chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suffered being tired; Put on my glasses to watch movie and screen looks fuzzy; wondering seems my eyes are little bit weaker; seems like my eyes are little bit weaker; Heart feels like racing; This 56- year-old female consumer (patient) reported for herself, received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6201 ), via an unspecified route of administration, on 20Feb2021 (at the age of 56-years-old) as a single dose for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated: "I had my second shot of Pfizer vaccine yesterday (20 Feb 2021), today, I suffered being tired.  I put on my glasses to watch movie and screen looks fuzzy. It seems like my eyes are little bit weaker or something. My heart feels like racing. I don't think it is racing but it feels like it is. I was wondering if there is any side effects like slightly less accurate vision."  The outcome of the events looks tired, fuzzy, eyes weaker, and heart feels racing was unknown.
I have sent y'all a long letter about it and several copies of about 500 pages of doctor/hospital records. High fever, constant crying, seizures, very pale, coma, brain surgery at base of brain. We feel if they would have admitted it was the shot that did it, it wouldn't got that far. Proof about this is in these records and letter.
Felt like the flu that night & all the next day.  Achey, painful joints, off-balance slightly, chills, no fever that i know of, headache, extremely painful left arm up & down, into shoulder & scapula. .  Stayed home all day., took Tyleno, benedril dye free the day after injection when feeling so bad
GRAND MAL SEIZURE; VISION SUDDENLY GOT MUCH WORSE; LEG CRAMPS; This spontaneous report received from a consumer via a company representative through social media (J and J Corporate) concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the patient experienced grand mal seizure, vision suddenly got much worse for which the eye doctor was shocked (physician office) and also had leg cramps that made patient and his wife to wake up at night.  The reporter stated that "My husband had a grand mal seizure after the J and J vax. Vision suddenly got much worse, too. Our eye doctor was shocked. Also leg cramps that wake us both up at night. 13K dollars in medical bills. Never again". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the grand mal seizure, vision suddenly got much worse and leg cramps was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20221257823- Grand mal seizures- The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
approximately 8 hours after injection I began to experience pain in my chest and head, arrhythmia, dizziness,  fever, shortness of breath, and loss of consciousness.  no treatment was received  beyond 2 days bedrest at home, due to inability to travel from symptoms. outcomes include continued shortness of breath, hypertension, waning loss of feeling in hands, arms legs and feet after short durations of sitting.
Fever, chills, joint pain, exhaustion subsided in 2 days, excessing sweating at night is still a problem 3 days later.  I just don't feel well, similar to the flu.
Given on 8/27/13. 3 hrs after shot, weakness, dizzy, very tired, (+) chills. HA (used Advil - helped). 8/28/13 - Woke up feeling ok, after 10 AM - started feeling bad again, paleness, chest tightness, SOB, palpitations.
PATIENT CAME NEXT DAY ON THURDAY AT 3:47 PM COMPLAINING OF PAIN AT THE SITE OF INJECTIONS STARTED THE NIGHT OF THE VACCINATION, THE PAIN WAS DESCRIBED AS TINGLING, NERVE PAIN AND PAIN AT THE SHOULDER, SHE TOOK SOME TYLENOL, WHICH MADE IT BETTER, HOW EVER, THE PAIN GOT WORSE THE NEXT DAY THAT SHE COULD NOT MOVE THE ARM AROUND, SHE HAD TO GO TO URGENET CARE AND SHE WAS TOLD AT THE URGENT CARE OFFICE THAT THE SITE OF INJECTIONS WAS VERY HIGH. IF THE PAIN CONTINUES MORE THAN A WEEK, PATIENT SHOULD SEEK MEDICAL HELP. THE PATIENT KEPT TAKING TYLENOL WHICH HLEPS LESSEN THE PAIN. UPON COMING TO THE PHARMACY, I OBSERVED THE SITE OF INJUECTION AND IT WAS VERY HIGH CLOSE TO SHOULDER AND FAR AWAY FROM DELTIOD MUSCLE
sore shoulder; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 25Jan2021 at 10:00 as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 26Jan2021, patient had a sore shoulder the next morning and then it was gone. Stated it was the normal thing that would happen. The outcome of the event was recovered.  Information about Lot/ Batch number requested  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
Got sick; This is a spontaneous case, reported by other non health professional (consumer) to Med Communications (reference number: SEQ20-00262) on 16-Jan-2020, concerning a male patient of unknown age.   The patient's medical history and concomitant medications were not provided.  On 17-Sep-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose, route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication.  On 09-Jan-2020, 3 months and 23 days after Fluad administration, the patient got sick.  On an unspecified day in Jan-2020, the patient performed flu tests for A and B strains and the results for both strains were negative.  At the time of this report, the outcome of sickness was not reported.  The reporter did not provide causality assessment to Fluad (TIV).  This case is linked to case 202000168 due to the same reporter.  Case comment: The event of sickness was assessed as related to Fluad (TIV).; Sender's Comments: The event of sickness was assessed as related to Fluad (TIV).
