chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: product COVID 19 Treatment, Brand: Paxlovid, treatment start date: 02Dec2022, treatment stop date: 05Dec2022 Indication: Treatment of COVID-19. No known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt said after few days of pneumonia shot her whole body ache, back ache, tired, hearing loss, little rash on arm, neck pain.
pt recv vax 615AM 29OCT97 @ work site;10PM noticed soreness in arm when rolled over;next AM had area size of silver dollar that was red warm & hurt to touch;saw 3rd shift Rn & went to work;930PM 30OCT97 was called to med;had infect;
Upset Stomach; Listedness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset Stomach), VACCINATION COMPLICATION (Listedness) and HEADACHE (Headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LOSARTAN and VITAMINS NOS for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset Stomach), VACCINATION COMPLICATION (Listedness) and HEADACHE (Headache). At the time of the report, ABDOMINAL DISCOMFORT (Upset Stomach), VACCINATION COMPLICATION (Listedness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.
diagnosed with covid; felt very terrible; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (diagnosed with covid) and ILLNESS (felt very terrible) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (diagnosed with covid) and ILLNESS (felt very terrible). At the time of the report, SARS-COV-2 TEST POSITIVE (diagnosed with covid) and ILLNESS (felt very terrible) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
no adverse effects; The patient was vaccinated with an improperly stored doses of Hepatitis A vaccine.; This spontaneous report was received from a nurse referring to patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 02-MAR-2020 at 08.39,  the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(manufacturer unknown), 0.5 milliliter, intramuscular in the right arm (strength, frequency, and expiration date were unknown) with lot # reported as "747P5"  for prophylaxis. The temperarure excursion was no reported for the other vaccine. No adverse effects reported.  Lot number 747P5 is an invalid lot number for hepatitis a vaccine, inactivated.; Sender's Comments:  US-009507513-2008USA008876: US-009507513-2008USA008885: US-009507513-2008USA008883: US-009507513-2003USA002275: US-009507513-2008USA008889: US-009507513-2008USA008875: US-009507513-2008USA008890: US-009507513-2008USA008877: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008932: US-009507513-2008USA008886: US-009507513-2008USA008887: US-009507513-2008USA008888: US-009507513-2008USA008891: US-009507513-2008USA008892: US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904:
Case previously recorded as MA2009-4374. Initial case report received from a medical assistant via agency, on 12 NOV 2009. A 3 year-old male patient was accidentally vaccinated with FLUVIRIN (batch no. 102041P) i.m. on 10 NOV 2009. No adverse effect was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Off label use (child under 4 years old) is unexpected regarding vaccination with FLUVIRIN. No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-008119.
Uncontrollable chills; Fever; Headache; Arm is sore a bit; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration at on an unspecified date at single dose for COVID-19 immunization.  Medical history included Covid.  The patient's concomitant medications were not reported.  On 16Dec2020, Last night, about 12 o' clock, patient woke up with the same side effects that patient had Covid. Patient had uncontrollable chills and a fever. Those were better. Patient still had a headache. Of course, his/her arm was sore a bit, that was expected. Outcome of uncontrollable chills and fever were recovering, outcome of other events was unknown.   Information on the lot/batch number has been requested.
Covid arm. A week later my shoulder started itching and there was a red spot that looked a little bit like a hive. It was puffy. I thought it was a spider bite but that would be too coincidental. I put some Benadryl cream on it and went to sleep. The next morning it was still itchy but it was flat and not puffy. It was more red but I left it alone and it went away within a few days.
cold-like symptoms, generalized body aches, diarrhea, nonproductive cough and some shortness of breath
Localized area of induration and redness around sites of vaccination (DTaP and IPV) on left upper extremity (Deltoid). Next day developed periorbital swelling. No dysphagia; no SOB.
