chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very tired; second dose: sore arm; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 28Apr2021 15:45 (Lot number: EW0153, Expiration Date: Jul2021) at the age of 56 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Suspect: Pfizer covid vaccine , First Dose, Time of Vaccination: 3:45 PM, Vaccine Lot number: EW0153, Vaccine lot expire date: Jul2021, Anatomical location of Administration: Right deltoid (0.3ml)), administration date: 07Apr2021, when the patient was 56 years old, for Covid-19 immunization, reaction(s): "Headache". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Apr2021, outcome "recovered" (30Apr2021), described as "second dose: sore arm"; HEADACHE (non-serious) with onset 28Apr2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 28Apr2021 18:00, outcome "unknown", described as "very tired". Therapeutic measures were taken as a result of headache.  Additional information: Reporter took her mother for both doses of Pfizer COVID19 vaccine. Second dose was on 28Apr2021. She had the first on 07Apr2021. They had the same vial number for both doses. Caller asked the pharmacist about it. It is caller's understanding that the vials are supposed to be kept at a certain temperature and not used again. She thinks it is weird it is the same vial 3 weeks later. Caller wants to make sure that is correct. She wants to make sure her mom is vaccinated appropriately. She didn't really have any side effects. She did have a sore arm after both doses. She had a headache after both doses. She was very tired mostly with the second dose. It was not as bad as most people have had. Second Dose Headache: started maybe three hours after vaccination. With the second one, she took Ibuprofen because the headache was a bit worse and she works using her arms and her arms were sore. She went to sleep after the Ibuprofen and woke up better.   Very tired: that occurred mostly with the second dose. She had vaccine around 3:45PM and got home around 5PM. Around 6PM, she felt extremely tired and didn't really wake up until the next day. She was tired throughout the night. Patient reported no AE following prior vaccinations.   No follow-up attempts are possible. No further information is expected.
BODY ACHES; FLULIKE SYMPTOMS; NOT FEELING WELL; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient 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, and batch number: C42A2LA expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced flulike symptoms. On 10-APR-2021, the subject experienced not feeling well. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications included: trimethoprim. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, body aches, flulike symptoms and not feeling well was not reported. This report was non-serious.
Chills, ice pick headache, distended stomach, belching, nausea, dizziness, muscle ache, painful sore swollen left arm @ injection site.. All symptoms EXCEPT for headache  & painful sore swollen left arm resolved within 12 hours.  The headache continued x 3 days. Arm is still sore but less swollen x 6 days. On day 4, small rash appeared on left arm & patch on upper left chest area.
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore Arm) 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.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced MYALGIA (Sore Arm). At the time of the report, MYALGIA (Sore Arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Weakness started at night and got progressively worse until I slid off the bed and could not get up without assistance. The problem continued thruout the day but diminishing in intensity until the following morning that I was able to get up but feeling very tired.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates the patients were vaccinated with doses of improperly stored oral, ROTATEQ (lot # was reported as L006184, expiry date 13-DEC-2016; lot # was reported as L008054, expiry date 30-NOV-2016) (oral, dose and dose number were unspecified). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
pt recv vax & later that day exp soreness (w/o skin rxn) @ inj site & flu-like sx; approx 1FEB95 three blisters devel @ the inj site which the reporting MD thought could be delayed hypersensitivity rxn (no tx prescribed); c/o arthralgia;
Patient was given Moderna at 8:45 am on 1/28/21 observed for 15 minutes.  Was fine.  Patient returned to clinic on 1/28/21 at 3:00 pm.  Was confused , trying to give me his remote to do what with I wasn't sure.  He had trouble with getting ideas across.  I wasn't sure if this was normal for him.  However, we called him this morning at 8:45 am and he was lucid, he stated that when he went home around 4 pm , his left arm , hand and face were numb.  He stated that he could not pick up his cap with his left hand.  Today he woke and feels normal.  He was lucid and able to present ideas in a normal manner.  He vaguely remembers coming back to the clinic yesterday.
MEDI-0003953 is a Non-Serious spontaneous case from a nurse in the USA of a 48 year old woman involving flu-like symptoms. The reporter causality is possible to FluMist. A 48 year old female pt received FluMist vaccination, intranasally on 12/22/2005 for influenza immunization. The pt received Trivalent Inactivated Influenza Vaccine (TIV) for the last 3 years. No other concomitant medications were reported. The night of the vaccination the pt began to feel ill. The feeling worsened over the next day. The exact symptoms were unspecified however they were described as "flu-like symptoms". No other information was provided.
