chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the vaccine, I had the normal sore arm that went away after a day or so, but no real side effects. On day 8 after receiving the vaccine, my arm around the injection site swelled up around 3in wide and 4-5in long. It has been extremely itchy for a couple of days with the swollen area being very red.
they administered 0.2 ml, undiluted second dose of the Pfizer Covid-19 vaccine (orange cap) to 11 year old patients; they administered 0.2 ml, undiluted second dose of the Pfizer Covid-19 vaccine (orange cap) to 11 year old patients; fever; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  An 11-year-old male patient received BNT162b2 (BNT162B2), as dose 2, 0.2 ml single (Lot number: FL8094, Expiration Date: 05Apr2022) at the age of 11 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (First Dose, Dose: 1st, Date: 02Mar2022, Anatomical site of injection: Deltoid, Route of Administration: Intramuscular, Batch/Lot number: Misplaced/Discarded), administration date: 02Mar2021, when the patient was 11-year-old, for COVID-19 Immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "they administered 0.2 ml, undiluted second dose of the Pfizer Covid-19 vaccine (orange cap) to 11 year old patients"; PYREXIA (non-serious), outcome "unknown", described as "fever"; HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown".  Additional information: Caller was seeking guidance on what to do and any possible effects that the parents need to look for. They said he was fine but caller wanted to find out if there was anything that the parents need to be watching for. The child is healthy normal.  Follow-up (04May2022): This is a spontaneous follow-up report from a contactable nurse. This nurse reported in response to HCP letter sent which included that: Updated information: Reporter's address updated, RMH, Anatomical site of administration, Facility details, and new events added   No follow up attempts are possible. No further information is expected.
Six days after my 2nd vaccine I had an anaphylaxis reaction.  Out of the blue while I was driving my face started to burn like acid was rubbed on it. It got really hot and turned very bright red. Then my lips began to feel like they had been sunburned badly. Then my forearms both started burning and also turned bright red. I was very anxious. Had two bouts of diarrhea. All this occurred within about a 20 minute time-frame.  I chewed up 4 children's Benadryl (50mg) and the redness, burning and anxiousness subsided mostly. My heart rat was still over 100 bpm even after  6 hours. (Usually my HR is 68-70 bpm). I slept for 12 hours and the next day seemed fine.  This has occurred two more times since that first time. The 2nd reaction being 5 days after that first one and the 3rd reaction being 5 days after that. Same reaction, same treatment and same outcome.
Headache after vaccine; denied vision changes, trouble breathing, no lightheadedness. Reports headache 3 hours after first vaccine; reported to MD "if severe, seek medical care". Will be following up with MD tomorrow (as is Sunday); Neurologist (seizures, hx stroke) on Wednesday. HA same as when started 8/10; VSS; BP 132/80. Last time, took tylenol for headache; rested in "dark room" (gets migraines). Has BP cuff at home, pulse ox. Will f/u if symptoms worsen.
On 10/22/2022, I started to have the symptoms you would associate with a severe cold. Head congestion, headache, fatigue, a runny nose. I was not running a fever and did not run one the entire time I was testing positive for COVID-19. My symptoms lasted around 5 or 6 days before they got better and then disappeared, but I was still testing positive. I didn't test negative until 11/04/2022. I tested myself every few days and the tests were coming back clearly positive. I contacted my primary care physician and spoke with someone in their office. They suggested I consider Paxlovid. I wasn't unable to obtain that over the weekend. I contacted my cardiologist and pulmonologist who advised that I would have to stop taking multiple medications I'm on in order to take Paxlovid and suggested that my symptoms were not severe to the point that she thought it necessary.
The child was given the PREVNAR 13 dose meant for her younger sibling in error.
Felt like I had the flu all day long. Woke up at 5 am with chills, aches, headache, dizziness, and nausea. These symptoms lasted all day until I went to bed at 9:45 pm.
