chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner, referring to a 17 years old female patient. The concurrent conditions included diabetes and hidradenitis. The patient had no drug allergy. Concomitant therapies included metformin, insulin lispro (HUMALOG), insulin lispro and insulin glargine. On 04-MAR-2019, the patient was vaccinated with first dose GARDASIL 9 (dose, strength,  lot# R017133 and expiration date not reported, but upon internal validation established as 29-APR-2021)  intramuscularly for prophylaxis. On 04-MAR-2019 (reported as immediately after administration), the patient experienced pain at the injection site. On 01-APR-2019, the patient experienced pain and swelling at the injection site and was treated for suspected cellulitis. The treatment included amoxicillin (+) clavulanate potassium (AUGMENTIN) 875mg for 7 days. The patient continued to have a painful bump under the skin at the injection site. The physician reported the patient was apprehensive and afraid to get the second GARDASIL 9 injection. There was no lab diagnostics or studies performed. The outcome of the events was reported as not recovered. The causality assessment with GARDASIL 9  was not reported. Upon internal review, suspected cellulitis was determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: An unidentified patient received her fisrt dose of Gardasil 9 at age 12 years and her second dose at age 16 years; No adverse effects reported; This spontaneous report as received from a nurse prescriber and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dosage schedule, route of administration, anatomical site, lot number and expiration date were not reported).   It was reported that the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) when she was 12 years old and the second dose at the age of 16 (Inappropriate schedule of vaccine administered). Both administrations were performed by a different healthcare provider. No adverse effects were reported.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient was administered the first dose of GARDASIL 9 when the patient was 13 years old and was administered the second dose of GARDASIL 9 when the patient was 20 years old on unspecified dates; No adverse effects were reported; This spontaneous report was received from a physician concerning a 20-year-old patient of unknown gender.  The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not provided.  The patient had the 1st dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, and frequency were not provided; lot # and expiration date were unknown) was administered intramuscularly for prophylaxis, when the patient was 13-years-old.  The patient's 2nd dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, and frequency were not provided; lot # and expiration date were unknown) was administered intramuscularly, when the patient was 20-years-old (Inappropriate schedule of product administration). No adverse effects were reported and no additional information was provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple, unspecified patients received improperly stored doses of ROTATEQ on multiple, unspecified dates from 4/10/2019 to 5/15/2019; No adverse effects reported; This spontaneous report was received from a nurse concerning multiple unspecified patients.   The patients' medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not provided.  From 10-APR-2019 to 15-MAY-2019, multiple unspecified patients were vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R016792 with expiration date: 29-APR-2020; and lot # R016790 with expiration date: 20-APR-2020). (strength, dose, frequency, anatomical location and route of administration were not provided), administered for prophylaxis.  The lowest storage temperature of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was reported as below 36 degrees Farenheit (°F) (also reported as 34.3°F) for a time frame of 2 hours and 26 minutes. There was no previous temperature excursion. The call was due to a data logger.  No adverse effects were reported. No additional information was provided.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EFFECT; expired dose administered to patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent condition, medical history, drug reaction/allergies were unknown. The patient's concomitant therapy includes sterile diluent.  On 16-MAY-2019, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (M-M-R II) (frequency unknown) (lot # N014486 and expiration date:10-MAY-2019) subcutaneous in the left arm for prophylaxis (PT: Expired product administered). It was reported that both measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and sterile diluent has not had any prior temperature excursion. No adverse effect reported.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event, Wrong product administered
