chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: soreness; nausea; headache; body ache; flu like symptoms; not feeling well; diarrhea; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm, nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea. On an unknown date, the outcome of the pain in arm, nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea were unknown.   It was unknown if the reporter considered the pain in arm, nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea to be related to Shingrix.  Additional details were provided as follows: This case was reported by the pharmacist on behalf of her co-worker who spoke about another patient who had similar side effects, however, her co-worker had no details to provide. The patient demographic details were not provided. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient experienced pain in arm, nausea, headache, general body pain, influenza-like symptoms, feeling unwell and diarrhea, after vaccination with dose of Shingrix. The reporter consented to follow up. This case has been linked with case US2019158433, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Vaccine positive rechallenge
Clinical narrative: Nausea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, refer case US2019AMR167659).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea was recovered/resolved.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, her friend's husband received dose of Shingrix and next day after vaccination experienced nausea. The nausea recovered in 1 days. The reporter did not provide additional details. This was 4th of 4 reports described by the reporter.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Medical Assistant forgot to mix the ActHIB and the Ipol and the DTAP and only injected the Ipol and DTAP/ No AE; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old male patient for whom it was reported that Medical Assistant forgot to mix the ActHIB and the Ipol and the DTAP and only injected the Ipol and DTAP (Inappropriate reconstitution technique) while received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] 0.5 mL dose, lot C5426AA via intramuscular route in the left thigh on 26-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique.  The patient did not have any AE as a result of this event.  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.  Documents held by sender: none.
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: Quadracel administered to patient inadvertently on 10/16/2018 and 08/09/2019, no AE; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old female patient who was inadvertently given 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5500CA, expiry date: 16-Aug-2020 via intramuscular route in the left deltoid) on 16-Oct-2018 and on 09-Aug-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  It was an actual medication error due to extra dose administered.  It was unknown if any adverse event 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.  List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: consumer felt the wetness, sprayed some of the injection out upon removing the needle from the consumer arm, no AE; plunger was more difficult than usual, no AE; Initial information received on 10-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 72 years old female patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (frequency once) lot UJ221AB, expiry date: 01-Apr-2020 via intramuscular route in the left deltoid on 10-Sep-2019.  The patient's past medical history, medical treatment(s), concomitant medications and family history were not provided.  It is an actual medication error case due to vaccine under dose and it is also a case of syringe issue. It was reported that having difficulty while pressing down the plunger, the plunger was more difficult than usual and nurse reported that may have sprayed some of the injection out upon removing the needle from the consumer arm.  At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: a 15 months old patient received a dose of Pentacel which had a temperature excursion below zero/No AE; Initial information received and additional information received on 10-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA255196, 2019SA254282 and 2019SA255195 (same reporter).  This case involves a 15 months old male patient who received a 0.5 ml fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which had a temperature excursion below zero/ lot UJ135AA, expiry date: 26-Feb-2021 via intramuscular route in the left thigh on 12-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR).  