chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; nape pain; chills; 2 days later he felt pain in screws and other instrumentation instaled in his body due to a hip surgery; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient called in to report the symptoms experienced after first dose of Pfizer's COVID-19 vaccine. Patient reports that the same day of vaccination patient had headache, nape pain and chills. The patient reports that 2 days later he felt pain in screws and other instrumentation installed in his body due to a hip surgery, the pain was gone after this time. Outcome of the event Medical device site pain was recovered on an unknown date and for remaining events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a healthcare worker refers to a unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. Doses of PROQUAD (Merck) lot # L026728, expiry date 15-JAN-2017 or lot # L019996, expiry date 02-FEB-2016 (routes and sites of administration, doses were not reported) which were exposed to temperatures outside of the recommended range, have been administered to unspecified patients on unspecified dates since 24-SEP-2015 - the date of the excursion. Other suspect therapies included VARIVAX (Merck). No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Cant lift left arm; Burning sensation in upper arm/pain; pain; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Burning sensation in upper arm/pain), PAIN (pain) and VACCINATION SITE MOVEMENT IMPAIRMENT (Cant lift left arm) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No medical history reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced SKIN BURNING SENSATION (Burning sensation in upper arm/pain) and PAIN (pain). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Cant lift left arm). At the time of the report, SKIN BURNING SENSATION (Burning sensation in upper arm/pain), PAIN (pain) and VACCINATION SITE MOVEMENT IMPAIRMENT (Cant lift left arm) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.  No relevant concomitant medications were reported.  No treatment information was provided.
Patient called stating she had fever/chills, nausea & vomiting the evening of vaccine. Stated that she felt as though " she was going to die." She contacted her husband to bring her to the hospital, he came home and brought her "salt bread" and fluids, did not go to hospital. Stated to our RPh that she felt much better on the 25th.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (oozing with pus and he thinks it was a major infection), INFECTION (oozing with pus and he thinks it was a major infection) and VACCINATION SITE MASS (large lump at the vaccination site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 030A21A) for COVID-19 vaccination.  No Medical history was reported. Concurrent medical conditions included Gouty arthritis. Concomitant products included PREDNISONE for Gouty arthritis. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced VACCINATION SITE DISCHARGE (oozing with pus and he thinks it was a major infection), INFECTION (oozing with pus and he thinks it was a major infection) and VACCINATION SITE MASS (large lump at the vaccination site). At the time of the report, VACCINATION SITE DISCHARGE (oozing with pus and he thinks it was a major infection), INFECTION (oozing with pus and he thinks it was a major infection) and VACCINATION SITE MASS (large lump at the vaccination site) had resolved. Patient stated that about a week or so after he got the vaccine, while he was taking a shower, he noted a large lump at the vaccination site. He went to see a doctor at an Urgent Care and he was prescribed with a local antibiotic and an antibiotic pill. They drew a circle around the lump and he was advised to keep a close eye on it which he said made it sound severe. It was oozing with pus and he thinks it was a major infection. It resolved in a week or two. Patient stated that he was prescribed with a local antibiotic and an antibiotic pill as a treatment.
pampers were grey, like grey pee; This is a spontaneous report from a contactable consumer (patients mother). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EWO171 Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 25May2021 as 1st dose, single dose for covid-19 immunization. Medical history included quadriplegic cerebral palsy (she was born with this), heart beats fast; she has always had this. Concomitant medications included vitamin c:ascorbic (500); buspirone(200 mg) taken for pain; ibuprofen. The patient experienced pampers were grey, like grey pee on May2021. Caller stated that she was calling about her daughter. Caller confirms she was calling about the Pfizer Covid-19 Vaccine. The day before yesterday, her daughter got the Pfizer vaccine and she had quadriplegic cerebral palsy and did not walk or sit. Caller noticed that her daughter wears pampers and it was grey. It was grey, like pee, or whatever. The Pamper was grey. There was no blood or anything, it was just greyish. States she has nothing else to add to the report and that her daughter just told her, ma, you and people to the bathroom and pee. Adds that she, the caller, took the shot and nothing happened to her and her friends but her daughter said that they were peeing in the bathroom and do not look at their urine to see if it was grey and when it was in the water. It was noticeable because her daughter was in a Pamper, she uses Pampers and not the bathroom. Stated that her daughter had been on these for years. Caller just wants to make sure this was reported, because she was so scared and said maybe people urinate in the bathroom and they do not notice because it goes into the water. The outcome of event was not recovered.   Information on lot/batch number was available. Additional information has been requested.
