chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; stomach pain; headache; Diarrhea; shaking; body ache; no appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach pain"; HEADACHE (non-serious), outcome "unknown", described as "headache"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; TREMOR (non-serious), outcome "unknown", described as "shaking"; PAIN (non-serious), outcome "unknown", described as "body ache"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse referring to a 1 year old patient of unknown gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On 15-NOV-2016, the patient was inadvertently administered a dose of PROQUAD (lot #, expiration date, dose and route were not reported) and a dose of VARIVAX (lot #, expiration date, dose and route were not reported), simultaneously. No adverse effects were reported. Additional information has been requested.
PT FAINTED SUDDENLY 5 TO 10 MIN AFTER GETTING ADACEL (TDAP) AND HAVRIX (HEP A) AROUND 5:55PM.
64 year old patient given FLUZONE HIGH-DOSE QUADRIVALENT with no reported adverse event; Initial information received on 20-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 64 years old male patient who was given fluzone high-dose quadrivalent with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE) for Immunisation.  On 19-Oct-2022, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ919AD and expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for prophylactic vaccination.  On 19-Oct-2022, (latency: same day) the 64 year old patient was given fluzone high-dose quadrivalent with no reported adverse event (product administered to patient of inappropriate age) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, two 64 year old patients were given FLUZONE HIGH-DOSE QUADRIVALENT per their request when they declined FLUZONE QIV.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.; Sender's Comments:  US-SA-2022SA439832:
Initial report received on 02 January 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 19 month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3772AA received on 19 July 2011, lot number C3895AA received on 20 September 2011 and lot number C3923AA received on 17 January 2012 (routes and sites of administration not reported). Approximately 10 months after the last dose, on 11 December 2012 the subject developed a cough and paroxysmal cough on 18 December 2012 without a whoop. The subject also experienced posttussive vomiting, sleep disturbance, and apnea. Laboratory testing included positive PCR on 21 December 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 21 December 2012 for five days. The subject was not hospitalized. At the time of final contact on 27 December 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Slight fever for a week (never over 99 degrees). One week later developed hives on injection site.
Side effects - fever, chills, numb tongue, numb lips, numb fingers, blister under tongue - all gone within 24 hours.
Chills, aches, pain in neck per patient approximately 24 hours after vaccine. 2 days, post vaccine - arm slightly swollen & red, minimal pain.
Intense dizziness and loss of balance (an disorientation) and a fast heartbeat, on rising. Stayed in bed and rested for three more hours.
Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: RASH ON ARM AND BACK-Severe, Additional Details: PATIENT BROKE OUT IN RASH AND ABOUT 2 TO 4 DAYS OF RECEVING SECOND DOSE OF PFIZER COVID VACCINE AND SHE IS STILL ITCHING . THE RASH IS STILL VISIBLE AND I RECOMMENDED BENADRYL
LOCALIZED RED SWOLLEN AREA WHERE INJECTION WAS GIVEN. VERY SORE. SIZE OF AN ORANGE.
Information has been received from a physician concerning a pt who was vaccainted with  a dose of Rotavirus vaccine. it was reported that the pt was experiencing diarrhea for 14 days post vaccination. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Headache Exaggerated arm pain Dizziness Nausea Chill Altered organs, muscles and back problem while breathing
got shingles after second shot/Suspected vaccination failure; shingles; 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 Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient got the Shingles vaccine and got the shingles after 2nd shot. So the reporter thought it would be safe to say yes. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Decline in condition 12/11/2022 followed by death on 12/19/2022
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 59-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 26-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Mother phones public health office in the AM of 1/7/2016 to report suspected reaction to influenza vaccine. Reports child to be fatigued, fussy, not her self, axillary temperature of 102-103 degrees F, and red pinpoint at injection site. Child also had PCV13, Pediarix, and Hib that same day. None of the other sites are red or significant. Mother reports has been giving child recommended dose of acetaminophen on schedule. Encouraged hydration, cool sponge bath, and notified mother of symptoms that would be significant enough to bring child to ER. Mother reports understanding. Public Health nurse phones mother again at 4:45 PM on 1/7/2016 to check on child. Mother reports child's fever has gone down and is now at 100.8 degrees F. Child is now acting more like herself and eating and drinking normally. Mother will call with any additional questions.
