chrisvoncsefalvay/vaers-outcomes huggingface dataset:
more than 36 days without receiving second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days without receiving second dose) 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 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days without receiving second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days without receiving second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Pt. states he received his first dose of Moderna yesterday 4/8/2021 and today feels fatiqued and has a fever of 101-102. Denies n&v or other symptoms and is able to keep food and drink down.
She experienced stroke,between the first and second dose; I'm not speaking well; Patient had difficulties to understand; A spontaneous report was received from a consumer concerning, a 73 year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced stroke (cerebrovascular accident) and was not able to speak well (speech disorder) and understand (confusional state).  The patient had claustrophobia. Concomitant medications were multivitamins.  On an unknown date, prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number: 00M20A), intramuscularly in the arm for prophylaxis of COVID-19 infection.  On an unknown date in Mar 2021, after administering the vaccine, the consumer experienced stroke. She was hospitalized to perform an open-MRI as she was claustrophobic. Reporter also stated that patient was not able to speak and understand well and required an assistance while speaking over the phone at the time of this report. Patient did not receive any treatment.   On 10 Mar 2021, after the events occurred, the patient received her second of two planned doses of mRNA-1273 (Batch number: 044A21A), intramuscularly in the arm for prophylaxis of COVID-19 infection.  The outcome of the event stroke was unknown and the events speech disorder and confusional state were not recovered at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Had ringing in his ears very laud/major ringing in his ears, got worst; On blood thinner at the time, and had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Had ringing in his ears very laud/major ringing in his ears, got worst) and VACCINATION COMPLICATION (On blood thinner at the time, and had a reaction) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023m20a and 030l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Had ringing in his ears very laud/major ringing in his ears, got worst) and VACCINATION COMPLICATION (On blood thinner at the time, and had a reaction). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, TINNITUS (Had ringing in his ears very laud/major ringing in his ears, got worst) and VACCINATION COMPLICATION (On blood thinner at the time, and had a reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient didn't want to provide concomitant medication  Treatment information was not provided  Patient had ringing in ears very laud until 20-MAR-2021, major ringing in his ears, got worst.   This case was linked to MOD-2021-375190 (Patient Link).
Patient was fully vaccinated and boosted for COVID19, patient received his booster dose on 08/25/2021, developed COVID19 on 12/13/2021, and passed away on 01/11/2022. department of health is currently investigating to determine if this is a COVID19 related death.
Metallic taste in mouth  Severe back muscle pain  Swollen groin lymph nodes  Headache  Chills  Generalized severe pain throughout body  Pain to move
injection site pain, injection site swelling, muscle pain, chills, swollen lymph nodes, nausea
Information has been received from a consumer who was told by a person that her son was vaaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not given) "and then became autistic". The child "became very autistic a few weeks after the vaccine, showing less affection and in his own world". The reporter stated that there was a second report from a separate person regarding their son (WAES0208USA01728) who also developed autism after received  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine (second generation). It  was unknown if medical attention was sought. Upon internal review, the patient's experience was considered to be an important medical event. Additional information has been requested.
Administered the vaccine into gluteal muscle; A spontaneous report was received from a nurse concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273)  and was administered the vaccine into the gluteal muscle.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the gluteal muscle for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient was administered the vaccine into gluteal muscle.   Action taken with mRNA-1273 in response to the event was not reported.   The event, administered the vaccine into the gluteal muscle, was considered resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a patient who received mRNA-1273 (Lot# not reported), reporting Product administered at inappropriate site without reported associated adverse events.
had MMR vax, PPD test pt vomited, felt weak & cold & shaking;
I did not realize having reaction till weeks after my vaccine. I experienced one week after breast became very tender, hard, nipples got very sore, lasted for five to six weeks then it went away. My nipples hurt so bad to the touch. My routine mammogram was abnormal in June 2021 and they found a cyst on my left breast that needed additional views. I went back to the doctor and they told me to follow up in 6 months which I just did in January 2022. I started having breast pain again in my left breast and I told my doctor and they did a repeat mammogram and they saw again a cyst and recommended a breast biopsy. When I went back for my breast biopsy, the doctor saw another area where I needed to biopsy, a pus cyst, blood fluid filled cyst. Now I have to go back in 6 months for a routine check up and ultrasound. I do not have lot# to provide.
