chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Haematuria, Hyperoxaluria, Injection site reaction, Local reaction
Clinical narrative: Information has been received from an unspecified reporter via company responsive referring to a 53 year old male patient. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On an unknown date about one year ago in 2018, the patient was vaccinated with PNEUMOVAX 23 (dose, strength, route, batch/lot number and expiration date were not provided) for prophylaxis. On an unknown date within 48 hours of receiving PNEUMOVAX 23 in 2018, the patient developed large local injection site reaction, red streaking followed by hematuria and oxalate crystalluria/ kidney stones. The outcome of all the events was unknown.The reporter considered large local injection site reaction to be related to the suspect vaccine. The causality assessments regarding other events were not reported by the reporter. Upon internal review, kidney stones was determined to be medically significant.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Nephrolithiasis
Clinical narrative: Information has been received from an unspecified reporter via company responsive referring to a 53 year old male patient. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On an unknown date about one year ago in 2018, the patient was vaccinated with PNEUMOVAX 23 (dose, strength, route, batch/lot number and expiration date were not provided) for prophylaxis. On an unknown date within 48 hours of receiving PNEUMOVAX 23 in 2018, the patient developed large local injection site reaction, red streaking followed by hematuria and oxalate crystalluria/ kidney stones. The outcome of all the events was unknown.The reporter considered large local injection site reaction to be related to the suspect vaccine. The causality assessments regarding other events were not reported by the reporter. Upon internal review, kidney stones was determined to be medically significant.
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Immune thrombocytopenic purpura, Platelet count
Clinical narrative: Child who recently immigrated, living elsewhere and visiting here for holiday. Received MMR vaccine 4-6 weeks ago, developed ITP.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lethargy, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Severe sore throat, lethargy, body aches, headache, some nausea - symptoms are now abating.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: erythema, edema, itching, warmth to the injection site lasting 6 days
Age: 1.17
Sex: M
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Central nervous system lesion, Communication disorder, Crying, Generalised erythema
Clinical narrative: On 7/10/16, patient developed a fever. He began to cry inconsolably for days on end, to the point of vomiting. 7/11/16 he was seen by the Clinic. It was noted that on 7/1/16 that Varicella had been given, despite me saying numerous times he had received multiple vaccines. He presented with fever, rash, vomiting, (viral) upper resp infection. Dr stated that this was viral exanthem, despite my objections that this was a reaction. (Dr even noted that I agreed with findings. That is a false statement.) On 7/13/16, he was seen again, and erythematous papules were noted on entire body, still fever, disrupted sleep, etc. By 12/1/16, patient had regressed in speech and motor skills. It was noted that he had speech delay, behavioral changes, loss of communication, and he was referred for autism diagnosis. On 10/11/17, patient was again seen by the clinic. Fever, rash, etc. Told it was an URI. On 10/12/17, he was dx with chickenpox. 3/6/18 noted MRI showed lesion on brain.
Age: 1.17
Sex: M
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Papule, Psychomotor skills impaired, Pyrexia, Rash
Clinical narrative: On 7/10/16, patient developed a fever. He began to cry inconsolably for days on end, to the point of vomiting. 7/11/16 he was seen by the Clinic. It was noted that on 7/1/16 that Varicella had been given, despite me saying numerous times he had received multiple vaccines. He presented with fever, rash, vomiting, (viral) upper resp infection. Dr stated that this was viral exanthem, despite my objections that this was a reaction. (Dr even noted that I agreed with findings. That is a false statement.) On 7/13/16, he was seen again, and erythematous papules were noted on entire body, still fever, disrupted sleep, etc. By 12/1/16, patient had regressed in speech and motor skills. It was noted that he had speech delay, behavioral changes, loss of communication, and he was referred for autism diagnosis. On 10/11/17, patient was again seen by the clinic. Fever, rash, etc. Told it was an URI. On 10/12/17, he was dx with chickenpox. 3/6/18 noted MRI showed lesion on brain.