a rash first noticed on 8NOV96 morning;warm to palpation;borderline sl raised;size 2.5 x 1.5; t98;no resp problems;no GI complaints;physically healthy & nl;
No immediate or other reaction at all to vaccine; injection site completely pain free. Felt perfectly healthy except for this new tinnitus condition.  About 48 hours after Pfizer vaccine dose #1, ears began to feel full/pressure.  The next day was peak "fullness" but also noticed start of tinnitus.  The tinnitus has remained constant ever since.  It sounds like a bilateral/stereo 18 kHz sine wave at 30 dB.   Primary care doc referred to audiologist, audiologist referred immediately after testing to ENT.  After discussing with ENT, was prescribed tapering course of prednisone (60mg/day for 10d, 40mg/day for 4d, 20mg/day for 5d), which I began on 4/14.  Symptom has continued unabated.
Felt extremely dizzy, never felt dizzy before; Muscles of back were tight; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt extremely dizzy, never felt dizzy before) and MUSCLE TIGHTNESS (Muscles of back were tight) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced DIZZINESS (Felt extremely dizzy, never felt dizzy before) and MUSCLE TIGHTNESS (Muscles of back were tight). At the time of the report, DIZZINESS (Felt extremely dizzy, never felt dizzy before) and MUSCLE TIGHTNESS (Muscles of back were tight) had not resolved. Not provided. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Patient parent had no vaccination record when coming to clinic. CMA checked Registry and vaccinated client. After reviewing records from system found patient had already received required doses of Dtap,HepA,PVC13 and HIB. Patient received vaccines that were not needed
thumb with faint pink area on pad, scattered papulopustular lesions on trunk, neck and a few on extrems, spares palms, soles and scalp at present
swelling or puffiness of lip; some numbness; Itchy rash/itchy blotches; Rash; red itchy blotches/spots in upper chest and neck; This case was reported by a consumer via call center representative and described the occurrence of rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) unknown for product used for unknown indication.   On 27th June 2022 10:00, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Nucala at an unknown dose and frequency. On 27th June 2022, less than a day after receiving Shingrix and unknown after starting Nucala, the patient experienced rash, red blotches and itchy rash. On 28th June 2022, the patient experienced lip swelling and numbness. The action taken with Nucala was unknown. On an unknown date, the outcome of the rash, red blotches, lip swelling and numbness were not recovered/not resolved and the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the rash, red blotches, lip swelling, numbness and itchy rash to be related to Shingrix and Nucala.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The case was reported by the patient. The reporter who called to report side effects of Shingrix.  She stated that, 1-2 hours after vaccination she noted a rash which she described as red itchy blotches/spots in the upper chest and neck area.  At the time of reporting, she noted some swelling or puffiness to the corner of her lip and some numbness. The symptoms had not yet resolved.  The patient stated that, she also recently was started on Nucala.  The reporter provided medical advice disclaimer and referred to healthcare professional. The reporter consented to follow up.
Adult dose of Pfizer vaccine was given to 8year old child.  The child did not receive the kid version of the vaccine.
Severe chills, dizziness, chest pain, palpitations, nausea, severe body aches
Patient's Home Health Aide reported patient had PCV13 on 5/11/2018, this morning when patient got up, upper body trembling, also noticed swelling below injection site about 1-2" with skin rash, ate breakfast, still tremble, called 911, sent to ER.
Pt received her flu shot in her left deltoid, during administration of her COVID Spikevax in her right deltoid, she began to appear shaky, her head sunk forward and she slumped forward out of her chair, her fall was slowed as an attempt to catch the patient was made. Upon impacting the ground the patient "came to". Pt was evaluated and was discovered to have a small laceration on her forehead (carpet burn), but otherwise no outward signs of injury. Pts BP was 79/48, she presented as lightheaded and claimed she was "probably dehydrated". Pt was given a bottle of water and allowed to rest for several minutes, after approx 5 minutes time, pt wanted to return to her chair. She was assisted to her chair by her mother, myself (pharmacist), and my technician whom had administered the vaccines.
Dry, flat, red rash to face, neck, ears and chest. No other symptoms present. Rash remained visible 7-8 minutes. Pt states she ate sunflower seeds moments before the rash appeared and stated "I always get this when I eat sunflower seeds".