It was an actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received a 0.5 ml second dose of Pentacel vaccine which had a temperature excursion below zero, no adverse event; Initial information received on 10-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA255196, 2019SA255155 and 2019SA254282 (same reporter).  This case involves a four months old male patient who received a 0.5 ml second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/ IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine which had a temperature excursion below zero lot UJ135AA, expiry date: 26-Feb-2021 via intramuscular route in the left thigh on 12-JUL-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included a dose of PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was an actual medication error due to incorrect product storage.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Neuralgia, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Pt stated that she thought the placement was not into the muscle.  She was getting radiating nerve pain down the back of her arm.  She came in with the bandaid still intact and it looked to be more towards the back of her arm, almost subcutaneously.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS SIZE OF BASEBALL, HOT TOTOUCH, PATIENT STATES VERY SWOLLEN THE DAY BEFORE BUT THAT SEEMS TO HAVE RESOLVED, INJECTION SITE MIDWAY DOWN ARM NOT IN DELTOID
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm very swollen, red and hot to touch.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Dizziness, Vomiting
Clinical narrative: Extreme dizziness, chills, vomiting, diarrhea
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Cold sweat, Malaise, Pallor, Presyncope
Clinical narrative: POST VACCINATION PATIENT REPORTED NOT FEELING WELL, TURNED PALE AND CLAMMY BUT DID NOT LOSE CONSCIOUSNESS. PATIENT DID NOT FALL D/T NEAR SYNCOPE EPISODE. BP 114/66 RIGHT ARM LYING DURING EPISODE. HR 66. PATIENT WAS SITTING IN A CHAIR W/HIS HEAD DOWN, BETWEEN HIS KNEES WHEN I ENTERED THE ROOM. DAD REPORTED HE DID NOT FEEL GOOD. PATIENT INSTRUCTED TO LAY DOWN ON EXAM TABLE, FEET ELEVATED X 5 MINUTES W/COOL CLOTH PLACED ON FOREHEAD. ABOUT 3 MINUTES AFTER LYING DOWN, PATIENT BEGAN FEELING BETTER. AFTER 5 MINUTES OF LYING DOWN W/FEET ELEVATED HE SAT UP FOR A 5-7 MINUTES AND HE WAS GIVEN A BOTTLE OF WATER, A PACKAGE OF FRUIT SNACKS, AND SOME CANDY TO DRINK/EAT. HE THEN STOOD UP FOR A FEW MINUTES AND THEN WAS D/C FEELING NORMAL AFTER 15 MINUTES OF OBSERVATION. DISCUSSED W/PATIENT AND DAD PATIENT HAD A VASOVAGAL RESPONSE TO THE VACCINATION WHICH IS NOT AN ADVERSE REACTION TO VACCINATION. UNDERSTANDING VOICED
Age: 0.75
Sex: F
Vaccine: PNC13
Symptoms: Crying, Decreased appetite, Electrocardiogram normal, Eye movement disorder, Flushing
Clinical narrative: The patient was flush and felt warm to the touch. She didn't register a fever that day but temperature was taken multiple times. She was very fussy (crying and didn't want to eat) around dinner time and I took her upstairs to get her ready for bed around 6:30pm. I gave her the bottle while I changed her diaper and put on pajamas. When I took the bottle away, she stared blankly and I picked her up. Her body went limp and her eyes rolled back. I immediately patted her back and yelled her name and she came back to consciousness within a couple of seconds. She cried for a little while and I gave her a pacifier to help soothe her. This all happened between 6:30 and 6:40pm.
Age: 0.75
Sex: F
Vaccine: PNC13
Symptoms: Hypotonia, Irritability, Skin warm, Staring
Clinical narrative: The patient was flush and felt warm to the touch. She didn't register a fever that day but temperature was taken multiple times. She was very fussy (crying and didn't want to eat) around dinner time and I took her upstairs to get her ready for bed around 6:30pm. I gave her the bottle while I changed her diaper and put on pajamas. When I took the bottle away, she stared blankly and I picked her up. Her body went limp and her eyes rolled back. I immediately patted her back and yelled her name and she came back to consciousness within a couple of seconds. She cried for a little while and I gave her a pacifier to help soothe her. This all happened between 6:30 and 6:40pm.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Fatigue, Headache, Nodule, Pain
Clinical narrative: By the next morning had painful quarter size knot, red and hot to the touch. Throbbing pain radiating down right arm from knot. Fatigue, headache.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Skin warm
Clinical narrative: By the next morning had painful quarter size knot, red and hot to the touch. Throbbing pain radiating down right arm from knot. Fatigue, headache.
