chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No specific issues noted. VSAFE asked whether I obtained medical care subsequent to the vaccination. I had two pre-scheduled medical appointments in the week after the vaccination which were unrelated to either COVID or the vaccination itself. In other words, the VSAFE question required a misleading answer; I did get medical care but was not relevant. Suggest that question be reworded. No significant side-effects of the vaccine were noted beyond a sore arm which lasted about a week.
Fever 103 degrees-104 degrees (per mother). No rash, no edema, no fever at injection site. Mother took to ER- Tx with TYLENOL & Ibuprofen piggybacked & cool baths per the ER Dr. order.
Patient stated she awoke in the middle of the night with itchy hands.  She described it as both palmar surfaces were very itchy and red.  She called me at approximately 11:30 am on 11/24/19.  No other areas were itchy and no obvious swelling.  She was advised to take diphenhydramine or loratadine and if worsened conditioned to see a medical doctor.  Follow up with her at 4:15pm she reported palms were better but she also noticed some itching of knees.
The incorrect vaccine was administered, patient was to receive FLUCELVAX 2022-23 PFS 0.5 ml
persistent bilateral calf pain starting about 16 hours after immunization, continuing at least through 1/21/22.
feeling miserable; aches; nausea; dizziness; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling miserable), MYALGIA (aches), NAUSEA (nausea), DIZZINESS (dizziness) and CHILLS (chills) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 939893) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced FEELING ABNORMAL (feeling miserable), MYALGIA (aches), NAUSEA (nausea) and DIZZINESS (dizziness). At the time of the report, FEELING ABNORMAL (feeling miserable), MYALGIA (aches), NAUSEA (nausea), DIZZINESS (dizziness), CHILLS (chills) and PYREXIA (fever) outcome was unknown. Not Provided          No concomitant medications was reported. No treatment information was provided.    This case was linked to MOD-2021-313344 (Patient Link).
Expired vaccine administered. Pfizer was consulted and advise to revaccinate immediately with no timing interval. Parents contacted.
This spontaneous report as received from a 65 year old pharmacist refers to himself. Patient had elevated cholesterol, hypertension and glaucoma. On 20-FEB-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml. Concomitant therapies included LIPITOR, COSOPT and AMLODIPINE. On 20-FEB-2013, immediately after receiving the ZOSTAVAX, the injection site was "puffed up" with fluid from the vaccine. The pharmacist stated that he pressed down on the injection site and the vaccine was eventfully absorbed. The pharmacist reported that the ZOSTAVAX was administered with an insulin syringe with a "5/16 inch" needle length and the vaccine may have been administered intradermally (wrong route of administration). The outcome of injection site was "puffed up" with fluid from the vaccine was reported as recovered on 20-FEB-2012. No other information was available at the time. The relatedness for the event was not reported for ZOSTAVAX. Additional information has been requested.
Pt. with red rash 24 hrs. after administration of vaccines. Red confluent rash upper ext & (R) axilla also in groin extending to thigh lower. No petechiae no pustules - rash not over sites of injection.
He had the vaccine, and had some pain in his arm and a headache.  He woke up Thursday  morning 4/1/21 with severe back pain, spasm, and not able to more.  He did not have this pain before the vaccine.  He did alternate between Ibuprofen and Tylenol for the pain and it did not help.
This spontaneous report was received from a medical assistant and refers to a currently 1 year old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # K015464 with expiration date 09-JUL-2017 (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
A 60-year-old patient presents herself to the vaccination center on July 8, 20022, where she reports that after her first booster in January 2022, she began to have a deep itch several weeks in her anus. She comments that a remedy was placed and I managed to control her itching.
gradually lt deltoid edema w/significant erythema 8x5 area; no tenderness, no restricted motion; venous constriction; warm compresses only as tx;
becoming more severe and then now its spreading throughout entire body on arms thighs legs and chest and belly.; She can't get a good night rest; very itchy and scaling skin; red spots itchy; very itchy and scaling skin; This is a spontaneous report from a contactable consumer (patient).  A 29-years-old female patient received bnt162b2 (Pfizer-BioNtech Covid-19 Vaccine) at 29-years-old, dose 2 via an unspecified route of administration on 29Apr2021 (Batch/Lot Number: EW0171) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications was none. Historical Vaccine included BNT162B2 on 01Apr2021 at 29-year-old for COVID-19 immunization experienced rash on her right wrist (first dose in left arm Lot Number: EW0150). The consumer reported she took first dose on 01Apr2021 and the second dose on 29Apr2021. On 01Apr2021, about a couple of days after the first dose, the patient started getting a rash on right wrist. She took the shot in left arm. And then afterwards it cleared up a little bit but when she took the second dose on April 29th it actually started becoming more severe and then now its spreading throughout entire body on arms thighs legs and chest and belly. The doctor and prescribed topical steroid cream and said it should go away after a few weeks. There's a lot of itchiness especially at night. Kind of bothersome at night and could not get a good nights rest. Its like eczema very itchy and scaling skin. Most of the parts on body, upper arms its red spots and itchy. Hasn't manifested on to the surface of the skin yet. It got worse 21 days after the second shot.  The event outcome was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. In 2018, the patient received a dose of SHINGRIX. No further details were provided. This case has been linked with case US2018183655 (vaccinated with same lot number), reported by the same reporter.
