chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine at 1330.  Walked to chair to sit for 15 min.  6 min later put hand up for RN to come over.  Stated "I don't feel so good", became very pale/diaphoretic, then became unresponsive.  RN x 2 at side lifted pt to recliner and laid flat.  911 called.  Pt became alert and oriented, continued to be diaphoretic.  Stated he felt dizzy.  Declined assessment by EMS.  States this has happened to him before when he received a vaccination.  Observed x 30 min, skin back to wnl.  pt states feeling much better.  provided water to drink, sat up and VS checked multiple times throughout stay.   1339 124/69 HR 84, RR 16 O2sat 100.  1345 143/75 HR 85 O2 sat 100.  1400   sitting 110/68 HR 69 O2 sat 98.  1410 sitting 102/64 HR 70 O2 sat 97.   standing 1412 106/73 HR 88 O2 sat 97.  Declines evaluation in ER.  left ambulatory instructed to follow up with primary doctor and to notify staff at 2nd covid vaccine of event prior to vaccine.
Injection site necrosis Injection site reaction Injection site redness Injection site induration Injection site itching. Medication error Initial report received on 23/Nov/2005 from a health care professional. Per the reporter, several people may have been administered 0.5cc to 1.0cc of TET TOX ADG USP, lot number U1367AA, intradermally in the forearm on 26/)ct/2005. At an unspecified time later, fourteen patients reported redness, induration and itching at the test site. One of those fourteen patients additionally developed necrosis at the test site. At the time of this report, the symptoms were still persisting for all fourteen patients. Follow-up information received on 03/Apr/2006. The patient for this case is a 46 year old male and had no illness at the time of vaccination. Immunization was received on 26/Oct/2005 at 07:45. Recovery status was not reported. No further information expected. The reporter for this case is the same as for cluster of cases 2005-02571, 2005-02572, 2005-02573, 2005-02574, 2005-02575, 2005-02576, 2005-02578, 2005-02579, 2005-02580, 2005-02581, 2005-02582, 2005-02583.
Within 4-5 minutes after receiving the vaccine the recipient became Hypotension  and Diaphoretic . blood Pressure 78/59 and HR 89. She was given oxygen, and bolus of IV fluids in ambulance. BP inproved to 112/76. She was taken to the ER and after additional tests, she was discharged around 9pm with diagnosis of Vasovagal Syncope.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient recieved the vaccine (sitting) and was instructed to sit for 15 minutes post vaccination.After about 5 minutes, patient stated that he was feeling light headed. Patient was seated when he fainted and was out for about 12-15 seconds. Patient came back and was able to speak with us.We provided him some water and called the EMT's. EMT's looked after patient/checked vitals and everything was okay. Patient states he has a fear of needles. Called patient a few hours after the incident to check
3-4PM Very Blood Shot eyes 7-9PM Eyes more irritated, chest/lung tightness (felt as though patient couldn't catch their breath), hoarse voice. 9-11 Eyes (sclera) bright red, chect congestion/tightness continued - eased only slightly after 4 Advil cold and sinus over the course of the night. Symptoms eased a bit but persisted through the next day.
This spontaneous report as received from a consumer (patient's sister) refers to a male patient of unknown age with lymphoma. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose, route were not reported). Concomitant therapies included unspecified chemotherapy. On an unknown date, shortly after injected with ZOSTAVAX (also reported as "some time ago") the patient showed signs of Parkinson's Disease. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected due to lack of patient and physician's contact information.
This spontaneous report was received from a Registered Nurse refers to twin 4 year old female patients Vaccinated with VARIVAX (Merck), vaccine. On 20-JUN-2014, the patient was vaccinated with VARIVAX (Merck), subcutaneous. This is the second dose in the series. On an 20-JUN-2014, the patient received VARIVAX that was exposed to a maximum of 17.2 Fahrenheit for cumulative 41.5 hours (supported). The Nurse also reported there were other patients (an unspecified number) who received improperly stored VARIVAX Patient data not presently available. The Outcome of receiving VARIVAX that was exposed to a maximum of 17.2 Fahrenheit for cumulative 41.5 hours is unknown. Additional information is not expected. This case is linked to 1408USA009865 due to twin patients who were vaccinated on the same date 20-JUN-2014. This case is linked to 1407USA012109 due to twin patients who were vaccinated on the same date 20-JUN-2014.