Shoulder blade hurts; Upper arm now has shooting/stabbing pain that comes and goes all day long; I started to get bumps on my left shoulder blade that are deep under the skin; Left arm to be tender to the touch; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 19Apr2021 at 12:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 08:00, patient started to get bumps on my left shoulder blade that were deep under the skin which appeared within 24 hours of the vaccine. There was probably 5 of them in a cluster. They seemed to be pressing down on a nerve that caused the whole bottom of the patient's left arm to be tender to the touch, all the way down the side of the thumb. On 25Apr2021, that pain just ended, but now more bumps appeared above the injection site (three of them in a line). On 26Apr2021, the patient experienced shoulder blade hurts if someone were to touch it and when the patient would move her arm. The patient's upper arm had shooting/stabbing pain that would comes and go all day long. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left arm to be tender to the touch was recovered on 25Apr2021. The clinical outcome of the events I started to get bumps on my left shoulder blade that are deep under the skin, shoulder blade hurts, upper arm now has shooting/stabbing pain that comes and goes all day long was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Terrible migraine; Taste of metal in mouth; Severe mouth pain; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 at 14:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included unspecified birth control medications, spironolactone (MANUFACTURER UNKNOWN), ambrosia artemisiifolia pollen (RAGWITEK) and escitalopram oxalate (LEXAPRO); all for an unknown indication since an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 14:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Apr2021 at 16:30, 2.5 hours after the vaccination, the patient experienced terrible migraine, taste of metal was her in mouth. The patient looked it up and it was rare but she keeps experiencing severe mouth pain. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported adverse events. The clinical outcome of the events terrible migraine and taste of metal in mouth was unknown and the clinical outcome of the event severe mouth pain was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swollen ankles; in a lot of pain; sprained his left ankle / heard crack, crack, crack /went down like a ton of bricks; This spontaneous case was reported by a consumer and describes the occurrence of LIGAMENT SPRAIN (sprained his left ankle / heard crack, crack, crack /went down like a ton of bricks), JOINT SWELLING (Swollen ankles) and MYALGIA (in a lot of pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B217) for COVID-19 vaccination.     Concurrent medical conditions included Foot drop (Left foot drop- started years ago) and Ankle instability (Ankle pops in and out). Concomitant products included TOFACITINIB CITRATE (XELJANZ XR), SERTRALINE HYDROCHLORIDE (SERTRALINE [SERTRALINE HYDROCHLORIDE]), SIMVASTATIN, CYCLOBENZAPRINE, DICLOFENAC SODIUM, LISINOPRIL, HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), GABAPENTIN and METFORMIN HYDROCHLORIDE (METFORMIN ER) for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced LIGAMENT SPRAIN (sprained his left ankle / heard crack, crack, crack /went down like a ton of bricks). On 10-Jun-2021, the patient experienced JOINT SWELLING (Swollen ankles) and MYALGIA (in a lot of pain). At the time of the report, LIGAMENT SPRAIN (sprained his left ankle / heard crack, crack, crack /went down like a ton of bricks), JOINT SWELLING (Swollen ankles) and MYALGIA (in a lot of pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Swollen, right, Red, hot and hard muscle. Happens every time she gets the flu shot.
Cough, shortness of breath, nausea for 3 month since vaccination   Next day after second dose of vaccine I had headache,nausea, exhaustion, cough. Most of those symptoms went away that same day
Awakened at 2 a.m. by extreme sore throat. Accompanied by a fever of 100 degrees at 5 a.m.
Tender leg and temperature at 100.2F about 15 hours, post vax, associated with multiple insect bits with area of 1 1/2" erythema at groin, not at site of injection. Muscle diffusely tender with some decreased motion at left hip. Admitted with cellulitis versus vaccine reaction.
Fever up to 101, achy, headache, dizzy   Patient received injection on Thursday 11/20/08 and symptoms started Saturday 11/22/08. Patient feels some better today 11/25/08. He will update prn.
Sudden sensorineural hearing loss 3 days after 1st injection and then Bell's Palsy about 10 days later.
After getting  the second Covix vaccine. I experienced intermittent  numbness and tingling in both arms. over time, the left arm got better  but I continue  to get the numbness  and tingling on and off throughout  the day I. my right arm.
DOSE ADMINISTERED AFTER BEING A STORAGE FOR 30 DAYS BETWEEN 2-8 DEGREE C
Took a generic version of Miralax and had anaphylactic reaction and ended up in ER; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Took a generic version of Miralax and had anaphylactic reaction and ended up in ER) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced ANAPHYLACTIC REACTION (Took a generic version of Miralax and had anaphylactic reaction and ended up in ER) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Took a generic version of Miralax and had anaphylactic reaction and ended up in ER) outcome was unknown.        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.  Company Comment: Based on the reporter's description of the event after taking Miralax and the temporal relationship occurring closer to Miralax dosing, the event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the reporter's description of the event after taking Miralax and the temporal relationship occurring closer to Miralax dosing, the event is assessed as unlikely related to mRNA-1273.
Information has been received from a licensed practical nurse concerning an approximately 38 month old patient who on 15-MAR-2006 was vaccinated with a dose of VARIVAX (Merck) (lot# 652456/1019R, route and site of administration not reported). On approximately 12-APR-2008 the patient developed chickenpox, lesions all over body. At the time of reporting, the patient's outcome was unknown. This is one of several reports from the same source. No further information is available.