Age: 1.17
Sex: M
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Regressive behaviour, Sleep disorder, Speech disorder developmental, Streptococcus test negative
Clinical narrative: On 7/10/16, patient developed a fever. He began to cry inconsolably for days on end, to the point of vomiting. 7/11/16 he was seen by the Clinic. It was noted that on 7/1/16 that Varicella had been given, despite me saying numerous times he had received multiple vaccines. He presented with fever, rash, vomiting, (viral) upper resp infection. Dr stated that this was viral exanthem, despite my objections that this was a reaction. (Dr even noted that I agreed with findings. That is a false statement.) On 7/13/16, he was seen again, and erythematous papules were noted on entire body, still fever, disrupted sleep, etc. By 12/1/16, patient had regressed in speech and motor skills. It was noted that he had speech delay, behavioral changes, loss of communication, and he was referred for autism diagnosis. On 10/11/17, patient was again seen by the clinic. Fever, rash, etc. Told it was an URI. On 10/12/17, he was dx with chickenpox. 3/6/18 noted MRI showed lesion on brain.
Age: 1.17
Sex: M
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Upper respiratory tract infection, Varicella post vaccine, Viral rash, Vomiting
Clinical narrative: On 7/10/16, patient developed a fever. He began to cry inconsolably for days on end, to the point of vomiting. 7/11/16 he was seen by the Clinic. It was noted that on 7/1/16 that Varicella had been given, despite me saying numerous times he had received multiple vaccines. He presented with fever, rash, vomiting, (viral) upper resp infection. Dr stated that this was viral exanthem, despite my objections that this was a reaction. (Dr even noted that I agreed with findings. That is a false statement.) On 7/13/16, he was seen again, and erythematous papules were noted on entire body, still fever, disrupted sleep, etc. By 12/1/16, patient had regressed in speech and motor skills. It was noted that he had speech delay, behavioral changes, loss of communication, and he was referred for autism diagnosis. On 10/11/17, patient was again seen by the clinic. Fever, rash, etc. Told it was an URI. On 10/12/17, he was dx with chickenpox. 3/6/18 noted MRI showed lesion on brain.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: Based on readings of my smart watch, my heart rate bpm was almost double the normal value for 2 days after the injection. Normal for me in the average resting range is 60-75 bpm (based on over 2 years of daily readings) and after the injection, the rate was 77-101 the first day after injection and 67-99 the 2nd day after injection and is still higher than normal today, the 3rd day after. Is this something to be expected? It is not noted in the adverse reactions information provided with the injection, nor could I find any info about this via a web search.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored (6.7F for 46 hours) VARIVAX was administered to the patient; No adverse effects; improperly stored (6.7F for 46 hours) VARIVAX was administered to the patient; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided. Concomitant therapy included sterile diluent.  On 16-OCT-2018, improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number N031002, expiration date 03-NOV-2019; strength, dose and frequency were not reported) was subcutaneously vaccinated to the patient for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot and expiration date unknown by the reporter). No adverse effects reported for the patient. The vaccine was store at temperature maximum of 6.7 F and the time frame was 46 hours, which was detected by a data logger. There is no previous temperature excursion.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005815:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored (6.7F for 46 hours) PROQUAD was administered to the patient; No adverse effects; improperly stored (6.7F for 46 hours) PROQUAD was administered to the patient; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided. Concomitant therapy included sterile diluent.  On 24-OCT-2018, improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number R001540, expiration date 15-JUL-2019; strength, dose and frequency were not reported) was subcutaneously vaccinated to the patient for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot and expiration date unknown by the reporter). No adverse effects reported for the patient. The vaccine was store at temperature maximum of 6.7 F and the time frame was 46 hours which were detected by a data logger. There is no previous temperature excursion.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005465:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received from a lawyer on 19-APR-2019 regarding a case in litigation concerning a female (age and medical history not provided). In or around 30-SEP-2016 the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles. Four days after receiving the vaccine the patient suffered from a painful rash on left arm and was diagnosed with herpes zoster. As a direct and proximate result of ZOSTAVAX the patient symptoms have resulted in physical imitations not present prior to using the vaccine. The patient also experience mental and emotional distress due to resulting physical limitations and seriousness of condition. The patient has suffered severe and permanent personal injuries and 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. The patient suffered and incurred damages including medical expenses, the loss of accumulations and other economic and other economic damages. Herpes zoster was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from social media, refers to an unspecified group of young female patients (reported as young girls). The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, frequency, route of administration, expiry date and lot # were not specified) for prophylaxis. It was reported in the social media report that dangerous bills were being processed, not only to mandate this lethal injection but to allow minors to receive it without parental consent. This vaccine was presented under the guise of prophylactic treatment to prevent STDs. GARDASIL was given to millions of young girls in more than 52 countries around the world. On unknown dates, GARDASIL had caused unfathomable suffering, loss of life (death) and unspecified injuries in the unspecified number of girls. Cause of death was not reported. It was unknown if autopsy was performed. Outcome of the events unfathomable suffering and unspecified injuries were not reported. Causality of the events were not reported. This is one of the several reports.; Reported Cause(s) of Death: loss of life (death).