Age: 84.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Patient experienced swelling at the injection site that would not subside with ice and benadrul
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Dry mouth, Peripheral swelling, Pharyngeal swelling
Clinical narrative: Pt started to have swelling in throat, and swelling in hands complained of mouth dry at 15 mins after receiving flu shot. Pt was seen by nurse practitioner and given Epi Pen, Benadryl 25 mg IM, and non-rebreather was applied. V/S was monitored and EMS was intiated and arrived to pick up patient to take her to the ER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Local reaction
Clinical narrative: Received a call form parent and said they had a local reaction
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Flushing, Heart rate increased, Hypopnoea, Mobility decreased
Clinical narrative: Extreme Pain in arm and shoulder burning of forearm and thumb and first finger,  I am not able to lift my arm because of the pain it is so extreme. Fever of 100, headache, flush, breathing is shallow and rapid heart rate all night long.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: Extreme Pain in arm and shoulder burning of forearm and thumb and first finger,  I am not able to lift my arm because of the pain it is so extreme. Fever of 100, headache, flush, breathing is shallow and rapid heart rate all night long.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Chest discomfort, Dyspnoea, Immediate post-injection reaction, Oral discomfort
Clinical narrative: The patient received an MMR and had difficulty breathing, skin rash, and itching.  She stated immediately after the shot she had a burning feeling on her nose.  After a few hours the shortness of breath and tight chest started.  She had itching on her chest, legs and a rash on chest only.  She admits to her lips and tongue feeling tight.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash, Tongue discomfort
Clinical narrative: The patient received an MMR and had difficulty breathing, skin rash, and itching.  She stated immediately after the shot she had a burning feeling on her nose.  After a few hours the shortness of breath and tight chest started.  She had itching on her chest, legs and a rash on chest only.  She admits to her lips and tongue feeling tight.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Product preparation issue
Clinical narrative: The nurse did not mix the liquid vial (DTap and IPV) with the powder vial (Hib) for the combination of Pentacel. The patient only received DTap and IPV instead of all 3.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 13-FEB-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The lawyer considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MENB
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report from a contactable other healthcare professional on behalf of a physician. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced anaphylaxis after the administration of meningococcal group b rlp2086 on an unspecified date. Outcome of the event was unknown.  Information on the 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: F
Vaccine: PNC13
Symptoms: Allergy to metals, Allergy to vaccine, Drug hypersensitivity
Clinical narrative: Drug allergies: Prevnar, Hydrocodone, Nickel; This is a spontaneous report from a Pfizer sponsored program. A contactable other hcp reported that a 45-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at single dose for immunization, hydrocodone (manufacturer unknown), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication, nickel (manufacturer unknown), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced drug allergies with pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein), hydrocodone, and nickel on an unspecified date. The action taken in response to the event for hydrocodone and nickel was unknown. Outcome of the event was unknown.   Information on the batch number has been requested.
Age: 25.0
Sex: F
Vaccine: MMRV
Symptoms: Vaccination site cellulitis
Clinical narrative: cellulitis at vaccination site, ~ 2x2 inches
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Arthropod bite, Erythema, Papule, Rash vesicular, Skin warm
Clinical narrative: erythematous  warm to touch no drainage Linear vesicular Left groin groin area has a papular lesion with localized erythema no drainage from the tick bite
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Aches and pain from head to toe.  Severe pain all over for 3 days.  4th a little better. 5th day was able to get out of bed. Worse then the shingles that I had in the past. Left arm is still sore.
Age: 10.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Consciousness fluctuating, Dizziness, Headache, Hyperhidrosis, Loss of consciousness
Clinical narrative: A minute or so after receiving both vaccinations, my son said he started blacking out, was dizzy and wanted to vomit. He tried walking over to the sink to throw up, but he fainted. He was carried over by his mother and a nurse to the bed and he was in and out of consciousness for a couple minutes. Doctor came in to assess and he was pale, sweating and his BP was 62/47 with a pulse of 58. Doctor gave him pedialyte and he stayed lying down for about 30 minutes. He was better, but had a headache for a few hours.
Age: 10.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Nausea, Pallor, Syncope
Clinical narrative: A minute or so after receiving both vaccinations, my son said he started blacking out, was dizzy and wanted to vomit. He tried walking over to the sink to throw up, but he fainted. He was carried over by his mother and a nurse to the bed and he was in and out of consciousness for a couple minutes. Doctor came in to assess and he was pale, sweating and his BP was 62/47 with a pulse of 58. Doctor gave him pedialyte and he stayed lying down for about 30 minutes. He was better, but had a headache for a few hours.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Local reaction
Clinical narrative: Localized reaction
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: Arthralgia, Cough, Diarrhoea, Myalgia, Nausea
Clinical narrative: Nausea, cough, diarrhea, joint pain, muscle pain ,throat irritation.  Lasting 5 days  Still not totally resolved   Utilized Tylenol (OTC) around clock every 3.5 hours.