I am post menopausal and on hormone replacement therapy, thus I should not have menstrual bleeding. Bleeding started the day after my Moderna booster which I had on the 4th of January, and I am still bleeding. This also occurred after my 2nd Moderna dose which I had on April 29th, '21 at a Clinic. The lot number for that Moderna dose, which I received in my right arm,  is 042B21A. I experienced bleeding after that second dose for approximately 4 weeks.
Redness, swelling x 3 d post vac. Started on Erythromycin 250mg x 7-10d.
Information has been received from a consumer concerning her 19 month old daughter and follow up from a physician concerning the 19 month old white female patient with sinusitis, otitis media, allergies, and penicillin allergy with no other pre-existing medical conditions, who on 06/07/2004 was vaccinated subcutaneously in the right thigh with a first dose of varicella virus vaccine live.  Concomitant vaccine therapy on 06/07/2004 included a fourth dose of diphtheria toxoid, pertussis acellular Biken vaccine, tetanus toxoid, administered intramuscularly in the left thigh.  Other concomitant therapy included azithromycin started on 05/07/2004 for sinusitis and cetirizine hydrochloride for allergies.  On 06/10/2004, the patient developed respiratory symptoms, a runny nose, sneezing, a rash on her back and front torso, and coryza and cough.  On 06/13/2004, the patient also developed a low grade/tactile fever and ibuprofen was given.  The duration of the symptoms was reported unknown.  The physician reported that no medications were prescribed.  On 06/14/2004, the patient was seen by a physician.  The evaluating physician felt that the patient had a viral infection versus a reaction to varicella virus vaccine live.  Also reported as a diagnosis of adverse reaction to varicella virus vaccine live.  Also on 06/15/2004, there was slight improvement.  It was noted that the patient also had a diaper rash, which appeared to be a yeast infection from the antibiotic.  It was also noted that the patient did not have adverse events following prior vaccination.  A product quality complaint was not involved.  Follow up information reported that at an office visit on 07/12/2004, the patient had no further signs or symptoms of a reaction to varicella virus vaccine live.  It was noted that the patient recovered.  No additional information is expected.
no adverse effect; a patient was administered improperly stored dose of Varivax; This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On 20-NOV-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S002736, expiry date : 28-JAN-2021) for prophylaxis. It was reported that the vaccine experienced a temperature excursion of -0.2 degrees Celsius for 2 hours and 40 minutes (product storage error). There was previous temperature excursion of 4.25 degrees Celsius for 2 hours and 40 minutes. There were no adverse effects reported. There was no product quality complaint involved. It was reported that this call was reported due to a digital data logger.
headache; Head Bumps; Head itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN MASS (Head Bumps), PRURITUS (Head itching) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG), METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), CLOPIDOGREL, METOPROLOL, LOSARTAN and GABAPENTIN for an unknown indication.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced SKIN MASS (Head Bumps) and PRURITUS (Head itching). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with FLUOCINONIDE at a dose of 0.05 %; TEA TREE OIL for Itching, at a dose of 1 dosage form and CLINDAMYCIN at a dose of 0.1 %. At the time of the report, SKIN MASS (Head Bumps), PRURITUS (Head itching) and HEADACHE (headache) outcome was unknown.            other concomitant medication were supplements
Pt c/o pain, & the needle felt dull when inject was given; visually nothing could be seen wrong w/needle but when it was dragged across paper, it tore fibers up;
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild
Patient received the dtap/ipv portion of Pentacel vaccine without reconstitution with the hib portion of the vaccine. The patient was then revaccinated with dtap/ipv/hib (pentacle) that was reconstituted properly. These were given the same day but in separate sites. The parents were notified same day of error and the only reaction noted by  parents and reported to provider was that the patient slept more than usual, patient did not have any adverse effects from vaccination. No fever, no adverse site reaction. Patient was monitored by parents and reported above to provider more then 24 hours after vaccination.
Stopped menstruating completely in June 2021. Until May 2021, I was menstruating regularly with no perimenopausal symptoms or test results.
Became nauseous with headache within one hour of getting vaccine, developed irritable bowels third day after, and became extremely hot the morning of the fourth day after the vaccine and again on the seventh day after the vaccine.  The nauseous, headaches, and irritable bowels subsided by fourth day after the vaccine.  Did not receive any treatment.
