chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red blood vessels in eyes, worse in left eye; watery eyes; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), via an unspecified route of administration in the right arm on 29Dec2020 08:15 at a single dose for COVID-19 immunization. The patient's medical history included mild von willebrand's, situational anxiety, allergies to penicillin, and Visian ICL surgery in August. The patient was not pregnant. Concomitant medications included calcium carbonate, famotidine, magnesium hydroxide (PEPCID COMPLETE), ethinylestradiol, etonogestrel (NUVARING), fexofenadine hydrochloride (ALLEGRA), and hydroxyzine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 31Dec2020 07:00, the patient experienced red blood vessels in eyes, worse in left eye. She also had watery eyes. No pain. No treatment was received for the adverse events. Outcome of the events was recovered with sequel. The events were considered non-serious.  No follow-up attempts are possible. No further information is expected.
The needle detached from the syringe immediately after injection.  The fluid drained out of the syringe  onto the nurses hand and patient's arm.  None of it made it's way into the patient.   It was determined that a repeat vaccine was needed because the entire volume was lost.
Received vacc. approx 1500 5/20/09; approx. 12-14 hours later woke up with severe muscle/joint pain and fever, seen in office @ 1530 05/21/09 still with complaints.  Mother has been giving her MOTRIN
Around 2pm day of vaccine, started getting headaches, neck aches, nausea, fatigue, sore arm at injection site. By evening, had shivers and chills but no fever. Had to wear three layers of clothes for an hour to get warm. Had fatigue, headaches and neck aches for about 3 more days after. I had previously had Covid-19 a few months before..
she just does not feel good; Feeling like she is getting a cold; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283 and expiry date: 30Apr2021), via an unspecified route of administration on the right arm, on 22Jan2021 at 0.3 mL, single for COVID-19 immunization. There were no medical history and concomitant medications. Patient stated she was feeling like she was getting a cold. She clarified that she started feeling this way starting last night on 25Jan2021, and today on 26Jan2021, she just does not feel good. Outcome of the events was not recovered. The reporter considered the events non-serious.
patient was administered an expired dose of Twinrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 68-year-old male patient who received HAB (Twinrix) (batch number 3C422, expiry date 27th April 2021) 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 4th May 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 4th May 2021, 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 was provided as follows:  The age at vaccination was not reported. On 4th May 2021, the patient received Twinrix which was expired on 27th April 2021, which led to expired vaccine used. The reporter stated that, it was the first dose of the vaccine, patient didn't take the vaccination record. No further events were reported at the time call. The reporter did not consent to follow up.
fever; stomach pain/his stomach hurts; stomach burning; he experienced a bad headache/head hurt really bad; This is a spontaneous report from a contactable consumer or other non hcp (Daughter) reporting for father (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date are unknown), via an unspecified route of administration on 15Jul2021 between 16:00-18:00 at the age of 55-years-old as dose 2, single for COVID-19 immunisation. Patient's medical history including any illness at time of vaccination and concurrent conditions included ongoing High Blood Pressure and ongoing Cholesterol from unspecified date. There were no concomitant medications. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date as dose 1, single for COVID-19 immunisation. Additional vaccines administered on same date of the pfizer suspect were none. Prior vaccinations within 4 weeks were none. AE(s) following prior vaccinations were none. Family medical history relevant to AE(s) was none. Relevant tests were none. Patient age at time of vaccination was 55 years. On 15Jul2021, the patient experienced headache, head hurt really bad, stomach hurts and burns and on 18Jul2021, experienced fever. Caller was a caregiver calling on behalf of her 55-year-old father. The caller reports that he received his second dose of the Pfizer BIONTECH COVID-19 vaccine on 15Jul2021. Afterwards he experienced a bad headache and a fever, those symptoms have since resolved. He was now experiencing stomach pain, stomach burning and diarrhea. The case was reported as non-serious. The patient took received Tylenol as treatment for headaches and pyrexia. The outcome of event headache was recovered on 15Jul2021 and fever was recovered on 18Jul2021 while other events were not recovered.  Information about lot/batch number has been requested.
