chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication provided. On 14-NOV-2018, the patient was vaccinated with an expired dose of VAQTA lot # N030286, expiry date 10-NOV-2018, intramuscularly for prophylaxis. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1811USA009191.
Initial report was received from a health care professional on 19 January 2012. This case is one of a cluster of seven patients reported by the same reporter who each experienced adverse events following administration of FLUZONE (lot number not reported). The events for the other patients were captured in case numbers 2012-00770, 2012-00771, 2012-00772, 2012-00773, 2012-00774 and 2012-00775. A 26-year-old female patient had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, route and site unknown) on 13 October 2011 and an unspecified amount of time later experienced a fever to 102, body aches and nausea. Illness at the time of vaccination, pre-existing medical conditions, any other vaccinations within four weeks of FLUZONE and number of previous doses of influenza vaccine were unknown. The patient's also took CLOMID, estrogen and metformin. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None. Follow-up information received from a healthcare professional on 21 February 2012. The patient received an intramuscular right deltoid injection of FLUZONE, sanofi pasteur Inc. lot number UH467AB, on 12 October 2011. On 14 October 2011, the patient's symptoms were fever (102), body achy and very nauseous. The patient's concomitant medications included CLOMID, estrogen, metformin and progesterone (taking all medications through the month of October, not all at one time). The patient was concerned about interference with her fertility medications. The outcome remained recovered. No additional information was available. Documents held by sender: Medical timeline.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 02-NOV-2012 at 11:58, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Pt c/o tingly feeling to hand s/p 2nd vaccine . states had similar reaction after 1st vaccine.  Pt also informed paramedics that she had a "metallic taste" in her mouth also.
Pt received vaccine on Friday 4/16/10.  Mom was advised of adverse reactions.  Minor ache noted on Friday on L thigh.  Saturday redness and swelling occurred.  Sunday it worsened and mom took pt to urgent care.  Dx of cellulitis was given and treated with KEFLEX for 10 days.  F/U with provider on 4/20/10 cellulitis now resolved.
Patient came to clinic and consented to receive Covid vaccine. She consented that she had not previously received a Covid vaccine. However, she did receive a Janssen vaccine (Lot 1805020) at another Pharmacy on 03/05/2021.  Patient telephone on 08/27/2021. She states she wanted to be "double vaccinated" due to travel next month. She denies any side effects or adverse effects. Patient was educated to notify Public Health if side effects developed.
Mom called on 2/20 stating pts had "pimples" started 3 days previous now like water blisters. Small amount less than 10 spots- scattered.
Malaise, fatigue, body aches, non-bloody diarrhea, dizziness, lightheadedness, disoriented, oral Tmax 100.4
Positive antigen tests for COVID-19; Positive antigen tests for COVID-19; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 31Dec2021 (Lot number: EF3594) as dose 3 (booster), single, administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "Positive antigen tests for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive; (09Jan2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200036498 Same reporter/drug/event, different patient
Right swollen cheek, started under ear. temp 24 degrees. Parotitis.
On 10/15/99, the pt developed an itchy, red rash which extended over the entire body.
Information has been received from a healthcare worker referring to 6 patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with ROTATEQ (lot # L035508, expiration date 12-MAY-2017, dose and dose # unknown, oral) which were improperly stored. The vaccines were stored under 48 F for 1 hour and had been back in range. The vaccines were not out of range before. No adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Within one hour of administration, pt. developed redness & swelling below site 10 inches across.
5 cm X 3 cm warm erythematous area at vaccination sites. Therapy with reflex 500 mg twice daily.