Fever up to 100.6 Fatigue Chills Body aches No treatment. Resolved by morning.
Occured 6/4/04 (the day the vaccine was given). Left thigh swelling and redness around the area. No fever with the reaction
tested positive for SARS-Cov-2; tested positive for SARS-Cov-2; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient himself) reported a male patient of an unspecified age (also reported as: age: 71; unit: unspecified) who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. It was reported that patient received first dose on 30Jan2021 and tested positive for SARS-Cov-2 on 13Feb2021. Patient was asking how long to wait for the second shot. Outcome of events was unknown.   Information about lot/batch number has been requested.
For two days, after vaccine administered, very painful. But it never improved. Arm continued to be sore, difficult time to raise and lower left arm. Difficulty changing shirts, reaching, setting hair, lying on left side or doing anything w.my left arm.
Patient gave screener second shot vaccine card with first shot showing as Moderna. Patient confirmed that she received Moderna as first shot. Vaccinator filled out second slot on card with new lot number. Vaccinator reconfirmed with patient that they had gotten Moderna as first shot and administered vaccine. During signing of the chart vaccinator saw that the system didn't match vaccine given. Patient paper record reviewed. Patient got 1st dose of Pfizer. Second dose administered was incorrect vaccine brand.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. On an unknown dates in 2015, starting on or after 28-OCT-2015, an unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (route of administration and dose number were not reported, lot number: J007296 (verified as not valid), expiry date: 05-FEB-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Right arm not able to lift.  Fury hurt,  nerve  down arm effected. Have seen pain management, physical therapy
Had spot on rear end.  Showed his sister, but did not tell adults.  8:45 PM severe hives on arms, legs, trunk, started on face.
Aches and chills, headache. Lasted most of the day but felt better by evening. Spent most of the day resting. Took ibuprofen for headache in afternoon and that helped.
Inflammation and redness around injection site from COVID booster received; redness around injection site from COVID booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9-year-old male patient received BNT162b2 (BNT162B2), on 28Jul2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 9 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:1st, Time: 16:45, Site and Route of injection:, Anatomical site of injection: Left arm, Batch/Lot number: FK5127), administration date: 18Nov2021, for COVID-19 immunization; BNT162b2 (Dose:2nd , Time: 14:15, Anatomical site of injection: Left arm, Batch/Lot number: FK5127), administration date: 28Dec2021, for COVID-19 immunization, reaction(s): "hyperactivity", "increased appetite/ Voracious appetite". The following information was reported: VACCINATION SITE INFLAMMATION (non-serious) with onset Jul2022, outcome "unknown", described as "Inflammation and redness around injection site from COVID booster received"; VACCINATION SITE ERYTHEMA (non-serious) with onset Jul2022, outcome "unknown", described as "redness around injection site from COVID booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 at 11:00 as dose 1, single (Lot number: EN6203), in left arm, on 26Mar2021 at 11:30 as dose 2, single (Lot number: ER8732), in left arm and on 14Dec2021 at 19:00 as dose 3 (booster), single (Lot number: Fj8757) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (29May2022) Positive, notes: very positive; (04Jun2022) Positive, notes: still slightly positive; (06Jun2022) Negative; (08Jun2022) Positive; (12Jun2022) Positive, notes: still slightly positive; (14Jun2022) Negative; (29May2022) Positive, notes: very positive; (02Jun2022) Positive; (06Jun2022) Negative.  Clinical course: Adverse event: No Known allergies were reported. 29May2022: Mild Symptoms Binax both very positive. 02Jun2022: test still positive. 04Jun2022: Binaxnow still slightly positive. 06Jun2022 Binaxnow Negative. Felt great. 08Jun2022: Stuffy nose Binaxnow positive again. 12Jun2022: still slightly positive. 14Jun2022 Negative. Feel great. Reporting Today 15Jun2022. Something wrong with an app. Patient cannot enter the correct adverse correct event stop date. Third week in June was inaccessible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200842391 Same patient, different product and event;
This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age. On 04-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported) that was improperly stored. No adverse effect was reported. Additional information has been requested.
Immediately after injecting the 0.5 ml vaccine dose, the patient started bleeding and then a lump slightly smaller than a grape formed. The lump was not warm to the touch and the patient said it didn't hurt or make him feel any different. The lump was still there 5 minutes later and the patient confirmed no swelling of face/throat, itching, or tingling and refused to stay any longer for observation.