Myalgia, Arthralgia, Fever,  chills, injection site pain  Narrative:
Broke out in hives a few hours later around 8:00 pm.  Hand swollen with bruising, left arms started with hives than moved all over body and didn't go away. Took benadryl and zyrtec over the weekend. Contacted my primary physician on the Monday morning following the Friday shot and went in. Perscribed Prednisone and told to take Pepcid. When the hives returned after completing the prednisone, I contacted my Allergist, she prescribed high dose antihistamines and prednisone. When the prednisone stopped the hives came back. More was prescribed and I was told to see a dermatologist for a biopsy to rule out vasculitis, chronic Idiopathic urticaria diagnosed. Given prednisone and  chromolyn and to to continue high does antihistamines.  No change. Biospy taken as requested, findings Hives. Now taking Xolair shots once a month.
No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 23-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes; Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.     No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
On 12/16, about 1 hour after receiving the shot I began to feel pangs of pain around the heart. After two days the pain steadily got worse and I went to the emergency room on 12/18.  An EKG, X-ray, and blood lab showed that I developed costochondritis. I was given a steroid, and anti-inflammation injection whose name I do not remember, and a prescription for ibuprofin and discharged.
Information has been received from a health professional concerning a 65 year old Caucasian female pt who on 8/31/00 was vaccinated, IM, in the right arm with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot 633103/1216J). There were no illnesses at the time of vaccination. On approx. 9/1/00, the pt experienced pain of the arm and it was noted that the arm was warm to the touch. She was "unable to move/life arm". The pt applied heat to the area and relief was noted. Tylenol was used for pain. On 9/22/00, the pt was seen in the physician's office for re-check. It was reported that the pain was better, but not resolved. Additional pts (WAES 0091200 & 00091194) had a similar experience following exposure to this same vaccine. Follow-up information from a physician's assistant indicated that the pt is no longer symptomatic, as of 11/2/00. No further information is available.
Patient presented to the ED with STEMI and subsequently hospitalized; this is within 6 weeks of receiving COVID vaccination.
Approximately 28 days after receiving 2nd dose or 3rd dose*, (*if duplicate occurred), individual experienced 2 witnessed seizures and was hospitalized thereafter - has since been diagnosed with Epilepsy and treated with anti-seizure prescription medication in addition to receiving the following accompanying diagnoses: EPILEPSY, ATRIAL FIBRILLATION, PAROXYSMAL, ATHEROSCLEROSIS OF AORTA, LONG TERM CURRENT USE OF ORAL ANTICOAGULANT. Individual has since lost the ability to drive and had an overall significant decrease in quality of life and ability.
I?m reporting this so late because I didn?t realize there was an adverse reporting site until today. I woke up in the middle of the night and was not able to move my arms or legs or speak. I sweat through my clothes and felt incredibly sick.  It passed sometime before morning. My arm was sore for several days.
lost of taste; lost of smell; not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost of taste), ANOSMIA (lost of smell) and MALAISE (not feeling well) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced AGEUSIA (lost of taste), ANOSMIA (lost of smell) and MALAISE (not feeling well). At the time of the report, AGEUSIA (lost of taste), ANOSMIA (lost of smell) and MALAISE (not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.
Left thigh swelling 10 by 10 centimeters red, hot to touch, swollen.
Significant feeling of flu like symptoms. Fever, chills, body aches severe with rapid onset. Difficulty moving body and restlessness. Insomnia and malaise, fatigue. Severe injection site pain, could not lift arm. Symptoms severe until 8AM. Then moderate symptoms with fatigue as I did not sleep much until mid afternoon, chills and body aches continued until 9PM. I had a good nights sleep the following night and symptoms were gone by morning.
Patient received two doses of Gardasil at the appropriate intervals on 3/12/08 and 5/14/08. On 9/10/08 she refused the third dose and showed us her right arm. She stated that the vaccine had "bleached her skin white". The patient is darker skinned. Her arm displayed a circular area at what would have been the site of injection that was the size of a quarter and was very light in color, markedly lighter than the surrounding skin. She denied pain at the site. She also stated that the injection site on the opposite arm did not "heal" well and displayed a 1-2 mm scabbed area at what would have been an injection site. This was several months after the injection was given. No treatment was initiated.
Itching and redness at injection site about 3 inches, very itchy, not painful   Will get some cortisone creme
Pt. says that went to bed at 8PM as was extremely tired - FLUZONE HIGH DOSE given around 1 PM on 10-1-13 - during night had very vivid dreams and woke up in AM was having hallucinations - said same thing happened last year but thought it was due to pneumonia shot she got at same time as HIGH DOSE FLUZONE.
