chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vax at noon. Mid day knot in arm, painful, achy. Terrible HA, nauseated, head pounding. Went to bed. No fever. Tues HA, Wed HA. Started feeling better by weekend.
6MAY96 devel varicella-like lesions on scalp,3 on face,1 on abd;no fever or other sx;resolved p/several days w/o tx
Expired Twinrixadministered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 53-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th February 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 16th February 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter was medical assistant. The reporter called to report that a patient received an expired Twinrix dose at the time of reporting. The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up via email/ fax. Additional Supportive Information: The reporter called to report that a patient received an expired Twinrix dose, which led to expired vaccine used.
Bell's palsy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: BELL'S PALSY (medically significant), outcome "recovered with sequelae". The event "bell's palsy" required emergency room visit. Therapeutic measures were taken as a result of bell's palsy.  Clinical information: It was reported that patient had no Known allergies. Patient did not receive any other vaccine within four weeks of vaccination. Patient had not taken other medication in two weeks of vaccination. Patient had not COVID prior to vaccination and not tested for COVID post vaccination. The device date was mentioned as 30Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She had pain, the next day after the shot was done, on her left arm. The pain lasted 3 months. After that the pain started on her shoulder too. She is taking Tramaolol and Methylprednisdone. Per annual follow, hundreds of the same vaccine lot # and dose were administered without any negative complaints. Follow-up: Without further evaluation - one can not say with certain authority that this event was related to the Vaccine.
Doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist reported that they gave 26 doses after the 30-day use by date. Pharmacist would like to know if those doses were viable or not. Number of doses/vials: 26 Date the vial was initially stored in the refrigerator : 14Jan2022  Date(s) of administration of vaccine: 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022.Vial did not undergo any temperature excursions. No concomitant products were reported. No treatment information was reported. .
Hives, burning sensation in chest, tightness, difficulty breathing, rapid heart rate, high blood pressure.
Shoulder joint and deltoid muscle pain, worsening over the last 4 weeks to the point patient can no longer raise arm and has swelling in the shoulder joint.
pain all over my body/Body aches; itching; chills; headache; joint pain; vomiting; fatigue; muscle and body aches; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Aug2021 10:45 (Lot number: Evv0169) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Borderline high bp" (unspecified if ongoing); "known allergies : penicillin" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN. The following information was reported: PAIN (non-serious) with onset 23Aug2021, outcome "not recovered", described as "pain all over my body/Body aches"; PRURITUS (non-serious) with onset 23Aug2021, outcome "not recovered", described as "itching"; CHILLS (non-serious) with onset 23Aug2021, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 23Aug2021, outcome "not recovered", described as "headache"; ARTHRALGIA (non-serious) with onset 23Aug2021, outcome "not recovered", described as "joint pain"; VOMITING (non-serious) with onset 23Aug2021, outcome "not recovered", described as "vomiting"; FATIGUE (non-serious) with onset 23Aug2021, outcome "not recovered", described as "fatigue"; MYALGIA (non-serious) with onset 23Aug2021, outcome "not recovered", described as "muscle and body aches"; DIARRHOEA (non-serious) with onset 23Aug2021, outcome "not recovered", described as "diarrhea". The events "pain all over my body/body aches", "itching", "chills", "headache", "joint pain", "vomiting", "fatigue", "muscle and body aches" and "diarrhea" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, pruritus, chills, headache, arthralgia, vomiting, fatigue, myalgia, diarrhoea.  Additional information: The patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 10:45 AM (Lot number: EH0150) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. List of any other medications the patient received within 2 weeks of vaccination includes Tamsulosin. Adverse event treatment: medication/ongoing stress exam/heart monitor. Prior to vaccination, the patient was  not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Covid test post vaccination on 12Sep2021: covid test type post vaccination=Nasal Swab, covid test result was Negative. Device Date : 25Oct2021  Follow-up (28Oct2021): Follow-up attempts are completed. No further information is expected.