After one hour of getting the vaccine Dizziness. After 8 hrs fever, chill, headache, left arm ache. After 24 hrs weakness, heartache, Tachycardia, liver area pain, left arm ache. After 48 hours of vaccination weakness, left arm, and underarm ache.
Numbing in left arm, within 5 minutes, that traveled halfway up the left side of my face. Once it finished traveling, approximately 10 minutes after shot, the taste of metal appeared on the back of my tongue. The numbness passed within 15 minutes of the shot and then pain began radiating from the shot to my elbow every few minutes. I had a feeling that could be best described as inebriation after about 15 minutes and could smell pizza to be specific. There was no pizza around. This went away within about 10 minutes of onset. I slept for about 4 hours, woke up with a headache, and arm pain for 2 days.
Treatment of COVID-19; Treatment of COVID-19; Dose: 1 and 2: Pfizer/Dose 3: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 12Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "pre-diabetes" (unspecified if ongoing); "controlled blood pressure" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing); "prostate cancer surgery", start date: 2014 (unspecified if ongoing); "known allergies: horse serum" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lamisil, reaction(s): "known allergies: oral Lamisil"; Simvastatin, reaction(s): "known allergies: simvastatin"; Atropine, reaction(s): "known allergies: atropine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Nov2021, outcome "unknown", described as "Dose: 1 and 2: Pfizer/Dose 3: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 07Sep2023 to 08Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300296453 same patient, different drug/event;
This case was reported by a pharmacist and described the occurrence of an allergic reaction in a female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On an unspecified date, the pt received diphtheria and tetanus toxoids and acellular pertussis vaccine (dose number not specified). At an unknown time after administration of diphtheria and tetanus toxoids and acellular pertussis vaccine, unspecified tests revealed that the pt developed an allergic reaction to an unspecified component of the vaccine.
Information has been received from a nurse concerning a 13 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (route and lot# not reported). Two months after (on an unspecified date) the patient had received the GARDASIL, the patient experienced a seizure. The patient's mother took her to the local emergency room and the Emergency room physician told them that the vaccination had nothing to do with seizure the patient experienced. At the time of the report, the patient's outcome was unknown. Upon internal review, seizure was considered to be an other important medical event. No further information is available.
Severe vomiting for 12 hours (unable to keep down food or water), lowered body temperature, rapid heart rate and tachycardia, headache. No fever or chills or body aches. These are the identical symptoms for me, patient, for sulfite reactions.
Vision Change Narrative: Reported vision change within 24 hours of receiving injection. Noted black spot in peripheral vision of right eye. Saw retinologist for follow-up. Mentioned there was some improvement.
Patient had his left leg get very swollen and red . Seen at Urgent care on 10/19/19 and diagnosed with cellulitis and given keflex and zyrtec. I saw him in the office on  10/21/19 and the rash had resolved.
After taking the J&J vaccine, I have not been feeling well for about three weeks.  I have had a persistent headache, body aches and inflammation in both my hips.  Immediately after the vaccine was administrated, I had the typical reactions, flu like symptoms, sore arm and headache.  A few days after the vaccine, I could hardly put any weight on my right leg due to my hip pain.  This morphed into my other hip resulting in throwing my back out and being in bed for three days.  I have since gone to two different Chiropractors and my relief is only temporary.  One of the Chiropractors mentioned that he is seeing lots of patients coming in with joint inflammation after taking the vaccines.  I have since read on the FDA website that body's immune system damages nerve cells, causing muscle weakness and sometimes paralysis.   I am not at the point of not functioning, but I will seek medical advice if I don't improve by next week.