Clinical narrative: patient had received doses of the following vaccines on the following dates:gardasil on 11-2-2015, gardasil 9 on 1-19-2017, gardasil 9 on 03-4-2019 and gardasil 9 on 5-15-2019; no adverse effect; patient had received doses of the following vaccines on the following dates:gardasil on 11-2-2015, gardasil 9 on 1-19-2017, gardasil 9 on 03-4-2019 and gardasil 9 on 5-15-2019; patient had received doses of the following vaccines on the following dates:gardasil on 11-2-2015, gardasil 9 on 1-19-2017, gardasil 9 on 03-4-2019 and gardasil 9 on 5-15-2019; This spontaneous report was received from a nurse regarding to a patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On 02-NOV-2015, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, frequency, route, lot and expiry date was not reported) for prophylaxis. On 19-JAN-2017, the patient was vaccinated 1 dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, frequency, route, lot and expiry date was not reported),(wrong product administered and interchange of vaccine products). On 04-MAR-2019, the patient was vaccinated 2 dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R020200 and expiry date 05-MAY-2021, (strength, dose, frequency, route were not reported). On 15-MAY-2019, the patient was vaccinated dose 3 with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R004689 and expiry date 29-NOV-2020, (strength, dose, frequency, route was not reported) for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: the patient developed a localized rash with no bumps at an unspecified location; the patient also developed a fever that reached up to 103.9F; This spontaneous report was received from a nurse practitioner via a company representative, concerning to her daughter, a 12 month old female patient. The patient had not pertinent medical history, concomitant medications, drug reactions or allergies. Information regarding the patient's pertinent concurrent conditions was not provided.  On 03-MAY-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R026362, expiration date reported as 31-MAR-2020, but upon internal review validation established as 15-MAR-2020, subcutaneously (strength and anatomical location were not provided) for prophylaxis. On 10-MAY-2019, the patient experienced a localized rash with no bumps at an unspecified location and also a fever that reached up to 103.9 fahrenheit (pyrexia). On 12-MAY-2019, reported as two days later, the patient recovered from the event pyrexia. It was reported that no medical attention was sought for the events and no laboratory diagnostic studies were performed. It was unknown whether the patient received treatment for the events.   The outcome of rash was reported as resolved on an unknown date in May 2019. The causality between the events and therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; Patient was inadvertently administered an expired dose of M-M-R II; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medications.  On 17-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rha(M-M-R II) lot # N014483 with expiration date of 10-MAY-2019, subcutaneously for prophylaxis (dose, frequency and anatomical location were not provided). No adverse effects were reported.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; Received a dose of MMRII taht was reconstituted with a expired diluent; This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 02-MAY-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) one dose, for prophylaxis (strength, frequency, route of administration, lot number and expiration date were not reported). The vaccine was reconstituted with an expired sterile diluent (MERCK STERILE DILUENT) lot #M016884 and expiration date 04-DEC-2018 (strength, frequency, and route of administration were not reported). No adverse effects.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA002598:
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; administered first dose on 3/28/2019 and second dose little early on 5/17/2019; This spontaneous report was received from a consumer refers to a 25-year-old female patient. The patient's medical history, current conditions and concomitant medications were not reported. On 28-MAR-2019, the patient administered her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot and expiration unknown). On 17-MAY-2019, little early the patient administered her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot and expiration unknown) (inappropriate schedule of product administration). The consumer reported her physician authorized the second dose early because she was going to travel. No adverse effects reported.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: felt shit for two days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient had the flu jab once and felt shit for two days.  The patient never actually had flu. The patient stated if ever the patient received next flu jab, it might change patient's mind about the jab.
Sex: U
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: had the worse winter ever; This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included laceration of foot. Previously administered products included Polio (received on an unknown date, when patient was in school), TB (received on an unknown date, when patient was in school), Tetanus (received on an unknown date for foot cut), Antihistamine (received on an unknown date for reaction to the jab (shot)) and Small pox vaccine (received in 1978).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient did not had many vaccinations and was cautious about the vaccines which were received .  The patient received small pox vaccine when started working in the HS (Health Service) and then again and again when the patient was in contact with one involved with the outbreak in State.  The patient had one flu vaccine when they started inoculating HS staff but the patient had the worse winter ever due to the unspecified adverse reaction and then after the patient refuses to have any more flu vaccines.
