chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fainted; Clammy; Nauseated; Felt sick all over; This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 2HC4L, expiry date 09-JUL-2024) for prophylaxis.   On 19-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular). On 19-MAY-2023, 6 hrs after receiving Shingrix, the patient experienced fainting (Verbatim: Fainted) (serious criteria GSK medically significant), clamminess (Verbatim: Clammy), nausea (Verbatim: Nauseated) and feeling unwell (Verbatim: Felt sick all over). On 20-MAY-2023, the outcome of the fainting, clamminess, nausea and feeling unwell were resolved.   It was unknown if the reporter considered the fainting, clamminess, nausea and feeling unwell to be related to Shingrix.     It was unknown if the company considered the fainting, clamminess, nausea and feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUN-2023 The reporter was the patient. The patient stated that she received her 1st Shingrix vaccine on 19-MAY-2023 and within 6 hours started having this reactions such as Clammy, Nauseated, fainted, and felt sick all over.  Patient stated this lasted until the morning of 20-MAY-2023 and everything was completely resolved.
Very next day Shaky, unfocused, headache, body aches, exhaustion,.... Once home, took two(2) Advil PM tablets and got roughly 8 good hours of sleep.  Much better next morning.
DVT left arm, swelling, bruising and pain Anti-coagulant/blood thinner daily Monthly monitoring of blood clot
Dizziness; Weakness; Fever; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unknown date (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included heart failure. Concomitant medications were not reported. The patient had known allergies to pecan, cats and cefzil. Prior to vaccination, the patient was not diagnosed with COVID-19. On 13Apr2021 at 02:00, the patient experienced dizziness, weakness, fever and chills. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events- dizziness, weakness, fever and chills was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
IZ reaction on 1/31/01. Upper arm swollen 11cm X 11cm on 2/2/01. No pain at site. Received Claritin 1 1/2 tsp every day. No further complaints with next doctor's visit on 2/12/01.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. An 86 year-old female patient received PREVNAR 13 (Lot number: unknown if J49845 or J49847, expiry date 21Mar2016, NDC: 00051971-02) at 0.5 ml single intramuscular in the arm (recommended vaccine for the patient age) on 18Nov2014. Medical history and concomitant medication were unknown. No other vaccine was administered besides PREVNAR 13 on the same day. The patient experienced pain, severe swelling arm, redness in the arm that was injected, fever, flu-like symptoms, almost cellulitis type swelling on unknown day in Nov2014. No emergency room treatment was required for the adverse event however there was a doctor visit as they wanted the doctor to look at the side effects. The outcome of the events was unknown. The Pfizer sales representative mentioned that the physician believed that the adverse events were caused by PREVNAR 13. Follow-up (25Nov2014) and FU (26Nov2014): New information reported from the same contactable physician via a Pfizer sales representative includes: patient details (age, gender, ethnicity), suspect product details (doubtful lot number, expiry date, NDC number, vaccination date, dose, frequency, anatomical location of vaccination, route of administration), absence of other vaccines given the same day, reaction date (event swelling was updated to severe swelling arm, events redness in the arm that was injected, fever, flu-like symptoms, almost cellulitis type swelling were added).
Around 2:00am I wokeup with extreme pain in my left upper arm. The shot was given almost in my should.  I also had muscle & joint aches & 102 temp. By 5:00 am I felt worse.  I have a light sore throat. I have controlled diabetes type 2 & since the vaccine my blood sugar will go above tje 200s then back to the low 80s.  My left ear also hurts. I went to Urgent Care for that 4/28 & had fluid behind my ear & was prescribed Flonase. I am still sick today. I had COVID Sept. 2020 & was hospitalized 5 days. I feel the same way I did when I had COVID other than no cough.
