chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme exhaustion; irritability; menstrual bleeding; cold body that I am unable to warm up; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 44-years-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration, administered in arm left on 04Mar2021 17:30 (at the age of 44 years) as single followed by patient took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported) second dose via an unspecified route of administration, administered in Arm Left on 25Mar2021 17:30 single for covid-19 immunization. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) included insulin aspart (NOVOLOG), atorvastatin calcium, sertraline hydrochloride (ZOLOFT), aspirin [acetylsalicylic acid] taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 02Apr2021 18:00 the patient experienced extreme exhaustion, irritability, menstrual bleeding, cold body that patient was unable to warm up. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Adverse treatment included Increase of Zoloft until symptoms resolve. The outcome of the events was Not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SEVERE CRAMPS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced severe cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe cramps was not reported. This report was non-serious.
Symptoms- Itching, neck, ear  ice pack  was applied to neck Pt was observed for 30 min and released by physician
She got the vaccine and later that evening she got the shakes so bad that the bed was shaking, achy.  the next day same reaction, and had the itchy rash that was 3" down from the shot site and went down near her elbow.  Then, a week after that on 4/4/21 she started getting a rheumatoid flare up which has never had one like this before, which has lasted now about a month.   On 4/9/21 she started with back pain and went to her PCP and diagnosed with a UTI.   You then continued with the same problems, and called her rheumatologist on 4/12/21 and was put on Prednisone.  On 4/14/21 the lower right forearm had a blotch that looked like cellulitis but was not, and felt that it was an allergic reaction/possibly related to the RA flare up.  The flare was in multiple joints and kept moving around.   On 4/22/21 she was started on a 2nd dose of steroids and it didn't work.  Everything has swollen to the point that she had to have  her wedding band cut off due to the extreme swelling on 4/28/21 she had her last pill of steroids.  She ended up getting an IV while in the ER of Methyl prednisolone, which did help her and today she is a different person.  They also gave her a Toradol shot and now on a steroid pack, but this has been almost a month reaction and was having no symptoms before the vaccination.   She does take Humira for her RA.
Patients own words:   I felt fine until 4/11/22. For the next two weeks I experienced low grade temps of about 100 degrees, a temp for me as my baseline temp is 97.8. On 4/11 started the extreme dizziness?had to hang into the walls to walk for about a week although the dizziness persisted for a full six weeks. I avoided driving. Muscle exhaustion (legs tired after doing one set of stairs) and extreme general fatigue lasted a full six weeks also. My body would shut down and multiple naps were needed each day to function at all. I am finally getting back some energy and stamina after two months.
Covid arm. Small rash at the injection site, larger round rash about 4 inches circumference about 4 inches lower than the injection site almost over bicep. Developed the next day to a couple days after the shot, it's itchy, red and a little swollen. It was all over my arm the second day, with my arm being very red and swollen so I assumed that was the immediate reaction/side effect.   A couple days later the new rash position developed and is itchy, a little swollen, and very red. It's a little painful as well.
didnt recieve second dose; Running nose; Fever; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (didnt recieve second dose), RHINORRHOEA (Running nose), SARS-COV-2 TEST POSITIVE (COVID-19) and PYREXIA (Fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didnt recieve second dose), RHINORRHOEA (Running nose) and PYREXIA (Fever). On 17-Feb-2021, SARS-COV-2 TEST POSITIVE (COVID-19) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (didnt recieve second dose) had resolved and RHINORRHOEA (Running nose) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, SARS-CoV-2 test: positive (Positive) diagnosed positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: follow-up received on 22 may 2021.event outcome was added. On 21-Jul-2021: Non significant follow up-Supplemental Follow-up Questions for Report added
bruising at injection site; sharp pain at the injection site, pain that wake me up from my sleep; Crohn's has acted up; colitis has acted up; Sore Arm; A spontaneous report was received from a consumer who was also an 83-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Crohn's and colitis flare-up, sharp pain and bruising at the vaccine site, and sore arm.  The patient's medical history was Crohn's disease and colitis. No relevant concomitant medications were reported.    On 10 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 038K20A) for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient's Crohn's and colitis has acted up. She also experienced sharp pain at the injection site that wakes her up at night. On 23 Feb 2021, the patient's arm is still bruised at the injection site. Treatment details included Tylenol with codeine.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events Crohn's and colitis flare-up, sharp pain and bruising at the vaccine site, and sore arm) was unknown. Patient's follow-up consent is not clear.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the vaccine site pain and bruising, a causal relationship cannot be excluded. Patient referred easily bruising which can be a cofounder. Very limited information regarding the Crohn's and colitis aggravation has been provided at this time.  Further information has been requested.