COULDN'T WALK WITHOUT PAIN ON THE RIGHT SIDE OF BODY; PAIN WHILE BREATHING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced couldn't walk without pain on the right side of body. On APR-2021, the subject experienced pain while breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from couldn't walk without pain on the right side of body, and pain while breathing. This report was non-serious.
Symptoms started in June, slowly worsening, and continued until Booster in January. I had swollen fingers and wrists, pain in the fingers, and went to the doctor on October about it. She thought maybe Rheumatoid Arthritis but comprehensive blood test came back "perfect"  and with no RA.  This continued until my BOOSTER on 01/12/2022, Pfizer-BioNTech Lot FJ6369, when all of the previous symptoms quickly escalated into very restricted finger movements,tingling, exteme swelling, numbness, loss of hand strength, and barely able to bend fingers. Then it also caused swelling of area around the knees and knee joint pain, swelling of feeet/ankles/toes and ankle joint pain, and now near elbows too. It is the end of June 2022 and I still have all of these issues - and I was in PERFECT HEALTH prior to two vaccines and booster - pain free walking five miles a day. (First vaccine 04/20/2021 at 4:40 PM Pfizer-BioNTech Lot EW0172)
pt recv vax & subsequently devel red, itchy eyes;no further info was available @ the date of this report;
This consumer spontaneous report (initial receipt: 13-MAY-2011) concerns a 70-year old female patient, who had a medical history of allergy to egg whites. She experienced 'anxiety attacks' when she took hydrochlorothiazide. On an unknown date, the patient received a flu vaccine 'when it first came out' (brand name unspecified). The patient reported that immediately after she received the vaccine she was unable to move her arm for three months. She sought medical attention. The patient had recovered from the event and regained full use of her arm. Rechallenge was not performed. The reporter considered event serious (significant disability or incapacity) as she could not move her arm for 3 months.
p/vax a serum varicella zoster virus antibodies test revealed vaccine failure (0.25);
At the time of the first injection on Dec 28th I noticed I began itching a few days later.  I did not put the itching together with the injection due to the dry weather.  As time went on I noticed the itching mainly on head and upper torso.  I had pain by the injection site but lasted only 2 days and was not that bad.  The itching improved over the past week but noticed after my second injection that the itching has started back full force.  I wake up scratching during the night.  The pain in the arm was worse this time and did interrupt my sleep.  Today at work I noticed my arm being sore and increased itching and decided to check the site.  I found the site to be sightly swollen, red and warm to the touch.  Was advised by provider that I work with to take Benadryl which I cannot do at this time until I am off shift as it makes me drowsy.
FATIGUE, CHILLS, MILD GI UPSET, PAIN TO INJ SITE
IM Influenza vaccine was mistaken for "Flu Mist" and administered to the nasal passage as a liquid. One mistake was determined it was given IM
This is a spontaneous report obtained from a contactable physician through a sales representative. A 72 year old female patient received PREVNAR13, single dose, on her arm in DEC2012. Relevant medical history included multiple sclerosis (ongoing at the time of event onset). It was unknown if she had any siblings. Concomitant medications were unknown. Vaccines given on the same day and taken within the last four weeks were unknown. In DEC2012, she developed redness and swelling at the site of injection. At the time of the report the clinical outcome of the events was unknown. Follow-up (22FEB2013) Follow-up attempts completed. No further information expected.
Information has been received from a physician concerning two patients who on unspecified dates received both doses of VARIVAX (Merck) and they were both exposed to an outbreak situation and both developed a mild case of varicella.  There was no concomitant medication and no pertinent medical history.  The patients saw physician for medical attention.  Follow up information has been received from the physician's office, concerning a male patient who received the first dose of VARIVAX (Merck) on 08-AUG-2002, and received the second dose on 26-SEP-2007.  The reporter indicated that the lot numbers were unknown because the vaccines were given in another center.  Follow up information has been received from a physician concerning a 6 year old male student (also reported as female) who received two doses of VARIVAX (Merck), the first one on 08-AUG-2002, and the second dose on 26-SEP-2007 (SQ, 658430/1183U).  On 20-MAY-2008 the patient had a case of chickenpox.  The chickenpox lasted 4 days with a non complicated course.  The patient recovered on 24-MAY-2009.  This is one of two reports from the same source.  No further information is available.
