chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe center upper back pain; joint pain; muscle aches; fainting episodes; throat discomfort; weakness; diagnosed with acid reflux; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 11Jun2021 at 10:15 am (Lot Number: EW0179, unknown expiration; at the age of 48 years old) as dose 2, single for COVID-19 immunization.  Medical history reported as none. No known allergies. No past drug history. Concomitant medication included unspecified vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8736) on 21May2021 at 10:15 am in the left arm at the age of 48 years old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the date of the 2nd shot (on 11Jun2021 at 22:00), the patient experienced joint pain and muscle aches that lasted 1.5 days. Then the patient experienced severe center upper back pain the next day on 12Jun2021 that lasted for a few hours. Two weeks later (in Jun2021), the patient visited emergency room due to near fainting episodes, throat discomfort, and weakness. The patient had followed up with doctor one week later and diagnosed with acid reflux. The patient is taking pantoprazole as treatment for acid reflux. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient recovered from events joint pain, muscle aches, and back pain in Jun2021, while recovering from the remaining events. The events were assessed as non-serious.   No follow-up attempts are possible; information about batch number was already obtained.
Information has been received from a health professional concerning a 4 year old male pt who was vaccinated on 21Aug00 with a dose of varicella virus vaccine live. Subsequently, on approx 23Mar04, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that there was no a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00586, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, WAES0405USA00619). No additional information is expected.
This case was reported in a literature article and described the occurrence of uveitis in a 39-year-old male subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On an unspecified date the subject received 3rd dose of Hepatitis B vaccine (unknown). One day after vaccination with Hepatitis B vaccine, the subject experienced uveitis. 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.
Information has been received from a licensed practical nurse (L.P.N.), reporting on herself, who on 09-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) intramuscularly (dose and lot number not reported). Nurse reported that she received ZOSTAVAX (Merck) at the pharmacy but it was administered via intramuscular route rather than via subcutaneous route. No adverse effects were reported. Information has been received from the female licensed practical licensed practical nurse with a history of migraine who on 09-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) intramuscularly rather than subcutaneously. The nurse reported that after being administered ZOSTAVAX (Merck) on 09-MAY-2012 her "muscle hurt" where the vaccine was administered intramuscularly. The nurse also noted that on Saturday 12-MAY-2012 she woke at 7:00 am with headache in lower right portion of her head, with nausea and vomiting. The nurse noted she had "a history of migraines, but these symptoms were not from a migraine". The nurse also noted diaphoresis. All the events lasted for two hours then ended. On 12-MAY-2012, the patient recovered. Follow up information was received from the nurse who reported that last night, on 31-MAY-2012, she developed shingles. The shingles was described as itchy, burning rash on the left side of her waist. At the time of the report, the outcome of shingles was unknown. Follow up information was received from the nurse who reported that she became infected with shingles on 24-MAY-2012 (previously reported that she developed shingles on 31-MAY-2012) with diagnosis by physician's assistant. She was placed on acyclovir for 7 days. The rash was on her waist, left side of her back area (back rash area erupted 2 days after initial). At the time of the report, the outcome of shingles was unknown. Follow-up information was received from the nurse who reported that the vaccine was given IM (not SC) on 09-MAY-2012. On 12-MAY-2012 at 07:30 AM, severe headache, nausea, vomiting and diaphoresis lasted 2 hours. No treatment was given. Also the nurse got shingles 3 weeks after vaccine (previously reported as 31-MAY-2012). The patient recovered on 12-MAY-2012 from severe headache, nausea, vomiting and diaphoresis, the outcome of shingles was unknown. The patient did not seek medical attention. Additional information is not expected.
My lips were burning and pulsating, my upper lip had gotten a dry bump. I had tried throwing up once but all I could do was gag. The next day my body felt tired and I had slept the majority of the day my arm had also hurted. My seasonal allergies were bothering me so I took Benadryl only one before bed. Today I woke up my arm is still hurting although not as bad. But I'm still tired I felt like I haven't slept enough but I had gotten about 7 or 8 hours of sleep.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: pt reported on 12/5/2022. pt claims that rash was all over body, back, arms, legs and buttocks. she only used benadryl otc. rash resolved after 3 weeks per pt
Itching and hives occurring at random on different areas of body (affected areas change periodically, although having itching/hives is an every day occurrence)
Achy arm. In the same arm I developed a big red rash that itched intensely for 5-6 days. I am very tired and lethargic. My stomach hurts/aches. The doctor said I don't look good. My blood pressure is high. I also get short of breath and I know its the shot because I didn't feel this way before the shot.