perpetual cold; Initial information received on 03-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves patient who experienced perpetual cold (nasopharyngitis), after receiving  INFLUENZA VACCINE.  Patient have not had the shot in 20 years and have not had the flu.   Past medical treatment(s), vaccination(s), concomitant medication(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 expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious perpetual cold (nasopharyngitis) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the reporting, the outcome was unknown for the event nasopharyngitis.  There will be no information on the batch number fir this case.
had a fever of 99 F that lasted the rest of the day; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (had a fever of 99 F that lasted the rest of the day) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. # 010M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (had a fever of 99 F that lasted the rest of the day). At the time of the report, PYREXIA (had a fever of 99 F that lasted the rest of the day) had resolved.            No concomitant medications were provided by reporter. No treatment details were provided by reporter.   This case was linked to MOD-2021-290618 (Patient Link).
Diarrhea and vertigo for 3 weeks straight. After being admitted to the hospital and being put on Imodium diarrhea has subsided, been told viral diarrhea can be associated with vaccines. Still having vertigo, feeling more tired an usual and having trouble focusing.
S/P DTaP at L deltoid 8/13/03. Erythema, warmth, and indurations with tenderness occurred later same day. Seen for f/u 8/15/03 with 7" x 4" area of significant induration. Benadryl recommended. Will Rx with ?
Approximately 12 hours after receiving the booster vaccine, I had cold chills, a fever and muscle aches, just generally not feeling well. I was exhausted and unable to get out of bed. Within 24 hours of getting the booster, I started experiencing chest tightness and shortness of breath.
Within 1-2 days after vaccine, he did have chest pain that radiated tothe shoulder. He also experienced some dyspnea. After a few weeks the chest pain moved tothe center chest and progressed .He went to ED 6/20/2021.He was diagnosed with pericarditis
Rash; Itch; hurt arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (hurt arm), RASH (Rash) and PRURITUS (Itch) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced LIMB DISCOMFORT (hurt arm). On 17-Feb-2021, the patient experienced RASH (Rash) and PRURITUS (Itch). At the time of the report, LIMB DISCOMFORT (hurt arm), RASH (Rash) and PRURITUS (Itch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
I had an attack of A-Fib on 10/31 and several attacks after that.  I am being treated for A-Fib.
Localized swelling, mass and lump, right upper limb requires KEFLEX, bacitracin and MOTRIN.
Chills and severe shivering, for about an hour starting at 9:30 pm.  Fever overnight and into the next day, 101 degrees at 6:00 am, 100 degrees at 11 am.
6 X 7cm area of erythema right anterior thigh, 9 X 11cm area of erythema left anterior thigh. No induration, pain or tenderness, only minimal swelling. No fever. Pt cooperative and not fussy or in pain.
Shortness of breath and dizziness within one hour, headache and fever within 24 hours, continuing head ache and body aches into 3rd day following.
4 month old received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 25th August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was 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: 26-AUG-2022 Reporter's Comments: The health care professional (HCP) reported that a 3 month old received the Kinrix. No other reactions were reported. The vaccine administration facility was the same as primary reporter The reporter consent to follow up. Additional Supportive Information: 3 months old patient received Kinrix, which led to inappropriate age at vaccine administration. Note: As per case narrative patients age was given as 4 months but by the calculation form date of birth to vaccination date the patient was 3 month old.
vaccine brand: Pfizer/BioNTech; Vaccine lot unknown: Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 92-year-old male patient received bnt162b2 (BNT162B2 NOS), on 26Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 91 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disorder" (unspecified if ongoing); "Lung disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (Sep2023) and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered", described as "vaccine brand: Pfizer/BioNTech; Vaccine lot unknown: Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative, notes: I was ok tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 21Sep2023 to 25Sep2023. Clinical course: No known allergies.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300317336 same reporter/patient, different drug/event;
Non specific blotchy, red rash 2 hrs after immunization on trunk & Rt side forehead. No rxn injection site.
Patient  Complained of dizziness, denies shortness of breath and/or  chest pain provided fluid and ice pack. Vital signs started, legs elevated. Kept patient for extra time. At 5:30 pm, patient complained of severe headaches, tingling  of extremities, and flushed.  Patient was placed on the floor from chair as a precaution, patient placed on right side position. At 5:45 pm Ems was activated. EMS arrived at 6:01 pm. Patient left on stretcher with sister and siblings on an ambulance.