Got a severe case of shingles less than 5 years after getting ZOSTAVAX.
Pfizer BioNTech COVID-19  Vaccine EUA given on 12/29/20 at 1530. Experiencing severe body aches, fatigue, sweats, and headache the next morning.
She experienced swelling of her arm; Achiness; Slight fever; Headache; Heavy fatigue; She experienced lymph node swelling under her left arm for about ten days; Pain in spine; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (She experienced swelling of her arm), SPINAL PAIN (Pain in spine), FEELING ABNORMAL (Brain fog), PAIN (Achiness) and LYMPHADENOPATHY (She experienced lymph node swelling under her left arm for about ten days) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 002A21A) 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 adverse event). Concomitant products included METHOTREXATE, GABAPENTIN and ACICLOVIR SODIUM (ACYCLOVIR VIAL) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced SPINAL PAIN (Pain in spine), FEELING ABNORMAL (Brain fog) and LYMPHADENOPATHY (She experienced lymph node swelling under her left arm for about ten days). On an unknown date, the patient experienced PERIPHERAL SWELLING (She experienced swelling of her arm), PAIN (Achiness), PYREXIA (Slight fever), HEADACHE (Headache) and FATIGUE (Heavy fatigue). At the time of the report, PERIPHERAL SWELLING (She experienced swelling of her arm), SPINAL PAIN (Pain in spine), FEELING ABNORMAL (Brain fog), PAIN (Achiness), LYMPHADENOPATHY (She experienced lymph node swelling under her left arm for about ten days), PYREXIA (Slight fever), HEADACHE (Headache) and FATIGUE (Heavy fatigue) outcome was unknown.            Treatment medication include ibuprofen
Pt received a second dose of the flu and covid vaccines. First dose was administered on 10/30/23. Pt denied receiving both vaccines previously. There were double orders for the same vaccines. There were no adverse reactions after the administration. The observation time was 30 minutes.
A nurse reported that a 2 month old female received her first dose of Prevnar vaccine on 10/30/2001. Post immunization, the infant developed an injection site reaction characterized by a bump and a brown spot. The brown spot was still present two months later when the infant received her four month old immunization. No further info was available at the date of the report.
Pinched nerve in neck, knee cap was blown out, pinch nerve in lower back, pinched nerve in neck again causing a shoulder injury. Inflammation of the joints was diagnosed by chiropractor.
Deep vein thrombosis leg; PULMONARY EMBOLISM; BLOOD CLOT; MUSCLE CRAMP; SWELLON LEG; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (PULMONARY EMBOLISM), THROMBOSIS (BLOOD CLOT) and DEEP VEIN THROMBOSIS (Deep vein thrombosis leg) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced MUSCLE SPASMS (MUSCLE CRAMP) and PERIPHERAL SWELLING (SWELLON LEG). On an unknown date, the patient experienced PULMONARY EMBOLISM (PULMONARY EMBOLISM) (seriousness criterion medically significant), THROMBOSIS (BLOOD CLOT) (seriousness criterion medically significant) and DEEP VEIN THROMBOSIS (Deep vein thrombosis leg) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) at a dose of UNK, qd. At the time of the report, PULMONARY EMBOLISM (PULMONARY EMBOLISM), THROMBOSIS (BLOOD CLOT), DEEP VEIN THROMBOSIS (Deep vein thrombosis leg), MUSCLE SPASMS (MUSCLE CRAMP) and PERIPHERAL SWELLING (SWELLON LEG) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.  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.; 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.
Rash at Injection site and going down to elbow. Patient is to take 50 mg of benedryl and apply ice at the injection site.
Headache, Fever, NauseaVomiting, right arm pain at injection site, chills Narrative:
Approx. 1-2 hrs after receiving the flu vaccine, pt. experiencing heart palpitations, dizziness, and generalized weakness. BP elevated to about 140/90. Pt. had Hx. of recent bronchitis and on last day of antibiotic, of which could not remember the name. Pt. states went to cafeteria to eat and then felt better, later that day. Pt. called and f/u with Dr., but did not see physician. 11/20, pt. called back and was on a Z-pack.