Received varicella vaccine left thigh on 12/12/06. PT RTO 12/22/06 with redness left thigh size of quarter.
pt came home took Tylenol and went to bed.  He developed 103.6 fever.  He was nauseated and had diarhea.  Pt says he felt so bad he couldnt move for about 4 hours.  He says now his fever is dropping and think his symptoms are getting better.  Pt will call his PCP if symptoms do not get better.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, reported as since December 2013, the patients were possibly administered doses of RECOMBIVAX HB injection 10 "Y" (dose, route and lot number were not reported) which were not stored properly. No adverse effects were noted. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Second Shot at 9:15 am I felt great all day. Extreme chills and shivering started at 7:15 pm. An internal cold I couldn?t warm. Fever started a couple hours later. Fever of 101-102 through the night. I had 103 fever at 10:30 Saturday morning. Achey, indigestion, heartburn, gassy, and basically down for the count. I had no appetite, from lunch on Friday to Saturday night. I was however thirsty. I was very sick and didn?t leave my bed until today(Sunday).  Today I feel extremely weak and spent but way better than I was.
Tested positive for COVID-19 test; Tested positive for COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with therapy date and route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after the first dose of vaccination, the patient had tested positive for COVID-19 test. The outcome of the event was unknown. The patient was asking how long to wait to get the second dose of vaccination.  Information on the lot/batch number has been requested.
Hospitalization: 10/8/2022 - 10/18/2022  Presentation to the ED: FALL W/ R KNEE AND LEG PAIN.  COVID + date: 10/13/2022. Treatment: Decadron and remdesivir, SUPPLEMENTAL OXYGEN.  Discharge to: SNF
PFIZER MONOVALENT VACCINE GIVEN AS BOOSTER ON 09/01/2022.  RECEIVED EMAIL ORDERING THE DISCONTINUATION OF USING PFIZER MONOVALENT VACCINE ON 09/01/2022 2 3:42 pm.   NO PHYSICAL ADVERSE REACTION IN PATIENT.
23AUG 6PM chills, fever 101 orally, body aches, joint aches, pins & needles in both hands; local swelling redness & soreness in lt deltoid (inject site); 24FEB lethargy, achy all over; 25FEB lethargy only; 26AUG back to nl;
suspected vaccination failure; shingles twice; This case was reported by a consumer via (Shingrix  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient.  The age at vaccination was not reported. The patient had shingles twice after being vaccinated for shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided
This spontaneous report received from a patient concerned a male of unspecified age of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, patient had Covid (coded to suspected clinical vaccination failure) and was positive (coded to suspected covid-19 infection) after being tested at the pharmacy in which he received the results 2 hours later. Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000203023.; Sender's Comments: V0: 20211142926-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Influenza-like symptoms; injection site soreness; Generalized tiredness; generalized muscle soreness; body aches; malaise; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received at the age of 48 years) and Hepatitis B vaccine with an associated reaction of therapy non-responder (received 6 doses over past 20 years, refer case US2019GSK093765).   On 15th May 2019, the patient received Shingrix. On 16th May 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, injection site pain, tiredness, generalized muscle aches, general body pain and malaise. On an unknown date, the outcome of the influenza-like symptoms, injection site pain, tiredness, generalized muscle aches, general body pain and malaise were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site pain, tiredness, generalized muscle aches, general body pain and malaise to be related to Shingrix.  Additional details were provided as follows: The reporter was the concerned patient. In the morning of reporting day, the patient experienced flu-like symptoms which lets him know a response was being stimulated.  The patient reported generalized tiredness, generalized muscle soreness, body aches, malaise, and injection site soreness. Injection site soreness was no worse than a Tetanus shot (unspecified vaccine).
Mosquito bite like reaction at the injection site; Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and VACCINATION SITE REACTION (Mosquito bite like reaction at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced URTICARIA (Hives). On an unknown date, the patient experienced VACCINATION SITE REACTION (Mosquito bite like reaction at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives) had resolved and VACCINATION SITE REACTION (Mosquito bite like reaction at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Patient was fine now   Most recent FOLLOW-UP information incorporated above includes: On 19-Mar-2021: Additional information received and new event Mosquito bite like reaction at the injection site was added On 19-Jun-2021: Additional information received and updated about 2 nd dose
Approximately 10-15 minutes post vax, pt developed erythema at injection site. Pt was crying uncontrollably and could not be comforted by parents. Pt treated with Benadryl. Redness also developed at this site.