chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up 8/13/21 fine as I was working I felt weak, went and sat down. Couldn't move arms or legs, very weak. I went to ER got blood work and CT scan of chest (came back good). Had IV for fluids
This spontaneous report as received from a pharmacist refers to a 55 years old female patient. On 08-APR-2014, the patient was vaccinated with ZOSTAVAX lot # J012659, expiry date 10-JAN-2015, dose (unknown), frequency (unknown) and route of administration (unknown). No concomitants were reported. On 09-APR-2014, the patient developed as a red, warm area at the site of administration of the ZOSTAVAX that was about 2 inches in diameter. Patient sought medical attention, she contacted pharmacy. No lab diagnostics studies were performed. No treatment was given for adverse events. Action taken with respect to ZOSTAVAX was not applicable. No product quality complaint was involved. The outcome of events was reported as not resolved. No other information was reported. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2013, the patient was vaccinated with an improperly stored vial of ZOSTAVAX (strength, dose, route of administration, lot number and expiration date were not provided) for prophylaxis. No adverse events were reported. There was no product quality complaint (PQC) involved. Additionally, the registered nurse stated that she called previously about this event in 2013;  she did a trial with a vial of ZOSTAVAX and put it on the ice packs with a calibrated thermometer the way the medical assistant did in the facility where she received her ZOSTAVAX injection (no adverse effects reported). She recorded all the temperatures and the highest it got was 38F for 20 hours. It was unspecified if  a data logger was involved, but it was reported that at the time of original case intake, the administration of improperly stored vaccine was considered as not a reportable event. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005381:
4/23/18 patient presented to ED with increased fussiness and bulging fontanelle. Head CT done was WNL and d/c to home. Patient returned to the ED on 4/24/18 with continued fussiness, bulging fontanelle and new onset fever.
Bottom lip swelling with right side tongue swelling and burning  Lip swelling and tongue resolved by the time of awakening next morning but left slight numbness with burning at site of lip swelling as if I had novacain  from dentist.
I don't know if there's a link, but I got Guillain-Barre syndrome diagnosed in early March 2014. I also had a confirmed case of the flu in January, after getting the shot. Symptoms were typical GBS: numb hands, muscle weakness, etc.
She got her vaccine, nothing at first, she didn't get sick and felt fine.  Then just over time her tremors started getting worse, they didn't get to the point that they are now.  The people at her job were concerned as she was a waitress and she could not pour coffee without spilling it, could not bring drinks without spelling it, and they decided to help her out and make it work.  In March she got in a car accident, but a minor accident, wasn't hurt at all, then a couple of days later the tremors went from 0-100 and it wasn't because of the accident, got checked out and everything was fine.  So she thought the tremors were going to go away, which is usually how they go, but they have stayed, and are getting worse a and worse.  Then she had to take medical leave off of work as she could not stand for 5 seconds.  She is seeing many doctors, has had numerous tests run and everything comes back normal, but you can visibly see there is a problem.     Her entire life she has had a slight tremor disorder.  She could write, walk and has had a job all these years.  After the vaccine something exploded in her to the point that she is crippled.  She cannot carry a cup of water that is halfway full as she will spill it.  Something changed in her dramatically after she got the vaccine.  MRI, CAT scan, EEG, everything is normal, but anybody can see how disabled she is.   Her movement specialist is Dr.    She did have a PCP but had not been sick and had not seen her for 2 years and she dropped her as a patient.  She sees many specialists and other doctors and does not feel that she needs a PCP due to her multiple doctors.    She now takes Alprazalam, Propranalol, Topurimac, Ambien, Gabapentin, Hydroxyzine for her current symptoms.  These medicines are for her tremors, anxiety, seizure medicine and a tremor control medicine which are not really working, they do help some.  She was to the point that she was crawling as she could not walk, but she can now.  She cannot work, cannot text or anything like she used to.    She has had episodes/seizures and did not show up on the EEG, and it showed that she has tremors, but no finds of seizures.  She has probably had about 30 seizures since this has happened, and had never had a seizure in her entire life prior to the vaccine.
