chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight arm soreness; head ache; fever (100 degrees); This is a spontaneous report from a contactable other healthcare professional (patient). A 19-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number: EI3302; Expiration date was not reported), via an unspecified route of administration in the left arm on 12Feb2021 04:45 PM (at the age of 19-years-old) as dose 1, single for COVID-19 immunisation at a workplace clinic. The patient's medical history was not reported. The patient has no concomitant medications. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient experienced slight arm soreness, head ache and fever (100 degrees; unit: unspecified) on 13Feb2021 01:00 PM. No treatment was received for the events. The outcome of the events was recovered on 14Feb2021.
24OCT95 OV rt arm area of inj burised, below large red, swollen, inc temp;pt c/o itching;leaving town today;DPH gor discomfort of itching;
Headache chills nausea dry heaves extreme lethargy. Diarrhea cramping for 6 days
Tdap and PPV23 administered. Approximately 12h later, patient experienced subjective fever/chills, erythema, warmth at vaccine site. Symptoms persisted for 2-3d prior to presenteation to ED. ED diagnosed cellulitis- treated patient with oral abx, antiinflammatories.
Rheumatoid arthritis flare up; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 50-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.    No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant) and HERPES ZOSTER (Shingles). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and HERPES ZOSTER (Shingles) had not resolved.            No concomitant medications were reported. It was unknown if 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 50-years-old female patient with relevant concurrent medical condition of Rheumatoid Arthritis that was treated with ADALIMUMAB (HUMIRA), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up). The event occurred on an unknown date in context to second dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was not resolved. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a 50-years-old female patient with relevant concurrent medical condition of Rheumatoid Arthritis that was treated with ADALIMUMAB (HUMIRA), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up). The event occurred on an unknown date in context to second dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was not resolved. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
After first dose:  swollen armpit for a week. Could not keep my arm close to the body from swelling: also had ?Covid arm? on the site of the vaccine, itchy and painful.  Second dose: Fever (101 and above) for 7 days straight. Was taking over the counter medicine to lower it. Severe headache- never experienced anything like that before Shortness of breath- could barely finish my sentence  Extreme body pain - head to toe  Fatigue. minor  symptoms: Congested nose Pain under eyes . My symptoms lasted 7 days, I was in agony for a whole 7 days. They went always ?completely? in about 2 weeks. After vaccination: I tested positive for an autoimmune disease - investigating now what it is that I have. I do have heart palpitations that didn?t go away even after 6 months. My VO2 level went down  to a ?below average? level, even though I am active and work out on a regular basis. Struggling to bring it back up.  I do not want a third dose. I am scared to get it.
Immediate, sharp, shooting pain at time of vaccination that has continued for 2 weeks now. It has lessened but pt still reports shooting pain when she moves her arm in a certain way and she has limited range of motion. Appears this may have been injected too high.
Chills; Aches; Very tired; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6203), via unspecified route of administration on left arm on 12Mar2021 (at the age of 57-year-old), as a single dose for COVID-19 immunisation. Medical history included Penicillin allergy. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and vitamin C (MANUFACTURER UNKNOWN) for unknown indication from unknown date. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: el3247) via unspecified route of administration on left arm on 17Feb2021 for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 at 11:30, the patient experienced chills, aches, and became very tired. The patient did not receive any treatment for reported events. The clinical outcome of reported events chills, aches and tiredness was recovered.  No follow-up attempts are needed. No further information is expected.
Redness, Itching, Very Swollen - all signs still present one week later-11/09/2009. Almost 2 weeks later-11/12/2009, still  present "pink" and bruise in the vaccination site.
Diarrhea for about 10 days; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 09:45 (Lot number: 320308 D) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; OXYBUTYNIN; CALCIUM CITRATE. Past drug history included: Erythromycin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Vaccine Administration Time: 08:30 AM, DOSE 2, SINGLE, Batch/Lot No: EN 6205, Location of injection: Arm Right), administration date: 15Mar2021, when the patient was 74 years old, for Covid-19 Immunization; Bnt162b2 (Vaccine Administration Time: 08:30 AM, DOSE 1, SINGLE, Batch/Lot No: EL 9266, Location of injection: Arm Left), administration date: 22Feb2021, when the patient was 73 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 09:45, outcome "unknown", described as "Booster"; DIARRHOEA (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Diarrhea for about 10 days". Therapeutic measures were taken as a result of diarrhoea. Additional information: No other vaccine was administered in four weeks. Patient's concomitant medication included multivitamin. The patient was treated with BRAT diet, Pedialyte, and occasionally with Immodium for Diarrhea. The patient did not have covid prior to vaccination. The patient was not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Patient originally returned to pharmacy on or around 03/15/19 and spoke to another pharmacist to report his arm pain. Patient was advised by other pharmacist to use OTC pain relievers and check back in a few days. I spoke to patient 03/19/19. He states he had a lot of pain when the vaccine was administered and has continued to have pain in the left arm ever since. States he will sometimes has limited range of motion in the left arm if he sleeps on the left side. Patient reports a hard lump at the injection site and states has difficulty with certain activities such as pushing with arm to get out of chair.