Information has been received from a 78 year old female patient who on 01/16/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645249/1196M).  Concomitant therapy included atorvastatin calcium (LIPITOR) 10mg daily and latanoprost (XALATAN) 0.005% opthalmic administration at bedtime.  Subsequently on 01/16/2003, the patient developed severe pain from her upper shoulder to her wrist.  Unspecified medical attention was sought.  The patient was treated with prednisone 10 mg, diphenhydramine hydrochloride (BENADRYL) and acetaminophen (+) hydrocodone bitartrate (VICODIN) 500mg.  Subsequently, the patient recovered.  No further information is available.
At 0959, patient reported feeling "woozy" to vaccinator. Patient given water and assisted to anti-gravity chair by EMT. Patient reported eating at 0830, no similar reactions with prior vaccinations and no known allergies. Patient denied itchiness, rashes, hives and difficulty swallowing/breathing. Patient given water and crackers. At 1002 EMT assessed patient vitals: blood pressure 90/70 mmHg, pulse 69 beats/minute, and SpO2 96%. Patient vitals reassessed at 1018: blood pressure 90/70 mmHg, pulse 63 beats/minute, and SpO2 99%. Patient vitals reassessed at 1031: blood pressure 90/60 mmHg, pulse 64 beats/minute, and SpO2 99%. P educated patient on signs/symptoms of when to seek emergency care, to follow up with healthcare provider, and to sign up on v-safe.
Itching from head to toe on scalp neck back and hands and leg about a week before time to take the second vaccine. Saw the doctor on 4/20/21.  Being treated antihistamine and steroid cream for Pruritic rash for a time of 10 days.
Chest Pain day after 2nd ModernaVax. Returned to clinical site for evaluation...no blood work or ECG performed
ADMINISTRATION OF EXPIRED  VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 30-MAY-2021 01:00 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210611858, 20210612634 and 20210612779.
9JUN92 9PM temp check by mom; t99.2 R mom gave APAP @ 9PM convuls episode; taken to ER; seen by MD dx ear infection;
Information has been received from a physician concerning a 19 year old female patient with no pertinent medical history and no known allergies who on unspecified dates in 2008 was vaccinated intramuscularly with all three 0.5 ml doses of GARDASIL. The dates of administration and lot numbers were unknown because the patient received vaccine from another physician. Concomitant therapy included ZOLOFT. The patient was told after donating blood this week (approximately 19-AUG-2009) that she had "blood clotting problems". Medical attention was sought via telephone call. There were no lab studies performed. At the time of the report, the outcome of the patient was not reported. Additional information has been requested.
Patient developed a small knot (unremarkable) on left thigh after 4 month shots. After 6 month shots developed significant "knot" linear and horizontal on left thigh with bruising and hyperpigmentation that is present on exam 1 month after shot. Papular lesion over area. Referred to Doctors for evaluation.
My daughter was sitting on her bed watching tv Friday night when she began to feel her top lip go numb. After a few seconds she began to feel her lip blowing up so terrified she immediately ran into my room and told me something was wrong with her lip. As I was looking at her I could see her lip doubling in size right in front of me. I asked what happened she said I don?t know I was just sitting down on my bed when it started happening. I took a closer look at her lips and there was small bumps on the edge of the lip and a knot in the middle of her lip that was getting bigger. My daughter started having trouble talking because of the numbness. I assumed it was an allergic reaction to something but she does not have any food allergies so I could not understand what. My partner suggested I give her some Benadryl and after she took the Benadryl I made her ice her lip for increments of 5 mins until the swelling went down. About 20-30 mins later the lip was still numb but the swelling had gone down. After leaving the ice off for 10 minutes the numbness disappeared.
Palpitations felt. BP 142/77 HR 83.  No SOB.  Vital signs rechecked. BP 140/72, HR 76.  Feeling better. Observed for 30 minutes and released.
pt exp seizure-like shaking then legs got very red; t100.9 p/APAP; No further sz;
Patient had no reported side effects; expired dose administered to a patient; This spontaneous report was received from a nurse, and refers to a 6-months-old patient of unknown gender. Concomitant medications, concurrent conditions and medical history were not reported.  On 11-MAR-2022, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral liquid, in dose 2 ml, by mouth, lot # P028132, expiration date 22-FEB-2022. Lot number P028132 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ). Lot number P028132 does not match any Company product as confirmed by Lot Verification team.. It was reported, that vaccine had no known temperature excursions. Patient had no reported side effects.
Patient reported nausea and stated that she had to sit down. We gave the patient a bottle of cold water and had her sit down in a chair in front of the pharmacy. We monitored the patient for 30 minutes. Patient stated that she felt nauseous and that she did not feel like she can walk to her car. After speaking with a family member who was a nurse, she said she felt better and went to her car after wards.
