chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed cough, chills, upper back pain, left eye blurring vision, and diffuse myalgias and paresthesias. She described tingling on her fingers of both hands, on toes of right foot, and abdominal region.  Patient was admitted to the hospital for evaluation and was diagnosed with Guillain-Barré syndrome and possible acute disseminated encephalomyelitis. Patient is being treated with IVIG for 5 days and methylprednislone, with improvement in symptoms.
Vaccine was at room temperature for > 6 hours at time of administration. Very sore arm.
Covid arm. Red, tender, swollen to the size of a softball arm where the vaccine was received.
TERRIBLE BODY PAINS; VOMITING; SOME FLU; DIDN'T SLEEP WELL; TERRIBLE HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced terrible body pains, vomiting, some flu, didn't sleep well, and terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible body pains, terrible headache, vomiting, some flu and didn't sleep well was not reported. This report was non-serious.
Red, itchy rash at vaccination site (on left arm).   Ongoing for 3 days now.
Pain in the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in the shoulder) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiovascular disease, unspecified. Concomitant products included APIXABAN (ELIQUIS), LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN, METOPROLOL SUCCINATE (TOPROL), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced ARTHRALGIA (Pain in the shoulder). At the time of the report, ARTHRALGIA (Pain in the shoulder) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was planning to take Extra strength Tylenol as treatment.
took the shot and broke out in shingles; broke out in shingles, was horribly sick; horribly sick; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 93-year-old male patient who received Herpes zoster (Shingles vaccine) for an unknown indication.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: took the shot and broke out in shingles) (serious criteria GSK medically significant), shingles (Verbatim: broke out in shingles, was horribly sick) and sickness (Verbatim: horribly sick). The outcome of the vaccination failure and shingles were unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-Mar-2023 The reporter's cousin, who was 93 at the time, asked the doctor if he should take the shot because he thought he was in group of people who were sensitive to the shot.  He was assured it would not affect him.  So, he took the shot and broke out in one of the worst-case scenarios of shingles.  He was horribly sick for over a year.  The reporter wished he could tell all what the factor was, but he could not understand what he said.  The follow-up would not possible as no contact details were available This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
2nd On 2/2/21, patient had headache, and was nauseous about 12 hours after the vaccine.  On 2/3/21 still had head and neck ache, chills and was extremely nauseous; body aches; this lasted until the afternoon of 2/5/21, when patient started feeling better. Patient feels good now.  Member only had a very sore arm after the first vaccine; 24 hrs symptom lasted.
Within 30 minutes of the 4th polio vaccine patient started getting a dull headache. Within 60 minutes he had a full blown migraine. He needed to take 3 ADVIL and a rescue medication. Within 1 hour the pain subsided from what he said an 8 to a 3 and remained at a 3 for 24 hours.
Swollen lip on right side - roof of mouth on right side.  Diarrhea
This spontaneous report was received from a 60 year old female patient regarding herself. The patient's historical medications included clindamycin and penicillin. The patient's concurrent conditions included asthma, allergy to clindamycin and penicillin. On 16-NOV-2015 the patient was vaccinated with ZOSTAVAX (with batch number-L028285 and expiry date-28-OCT-2016), 1 vial, subcutaneous on her arm. The patient was also on unspecified concomitant medications. On 16-NOV-2015, in the evening the patient began to develop a rash right above the injection site and her arm began to swell and had the swelling had extended from elbow to her shoulder. The patient called her physician on 17-NOV-2015 and went to see him on 18-NOV-2015. The physician told the patient to use BENADRYL and hydrocortisone to treat the swelling and rash. No product quality complaint (PQC) was involved. The outcome of the events was reported as not recovered/not resolved. The causality assessment was not provided. Additional information has been requested.
