chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of throat tightness in a 54-year-old female subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). On an unspecified date in 2009 the subject received a dose of influenza vaccine unspecified (details unknown). On an unspecified date in 2009, "a few hours" after vaccination with influenza vaccine unspecified, the subject experienced throat tightness. The subject went to the Emergency Room and received unspecified oral medications. At the time of reporting the event was resolved.
Patient describe  inflammation in the left arm specially in the lymphoid region.  She report that feel pain specially when she is doing pressure.  Pain in the scale 1 to 10 is  5  in the day but in the night increased to 8.
14 hours after vaccination, woke up to slight body aches so went to take Tylenol and sudden wave of nausea hit and passed out falling on floor.  Had slight stomach upset and significant chills.  Took Tylenol and was recovered by 8 a.m.
Symptoms of A Fib before 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included atrial fibrillation (Patient had occasionally A Fib).   On 19th September 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the outcome of the atrial fibrillation was unknown.   It was unknown if the reporter considered the atrial fibrillation to be related to Shingrix.     Linked case(s) involving the same patient:  US2022187987   Additional Information: GSK Receipt Date: 15-DEC-2022 Reporter's Comment: The patient was self-reported this case. The patient reported that he received Shingrix vaccine on the right arm. The patient stated that after received Shingrix vaccine he experienced the symptoms of A Fib before receiving the 2nd dose of Shingrix vaccine. The lot number and expiration date of the vaccine was unknown. The reporter did consent to follow up. Additional supportive information: for the tolerance of the 2nd dose, refer linked case US2022187987 reported by same reporter.; Sender's Comments:  US-GSK-US2022187987:same reporter - 2nd dose case
Within 12 hrs of vaccine, watery stools in 36 hrs, refusal of food (22 ounce formula per day to 6 ounces per day x 4 days). More fussy, gassy. Resolved after approx. 6 days.
fell; injured her back; couldn't sleep; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown) (This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected) via an unspecified route of administration on 26Jan2021 at 11:30 (at the age of 75-year-old) as SINGLE DOSE for an COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient states that sometime during the afternoon that same day of the vaccination, she was carrying boxes and fell and hurt her back, the pain is excruciating, injured her back. She said that it was hurting so bad and she couldn't sleep. She said her daughter told her to not take Aspirin or Tylenol because it would compromise the vaccine. She wanted to know if that was true. She was wondering if there was a time limit to when she could start to take something to alleviate the pain and if she has compromised the effect of the vaccine by taking that. Consumer states that before her daughter told her that she cannot take those medications, the consumer did take two Tylenol for her backache on last night 17Jan2021 and not taken any more since, and she was sitting there with a heating pad and she had limping around dying. Consumer states that at first, she thought her back ache might have been muscle pain following the shot, but she was putting Christmas stuff away, and it just kept getting worse. She states that she does not think the back pain has anything to do with the shot, she had been taking boxes up and down stairs, and caller states that her daughter is a nurse, and her daughter told her that she just had a back injury, and that she just needs an Aspirin or something. she states that she had no other complaints since getting the shot, except her stupid back. Consumer states that after taking the Tylenol, she has been hoping that she did not compromise the vaccine. On unspecified date of Jan2021, the patient experienced fell, injured her back and couldn't sleep. Therapeutic measures were taken as a result of injured her back treatment included with two Tylenol and with a heating pad. The outcome of the event was unknown.  Information on lot number/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Passed out; she does not remember passing out; did not wake up till 3 in the afternoon that day; she was nauseous and in the morning when she got up she was extremely nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), AMNESIA (she does not remember passing out), SOMNOLENCE (did not wake up till 3 in the afternoon that day) and NAUSEA (she was nauseous and in the morning when she got up she was extremely nauseous). On 12-Mar-2021, LOSS OF CONSCIOUSNESS (Passed out), AMNESIA (she does not remember passing out), SOMNOLENCE (did not wake up till 3 in the afternoon that day) and NAUSEA (she was nauseous and in the morning when she got up she was extremely nauseous) had resolved.            Concomitant medications were not provided. The patient did not remember passing out but found herself on the bathroom floor. Treatment information included bismuth subsalicylate.   This case was linked to MOD-2021-081743 (Patient Link).; 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.