Fall; Pain; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall), PAIN (Pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 01-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On an unknown date, the patient experienced FALL (Fall) and PAIN (Pain). At the time of the report, FALL (Fall) and PAIN (Pain) had resolved with sequelae and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  On an unknown date, patient fell and experienced pain. Recovered with some sequalae. Patient took the booster dose of vaccine much after the standard time gap between the doses.  Reporters causality of events with Humira was no reasonable possibility.  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
The bump was measured: 6 inches long and 11 inches wide; very red,hot, hard bump on the right thigh which is swollen and growing; very red,hot, hard bump on the right thigh which is swollen and growing; very red,hot, hard bump on the right thigh which is swollen and growing; This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE VACCINE) for prophylaxis.   On 28th September 2020, the patient received Kinrix and FLUZONE VACCINE. On an unknown date, less than 3 weeks after receiving Kinrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site induration were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site induration to be related to Kinrix.  Additional details were reported as follows: Reporter was medical assistant. On 28th September 2020, the patient received both Kinrix and Flu vaccine (Fluzone) on the same day, on the thigh. The patient developed a very red, hot and hard bump on the right thigh which was swollen and growing, the bump was measured 6 inches long and 11 inches wide, it goes from the top of the thigh to almost reach the knee. The reporter consented to follow up. This case had been linked with US2020203021, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020203021:same reporter
Itchy on day 8 but no inch on day 9, red,  hot to the touch,  swollen (4 inches wide), throbbing
swelling at the injection site (size of her palm); redness at injection site (around 1 inch in diameter); warmth and itchiness at the injection site; itchiness at the injection site; A spontaneous report was received from a other health care professional  concerning a 36-year's-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling (size of her palm), redness (around 1 inch in diameter), warmth and itchiness at the injection site.  As provided by the reporter the patient does not have medical history.  On 07 Jan 2021 at, the patient received their first of first planned dose of mRNA-1273 (Lot number: 025L20A) was administered on her L arm, at 0.5 ml with unknown route of administration for prophylaxis of COVID-19 infection.   On  07 Jan 2021, After  receiving mRNA-1273, the patient experienced On 14Jan2021 swelling (size of her palm), redness (around 1 inch in diameter),warmth and itchiness at the injection site.   Action taken with mRNA-1273 in response to the events was not reported.; 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.
101 degree temperature; left lymph gland became extremely swollen; left lymph gland became extremely swollen, tender and sore; first Shingrix shot was on 02 JUN 2020 / second Shingrix shot was 14 DEC 2020; worst aching; chills; felt miserable; This case was reported by a consumer and described the occurrence of pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose received on 2nd June 2020, for further information refer case id US2020AMR253295).   On 14th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 14th December 2020, less than a day after receiving Shingrix, the patient experienced pain, chills and drug dose administration interval too long. In December 2020, the patient experienced feeling miserable. On 20th December 2020, the patient experienced fever, enlargement of lymph nodes and lymph node tenderness. On an unknown date, the outcome of the pain and chills were recovering/resolving and the outcome of the feeling miserable was recovered/resolved and the outcome of the fever, lymph node tenderness and drug dose administration interval too long were unknown and the outcome of the enlargement of lymph nodes was not recovered/not resolved.   It was unknown if the reporter considered the pain, chills, feeling miserable, fever, enlargement of lymph nodes and lymph node tenderness to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in the left arm. The patient experienced worst aching and chills she had ever experienced; she was miserable but after 5 days it was resolving. On 20th December 2020, the patient had left lymph gland became extremely swollen, tender and sore and 101 degree F temperature last night. After 6 days of receiving shingrix patient experienced  fever, lymph node tenderness ,enlargement of lymph nodes and after less than week experienced feeling miserable. The reporter did not have batch number or expiration date. The reporter did not consent to follow up. No further information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR253295:same reporter
Headache, Myalgia, Fever, NauseaVomiting, SWOLLEN LYMPH NODE Narrative:
I had a really bad reaction to shot number 2 that I did not report. On this booster shot I felt fatigued about 8 hours after the shot. I could barely lift my left arm. I started to develop a bad headache that evening.  The following morning when I woke up at 0730 I had a severe headache and pain in all my joints. I was barely able to lift myself up or move due to the pain and fatigue. I took anti inflammatory and rested. About mid afternoon the next day I noticed under my  left collarbone I had a large swollen lump. I still felt very fatigued. Headache went away, but the next morning today I noticed that in addition to the lump under my left collarbone my entire left armpit is swollen. The injection site is sore and hot to the touch.
From initial information received on October 20,2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a female patient (age and birth date not reported) received a dose of Fluzone SV '2003-'2004 USP, lot number U1137HA, on October 02,2003 at 4:15PM (route and site of administration not reported). On October 03,2003 at 9:00AM, the patient developed left shoulder pain with movement.  The patient's recovery status is currently unknown. From additional information received on 11/17/2003 from the initial reporter, it was reported that the vaccine was administered intra-muscularly in the left deltoid.  Treatment included Aleve three times a day as occasion as needed and Icy Hot to the shoulder.  No relevant diagnostic tests were performed at this time.  The patient is still under a doctor's care and is being treated for possible mild to moderate subacromial bursitis.  No other information reported at this time. Further information is not anticipated, this case is considered closed.