PT HAD NAUEA AND IGHT HEADEDNESS 5 MIN AFTER SHOT LASTING ABOUT 10 MIN--I HAD PT STAY FOR 15 MIN MORE TO ENSURE RECOVERY WAS COMPLET UPON DRINKIN GINGER ALE
Redness, swelling, hard area at site of injection, increased to approx 3/4 inch size by the next day 5/23/12; by 5/24/12 was no longer red or warm but still with some swelling.
10 minutes after shot was administered, I had a very cold sensation in the middle of my chest and left arm tingling all the way down to my fingertips. Each day after I have had worsening symptoms of bilateral leg burning, tingling and left calf pain. Also extreme fatigue in both my legs after walking a few steps.
Information has been received through the pregnancy registry for GARDASIL from a physician concerning a 16 year old female with no pertinent medical history and no history of drug reactions or allergies who no 06-MAY-2008 was vaccinated with the first dose of GARDASIL. On 08-JUL-2008 the patient had her last menstrual period. On 18-AUG-2008 the patient was vaccinated with the second dose of GARDASIL (lot#: ). On 26-AUG-2008 the patient was seen in the physician's office due to nausea. Urine pregnancy test result was positive. The patient was pregnant at 7 weeks gestation. The estimated delivery date is 15-APR-2009. Additional information has been requested.
COVID-19 infection (Confirmed); COVID-19 infection (Confirmed); This is a spontaneous report received from contactable reporter(s) (Physician).  A 50-year-old female patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 13Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic Arthritis", start date: 2013 (ongoing); "Psoriasis", start date: 2013 (unspecified if ongoing); "Hypothyroidism", start date: 1983 (ongoing), notes: Hypothyroid; "Tooth abcess", start date: 02Nov2020 (unspecified if ongoing); "non melanoma skin cancer" (unspecified if ongoing); "Former smoker" (unspecified if ongoing); "Migraine" (unspecified if ongoing), notes: Migraine. Concomitant medication(s) included: METHOTREXATE oral, start date: Jan2020 (ongoing); NARCOTINE (ongoing); LEVOTHYROXINE taken for hypothyroidism, start date: 20Aug2016 (ongoing); TOPIRAMATE taken for migraine, start date: 28Jul2016 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "recovered" (07Jan2022) and all described as "COVID-19 infection (Confirmed)". Patient's height was 64 inches, weight was 203 lbs. It was reported the patient had a confirmed COVID-19 infection on 01Jan2022, On that day, she was tested positive using a COVID- 19 real time PCR test. The patient had a runny nose and a sore throat during the event. The event did not require hospitalization and she did not receive any treatments for the infection. Prior to the event, the patient had low disease activity. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Positive. Therapeutic measures were not taken as a result of covid-19. The reporter did not attribute the COVID-19 infection to Xeljanz or any other medication.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.
Within one minute of vaccination with Gardasil, the patient felt nausea, and fell over the side of the bed on which she was sitting with complete loss of conciousness. She fell on her face and was unresponsive and hypotonic for about one minute. She then became hypertonic and rigid for thirty seconds before responding. She had post ictal headaches, dizziness and no memory of the event. This episode is in keeping with seizure like activity.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 03-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose and number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 1/26/2023 --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Approx 8 hours after vaccination arm became red, swollen, painful to the touch from mid deltoid muscle down to the elbow.  Systemic affects were fatigue and malaise for 24 hours. Arm  Reaction reached is worse about 18 hours after vaccination and then gradually subsided and completely gone after 7 days.
