chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bruise; dizzy; nose bleed; This is a spontaneous report from a contactable consumer. This female consumer of unknown age reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 09Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history included lung problem. The patient's concomitant medications were not reported. On 10Mar2021, the next day she noticed a bruise (green circle) on her hand, not where the vaccine was given. She also stated that she was dizzy and had a nosebleed upon waki ng up. The consumer wanted to know that were these normal events and should she still get the second dose. If she did not have a severe allergic reaction with the first dose, was she safe to take the second dose. The vaccination site only watched them for 10 minutes after the first dose. The event outcome was unknown. The caller also wanted to know about reports of death caused by the vaccine and her auntie felt like she had the flu after the second dose.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
received Menveo reconstituted with sterile water; received Menveo reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA571A, expiry date 30th June 2022) for prophylaxis.   On 1st October 2021, the patient received Menveo. On 1st October 2021, unknown after receiving Menveo, the patient experienced inappropriate reconstitution technique and incorrect dose administered. On an unknown date, the outcome of the inappropriate reconstitution technique and incorrect dose administered were unknown.   It was unknown if the reporter considered the inappropriate reconstitution technique and incorrect dose administered to be related to Menveo.  Additional information was provided as follows: The patient received a Menveo vaccination on the day of reporting but they reconstituted with sterile water instead of the approved diluent of Menveo, which led to inappropriate reconstitution technique and incorrect dose administered.
SWELLING IN NECK, WRISTS, KNEES AND SHOULDERS PAIN IN WRISTS, NECK AND BACK
feeling of panic; diarrhea; cold sweat; bad dream; chills; nausea/ slight nausea; after both vaccines she experienced a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PANIC DISORDER (feeling of panic), DIARRHOEA (diarrhea), COLD SWEAT (cold sweat), NIGHTMARE (bad dream) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DOFETILIDE (TIKOSYN), METFORMIN, INSULIN GLARGINE (LANTUS), METOPROLOL SUCCINATE and APIXABAN (ELIQUIS) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANIC DISORDER (feeling of panic), DIARRHOEA (diarrhea), COLD SWEAT (cold sweat), NIGHTMARE (bad dream), CHILLS (chills), NAUSEA (nausea/ slight nausea) and VACCINATION SITE PAIN (after both vaccines she experienced a sore arm). At the time of the report, PANIC DISORDER (feeling of panic), DIARRHOEA (diarrhea), COLD SWEAT (cold sweat), NIGHTMARE (bad dream), CHILLS (chills), NAUSEA (nausea/ slight nausea) and VACCINATION SITE PAIN (after both vaccines she experienced a sore arm) outcome was unknown.            Treatment included Tylenol and as well as coco-cola.     This case was linked to MOD-2021-231090 (Patient Link).
Intense itching and a red sore area surrounding the point of injection in a circular area approximately 3 inches in radius. Itching was intense for 2 days, less intense on the third day, and has now stopped.
Having a lot of pain on arms after first. Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Having a lot of pain on arms after first. Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Having a lot of pain on arms after first. Vaccine). At the time of the report, MYALGIA (Having a lot of pain on arms after first. Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment products were not provided.
chills, fever, cough, diarrhea, arthralgias, myalgias
After approximately 12-24 hours after vaccination, patient experienced a red warm rash encircle her arm. Patient reported rash on 10/26 and instructed to take some BENADRYL by me (RPh) and if the rash either got larger or didn't regress to go to ER. Patient later went to ER and diagnosed with cellulitis and started on antibiotics.