Worsening/flare of plaque psoriasis skin symptoms and onset of psoriatic arthritis symptoms including enthesis pain at tendon insertion points and fatigue.  It should be stated that psoriasis skin symptoms were present BEFORE any COVID vaccinations, but enthesis and fatigue were not.   I was diagnosed officially on 2/20/2023 with psoriatic arthritis. I do not know if it is related to the COVID vaccine, but I did question it because the pain began in the tendons in the arm in which I received the shot, and fatigue began just a week or two after receiving the 4th dose, bivalent booster.
High fever, cough, and runny nose. The fever started 8/7/22 and was 101 and then got up to 102. The cough started on Saturday 8/6/22. They recommended alternating TYLENOL and MOTRIN. She is back to her normal self other than the cough.
Worse Migraine episodes; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Worse Migraine episodes) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 2029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Migraine (having migraine since the patient was 13 years old). Concomitant products included RIMEGEPANT SULFATE (NURTEC ODT), GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) and IBUPROFEN 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 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Worse Migraine episodes). At the time of the report, MIGRAINE (Worse Migraine episodes) had not resolved.            Treatment information was not provided.  The migraine episodes were more frequent and its worse after the administration of vaccine. Right and left Ora was recorded.
Initial and follow up information has been received from a physician (M.D.) concerning a 17 year old female patient with none of drug reactions/allergies, Asperger's syndrome, ADD (attention deficit disorder) and legal blindness who on 08-JUN-2011 was vaccinated IM with first 0.5 ml dose of GARDASIL (lot # not available) and on 15-SEP-2011 (also reported as mid-late April of 2012 by the patient's mother) was vaccinated IM with second 0.5 ml dose of GARDASIL (lot # 668262/00841AA). Second suspect therapy included AFLURIA (lot # U4114DA) on 15-SEP-2011. Concomitant therapy included ADDERALL tablets, PROZAC and MENACTRA. The patient's mother explained that her daughter had no issue following her first dose of GARDASIL. Following the patient's second dose of GARDASIL, the patient developed micronic seizures and had a regression of her receptive language which was discovered on Monday 11-JUN-2012. The patient had had some improvement in her receptive language since the discovery however she was still recovering. The patient received this dose of the vaccine with another physician not with her primary care physician. The patient had contacted the 2nd dose administered physician but not to the office. The last time this patient was seen was in the office was in April 2012. EEG and MRI had been performed but no treatment was given. Therapy with GARDASIL will be discontinued for the third dose. At the time of reporting, the patient was recovering. The 2nd dose of vaccine administered physician did not feel the events were due to the GARDASIL. Upon internal review, micronic seizures and regression of her receptive language were considered to be other important medical events. Additional information has been requested.
TWO HRS POST-IMMUN PT HAD SINUS CONG., EAR CONG., GREEN NASAL DISCHARGE.11-27-89 PT NOTED TO HAVE 99.2 TEMP,TENDER MAX SINUSES, ENOEXPIRATORY WHEEZING(LF BRONCHUS & UPPER RT LOBE).TREATED. PHYS FELT PT HAD VIRAL RESP INFECT(UNRELATED TO VAX
Got vaccination on 10/10/15 and reported to the pharmacy on 10/13/15 that there was site reaction, swelling and redness, relieved with cold pack and returns to swell and redness an hour later.