Patient complain of heat wave (flash like symptoms)  started from head radiating to abdomen, coughing, and watery eyes. Checked by EMS. VS  B/P 125/75, HR 69, 98% RA, Denies Nausea and vomiting. Cleared by EMS and NP
Patient had some pain at the injection site for 2 weeks and shooting pain down the arm to the hand
Hives, and scratchy throat, was given IM Benadryl after about 20 mins symptoms subsided
Flushing; break into sweats; on and off chills; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing), HYPERHIDROSIS (break into sweats) and CHILLS (on and off chills) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included levothyroxine for Hypothyroidism.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced CHILLS (on and off chills). On 21-Jan-2021, the patient experienced FLUSHING (Flushing) and HYPERHIDROSIS (break into sweats). At the time of the report, FLUSHING (Flushing), HYPERHIDROSIS (break into sweats) and CHILLS (on and off chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16-Apr-2021, Contains non-significant information
Assessment and Plan:   1. Local reaction to COVID-19 vaccine Active T88.1XXA 999.9     Plan: Patient has been reassured that his arm pain and localized erythema is consistent with known local reaction to the Covid vaccine.  Patient has been counseled to use over-the-counter ibuprofen or Tylenol as needed for pain, moderate the activities with the left upper extremity and to avoid itching or scratching the area.  Patient has been counseled the reaction will resolve on its own in the next few days. Follow-up: No follow-up provider specified. Subjective: Patient ID:  Patient is a 62 y.o. male who presents today with a chief complaint of: No chief complaint on file. 62-year-old male patient presents to express care with left arm deltoid pain with activities and erythema following his Covid booster vaccination.  Patient had his vaccine on Friday.  On Saturday morning he noted that his left arm was very sore with any activities.  He then noted that it turned red yesterday.  Patient is concerned about localized infection. HPI ROS Patient Reported Taking
10/2/12 Redness & swelling immediately status post giving vaccine - 2 1/2 inch x 3 inch. Ice applied for 10 min without significant reduction in erythema. 10/3/12 F/U: Spoke with pt on the phone. She states "she is much better. There is very little swelling and she feels soreness just from the needle stick." Offered to return to clinic if worsens. 10/4/12 RN's note above. Swelling essentially disappeared. Today, 10/4/12 - no swelling.
Sore arm; Headache; Administered 0.5, instead of 0.3 of the Covid vaccine; Caller reports that she did do the whole 0.2 instead of the 1.8; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot Number: FD8448), via an Intramuscular route on 08Aug2021 11:00  at the age of 42 years as DOSE NUMBER UNKNOWN, 0.5ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had administered 0.5, instead of 0.3 of the covid vaccine on 08Aug2021, caller reported that she is a pharmacist who has been giving vaccinations. She gave some yesterday and gave the wrong dose. She wanted to know what to do. She is really felt upset and stated that, it was just 4 patients and she does not have any patient information to provide. It was reported that she is not at work today but will be tomorrow. She had been looking up all kinds of stuff about it. She is a floater and is working at With held. She had been working at an independent sore and only been giving Moderna, if it was Moderna, she would have probably had it memorized. She did a training back, a year ago. When she got to work, she hadn't been there in 2 days. She did not know that it was Pfizer. About 10 people were waiting and the alarm was going off. She had been trying to look up stuff to know all about it. It had been a while and it was different. She knows that it was supposed to be 5 to 6 doses and there was only 4 left. She had been over this and was worried this morning. The diluent was correct. She had used the 2ml vial and just threw out the vial. Caller reported that she did do the whole 0.2 instead of the 1.8, which is a mistake too but at least made it not as strong. Maybe this helped it out some. She clarified she used the 2ml vial for the diluent. On 08Aug2021 20:00 patient experienced pain in extremity (non-serious)  and headache (non-serious).Patient recovered from both events on 09Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (31Aug2021) This is a follow up-spontaneous report from a contactable Pharmacist. This Pharmacist reported in response to HCP letter via follow-up letter which included that: At risk classification was removed as new events are added. Patient initials and age at vaccination was captured as per follow up report. The dose route and time added. Narrative updated.  Follow-Up (10Sep2021): Follow-up attempts are completed. No further information is expected.