Information has been received from a medical assistant concerning a female patient who on unspecified dates was vaccinated with the first and second dose of GARDASIL (lot # not available). It was reported that the patient experienced shortness of breath and felt like there was a brick sitting on her chest after receiving her first and her second dose of GARDASIL. The patient was seen by her physician. At the time of reporting, the patient had recovered. Additional information has been requested.
Patient was given GARDASIL; kept in exam room for observation, approximately 1 1/2 minutes after vaccine was given.  Patient was found laying down on exam table, stating she thought she fainted.  Vital signs were monitored - stable.  Observed in office by MA and physician; was not allowed to drive home from office.
Prolonged episodes of continuing irregular heartbeats.  Many episodes of long duration; chest tightness, burning, thumping; "heart in my throat" sensation, a sense of "ragged" breathing at times, lack of energy, couldn't sleep. Omron blood pressure monitor showed higher-than-usual pressure and rate, and triggered the irregular symbol. Pulse in wrist was difficult to follow because of gaps, weak beats. Pulse oximiter showed 99% oxygen, some periods of regularity, but then an irregular beat display with extra peaks, short peaks, long gaps that would trigger the bpm to fall from 60 to under 30 because of the irregularity.  During the more severe episodes (some lasting 45 minutes or more, and repeating for up to several days), pulse monitor would show several beats, then a long delay, several more beat, then another delay, etc.
Her arm got red on shoulder; Her arm also got hot and have very noticable heated; A very noticeable heated, raised red rash on her arm; Tender to touch,pain from the rash and arm; Nervous; Deltoid has been sore like a bruise; Pain under her armpit; Arm was a little sore; A spontaneous report was received from 23 year old, female patient concerning herself who received Moderna's covid-19 vaccine(mRNA-1273) and experienced sore arm( pain in extremity), pain under the armpit (axillary pain), red arm at shoulder part(erythema), heated ,raised red rash on the arm(miliaria), nervousness, pain from the rash and arm, deltoid has been sore all day like a bruise(injection site bruising).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 30 Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number:026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 30 Dec 2020, after the vaccination, the patient stated that her arm was a little sore and  On the next day (31 Dec 2021), the patient had pain under the armpit, her arm got red on the shoulder part, her arm also got hot, had a very noticeable heated, raised red ash on her arm. The patient stated that the area is tender to the touch and experienced pain from the rash and arm. Additionally, she stated that her deltoid has been sore all day like a bruise. The patient was nervous. Treatment medication included Benadryl 25 mg.  Action taken with mRNA-1273 in response to the event was not reported.  Outcome of the events, sore arm, pain under the armpit, red arm at shoulder part, heated ,raised red rash on the arm, nervousness, pain from the rash and arm, deltoid has been sore all day like a bruise, were considered as not reported.; Reporter's Comments: This case concerns a 23-year-old female who experienced NS unexpected events of pain in extremity, axillary pain, skin warm, miliaria, pain of skin, nervousness, injection site bruising and NS expected events of erythema. Event onset occurred the same day as the first dose of mRNA-1273. Treated with Benadryl. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Covid vaccine diluted with sterile water instead of diluent provided with Pfizer vaccine, clinical team working on follow up if revaccination needs to take place. No adverse events reported
No adverse event noted. Vaccine was 2 months out of date. Patient was administered PENTACEL on 4/6/18 at 5:13 pm. Shortly after, it was noted that the PENTACEL given had expired in 2/2018. Mother was immediately notified and she was not charged for this vaccination. She denied any adverse reaction to vaccine. Dr. also notified same day.
Mother states a child experiencing "continued rash". Since receiving vaccines. The pt was seen by private physician and diagnosed with shingles.
