chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist of unknown age reporting on himself. Patient medical history and current condition was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, via subcutaneous route. It was reported that increased pressure irregularity with a ZOSTAVAX vial caused the vaccine to drip on to his skin just past his protective gloves. Also reported contracting "chicken pox". Cancer and overdose was not reported. The outcome of the event contracting "chicken pox" was reported as recovering/resolving. The outcome of increased pressure irregularity with a ZOSTAVAX vial caused the vaccine to drip on to his skin just past his protective gloves and vaccine drip on to his skin is unknown. Additional information has been requested.
right arm red sore , painful touch ,itching at injection site  pt states redness is about 3" across  injection .
This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 16-JUN-2015, the patient received improperly stored VARIVAX (Merck) (lot#J012151, expiry date: 28-SEP-2015, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative: COVID infections following completion of COVID vaccine series 04/09/21 COVID vaccine dose #1 (J&J) 07/26/21 Pt reports being sick since last Tues (07/20) and spouse tested positive for COVID 07/26/21 Pt presents to screening reporting cough and fever (temp 99.0) and exposure to COVID positive person; COVIV POSITIVE 07/30/21 Pt reports chills, fever, headache, loss of taste/smell, muscle pain, runny nose 07/11/21 Pt calls clinic complaining of pain in left elbow with swelling and redness; reports no COVID symptoms
Inflammation at injection site about the size of a golf ball. No other apparent distress. Area was iced for about one hour. Inflam. decreased to 1/4 or 1/3 of original size before pt. left.
At Approx. 6.30 AM on Thursday 2/11/2021.  I was very lightheaded after urinating, I sat on the bed and drank some water I then disarm my home and called my neighbor asking her to come over since I am not feeling well.  I went to the kitchen to get some more water and then I had an episode of Syncope.  I regain consciousness and my neighbor found me on the kitchen floor.  I was lift off the floor and taken to the bed I checked my blood pressure and on the (L) arm I got 55/62 on the (r) I got 88/62.  I was taken to the ER and at that time my pressure was 102/68
Given possible very mild allergic reaction to first shot, nurses were informed of that condition and I was monitored for 45 minutes. 15 minutes post-injection: very mild scalp itch, less than first shot.  Gone in 1 hour. 20 minutes post-injection: very mild itch on forearms, less than first shot.  Gone in 1 hour. 5 hours post-injection: slight fatigue. 10 hours post-injection: fatigue, body aches, slight chills, slight sore throat, headache.  Body aches, chills, sore throat, headache gone in 24 hours.  Fatigue persisted and was gone in 48 hours. 3 days-post injection: a few hives on legs after shaving. 4 days post-injection: developed exercise-induced hives on arms, legs, and stomach, not a condition present before 2nd shot, after 30 minute vigorous bike ride.  Condition repeated 8 days post-injection under similar conditions and every bike ride after that.  Longer bike rides result in more widespread hives.  Hives disappear after about an hour after exercise ceases. 12 days post-injection: developed hives on legs after exposure to sea water.  Hives disappeared after about an hour after rinsing legs off with fresh water.
1)16 hours post vaccine, severe chills, headache, exhaustion, fever up to 104.4, body aches....took 2 tylenol every 6 hours after 12-15  hours, fever broke, still tired, headache for another 24 hours 2)60 hours post vaccine, enlarged painful lymph nodes in right clavicle and axial, still fatigued 3) 84 hours post vaccine: large red, swollen, warm, hard area on entire upper right arm, visited Internal Med where doc evaluated and said to monitor and call them if it worsens, advised to take Benadryl and Tylenol as needed
severe edema lower extremities Both feet red and swollen pustular rash all over the abdomen, back,legs, and arms severe itching
Case number PHEH2016US029994, is an initial spontaneous report from a pharmacist on 11 Nov 2016. This report refers to a female patient. Past medical history and concomitant medication were not reported. She was vaccinated with a single dose of FLUVIRIN (batch number: 168805, Expiry: Apr 2017) at a dose of 0.5 ml intramuscularly on 20 Oct 2016. After vaccination, on the same day, she experienced arm pain and pain in shoulder upon lifting and when driving. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Pinpoint rash on trunk and back, thighs and legs, neck and injection site on each leg. No difficulty breathing.
1. Very mild joint pain in my right ring finger. This is the one I would like to report as it is kind of rare. It started same day after my first dose, but I did not pay much attention to it. I thought it will go away. However two weeks have passed since my first dose, this mild joint pain in my right ring finger is still there. So I think I should report it.  2. Injection /shot area in right arm is a little sore which I consider normal.
Disturbed sleep , Intense uncomfrtable dreams , daytime "fog" . Has been 3 weeks now and stilloccuring .