PT REPORTS 3 DAYS FOLLOWING 2ND SHINGLES VACCINE, SHE DEVELOPED SHINGLES, CONFIRMED BY DR UPON FOLLOWUP VISIT IN OUR OFFICE.  PT REPORTS RASH, PAIN AND ITCHING NEAR THE LEFT DELTOID AREA, NEAR WHERE THE INJECTION WAS GIVEN WHICH THEN SPREAD TO SURROUNDING AREAS.
Chest pain and shortness of breath started about 2 hours after the vaccine shot. Repeated multiple times within 24 hours up to now when filing this report.
numbness and itching of L cheek (face) w/in 15 min of vaccination, numbness resolved within 15  additional minutes and itching decreased, but persisted into next day at low level. No rash was involved, just a little redness from scratching.
7/27/09 Came in to HD c/o side effects since vaccination. Symptoms: dizziness (7/16/09), vomitting (7/22/09), passed out (7/23/09), hives on chest, remains weak and tired. Referred to MD. Note: Patient also participates in band practice
5 days after the shot, the right side of my body felt like it was on fire; it felt like a jolt of electricity was shooting through it. Exactly 4 weeks after the shot, I was admitted to the hospital through the ER with Afib - this was new to me. 21 weeks after the shot, I started feeling 'pins and needles' on my left side (lower back,  buttocks, leg and toes.  I saw my PCP who ordered a back xray, and nerve test (scheduled for Sept. 16th)
Pt recvd vax 29JUL93 @ 1120AM; 1133AM pt was found face down w/all extremities involuntarily moving; rigid; unresponsive;  pt log rolled to supine position & was given Epi; pt oriented but c/o numbness in extremities, dehydrated & not nouri
Redness at injection site -patient described as approximately half-dollar size. Muscle soreness -generalized all over body.
Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked to case 2018SA266204 (same reporter). This case involves a 75 years old male patient who experienced naggy, runny nose and coughing, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Sep-2018, the patient received a 0.5 mL dose of suspect FLUZONE HIGH DOSE lot number not reported via intramuscular route (expiry date and site of administration were not reported). On an unknown date, on same day of post-vaccination patient developed a non-serious coughing of an unknown latency following the administration of FLUZONE HIGH DOSE. On an unknown date, next day post-vaccination patient developed a non-serious naggy (sneezing) and runny nose (rhinorrhoea) following the administration of FLUZONE HIGH DOSE. Relevant tests were not reported. Final diagnosis was runny nose, naggy and coughing. It was not reported if the patient received a corrective treatment. The outcome of the event not reported.
low back pain; chills; had a fever; had injection site pain; tired; feeling achy; muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2020, immediately after receiving Shingrix, the patient experienced injection site pain, fatigue, general body pain and myalgia. On 7th November 2020, the patient experienced fever and chills. On 8th November 2020, the patient experienced back pain. On 7th November 2020, the outcome of the fatigue, general body pain, myalgia and chills were recovered/resolved. On an unknown date, the outcome of the injection site pain, fever and back pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue, general body pain, myalgia, fever, back pain and chills to be related to Shingrix.  Additional details were provided as follows: The patient immediately had injection site pain that continues till the time of reporting. On 7th November 2020, within two hours of receiving the vaccine he started feeling achy, tired and having muscle aches which were resolved. Also he had fever that had been intermittent and ongoing and he had chills that night which resolved that night itself. On 8th November 2020, he started having low back pain that continues till the time of reporting. No further information was available. The reporter did not consent to follow-up.
ON/OFF KNEE AND LEG SWELLING; ON/OFF DIARRHEA; ON/OFF STOMACH HURTING; ON/OFF PERSISTENT HEADACHE; INJECTION SITE SORE ARM; MUSCLES TWITCHING WHERE GOT SHOT; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included chorionic villus sampling, and concurrent conditions included cholesterol, diabetes, chronic obstructive pulmonary disease, and gout. The patient experienced drug allergy when treated with quetiapine fumarate.  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 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced muscles twitching where got shot. On 02-APR-2021, the subject experienced injection site sore arm. On 03-APR-2021, the subject experienced on/off persistent headache. On 04-APR-2021, the subject experienced on/off knee and leg swelling. On 04-APR-2021, the subject experienced on/off diarrhea. On 04-APR-2021, the subject experienced on/off stomach hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscles twitching where got shot on 20-APR-2021, and injection site sore arm on 16-APR-2021, and was recovering from on/off persistent headache, on/off knee and leg swelling, on/off diarrhea, and on/off stomach hurting. This report was non-serious.