Sex: M
Vaccine: FLUX
Symptoms: Apparent death
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced near death experience (serious criteria GSK medically significant). Influenza vaccine was discontinued. On an unknown date, the outcome of the near death experience was unknown. It was unknown if the reporter considered the near death experience to be related to Influenza vaccine. Additional details were reported as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The nurse recommended the Flu vaccine to the patient which nearly killed him off. It was reported that, the patient would never receive the Flu vaccine again.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Dyspepsia, Flatulence
Clinical narrative: heart burn; pain under her heart/ sharp pain under her heart/ overall aching under her heart, in the middle of the chest; Gaseousness; This case was reported by a consumer via call center representative and described the occurrence of heartburn in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced heartburn, chest pain and gaseousness. On an unknown date, the outcome of the heartburn, chest pain and gaseousness were recovered/resolved.   It was unknown if the reporter considered the heartburn, chest pain and gaseousness to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain under her heart, sharp pain under her heart and overall aching under her heart, in the middle of the chest for about a week.  It came and went.  She thought that it would be heart burn and felt like  getting gas. The pain came and went and it lasted about a week.   The reporter did not consent to follow up. For tolerance of 2nd dose of Shingrix refer case US2019071004.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles on trunk; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 2Y9R4, expiry date 28th June 2021) for prophylaxis.   Concomitant products included chemotherapy, nos (Chemotherapy).   On 28th March 2019, the patient received the 1st dose of Shingrix .5 ml. On 5th April 2019, 8 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated on left arm and was diagnosed with shingles on his trunk. The patient had been receiving chemo therapy treatments starting in November 2018. His last round was on 18th March 2019 to 22nd March 2019. The reporter consented to follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number NX952, expiry date 6th March 2020) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced headache. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. Till the time of reporting The patient did not received their second dose of Shingrix due to having a bad headache after receiving the first dose. The symptoms began the same day and had since resolved. Duration was unknown.  The patient took Benadryl for their symptoms. The reporter consented to follow up This case was linked to case US2019085102 same reporter.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Chest X-ray, Computerised tomogram, Full blood count, Metabolic function test, Seizure
Clinical narrative: Patient had a seizure at home on 05/16/19 and went to the ER and was transferred to Hospital.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: headache, chills, muscle pain, feeling tired and weak
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Computerised tomogram, Contusion, Head injury, Immune thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Patient developed bruising over entire body, diagnosed with ITP on 5/19/15 per lab studies.  Followed by Hematology.  Patient had to be seen twice in ED for head injuries, once required a CT scan due to low platelets.  Symptoms resolved completely in 9/2015 without any further sequela.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Fever (100.5), chills, general body aches, fatigue, sore throat, mild nausea.  Noticed when I woke up next day after injection.  Fever lasted about 24 hours.  other symptoms have continued after fever.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever (100.5), chills, general body aches, fatigue, sore throat, mild nausea.  Noticed when I woke up next day after injection.  Fever lasted about 24 hours.  other symptoms have continued after fever.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Cellulitis, Erythema, Lethargy, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: Patient presented at the Emergency room on 5/7/2019 at 13:47 for complaints of right shoulder and arm discomfort, Right cheek and right ear warm to touch and red.  Fever of 100.7 at home.  Per mother patient is subdued and more lethargic.   Eating and drinking normally.   Motrin Ranitidine, Benadryl given at 16:19 in the ER.   05/09/2019 Mother took patient back to the ER with concerns of redness on right arm.  Diagnosed with Cellulitis.  Keflex , tylenol, ibuprofen and benadryl give.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Patient presented at the Emergency room on 5/7/2019 at 13:47 for complaints of right shoulder and arm discomfort, Right cheek and right ear warm to touch and red.  Fever of 100.7 at home.  Per mother patient is subdued and more lethargic.   Eating and drinking normally.   Motrin Ranitidine, Benadryl given at 16:19 in the ER.   05/09/2019 Mother took patient back to the ER with concerns of redness on right arm.  Diagnosed with Cellulitis.  Keflex , tylenol, ibuprofen and benadryl give.
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Gastrointestinal disorder, Haematochezia, Occult blood positive
Clinical narrative: Substantial blood in stool. Intestinal Permeability. Colic.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blepharospasm, Dyskinesia, Head titubation, Pallor, Unresponsive to stimuli
Clinical narrative: Patient given 2nd dose of HPV 8:45, at 8:50 became pale.  While holding her Mother's hand, she then had eye twitching and head shaking with movement to the left.  Unresponsive for approximately 30 seconds.  Then started to waken, unaware of what had happened.  Primary care physician evaluated heart, lungs, blood pressure, heart rate.  All normal.  After resting for 15 additional minutes patient was able to ambulate to lobby and discharged home.  Contacted parent at 4:30 pm. and was told she was able to attend school and had no additional problems.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effects are being reported; she received the MMR II vaccine incorrectly via IM in the right deltoid; This spontaneous report was received from a female registered nurse of unknown age via a company representative. The nurse was referring to herself. The patient's medical history included delivery. The patient's concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 22-DEC-2018, after delivering her child, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), (dose, lot # and expiration date were not reported) incorrectly via intramuscular route in the right deltoid instead of subcutaneous route of administration. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Painful reaction; fever; This case was reported by a nurse via sales rep and described the occurrence of pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced pain and fever. On an unknown date, the outcome of the pain and fever were unknown.   It was unknown if the reporter considered the pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had painful reaction no redness and swelling and reported fever. The patient felt this way for two days after shot. The shot was received at family pharmacy. The provider could not confirm whether or not from shot. The reporter agreed to follow up from GlaxoSmithKline
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: allergy; This case was reported by a physician via other manufacturer and described the occurrence of allergy in a 81-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included pregabalin (Lyrica) capsule for neuropathy.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and Lyrica (oral) 100 mg twice daily (200 mg daily). On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced allergy (list might be incomplete). The information provided in the source document was not clear. It was unknown whether the reporter gave consent to further follow up or the patient consented to follow up with the reporter.