Dizziness even when lying down (72 hrs) Fever between 101.5 and 103.5 despite Tylenol and ibuprofen on q 3 hr schedule (96 hrs) Severe headache (48 hrs)  Fatigue (96hrs)  All started by 8:30 pm (1.5 hours after vaccination) the day I received the vaccine except the headache.  It started at 36 hours and lasted for 48 hours.    Sore arm (96 hrs)  Continued mild intermittent lethargy/fatigue and fever 100.5-101 since 1/27/2021 thru today 2/6/2021
Pimples appeared on left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Pimples appeared on left shoulder) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACNE (Pimples appeared on left shoulder). At the time of the report, ACNE (Pimples appeared on left shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported
tested for antibodies, and does not have any; States her second dose was on 05Jan2021, that was day number 18 after the first one.; States her second dose was on 05Jan2021, that was day number 18 after the first one.; This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist (patient).  A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 05Jan2021 at single dose (reported as 0.3, unit not provided) for COVID-19 immunisation, by injection to left arm.  Medical history was none. Concomitant medications included levothyroxine sodium (SYNTHROID). Historical vaccine included first dose of BNT162B2 on an unknown date for COVID-19 immunisation. The patient states her second dose was on 05Jan2021, that was day number 18 after the first one.  On 18Jan2021 the patient was tested for antibodies, and does not have any. She was expecting to have antibodies. She is not sick, she did not get sick, but because she didn't have antibodies it is upsetting, but there is nothing going on with body because she doesn't have the antibodies. Calling to find out what she should do now, if she needs to be revaccinated. The event was reported serous as medically significant. Outcome was not recovered. Method of assessment: Global Introspection was related, there is no reason why she wouldn't develop antibodies normally.; Sender's Comments: The 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unknown date, and then received second dose on 05Jan2021, that was day number 18 after the first one.  On 18Jan2021 the patient was tested for antibodies, and does not have any.  There is possibility of false negative COVID-19 antibody test. The exact reason was unknown.  The case will be reassessed should additional information become available.  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.
symptoms started that night and then I tested positive for covid; This is a spontaneous report from a contactable Nurse (patient) via Medical Information Team.  A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EK9231, NDC number and Expiry Date: unknown), via an unknown route of administration in Deltoid, Left on 08Jan2021 at 16:00 (04:00 PM) the facility she works for Covid-19 immunization. Patient medical history reported as no and also reported that she had a lot of past medical history, but nothing that she thinks is relevant to her COVID19 Virus diagnosis. No other concomitant products. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks) were reported none. Adverse events prior vaccinations was none. Family medical history relevant to adverse event was included Positive COVID-19 Virus Test (test type unknown). COVID-19 vaccine was a Pfizer product. COVID-19 vaccine manufacturer was unspecified. The patient was given her first COVID-19 Vaccine on Friday, 08Jan2021 by the facility she works at. As per her apparently she already had the COVID-19 Virus prior to receiving her first dose of the COVID-19 Vaccine because she started with symptoms on 08Jan2021 (the night of the day she got her first COVID-19 Vaccine dose). She said she was now recovering from the COVID-19 Virus, and should have been re-vaccinated today, 29Jan2021. Her doctor told her it is too soon for her to receive the second dose of the COVID-19 Vaccine since she was positive for the COVID-19 Virus. She is in the 3rd week after receiving her first dose of the COVID19 Vaccine. She was tested for the COVID19 Virus on Monday, 11Jan2021. She didn't know what COVID-19 Virus test was used, but she knew the facility where she works (who performed the test) does not use the COVID-19 Virus rapid test. She said she received the positive COVID19 Virus test result on Wednesday, 13Jan2021. She went to the Emergency Room on 15Jan2021-stated she was not admitted to the hospital), and was given IV fluids and a 1-time infusion of "mono-something", and was discharged home. She can't remember the name of the infusion, and does not have the NDC, Lot and Expiration Dates for the infusion and IV fluids. No Physician office visit was reported. Outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Starting in Aug/Sept 2003 Chronic sore throats, tonsillitis, strep throat, swollen tonsils, rhinitis, on antibiotics for months with no resolution, bacteria was resistant. Ended up having a tonillectomy in April 2004.
got some reactions after about 3-4 days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (got some reactions after about 3-4 days) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (got some reactions after about 3-4 days). At the time of the report, VACCINATION COMPLICATION (got some reactions after about 3-4 days) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   Concomitant medication was not reported. The patient has been brought to a location (was told the Infectious Disease) and stayed there for 4 days (almost 5 days). The patient was given some antibiotics, but they don't seem to work. Patient had been in and out of the Hospital.
Blister in mouth; Very light headache; Pain in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (Blister in mouth), HEADACHE (Very light headache) and VACCINATION SITE PAIN (Pain in injection arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030821A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced HEADACHE (Very light headache) and VACCINATION SITE PAIN (Pain in injection arm). On 30-Mar-2021, the patient experienced ORAL MUCOSAL BLISTERING (Blister in mouth). On 27-Mar-2021, HEADACHE (Very light headache) and VACCINATION SITE PAIN (Pain in injection arm) had resolved. At the time of the report, ORAL MUCOSAL BLISTERING (Blister in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Pain like "muscle spasm" down to left elbow. Tingling to finger at times. Relieved only when in hot shower, pain intermittent. 8/8/02 TDM nurse checked client. One inch knot at left scapula. Referred to private MD for evaluation to see if knot is causing problem. No redness, knot to left deltoid. Knot resolved about 2 weeks ago.