Varicella given Rt arm SQ on 9/14/09. Onset: 9/15/09 4.5 cm long by 4 cm width with reddeness, warm to touch. SM. amount swelling noted.
pt recv vax 12FEB97 & 10APR pain & limp of lt hip 5 days into sx seen by MD cont pain;1MAY97 MRI bilat hip effusion;improved thereafter now exam neg;
WEIGHT GAIN; PAIN IN BODY; SYMPTOMS OF LUPUS; SWELLING INJECTION SITE; TIRED FEELING; This spontaneous report received from a patient concerned a 62 year old male. 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, and batch number were not reported) dose was not reported, 1 total administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On MAR-2021, the patient experienced short term reaction: swelling injection site and tired feeling for 3 to 4 days. Approximately 30 days later, On APR-2021, the patient experienced significant swelling in both legs and feet. The patient stated that he never had edema prior to that date and it persisted since then. Laboratory data included: Cardiac imaging procedure (NR: not provided) not reported, blood test (NR: not provided) positive/high RNP Antibodies, and Renal function test (NR: not provided) not reported. Doctor has ruled out other organ issues. On an unspecified date, the physician indicated symptoms of lupus and had referred to a specialist. Doctor has started diuretics once per day as the patient gained 20 pounds in 4 weeks period. The patient had gained weight of 20 pounds. Swelling has reduced in legs but feet remain swollen. On 17-AUG-2021, the patient had pain in body and not relieved on over the counter (OTC).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling injection site, and tired feeling on MAR-2021, had not recovered from pain in body, and symptoms of lupus/swelling in both legs and feet/edema, and the outcome of weight gain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210834929-COVID-19 VACCINE AD26.COV2.S -SYMPTOMS OF LUPUS. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
fever up to 102 by report. in office s/p ibu and APAP at home >1hr prior, 99.3 axillary
This spontaneous report as received from a physician via Company Representative refers to a male patient of unknown age. There were no concomitant medications, concurrent condition and medical history reported. On an unknown date, in approximtely 2013 (reported as "around two years ago") the patient was vaccinated with GARDASIL, first dose (route of administration, strength, lot number and expiration date were not reported) for prevention of HPV. After receiving his first dose, the patient "fainted and fell straight off the examination table". The patient was send to the "ear nose and throat specialist for unspecified reasons" after the fall. The patient refused to get the two remaining doses recommended for GARDASIL because of his bad experience. The outcome of the events was reported as recovered (date not provided). The relatedness between adverse events and therapy with GARDASIL was not reported. Additional information has been requested.
Patient stated her throat felt tight and she was having trouble swallowing and her heart was racing.  She was given diphenhydramine 50 mg IM and taken to the emergency room for observation.  She was not given any additional medication in the emergency room and was discharged to home approximately 3 hours later.
The patient had a vasovagal response about 10 minutes into the 15 minute holding protocol. Passed out in the chair, got pale, and very sweaty. The patient came to after about 1 minute. Stayed conscious enough to sip water and say he was ok.. He then passed out again. We called 911, an ambulance came, but the patient didn't want to be taken to the hospital. The patient then sat for another 15 to 20 minutes.  He had regained his color, and was no longer nauseous. He went home after this additional waiting period.
HYPOTENSION 3/11/2023 &  3/15/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
On 8/31, 21 days after first dose of Moderna COVID-19 vaccine, patient experienced new-onset dyspnea and chest pain at restChronic heart failure, atrial fibrillation, sick sinus syndrome, hypertension, COPD, cirrhosis, arteriosclerosis, asthma, nontoxic thyroid nodule, atherosclerosis of right carotid, vascular claudication. Patient was hospitalized from 8/31/2021-9/4/2021 for atrial fibrillation with RVR and acute CHF secondary to afib.
This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 05-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Pt recvd Td vax & pt devel hard, red, itchy arms;
patient received the first dose of SHINGRIX 3 years ago second dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of shingrix 3 years ago.).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received the first dose of SHINGRIX 3 years ago second dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 09-JUN-2023 A pharmacist reported about a patient who received the first dose of SHINGRIX 3 years ago, and never received the second dose. The reporter did not consent to follow-up. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023081616:Same reporter