This spontaneous case was reported by an other health care professional and describes the occurrence of VISUAL IMPAIRMENT (Reduced vision), TINNITUS (Tinnitus (ringing in the ears)), DIZZINESS (Dizziness), MYALGIA (Body aches) and PYREXIA (Fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 039K20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Tinnitus (ringing in the ears)). On an unknown date, the patient experienced VISUAL IMPAIRMENT (Reduced vision), DIZZINESS (Dizziness), MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Persistent headaches). At the time of the report, VISUAL IMPAIRMENT (Reduced vision), DIZZINESS (Dizziness), MYALGIA (Body aches), PYREXIA (Fever) and CHILLS (Chills) had not resolved and TINNITUS (Tinnitus (ringing in the ears)) and HEADACHE (Persistent headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment medications were not provided.   This case was linked to MOD-2022-453877 (Patient Link).
This spontaneous report as received from a other health professional (registered nurse) refers to a unspecified number of patients of unknown age. Current conditions and medical history was not reported. Since 05-NOV-2014, patients were administered with RECOMBIVAX HB injection (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On 05-NOV-2014, RECOMBIVAX HB vaccine was exposed to temperatures (9 degree for 4 hours) out of recommended range and administered to unspecified patients. It was reported that the nurse was not aware of any adverse effects. At the time of this report, the excursion has not ended. It was reported to nurse that as per stability assessment data, RECOMBIVAX HB would not be adversely affected by this specific temperature excursion. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a patient with positive history of papilloma viral (HPV) who on 22-SEP-2008 and 08-DEC-2008 was vaccinated with the 1st and 2nd doses of GARDASIL respectively.  She also had abnormal cells and genital warts before she was given GARDASIL.  Subsequently her abnormal cervical cells had "gotten worse" and she believed it might have caused an "outbreak" of genital warts.  The patient did not want to get the third dose of GARDASIL.  At time of reporting, the patient did not recover.  Additional information has been requested.
Fluzone Quadrivalent 0.5ml from a multiuse vial on Tuesday evening (15Oct2019) and administrated the vaccines to 66 patients on Wednesday morning (16Oct2019) starting at 9am/No AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves 66 patients who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] from a multiuse vial which was prepared on Tuesday evening (15-Oct-2019) and administrated the vaccines to on Wednesday morning (16-Oct-2019) starting at 9am lot UJ255AA, expiry date: 30-Jun-2020 via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to wrong technique in product usage process.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Screaming and arching back, dead eyes inconsolable, low grade fever, not sleeping or eating, not acting herself, not using her words.
2 days after vaccine, pt's mom noted that pt woke up with a pink splotchy rash to backs of knees, chest, warmth around L thigh injection site, abdomen, back, axilla, bilateral arms
On Saturday I had been having come headaches and some congestion. By the 16th I went to urgent care and tested positive for covid-19.  I had ton of fatiuge and a runny nose, my head and nose were stuffy it was hard to swallow and I had this bad post nasal drip that made me feel worse. I was given Molnupiravir and that helped. At this point I am better but still have the cough.
This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 50-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concurrent medical conditions included rash. On 21st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 7 days after receiving SHINGRIX, the patient experienced abdominal pain, nausea, abdominal discomfort and abdominal tenderness. On an unknown date, the patient experienced cellulitis (serious criteria GSK medically significant) and pain in arm. The patient was treated with antibiotics nos (Brand Names Not Known). On an unknown date, the outcome of the cellulitis was unknown and the outcome of the abdominal pain and abdominal discomfort were recovering/resolving and the outcome of the pain in arm and nausea were recovered/resolved and the outcome of the abdominal tenderness was not recovered/not resolved. It was unknown if the reporter considered the cellulitis, abdominal pain, nausea, abdominal discomfort and abdominal tenderness to be related to SHINGRIX. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: One week after receiving SHINGRIX, the patient experienced abdominal discomfort, pain, cramping, and nausea. An abdomen was tender till the time of reporting. The patient also had soreness in arm. Less than a year after receiving SHINGRIX, the patient developed cellulitis which was thought to be unrelated to the vaccine and was given antibiotics. The patient was then developed a rash from the antibiotics. The healthcare professional stated that the patient went to the emergency room because of the abdominal pain and did not provide the name of the antibiotics the patient was on. The healthcare professional did not have any information on the 2nd patient in which the abdominal pain occurred. This case has been linked with case US2018GSK099775, reported by same reporter.