Age: 1.17
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever to 102 on day of vaccines. Fever lasted approx. 72 hours
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Immunology test, Mycoplasma test, Pyrexia, Streptococcus test, Urticaria
Clinical narrative: Patient ran a fever immediately after vaccines, then broke out into a hives type rash 3 days later.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Antinuclear antibody, Arthralgia, Double stranded DNA antibody, Erythema, Full blood count normal
Clinical narrative: Patient complained of ankle swelling and redness the night of receiving HPV vaccine. Overnight, progressed to pain, redness, and swelling of knees bilaterally.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Joint swelling, Metabolic function test normal, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Patient complained of ankle swelling and redness the night of receiving HPV vaccine. Overnight, progressed to pain, redness, and swelling of knees bilaterally.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 3 inch area of redness at injection site on left leg. No fever or discomfort
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Induration, Rash, Swelling
Clinical narrative: Rash after administration  Next day red, hardened area, swollen
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cyanosis, Irritability, Nasal congestion, Peripheral coldness, Pyrexia
Clinical narrative: Fussiness, nasal congestion, rhinorrhea started evening of 4/24/19. Fever & developing rash started 4/25/19. Cyanosis & coolness of feet noted last night.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Rhinorrhoea
Clinical narrative: Fussiness, nasal congestion, rhinorrhea started evening of 4/24/19. Fever & developing rash started 4/25/19. Cyanosis & coolness of feet noted last night.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis of left upper extremity started within 24 hours of receiving vaccine. Patient was seen by Dr  and prescribed cephalexin 500 mg by mouth three times daily for 10 days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Terrible fever, body aches, muscle and joint aches, nausea.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Bone pain, Chills, Confusional state, Dizziness
Clinical narrative: Dizzy, trouble walking, stomach pain, nausea, 100.9  fever for 8 hours, confusion, bones all paining in back, chills.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Nausea, Pyrexia
Clinical narrative: Dizzy, trouble walking, stomach pain, nausea, 100.9  fever for 8 hours, confusion, bones all paining in back, chills.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunisation, Syringe issue, Underdose
Clinical narrative: Vaccine came out the sides of the syringe and amount of vaccine given was unknown. She was re vaccinated with another full dose in the right arm. She was told to watch out for side affects and to call the pharmacy if she has side affects, feels lethargic or has a fever for more than 24 hours after the vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Injection occured without incident per patient. Pain at injection site became a 7 out of 10 and lymph node became very swollen and was reported as a pain of 4 out of 10 the starting the next day (Wed 04-24-19). Patient reported normal range of motion of the arm with pain, extremely large and swollen lymph node in armpit (visibly enlarged), no fever, no tingling or numbness in arm or fingers, no redness at injection site or anywhere on arm/armpit, and no heat to injection site/lymph node. Patient took an ibuprofen but didn't get much relief and had appt with MD on 4-25-19 to check on reaction. Per patient account to pharmacy, MD was concerned with size of lymph node but wanted to wait to see if it would go down over next 2 weeks or develop heat to site/fever, redness, or continue to enlarge. If the reaction got worse would do a scan to help determine cause. MD was hoping reaction would decrease over next 1-2 weeks per patient. Patient was going to continue ibuprofen to help with swelling/pain. Patient's pain at injection site was decreased slightly 48 hours post injection with lymph node pain still had no change.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Urticaria, Vomiting