general malaise; major tinnitus; burning brain with burning ears and burning tongue; crushing headache; Ringing ear; Tongue tingly; Brain tingly; Cold; Shaking; Fever; Headache; very ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very ill), TINNITUS (Ringing ear), PARAESTHESIA ORAL (Tongue tingly), PARAESTHESIA (Brain tingly) and NASOPHARYNGITIS (Cold) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (very ill). On 17-Apr-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On 19-Apr-2021, the patient experienced TINNITUS (Ringing ear), PARAESTHESIA ORAL (Tongue tingly), PARAESTHESIA (Brain tingly), NASOPHARYNGITIS (Cold) and TREMOR (Shaking). On an unknown date, the patient experienced MALAISE (general malaise), TINNITUS (major tinnitus), BURNING SENSATION (burning brain with burning ears and burning tongue) and HEADACHE (crushing headache). On 18-Apr-2021, PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, ILLNESS (very ill), TINNITUS (Ringing ear), PARAESTHESIA ORAL (Tongue tingly), PARAESTHESIA (Brain tingly), NASOPHARYNGITIS (Cold), TREMOR (Shaking), MALAISE (general malaise), TINNITUS (major tinnitus), BURNING SENSATION (burning brain with burning ears and burning tongue) and HEADACHE (crushing headache) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up information received on 28-APR-2021 Updated AE information
Patient reports she developed Herpes Zoster on left chest wall 11 days after second Covid Pfizer shot. She feels the vaccination caused the Shingles and requested a VAERS report be completed.
Information has been received from a registered nurse referring to a 10 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 11-DEC-2015 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # J006365, expiration date: 05-DEC-2015, dose, route and strength were not reported). Concomitant drug was not reported. No adverse effects were reported. Additional information has been requested.
Flu like - intense body aches and slight fever for 3-4 days; Felt very worn down; Achy; Could not get comfortable; Nor sleep solidly; Fever/slight fever for 3-4 days; Joint pain was pretty intense; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like - intense body aches and slight fever for 3-4 days), MALAISE (Felt very worn down), PAIN (Achy), DISCOMFORT (Could not get comfortable) and SLEEP DISORDER (Nor sleep solidly) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine Allergy).    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like - intense body aches and slight fever for 3-4 days), MALAISE (Felt very worn down), PAIN (Achy), DISCOMFORT (Could not get comfortable), SLEEP DISORDER (Nor sleep solidly), PYREXIA (Fever/slight fever for 3-4 days) and ARTHRALGIA (Joint pain was pretty intense). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like - intense body aches and slight fever for 3-4 days), MALAISE (Felt very worn down), PAIN (Achy), DISCOMFORT (Could not get comfortable), SLEEP DISORDER (Nor sleep solidly), PYREXIA (Fever/slight fever for 3-4 days) and ARTHRALGIA (Joint pain was pretty intense) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the symptoms lasted for about 2 days intensely and then another 2 of milder symptoms.  No Concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-395635, MOD-2021-412957 (Patient Link).
felt lightheaded; a little bit of muscle pain and joint pain/ left bicep after got home had a pain in it; a little bit of muscle pain and joint pain; Took his blood pressure and it was really high like 150 something; bump at the injection; bump at the injection, it hurt if he pushed on it or bumped it; His joints felt weird. It was on the right and left which is unusual; Right forearm has slight pain in it; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). This 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) in the right arm on 18Jan2021 at single dose for COVID-19 immunization. Medical history included bad arthritis in right wrist. There were no concomitant medications. When shot, patient felt lightheaded and a little bit of muscle pain and joint pain. He told the nurse there and they sent over a Physician Assistant. He took his blood pressure and it was really high like 150 something. Patient was cleared after 30 minutes. Since being home he has noticed a couple of things. Mostly muscle pain or discomfort. He had a bump at the injection, it hurt if he pushed on it or bumped it. Four days later and there is no bump or pain there. The other thing is his joints. His joints felt weird. It was on the right and left which is unusual. His left bicep after he got home had a pain in it. The right forearm has slight pain in it. He is not sure if it is the muscle or ligament. If he rubs it doesn't bother him at all. The outcome of "blood pressure 150", "bump and pain at the injection" was recovered, of other events was unknown.