Headache, body aches, low fever, intense shivering  for 12-24 hours; headache continued with mild body aches for two additional days
Patient in the hospital with myocarditis. Patient confined inflamanahun of the  heart lining.
hair loss; incredibly itchy; experiencing eczema on scalp,face,forehead and neck; rashes from the eczema would come and go and move. She has had it on the back of her knees, belly button, top to thighs, and all over her back; 1st dose of the Moderna COVID-19 vaccine on 29JAN2021 Expiration date for lot # is unknown) and the second dose on 3MAR2021; after 2nd dose it became full blown eczema; I've had it on eyelids; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (after 2nd dose it became full blown eczema), ECZEMA EYELIDS (I've had it on eyelids), ALOPECIA (hair loss), RASH PRURITIC (incredibly itchy) and ECZEMA (experiencing eczema on scalp,face,forehead and neck) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Asthma. Concomitant products included MOMETASONE FUROATE (NASONEX) for Allergy, LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX) for Asthma.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ECZEMA (after 2nd dose it became full blown eczema), ECZEMA EYELIDS (I've had it on eyelids), RASH PRURITIC (incredibly itchy), ECZEMA (experiencing eczema on scalp,face,forehead and neck), ECZEMA (rashes from the eczema would come and go and move. She has had it on the back of her knees, belly button, top to thighs, and all over her back) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna COVID-19 vaccine on 29JAN2021 Expiration date for lot # is unknown) and the second dose on 3MAR2021). On an unknown date, the patient experienced ALOPECIA (hair loss). At the time of the report, ECZEMA (after 2nd dose it became full blown eczema) and ECZEMA (experiencing eczema on scalp,face,forehead and neck) had not resolved, ECZEMA EYELIDS (I've had it on eyelids), ALOPECIA (hair loss), RASH PRURITIC (incredibly itchy) and ECZEMA (rashes from the eczema would come and go and move. She has had it on the back of her knees, belly button, top to thighs, and all over her back) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna COVID-19 vaccine on 29JAN2021 Expiration date for lot # is unknown) and the second dose on 3MAR2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: other (High) high level of antibodies.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was prescribed 3 or 4 topical ointments by her dermatologist but nothing seemed to help.   This case was linked to MOD-2021-414585 (Patient Link).
Tinnitus, ear congestion, ear pressure, ear pain in right ear (same side as vaccine). Started 11 days post 1st dose (3/31) and has not subsided as of 4/19.
Patient felt dizzy and warm while sitting in chair outside vaccination room, then fell to floor. HCPs immediately went to him, and he came to within seconds.  Management stayed with patient while medic evaluated for possible hitting head on floor.  No injuries known.  Patient was able to leave on his own within 30 minutes.
Developed moderate/severe injection site reaction to pneumovax. Was given in left arm. Injection site is swollen, red, warm to the touch, and painful. She took ibuprofen which helped a little. Told her to continue taking ibuprofen and try using a cold compress as well.
It started with a mild headache, a few days later my lymph nodes/glands in my neck were tender and swollen, then nasal drainage/sore throat, now I have deep red hives on my entire body (primarily chest area). I am not sure when the hives started, it is very prevalent today.
This is a spontaneous report from a contactable consumer (patient). A 55-year-old (non-pregnant)  female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 55, via an unspecified route of administration, left arm, on Apr 4, 2021, at 13:00, single dose, for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included amlodipine from unknown date for unknown indication. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 55, via an unspecified route of administration, left arm, on Mar 16, 2021, at 12:15, single dose, for COVID-19 immunisation. The patient previously took penicillin on unknown date for an unspecified indication; and experienced drug allergy. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On Apr 6, 2021, patient experienced sense of vibration in the body on day 2 and 3. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of sense of vibration in the body on day 2 and 3 after 2nd shot recovered on an unknown date in Apr 2021. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
consumer received an expired dose of Pentacel  with no adverse event; Initial information received on 14-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  Country:  This case involves a 4 months old male patient who had received an expired dose of pentacel  with no adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj (pneumococcal conjugate vaccine) and rotavirus vaccine (rotavirus vaccine) for immunisation.  On 19-Jul-2021, the patient received a dose 0.5 ml once a day of suspect Pentacel (lot UJ214AAA, expiry date: 02-May-2021) via intramuscular route in the right leg for immunization On 19-Jul-2021 the patient received an expired dose of pentacel  with no adverse event (expired product administered) (latency: same day).  Action taken: not applicable  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient experienced a syncope immediately following vaccination. Episode lasted no more than x10 seconds. Patient was placed in Trendelenberg position, regained consciousness almost immediately and recovered well.  She had not eaten prior to vaccination and was given some crackers and a glass of water.