Clinical narrative: pt developed hives, vomited once.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Within hours of injection I felt significant muscle and joint soreness throughout my body. Fatigue as well. These side effects were not as prevalent after the first vaccination a couple of months ago. I am a fit and active 59 1/2 year old man.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; patient was inadvertently administered one expired dose of MMR II; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history or concurrent conditions.  On 22-APR-2019, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) 1 dose, subcutaneous, for prophylaxis (lot # N009168 with expiration date on 20-MAR-2019) (expired product administered). The vaccine was reconstituted with properly stored MRK sterile diluent (lot # R034106 with expiration date on 22-JUN-2021). No adverse effects were reported. At the moment of this report the outcome of patient was inadvertently administered one expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 85-year-old female patient who received SHINGRIX (batch number BF4J5, expiry date 5th July 2021) for prophylaxis. Concurrent medical conditions included chronic lymphocytic leukemia and shingles. On 2nd April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2019, 7 days after receiving SHINGRIX, the patient experienced shingles, swelling arm, erythema of extremities and pain in arm. The patient was treated with antivirals for systemic use. On an unknown date, the outcome of the shingles was unknown and the outcome of the swelling arm and pain in arm were recovering/resolving and the outcome of the erythema of extremities was not recovered/not resolved. It was unknown if the reporter considered the shingles, swelling arm, erythema of extremities and pain in arm to be related to SHINGRIX. Additional details were provided as follows: Less than a week after vaccination, the patient experienced swollen arm that was red and painful. The patient's arm had improved but was still red at the time of reporting. The patient also reported that about one week later she developed a shingles outbreak that was diagnosed by her dermatologist and treated with prescription antiviral. The reporter gave consent to follow up. The batch number of SHINGRIX was reported as BF4JB. However, based on a safety lot number review, the batch number was updated to BF4J5.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, muscle aches, malaise, sore arm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Patient had shot in Morning and by that Night she had Headache, Muscle aches, fever and shivering. Was in bed till 3 pm the next day when she started feeling better.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Anxiety, Blood glucose normal, Oxygen therapy, Urticaria, Vomiting
Clinical narrative: 4yo male received PROQUAD and KINRIX in clinic at approx 16:40. At around 16:45, patient was noted to be anxious and started vomiting. Patient brought back to exam room at 16:55 when hives were noted on face. Vitals (BP 90/61, HR 165, SpO2 on room air 82%). Supplemental O2 started via mask-- >3L and SpO2 at 98%. Wheezing on exam in mid lung fields Hives on face and arms Epinephrine 0.15 mg IM and Benadryl 20 mg IM administered at 17:06 and patient transported to ED via EMS at 17:20. In ED patient was given prednisoLONE 15 mg/5 mL oral syrup (Order): 21 mg, PO, ONE TIME and Pepcid pediatric (Order): 11 mg, IVPush, ONE TIME. Admitted overnight to general pediatric floor for observation and had no recurrence of symptoms. Discharged 4/25/2019.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Wheezing
Clinical narrative: 4yo male received PROQUAD and KINRIX in clinic at approx 16:40. At around 16:45, patient was noted to be anxious and started vomiting. Patient brought back to exam room at 16:55 when hives were noted on face. Vitals (BP 90/61, HR 165, SpO2 on room air 82%). Supplemental O2 started via mask-- >3L and SpO2 at 98%. Wheezing on exam in mid lung fields Hives on face and arms Epinephrine 0.15 mg IM and Benadryl 20 mg IM administered at 17:06 and patient transported to ED via EMS at 17:20. In ED patient was given prednisoLONE 15 mg/5 mL oral syrup (Order): 21 mg, PO, ONE TIME and Pepcid pediatric (Order): 11 mg, IVPush, ONE TIME. Admitted overnight to general pediatric floor for observation and had no recurrence of symptoms. Discharged 4/25/2019.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient given combo vaccine Pentacel. Patient is to young for Pentacel due to Polio vaccine being in the combo.  Spoke to mother, 4/25/2019 who states baby seems fine
Age: 1.92
Sex: F
Vaccine: UNK
Symptoms: Blood test abnormal, Diarrhoea, Measles post vaccine, Morbillivirus test positive, Parainfluenzae virus infection
Clinical narrative: High Fever for 9 days, rash started small and began to cover her whole body after 1st, 3days of fever.Runny nose, throwing up, diarrhea.