Sept 7th Covid-19 positive, IV antibiotic was given and did not have any symptoms from Covid-19. I had to go back to the ER on Friday and then on Saturday they diagnosed me with Covid-19. I was then given antibody treatment the following Tuesday when they diagnosed me with C. difficile. Could not leave the house for all of Sept. to part of October. I was on medications until Christmas. I was extremely ill and now I am recovered. The medication received was for C-Diff, I never had any symptoms of Covid-19.
Myalgia, Arthralgia, malaise, site pain Narrative:   Other Relevant History:
pt recvd vax & reported that began to feel ill approx 304 wks p/vax;23SEP94 began exp severe abd & flank pain,& a burning sensation radiating to back;can perform simple household tasks w/o extreme pain/fatigue but not able to function job
Information has been received from a nurse concerning an unspecified number of patients who were vaccinated with a first dose of GARDASIL vaccine. The patients became dizzy, pale and diaphoretic after receiving a dose of GARDASIL vaccine. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. This is one of several reports from the same source. This is in follow-up to report (s) previously submitted on 7/15/2008. Follow up information was received from a registered nurse indicating she would not be able to provide the exact number of patients or patient identifiers. This is one of several reports from the same source
Pfizer BioNTech COVID 19 vaccine EUA-  vial of pfizer was mixed at 0955, set at room temperature 72 degrees F, was to waste at 1555, dose was administered at 1642. No adverse reaction noted, patient denies any symptoms. Pt waited 15 minutes after injection and still denied any problems
FEVER, ABD PAIN, DIZZY, MUSCLE ACHES, INSOMNIA
Rheumatoid arthritis flare up; This is a solicited report based on information received by Pfizer, (manufacturer control number: 21K-163-4111476-00). A contactable consumer (patient) reported that a 60-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot Number: 1153557) at unknown dose for Moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced rheumatoid arthritis flare up. PFIZER BIONTECH COVID-19 VACCINE (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the event for adalimumab was permanently withdrawn on an unspecified date. The outcome of event was not recovered. Causality for adalimumab was not provided by reporter and for bnt162b2 was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported event of Rheumatoid arthritis flare up. The case will be reassessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Fever ranging from 99.9 to 101.0 Stuffy nose Headache
10/28 (Tuesday)= started, itching of the neck. Noted (L) eye slightly mid and lower lid was puffy/swollen. By the time I was driving home, itching was getting worst. Noted that my back and chest were also very itchy; (L) lower lid was getting more swollen. Turned back to the hosp. w/intention of going to ER. Checking my body, noted that my chest and back were covered w/welts, rashes and red areas. I decided to get/took BENADRYL orally when I went home (decided to go home instead of going to ER). BENADRYL took care of the welts and rashes. But after the oral BENADRYL wore of, noted that rashes/welts came back-> face, eye lids, body and extr (Before taking 1st dose of BENADRYL, on this 1st day, noted lips got tingly and (R) decrease eyelid was swollen. No difficulty w/breathing). This rashes/welts comes and goes. Finally saw dr on 10-20-14. Was told to take MEDROL Pack, continued BENADRYL po. Episode continued till Saturday 11-1-14.
Large red indurated area anteriorly on site of vaccination that decreased in size over 3 days still > 4 cm on day 4. Reported to clinic similar reaction in another child from same lot.
Several pts exp local rxn of redness, swelling past the elbow (no streaking) & low grade fever;
Left Arm Pain - Severe.  Area of numbness in/on arm.  Pain increasing.  Pain still intense today over 2 months post vaccine.  Stinging sensation in arm.  Burning sensation in Arm.  At times, pain moving upwards to shoulder, lower neck.  At times, pain travels down arm towards hand.
Was feeling nervous and shaky prior to arrival at vaccine center, not much to eat today. Received Pfizer vaccine #2, few minutes later, shakiness increased, with observed mild physical shaking of arms. Patient brought to Med Obs #1,  Assessed by PA and MD. VS initially at 1405- BP 174/80, HR 72, R 16, O2 sat 100, CTA, RRR, no focal neuro signs, mild B arm tremor, voluntary. Pt observed x40 minutes, shakiness resolved, VS 1415 HR 72, R 16, 156/81, O2 100%, pt released to son at 1445.