Legs swelled up really bad ; it left blotches in my leg; Legs swelled up really bad ; it left blotches in my leg; Fever; Bladder infection; UTI; He gave me some medications and it is helping the rash; stomach even swelled up; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 77 years old) for covid-19 immunisation.   The patient's medical history and concomitant medications were not reported. Historical vaccine information included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, for COVID-19 immunization, dose 1 on 17Jan2021 at age of 77 years old. On 23Feb2021, the patient experienced legs swelled up really bad it left blotches in my leg and she went to the doctor, she had fever, bladder infection and Urinary tract infection  (UTI). The legs swelled up real bad, her thighs from the waist, she just swelled up everywhere. Her stomach even swelled up but the right leg mostly. She experienced the blotching, it looks like a birth mark on my right leg and the left leg. It is blotchy, looks like a birth mark on the legs. The right one got really big. She did go to doctor and he said it was not a blood clot. He said people are getting swelled up with rash, some people are having rashes and swelling. Treatment included the physician gave her some medications and it is helping the rash and "cephalexin 500 mg, 3 times a day" for the UTI. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient came in wanting to get her COVID-19 vaccine. She said it was her first vaccine. She even circled she has never had a COVID-19 vaccine before. I administered the Pfizer vaccine to her. We kept her for 20 minutes. I went to go chart the vaccine given, and I found that she has already had 3 Moderna vaccines. Our provider talked to her about what we found. Patient was allowed to leave after the 20 minutes was over.
Pain, tingling, numbness down left arm in to fingers. Dull aching pain down left arm.
Nausea, vomiting and urticarial pruritic rash on hands, legs and thorax and face. Lip swelling and erythema but no pharygial or airway obstruction.
muscle pain; joint pain; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 021B21A) for COVID-19 vaccination.     Concomitant products included ALENDRONATE SODIUM (FOSAMAX) for Osteopenia.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, MYALGIA (muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Vaccine administered, immediate rash, red raised bumps noted on bilateral hands and arms, was escorted to the Emergency Room. Employee returned to Employee Health approx 5 hours after onset and rash had decreased. Rash and urticaria, pruritus. Dexamethasone 4 mg once, Diphenhydramine 50 mg once.
Headache; Fatigue; Right arm injection site swollen; Right arm injection site red; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 26Apr2021 at 13:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Concomitant medications included ascorbic acid (VITAMIN C) from an unknown date and for an unknown indication. The patient previously took duricef and shellfish. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 05Apr2021 at 13:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021, the patient experienced headache, fatigue, right arm injection site swollen and red and sore arm. The clinical outcome of the events headache, fatigue, right arm injection site swollen and red and sore arm were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Mom called on 3/15 stating child had reaction to "shot in left arm". Left arm swelled at shoulder, armpit and down to elbow. Had redness with a hard knot from 03/11-03/14. Had mild temperature x 2 days. Child had no problems today. Didn't take to MD. Fully recovered.
pt became ill 21AUG93 @ 10PM w/fever of 104 began vomiting 22AUG93, also devel red blotchy "hive like" rash, swelling in glands of neck, & loss of appetite; fever & rash still present 23AUG93; rash gone 24AUg93, but fever of 103 persists;
Patient received Moderna bivalent booster dose that had undergone a temperature excursion.; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (Product storage error).    This case is for 55th patient out of 77 patients. Concomitant product use was not provided by the reporter. It was reported that the vaccine was administered to 77 patients before it was known if the vaccine was ok to use after the excursion. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Pfizer Bivalent 2023-2024 season vaccine administer without being diluted first.  0.3ml of undiluted vaccine administered to patient.
VACCINE WAS EXPIRED BY THE TIME OF ADMIN - NO HARM DONE  PATIENT WILL COME IN FOR A REPLACEMENT DOSE
Patient is a 76 years old male who only speaks a foreign language.  Patient lives in a private house and is able to do activities of daily living.  His family member for/cousins who take care of him on a daily basis speak our language.  Patient has no other immediate family.   Patient was recently diagnosed to have cancer most likely in the form of gastric cancer and is undergoing radiation and chemotherapy as an outpatient.  Patient usually follows with cancer centers and apparently was recently diagnosed to deep vein thrombosis of the left lower extremity.  Worth mentioning is the patient is status post amputation of the right lower extremity.  His left lower extremity was noted to be swollen and was diagnosed to have DVT and was started on Eliquis as an outpatient by his cancer doctors however he continued to have worsening symptomatology with increasing swelling and rib pain for which reason he was sent to the hospital by his cancer centers and is recommended admission.  He denies any fevers or chills.  Denies any palpitations.  Denies any chest pains.  He denies any relieving or aggravating factors otherwise.  He has no radiation of pain either.
pt recv vax 9MAY95 & 9APR96 pt devel full blown chickenpox;pt twin sibling recv vax on same day & also devel chickenpox (WAES96051478);pt recovered & no other complications were noted;
Injection site reaction lasting approximately 1 week - painful, itching, and warm to touch. Was seen by PCP and prescribed cephalexin on 8/5/14. Affected area approximately 2" surrounding injection site.