Age: 1.92
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Rash generalised, Rhinorrhoea, Viral test positive, Vomiting
Clinical narrative: High Fever for 9 days, rash started small and began to cover her whole body after 1st, 3days of fever.Runny nose, throwing up, diarrhea.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a adult female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, however the patient was in between the age of 50 and 60. The patient developed cellulitis after receiving SHINGRIX. The sales representative was unable to provide initials or ages for the patient. The sales representative could not provide the date the event occurred or the date of vaccination or if 1st or 2nd dose. This is 1 of the 2 cases reported by the same reporter. The batch number reported for INFANRIX (465HX) did not exist and was updated to 4G5HX, as per sales database.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus, Swelling of eyelid
Clinical narrative: Late on evening of 4/19/19 developed swelling of L arm. Markedly worse on 4/20/19 with itching and erythema continued spreading down upper arm through 4/22/19 when seen in the office. No fevers (Tmax 100F). Left upper eyelid swelling only on 4/20/19, then resolved.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: erythema with demarcation, warmth, firm, tenderness to Left deltoid. Generalized fever. Refused IM steroids but will use topical Triam cream.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Mobility decreased, Myalgia, Tremor
Clinical narrative: Pt complained of these reactions after receiving SHINGRIX and visited his MD. Muscle pain, weakness, can't lift arm. Shaking arm stated about 4/13/19, TYLENOL is improving, MD provided Prednisone 4/18/19. Still recovering as of 4/24/19.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Arm became so sore, could not lift above my head - fever from night of shot, thru all next day, and night highest 99.8, - arm also large red place, big as my hand, stayed sore for five days (felt horrible).
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Insomnia, Pain, Pyrexia
Clinical narrative: Body aches, fever (100.7), very tired partly because it started in the middle of the night so I didn't sleep. Took TYLENOL, drinking fluids. Symptoms eased significantly, no fever by noon.
Age: 70.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Decreased appetite, Hyperhidrosis, Pain, Vomiting
Clinical narrative: Patient experienced some body aches starting the night after administration of the vaccine. She woke up the next morning with body sweats which then lead to vomiting. Patient states that she was on the floor with nonstop vomiting for most of the day. The next day she felt a little better but didn't eat anything. The following day she was back to her normal self again. Her husband had a similar experience but he didn't vomit until the 3rd day after administration (submitting another VAERS for him).
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and low grade fever.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Acoustic stimulation tests, Blood test normal, Intensive care, Lumbar puncture normal, Pyrexia
Clinical narrative: Against my wishes, my son was sneakily given the Hep B vaccine. On the early morning of June 19, 2017, my son was taken to do a routine hearing screening. Over an hour later he was brought to me, lungs retracting and running a high fever. They prepped him, did a spinal tap, did multiple blood draws and tried to cath him, and got an IV started in his head which later had to be moved to his foot. He was then transported to the ICU. There he stayed for FOUR days until his bloodwork and spinal tap came back completely NORMAL. During his time in the NICU, he was administerd 72 hours of antibiotics through his IV.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Use of accessory respiratory muscles
Clinical narrative: Against my wishes, my son was sneakily given the Hep B vaccine. On the early morning of June 19, 2017, my son was taken to do a routine hearing screening. Over an hour later he was brought to me, lungs retracting and running a high fever. They prepped him, did a spinal tap, did multiple blood draws and tried to cath him, and got an IV started in his head which later had to be moved to his foot. He was then transported to the ICU. There he stayed for FOUR days until his bloodwork and spinal tap came back completely NORMAL. During his time in the NICU, he was administerd 72 hours of antibiotics through his IV.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives began about 10 minutes after the injection was administered. Hives started at the injection site and rapidly spread to chest and other extremities. Benadryl was administered and the hives then went away.
Age: 75.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Diarrhoea, Hyperhidrosis, Vomiting
Clinical narrative: Patient experienced sweats on Friday morning, 1 day following the vaccine on Thursday. He felt fine the rest of the day on Friday and most of the day on Saturday. Sunday the patient started to vomit and have diarrhea. Monday he was feeling better but not 100% and he felt better on Tuesday. This patient had very similar adverse reactions as his wife (VAERS #165254), just occurring 2 days after her illness.