Information has been received from a published article, titled as stated above. This literature article was initially reported to a foreign agency on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a hepatitis B virus vaccine, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #6 of 32, a 45 year old female. On an unreported date  between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 45 year old female on an unspecified date was vaccinated with her first dose of RECOMBIVAX HB (lot number, route and site not reported). Concomitant therapy included fluoxetine. Two days after the first dose, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of fatigue and pyrexia. The authors stated the RECOMBIVAX HB vaccine may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB vaccine (WAES #1004USA01716, WAES # 1004USA02327, 1004USA02328, 1004USA02329, 1004USA02330, WAES # 1004USA02332 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Woke up soaking wet; Had to urinate every 10-15 minutes which occurred for about 2 hours; whole upper arm was super sore; Felt so Nauseated; Chills; Head felt like it was going to blow up; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Woke up soaking wet), URINE ABNORMALITY (Had to urinate every 10-15 minutes which occurred for about 2 hours), PAIN IN EXTREMITY (whole upper arm was super sore), NAUSEA (Felt so Nauseated) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced HYPERHIDROSIS (Woke up soaking wet), URINE ABNORMALITY (Had to urinate every 10-15 minutes which occurred for about 2 hours), PAIN IN EXTREMITY (whole upper arm was super sore), NAUSEA (Felt so Nauseated), CHILLS (Chills) and HEADACHE (Head felt like it was going to blow up). At the time of the report, HYPERHIDROSIS (Woke up soaking wet), URINE ABNORMALITY (Had to urinate every 10-15 minutes which occurred for about 2 hours), PAIN IN EXTREMITY (whole upper arm was super sore), NAUSEA (Felt so Nauseated), CHILLS (Chills) and HEADACHE (Head felt like it was going to blow up) outcome was unknown.      Action taken with mRNA-1273 in response to the events was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medications include Blood thinners No treatment medications provided
BURNED LIKE HOLY HELL; CHRONIC SINUSITIS; SCRATCHY THROAT; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 204A@1A, expiry: 23-JUN-2021) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced burned like holy hell. On 27-APR-2021, the subject experienced chronic sinusitis. On 27-APR-2021, the subject experienced scratchy throat. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from chronic sinusitis, and scratchy throat, and the outcome of burned like holy hell was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be confirmed nothing was identified within the reported complaint reported. complaint is approved for void based on the  evaluation/investigation performed.
Menstrual cycle was not due during this time but showed up unexpectedly and viciously. Cramps were so horrendous I was bed ridden for 24 hours. This has NEVER happened before. The pain was literally unbearable.
Headache; Nausea; Joint pain; Muscle pain; Tingling sensation as soon as the vaccine was received in the whole arm plus a little of swollen; Tingling sensation as soon as the vaccine was received in the whole arm plus a little of swollen; Fast heart beat rate; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration on 04May2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously took received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration on 13Apr2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 04May2021, the patient experienced a tingling sensation as soon as the vaccine was received in the whole arm plus a little of swollen and fast heart beat rate. On 05May2021 at 04:00, the patient experienced headache, nausea, joint pain, muscle pain. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, nausea, joint pain, muscle pain, tingling sensation, swollen arm and fast heart beat rate was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
soreness at the injection site; chills; Temperature went up to 101.1; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness at the injection site), CHILLS (chills) and PYREXIA (Temperature went up to 101.1) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PROBIOTIC 10, METFORMIN, LISINOPRIL, ALFUZOSIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ATORVASTATIN CALCIUM (LIPITOR) and FINASTERIDE (PROSCAR) for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (soreness at the injection site), CHILLS (chills) and PYREXIA (Temperature went up to 101.1). At the time of the report, INJECTION SITE PAIN (soreness at the injection site), CHILLS (chills) and PYREXIA (Temperature went up to 101.1) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 101.1 (High) 101.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report was received from a licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown dates, the patient were vaccinated with improperly stored doses of ROTATEQ (exact dose was not reported, orally, lot # L035510, expiration date 13-MAY-2017; lot # L023866, expiration date 24-MAR-2017). These doses were exposed to 56.80 degrees Fahrenheit (F) for 12 hours and 30 F for 24 hours. A data logger was used to log the temperatures. There were no prior excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
4 days after getting the covid vaccine, child broke out in hives on face, arms, torso, back and buttocks. 5 days after vaccine, her hands and feet became swollen.
Client called 12/28/19 to complain of redness, itching, and swelling R deltoid. Symptoms persisted client went to walk in clinic next and was told she had cellulitis. She was given Doxycycline. She returned the next day because arm was red swollen and warm with diffuse red rash. At that visit she was given ROCEPHIN. Symptoms improved after 4th day.