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: Throat irritation
Clinical narrative: Nausea, cough, diarrhea, joint pain, muscle pain ,throat irritation.  Lasting 5 days  Still not totally resolved   Utilized Tylenol (OTC) around clock every 3.5 hours.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Local reaction
Clinical narrative: localized reaction
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling
Clinical narrative: My left eye started swelling like I had the shingles again. I had the shingle previously in the same location.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Patient had a headache, chills, aches, and sore arm. He did not receive any additional treatment, and is doing ok now.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Influenza virus test negative, Pyrexia
Clinical narrative: reported headache, fever of 103 on night of vaccine administration and lasted for the next 2 days and then was gone
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Migraine, Vision blurred
Clinical narrative: Extreme dizziness, migraine headaches for 3+ weeks, difficulty focusing
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Nausea, Pyrexia, Retching, Rhinorrhoea
Clinical narrative: Later that night patient had symptoms of abdominal pain, nausea, rhinorrhea and fevers. Patient described dry heaving as well. Patient states that similar symptoms occurred after the first shot but less severe.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Chills, Headache, Influenza, Influenza virus test negative, Pain
Clinical narrative: Mother called reporting fever of 101 with chills and sever body aches and headache on the night after the vaccine was given. The fever and symptoms lasted for 2 days and then was gone.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Pyrexia
Clinical narrative: Mother called reporting fever of 101 with chills and sever body aches and headache on the night after the vaccine was given. The fever and symptoms lasted for 2 days and then was gone.
Age: 43.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Burning sensation, Cough, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Localized redness and swelling at sights of injection. Itching, burning and redness to left upper extremity reported by patient. No SOB, but slight cough present. Denies nausea, throat swelling or difficulty swallowing. No angioedema and no anaphylaxis. Patients received vaccinations on 09/16 @ 12:50p symptoms developed during 09/17 leading to presentation morning of 09/18. Treated with diphenhydramine 25mg capsule PO once, famotidine 20mg tablet PO once, and prednisone 60mg tablet (3x20mg) PO once. Patient discharged after short observation post-administration of the above medications.
Age: 43.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pruritus
Clinical narrative: Localized redness and swelling at sights of injection. Itching, burning and redness to left upper extremity reported by patient. No SOB, but slight cough present. Denies nausea, throat swelling or difficulty swallowing. No angioedema and no anaphylaxis. Patients received vaccinations on 09/16 @ 12:50p symptoms developed during 09/17 leading to presentation morning of 09/18. Treated with diphenhydramine 25mg capsule PO once, famotidine 20mg tablet PO once, and prednisone 60mg tablet (3x20mg) PO once. Patient discharged after short observation post-administration of the above medications.
Age: 28.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effect, patient given adolescent dose
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Neck pain
Clinical narrative: The morning following vaccination, patient reported a splitting headache and a severely sore neck. This persisted for 2 days. Patient's mother gave ibuprofen, which seemed to help. Upon follow up on Day 5, symptoms have almost completely subsided and now reporting a mildly sore neck.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Impaired work ability, Lethargy, Nasopharyngitis, Nausea
Clinical narrative: This was for the Shingrix shot. First shot I had a 4" diameter welt that was itchy and painful. The welt lasted 3 weeks.  Second shot I experienced congestion, bad headache, fever of 101, nausea, body aches, lethargy, sore throat in less than 24 hours after the shot. Could not go to work. Day 2 I have cold-like symptoms, lethargy.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: This was for the Shingrix shot. First shot I had a 4" diameter welt that was itchy and painful. The welt lasted 3 weeks.  Second shot I experienced congestion, bad headache, fever of 101, nausea, body aches, lethargy, sore throat in less than 24 hours after the shot. Could not go to work. Day 2 I have cold-like symptoms, lethargy.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient inadvertently received an expired dose of VARlVAX on 9/13/2019. No adverse effects reported.; the patient inadvertently received an expired dose of VARlVAX on 9/13/2019. No adverse effects reported.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 13-SEP-2019, the patient inadvertently received an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot# N022996 with expiration date of 23-AUG-2019, for prophylaxis (route and frequency were not reported). Concomitant therapies included sterile diluent (DILUENT MRK INJ) with lot# N021894 with expiration date of 28-NOV-2019.      No adverse effects were reported. No additional information provided.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: one patient was administered a dose of PNEUMOVAX 23 which was improperly stored. No adverse effects reported.; one patient was administered a dose of PNEUMOVAX 23 which was improperly stored. No adverse effects reported.; This spontaneous report was received from a pharmacy manager and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R027299 with expiration date of 09-APR-2020, for prophylaxis (route and frequency were not reported). No adverse effects were reported.    It was stated that the vaccines underwent a temperature excursion above 47°F (degrees Fahrenheit): 57F 59 minutes. The call was because of a "data logger". No further information was provided. There was no Product Quality Complaint (PQC) involved in this case.