Achy; Flu like symptoms; He is tired; A spontaneous report was received from a  Consumer concerning a male patient of unkown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like achy, flu like symptoms and he was tired.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 17/Feb/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: if reported or unknown) for prophylaxis of COVID-19 infection.  On date or an unknown date, The patient experienced the events like achy, flu like symptoms and he was tired.    Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was unknown.
Tingling in right foot and leg; Numbness in right foot and leg; This is a spontaneous report from a contactable consumer, patient. A 33-year-old non-pregnant female patient received BNT162b2(PFIZER-BIONTECH COVID19 mRNA VACCINE; Lot number: ep7534) on the right arm as a first dose on 20Mar2021 at 12.45(at the age of 33 years old) for COVID-19 vaccination. The patients medical history was not reported. No concomitant medication was reported. The patient did not have any allergies to medication, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 20Mar2021, the patient developed tingling and numbness on right foot and leg that come and go away . 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 outcome of the event tingling and numbness on right foot and leg was unknown at the time of report.    No follow-up attempts are possible. No further information is expected.
fatigued; sore arm; chills; body aches; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 01Dec2021 (Lot number: FH8027) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Anatomical site: Left arm, Batch number : EL3247), administration date: 18Feb2021, for COVID-19 immunization; Bnt162b2 (DOSE 2, Anatomical site: Left arm, Batch number : EN6203), administration date: 11Mar2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 02Dec2021 10:00, outcome "recovered" (03Dec2021), described as "fatigued"; VACCINATION SITE PAIN (non-serious) with onset 02Dec2021 10:00, outcome "recovered" (03Dec2021), described as "sore arm"; CHILLS (non-serious) with onset 02Dec2021 10:00, outcome "recovered" (03Dec2021), described as "chills"; PAIN (non-serious) with onset 02Dec2021 10:00, outcome "recovered" (03Dec2021), described as "body aches".  Follow-up (09Dec2021): This is follow up spontaneous report from a contactable consumer. This consumer reported in response to Non-Hcp letter sent which included that: Additional information: Lot number for 1st,2nd,3rd are given, anatomical site for both three dose are provided, age of the patient at the time of vaccine is given.  Follow-up attempts are completed. No further information is expected.
patient reported mild tingling/burning in lower lip; symptoms did not worsen during 30 minute observation period; patient denies any additional symptoms; states that she had this same symptom after her first vaccination and that it lasted for about 1 hour
Information has been received from a medical assistant concerning an 18 year old female with a history of Papanicolaou smear abnormal and loop electrosurgical excision procedure who on 26-NOV-2007 was vaccinated with Gardasil vaccine (lot# 659437/1266U) 0.5 mL IM. Concomitant therapy included Kariva. On 27-NOV-2007, the patient experienced dizziness, abdominal cramps and abdominal pain. The patient stated that she "felt like she was going to black out." On 28-NOV-2007, the patient is experiencing hallucinations, dizziness, nausea, and still feels as though she is going to "black out". The patient stated that she has been talking to people that are not there. The physician instructed the patient to go to the emergency room. No further information is available. Follow-up information was received from the medical assistant. As of 29-NOV-2007, the patient had fully recovered from the afore-mentioned adverse experiences and is not symptom free. Additional information has been requested.