pt developed  acute confusional state w paranoia, delusiona, AMS. irrational behaviour w outbursts,  required hospital security team to hold pt for nurse to administer Haldol shot
Swollen on rt upper arm tense and red where DTaP/IPV was given.
Patient said the evening of vaccine/overnight, patient said her chest felt tight, the inside of her mouth was sore and her jaw was sore. She said she felt ok the following day.
Arthritis has rapidly grown in hands, unable to hold objects properly, weakness, no strength in hands.
pain in back of neck and down the upper spine; pain in back of neck and down the upper spine; Headache; arm injection site pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Feb2021 13:30 (Lot number: EN6205) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bell's palsy" (unspecified if ongoing), notes: Verbatim: Bell's palsy; "Arthritis right hip" (unspecified if ongoing); "her allergies to Penicillin IV dye at the facility" (unspecified if ongoing). Concomitant medication(s) included: DICLOFENAC taken for arthritis. The following information was reported: NECK PAIN (non-serious), SPINAL PAIN (non-serious) all with onset 28Feb2021, outcome "recovered" (2021) and all described as "pain in back of neck and down the upper spine"; HEADACHE (non-serious) with onset 28Feb2021, outcome "unknown", described as "Headache"; INJECTION SITE PAIN (non-serious) with onset 28Feb2021, outcome "recovered" (2021), described as "arm injection site pain". Therapeutic measures were taken as a result of neck pain, spinal pain.  Additional information: concomitant medication Diclofenac, Dosage text: 75mg one every twelve hours as needed by mouth. The patient ibuprofen as a treatment medication.  No follow-up attempts are possible. No further information is expected.
My symptoms came on suddenly and strong. I could feel my heart rate accelerate; it felt  like a 50% increase, in beats. It was different to get a breath, and I had no stamina. I could not walk up or down a standard set of stairs without needing to pause to catch my breath.  I experienced overwhelming fatigue and exhaustion. I could not do anything easily. I could only lay down and sleep. These symptoms did not alleviate or change. The heart beat stayed accelerated. I continued to feel this way with these symptoms and same intensity without relief. It felt like my heart was going to give out, and I was dying. I went to the ER on 04/19/2021 and was diagnosed with atrial fibrillation. On 05/12/2021 I underwent an electrical cardioversion. I immediately felt relief. My heart rate felt normal. I felt short of breath. I felt like I had most of my life back. On 05/27/2021,I felt my heart rhythm change. It accelerated and felt just like before the cardioversion. I felt tired, and I had no stamina. My heart rate was accelerated. My blood pressure cuff read my pulse rate jumping from 50bpm to 80 to 120 within a span of five minutes. My heart was pounding and beating really fast. I underwent an electrical cardioversion on 06/07/2021. I could feel my heart rate return to a slower more normal rhythm, but it didn't feel completely the same. I don't have the stamina I had before. I easily get short of breath. I feel so tired once-a-day that I need to take a nap or lay down as it feels dangerous to stay awake. At my most recent appointment, the EKG revealed pre-ventricular contractions. I continue to have no stamina, am easily short of breath, and feel overwhelmingly tired once-a-day. I can feel my heart flutter and accelerate. This feeling is sporadic and typically does not exceed 24 hours. With this fluttering feeling, my blood pressure cuff reads my pulse rate jumping from 50-80 bpm.