Age: 72.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: "72-year-old patient was administered GARDASIL 9 today." No adverse effects reported.; "72-year-old patient was administered GARDASIL 9 today." No adverse effects reported.; This spontaneous report was received from an administrator and refers to a 72 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 16-SEP-2019, reported as "today", the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (route, frequency, lot/batch # and expiration date were not reported). No adverse effects were reported. No further information provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; one patient received an improperly stored VARlVAX; This spontaneous report was received from a nurse and concerns to a 4 year old patient of unknown gender. The patient's historical condition, and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.     On 13-AUG-2019,  the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dosage schedule, route, anatomical location were not reported)(it can not be determined with which lot number was vaccinated the patient (R006221 and expiration date 29-FEB-2020 or R029517 and expiration date 14-OCT-2020)) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 8 hours as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-1909USA002960: US-009507513-1909USA006331: US-009507513-1909USA006332: US-009507513-1909USA006330: US-009507513-1909USA006334: US-009507513-1909USA006329: US-009507513-1909USA006328: US-009507513-1909USA006341:
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: rash; This case was reported by a consumer via call center representative and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th July 2019, the patient received the 1st dose of Shingrix. In July 2019, 1 day after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. About 24 hours after the vaccine the patient had a red rash across patients torso.  The patient reported to the pharmacy the patient received it from they informed me that it was not a side effect. For tolerance after 2nd dose refer case US2019AMR166978.
Age: 77.0
Sex: M
Vaccine: HEPA
Symptoms: Hepatitis A antibody negative, Therapy non-responder
Clinical narrative: therapy non-responder; This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 77-year-old male patient who received HAV (Havrix adult) (batch number 37RY4, expiry date 6th March 2021) for prophylaxis.   On 17th June 2019, the patient received Havrix adult. In July 2019, less than 3 weeks after receiving Havrix adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Havrix adult.  Additional details were provided as follows: The patient received a dose of Havrix in the right arm had his blood work done about 2 and a half weeks later and it was negative for hepatitis A antibodies. The physician recommended to get revaccinated after 7th September 2019. The patient consented to follow up.      Lab Comments: On an unknown date lab test was performed
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: fatigue; muscle aches; fever; lump at the injection site; swollen at the injection site; red at the injection site; hot at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 59EA2, expiry date 13th September 2021) for prophylaxis.   On 19th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fatigue, muscle pain, fever, injection site lump, injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the fatigue, muscle pain, fever, injection site lump, injection site swelling, injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the fatigue, muscle pain, fever, injection site lump, injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient experienced fatigue, muscle aches and fever. The patient was concerned because she also experienced a lump underneath the injection site that got swollen, red and hot. All the events lasted for 7 to 10 days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: fatigue; muscle aches; fever; lump at the injection site; swollen at the injection site; red at the injection site; hot at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 59EA2, expiry date 13th September 2021) for prophylaxis.   On 19th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fatigue, muscle pain, fever, injection site lump, injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the fatigue, muscle pain, fever, injection site lump, injection site swelling, injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the fatigue, muscle pain, fever, injection site lump, injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient experienced fatigue, muscle aches and fever. The patient was concerned because she also experienced a lump underneath the injection site that got swollen, red and hot. All the events lasted for 7 to 10 days.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness at the injection site; Injection site was red; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019, the patient received the 1st dose of Shingrix. On 6th September 2019, 1 days after receiving Shingrix, the patient experienced injection site pain. In September 2019, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site erythema was recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and developed soreness at the injection site. Also, the injection site was red and the redness extended approximately three inches down from the injection site. She said that at the time of reporting the redness was almost gone. Her arm was still sore, but it was less sore than it was initially. The reporter consented to follow up. The reporter gave permission for her physician to be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: fever; headache; shivering; muscle pain; dizziness; weakness; itchiness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced fever, headache, shivering, muscle pain, dizziness, weakness and pruritus. