chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever, chills and pain at the injection site about 12 hrs after patient received her 2nd dose of Moderna vaccine.  Pt said she felt much better today and no other symptoms since then.
Evening after shot had fever of 102.3, chills, body aches bad enough to make it hard to walk. Those ended by next day.   Developed very sore left hip/buttocks. Pain up to level 8. Now about 3-4.   Saw pediatrician today to see if there was concern for blood clot. Was told to watch for sudden changes and sharp pain.
flu-like symptoms for three days. Fever, chills, both ears draining, cough  and fatigue. Day four symptoms started clearing but extreme fatigue and left ear still draining. Day five back to work normal schedule still extreme waves of fatigue and left ear draining. Day seven trip to at Clinic and she said residuals from shot stay home a few days. Day twelve same symptoms saw Staff and took a z-pack and steroids. day nineteen no affect from steroids except to stop ear drainage for a week. Referred To ENT specialist and Dr. found aspergillus growing in my left ear.  Day forty-one same symptoms but ear being treated and no longer draining.
backache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "backache". Therapeutic measures were taken as a result of back pain.  Additional info: The reporter wanted to know if it is okay to take Advil, though it is not for the vaccine but for his backache, after the vaccine. The patient took 2 Advil after the first dose. Reporter also wanted to know if he can take his diabetic medications and Muconase after the dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash generalized (systemic) Started at injection site then spread to body/c/o itching
Patient fainted approximately 15 minutes after administration. He felt nauseated immediately before, then fainted, falling to the floor and striking his head.
On day 9 after vaccination. Red, itchy, warm, blotch about 2-3 inches in diameter at injection site. Looked it up in internet and took some Benadryl twice a day for 3 days.  Today 2/10/2021 almost resolved  No other symptoms
presents with sudden onset of subjective fever, chills, headache, n/d/ since yesterday. received a COVID vaccine at the end of Dec 2020. denies chest pain, sob, abd pain. supposes to have 2nd vaccine on 28 Jan 2021.
Received flu shot on 9/1/09 by 1200 on 9/2/09 right deltoid developed a silver dollar welt it was red, hard and painful. She took Benadryl, Tylenol and heat until 9/6/09 went it was gone. On 9/3/09 she reported it to Hospital.
episodes of Myoclonus (jerking) that seem to have accelerated of late; episodes of Myoclonus (jerking) that seem to have accelerated of late; This is a spontaneous report from a contactable consumer or other non hcp (patient himself).   A 67-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, batch and expiration date not reported), via an unspecified route of administration, administered on the right arm on 19Jan2021 15:00 (at the age of 67-years-old) at a single dose for COVID-19 immunisation. Medical history included degenerative disc disease, allergies to penicillin, and ongoing myoclonus. Prior to vaccination, the patient was not diagnosed with COVID-19.The patient's concomitant medications were not reported. Since the vaccination, has not been tested for COVID-19. The patient experienced episodes of myoclonus that seem to have accelerated of late on an unspecified date. Events were assessed as non-serious. Treatment was not received for the events. The outcome of the events reported was not recovered.
very bad joint pain; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (very bad joint pain) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced ARTHRALGIA (very bad joint pain) and CHILLS (chills). At the time of the report, ARTHRALGIA (very bad joint pain) and CHILLS (chills) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 65-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F. On 11-Sep-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804093 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Med info number (SEQ18-04086) was updated in the additional information tab. No changes were made in the narrative.