This spontaneous report as received from nurse refers to approximately 52 year old male patient. The patients pertinent medical history included diabetes. The reporter stated that the patient developed unspecified rash approximately on an unknown date in 2014, after the patient was vaccinated with (Oka/Merck) VARIVAX lot J006807, expiration date 30-MAY-2015, dose called doctors office and left message for the doctor on 16-JUL-2014 to inform them of the unspecified rash. The outcome of rash was reported as not recovered/not resolved. No product quality complaint was involved. Additional information has been requested.
Approx. 10:00 given Flu vaccine. Waited 5 mins. for adverse reaction. Returned to work = came back approx. 10 mins later with c/o numbness/tingling in hands and knees. Then broke out in hives. To ER for Benadryl IV drip.
could not move her left arm; left side of neck was becoming numb; pain burning; Itching from waist to face; pain; injection site started hurting really bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her left arm), HYPOAESTHESIA (left side of neck was becoming numb), PAIN (pain burning), PRURITUS (Itching from waist to face) and PAIN (pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergic to codeine) and Cough. Concomitant products included MONTELUKAST, OMEPRAZOLE and IBUPROFEN.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her left arm), HYPOAESTHESIA (left side of neck was becoming numb), PAIN (pain burning), PRURITUS (Itching from waist to face), PAIN (pain) and VACCINATION SITE PAIN (injection site started hurting really bad). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her left arm), HYPOAESTHESIA (left side of neck was becoming numb), PAIN (pain burning), PRURITUS (Itching from waist to face), PAIN (pain) and VACCINATION SITE PAIN (injection site started hurting really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Positive covid test; Headache; Nauseousness; a little bit of a fever; Chills; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm on 25Feb2021 the age of 58-year-old year, as first dose, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications was not reported. the patient was taking Pfizer COVID-19 vaccine works at a school, around her mom who is an elderly lady and they offered it so she took it. The patient did not receive other product prior to vaccine. The patient experienced, headache, nauseousness, a little bit of a fever on 05Mar2021, positive COVID test on 07Mar2021. Patient stated she received her first dose of the Pfizer Covid-19 vaccine on 25Feb2021. She was supposed to go back 18 Mar 2021 for her second dose, but she was not feeling well so she took a COVID test and it came out positive. She clarifies her symptoms began on 05 Mar 2021 and then she went and got tested for COVID and tested positive on 07Mar 2021. Caller states she had chills Friday evening and Saturday, but her temperature was like 98.6 or 98.9, but then she got the fever. Caller reports the chills stopped yesterday (Tuesday) or Monday. Treatment-she has been taking 500 mg Ibuprofen. She stated she has not given the fever a chance to get up there. She wanted to know what the next step is; should she go to her appointment or reschedule. She really just wants to find out what she has to do. Does she have to wait 14 days or 2 weeks or 3 weeks or what. Seriousness of the event was reported as non-serious. The outcome of events headache, nauseousness, not recovered, fever was recovering, Positive COVID test was unknown and chills was recovered.  There was a Product Complaint, description of Product Complaint: Caller stated she received her first dose of the Pfizer Covid-19 vaccine on 25 Feb 2021. She is supposed to go back 18 Mar 2021 for her second dose, but she wasn't feeling well so she took a COVID test and it came out positive. She clarifies her symptoms began on 05 Mar 2021 and then she went and got tested for COVID and tested positive on 07Mar2021. Caller does not have her vaccine record card at the time of the call. No further details were provided or obtained.  No follow up attempts are possible: No Further information is excepted.
"left shoulder pain that started 5 days after receiving the second COVID-19 vaccination (Pfizer).  Last second COVID-19 vaccination 4/9/21.  Patient received both injections in the right shoulder.    She has been using rubbing alcohol and lidocaine without relief.  No relief with acetaminophen. Limited range of motion and weakness of left shoulder.
Fevers throughout the day of the vaccine and the following day.  Body aches the first two days. Left armpit glands are swollen.
Per pt, 2 hours after receiving 2nd dose of vaccine began to experience headache, numbness and tingling to face. Vaciine administered at Clinic
Itching around jawline, chin.  Comes and goes for the past 4 days.  Began one hour after shot.
fever of 105 p/vax w/sz like activity w/in 48 hrs of vax;
Patient was given vaccine and then was seated in the waiting room when he started to feel faint and nauseated within 5 minutes of administration. Pharmacists were alerted by the patient's mother immediately. Patient was sitting upright when initially approached with his head down but since his mother stated he was feeling dizzy and nauseous, we laid flat in the waiting room and called 911. Patient had no rash upon inspection or breathing problems. Patient never lost consciousness and was responsive to questions. Paramedics arrived and sent him to hospital for further observation.