Patient came into walk up clinic to receive Pfizer vaccine. Patient didn't disclose she had already received Janssen on 4/1/21 at another clinic site. No information documented in  at the time. Patient received first dose 4/23/21 and returned for the second dose on 5/14/21. No adverse reaction noted during the 15 minute post vaccination observation period of either instance.
reports enlarged lymph node, headache, and arm pain since the day after his immunization.  He reports headache and arm pain have been intense at times, but reports some relief after taking acetaminophen. He reports these symptoms have disrupted daily activities at times.
Redness, soreness, swelling, itching cellulitis (4 inches), hot for itching takes some Diphenhydramine.
After injection, patient reported a racing heartbeat and onsite EMS was notified.  Patient also had redness in back of throat.  Given 50mg of Benadryl IM and transferred to ED.
was sick for 3 weeks and 2 days after the vaccine; fever; Head congestion; Woke up the next day not feeling well; Fatigue; Upper chest congestion; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (Upper chest congestion), OROPHARYNGEAL PAIN (Sore throat), ILLNESS (was sick for 3 weeks and 2 days after the vaccine), MALAISE (Woke up the next day not feeling well) and FATIGUE (Fatigue) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The Caller reported that her son had COVID in September/October one month after moving to another city).    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced RESPIRATORY TRACT CONGESTION (Upper chest congestion), OROPHARYNGEAL PAIN (Sore throat), MALAISE (Woke up the next day not feeling well), FATIGUE (Fatigue) and HEADACHE (Head congestion). On 27-Apr-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced ILLNESS (was sick for 3 weeks and 2 days after the vaccine). On 03-May-2021, RESPIRATORY TRACT CONGESTION (Upper chest congestion), OROPHARYNGEAL PAIN (Sore throat), MALAISE (Woke up the next day not feeling well), FATIGUE (Fatigue), PYREXIA (fever) and HEADACHE (Head congestion) had resolved. At the time of the report, ILLNESS (was sick for 3 weeks and 2 days after the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 99.5-100 degree f The patient got a fever that ranged from 99.5-100.2 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  The patient got an antibiotic to relieve the symptoms.  Action taken with mRNA-1273 in response to the event was unknown
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date these unknown number of patients were vaccinated with ROTATEQ (lot#, dose not reported, default route: oral) that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/23/21Lot#ER8727 2nd dose 04/13/21,lot#EW0150 Diagnosed covid positive:08/05/21 Symptom onset:08/03/21 Exposure:community Symptoms:fatigue,runny nose,sore throat,headache.
Normal scheduled c-section delivery on 11/15/2021. Hospital admission within 6 weeks of receiving the COVD vaccine.
Patient states she developed swelling and redness of skin where the vaccine was given (3 days after the Td was given to left deltoid muscle). She had pain also. Today that is visible, redness and swelling of left arm down to patient's elbow.
Abdominal pain lower right side; diarrhea; loss of appetite; spasms all unexplained; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 12:00 (Lot number: ER8727) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number:1, administration time: 12:00 PM, vaccine location: Right arm, lot number: En6205), administration date: 03Mar2021, when the patient was 59 years old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN LOWER (non-serious) with onset 29Jul2021 13:00, outcome "not recovered", described as "Abdominal pain lower right side"; DIARRHOEA (non-serious) with onset 29Jul2021 13:00, outcome "not recovered", described as "diarrhea"; DECREASED APPETITE (non-serious) with onset 29Jul2021 13:00, outcome "not recovered", described as "loss of appetite"; MUSCLE SPASMS (non-serious) with onset 29Jul2021 13:00, outcome "not recovered", described as "spasms all unexplained". The events "abdominal pain lower right side", "diarrhea", "loss of appetite" and "spasms all unexplained" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abdominal pain lower, diarrhoea, decreased appetite, muscle spasms.  Follow-up (02Sep2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101100617 Same reporter/drug/event, different patient.;US-PFIZER INC-202101100616 Same reporter/drug/event, different patient.;US-PFIZER INC-202101100615 Same reporter/drug/event, different patient.
