chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It started with a headache felt like migraine. On 12/26 exp difficult breathing, felling fatigue with fever of 102, joint pain in fingers/toes moving to wrist and ankles. Then on 12/27 the joint pain was traveling to knees and 12/28. The symptoms got severe on12/29 followed with a cough. By the 12/30 cough was still there and joint pain. On 12/31 still exp cough until 1/4 and less joint pain. I missed 2 1/2 days of work.
Received DTaP boaster on 2/9/10 in left arm IM. On 2/10/10 left later upper arm had 7-8 cm area red and warm and tender, no fever. Patient seen in office, given Reflex PO on 2/10/10. Still increased swelling on 2/11/10. Still afebrile give Rocephin 1gm IM x 1 days improved. Switched to Lefadroxil B 10  x10days.
ACCIDENTAL EXPOSURE WHILE ADMINISTERING DRUG/ A SMALL AMOUNT OF VACCINE CAME IN CONTACT WITH FINGER; PERSISTENT BURNING SENSATION DUE TO VACCINE ACCIDENTAL EXPOSURE; 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, and batch number were not reported) dose, start therapy date were not reported 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 accidental exposure while administering drug/ a small amount of vaccine came in contact with finger, and persistent burning sensation due to vaccine accidental exposure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent burning sensation due to vaccine accidental exposure, and the outcome of accidental exposure while administering drug/ a small amount of vaccine came in contact with finger was not reported. This report was non-serious.
his voice changed; pain in his left kidney; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that he got his first dose of the Pfizer Covid vaccine on Sunday, 14March2021 and said that his voice changed and experienced pain in his left kidney. Asking if these are side effects of the vaccine and if he should be concerned about it. The outcome of the events was unknown.  Information on lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Pfizer 4/1/21, 4/22/21, 11/13/21. Positive on 1/31/22
Moderate flare of eczema to bilateral hands that seem to coincide with both first dose of vaccine, some calming of eczema between doses, and again flare up after second dose. At the same time she was also starting on anxiety medication Zoloft
Since I received my first dose of the vaccine I have had occaisional instances where my vision gets really weird. It's like the room is spinning. I have told 2 doctors about this and they don't seem to think anything about it.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 3:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 3:09 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.04.  No concomitant medications were reported.  Batch number 035C21A administered on 03-Nov-2021 with temperature 35 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 05-Oct-2021 and beyond use date for the vial was reported as 05-Nov-2021. Product moved to clinic on 03-Nov-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
No adverse event at this time-- this is an error report. Early booster of Moderna vaccine. The patient (who is a nurse practitioner) is moving from state to state. Out of concern for losing access to her booster dose, she scheduled herself to get one early, before moving (19 days after the first dose). By the time we realized what had occurred, we were in the position of having to waste that dose if we did not administer it to her. So we allowed her to have it. The following day, we reviewed our scheduling process to prevent this error from reoccurring.
Patient received pneumonia vaccine in LUE on 3/26/07. Has had pain and redness over triceps area x 2 days. Denies numbness and tingling of LUE. No pruritis. Denies hx of previous AEFI. Reports receiving previous pneumonia vaccine since coming on in Oct 2005, but no entry on form. NKDA. Patient examined at bedside by doctor, (limited exam due to pt discomfort)- Erythema, increased warmth and tenderness extending from upper triceps area to just below posterior left elbow. Extremely TTP. No clavicular, cervical or axillary adenopathy. Neurovasc check of LUE intact. Contacted patient on 4/2/07. He said redness, warmth and tenderness surrounding vaccine site have all completely resolved. (This was all incidental to a hospitalization for left shoulder pain (possible left pectoralis tear) and bacteremia with infectious source likely dental procedure).
