chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1520 Pfizer 0.3ml vaccine booster administered to left deltoid 1535 Patient complaints of throat swelling  1535 Epi Pen 0.3mg IM dose administered to left middle outer thigh 1535 Emergency initiated 1542 Patient complaints of  tightness and swelling of throat and panicky feeling 1542 Epi Pen 0.3mg IM dose administered to right middle outer thigh 1600 EMS arrived and transfer of care completed
"12 Hours after pneumonia/flu injection felt sick" "24 hours after Pneumonia/flu injection very sick with increased reddness in arm with chills and ached all over". Was given the injection on Dec 8th and was seen at the Dr office on Dec 20th
Patient was light headed and pale after administration of vaccine. Had her lay down with knees up for approx 5 minutes. Then had her sit up and drink water for another few minutes.  She stood up and left with her mom and brother and approx. 15 feet later she informed her mom she needed to lay down. Mom assisted her to ground. Did not hit head. Client fainted and was unconscious for 15-20 seconds. Legs contracted. Once client regained consciousness, she did not recall what happened initially. After a few seconds, she was A&Ox4, eyes displayed PERLA, hand grasps and ankle pumps equal, and no abnormalities noted with her neuro-checks. Intervention included having her lay on her back with knees ups for another 5 minutes, then provided her some juice when she sat up. Had her staying sitting for another 10 minutes. Mother present for entire event. After approx. 15 minutes of the incident, the client reported she was okay. I offered to help her walk to car, mother denied assistance.  Followed up with mom and reported she napped and no medical care follow up.
Developed macular popular rash on upper left trapezius and another 1 in spot over left scapula at 72 hours post shot; Developed macular popular rash on upper left trapezius and another 1 in spot over left scapula at 72 hours post shot; At 96 hours 4 spots of rash on upper middle chest. Fluid loses from papules and scabs over. Severe itching; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on unspecified date in Feb2021 at 11:00 as single dose for COVID-19 immunization.  There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included atopic dermatitis, osteoarthritis, mild asthma, and diarrhea-predominant irritable bowel syndrome (IBS-D). The patient had known allergies: sulfa. The patient previously used povidone-iodine (BETADINE) and experienced allergies. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast, and carisoprodol (SOMA); all from unspecified date for unspecified indication. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient developed macular popular rash on upper left trapezius and another 1 in spot over left scapula at 72 hours post shot. At 96 hours 4 spots of rash on upper middle chest. Fluid loses from papules and scabs over. Severe itching, all non-serious on 04Mar2021. No treatment received for the events. The patient received second dose of BNT162B2 via an unspecified route of administration administered in left arm on unspecified date on 08Mar2021 at 11:00 as single dose for COVID-19 immunization. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch no cannot be obtained.
This patient was scheduled to receive the Covid 19 Bivalent Booster but instead received the monovalent primary series covid 19 vaccine.
Right arm redness, warmth, discomfort, and mild pruritis. No constitutional symptoms. IBU 200mg three times daily - BENADRYL 12.5mg three times daily PRN - Ice area x 15 mins 3-4 times daily - F/U PRN.
door being left open for too long during inventory-human error with no adverse event; Initial information regarding this unsolicited valid non-serious case from a other health professional was received via call center and transmitted to Sanofi on 08-Jun-2020.  This case involved an unknown age patient of unknown demographics for whom door being left open for too long during inventory-human error (Product storage error), while the patient store the vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and IPV (VERO) [IPOL].  Medical history and concomitant drug were not reported.  On an unknown date, it was reported that the vaccines were stored in refrigerator. And reported that Menactra and Ipol (opened) were exposed to 9.4C for 2 hours and 15 minutes due to the refrigerator door being left open for too long during inventory-human error (Product storage error).  Also it is a case of actual medication error due to Product storage error.  No relevant laboratory data was reported.  Final diagnosis was Product storage error.  Action taken with the suspect was not applicable. Corrective treatment was not reported. Outcome of the event was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.  No further relevant information were received.
Pt recv vax on 3/13/96; post vax pt exp demyelination
Very mild side effect symptoms. Slight soreness in arm at vaccine site. Feels similar to other vaccines, a bruise, etc. Next morning sore throat, fatigue. Both mild. No problem, just reporting to add additional data.