to ED c/o abd pain, n/v, no resp s/s--+ pneumonia; TX: rocephin, zithromax, no indication for decadron/remdesivir, did not require supplemental O2; D/C'd home
This spontaneous report as received from a 66 year old female patient refers to herself. The patient experienced on unspecified dates in the past severe bone pain with use of lisinopril (manufacturer unknown) and bronchitis, trouble breathing with use of CYMBALTA. The patient concurrent condition was diabetes and hypertension. On 08-JAN-2015 at 11 AM the patient was vaccinated with ZOSTAVAX (dose, route, lot # not reported). Concomitant therapies included DIOVAN, JANUVIA and glimepiride. On 08-JAN-2015 by 5 PM the patient began to feel "real tired" and she developed spasms from the back of her calves, down to her ankles. On 09-JAN-2015 (reported as "today") the patient was still experiencing those symptoms and moreover on 09-JAN-2015 (reported as "now") she had pain in her hands, face and back. The patient did not seek medical attention and there was no lab diagnostic studies performed and no treatment was given for the event. By the time of the patient did not recover from adverse events. Relatedness between the events and ZOSTAVAX was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Angioedema extending from the right side lower lip back to my ear and under my jaw on the right side/Doctor's diagnosis was angioedema secondary to vaccination; This is a spontaneous report from a contactable Other HCP (patient). This 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL1283) at single dose on 22Jan2021 09:00 in left arm for COVID-19 immunisation. The first dose (Lot#: EK9231) was received on 04Jan2021 at 02:30 PM in left arm. Medical history included known allergies to penicillin. Patient also had known allergies to cefalexin monohydrate (KEFLEX) in the past. There was no other medications in two weeks. There was no other vaccine in four weeks. There was no covid prior vaccination, no covid tested post vaccination. Patient experienced angioedema extending from the right side lower lip back to my ear and under my jaw on the right side on 25Jan2021 at 03:00 AM. It resulted in emergency room (ER)/department or urgent care and treatment included epinephrine, steroids, and diphenhydramine hydrochloride (BENADRYL). She went to ER due to side effect of the vaccine - Doctor's diagnosis was angioedema secondary to vaccination. The outcome of event was resolved in Jan2021.; Sender's Comments: Based on the compatible time association and drug's safe profile, the angioedema is possibly related to suspect vaccine BNT162B2 administration. 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.
Called 7/24/12 at 8:35 AM. Per grandmother of pt, the pt. had a blank stare on her face, pupils dilated, wasn't responding, and stopped breathing for 5-7 seconds this lasted. States they stimulated pt. and then she has been doing well ever since. Happened 10-15 minute after leaving our office.
DIAGNOSED WITH BELLS PALSY VS. RAMSAY HUNT SYNDROME. MY FACE IS PARALYZED ON THE RIGHT SIDE AND I CANNOT CLOSE MY RIGHT EYE.  NO KNOWN TREATMENT.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-OCT-2015 16:03, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 6 and 1.8 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
p/vax pt broke out in a rash, was itchy, and on feet, legs, arms, stomach, back, described as lacy. pt felt warm to touch, rash became worse x days, rx benadryl
Hives for 3 days over entire body. Lips and eyes were swollen for a few hours until I took Benedril.  Went away for 1 day and then hives returned off and on. (Not as bad when they returned as the first 3 days.  No swelling of lips or eyes after the first event.  Skin still itches but less hives. Took Benedril when present which seemed to take care of problem for a while.
Swelling and redness at injection site, pt refused appointment to look at area therefore we were not able to see exact reaction only patient report.
Pt. developed hives, urticaria, swollen buttocks, and mood behavioral changes after vaccine was administered (weeping wound).
Pt. complaint of malaise, chills, headache.  Smallpox vaccine was recieved on 22July08.  Site was checked and appeared red.  Baseline vitals taken: T 102.6 oral, BP 130/80, pulse 88, resp 18.  Pt. evaluated by LPN on duty.  Pt stated that "medic for unit had given 500cc of fluid previous day, but had no effect on symptoms.  EMS notified, PT transported to Hospital.
Caller stated that her brother's child received the PROQUAD vaccine intramuscularly instead of subcutaneously; No additional AE information provided; This spontaneous report was received from patient's family member and refers to a patient of unknown age and gender (age group - child). The patient's medical history, concurrent conditions and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered intramuscularly instead of subcutaneously for prophylaxis (strength, lot #, and expiry date were not provided) (incorrect route of product administration). No additional adverse event was reported (no adverse event).
I am perimenopausal and have light periods. Less than a week after my second dose of the Pfizer Covid vaccine, I experienced the heaviest period of my life with over a hundred extremely large blood clots.  I haven't passed clots for decades. My period felt like I was passing thick jello and for nearly a week (e.g. a tampon and pad would become saturated within minutes). I also experienced severe fatigue that continues more than a month later.
This spontaneous report as received from a licensed practical nurse refers to multiple patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies provided. On multiple unspecified dates, the patients were vaccinated with an improperly stored doses of ROTATEQ (lot # L033545 with expiration date 30-MAY-2017, dose was not reported, orally). It was also reported that the first improperly stored doses were administered on 04-DEC-2014. The reporting nurse stated that the products were exposed to a low temperature of 33 Fahrenheit for an unknown amount of time. On an unknown dates, there were multiple excursions for these product encompassing various lot numbers (some of which were exhausted). No adverse effects were reported. This is one of several reported received from the same reporter.  Additional information is not expected as there was no consent for follow up.