All of them - as listed  on possible reactions including COVID ARM plus vertigo  And itchiness
Dizziness, Myalgia, Fever, chills Narrative:  Employee reports feeling lightheaded after receiving the shot and experienced fever (101.8 F), chills and body aches the following morning. Used Tylenol for symptom relief.
Pt had dizziness and headache. Dizziness resolved after pt in trendelenberg. Headache medicated with Tylenol 1000mg po. Pt felt ok to go home with husband driving. Pt discharged to home.
I had flu like symptoms, a very bad headache, fatigue. I used a home COVID-19 test that came back positive. I did not call my doctor; I chose to self-quarantine per the CDC guidelines. I rested, took Tylenol for the headache, drank plenty of fluids and got rest to help my body recover. I do not feel that I had a very bad case. It took me one week for the major symptoms to go away, an additional week to start feeling more like myself.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. No concurrent or historical condition was reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, frequency, lot number and anatomica location were not reported. No concomitant medication was reported. On an unknown date the patient developed a rash at the injection site. At the time of the report the outcome of rash at injection site was unknown. Additional information has been requested.
exhaustion; nausea; arthritis got worse; haven't felt right since my 1st pfizer covid 19; Red patches; size of a quarter a little itchy,on both legs and hands and wrists; thrush in her mouth; This is a spontaneous report received from a Pfizer Sponsored Program via a contactable other health professional and a female consumer (patient). A 70-year-old female patient received received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Apr2021 (at the age of 70-years-old), as 1st dose single for covid-19 immunization and tofacitinib citrate (XELJANZ XR, Formulation: Prolonged-release tablet, strength: 11 mg, Batch/Lot number was not reported), via oral route from on 23Apr2021 to 28May2021, at 11 mg, once a day for rheumatoid arthritis. The patient's medical history included rheumatoid arthritis and concomitant medications were not reported. Patient was reported that she was changing medication of tofacitinib as it wasn't working, arthritis got worse. Tofacitinib was discontinued. She had thrush (mouth) for a month, starting on 05May2021, and on 10May2021 started with red patches, size of a quarter a little itchy, on both legs and hands and wrists, doctor gave a cream, haven't felt right since my 1st dose of covid 19 vaccine on 16Apr2021 (not taken the 2nd dose). Patient reports possibly having thrush in her mouth and was "just now getting over" side effects from covid-19 vaccine. Patient stated she experienced exhaustion as well as having nausea. Patient stated all symptoms started two days after she received vaccine and believed it was related to covid vaccine and not related to. No further details or dates of covid-19 vaccine was given, and no missed doses were reported.  MD was aware. Patient to follow up with MD. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information was expected.  Follow up (08Jun2021): New information received from contactable consumer includes clinical course of the events, Sender's Comments: Reported events are probably intercurrent medical conditions and are unlikely related to tofacitinib. Events Causal relationship  with BNT162B2 cannot be excluded. Association of oral thrush with the use of tofacitinib is also possible. Case to be re-assessed upon receipt of new information.
sick to the stomach; Fever; chills; fatigue; Received second dose 22 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC DISORDER (sick to the stomach), PYREXIA (Fever), CHILLS (chills), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 22 days after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 029A21A) for COVID-19 vaccination.     The patient's past medical history included Hashimoto's disease (immunocompromised). Concomitant products included LEVOTHYROXINE, MULTIVITAMIN [VITAMINS NOS], ZINC and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 22 days after first dose). On an unknown date, the patient experienced GASTRIC DISORDER (sick to the stomach), PYREXIA (Fever), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. On 23-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 22 days after first dose) had resolved. At the time of the report, GASTRIC DISORDER (sick to the stomach), PYREXIA (Fever), CHILLS (chills) and FATIGUE (fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient states that the symptoms had lasted for about 12 to 18 hours.   This case was linked to MOD-2021-317925, MOD-2021-317961 (Patient Link).