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the vaccination failure, whooping cough and pain were unknown. It was unknown if the reporter considered the vaccination failure, whooping cough and pain to be related to dTpa vaccine. Additional details were provided as follows: The case was reported by patient's mother. The age at vaccination was not reported, but the patient received dTpa in his teenage. It was reported that let the kids get their childhood diseases and then they would be good for their life. Forgot about the chemicals the reporter survived them all and experienced polio from the damn shot. The patient probably would never experience it otherwise. It was unknown when the patient was administered DPT, but the patient experienced whooping cough from it. It was reported that hell the doctors did not knew what they had and tried telling them that could not experience the events from the vaccine. It was reported that a year later they told the patient that he was right. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. This case was linked with case US2019AMR084176, reported by the same reporter for patient's father.
Sex: M
Vaccine: TDAP
Symptoms: Chronic obstructive pulmonary disease, Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult male patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant) and chronic obstructive pulmonary disease. On an unknown date, the outcome of the vaccination failure, whooping cough and chronic obstructive pulmonary disease were unknown. It was unknown if the reporter considered the vaccination failure, whooping cough and chronic obstructive pulmonary disease to be related to dTpa vaccine. Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. It was reported that let the kids get their childhood diseases and then they would be good for their life. Forgot about the chemicals the patient survived them all and experienced polio from the damn shot. The patient probably would never experience it otherwise. The patient experienced  whooping cough from it. The patient also experienced chronic obstructive pulmonary disease (COPD). The patient survived it. The patient stated that hell the doctors did not knew what they had and tried telling them. that could not experience the events from the vaccine. It was reported that a year later they told the patient that he was right. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. This case was linked with case US2019AMR084174 reported by the same reporter for patient's son.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Blood test normal, Chest X-ray normal, Dehydration, Influenza virus test negative, Pyrexia
Clinical narrative: Woke up Thursday morning screaming. Screamed for 2 hours I took him to the doctor he had a low grade fever. Doc said all was normal for just having shots. I checked his temperature at 2:15 and it was 102.4 called the office back was told again it was normal as long as his fever didn't reach 105. Also gave him fever reducer at this time.So I put him down for a nap he woke up around 4 and his fever was 103. About 6:15 I took him to urgent care and his fever got up to 104.3 they said he tested positive for flu I didn't feel like this was right so I took him to a different urgent Care Friday around 1:30 they retested for flu it was negative and they told me it was just from the shots. Saturday morning he woke up still with a fever of 102.2 I took him to er and they ran test blood work chest x-ray and flu strep and rsv test all came back normal.fever broke Saturday afternoon. He was also given I've fluids in the ER because he was dehydrated Sunday afternoon he started getting a rash and by Monday from his neck down was covered.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash generalised, Respiratory syncytial virus test negative, Screaming, Streptococcus test negative
Clinical narrative: Woke up Thursday morning screaming. Screamed for 2 hours I took him to the doctor he had a low grade fever. Doc said all was normal for just having shots. I checked his temperature at 2:15 and it was 102.4 called the office back was told again it was normal as long as his fever didn't reach 105. Also gave him fever reducer at this time.So I put him down for a nap he woke up around 4 and his fever was 103. About 6:15 I took him to urgent care and his fever got up to 104.3 they said he tested positive for flu I didn't feel like this was right so I took him to a different urgent Care Friday around 1:30 they retested for flu it was negative and they told me it was just from the shots. Saturday morning he woke up still with a fever of 102.2 I took him to er and they ran test blood work chest x-ray and flu strep and rsv test all came back normal.fever broke Saturday afternoon. He was also given I've fluids in the ER because he was dehydrated Sunday afternoon he started getting a rash and by Monday from his neck down was covered.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient reports swelling, redness, itching began night of injection (seen in afternoon for appt) with cool compresses tried
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities, Vomiting