Woke up twice not really feeling right.  Restless sleep and woke up the second time with stomach upset as if going to have diarrhea.  minor lower stomach cramping.   Did have a bowel movement within 2 hours that was soft with lower abdominal discomfort but wasn't diarhhea.  Felt as if a headache was starting
Passed out; Nauseated; Having hard time in breathing; Made him sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 76 year-old male patient received bnt162b2 (BNT162B2), administration date 29Jan2022 13:00 (Lot number: FL3198, Expiration Date: Jun2022) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lungs problem" (unspecified if ongoing); "Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (2nd dose, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset Jan2022, outcome "unknown", described as "Passed out"; NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nauseated"; DYSPNOEA (non-serious) with onset Jan2022, outcome "unknown", described as "Having hard time in breathing"; ILLNESS (non-serious) with onset Jan2022, outcome "unknown", described as "Made him sick". No follow-up attempts are possible. No further information is expected.
03/29/2021 Patient 63-year-old male Reporting patient reaction to Covid-19 vaccination. 8:32 AM patient received 0.5ml Moderna vaccine IM in left deltoid 8:38 AM Patient experienced tightening of airway  8:39 AM EMS contacted  8:39 AM received 0.3 Epinephrine IM left arm 8:39 oxygen at 2 liters per minute applied nasal canula  8:42 vital signs BP 160/110 HR 70 oxygen 97% 8:47 Epinephrine 0.3 ml IM left arm 8:48 vital signs BP 164/104 HR 68 O2 99% 8:48 EMS arrived Patient left with EMS 8:56 AM of own power and was transported to local hospital for evaluation. 03/30/2021 9:45 AM contacted patient to check condition. Patient reports that he was monitored for approximately 2 hours and released. Patient denies any further reactions or side effects.
High fever, no energy. Felt as bad or worse than when I had Covid-19. Took generic Advil, fever came down quickly, still felt pretty awful the rest of the day. Stated feeling better by the next day. Took me 3 or 4days to feel "normal" again.
Post vaccine patient became lightheaded O: unresponsive x 30 sec; HR 64 regular; O2 99% 1:50 pm BP systolic 100; diaphoretic; pale; RN present 1:55pm - color improving; answering questions correctly O2-4L nasal canuli; EMT RN present applied ice to neck 2:05pm - pt admits to h/o syncope with bld work HR - 68; radial BP 140/100 2:10p called for ambulance, patient denied medical attention. Patient spoke with wife, she'll escort patient home 2:30pm pt sitting comfortably with no problems S: I feel much better O: HR 72 BP 150/110 (radial) RR 12 O2 100% A/P: syncopal episode post vaccination provided H2O / apple juice ice to back of neck elevated legs check BP / HR q 15 min EMT/RN present discharged to wife to home encouraged patient to f/up with primary care MD for routine physical, annual bld work f/u with patient tonight via phone call discharged pt @ 3:30pm to daughter
Erythema 16cm X 18cm on right arm with induration at DT site.
Initial misuse report received from a healthcare professional on 19 June 2013. A child had received DTaP-IPV portion of PENTACEL vaccine without the HIB portion. No adverse event was reported. Documents held by sender: None.
during administration of the Fluad vaccine, the vaccine itself seeped out of the syringe/needle all over the floor.  The patient did not receive much of the vaccine if any.  The dose was re administered at least one inch from original injection site due to comirnaty vaccine in the other arm.
9 days after vaccine mild fever jumped to 101.9. fluctuated between 100.5 and 103.1 for 7 days. Fever also brought Diarrhea, severe nausea, muscle aches, chills and stomach pain. Took Tylenol, Ibuprofen, Nyquil and nothing broke the fever. Today, day 8 fever is starting to break but still have other symptoms.
Pt received immunizations (DTAP, IPV, Prevnar) on 8/25/04 rash started on 28th/29th Urticaria, had viral illness at time of urticaria. Seen in clinic 9/2 for eval. Tx'd Benadryl. No viral illness at time of shots.