PT STATES LAST NIGHT SHE COULD NOT HOLD HER LEFT ARM UP. AFTER EXAMINING PT'S ARM SHE CAN MOVE WITH FULL RANGE OF MOTION WITHOUT HAVING PAIN. SAYS WHEN IT'S MOVED IT'S PAINFUL.
supraventricular tachycardia; her pulse was racing and then slow, fluctuating; uneven beats in her heart; some soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EM9810) intramuscular, administered in Deltoid Left on 06Feb2021 as dose 1, single for covid-19 immunisation (vaccinated at 70-years age). Medical history included ongoing high cholesterol (Verbatim: High cholesterol), Breast cancer, hypothyroidism, blood pressure. Concomitant medication included ongoing Exemestane taken for breast cancer from Jun2020 to an unspecified stop date; ongoing levothyroxine sodium (SYNTHROID) taken for hypothyroidism 125mcg 5 times a week. 100mcg 2 times a week (Tuesday and Saturday)Once a day by mouth - Thinks she started it around 1999; ongoing hctz (Hydrochlorothiazide) taken for blood pressure 25mg once a day by mouth, ongoing lisinopril taken for blood pressure 40mg once a day by mouth- Probably been on it since around 1993. It was reported that patient had the first vaccine on 06Feb2021 and she was in her usual state of health aside from some soreness in her arm. On 26Feb2021, she developed tachycardia and had uneven beats in her heart. Patient stated she reported cardiac effects she and her husband (73 years old) experienced after taking the Pfizer covid Vaccine. She had supraventricular tachycardia (SVT) 20 days after the first dose that lasted for 2 weeks. her pulse was racing and then slow, fluctuating. She and her husband received first dose on 06Feb2021 and second dose on 01Mar2021. The patient received the treatment for the events. Lab test included heart rate: uneven beats on 26Feb2021. The clinical outcome of the events supraventricular tachycardia was resolved on 13Mar2021, remaining all other events were resolving.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
he was scheduled to have a back surgery a week before the 2nd dose and had surgery; shingles; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient stated, "I received the first dose of the Pfizer vaccine on 16Feb2021 and the second dose was due on 09Mar2021. One week before my second dose I had my surgery and the following week I got shingles. I have fully recovered from the shingles. When can I receive my second dose?" The patient was supposed to get the 2nd dose on 09Mar2021, however, he was scheduled to have a back surgery a week before the 2nd dose; thus, he wasn't able to get it. Then he returned to the facility on 16Mar2021, but they did not allow him to be vaccinated because he contracted shingles and was advised to delay the 2nd dose. Now, the patient wants to know how long he should wait to get his 2nd dose. The outcome of shingles was recovered on unspecified date and unknown outcome for the other event.  Information on the lot/batch number has been requested.
Patient reports having an asthma attack ~5am this morning.  She used her Albuterol inhaler shortly before receiving her vaccination.  Patient reported shortness of breath and wheezing ~5 minutes after being vaccinated.  Per patient, it felt like a "normal" asthma attack.  She denied dizziness or swelling of the face/tongue/throat/etc.  She was transferred to med obvs for further evaluation.  Vitals remained stable.  On exam, there were mild, diffuse expiratory wheezes.  Patient was able to comfortably have a conversation with me without becoming dyspneic.  There was no evidence of cyanosis.  Per patient, her oxygen saturation is usually around 90%.  Vitals as follows: 9:50- HR 98, BP 127/64, O2 92% 9:59- HR 98, BP 120/73, O2 93% 10:02- HR 94, BP 118/76, O2 93% 10:07 (sitting)- HR 94, BP 135/76, O2 94% 10:10 (standing)- HR 96, BP 134/86, O2 93% Pt released to home with her partner at 10:20
covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "covid".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Reported having itchy rash starting on the right arm and spreading to other extremities.  No swelling or other symptoms noted. Advised OTC benadryl, if no improvement see PCP.
Facial tingling 30 minutes post injection, facial swelling and flushing at 12 hours post injection, fever (99.0 F-101.0 F), chills, body aches, and shivering starting at 16 hours post injection and continuing for 48 hours post injection, headache and neck ache from 48-72 hours post injection.