Clinical narrative: I believe in vaccinating children, my child had a HPV vaccine and shortly after began vomitting every morning and experiencing chronic fatigue and headaches. I brought it to our pediatricians attention and she told us she felt it was not from the vaccine.Then we went to several other Dr and the Pediatric stomach specialist felt because this happen almost immediately after the vaccine there could be some  correlation. She said the vomitting could last 6-8 weeks which it finally subsided(Thank God) but we are still dealing with chronic fatigue and headaches. My child also missed almost 3 full months of school and needed a tutor. I called the CDC to find out if there was anything i should do and this was how i was directed.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Decreased appetite, Fatigue
Clinical narrative: On the evening of 5/15, patient started with a fever all night and it continues to morning of 5/17.  Patient specified that it was hard to get out of bed, felt very tired, that legs, arms do not want to work, and was moving very slowly/shuffling her feet and no appetite.  Mother called pediatrician on 5/16 and was sent to ER.  Patient went to ER Urgent Care clinic; patient was not admitted. Patient reports pain in her back--about her butt--and stomach pain.  It also hurts when she moves her chin to her chest and lifts her arms. Patient reports joint pain and stiffness. Per doctor, these adverse events are seen in women and teens not in young children.  Patient has been taking Motrin for fever.  Mother will follow-up with pediatrician in 3 days and was told to bring her immediately back to ER if any other symptoms occur.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Gait disturbance, Joint stiffness, Mobility decreased, Pain, Pyrexia
Clinical narrative: On the evening of 5/15, patient started with a fever all night and it continues to morning of 5/17.  Patient specified that it was hard to get out of bed, felt very tired, that legs, arms do not want to work, and was moving very slowly/shuffling her feet and no appetite.  Mother called pediatrician on 5/16 and was sent to ER.  Patient went to ER Urgent Care clinic; patient was not admitted. Patient reports pain in her back--about her butt--and stomach pain.  It also hurts when she moves her chin to her chest and lifts her arms. Patient reports joint pain and stiffness. Per doctor, these adverse events are seen in women and teens not in young children.  Patient has been taking Motrin for fever.  Mother will follow-up with pediatrician in 3 days and was told to bring her immediately back to ER if any other symptoms occur.
Age: 20.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Patient reports extreme pain in Right upper arm "rotator cuff area" for 1+week/since receiving vaccines. Patient reports not being able to eat or dress herself with the effected arm or swim. Patient denies any other symptoms such as redness, swelling or s/sx of infection. Patient reports pain being continuous since injection and describes pain as being similar to an "injury". She swims for college and has not been able to swim using the affected arm since the injection. Patient in college so report filed via phone. Patient has not seeked any additional medical care at this time.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got Shingles - Mild case #1 - 4-22-14     #6 - 12 -2016     #11 - 5 - 2018 #2 - 6 - 2015    #7 - 1 - 2017      #12 - 10 - 2018 #3 - 8 - 2015    #8 - 3 - 2017      #13 - 1 - 2019 #4 - 1 - 2016    #9 - 9 - 2017     Shingrix Vac-3-28-19 #5 - 8 - 2016    #10 - 12 - 2017   #14 - 5-2019
Age: 66.0
Sex: F
Vaccine: VARCEL
Symptoms: Tendon rupture, X-ray
Clinical narrative: Ruptured proximal biceps tendon.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: soreness and redness at site.  Fever for 48 hours of 100.5, headache for 48 hours.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: Shingles involving left upper extremity. Started with generalized body aches, fatigue and pruritus then developed rash that started on her left palm and spread to her axilla and then her elbow. Rash is painful and pruritic and vesicular in appearance. She was started on valtrex on 5/21/19
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Shingles involving left upper extremity. Started with generalized body aches, fatigue and pruritus then developed rash that started on her left palm and spread to her axilla and then her elbow. Rash is painful and pruritic and vesicular in appearance. She was started on valtrex on 5/21/19
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Haematoma, Nerve compression, Ultrasound scan
Clinical narrative: possible inflammatory vs allergic reaction. suspect more 2/2 hematoma and resultant pressure on nerves
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Injection site bruising, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Pt called pharmacy on Sat May 18th reporting large area of redness surrounding the area of vaccination.  Pt came in May 21 st stating that the arm became painful Monday the 20 th.  I examined the area and found a bruise at injection site and an area of 7 inches by 7 inches below that had a 4 x 4 in white area and the remaining area was all red and warm to the touch. After calling Glaxo I sent patient to Urgent Care for further evaluation as pt seemed anxious about the situation.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Discomfort, Erythema, Feeling hot, Injection site bruising