Symptoms returned and tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Symptoms returned and tested positive) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Concurrent medical conditions included Gout and Allergy NOS. Concomitant products included PRAVASTATIN from an unknown date to 17-May-2022 for an unknown indication.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 05-May-2022, the patient experienced COVID-19 (Symptoms returned and tested positive). At the time of the report, COVID-19 (Symptoms returned and tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive with symptoms on May 5. On 13-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative on May 13. On 17-May-2022, SARS-CoV-2 test: positive (Positive) Symptoms returned and tested positive May 17.         No information on treatment medications was reported. Company comment: This spontaneous case concerns a patient of a 55-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19 approximately 7 months after the third dose of mRNA-1273 vaccine. No details of previous doses were provided. As per narrative of the source document, she experienced symptoms with a positive test, and the symptoms cleared in treatment with Paxlovid (ritonavir), but he reported after eight days the symptoms returned and tested positive again. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of a 55-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19 approximately 7 months after the third dose of mRNA-1273 vaccine. No details of previous doses were provided. As per narrative of the source document, she experienced symptoms with a positive test, and the symptoms cleared in treatment with Paxlovid (ritonavir), but he reported after eight days the symptoms returned and tested positive again. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Lightheaded, dizzy, hot-given water, BP 117/62 P 90 R 16 WNL.
seen 5/8/07 for Shingle-varicella-zoster virus (L) low and upper chest
Vaccine exposed to 27 F for more than 3 hours due to the temperature in the refrigerator was manually changed, given to 15 months old patient, no AE; Initial information received on 01-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA172973, 2020SA172697 ,2020SA174880, 2020SA174942, 2020SA174941, 2020SA174940, 2020SA174906, 2020SA174932, 2020SA174911, 2020SA174910 and 2020SA173110(same reporter).  This case involves a 15 months old male patient who was vaccinated with the  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], that was exposed to 27 Fahrenheit for more than 3 hours and the excursion occurred due to temperature of the refrigerator was manually changed.it   Medical history, medical treatment(s), vaccination(s) family history and concomitant medications were not provided.   On 18-May-2020, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ196AB and expiration: 2-Mar-2021) via unknown route in unknown administration site as prophylactic vaccination.  It was an actual medication error case due to Product storage error temperature too low.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine until about 3pm. Just typical arm pain.   Moderate/Severe Fatigue set in around 3-6pm. Needed to nap from 4-5pm (extremely unsusual). Felt fine the next day. Moderate congestion in ears starting around the same time (6 hours after) and is persisting 30 hrs later. Feel like my ears will not pop and trying to yawn a lot. Also felt pretty bad sinus congestion starting at 7pm 12/21 (10 hrs after vaccine). Could not breathe through nostrils. Treated with sinus rinse and sudafed.
Fever up to 101.0, body aches, chills, fatigue, weakness, redness at injection site, tender at injection site, swollen lymph nodes in neck, axilla, L breast, headache that started at 6 am the following day.  I took Tylenol which did help fever and body aches.  I had symptoms until 1/11/21 and started feeling better at 11 am.
kidney failure; Initial information was received on 20-Nov-2020 regarding an unsolicited valid serious case received from a consumer or non health care professional via social media and additional information recieved on 23-Nov-2020  This case involves a patient (age unspecified) who had kidney failure (renal failure), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious kidney failure (renal failure) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and patient was hospitalized for this event.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a patient (age unspecified) who experienced renal failure after vaccination with INFLUENZA VACCINE. The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.