Mom called about 330 on 8JAN92 states the pt had fever 103 & was in the bath tub instructed to go to ER; mom called the next day & stated pt fever was 106; vomiting @ 230 PM on 8JAN92; @ the ER a CXR was done, chest clear, ears sl red;
My arm  was sore; I had dizziness late that evening; I had vision changes; My right eye was blurry; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm  was sore), DIZZINESS (I had dizziness late that evening), VISUAL IMPAIRMENT (I had vision changes) and VISION BLURRED (My right eye was blurry) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 011A21A and 037A21B) for COVID-19 vaccination.     The patient's past medical history included Eye laser surgery (Laser surgery on her right eye a few hours before she got the booster dose.) in November 2021. Concurrent medical conditions included Heartbeats premature, Anxiety (She had it all her life.) and Stress (She had it all her life.). Concomitant products included BISOPROLOL FUMARATE and CLONAZEPAM for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced PAIN IN EXTREMITY (My arm  was sore), DIZZINESS (I had dizziness late that evening), VISUAL IMPAIRMENT (I had vision changes) and VISION BLURRED (My right eye was blurry). The patient was treated with MECLIZINE [MECLOZINE] on 27-Nov-2021 for Dizziness, at a dose of 12.5 milligram. At the time of the report, PAIN IN EXTREMITY (My arm  was sore), DIZZINESS (I had dizziness late that evening) and VISUAL IMPAIRMENT (I had vision changes) outcome was unknown and VISION BLURRED (My right eye was blurry) was resolving.            On 24 Nov 2021 patient drove her self after vaccine administration. On 25 Nov 2021 patient had blurred vision and on 29 Nov 2021 she had the same blurred vision but it was better than the previous nights. Patient got lightheaded all the time with bisoprolol and had been taking this medicine for past 3 years.   This case was linked to MOD-2021-400034, MOD-2021-400041 (Patient Link).
reporting that a dose of pentacel was inadvertently administered to a patient who was not age appropriate with no reported adverse event; Initial information received on 25-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 40 years old male patient who took dose of diphtheria/tetanus/5 Hybrid AC Pertussis/IPV(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] inadvertently and who was not age appropriate with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Aug-2023, the 40 years old male patient received a 0.5 mL dose of suspect diphtheria/tetanus/5 Hybrid AC Pertussis/IPV(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot UJ8418A, Expiry date: 09-Feb-2024, Strength: standard, Frequency: once) via intramuscular route in the left deltoid as Immunization and (product administered to patient of inappropriate age) (Latency: same day).  First time product used : No Still using product : Yes   Action taken was not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
PATIENT PRESENTED WITH SUDDEN VERTIGO, NAUSEA, VOMITED 2X IN AM, PALLOR AND COLD/CLAMMY IN CLINIC. BACKGROUND - PRESENTED ON THE 10 JAN 08 WITH ODD LS-S1 OF THE THE L SPINE. HE RECEIVED EPIDURAL STEROID INJECTION OF 100MG DEPOMEDROL. PATIENT ALSO HAD A PHYSICAL THERAPY SESSION ON THE 11 JAN 08.
Local site reaction followed by high fever, vomiting, nausea, lethargic motion, rash, insomnia, irritability.  Required two visits to Emergency Room and two additional follow up appointments, 3 other calls to Dr over course of 7 days. Effects are still present, combined with large bruise to injection site at the time of this report.
Tried to reach parents repeatedly. Child would cry up to 20 minutes at a time. Saw NP on 12/19/02 and was told that vaccine caused her crying. Baby cried frequently for at least 2 days. Temperature high as 99.8F.
p/vax pt devel a rash on belly that spread to legs;pt had approx 20 lesions;pt also had fever ranging from 100 to 101;pt was not seen by MD
During 15 minute Observation immediately following injection: Tingling lips and mouth. (lasted two hours) Starting around 3 hours after the injection: Dizzyness, Fatigue, Muscles soreness, Fever 100.7, Swelling of injection site, bruise at injection site, muscle weakness, nausea. (all symptoms lasted two days, increasing in severity over that time. As of 1/25/21: Injection site still bruised and hard. It felt like I have a lump in my arm the size of a baseball. As of 2/4/21 (today): Injection site still red, lump is gone.
allergic rxn?; parasthesias & flushing; no resp problems; BP normal; pt recovered & was sent home w/no sequelae; was instructed to see pvt MD for f/u;
Pt received first Moderna injection and stated she had an episode an hour or so later when she almost passed out but started to feel better within a few minutes.  Later in the day after she had went home she notified the office at 16:30 that she was having some numbness and tingling sensations and not feeling well.  She was instructed to go to the ER for further evaluation.