Severe headache, severe stiff neck, chills, nausea, tiny purple dots on legs, feeling fatigue and weak, intense ringing in ears, stinging cold water (icy) spots all over body (started on arms/legs, muscle tightness, pain in fingers/hands/wrist/toes/feet/ankles, tingling in toes/fingers, sharp stabbing pain in arms/legs/thighs. Throbbing/worming wave pain fading in and out above eyebrows, pain top of head, above left eyebrow, left temple, dizziness, episode of extremely severe ringing in ears with feeling of going to pass out, light sensitivity and vertigo. Painful electric shocks in elbows, wrist, back of knees, fingers. Extreme fatigue that doesn't go away, back of neck pain. Ringing in ears that does not go away. Autoimmune autonomic neuropathy. Dizziness.  Neck stiffness. Cervical radicular pain.
hardly hurt but felt the pinch with both shots; hardly hurt; This is a spontaneous report from a contactable consumer (patient). A 84-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left (left shoulder) on 19Feb2021 (at the age of 84-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left (left shoulder) on 28Jan2021 (at the age of 84-year-old) as DOSE 1, SINGLE for covid-19 immunisation and experienced same events it hardly hurt, but she felt the pinch with both shots. On an unspecified date, the patient experienced hardly hurt but felt the pinch with both shots. Patient questioning if the vaccine is working because she had no reaction not even a sore arm initially. Reported that 2nd shot was taken 2 weeks after her first one. it hardly hurt, but she felt the pinch with both shots. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Weakness in legs (hard to walk); exhaustion; broke out into a sweat (hot, very clammy to the touch); aching (arms, legs, back); temperature of 100.3; headache.  Called on-call nurse and decided to get checked out at the ER.  Vitals were checked by a nurse but left before seeing a physician due to hours of waiting time.
This spontaneous report was received from a vaccine coordinator referring to an unspecified number of patients whose on an unknown dates were vaccinated with improperly stored doses of VARIVAX, (lots #s L031066, expiry date 18-AUG-2017; M022103, expiry date 04-MAY-2018; M034583, expiry date 27-JUL-2018; M038859, expiry date 14-SEP-2018 and L016127, expiry date 06-MAY-2017). The vaccine was stored in freezer at a temperature of 6°F to 14°F (6 °F) for current excursion, but data not available for prior excursions. The time frame was 6 minutes. No previous temperature excursions were reported. It was a datalogger reported. No adverse effects reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of five cases from the same reporter source, (linked to MARRS # 1704USA012566 and 1704USA013566 to 1704USA013568). Additional information is not expected as no information to obtain follow up was provided.; Sender's Comments: US-009507513-1704USA012566: US-009507513-1704USA013566: US-009507513-1704USA013567: US-009507513-1704USA013568:
Approximately there years post receiving one dose of varicella virus vaccine live the pt developed a mild case of chickenpox that lasted for a duration of four days. She recovered from rash.
Patient received Moderna COVID vaccine on 2/11/21, 3/11/21, and 11/2/21. On 10/1/22, patient admitted to our inpatient facility (med/surg unit) with COVID infection, SIRS/sepsis, and generalized weakness. Patient was discharged home on 10/5/22.
stiff arm; hard time moving arm; This case was reported by a consumer via call center representative and described the occurrence of limbs stiffness in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 2nd July 2019, the patient received the 1st dose of Bexsero and the 1st dose of Menveo. On 2nd July 2019, less than a day after receiving Bexsero and Menveo, the patient experienced mobility decreased. On 3rd July 2019, the patient experienced limbs stiffness. On an unknown date, the outcome of the limbs stiffness and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the limbs stiffness and mobility decreased to be related to Bexsero and Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the mother of the patient. Her son received two vaccines one day before reporting. The patient received Bexsero and Menveo vaccines. One was given in the arm and the other one on the thigh. The reporter did not know which one was which. The arm was stiff on the day of reporting and having a hard time moving his arm. As per narrative it seems that the patient experienced hard time moving his arm' on same day of reporting but event onset date was reported as 2nd July 2019 so kept as it is with time to event onset less than a day. The reporter did not have dosing nor lot numbers. The reporter gave consent to follow up.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Doses of ROTATEQ (dose, frequency, lot# and route were not reported) which were exposed to temperatures outside of the recommended range, were administered to unspecified patients on unspecified dates since 09-APR-2015. No adverse experience had been observed or reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. Additional information has been requested.