This spontaneous report as received from a physician refers to a 50 year old female patient with none pertinent medical history or drug reaction allergies. On 23-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H021459, expiration date 30-APR-2014) (dose and route not reported). Concomitant therapies included vitamin D (unspecified) and drospirenone, YAZ. On 11-JUN-2013 the patient developed 2 lesions on her inner elbow. On 21-JUN-2013 the patient had lesions in different stages of development ranging from lesions with yellow fluid leaking out to lesions that were scabbed over. The patient was seen by this physician in the office on 22-JUN-2013 and this physician noted that the patient had lesions which were very itchy mainly on her bilateral arms, a few on the right leg and abdomen and one on her left temple. This physician also noted that the patient had a fever on 22-JUN-2012, the day of the office appointment. The patient sought medical attention and this physician prescribed the patient Aveeno bath, ACYCLOVIR and ZYRTEC. Laboratory diagnostic studies were not performed. At the time of the report, the patient's outcome was not recovered. Additional information has been requested.
Pt/mother report pt awoke feeling hot, achy, headache, vomited x 1, came to school and temperature checked by school RN 102.5.
Flat red rash on arms, legs and cheeks, very itchy, 7 hours after administration.
Headache, Myalgia, Fever, Localized pain; chills, fatigue Narrative:  Other Relevant History:
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020). On 16th May 2018, the patient received SHINGRIX. On 17th May 2018, 1 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The adverse event was reported by Medical Information who transferred caller to the GSK response center. The patient reported that after receiving SHINGRIX, she developed Shingles the next day morning. The patient had indicated she would consult with an attorney. No additional information was provided.
Redness, swelling, warmth and itching at the injection site several days after injection.  2-3 cm diameter approx.  still going on.
Pt recieved Fluzone HD immunization on 09/22/15. Pt returned on 9/28/15 complaining of soreness and quarter sized bruise at injection site. Pt did bleed upon injection and sterile gauze was held in place for 30 seconds and then covered with band-aid.
10/12/08 - Symptoms of fatigue, tired, chills, fever (101.4), lasted approx. 6-8 hours.
This spontaneous report was received from a Physician via a company representative referring to a 26 year old female patient. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL 9 (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. The physician reported that a "lack of efficacy" took place on an unspecified date. It was also reported that the patient was diagnosed with advance cervical dysplasia and was also Human Papillomavirus (HPV) positive. Therefore, the patient sought medical attention and was seen by the physician. At the reporting time the outcome of the adverse events was unknown. The causality assessment between the adverse events and therapy with GARDASIL 9 was not reported.
11/16/09- Mother states child woke up in AM day after vaccine with rash-mild-over body which lasted about a day - also reported nasal congestion lasting about 2 days - denied fever- reports no current problems.
A report has been received from a Health Professional concerning  4 year old, subject of unknown gender, who had been received FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The patient had been administered expired FLUMIST quadrivalent, which was considered as medication error, it was states that the expired FLUMIST quadrivalent was one day past date. The outcome of the event of patient has been administered expired FLUMIST quadrivalent was unknown. The report was considered to be non-serious.
More than 6 months away from first shot and had not received the second shot; COVID Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID Arm) and PRODUCT DOSE OMISSION ISSUE (More than 6 months away from first shot and had not received the second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION COMPLICATION (COVID Arm). On 23-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 6 months away from first shot and had not received the second shot). In January 2021, VACCINATION COMPLICATION (COVID Arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 6 months away from first shot and had not received the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not reported   Reporter did not allow further contact
Mother reported today 1-11-11 @ clinic visit - that child became ill - within 24 hours after FLUMIST - states had vomiting, diarrhea, fever - 102.9 - lasting 3 days. Tx. TYLENOL & Ibuprofen - did not see MD.
Pfizer COVID-19 Bivalent vaccine incorrectly administered as a primary series monovalent dose.  No signs or symptoms of ADRs
erythema @ site of vax  x 16 days along w/tenderness, warmth & a mild fever of 99
I was extremely fatigue and slept a lot and decided to get tested. I went to local health clinic to take a Covid-19 test and tested positive for OMICRON. The fatigue lasted for 6 days. Within those 6 days I slept a lot trying to get better.  Since I recovered from Omicron I have had runny nose and a cough that has been lingering on for months.
Presented w/COVID-like symptoms; admitted for COVID-19 infection, pna, acute resp failure; tx w/abx, O2, remdesivir, steroids, zinc; weaned to RA for dc home.
09/13/06 pt went to school where she developed hives at 10am. She was sent home, mom came home and found pt unresponsive and called 911. Pt seen at ER. Became responsive and talking well at ER. Exam WNL. DX'd changed mental status sent home.