EYESIGHT GOT WORSE; BROKE OUT INTO HIVES AFTER SECOND DOSE OF COVID VACCINATION; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (EYESIGHT GOT WORSE) and URTICARIA (BROKE OUT INTO HIVES AFTER SECOND DOSE OF COVID VACCINATION) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis and Ulcerative colitis.    Concurrent medical conditions included Panuveitis (Non-infectious intermediate posterior), Ulcerative colitis (Moderate to severe) and Vision abnormal.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VISUAL IMPAIRMENT (EYESIGHT GOT WORSE) and URTICARIA (BROKE OUT INTO HIVES AFTER SECOND DOSE OF COVID VACCINATION). At the time of the report, VISUAL IMPAIRMENT (EYESIGHT GOT WORSE) had not resolved and URTICARIA (BROKE OUT INTO HIVES AFTER SECOND DOSE OF COVID VACCINATION) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant product use was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  All doses of vaccine was taken one in once. Humira was citrate free.  No treatment information was provided.  The reporter's causality for the event of eyesight got worse with Humira (Adalimumab) was a reasonable possibility. The reporter's causality with Humira (Adalimumab) for the event of broke out into hives after second dose of covid vaccination was not provided.
Information has been received from a certified medical assistant concerning a patient who was vaccinated subcutaneous with a 0.5 mL dose of VARIVAX (lot# 654327/0495F) instead of instead of ZOSTAVAX. It was confirmed that it was not product confusion. The patient is not experiencing any known symptoms. There was no product quality complaint involved. No further information is available.
pt hosp w/presumed sepsis;3 days later child remains hosp;exact etiology of illness unclear @ this time; Annual follow-up received 01/31/01 states the pt has recovered.
HAD A MILD FEVER AND SORE TONGUE AND MOUTH SHORTLY AFTER THE VACCINATION. WENT TO THE DOCTOR TODAY AND WAS PRESCRIBED CHLORHEXIDINE MOUTHWASH.
FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight, height, and medical history were not 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 10-APR-2021 09:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210427236.
This spontaneous report as received from a nurse refers to a multiple patients of unknown ages and genders. On an unknown dates in 2017 (reported as since 12-JUL-2017), the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # N001007 expiration date 19-SEP-2018 for prophylaxis. The temperature excursion lasted 15 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010515: US-009507513-1708USA010529: US-009507513-1708USA010532: US-009507513-1708USA010531.
had both shots and have them right now/suspected vaccination failure; have them right now, they have been worse; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had both shots and have them right now/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have them right now, they have been worse). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 24-MAR-2023 The case was received from the patient via interactive digital media. The patient have had both the shots and had them right now. The patient stated that they had been worse. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a nurse refers to an unspecified number of patients. In 2015 (reported as since 13-MAY-2015), the patients were vaccinated with doses RECOMBIVAX HB batch/lot # J013394, expiration date 25-AUG-2016, batch number/lot # reported as K018180, expiration date reported as 17-SEP-2016 that had been exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports from the same reporter. Additional information has been requested.
For about 2 weeks afterward (on and off, not constantly) I was feeling a tightness in my chest, and maybe I could describe the sensation as heart palpitations.  The second week it was more like chest tightening and heart fluttering which usually happened in the mornings when I woke up, still in bed.  The occurrences never lasted 10 minutes.  This past week I don't recall having any tightness nor unusual heart behavior.
This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received Shingrix for prophylaxis. On an unknown date, the patients received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patients experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix. Additional information received as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected adult as per vaccine indication. The 2 to 3 patients experienced flu-like symptoms. The reporter agreed to follow up from GlaxoSmithKline. This was 1 of the 4 linked cases reported by the same reporter.
Information has been received from a medical assistant referring to a 4 month old female patient. No relevant medical history or concurrent conditions were reported. On 13-JUL-2015 the patient was vaccinated with improperly stored PEDVAXHIB (lot # K004541, expiration date 04-DEC-2016; Dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash, itchy, redness, numbness on my lower face, underneath my chin and the whole front of my neck.  Started about 4 or 5 hours after the shot.
So on the Saturday after my vaccine, I was having chest pains which were like shooting pains which was pretty strange. I was driving so I pulled over and had some water then continued on. I had dinner and it continued, these shooting pains in my chest. I called the paramedics and had them evaluate me. They hooked me up to an EKG machine and they were alarmed and they recommended I go with them to the ER. I don't really know why they were that alarmed, I didn't feel that bad. The paramedic was like I have been working in cardiac care for 15 years. They wouldn't even allow me to walk down my stairs, they put me in a wheelie thing and I got in the paramedic vehicle. They said I was having premature ventricular contractions. They tested my blood levels and all that stuff and I was not having any indication of a heart attack or anything. They sent me home the next day, on 4/4/2021.