Patient received IMZ on 4/24/19 and said on 4/26/19  suffered from diarrhea, vomiting, and fever. Pt said went to hospital on 4/29/19 and they said she was dehydrated and had a kidney infection.  The patient said she did not have any swelling or problems with her arm that she received the IMZ in.  Pt also stated she did not know if the IMZ caused this problem.  The pt has a post follow up MD visit on 5/3/2019
been 2 weeks and still red; a little bit light, but not completely gone; rash 24 hours after shot; hardness; redness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INDURATION (hardness), ERYTHEMA (redness), RASH (rash 24 hours after shot) and ERYTHEMA (been 2 weeks and still red; a little bit light, but not completely gone) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced INDURATION (hardness) and ERYTHEMA (redness). On 14-Jan-2021, the patient experienced RASH (rash 24 hours after shot). On 27-Jan-2021, the patient experienced ERYTHEMA (been 2 weeks and still red; a little bit light, but not completely gone). At the time of the report, INDURATION (hardness), ERYTHEMA (redness), RASH (rash 24 hours after shot) and ERYTHEMA (been 2 weeks and still red; a little bit light, but not completely gone) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Patient experienced numbness, coldness, tingling and sensitivity to pressure in left arm, below site of vaccination,  within 1 minute of injection. Hands are equally warm, pulse is normal, no complaints of shortness of breath, local pain, or dizziness. Symptoms  have maintained severity for 30 minutes, seem to be beginning to lessen, but are still occurring.
Dizzy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 031L201) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (Dose one, injection and Left arm (body site)) on 18-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Drug allergy (Codiene allergy), Drug allergy (All pain medications), Allergy since 01-May-2005 and Back pain since 10-Oct-2016. Concomitant products included MONTELUKAST from 05-Jan-2019 to 28-Oct-2021, MULTIVITAMIN [VITAMINS NOS] from 01-Mar-2020 to an unknown date, BIOTIN from 01-Mar-2020 to an unknown date and ELDERBERRY [SAMBUCUS NIGRA] from 01-Mar-2020 to an unknown date for an unknown indication.   On 08-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DIZZINESS (Dizzy) and HEADACHE (Headache). In March 2021, DIZZINESS (Dizzy) and HEADACHE (Headache) had resolved.            No treatment medication were provided.   This case was linked to MOD-2021-388568, MOD-2021-388496 (Patient Link).
injection site it was a little warm; pinkish spots at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (injection site it was a little warm) and VACCINATION SITE RASH (pinkish spots at injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site it was a little warm) and VACCINATION SITE RASH (pinkish spots at injection site). At the time of the report, VACCINATION SITE WARMTH (injection site it was a little warm) and VACCINATION SITE RASH (pinkish spots at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
sore throat; allergic symptoms; headache; sneezing; sore throat that's burning; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on 31Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Medical history included bit by a tick (but did not realize she had a tick until a few days after and it was attached for a few days and then she had the vaccine and stated that she realized it the same day or the day before and was fine and got the vaccine and was fine for several days) from 2021 to an unknown date.  The patient's concomitant medications were not reported. Patient never was sick and never got COVID. On Apr2021, (symptoms did not appear right away, started earlier this week), had sore throat and allergic symptoms and she never had allergies to spring or anything at all before and stated that she had a headache and sneezing and no fever. Patient does have a sore throat that was burning. Patient was surprised and asked was it the vaccine or not. Patient is getting worse. Patient talked to her doctor and he doesn't know and did some tests just in case. Patient wanted to know if symptoms she was having could be from the vaccine even 4-5 days after the vaccine and with symptoms or if have a reaction or symptoms was it that same day or 2 days later or can it be later. Patient was also wondering if the tick like gave problems would that interact with the vaccine, was there consequences with that if it was only the tick or only the vaccine. Patient stated it was a mess. Patient does not know what to do and patient had no fever, and the doctor won't give her antibiotics. Patient stated that a few days after the vaccine she feels like this and was testing it is a little ridiculous and also concerning. On 09Apr2021, patient was tested for Covid and waiting for the results. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
myocarditis/pericarditis with chest pain, elevated inflammatory markers, EKG changes and elevated troponin, decreased heart function, requiring ICU admission, IVIG
Initial report received from healthcare professional on 06 Nov 2014. A 58-year-old female patient, had received a dose of Flu shot (lot number, dose, dose number, route not reported) in the arm on 04 Nov 2014. The patient had a medical history of urinary tract infection and had a course of antibiotics (within three weeks prior vaccination). The patient had been also taking AUBAGIO for multiple sclerosis as concomitant medication. About 8 hours after vaccination, the patient developed a reaction that was not quite the flu, but flu-like, and could hardly hold her head up, did not feel well, and was in a fetal position with chills, and blankets on her. The patient also had pain and soreness in her arm in the area where the flu shot was given. There was no diarrhea or vomiting. On 06 Nov 2014, in morning, patient felt better. Lab details and corrective treatments were not reported. The outcome of the event was not recovered. Documents held by sender: None.