No additional AE; Patient was administered expired MMRll on 07/07/2021; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 07-JUL-2021, the patient was vaccinated with an expire dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number S020162 has been verified to be a valid lot number, expiration date 30-JUN-2021 (dosage regimen and route of administration were not reported) for prophylaxis. No adverse event was reported. The vaccine had not had temperature excursions.  This is a non-valid case due to the lack of patient identifiers.  Follow-up information has been received from the office manager on 21-JUL-2021. The patient was a 12-month-old female. Her address was provided. The patient did not have allergies. It was reported that "active problems" included maternal history of hepatitis C and Coombs test. She had no history of an adverse event following previous vaccinations nor other illnesses at the time of vaccination. Birth weight was 7 lb 13 oz. She was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) administered subcutaneously in the left thigh. On the same date, she was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) and hepatitis a vaccine inact (HAVRIX). It was reported that the patient tolerated the adverse event well. It was a single use vaccine/ vaccine-device and it was used according to the instruction leaflet. The operator of the device was a healthcare professional and they were trained. The vaccine was available for return/evaluation. The adverse event was reported to a doctor.
8/13/03 family called and child's lip was swollen and numb. Instructed to go to ER. Was seen there and diagnosed with Bell's palsy. 8/14/03 saw ENT doctor, and neurologist doctor.
Patient received immunizations on 8/30/2007. They were administered via 5/8 inch needle. Patient's mother presented to the clinic on 9/27/2007 c/o nodules under the skin where immunization were given in child's thighs.
Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 21 years old male patient received vaccine MENACTRA twice on 22-Oct-2018 (lot number, expiry date, dose in series and route were not reported) and on 27-Nov-2018 (lot number: U5984AC, expiry date, dose in series and route was not reported) in the right arm. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. No adverse reactions reported. 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 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. List of documents held by sender: none.
On date of second dose, it was discovered that Moderna had been given as the first dose. Patient did not meet the minimum age of 18 years old. No signs or symptoms of adverse effects were noted.
Swelling at the site of injection with redness and swelling of the area causing limping when walking. No temperature.
This spontaneous report was received from an unspecified via an online article and refers to a 268 patients of unknown age and gender who reported the events via Vaccine Adverse Event Reporting System. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of HPV vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients experienced a cervical dysplasia. The outcome of cervical dysplasia was unknown. The relatedness between the cervical dysplasia and HPV vaccine (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information is not expected as no contact details were provided.
The question was did I have any diagnosis since the last report: partial thickness macular hole left eye. I do not believe this was related to the vaccine - seems age related. no treatment needed.
cough, slightly dizziness,  gave 50 mg Benadryl po, took vital signs every 5 mins patient recovered and walked out with friend to her car
Client reported "weird" taste in mouth, Tingling lips & Rt. hand tingling @ 1215 pm. BP 162/78 @ 1225 pm. BP @ 1235 pm 168/78 @ 1245 pm 166/78, @ 1255 pm 158/70, @ 105 pm 155/70.  Monitored client for worsening symptoms. Symptoms remain unchanged. Team lead called FNP. Verbal order for Benadryl 50mg IM. Benadryl 50mg given in Lt. thigh. Symptoms subsided. Continued
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). No concomitant therapy was reported. The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
20 minutes after injection I felt lightheaded. After drinking some water and sitting for 40 minutes I drove home. My body felt impaired as though I wasn't fully cognitive,  my heart rate increased and it was harder to breathe. I stayed home and watched tv all day and felt those symptoms subside.  I went to bed that night and woke up at 1 am. I went to the bathroom and had a small bowel movement and afterwards my lower abdomen became hard and swollen as if there was a half a melon sticking out. My pain was intense at about an 8 on a scale of 1-10. I drank some detox and digestion herbal tea to try to help. The pain lasted about 3 hours. About 2 days later, I went to the bathroom and what looked like dead cells came out in the toilet through my rectum. My doctor thinks that it may have been the lining of my intestines from the inflammation. This was from the first vaccine and for the record I will not take another.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 10-JAN-2017, the patient was vaccinated with the first dose of PNEUMOVAX 23 lot # M005286, expiration date 08-OCT-2017, (strength and route of administration were not provided) for prophylaxis. The reporter stated that on 09-AUG-2017, the patient was inadvertently vaccinated with the second dose of PNEUMOVAX 23, lot# N010106, expiration date 15-NOV-2018 (strength and route of administration were not provided) for prophylaxis.  No adverse events were reported.
In November 2022, my cardiologist had his physician's assistant call me to schedule a time to have me come in to have a heart monitor put on for two weeks. I was able to get in January 2023 and wear the monitor and go back in for the results. I had a telehealth conference for the results, I was notified that my heart had paused over one thousand times. I was asked if I had passed out or fainted during the two-week period. We scheduled to have a pacemaker put in the second Thursday of March. I am feeling better although I really did not feel bad before, I was trying to find out why my leg was swelling.