Itchiness, 2 inch circle of hives, redness and low grade fever of 99.5.
experienced swelling of his face; shortness of breath; Initial information received on 01-Nov-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 68 years old male patient who experienced swelling of his face and shortness of breath after receiving influenza quadrival A-b high dose HV vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or: no other vaccines   On 30-Oct-2023, the patient received a dose of 0.7 mL of suspect influenza quadrival A-b high dose HV vaccine (lot U8156AA, expiry date- 30-JUN-2024) (with an unknown strength, formulation) via intramuscular route in the left upper arm for Immunisation.  On 30-OCT-2023, (latency- same day), the patient developed swelling of his face (swelling face) and shortness of breath (dyspnoea) following the administration of influenza quadrival A-b high dose HV vaccine.  Reportedly, There was no apparent rash. The patient contacted the physician the next day and was instructed to take Benadryl. Patient noticed improvement with Benadryl. Patient was seen by the physician today, 01NOV2023. The physician was not able to see any swelling on the patient's face. The patient's symptoms lasted 2 days. The patient noted that this was the first time he had received a flu vaccine.   Action taken was not applicable.  Treatment: Physician recommended patient take Benadryl for symptoms. Patient noticed some improvement after taking Benadryl.  At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2023 for both the events.
This resident received the first dose of the Pfizer Covid vaccine at the Covid vaccine clinic at medical Facility. He had a rapid response, experienced low blood glucose and low heart rate. NP and medical director were in attendance. Heart rate remained low despite all measures. He was transferred to Hospital for bradycardia.
seronegative AIH or drug induced AIH;   Herein, the authors present a patient with drug-induced AIH with possible relation to Pfizer-BioNTech COVID-19 vaccine. Case Description/Methods: A 38-year-old female with a history of Helicobacter pylori treated with amoxicillin and pantoprazole three months ago and recent COVID-19 vaccination presented with two weeks of right upper quadrant pain and diarrhea. Patient received second dose of vaccination two weeks prior to symptom onset. Five days post-symptom onset, she developed a pruritic rash with vomiting and yellowing of her skin. Physical examination was notable for normal mentation, scleral icterus, jaundice, and a maculopapular rash. Initial blood workup showed international normalized ratio 2.4, alkaline phosphatase 212 U/L, ALT 3769 U/L, AST 1572 U/L and total bilirubin of 23.8 mg/ dL. Viral hepatitis serologies, chronic liver disease workup and autoimmune serologies were normal. Imaging demonstrated no intra- or extra-hepatic biliary ductal dilation. Liver biopsy showed portal inflammation with interface activity, diffuse lobular inflammation, and perivenulitis with abundant lymphocytes and plasma cells consistent with seronegative AIH or drug induced AIH. The patient developed altered mental status meeting the criteria of acute liver failure, she was started on corticosteroids as well as supportive care with resolution of encephalopathy and was discharged home on prednisone. Discussion: Several etiologies of drug-induced AIH are well-established, however cases secondary to COVID-19 vaccination have been minimally reported. Common adverse events for COVID-19 vaccination have been noted such as fever, chills, fatigue, headache, and muscle pain. Several rare side effects have occurred including immune thrombocytopenia and one other suspected case of Pfizer- BioNTech COVID-19 vaccination-induced AIH reported in the literature. In that case the patient developed symptoms within one week of the first dose. This case serves to report a potential association and not necessarily causation between the Pfizer-BioNTech COVID-19 vaccination and AIH.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event autoimmune hepatitis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
thyroiditis subacute; Blood thyroid stimulating hormone decreased; Iodine uptake decreased; Lymphocyte count decreased; Monocyte count increased; Red blood cell sedimentation rate increased; Serum ferritin increased; Thyroxine free increased; Tri-iodothyronine free increased; Pyrexia; This is a spontaneous report from a non-contactable consumer. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 44-years-old) for COVID-19 immunization. Medical history included Gilbert's syndrome; Ragweed allergy; COVID-19, showed as past COVID-19 infection (acute infection excluded via antigen test). Concomitant medication included ascorbic acid, colecalciferol, potassium, selenium; all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (Batch/Lot number and Expiration date: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single was taken for covid-19 immunization. The patient experienced thyroiditis subacute, Blood thyroid stimulating hormone decreased, Iodine uptake decreased, Lymphocyte count decreased, Monocyte count increased, Pyrexia or Fever of 40 centigrade for 36 hours, Red blood cell sedimentation rate increased, Serum ferritin increased, Thyroxine free increased, Tri-iodothyronine free increased. The patient underwent lab tests and procedures which included antibody test: covid on showed past COVID-19 infection (acute infection excluded via antigen test), blood thyroid stimulating hormone: decreased, body temperature: 40 centigrade for 36 hours, iodine uptake: decreased, lymphocyte count: decreased, monocyte count: increased, red blood cell sedimentation rate: increased, serum ferritin: increased on, thyroxine free: increased, tri-iodothyronine free: increased, radioactive iodine uptake test (RAIU): almost zero TC99 uptake in the thyroid; all on unspecified date. Outcome of the events was not recovered.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Pt came in 1 week after the vaccine for a separate appointment unrelated to the reaction and said that she had been having a itchy rash on her neck since getting the vaccine.  She stated this has been getting better.  It was only on her neck, but not on either arm.  She also received Shingrix # 2 this day, she did not have any issues with Shingrix #1.  Shingrix was in the left arm and lot was 5743A.