A patient received a booster dose instead of the 2nd full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (A patient received a booster dose instead of the 2nd full dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Apr-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2022, the patient experienced ACCIDENTAL UNDERDOSE (A patient received a booster dose instead of the 2nd full dose). At the time of the report, ACCIDENTAL UNDERDOSE (A patient received a booster dose instead of the 2nd full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No side effects reported. No treatment medication was reported.
Ears popped; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179), via an unspecified route of administration in the left arm on 01Jun2021 at 19:30 (at the age of 16-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported and the patient had a history of allergy to sinuses. Concomitant medications included cetirizine hydrochloride (CETIRIZINE), montelukast (MANUFACTURER UNKNOWN) and fluticasone propionate (MANUFACTURER UNKNOWN) all from an unknown date and for an unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0179), via an unspecified route of administration in the right arm on 11May2021 at 19:30 (at the age of 16-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported as unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 02Jun2021 at 06:30, the patient woke up the at morning with ears popped and has not gone away since an hour. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event ears popped was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient reported adverse events to another pharmacist on 09/01/2018 (3 days after vaccination). She said she experienced low grade fever, aches, and redness/irritation at injection site. She did say her symptoms have resolved.
Sore jaw on my right side and numbness on right side of face. And an odd sensation that feels like a vibration and  tickling on right temple and right ear.
PT HAD SYNCOPAL EPISODE SECONDARY TO RECEIVING VACCINATION TO LEFT DELTOID. SYCOPAL EPISODE  LASTED 3-5MIN. PT WAS LAID IN SUPINE POSTITION WITH LOWER EXTEMITIES RAISED. EMS CAME TO CHECK  ON THE PT. PT WAS NOT TRANSFERRED BY EMS. PT HAD FULL RECOVERY AND BECAME AAOX4. GCS 15.
Rash on her entire chest area and stomach; This non-serious case was reported by a physician via sales rep and described the occurrence of rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced rash (Verbatim: Rash on her entire chest area and stomach). The outcome of the rash was resolved (duration 45 days).   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-JUL-2023 The reporter reported that the patient came in office 2 week after receiving Shingrix vaccine. The reporter reported that rash went away in 45 days The reporter reported that after vaccination patient had a rash on her entire chest area and stomach. No other information was available. The reporter did consent to follow up.
Rash about three inches in diameter, in the area of the shot, and slightly itchy.  Slightly raised area where the rash is, and warm to the touch.  Today, several days later, it is quite faded, but still raised, and only slightly sore.
C/O dizziness, sweating, shakiness apprx. 15 mins after flu shot. Face flushed. No hives, SOB or wheezing. (Only went to ER because another client was also going) ER states was vasovagal Rx IV fluids
SOB, cough, saturation < 88%.  Treatment:   2-3 L nasal cannula oxygen.
Breakthrough case admission 6/13/21 Moderna Lot# 049C21A 7/11/22 Moderna Lot# 049C21A
I developed a headache, dizziness, chills, and general unwell feeling a few hours after the shot.  The headaches continue to occur everyday since the shot (5/14-5/26).  Two days after the vaccine, I developed night sweats, which have occurred every night since then.  Approximately a week after the vaccine, I woke up with swelling and pain in my shoulder and armpit area on the left side where I received the vaccine.  The swelling and pain in the area has improved, but is not yet better as of today (5/26/2021).  The swelling and pain moved into my neck area and is now in my face causing tightness and pain.  I believe my lymph nodes are swollen due to the vaccine.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit) for a total of 13 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding a 14 years old, male patient with no pertinent medical history reported. On 11-JAN-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 26-MAR-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. This is an amended report the adverse event codification was updated. Additional information is not expected.