Clinical narrative: Pt called pharmacy on Sat May 18th reporting large area of redness surrounding the area of vaccination.  Pt came in May 21 st stating that the arm became painful Monday the 20 th.  I examined the area and found a bruise at injection site and an area of 7 inches by 7 inches below that had a 4 x 4 in white area and the remaining area was all red and warm to the touch. After calling Glaxo I sent patient to Urgent Care for further evaluation as pt seemed anxious about the situation.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Malaise
Clinical narrative: Pt called pharmacy on Sat May 18th reporting large area of redness surrounding the area of vaccination.  Pt came in May 21 st stating that the arm became painful Monday the 20 th.  I examined the area and found a bruise at injection site and an area of 7 inches by 7 inches below that had a 4 x 4 in white area and the remaining area was all red and warm to the touch. After calling Glaxo I sent patient to Urgent Care for further evaluation as pt seemed anxious about the situation.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: Pt called pharmacy on Sat May 18th reporting large area of redness surrounding the area of vaccination.  Pt came in May 21 st stating that the arm became painful Monday the 20 th.  I examined the area and found a bruise at injection site and an area of 7 inches by 7 inches below that had a 4 x 4 in white area and the remaining area was all red and warm to the touch. After calling Glaxo I sent patient to Urgent Care for further evaluation as pt seemed anxious about the situation.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pyrexia, Swelling
Clinical narrative: redness, swelling, fever, soreness on the medial inside of arm
Age: 8.0
Sex: F
Vaccine: IPV, MMRV, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 9 mm in Diameter red swollen  on left upper arm said to be itchy  seen 5/20/19
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Influenza like illness, Pain
Clinical narrative: Very achy,  flu-like symptoms
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Child's arm was swollen, red and warm to the touch. Mom was told to treat with Hydrocortisone cream, Benadryl, and Ibuprofen  as needed.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: 3-5 MINUTES AFTER ADMINISTRATION, THE CHILD BROKE OUT IN HIVES ALL OVER HER BODY. SHE SEEMED HAPPY AND DID NOT SEEM TO EXPERIENCE ANY DIFFICULTY BREATHING. SHE WAS GIVEN 3.5 MG OF DECADRON (IM) AND 2.5 mL OF BENADRYL (ORAL). SHE WAS MONITORED HERE IN THE CLINIC FOR AN HOUR AND BEFORE SHE LEFT, ALL HIVES HAD GONE AWAY.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Injection site swelling, Migraine, Nausea
Clinical narrative: Nausea Swollen around injection site Migraine began 3:00 pm and lasted all night. It is lingering on at lower level and my eyes hurt
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient blacked out post  Menactra and Tdap vaccination  at school clinic
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccination expired. Spoke to GSK about this. They stated Bexsero Vaccination should remain effective for 30 days after expiration. No adverse events.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Extra dose administered
Clinical narrative: Incomplete medical record at time of visit. Extra dose of Dtap and IPV given in error.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Headache, Impaired work ability
Clinical narrative: Starting around 11:00pm on Fri, 5/17/19, pt  had fever, chills, severe joint pain in all joints, headache, nausea. States the pain was severe and debilitating all night. She did not sleep all night. Around 10:00am the next morning(Saturday), the joint pain started to let up but continued to have fever, nausea and slept most of the day and was feeling somewhat better Saturday evening. The joint pain increased again with fever and nausea on Saturday night, but less severe than the night before. On Sunday, still had a headache and nausea, chills and possible fever, but the joint pain was clearing up.  She stayed home from work on Monday, as she still had a headache and nausea. She states she had some side effects with the first vaccine in the series, but the second was much worse to the point that if she needed a 3rd one, she stated she would not have taken it. She stated the joint pain associated with this was very painful and debilitating.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Nausea, Pyrexia
Clinical narrative: Starting around 11:00pm on Fri, 5/17/19, pt  had fever, chills, severe joint pain in all joints, headache, nausea. States the pain was severe and debilitating all night. She did not sleep all night. Around 10:00am the next morning(Saturday), the joint pain started to let up but continued to have fever, nausea and slept most of the day and was feeling somewhat better Saturday evening. The joint pain increased again with fever and nausea on Saturday night, but less severe than the night before. On Sunday, still had a headache and nausea, chills and possible fever, but the joint pain was clearing up.  She stayed home from work on Monday, as she still had a headache and nausea. She states she had some side effects with the first vaccine in the series, but the second was much worse to the point that if she needed a 3rd one, she stated she would not have taken it. She stated the joint pain associated with this was very painful and debilitating.