24 hours after, achey body 48 hours after, joint pain in the shoulders, swollen lymph node in left underarm
Difficulty sleeping; Received dose of the Moderna COVID-19 vaccine bivalent, who are under 6 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of INSOMNIA (Difficulty sleeping) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose of the Moderna COVID-19 vaccine bivalent, who are under 6 years old) in a 2-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Oct-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose of the Moderna COVID-19 vaccine bivalent, who are under 6 years old). On an unknown date, the patient experienced INSOMNIA (Difficulty sleeping). At the time of the report, INSOMNIA (Difficulty sleeping) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received dose of the Moderna COVID-19 vaccine bivalent, who are under 6 years old) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information provided.  2 siblings had received a dose of the Moderna COVID-19 vaccne bivalent on 21 Oct 2022 (lot number 017H22A, expiration date 29 May 2023) who were under 6 years old. Both had difficulty sleeping since receiving these doses of the vaccine. No additional doses, medications, or treatments have been administered since this error.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662626 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662626:Patient-2 case
breakout/ looks like pox; hives; This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2019, the patient received Shingrix (intramuscular). On 19th July 2019, 3 days after receiving Shingrix, the patient experienced varicella-like rash and hives. On an unknown date, the outcome of the varicella-like rash and hives were not recovered/not resolved.   It was unknown if the reporter considered the varicella-like rash and hives to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and brokeout all over her body. The patient thought it looks like pox, but it might be hives. The reporter had consented to follow up. There was discrepancy in outcome reported in source document (recovering/ resolving) and (not recovered/not resolved). The outcome kept as reported.
Left delt local reaction at site of injection. Redness and swelling.  Responsive to compress, Ibuprofen.
Since day after vaccine pt has had hives (significantly improved now), cough/sob, more easily having MCAS reactions, +flushing, +diaphoresis, steroids have been helpful
Complaint of dizziness. Pale and diaphoretic. BP 108/60, P 53, R 16, T 96.8, O2 98%. Monitored in post vaccination area and discharged without any complaints.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/14/22 at approximately 09:10am. When error discovered facility contacted for course of action. At direction of the facility, patient contacted regarding occurrence to offer re-vaccination of dose. Patient accepted revaccination on 1/27/2022. No adverse side effects or event as result of dose.
Complained of pain, itching and redness to injection site. 1/2 dollar sized raised red area noted and complaints of itching. Ice given to apply and administered Benadryl 50mg for symptoms.
no additional adverse events have been reported since administration of PROQUAD/no additional information provided; an expired dose of PROQUAD was administered to a patient on 28MAY2021; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 28-MAY-2021, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) for prophylaxis (strength and route were not reported; lot# S035111, expiration date: 03-MAY-2021) (expired product administered). The vaccine did not experience any prior temperature excursions. The reporter did not have the information available for the sterile diluent used. No additional adverse event or information was reported since administration of the vaccine.
Minor rash at the area where he got the shot; Minor rash at the area where he got the shot- can barely see it, but there are little itchy red spots, area is about the size of a baseball; Minor rash at the area where he got the shot- can barely see it, but there are little itchy red spots, area is about the size of a baseball; This is a spontaneous report from a contactable consumer (patient) received from Medical Information Team. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Not reported), via an unspecified route of administration on an unspecified date in Feb2021 as a single dose for COVID-19 immunization. Patient medical history and Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Batch/lot number: Not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. On an unspecified date in 2021, after second vaccination, patient developed a minor rash at the area where he got the shot- can barely see it, but there are little itchy red spots, area is about the size of a baseball. It was reported that, patient had his 2 shots, going on a month now and was doing fine (at the time of report), he had second dose of the Pfizer COVID-19 vaccine near the end of the February (probably the week of 21Feb2021, Exact date unknown), and he developed a rash at the injection site that has lasted a little over 3 weeks. He describes the rash as, diameter is about the size of about a tennis ball. It's a light rash with pin point red marks or little red spots, it itches pretty bad, the area about the size of a baseball that is involved and it itches around the area of where the shot was administered. Patient have been putting lotion on it - clarified as 2% topical lotion, lotion seems to be helping a little but it doesn't seem to be going away, and he is not concerned about the rash itself but he wants to know if the rash is indicative of a more serious side effect or problem. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Rash appeared 2 weeks ago (June 2021). Pt feels since wife's rash started 6-10 days after vaccine, his rash is also from vaccine.  Has not seen MD at this time
Several hours after being vaccinated complained of left arm and underarm throbbing. The next day woke up with tingling fingers and swollen hand
side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication were reported by the reporter.   No treatment medication were reported.