she had a strong, whole body heat, and flushing; she had a strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 6th of 6 reports. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend is a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. The registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter did not know if the patient received any other vaccines at the same time as the COVID-19 Vaccine, and if had received any other vaccines within the last 4 weeks. The patient works at a hospital but doesn't believe that she received any medical attention. she believed just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020.  Information on lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported whole body heat, flushing, tachycardia and palpitations, and the administration of BNT162B2, based on the reasonable temporal association and lacking alternative explanations.   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 RA, IEC, as appropriate.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.
hour 28 after shot:sweating, chills, flushing hour 48 after shot: severe stomach cramps, diarrhea, vomiting, chills--resolved after 9 hours
Soreness in deltoid muscle where injection was administered, up to 2 weeks following administration. Denies redness or swelling at site. No fever or other signs of infection or nerve problem. Recommended to see physician.
shingles; This case was reported by a consumer via Shingrix GSK and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for himself/herself. The age at vaccination was not reported. The patient reported that, he/she had the Shingrix shot and within a few days the patient developed a few shingle spots. The patient asked was this normal.
Vaccine adinistered after the vaccine's storage viability had been exceeded; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine adinistered after the vaccine's storage viability had been exceeded) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine adinistered after the vaccine's storage viability had been exceeded). On 03-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine adinistered after the vaccine's storage viability had been exceeded) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This spontaneous report was received from patient's mother regarding her daughter of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (route, dose, lot # and expiry date not reported). Subsequently, on an unknown date, the patient experienced lethargy and had a speech impediment. The outcome of the events was reported as not recovered. The reporter did not assess the relatedness between the event and vaccine. No product quality complaint (PQC) was reported. Additional information is not expected as the reporter refused to provide further information.
1st of the series of the vaccine no problem...... adverse events due to 2nd shot......  felt fine all day friday following shot, but by evening, soreness was more intense......  did my pt exercises around 9pm that same evening and felt  pain in both right/left groin.....  took two tylenols before bed around 10:30 pm and had the chills.......  by around 4am could feel intense pain/throbbing in both right/left groin areas.....  hard to get up .....  woke husband up around 7:30am and asked for 2 tylenols......  relief for a few hours......  took two more tylenols mid afternoon.....  spent all day saturday in bed......  by evening, pain had subsided.....  do not know whether pain is related to the shot or just coincidental with my pt exercise and femoral nerve damage (left leg).....  i do have consistent slight pain in my right groin area and my left leg still has nerve damage ------  but at least, i can walk now!!!!!!!  sunday am better, but slight tiredness......  monday am fine and now back to 'normal' activities....
7AUG93 noted pain lt jaw; 9AUG93 swelling noted & inc til 1-AUG seen by MD; no tx no diagnostic tests; to return only if necessary; denies fever;
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by reporter.  No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
developed migraines; Flashes of light in her eyes; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received bnt162b2 (solution for injection), via an unspecified route of administration on an unspecified date as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took previously BNT162B2 (solution for injection), dose1 for covid-19 immunisation and experience no reaction. It was reported that patient had developed migraines, flashes of light in her eyes, and many additional symptoms after receiving the second dose. She was being seen with neurology, neuro ophthalmology, and may other doctors. The clinical outcome of the events was unknown.  Information on Lot/Batch has been requested.
States developed rash on left arm and shoulder extending towards back within one hour of vaccine. By the next day rash developed on his buttocks with itchy feeling on feet and knees. States had low grade fever, headache and general malaise.
Had rash for 5 days-2 wks later was unable to walk for 2 wks; taken Naprosyn then & now; still have fatigue, joint & muscle pain/stiffness; catches colds & flu very easy & always need rx for them;
This spontaneous report was received from a pharmacist via company representative, concerning her 48 year old her husband. Patient's concurrent condition included immune system "so low". On an unknown date within ten years, the patient was vaccinated with two doses of PNEUMOVAX 23 (dose, route, lot # and expiration date were not reported) for chronic obstructive pulmonary disease (COPD). On unspecified dates, the patient "almost died from his COPD". The patient sought medical attention through an unspecified source. Upon internal review, the event "almost died from his COPD" was considered as a life threatening. At the time of the report, the outcome of event was unknown. Additional information is not expected because the physician cannot be contacted.
Information has been received from a registered pharmacist concerning a 21 year old patient who was vaccinated with one or two doses of VARIVAX (Oka/Merck) (Lot # not reported). The patient was found to have negative antibody titers for varicella. No further information is available.
Fever, chills during night, inflamed lymph nodes under arm, goose egg bump where injection was given, then on  07/18/21 another dime size red itchy mark appeared on  the front close to my breast and I was extremely tired and feverish. Then four days later on 7/22/17 the new red mark became the size of a half dollar, went back to CVS to show PA and she prescribed  Triamcinolone .1% to the affected red marks.
1/4 nausea and GI, 1/5 stiff neck, chest pain, swollen lymph groin, 1/6 achy, more chest pain, 1/8 severe chest pain with pleurisy. MD said maybe pneumonia vax.