Information has been received from a medical assistant referring to a 13 months old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 11-JUL-2017, the patient was vaccinated with the first dose of ROTATEQ (lot # M040270, expiration date 29-APR-2018) (oral; dose was not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) on 13-JUN-2017, which lasted for a 18 hours. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA010591: US-009507513-1708USA005381: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012774: US-009507513-1709USA012777.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium
caller received the 1st dose of the Moderna vaccine on January 2021 and didn't receive the 2nd one; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (caller received the 1st dose of the Moderna vaccine on January 2021 and didn't receive the 2nd one) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (caller received the 1st dose of the Moderna vaccine on January 2021 and didn't receive the 2nd one). In January 2021, PRODUCT DOSE OMISSION ISSUE (caller received the 1st dose of the Moderna vaccine on January 2021 and didn't receive the 2nd one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Flu-like symptoms, including chills, stuffy head, headache, tiredness, body ache
Admitted for diarrhea dx'd as salmonella. MRI revealed bilat thalamus infarcts.
This spontaneous report as received from a certified medical assistant (C. M. A.) refers to an unknown number of patients of unknown age and gender. Medical history and drug allergies were not reproted. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot# reported as K013411 with expiration date 19-MAR-2016 and lot# reported as K015841 with expiration date 01-MAY-2016, route of administration default to oral, dose and frequency were not reported). Concomitant medications were not reported. The reporter stated that the vaccines were not expired at the time of administration. The reporter was calling for stability information for excursions that occurred before the vaccines expired. It was reported that the vaccines were not supported with in-house stability data. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received DTaP instead of Td vaccine.  Had increased soreness.  No redness/warmth/other problems.  Had only received one previous dose of DTaP.
Pt reported to pharmacy.  She had red, raised swelling about the size of a softball on her arm. The pharmacist on duty told the pt to ice it and return if it did no resolve.
Rash developed the day after vaccination.  Rash is erythematous and pruritic.  Rash began in left axilla and flexor surface of left elbow and has spread to include parts of the left chest, back, and abdomen.  Benadryl has helped some but rash continues to progress.  Patient was seen at Hospital ER and by her PCP.
Individual developed typical left deltoid area tenderness by 24 hours but has noted persistent tingling, pain into distal portion of left arm in addition to persistent discomfort at site of injection though no swelling, bruising evident on exam at time of visit to assess this 12/7/19.  No response to anti-inflammatories and topical therapies by individual.
This case was reported in a literature article and described the occurrence of uveitis in a 22-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On an unspecified date the subject received 1st dose of Hepatitis B vaccine (unknown). Three days after vaccination with Hepatitis B vaccine, the subject experienced uveitis and vision loss. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis b vaccine between 1982 and 2009. It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Shortly after shot given patient did not feel well and put his head between knees while seated. Shortly after this he fainted. Helped to floor and regained consciousness shortly after. Stayed on floor a few minutes with feet elevated, then was seated, and went on to recover fully.
I've had an itchy; I've had hot red lump appear on my arm; I've had hot red lump appear on my arm; I've had lump appear on my arm; 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 PRURITUS (I've had an itchy), ERYTHEMA (I've had hot red lump appear on my arm), FEELING HOT (I've had hot red lump appear on my arm) and SKIN MASS (I've had lump appear on my arm) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (I've had an itchy), ERYTHEMA (I've had hot red lump appear on my arm), FEELING HOT (I've had hot red lump appear on my arm) and SKIN MASS (I've had lump appear on my arm). At the time of the report, PRURITUS (I've had an itchy), ERYTHEMA (I've had hot red lump appear on my arm), FEELING HOT (I've had hot red lump appear on my arm) and SKIN MASS (I've had lump appear on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory data provided by reporter. No concomitant medication provided by reporter. No treatment medication provided by reporter.   Reporter did not allow further contact
WAS DOWN FOR 4 SOLID DAYS; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling unwell. This report was non-serious.