A consumer report has been received. The report concerns a 30 year old, female consumer, who had been receiving FLUMIST (intranasal). FLUMIST (intranasal) started during Oct-2008. The patient experienced tested positive for Flu B. The outcome of the event of tested positive for Flu B is unknown. The report was considered to be non-serious.
CHEST PAINS AFTER THE VACCINE; HIGH BLOOD PRESSURE; This spontaneous report received from a consumer via a company representative concerned a 31 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced chest pains after the vaccine, and high blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high blood pressure and chest pains after the vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220248513, 20220251231 and 20220255979.
9 month old patient given Kinrix (for age 4-6 years only) in error. Patient had no adverse reaction to vaccine.
This spontaneous report as received from a nurse refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 12-JUN-2018 at 10:00, the patient was vaccinated with a partial dose of VARIVAX (lot # and expiration date were not reported) subcutaneously for prophylaxis. Sterile diluent (lot # and expiration date were not reported) was used to reconstitute VARIVAX. The patient was crying and moved away as the vaccine was being administered and only about 0.25mL of the vaccine was given to the patient. No adverse effects were reported. Therapy was not discontinued.
8-1-07 Tdap given 12-29-06. Client in for immun 7-31-07 and was given Tdap again. No adverse events at this time. 8-7-07 No adverse events reported to Hth Dept.
rt upper arm sl ecchymosis & induration @ site of DTP inj;sl redness
Developed new onset joint pain and stiffness in bilateral hips, knees, shoulders after second vaccination. Referred to rheumatology and currently being evaluated for possible polymyalgia rheumatica.
"Moderna COVID-19 Vaccine EUA"  Experienced chest tightness and difficulty breathing 20 minutes after receiving the vaccine. Oxygen saturation dropped to 85-88%. Heart rate was 40 bpm and blood pressure was below normal. Went to the ER within 3 hours of receiving vaccine. Was diagnosed with "Allergic reaction to COVID-19 vaccine". Was administered Benadryl and Prednisone.  Was prescribed albuterol sulfate inhaler, Epi-pens, and Prednisone. Discharged from ER after 2 hours.
Rash pruritic from elbow to shoulder on injection site arm; received 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a health care professional and describes the occurrence of RASH PRURITIC (Rash pruritic from elbow to shoulder on injection site arm) and ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose). On 20-Nov-2021, the patient experienced RASH PRURITIC (Rash pruritic from elbow to shoulder on injection site arm). On 19-Nov-2021, ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose) had resolved. At the time of the report, RASH PRURITIC (Rash pruritic from elbow to shoulder on injection site arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
No adverse effects reported; 1-month-old patient received VAQTA; Information has been received from a nurse referring to a 1-month-old patient of unknown gender. Information about concurrent condition, concomitant medication medical history, drug reactions or allergies was not provided.  On 16-APR-2019, the patient received hepatitis a vaccine, inactivated (VAQTA) (lot # R034339, expiration date 23-NOV-2019; strength, dose, route of administration) for prophylaxis (inappropriate age at vaccine administration). No adverse effects was reported.
Local reaction: burning, stinging, redness, swelling and itching at injection site 1 week after injection.