A spontaneous report has been received from a consumer via Regulatory Authority (VAERS) concerning a 45 month old female patient. Neither concomitant medications nor medical history were reported for this patient. The patient had received influenza vaccination shot in the past. Around 09-Oct-2009, this patient received a first dose of FLUMIST (intranasal). On 06-Nov-2009, the patient received a second dose of FLUMIST (intranasal). On 08-Nov-2009, the patient experienced behavioral issues that persisted for several days and patient had encephalopathy. The patient could Not sleep, was very irritable and experienced delirium for about a week with nightmares. The patient also experienced fever of 103 F for two weeks and vomiting for five days after fever onset. On 26-Nov-2009 the patient experienced uncontrollable drooling and was unable to swallow. The patient was taken to emergency room and diagnosed with sore throat and sent home. On 27-Nov-2009 the patient did not improve and was admitted to hospital. It was reported the patient had a feeding tube, was unable to speak and unable to walk or sit up on her own. During the hospitalization the patient had multiple MRIs and two lumbar punctures, although no results were provided. The patient remains hospitalized and the reported events were ongoing. The reporter assessed the events encephalopathy to be serious with the seriousness criteria of Hospitalization and other events to be non-serious.
Headache, Myalgia, Fever, CoughWheeze, swelling and soreness to injection site, cough, HA, fever, chills, body ache Narrative: Day 2- noticed soreness and swelling to injection site, cough, headache, fever 102, chills, and body ache; Day 3 - only cough fever and chills remain; no further symptoms noted
PATIENT RECIEVED 2ND DOSE OF MODERNA AND AFTER ABOUT 10 MINUTES SHE SAID SHE COULD NOTICE SOME DISCOMFORT IN HER BREATHING- NOTHING SIGNIFICANT BUT ENOUGH IT BOTHERED HER. SHE WAS MONITORED AND FELT SHE NEEDED A BENADRYL 25 MG CAPSULE. SHE ALSO COMPLAINED OF A SLIGHT HEADACHE. INJECTION SITE WAS NORMAL. SHE CONTINUED TO BE MONITORED AND CONTINUED TO FEEL THE SAME OVER THE NEXT 10-15 MINUTES BUT AT THE 20 MINUTE MARK SHE SAID SHE DID FEEL BETTER. SHE WAS NOT DRIVING AND SHE DID FEEL WELL ENOUGH TO GO HOME. SHE WAS COUNSELED TO BE SEEN AND SHE AGREED SHE WOULD BE IF SHE HAD ANY MORE SYMPTOMS. PATIENT WAS FOLLOWED UP 6 HOURS LATER AND STATES SHE HAS HAD NO ADDITIONAL PROBLEMS AND FEELS PERFECTLY NORMAL.
Based on age pt received the wrong dose. Should have received the purple cap Pfizer 30 mcg. Instead received the orange cap Pfizer 10 mcg.
contracted Sars-Cov-2 in the interim/tested positive for vaccine; contracted Sars-Cov-2 in the interim/tested positive for vaccine; This is a spontaneous report from a non-contactable Other HCP. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received the first dose 24Dec2020 and is due for 2nd dose 13Jan2020 but contracted Sars-Cov-2 in the interim. She reports that she is currently symptomatic, but her employer will allow her to return to work after a 10-day quarantine. And then 07Jan2021 tested positive and a couple of days to me asymptomatic  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.
Shingles on left side; vesicular lesions, burning and pain, 2 days prior to appearance of rash.
This spontaneous report received from a pharmacist via Pfizer referred to around 65 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, lot number and expiry date not reported) for protection against pneumococcal pneumonia (prophylaxis). On an unspecified date, the patient experienced injection site bump. Outcome and causality of the event were not reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Starting with malaise and tiredness at about 5pm, this progressed to notable muscle tremors within 1 hour, getting progressively worse over the next hour or so.. Malaise and tremors continued for about 2 hours (approx) until sleep at about 9:30. The next day, tremors completely resolved but malaise and tiredness continued. This mostly resolve after 2 days, but notable I became tired more easily for the next couple of days, with no other change in routine. My wife, who received a vaccination at the same time (and from the same lot) as I did suffered similar symptoms but hers resolved somewhat more quickly and did not apparently last over days.
Agency nurse administered vaccine high near shoulder blade. Patient complained to me the next day of sharp pain of the shoulder and restricted movement. Possible injury due to vaccination may have occurred.
8 hours after shot started with muscle aches that progressed to uncontrollable body chills. Then got nauseated, took Tylenol and zofran.  At 9 too Ibuprofin and fever was still at 102.1. Also had insomnia. Finally around 11 nausea subsided as well as chills but was still very achy and couldn?t sleep. I am better this morning, just very tired, slight headache and slight achy.
Severe pain at site of injection erythema, swelling, fever, achy, gave pain killers, Benadryl at ER Prednisone 10 mg x 2D, dec to 10mg Q 2D