Bloating; Nausea; Abdominal cramps, it gets worse after she eats or drinks anything; Swelling of Injection site; Redness of injection site; Warmth of Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth of Injection site), ABDOMINAL DISTENSION (Bloating), ABDOMINAL PAIN (Abdominal cramps, it gets worse after she eats or drinks anything), NAUSEA (Nausea) and VACCINATION SITE SWELLING (Swelling of Injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (Allergic to food dye) and Glaucoma. Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for an unknown indication.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmth of Injection site), VACCINATION SITE SWELLING (Swelling of Injection site) and VACCINATION SITE ERYTHEMA (Redness of injection site). On 01-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal cramps, it gets worse after she eats or drinks anything). On 08-Mar-2021, the patient experienced ABDOMINAL DISTENSION (Bloating) and NAUSEA (Nausea). On 21-Feb-2021, VACCINATION SITE WARMTH (Warmth of Injection site), VACCINATION SITE SWELLING (Swelling of Injection site) and VACCINATION SITE ERYTHEMA (Redness of injection site) had resolved. At the time of the report, ABDOMINAL DISTENSION (Bloating), ABDOMINAL PAIN (Abdominal cramps, it gets worse after she eats or drinks anything) and NAUSEA (Nausea) outcome was unknown. Not Provided          Concomitant product included 2 eye drops for glaucoma and over the counter allergy medication..  The side effects redness, swelling and warmth at the injection site only lasted for 48 hours.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
After second dose, developed shingles/Suspected vaccination failure; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 17-May-2022 Reporter's comment: The pharmacist reported that the patient was administrated with the two doses of Shingrix in 2019.  After the second dose, the patient developed shingles. No other adverse event was reported. No lot number and expiration date were provided. It was not known when had shingles, how long it lasted and when it stopped having shingles. The reporter consented to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
ITCHY skin Pins and needles in arms and legs I get feeling like I am being pricked with a pin several times a day in various places on my skin, arms, legs, neck, feet  tired and fatigued difficulty breathing snoring
Child presented today with large area (approx. 10 cm x 10 cm) with induration on left thigh, very warm and tender to touch. Family member reports symptoms started yesterday evening. No fever. No drainage. Will treat with cephalexin for cellulitis and instructed to give BENADRYL. Apply ice 3-4 times daily. May give ibuprofen for pain. Will see patient back for follow-up and evaluation in 2 days. Family member instructed to call with any changes or if child develops fever.
Lingering shoulder pain, constant dull ache. Gets worse if pressure applied long term to arm. Only on right shoulder and emanates from the location of the shot. Occasional numb/tingling, but the major issue is the lingering dull shoulder pain. Scale of 1-10, I would say a 5-6. This has happened since the injection with no real improvement. Typically I will feel sore for a day or two after a shot, but never almost 3 weeks with no improvement.
J96.00 ACUTE RESPIRATORY FAILURE 4/21/2023 LATE EFFECT OF STROKE R09.02 HYPOXIA 4/21/2023 LATE EFFECT OF STROKE
Inappropriate schedule of vaccine administered; rash on both arms and legs; This is a spontaneous report from a contactable consumer, the patient. A 82-year-old female patient 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 19Mar2021 at 10:00 hours (at the age of 82-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number:3758 ) via an unspecified route of administration in the left arm on 19Mar2021(at the age of 82-years-old) as a single dose for COVID-19 immunisation( inappropriate schedule of vaccine administered). The patient had no known allergies to medicines, food or other products. The patient did not receive any medications within two weeks of vaccination. Prior to 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 vaccine within four weeks prior to vaccination. On 25March2021 at 05:00 hours after 7 days of vaccination, the patient experienced rash on both arms and legs. No treatment was received for the adverse event. The clinical outcome of the event rash on both legs and arms were recovering at the time of this report.  No follow up attempts are possible; Information about lot/batch number cannot be obtained.
Few scattered pink spots across b/l forearms. (Appear similar to an eczema-like rash.); Rabies vaccine is r/t vet school; Recent immunization history: 6/1 SinoPharm COVID, initial dose; 6/25 SinoPharm, second dose; 8/22 flu shot; 8/27 Varicella and Tdap; 9/13 rabies vaccine, initial dose; 9/14 started seeing pink bumps; Since then, the bumps are improving daily; Denies breathing change, or swelling in lips/throat/tongue.
When I came home I felt super tried with a runny nose, I took a covid test then I had pcr test came back positive for covid I had a sore throat and exhausted.
Sudden death approximately 24 hours after receiving 2nd COVID vaccine - symptoms unknown - autopsy revealed cardiac disease as the cause of death