Medical assistant diluting covid vaccines diluted the vaccine with sterile water instead of sodium chloride. She followed the rest of the steps of preparing the vaccine correctly other than what to dilute the vaccine with. It was not caught until a few month later that this MA had been diluting the covid vaccines with the incorrect diluent. Therefore many patients, including this patient, received the covid vaccine with the incorrect diluent. Pfizer, the manufacturer, was contact regarding this and no data is available if the incorrect diluent type is supported to be stable. Therefore this dose with the incorrect diluent should be considered invalid and should be repeated. Patient did not show any signs or symptoms of an adverse reaction. Patient appears to be well in health. Family is being notified of the incident and it will be recommended that patient get covid-19 bivalent booster as she is due for the booster and to revaccinate from the incident.
onset 2-3 hrs p/vax; cont crying, screaming & fussing; was given APAP routinely & fever never got above 101; was just seen in office which is approx 24 hrs p/inject;
I got sick for a week; Migraines; This is a spontaneous report from a Pfizer.  A 89-years-old contactable female consumer (patient) reported for herself she received BNT16B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included blindness, rheumatoid arthritis, fibromyalgia, osteoporosis, scoliosis, intervertebral disc protrusion, arthritis from an unknown date. The patient's concomitant medications were not reported. The patient experienced sick for a week, migraines on an unspecified date. The patient stated that the patient got sick for a week. Her rheumatoid arthritis was so bad that she can't open anything. Patient then mentioned having migraines. Patient then stated she was a nurse and hurt herself, my back. She had arthritis, fibromyalgia, osteoporosis and went to a surgeon for scoliosis. She had 9 docs with no cartilage. She had herniated bulging discs and was cut down my left side. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After receiving the Johnson & Johnson vaccine at a community vaccination site I noticed changes to my period. The first 3c periods post-vaccine were markedly heavier with greater flow as well as pain. Starting in September, my period has been very irregular and has come roughly 2.5 weeks, whereas previously it was regular at roughly 4 week intervals.
Patient states awoke to arm red swollen tender to touch.  Noted hard spot near tender arm size of prune.  Patient able to use arm c/o area itchy.  Will follow up.
Right eye ptosis that began 24 hours after vaccine administration and had not resolved 4 months later; This is a spontaneous report from a contactable other hcp (patient). A 30-years-old non pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 06Jan2021 16:00 (at the age of 30-years-old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history was none. No known allergies. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; intrauterine contraceptive device (PARAGARD) taken for an unspecified indication, start and stop date were not reported. No Covid prior vaccination. No other vaccine in four weeks. It was reported that, Right eye ptosis that began 24 hours after vaccine administration (Jan2021) and had not resolved 4 months later. The patient had Planned surgery. AE resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. On 23Mar2021, the patient had Covid antigen tested post vaccination with nasal swab which was negative. Outcome of the event was not recovered.  Information about the Lot/batch number has been requested. ; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, eyelid ptosis cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate.
Patient developed macularpapular, irregular patches distal injection site and redness a week after receiving Td injection. Patient saw a doctor on 02/20/06 and received Claritin. On 02/21/06 patient came back for a scheduled doctor's visit to have blood drawn to check for infection. Patient told doctor that she is improving. Blood work results were reported to be fine.
Read exemption form as if currently had eczema and not as history of. History of eczema as a child (9-10 years old) behind knees and arms.  No reoccurrence since. No other skin disorders voiced except history shingles in high school.  History of chicken pox disease.  No adverse reaction noted to date. Realized mistake several hours later after reading VIS forms and how to take care of the site. Advise given and symptoms to observe for.
After my vacine, I thought I was having a heart attack. I called 911 and they took me to the hospital and I was treated as if I had had a heart attack. At the hospital they performed EKG's and stress test. The EKG was slightly off but the stress test was normal. I felt all my body flushed after the Moderna vaccine. my cardiologist I am now seeing and at the hospital I saw another Dr.  I also stayed at the  Hospital one day for monitoring.
Couldn't move legs to get out of bed that night, in the morning was able to get out of bed, everything was normal again with no lingering effects.