Didn't feel good; Achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Mar2021 10:00 (Lot number: EN6204, Expiration Date: 30Jun2021) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: She has had asthma since childhood.; "Diabetes mellitus" (unspecified if ongoing), notes: Diabetes; "Over weight" (unspecified if ongoing), notes: Over weight; "Polycystic kidney disease" (unspecified if ongoing), notes: Polycystic kidney disease; "Covid-19", start date: Dec2020 (unspecified if ongoing), notes: She had COVID back in December. It was bad and she was in the hospital and almost died.; "surgeries" (unspecified if ongoing), notes: had all her surgeries. She can not find the one with all her surgeries. . Family history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing); "Stage 4 kidney failure" (unspecified if ongoing), notes: Stage 4 kidney failure. The patient's concomitant medications were not reported.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 09Mar2021, outcome "recovered" (Mar2021), described as "Didn't feel good"; PAIN (non-serious) with onset 09Mar2021, outcome "recovered" (Mar2021), described as "Achy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: information for Chronic lymphocytic leukemia reported as She had a thing where she ended up tearing her rotator cuff and blowing a disk and had to have surgery. They accidentally found in preop test that she had cancer. She would say she was diagnosed approximately 12 years ago. She got the first COVID shot and had pretty mild side effects. She had heard people with COVID reacted pretty bad. She just did not feel good and was achy, started when she woke up the next morning, 09Mar2021. She got the shot at 10AM and was fine that day. She woke up the next day with it.  No follow-up attempts are possible. No further information is expected.
Initial report received from a health care professional on 10 January 2007.  A 5 year old, male patient (with a history of local induration with other vaccines and no known allergies) developed swelling, erythema, induration and pruritus extending from the top of the shoulder to the mid arm anteriorly to the lateral edge of the scapula, within one day of receiving Fluzone (lot number U2169NA) intramuscularly in the left deltoid on 09 November 2006.  It extended posteriorly involving the bicep and tricep area.  It was further described as being "circumferential".  He denied any systemic symptoms.  There were no other vaccines administered at that time or within 4 weeks.  He had no medical conditions and did not have any illness at the time of vaccination.  The reaction was reported to be completely resolved by 13 November 2006.  Follow-up information received on 26 January 2007.  There was no treatment therapy.  The parents are physicians and reported to the reporter on 10 January 2007 that the area was just observed and since there was no systemic reaction, they were not concerned.  This child, as the mother reported, had had localized reaction to other vaccines.  There were no labs/no diagnostics performed.
Severe upper left extremity pain at injection site, Swollen approximate 5 inch diameter around injection site, Warm/ Slight Redness of skin- Prescribed Kflex 500mg (take 2 capsules by mouth twice daily for 10 days), Prescribed Deltasone 50mg (take 1 tablet by mouth daily).
After receiving SHINGRIX vaccine, pt reported serious swelling, redness and pain at the injection site that later developed an itchy rash. She also reported memory loss/difficulty recalling information.
Fever, aches, chills, shaking.   I had a severe case of covid one year ago.
After the vaccine on 12/21/2020 , I experienced mild muscle aches and fatigue. 12/22/2]20,I felt fine. 12/23/2020 at work I experienced an acute onset of nausea and explosive diarrhea.
pt recvd vax & 2 days later exp nausea, fever, back pain, which migrated for 1 wk, arthralgia, inc WBC count; also had a fever of 101;
Injection site seemed fine and pain free in subsequent days after vaccination. Injection site became sore on 4/30/2021 (22 days later) as if the vaccination had just occured.
PATIENT REPORTED HE EXPERIENCED BELL'S PALSY ON 1/22/2021, TWO WEEKS POST 2ND PFIZER COVID VACCINE. REPORTS HISTORY OF BELL'S PALSY.
04/21/2021 ~ 2200 last night developed chills, whole body aches, H/A and nausea Patient states he did have COVID 4 to 5 months ago and H/A is similar to that experience.  Patient denies fever
Child was given adult dose; Child was given adult dose; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 4-year-old male patient who received HAV (Havrix 1440) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th July 2022, the patient received Havrix 1440 (intramuscular) 1 mg/ml and Havrix Pre-Filled Syringe Device. On 18th July 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's comments: The nurse reported that a male child was given the adult dose of HAVRIX today instead of the pediatric dose. She had failed to obtain the patient's initials. The Vaccine Administration Facility is the same as Primary Reporter. Additional supportive information: The patient was given adult dose instead of the pediatric dose, which led to accidental overdose and inappropriate age at vaccine administration.