The patient stated that 36 hrs after receiving shingles vax he developed severe itching with red whelps all over his body. The patient also had a swollen lip and a red circle around the injection site. The patient went to the ER and was prescribed BENADRYL 30 mg and MEDROL dose pack. Patient still has not recovered.
had a circle appear even after 14 days later; had a similar reaction to what they have; 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 ERYTHEMA (had a circle appear even after 14 days later) and VACCINATION COMPLICATION (had a similar reaction to what they have) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (had a circle appear even after 14 days later) and VACCINATION COMPLICATION (had a similar reaction to what they have). At the time of the report, ERYTHEMA (had a circle appear even after 14 days later) and VACCINATION COMPLICATION (had a similar reaction to what they have) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 37-year-old male patient received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 20Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE oral. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: symptoms improved, had negative rapid; (24May2022) Positive, notes: Then on 24May2022 again with symptoms and positive rapid test. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Report about covid treatment was yes. If vaccine received reported as yes. Other medications in two weeks reported as yes. Adverse event: rebound covid. took paxlovid 12May2022-17May2022. Symptoms improved, had negative rapid. Then on 24May2022 again with symptoms and positive rapid test. Known allergies reported as no. Other medical history reported as obesity. Anti-viral details: Product :COVID 19 treatment, Brand: Pfizer-Paxlovid, Treatment start date: 12May2022, Treatment stop date: 17May2022, Indication: Treatment of COVID-19, Administrator route: Oral.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
Skin cancer; Fatigue; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4223419-00 (Abbvie).  A 69 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single and intramuscular, administration date 15Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN CANCER (medically significant), outcome "recovering", described as "Skin cancer"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue". The action taken for upadacitinib was unknown. Clinical course: It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter's causality for the event(s) of SKIN CANCER with RINVOQ (UPADACITINIB) was no reasonable possibility. The reporter's causality for the event(s) of fatigue are not provided. Abbvie's opinion is that the events of SKIN CANCER and FATIGUE are not assessable. The reporter's causality for the event(s) of Skin cancer and Fatigue for Pfizer Biontech COVID-19 vaccine (TOZINAMERAN) was Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and the possible contributory role of suspect product BNT162B2 to the development of events skin cancer, fatigue cannot be totally excluded. The case will be reassessed when additional information available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
17 year old female who received her first dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female who received her first dose of the Moderna COVID19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided.).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female who received her first dose of the Moderna COVID19 vaccine). On 16-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female who received her first dose of the Moderna COVID19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # 006B21A with no associated AEs.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # 006B21A with no associated AEs.
pt stated that has a rash on arms, trunk & face;face felt hot;told to call MD;
Swelling, redness and pain just below injection site. Lasted for 4 days.
Pt received first dose of COVID vaccine today and reports about 3 minutes later started feeling tingling and itching round his lips  And in the mouth, he reported his symptoms  About 10 min after the dose and white code was called . When we arrive patient sitting on a floor, appears anxious, ashen color, breathing hard, appears a little out of it but responding to questions well. His vitals were stable, , tachycardic 102-118,  No rashes, no wheezing on exam, lips not appear swollen, he is speaking OK, reports sensation of swelling or lump in his throat. EpiPen was used and 0.3mg administered at 16:59, 911 called ,  IV access obtained and solumedrol 125 mg administered followed by pepcid 20 mg IV.  Patient felt N, no V. His breathing efford and color improved, reports feeling better. Pt has h/o anaphilactic reaction to peanuts in th
pt recv vax & 26MAR it was reported there was redness & swelling @ the inj site;28MAR97 pt awoke w/rt side of face drawn w/twitching of rt side of face;3 more episodes lasting 1min followed by 10min of drawn lips & slurred speech;
Tenderness on left side. Blood flow occlusion if slept on left side. Woke up multiple time with loss os sensation on left side , especially frightening when head was numb too.  referred to neurological assessment. The doctor didn't take is seriously and follow up visit although recommended was never scheduled. I am still not able to sleep on left side.