OLU PATIENT POPULATION; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 16 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced OLU  - subject population. On 06-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the OLU - patient population and off label use was not reported. This report was non-serious.
Dizziness and lightheadedness on day 3-5 after second dose.; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date: unknown), via an unspecified route of administration (right arm) on 11Jan2021 at 12:15 at a single dose for COVID-19 immunization. Medical history included COVID prior vaccination, known since 25Dec2020 and unknown if ongoing. The patient had no known allergies. The patient is not pregnant. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on an unspecified date. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient experienced dizziness and lightheadedness on day 3-5 after the second dose on 14Jan2021 at 0900. No treatment administered for the event. The event was resolving.   Information about lot/batch number has been requested.
HEADACHE, EXTREME FATIGUE ON WEDNESDAY AND BOTH WORSED THEN DEVELOPED ON SUNDAY  MUSCLE ACHES, DIARRHEA, SORE THROAT WENT TO URGENT CARE ON 12/29/2020 (TUESDAY) TESTED FOR STREP AND COVID
vasovagal episode is reported in pt who recvd fluogen vax; pt recvd vax 6OCT93 & 5 mins p/vax pt felt lightheaded & collapsed; pt had a pulse of 60, & was not responding & had no BP; pt was given 02 & DPH;
Chills, body aches, headache 102 temp just reporting my symptoms taking Tylenol and anti inflammatory meds
Feaver of 100. Body aches especially lower half of body. Painful joints hips knees lower back. Took Tylenol later ibprofen.
Patient received 1st Pfizer vaccine 12/13/2021. Patient received 2nd dose Pfizer vaccine 01/03/22. Patient accidentally received a 3rd dose of Pfizer on 2/15/22. No adverse reactions or complaints of any kind. Mother states patient is feeling completely fine. Will continue to monitor and follow up with.
A week after getting two vaccination one vaccination was for Pneumonia the second was for Tetanus. Patient lost the use of her right foot and leg. Within the next 4 days she lost the use of her right leg. This has now moved in to her arms. She is unable to feed herself. She has to be taken to the bathroom and set on the commode. After she has finished using the toilet she has to be cleaned up by me because she can't clean herself. I have to carry her to the shower and bathe her while in the shower. Then I have to dry her and get her dressed. Then I take her back to her chair where she stays. She has lost about 13 pounds since she got the shots. 12/17/08-records received-for DOS 10/14-10/17/08-DC DX Right leg weakness, myopathy, neuropathy. Likely post-vaccination syndrome. In May received vaccine subsequently had progressive weakness involving right leg, had a fall due to leg weakness. Idiopathic lumbosacral plexitis.
Right lower back - few small red raised bumps. Left front chest 1 small / pinpoint raised red bump. Mom gave Benadryl P.O. after onset of symptoms.
After half an hour the vaccine was administered I had a feeing like tight throat feeling, no any other symptoms. It subsided after taking 0.25 mg Xanax. 8 days after choking feeling for two days like thumb was pushing on my throat feeling. It subsided after two days. 15 days after few rash, in my back like little pimple looking, itchy, they went away after I took Xanax and put cortisone cream on them. After 3 weeks again feeling lie a thumb was pushing on my throat for one day, I took Xanax it subsided. 24 days after the vaccine again few itchy rash in front of my belly only two, I put cortisone cream and took Xanax they went away with in 15 minutes. I made an appointment to a immunoligist and allergist, because I believe this flu vaccine may have made my immune system super sensitive! I never had these kind of problems ever in my life! I always got flu shots! Never had any problems, I can't say for sure but after getting tested I will have an answer! But it will cost me because my insurance does not pay for the first 2K of my tests!
Woke up in middle of the night with COVID symptoms, high fever, fatigue, cough. Left arm swelled up and unable to use arm for over 2 weeks.  Advised to not get 2nd dose by provider.
Red, firm, itchy, swelling at injection site and swollen neck lymph nodes 1 week after injection