Patient's first dose was Pfizer & he did not complete the series because his second dose on 11/12/2021 was Janssen not Pfizer.
Information has been received from a physician assistant concerning a male who was vaccinated with hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC). On approximately 29-NOV-2007 the patient developed a severe skin rash. No lot number was given and no further information was provided. Additional information has been requested.
Patient's guardian entered the incorrect date of birth on patient's vaccination form making the patient appear to be 13 years old instead of his actual age of 9 years. The date of birth/age of patient was not verified by the pharmacy and the patient was given an adult dose of pfizer instead of a pediatric dose.
Approximately 15 minutes after vaccine administration, individual experienced a rash & hives on both arms, neck, & chest.  No history of allergy to eggs or Flu vaccine ingredients.  Individual is an RN with known history of Penicillin(rash/hives)& shellfish (hives/anaphylatic shock hospitalization) allergies.  She carries Benadryl & EpiPen with her at all times, so she took some Benadryl and continued to her home.  Did not seek medical treatment.  Symptoms subsided within 30-45 minutes according to her report.  She left a phone message for writer on Infection Control Office phone the following morning reporting the adverse reaction.
PT REPORTS PAIN AND SWELLING IN RIGHT ARM AND SURROUNDING LYMPATIC AREA; SHE HAS TENDERNESS IN HER NECK, UPPER ARM AND BREAST AREA; PT TOOK TYLENOL AND BENADRYL AND IT DID NOT HELP; PT REPORTS REDNESS AND WARM TO THE TOUCH
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated intramuscularly with first dose of GARDASIL (lot number unspecified) 5 years ago, in approximately January 2008 and would be in the office to this week, in approximately January 2013 to received their second dose. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Two weeks after being vaccinated. I had severe chest pains and had food intolerance for 60 days.
Eye inflammation; Mobility decreased; Rheumatoid arthritis aggravated; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated/THE COVID VACCINE MADE OF BROUGHT RHEUMATOID ARTHRITIS TO THE FOREFRONT) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.  Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In March 2021, the patient experienced EYE INFLAMMATION (Eye inflammation). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated/THE COVID VACCINE MADE OF BROUGHT RHEUMATOID ARTHRITIS TO THE FOREFRONT) (seriousness criterion medically significant) and MOBILITY DECREASED (Mobility decreased/ WOKE UP UNABLE TO MOVE). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis aggravated/THE COVID VACCINE MADE OF BROUGHT RHEUMATOID ARTHRITIS TO THE FOREFRONT) and MOBILITY DECREASED (Mobility decreased/ WOKE UP UNABLE TO MOVE) outcome was unknown and EYE INFLAMMATION (Eye inflammation) was resolving.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 61-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after a dose of mRNA-1273. The event is described as a flare up. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Reporter did not allow further contact  Sender's Comments: This spontaneous case concerns a 61-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after a dose of mRNA-1273. The event is described as a flare up. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
"pain is in different areas" (back of the knee in calf area); this morning is worse than yesterday; "swollen, raised, puffy area on his left leg"; "raised veins"; rope- like; "warm to the touch"; Something isn't right here; worried about a possible blood clot; possible varicose veins; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OEDEMA PERIPHERAL ("swollen, raised, puffy area on his left leg"), VARICOPHLEBITIS ("raised veins"; rope- like), SKIN WARM ("warm to the touch"), PAIN IN EXTREMITY ("pain is in different areas" (back of the knee in calf area)) and FEELING ABNORMAL (Something isn't right here) in a 52-year-old male patient who received mRNA-1273 (batch nos. 038B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's medical history was not reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 16-Apr-2021 at 4:00 AM, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced VARICOPHLEBITIS ("raised veins"; rope- like), SKIN WARM ("warm to the touch"), FEELING ABNORMAL (Something isn't right here), ANXIETY (worried about a possible blood clot) and VARICOSE VEIN (possible varicose veins). On 29-Apr-2021 at 10:00 AM, the patient experienced OEDEMA PERIPHERAL ("swollen, raised, puffy area on his left leg"). On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY ("pain is in different areas" (back of the knee in calf area)) and CONDITION AGGRAVATED (this morning is worse than yesterday). At the time of the report, OEDEMA PERIPHERAL ("swollen, raised, puffy area on his left leg"), VARICOPHLEBITIS ("raised veins"; rope- like), SKIN WARM ("warm to the touch"), PAIN IN EXTREMITY ("pain is in different areas" (back of the knee in calf area)), FEELING ABNORMAL (Something isn't right here), ANXIETY (worried about a possible blood clot), CONDITION AGGRAVATED (this morning is worse than yesterday) and VARICOSE VEIN (possible varicose veins) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No treatment medications were reported Action taken with mRNA-1273 in response to the events were Not Applicable
Experiencing irregular heartbeat during intense cardiovascular exercise; symptoms remain for 5-10 minutes after ceasing exercise.