Age: 1.5
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Child had an extra dose of PCV13 due to records being sent. Pediatric office that sent us records sent two different records that did not match, and the nurse that completed immunizations reviewed the record that did not have the appropriate amount of PCV13 listed.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from contactable physician via Pfizer Sales Representative. A patient of unspecified age and gender received TRUMENBA (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for prevention of meningococcal meningitis. The patient's medical history and concomitant medications were not reported. The patient had redness, swelling and pain at injection site on an unspecified date in 2019 for two weeks. The outcome of the events was unknown. Information on lot number, batch number and expiration date has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction
Clinical narrative: reported reactions at the site; This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for 2 patients on behalf of Physician. This is the first of two reports. An adult patient of an unspecified gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date single dose for immunisation. The patient's medical history and concomitant medications were not reported.  It was reported that a patient reported reactions at the site. She did the reassuring thing, like to take Advil, and put ice on it, and told them to call back if it didn't improve. Outcome of the event was unknown.   Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019164502 same reporter, same product, same events, different patients
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Her arm is still red and sore and warm; Her arm is still red and sore and warm; Her arm is still red and sore and warm; This is a spontaneous report based on the information received by Pfizer from  Merck (manufacturer control number: 01162983). A contactable consumer reported that a female patient of an unspecified age received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on 09Apr2019, at 0.5 ml, single for immunization. The patient's medical history and concomitant medications were not reported.  The patient reported her arm was still red and sore and warm on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dehydration, Lethargy, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer-sales representative. A female patient of an unspecified received the first dose of TRUMENBA, at the age of 17, via an unspecified route of administration from 15May2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was hospitalized for three days after complaint of lethargic, aching, nausea, and dehydrationon an unknown date after the first dose of meningococcal group b rlp2086. Outcome of the events was unknown. Information on batch number has been requested; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: MENB
Symptoms: Erythema, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported that a 17-years-old male patient received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced low grade fever non-serious on an unspecified date with outcome of unknown, malaise non-serious on an unspecified date with outcome of unknown, red arm non-serious on an unspecified date with outcome of unknown. The information on the batch number has been requested.
Sex: M
Vaccine: MENB
Symptoms: Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 17-year-old male patient received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low grade fever, fever, and malaise. The outcome of the events was unknown. Information on the batch/lot number has been requested.
Sex: M
Vaccine: MENB
Symptoms: Nausea, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A male patient of an unspecified age received TRUMENBA, (lot number and expiration date were not reported), via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea and vomiting on an unspecified date. The outcome of the event was unknown. Information on the batch number has been requested.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administered an expired Menactra by a nurse; Initial information received on 18-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.(Physicians Assistant). This case involves a 17 years old male patient who received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] by the nurse.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient didn't get any other vaccine at the time of vaccination.   On 18-Apr-2019, the patient received second 0..5 ml  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5836BA(expiry date: 18-Mar-2019)  via intramuscular route in the arm nos.  It was of actual medication error due to  expired vaccine used.  It was unknown whether adverse event was occurred..  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: F
Vaccine: HPVX, MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was inadvertently given Menactra instead of the ordered HPV vaccine; patient had received the Menactra at 11 years and again received at 12 year inadvertently; Initial information received on 17-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 years old female patient who was inadvertently vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6151AA, expiry date: 16 March 2020 via unknown route in the left arm on 17-Apr-2019 instead of HPV vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to Wrong vaccine administered and extra dose administered.  It was reported that patients had received the Menactra at 11 years for routine vaccination and at 12 years, the patient was inadvertently given Menactra instead of HPV vaccine.  It was not reported if the patient experienced any adverse event following vaccination.  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.  List of documents held by sender: none.