Age: 26.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Blood glucose decreased, Injection site pain, Loss of consciousness, Malaise, Pallor
Clinical narrative: Gave first shot, Engerix-B and patient was fine, he stated it hurt but that was all.  Then I wend to give the shot in his left arm, and when I was done he stated that it hurt.  I was going to give him a MMR shot as well but he said his arm hurt and wawnted to wait for a minute.  I asked him if he wanted to sit on the bench but he was beginning to turn pale and stated he felt like he was going to get sick and pass out. I asked a technician to get a cold compress and a wet paper towel.  At this point he passed out and we has the compress on is neck and the wet papertowels on his arms.  His mother came over to try to wake him up, he slowly came around for about a minute and then he passed out again.  At that point we called 911.  When the EMT arrived they checked his blood sugar and it was 66.  I spoke with the patient Monday and he stated he was not admitted to the hospital and that he had blood drawn and he had elevated WBC but everything else was normal.
Age: 26.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: White blood cell count increased
Clinical narrative: Gave first shot, Engerix-B and patient was fine, he stated it hurt but that was all.  Then I wend to give the shot in his left arm, and when I was done he stated that it hurt.  I was going to give him a MMR shot as well but he said his arm hurt and wawnted to wait for a minute.  I asked him if he wanted to sit on the bench but he was beginning to turn pale and stated he felt like he was going to get sick and pass out. I asked a technician to get a cold compress and a wet paper towel.  At this point he passed out and we has the compress on is neck and the wet papertowels on his arms.  His mother came over to try to wake him up, he slowly came around for about a minute and then he passed out again.  At that point we called 911.  When the EMT arrived they checked his blood sugar and it was 66.  I spoke with the patient Monday and he stated he was not admitted to the hospital and that he had blood drawn and he had elevated WBC but everything else was normal.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria
Clinical narrative: pt broke out with 3 patches of hives in the area the the vaccine was given on 5/18/19, by the time she had called the office on monday she was feeling better.
Age: 1.08
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure, Dx AAMC ED.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Hypoaesthesia, Nausea, Paraesthesia, Vision blurred
Clinical narrative: Within 10 minutes of the injection, I started experiencing tingling and numbness of all my fingers, then started to experience blurred vision, I work in a medical office and had experienced difficulty in reading the words on my computer screen and could barely read the VIS read the VIS sheet provided to me by my pharmacist,  then I started to feel a bit of nausea coming on, no vomiting occurred. The adverse events lasted about 2-3 hours, but I did notice some trouble with my vision for a day or so afterwards. My doctor was informed of these adverse events, but no medical attention was deemed necessary.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: About 3 days after the shot, blisters appeared on my right arm - from wrist to shoulder - and three on upper right side of my back - there was a cluster around the elbow. I saw the doctor, she gave a medication tablet - blue & a white one - I don't know the names are.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Body temperature increased, Insomnia, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Given shot @ night (L) felt achy (L) swelling put ice then get stiff took tylenol let it go then called on 10th. had 100.5 - 100.7 the night of shot. trouble sleeping on 5-19 the whole weekend achy painful not able to raise above breast tried to exercise daughter OT advised  looked up if given to high called again on Wed. she is ortho she is gong thurs. wrist hurting some.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Given shot @ night (L) felt achy (L) swelling put ice then get stiff took tylenol let it go then called on 10th. had 100.5 - 100.7 the night of shot. trouble sleeping on 5-19 the whole weekend achy painful not able to raise above breast tried to exercise daughter OT advised  looked up if given to high called again on Wed. she is ortho she is gong thurs. wrist hurting some.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dysphonia, Fatigue, Injection site pain
Clinical narrative: Day of shot- left upper arm sore lasted three days. -5 hrs later hoarseness lasted about one hour or so Day after - fatigue Second day 2 1/2 days approx. diahrea