Accidentally gave a 5th dose of moderna vaccine to patient and another dose of flu vaccine.   I forgot to run a Immunization report before evaluating patient's immunization history.   Afterwards, when I was entering the info in the Immunization database, I saw patient already got flu vaccine (8/14/21  and Moderna (2 doses at Health Clinic (3/1/21, 3/29/21) AND pharmacy (11/03/21, 1/24/02)).  I notified the pharmacists at pharmacy and store, and spoke to the health office.   Patient denied every getting any aforementioned shots above.   She told myself and tech that this was her first shot at the drop-off station.    After a 15 minute observation period, patient didn't report any adverse outcomes.
This case was reported by a physician via sales rep and described the occurrence of shingles in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 2nd dose of SHINGRIX. On 29th August 2018, 28 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician for for himself. Four weeks after receiving SHINGRIX, the patient experienced mild case of shingles.
About 10 minutes after first dose (lot EN 6202, 2/25/21), briefly felt very flush in the face and faint. That passed quickly. Then had extreme burning sensation near injection site for about a minute. Did not report this at the time or before the second vaccine for fear of not being given the second injection.  About 10 minutes after second dose, suddenly realized it was difficult to breathe. Removed mask. Started to feel better after a few minutes, replaced bottom, more breathable mask (did not report to observers). Was urged to leave vaccination site due to backlog of patients, so walked back to car. Began to feel pretty out of it (faint again, plus heart racing) on the way back to the car. Considered getting the shuttle back to the injection site, but instead sat in the car until it passed. About 25 minutes after the vaccine, started feeling very hot all over. 30-40 minutes after the vaccine, all reactions seemed to have passed and drove home without incident.
m.d. rpt after 1st dose of vax pt broke out in hives & exp difficulty in breathing 20 minutes after the vax.
Fever , chills, severe body aches, neck stiffness, heal tenderness , back pain
Modern a COVID 19 Vaccine EUA. I got pressure in my head, dizzy, tired  and most of all I had a strong metallic taste in my mouth. The injection site hurt very bad so whenever I put an ice pack on it the metallic taste came back until I removed the ice pack.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 17-year-old male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSSERO. Additional information was provided as follows: The age at vaccination was not reported, but it could be 16 or 17 years. The patient received BEXSERO and experienced injection site pain lasted a week. The reporter gave consent to follow up. This case linked with case US2019GSK015211, reported by same reporter.
This spontaneous report as received from a Certified Medical Assistant refers to a female patient of unknown age with no pertinent medical history and no drug reaction or allergies. In 2009, the patient was vaccinated with live ZOSTAVAX lot # 665306/1150Y exp. 13-FEB-2011, 0.65 ml, subcutaneous (site of administration not reported). There was no concomitant medication. The reporter stated that the patient came down with a case in approximately November 2012 ("about 2 months ago"). The patient was treated with medications (unspecified) for shingles but she came down with another case of shingles in approximately December 2012 ("3 weeks after her first episode"). The reporter suspected that live ZOSTAVAX the patient received back in 2009 might have been improperly stored in a refrigerator for unspecified amount of time, and was administered to patient. The reporter did not have detailed temperature excursion information. The patient sought medical attention by an office visit. There was no laboratory tests performed. The outcome of shingles is unknown. The causality for shingles was not reported for live ZOSTAVAX. Additional information has been requested.
On the indicated date, I used a stamper to add info to vax cards at the center where i was working.  I did not apply any extreme pressure to my hand, but i felt something odd.  I looked at the inside knuckle of my ring finger and there was a large "blood blister" (like 3/4 by 1/2 inch).  I literally thought to myself that i might have leukemia and would need to see a doctor when i return from the work trip.  A few minutes later - having switched to the other hand - I had the SAME experience.    I spoke with the public health nurse on site who suggested I report to VAERS.  I forgot until last week, I got another bleed under the same right knuckle by turning a key in a door.    I never had a prior incident like this.
pt recv vax & whole lt side of buttock was red, according to father & pt was fussy & crying; t99.7R noticed a half inch induration;