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, headache, shivering, muscle pain, dizziness, weakness and pruritus were unknown.   It was unknown if the reporter considered the fever, headache, shivering, muscle pain, dizziness, weakness and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but would be between 77 and 78 years. The patient experienced fever, headache, shivering, muscle pain, dizziness, weakness and itchiness. The patient was not been seen by her doctor and that she had been taking Tylenol to help with the side effects. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: fever; headache; shivering; muscle pain; dizziness; weakness; itchiness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced fever, headache, shivering, muscle pain, dizziness, weakness and pruritus. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, headache, shivering, muscle pain, dizziness, weakness and pruritus were unknown.   It was unknown if the reporter considered the fever, headache, shivering, muscle pain, dizziness, weakness and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but would be between 77 and 78 years. The patient experienced fever, headache, shivering, muscle pain, dizziness, weakness and itchiness. The patient was not been seen by her doctor and that she had been taking Tylenol to help with the side effects. The patient consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Influenza like illness, Malaise, Pain
Clinical narrative: flu like symptoms; body aches; Dizziness; brain fog; malaise; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 2nd July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd July 2019, immediately after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, dizziness, foggy feeling in head and malaise. On an unknown date, the outcome of the influenza-like symptoms, general body pain, dizziness, foggy feeling in head and malaise were resolved with sequelae.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, dizziness, foggy feeling in head and malaise to be related to Shingrix.  Additional details were provided as follows: On 14th April 2019, the patient received the 1st dose of Shingrix. The patient immediately after receiving 2nd dose of Shingrix in the right deltoid experienced flu-like symptoms, body aches, dizziness, brain fog, and malaise lasting for one month. At the time of reporting all the events had resolved. The reporter did not consent to follow up.
Sex: M
Vaccine: PNC13
Symptoms: Atrial fibrillation, Blood cholesterol increased
Clinical narrative: a fib; Cholesterol high; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. This non- contactable Nurse reported that a 69-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  It was reported that the patient experienced Cholesterol high and a fib on an unspecified date. Events took place after use of product. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, Cholesterol high and fib represent intercurrent medical condition representing common cardiovascular occurrences in the patient with 69 years of age.  No known biological plausibility and close time association speak for the relatedness of the events with the vaccination.  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 and Investigators, as appropriate.
Sex: M
Vaccine: PNC13
Symptoms: Blood cholesterol increased, Cellulitis, Erythema
Clinical narrative: Cellulitis-arm turned red in about 15-20 minutes after immunization and the redness ran down the arm; Cellulitis-arm turned red in about 15-20 minutes after immunization and the redness ran down the arm; This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 69-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history included cholesterol high and atrial fibrillation (a fib). Concomitant medications were not reported. The patient experienced cellulitis-arm turned red in about 15-20 minutes after immunization and the redness ran down the arm on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, the vaccination with PREVNAR might play a contributory role in triggering the occurrence of cellulitis in arm.  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 and Investigators, as appropriate.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Joint range of motion decreased, Swelling
Clinical narrative: moderate to severe redness, pain at injection site; moderate to severe redness, pain at injection site; Swelling; Decreased range of motion.; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age (reported as age: 69, unit: unknown) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: X62332), via an unspecified route of administration on the left deltoid on 08May2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that 5 days after in office infection, patient contacted office for moderate to severe redness, pain at injection site on an unspecified date in 2019. Swelling, decreased range of motion were also reported on an unspecified date in 2019. The patient was seen in the office on 13May2019 and was prescribed Keflex (unspecified for which event). No other 5 injections were given. The outcome of the events was unknown.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling cold, Headache, Influenza like illness, Injection site pain
Clinical narrative: Patient reports that she got the first Shingrix vaccine Friday Sept 13, 2019 around 2pm, and around 10pm suddenly got cold, "felt like I had the flu" - no energy, whole body ached, had a headache; she's not sure if she had a temp, did not check; the last symptom to resolve was the headache, which was gone around 5pm on Saturday the 14th. No N/V. She also had soreness at the injection site. She did have 3 allergy shots around noon that day, 2 in right arm, 1 in left; the Shingrix was given in the left deltoid.