Two days after administration of 2nd dose of SHINGRIX. Patient experienced hives and swelling. Tx: ranitidine 300 mg twice a day for 10 days; prednisone 10 mg, 20 day course starting 4 tablets and decreasing, triamcinolone cream 0.1%.
Patient was inadvertently given half dose booster (3rd shot) early. Patient had reported that second shot in the series had been given more than the required 6 months however after dose was administered, Pharmacist discovered previous dose had actually been only 114 days previous. The patient did not qualify for early administration for immunocompromised condition. Patient was informed of early administration and possibility of increased side effects associated with early administration.  Patient reported no issues except sore arm which had occurred with the previous doses when contacted the next morning.
Patient experienced a sore arm at injection site post-vaccination; soreness lasted less than a week, approx. 3-5 days.  Patient cannot remember if this occurred after the 1st, 2nd, or both doses.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (172250). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Patient experienced a sore arm at injection site post-vaccination; soreness lasted less than a week, approx. 3-5 days.  Patient cannot remember if this occurred after the 1st, 2nd, or both doses.". Additional information: Patient experienced a sore arm at injection site post-vaccination; soreness lasted less than a week/approx. 3-5 days. Patient cannot remember if this occurred after 1st, 2nd, or both doses. Reporter consider that event was caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101748710 same patient, different dose of vaccine
This spontaneous report was received from a pharmacist referring to an unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unspecified dates, the patients were vaccinated with a dose of PNEUMOVAX 23 (strength, dose number, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. The reporter stated that on an unspecified dates, the patients experienced "winced" at the vaccination time (pain). The outcome of pain was not provided. The reporter did not assess the relatedness between the event and suspect therapy. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005477: US-009507513-1612USA005475: US-009507513-1612USA004758: US-009507513-1612USA005473: US-009507513-1612USA005474.
Huge red mark about the size of a baseball on backside of arm with bumps. Pains and soreness at injection site.
Two days of severe flu-like symptoms: headache, muscular and joint pain, weakness, exhaustion, feeling ill. No treatment beyond analgesics. Better after second day.
I was hospitalized twice, first time for stroke protocol (suspected stroke) and second for Gulliain-Barre.  Test negative for both.  Had a string of ER visits over the course of October, November, and December.  A long list of symptoms, illness.  Sudden allergic reaction to amoxicillin, neuropathy, paresthesia, diarrhea for weeks, kidney stones, hematuria, altered consciousness, sudden major depression, muscle spasms, weakness, and on and on.  I am sure I have neurologic damage, I still have numbness all over my body and after three and a half months now I have no definite diagnosis.  It has been overly apparent I have been ill, complete change.
Covid 19 vaccine: """feeling of lump in throat"" not endorsed until after 30 min of observation. Pt w/shellfish& peanut allergies. Pt observed for 30 minutes. At 15min mark, pt feeling ""lump"" in throat similar to ingestion of shellfish and peanuts not endorsed until 30min of observation. NP evaluated pt's speech, swallow, level of consciousness. Speech & LOC WNL, pt still endorses lump in throat. Voicemail left for Dr. 25 mg benadryl given @ 1838 at the 45minobservation mark. Pt observed for 15 more minutes w/symptoms 50% resolved.