Pt was vaxed w/Hep B vax on approx 27JUL91 & on 28JUL91 pt exp fever, nausea, vomiting, h/a, malaise, chills, joint pain, & lethargy; @ the time of report pt had recovered;
Pt. rec'd DTaP #5 at OV on 9/09/16. Seen on 9/12/16 for redness, edema and warmth at site (RT) arm. Reports s/s began am after vaccine given. Tx with PRN Ibuprofen and BENADRYL. (Note: Pt with Dx vaccine RXN to ? PCV-13 after 2 mo. shots in 2010).
I woke at 1:30 in the morning to a burning throat, head ache, upset stomach, nausea.    When I arose I started the dry heaves.   This lasted all day.    I was also very tired and slept on and off all day.   I slept well that night and woke feeling fine but still a bit on the tired side.   Thankfully, no more nausea or headache.   I had no treatments except what I did for myself which was to drink lots of fluids and have very bland food and little of it.   I live alone and have no family near so I take care of myself. I do need to know if I should have the second shot.    I have one scheduled but would rather not go through that nasty experience again.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 08-SEP-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength, dose and frequency were not reported).  The improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
The product was refrigerated on 29OCT2021 beyond expiration date 13Oct2021; 606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 13OCT2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 13OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 29OCT2021 beyond expiration date 13Oct2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 13OCT2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The product was refrigerated on 29OCT2021 beyond expiration date 13Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 13OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 29OCT2021 beyond expiration date 13Oct2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was mentioned that the vial was placed in the refrigerator on 29-Oct-2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.  No treatment information was provided.
High Fever, temp 103. Heart racing, heart rhythm issues, I went to my PCP and they ordered a heart monitor. Sometimes  I still experience a weird rhythm with my heart beating.
Itchy raised, pink, warm section of arm at injection site, bigger than just where shot went in. Spans the skin on outside of  arm in a roughly 1 inch band. Area is pink and a little warmer than rest of arm. Skin beginning to peel like after a sunburn. Itchy
Extremely swollen arm pit lymph node, size of a golf ball; Pain radiates through chest and fingers/joints; Cannot move arm, cannot lay arm flat against my side; dose number=3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 (Lot number: 330308D) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VENLAFAXINE. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "dose number=3"; LYMPHADENOPATHY (non-serious) with onset 01Dec2021, outcome "unknown", described as "Extremely swollen arm pit lymph node, size of a golf ball"; PAIN (non-serious) with onset 01Dec2021, outcome "unknown", described as "Pain radiates through chest and fingers/joints"; MOBILITY DECREASED (non-serious) with onset 01Dec2021, outcome "unknown", described as "Cannot move arm, cannot lay arm flat against my side". The events "extremely swollen arm pit lymph node, size of a golf ball", "pain radiates through chest and fingers/joints" and "cannot move arm, cannot lay arm flat against my side" were evaluated at the physician office visit.  Additional information: The patient was administered COVID-19 vaccine in a pharmacy. The patient was not diagnosed with covid-19 prior to vaccination and had not been tested for covid-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the covid vaccine.  No follow-up attempts are possible. No further information is expected.
Severe muscle soreness/pain (R) arm. General malaise/flu like symptoms. Member left work early on 6/9/16 due to symptoms.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 45 year old female. 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 (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, 1 total, administered on 23-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. The patient received additional dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-NOV-2021 for prophylactic vaccination.  Sometime the week of 09-NOV-2021, patient contracted covid-19 (Dose number in series 1). On 12-NOV-2021, the symptoms started like runny nose, sinus pressure behind cheeks, ears bothering her, hence confirmed covid-19 infection and had confirmed clinical vaccination failure (Dose number in series 1). Patient went to urgent care on 17-NOV-2021, and on same day confirmed to be covid-19 positive (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000229929.; Sender's Comments: V0:20220516327-COVID-19 VACCINE AD26.COV2.S- Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
12/01/2022 I had a bad cold that lasted for 14 days. I had severe congestion and a mild cough. I took an at home COVID test which was negative. On 12/2/22. I had a telehealth visit on 12/7/2022. She determined I had a viral cold and did not have a secondary infection. She said after a few days, I need to stop the TYLENOL and over the counter cough medicine in a few days. I am feeling fine, no congestion only a mild cough.
Fever, severe muscle aches and headache, and chills lasting for 12 hours beginning 24 hours after vaccination
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, for routine adult health maintenance and the intended purpose of long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 17-OCT-2016, the patient was treated by the same physician for herpes zoster, or shingles. The outcome of the events is unknown. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.