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 one patient and one combination product.  On 26-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # S032055, expiration date: 09-NOV-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. The administered vaccine experienced a temperature excursion of 12.1 degrees Celsius for 16 hours and 11 minutes. The digital data logger was involved in regards the temperature excursion details. No previous temperature excursion had occurred. No additional adverse event information was provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S032055; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; the patient was administered an improperly stored dose of VAQTA; This initial spontaneous report was received from a registered nurse and 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 one patient and one combination product.  On 22-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # S020241, expiration date: 23-AUG-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. The administered vaccine experienced a temperature excursion of 12.1 degrees Celsius for 16 hours and 11 minutes. The digital data logger was involved in regards the temperature excursion details. No previous temperature excursion had occurred. No additional adverse event information was provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S020241; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or additional adverse effects reported; Patient received unspecified dose in VAQTA immunization series that was improperly stored; This spontaneous report was received from a medical assistant referring to a 2 years old patient of unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 11-JUN-2020, the patient was vaccinated with an unspecified dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S030587 with expiration date 06-JAN-2021, dose detail and route were not reported) for prophylaxis.        The vaccine experienced improperly stored and was stored at 50 Fahrenheit degrees (F) for 34 minutes. There was no previous temperature excursion. The call was because of a data logger involved. No symptoms or additional adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; one patient was administered improperly stored PROQUAD; Information has been received from a vaccine coordinator in charge of vaccine storage referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 11-JUN-2020, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) (strength, dose detail, anatomical location and route of administration were not reported) (lot # S030214, expiration date 25-MAR-2021) for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) was reconstituted with properly stored sterile diluent (lot S038697, expiration date 10-AUG-2022).  The administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced a temperature excursion of 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (14 degrees Fahrenheit) for 20 minutes and from 15 degrees Fahrenheit to 46 degrees Fahrenheit (18 degrees Fahrenheit) for 20 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; patient was administered an improperly stored MMR II; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 11-JUN-2020, the patient was vaccinated with dose of improperly stored measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (rHA)subcutaneous injection, lot# S020161, expiration date 30-JUN-2021 (strength, dose and route of administration were not reported) reconstituted in properly stored sterile diluent, for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion above 47 Fahrenheit degrees (F) (53 F) for 1 hour 30 minutes. There was no previous temperature excursion. The call was not due to digital data logger. No additional adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Adolescent dose administered to adult; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) for prophylaxis.       On 2004 the patient experienced product use issue.    The outcome of product use issue is unknown.