Sex: F
Vaccine: HPVX, MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pateint was inadvertently given Menactra instead of the ordered HPV vaccine; patient had received the Menactra at 11 years and again on 13 years; Initial information received on 17-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked with 2019SA110183 and 2019SA110184 (same reporter).  This case involves a 13 years old female patient who was inadvertently vaccinated with a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6151AA, expiry date: 16-Mar-2020, via unknown route in the right arm on 17-Apr-2019 instead of HPV vaccine. The patient was previously vaccinated with a dose of MENACTRA on an unknown date at 11 years of age.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to wrong vaccine administered and extra dose administered.  It was reported that patients had received the Menactra at 11 years for routine vaccination and at 13 years the patient was inadvertently given Menactra instead of HPV vaccine.  It was not reported if the patient experienced any adverse event following vaccination.  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.  List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Heart rate increased, Vomiting
Clinical narrative: increased heart rate; felt fatigued; diarrhea; vomiting; gastrointestinal (GI) discomfort; Initial information received on 18-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a 12 years old male patient who experienced gastrointestinal (GI) discomfort, increased heart rate, felt fatigued, diarrhea and vomiting, while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-Apr-2019, the patient received a dose of 0.5 mL suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (frequency once) lot C5601AA (expiry date: 12-Mar-2021) via unknown route in unknown administration site.  On 17-Apr-2019, the patient developed a non-serious gastrointestinal (GI) discomfort (abdominal discomfort), diarrhea (diarrhoea) and vomiting one day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE On 18-Apr-2019 at morning, the patient experienced increased heart rate (heart rate increased) and felt fatigued (fatigue) two days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Other relevant tests were not reported.  Final diagnosis was vomiting, diarrhea, gastrointestinal (GI) discomfort, felt fatigued and increased heart rate.  It was not reported if the patient received a corrective treatment.  The patient's event outcome reported as recovering for all the events.  List of documents held by sender: none.
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, Measles antibody negative, Mumps antibody test positive, Rubella antibody positive
Clinical narrative: The patient had tioters drawn and were negative for measles / the titers were negative again for measles / patient had titers drawn again a week later, and they were still negative for measles; The patient had tioters drawn and were negative for measles / the titers were negative again for measles / patient had titers drawn again a week later, and they were still negative for measles; This spontaneous report was received from a physician concerning a 22-year-old female patient. The patient's medical history, concurrent conditions , and concomitant medications were not reported.   On unspecified dates (reported as "at the recommended age"), the patient received 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (route, lot # and expiration date were unknown) for prophylaxis.  On an unspecified date, the patient had titers drawn for entry into a school program and the titers were negative for measles (measles antibody negative), but positive for mumps and rubella. Subsequently, on 14-JAN-2019, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (route, lot # and expiration date were unknown) for the negative measles titers. On 22-MAR-2019, the titers were negative again for measles; therefore, on 15-MAR-2019, the patient received another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (route, lot # and expiration date were unknown) for the negative measles titers. Finally, in approximately March 2019 (reported as "a week later"), the patient had titers drawn again and the were still negative for measles (therapy non-responder).  At the time of reporting, the patient had not recovered from the events.  The causality assessment between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No known adverse effects; A patient received a dose of VAQTA on 09-DEC-2014 and on 18-APR-2019; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 09-DEC-2014, the patient was vaccinated with a dose of  hepatitis a vaccine, inactivated(VAQTA), intramuscular (strength, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 18-APR-2019, the patient received another dose of hepatitis a vaccine, inactivated (VAQTA), intramuscular (strength, anatomical location, lot # and expiration date were not provided). There were not known adverse effects.
Sex: F
Vaccine: MMR
Symptoms: Rubella
Clinical narrative: The patient has a history of rubella as a child and thinks she may have been vaccinated with MMR II; This spontaneous report was received from a nurse regarding a female patient of unknown age. No information was reported regarding the patient's concurrent conditions, medical history, and past drug reactions or allergies. Concomitant therapies included sterile diluent.  On an unspecified date, the patient was vaccinated with subcutaneously measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, lot# and expiry date were not provided) for prophylaxis.    On an unspecified date, as a child, the patient experienced rubella and she thought she might have been vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The patient did not seek for medical attention and she did not receive treatment for this event. It was unknown if any lab diagnostics or studies were performed. The outcome of rubella was not reported.  The reporter did not provide causality assessment between rubella and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of anaphylaxis in a 22-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.  On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had an anaphylactic reaction to a flu vaccine received 30 years ago and did not know which one it was or who made it. The patient stated that he was 22 years old at the time of the anaphylactic reaction. No additional details were provided.
Sex: F
Vaccine: MENB
Symptoms: Feeling abnormal
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A female patient of an unspecified age received 1st dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for prevention of meningococcal meningitis. The patient's medical history and concomitant medications were not reported. The patient felt bad on an unspecified date after she was given the first dose that she does not want a second dose. Outcome of the event was unknown.