RED RING 1INCH AROUND INJECTION SITE; Redness at injection site; ITCHING IN INJECTION SITE; Swelling; knot the size of a walnut; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SWELLING (Swelling), VACCINATION SITE MASS (knot the size of a walnut), INJECTION SITE ERYTHEMA (RED RING 1INCH AROUND INJECTION SITE), INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PRURITUS (ITCHING IN INJECTION SITE) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced SWELLING (Swelling) and VACCINATION SITE MASS (knot the size of a walnut). On 28-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PRURITUS (ITCHING IN INJECTION SITE). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (RED RING 1INCH AROUND INJECTION SITE). At the time of the report, SWELLING (Swelling), VACCINATION SITE MASS (knot the size of a walnut), INJECTION SITE ERYTHEMA (RED RING 1INCH AROUND INJECTION SITE), INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PRURITUS (ITCHING IN INJECTION SITE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
This spontaneous report as received from a nurse refers to a 21-year-old female patient. The patient's medical history was not reported. On approximately 21-MAR-2016 (reported as two weeks ago), the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscular in the arm (lot number not reported). In approximately March 2016, the patient developed redness and swelling of injection-site arm after receiving PNEUMOVAX 23. The patient sought medical attention and received unspecified treatment for the events. The outcome of the events was reported as recovered/resolved (unspecified date in 2016) (also reported as recovering). The relationship between PNEUMOVAX 23 and the events was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Symptom #1) Pain in/around my heart the same day and a few days following 1st vaccine, with sporadic pain throughout the month until the second dose. Upon receiving my second dose, I again felt the same kind of pain the day of the vaccine, and a few days following it. I still get occasional heart pain which seems to be random and not triggered by anything. It quickly passes, so far. I've never experienced this type of pain before. Symptom #2) I experienced deep pain in the vein of my left calf, on the right side of my calf, which lasted for a month or two. One thing I want to note is that I'm uninsured - had I been insured, I certainly would have gotten these issues checked out. They were very concerning. This symptom is also something I've never experienced this before. Symptom #3) I also  developed a lump/blister filled with blood inside my mouth, on the right side of my inner lip. This happened after my first vaccine in April 2021 and lasted for 2 months. At times, it was so large that it was uncomfortable to speak. It finally popped on its own one morning and has since resolved (apart from having what I felt was another blister form not long afterwards. It lasted for several days, but receded.) This is also something I had never experienced before receiving the Pfizer COVID vaccine.
Information has been received from a nurse practitioner (N.P.) concerning a female who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently, "after receiving the vaccination", the patient had a "bad" reaction and made her "sick". At the time of this report, the outcome was unknown. The patient was seen by the N.P. and sought unspecified medical attention. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 57 year old female patient. Patient had no pertinent medical history or drug reactions/allergies. On 04-DEC-2013 the patient was vaccinated with ZOSTAVAX lot # J006832 (expiry date 14-SEP-2014), 0.65 ml (once), subcutaneous. Concomitant therapies included XYZAL and METHIMAZOLE. On 05-DEC-2013, the patient experienced redness, swelling and itching at the injection site. The nurse mentioned that the redness appeared from top of her arm to below her elbow. Lab diagnostics studies were not performed. Patient contacted the office for medical attention. The patient was given TYLENOL, antihistamin for treatment of the events. The outcome of the events was reported as recovering/resolving. Causality assessment was not provided. This is 1 of 2 cases reported (reference not provided). Additional information has been requested.
A non-serious spontaneous report of inadvertently administered H1N1 to a 57yo male with type I diabetes was received from a registered nurse concerning a 57-year-old male. The patient had type I diabetes and no concomitant medication have been reported. The H1N1, Intranasal was administered on 12-Nov-2009. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments were not applicable, and the event is considered resolved.
Noticed redness, swelling and itching early in the morning.  This area kept expanding for about 4 days.  It remains red and itchy at the site of the injection.  I went to the doctors who said it was an allergic reaction and to wait for it to subside.   It has considerably.  I have photos if these would be helpful.
I experienced stiffeness in my left arm. It lasted for months and I still have remnants of it. I believe the shot was administered too high.
Itchiness starting in lower legs, arms, head, and back, started on Thursday, May 20, peaking on Saturday and Sunday, diminishing today, Monday, May 24. No related redness, splotches, or marks. No other symptoms related to shot.
Double Dtap dose to pediatric patient; This case was reported by a physician via call center representative and described the occurrence of accidental overdose in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th February 2023, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On 9th February 2023, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose 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: 09-FEB-2023 Reporter's Comments:  The reporter reported that Infanrix and Pediarix were administered on the same day to a 2-month-old patient.  Lot number and expiration date information was asked but declined. The reporter was consented to follow up. Additional Supportive Information: The patient received Infanrix and Pediarix on same day, which led to accidental overdose.
Eight days post vax, the pt developed an injection site reaction characterized by warmth and swelling extending from shoulder to elbow. A blister formed at the injection site.