This case was reported by a other health professional and described the occurrence of hives in a patient who received BOOSTRIX. On 2nd February 2016, the patient received BOOSTRIX. On an unknown date, less than a year after receiving BOOSTRIX, the patient experienced hives. The patient was treated with steroids nos. On an unknown date, the outcome of the hives was recovered/resolved. It was unknown if the reporter consider the hives to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received BOOSTRIX and experienced hives on entire body, which lasted a total of 5 weeks after taking steroids. The other healthcare professional would like to know whether BOOSTRIX contained golden mercury.
Fever headache muscle aches fatigue 6 days later Soreness and redness at arm lasted only 2 days
No adverse effects were reported in the patient.; Patient received a vaccine following a temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions/allergies, and concurrent conditions were not disclosed.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) vial, strength reported as 25/0.5 (units not reported) (dose number, anatomical injection site, route of administration, indication, lot number and expiration date were not disclosed).  It was reported that this vaccine had been on a temperature excursion and was stored below 36°F / 2°C (35F) during 430 minutes; but it was also noted that there had not been a previous temperature excursion.  At the time of this report, there were no adverse events reported. Digital data logger was not  involved.
4:00 pm 6/7/21 left shoulder pain becoming noticeable 10:00 pm 6/7/21 body aches and fever, temp 98.3 F which is about 1.5 F above normal, 2 acetaminophen 500 mg, went to bed 11:00, fell asleep 11:50 pm 5:30 am 6/8/21, aches continue, temp 99.8 6:00 am 6/8/21, 2 ibuprofen 200 mg, file this report, try to sleep
Had injection in left leg 08/04/03. Had pain in leg that PM with swelling left knee area 08/05/03.
FLU SHOT GIVEN APPROXIMATELY 12:00 PM ONSET SYMPTOMS 11/7 PERSISTENT RUNNY NOSE, SCRATCHY SORE THROAT LOW GRADE FEVER, CHILLS NOW PRODUCTIVE COUGH ACHING BODY, CONGESTION, TREATMENT WAS SYMPTOMTIC, DECONGESTANTS, ANTIHISTAMINES REST AND HYDRATIENS
A non-serious Spontaneous report of "a dose of H1N1 LAIV was administered to a 57 year old woman" was received from a Pharmacist concerning a 57-year-old Female. The relevant medical history has not been reported for this Patient. On 24-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
High fever night after vaccination. Allergic rash on left side of face and on top of head, neck pain, headache,  joint and muscle pain. Two days after vaccination developed shingles on head. Left eye extremely red  with xloudy vision
This is a spontaneous report from a contactable consumer (patient). A 42-year-old pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0162) via an unspecified route of administration in the left arm on 09Apr2021 at 12:00 (vaccination at the age of 42-year-old and pregnant at the time of vaccination), as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history of the patient included diabetic 2 and hsv2. The patient had a history of allergies to latex and penicillin on an unknown date and unknown if ongoing or not. Concomitant medications were reported as none. The patient gestation period was 9 weeks and delivery date was on 04Nov2021. It was reported that the patient last menstrual date was on 13Jan2021. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was pregnant during the vaccination on 09Apr21. On 11Apr2021 at 17:00, the patient's spine hurts and having trouble walking, weakness in the legs and chest pain, lower back pain felt like something sharp was poking. No therapeutic measures were taken for the events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of the events spine hurts, trouble walking, weakness in legs, chest pain and lower back pain felt like something sharp was poking was not recovered at the time of report.
non oncological HPV; This spontaneous report was received from another health professional referring to her daughter, a female patient of unknown age. The patient's pertinent medical history, previous drug reactions, allergies and concomitant medication were not provided.   On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. The reporter stated that the patient completed the vaccination scheme with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) on an unspecified date (reported as "years ago").   On an unknown date (reported as "recently"), the patient was diagnosed with a non-oncological type of human papilloma virus (HPV). It was unknown if the patient sought for medical attention, was treated for the event or had laboratory test performed. The outcome of papilloma viral infection was reported as resolved on an unspecified date. No additional information was provided.  The causal relationship assessment between the event and the suspect vaccine therapy was not provided.