chrisvoncsefalvay/vaers-outcomes huggingface dataset:
psoriatic arthritis flare up; right ankles hot; chest throbbing; humira wore off three or four days; Achy; fatigued; MARKETING PROGRAM NAME NOT AVAILIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4334407-00.  A 48 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single, intramuscular, administration date 20Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at unk (citrate free) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "psoriatic arthritis flare up"; JOINT WARMTH (non-serious), outcome "not recovered", described as "right ankles hot"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigued"; CHEST PAIN (non-serious), outcome "not recovered", described as "chest throbbing"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Achy"; THERAPEUTIC RESPONSE SHORTENED (non-serious), outcome "not recovered", described as "humira wore off three or four days". The action taken for adalimumab was dosage not changed.  Additional information- It was reported that the reporter's causality for the events of right ankles hot, fatigued, psoriatic arthritis flare up, chest throbbing and HUMIRA wore off three or four days before next HUMIRA injection with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the events of fatigued and achy with HUMIRA (ADALIMUMAB) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
This spontaneous report as received from a female patient of unknown age, who was also a pharmacist, via a company representative, and refers to herself. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and site of administration, lot # and expiry date were not reported) for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown). On an unknown date, reported as long time ago, the patient experienced shingles. On an unspecified date, the patient recovered from the event. The relatedness between shingles and the suspect therapies was not provided. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA008044.
soreness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (soreness). At the time of the report, ARTHRALGIA (soreness) outcome was unknown.            No concomitant medicines were reported Treatment information was not provided   Reporter did not allow further contact
w/in 12hr vax & devel a large amount of swelling & redness @ the site of vax;pt recovered;
The patient has a history of dementia. She was brought to the ED by EMS on 4/13/23 for evaluation after a witnessed fall that occurred at her memory care facility. Staff notes the patient "crumpled" to the ground and hit her head. They felt she was generally weak. On arrival to the ED, she was found to have a low grade fever. A rapid COVID PCR test resulted positive in the ED. Ultimately, she was admitted 4/13/23 - 4/20/23. Per the discharge summary, steroids were not indicated during her admission due to patient's stability, proper oxygenation, and normal d-dimer. Of note, the patient has received the primary COVID vaccine series and three boosters.
Patient received Hepatitis A (Havrix) vaccine and yellow fever vaccine on 07/16/2014, both in left arm. On 07/17/2014, patient reports that he received a pneumonia vaccine at another clinic (no further information known about this vaccine) in left arm, and after on 07/17/2014, he reports that his left arm "blew up," and he complained of erythema, edema, and itching of the left arm. Patient reports that he saw his doctor for this problem, and no treatment was required at that visit, as he said his symptoms were improving. By 07/29/2014, patient reported recovery.
Patient received the patient early evening on 8/29/18. On 8/30/18 (mid-day), she experienced inflammation and soreness around the injection site. She attempted to ice the site but it did not get better. On 8/31, around 6:45pm, patient called the pharmacy to complain of swelling and soreness that has not gotten better -- in fact it has spread. She was advised to take some ibuprofen with food. I called her back a couple of hours later and she said the ibuprofen did not help much. The site is still warm to the touch but swelling has not gotten worse but not better either. Will follow up with patient tomorrow.
I experienced COVID-19 after a trip. I took I got tested and was positive. I was sneezing and had a runny nose which started on 10/10/2022. I saw my doctor who prescribed PAXLOVID which helped me tremendously. I am now feeling much better.
No real problems.  A little tired the next day, injection site was a little tender, nothing to speak of.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient nervous/anxiety about shot, patient received shot. Approximately 5 min after vaccine, during patient's 15 min, patient became lightheaded, then fainted. Patient then became responsive less than a minute after fainting. 911 was called at 6:58pm. EMT arrived, took over and patient/mother declined to hospital transportation. Patient left pharmacy on own.
Sisters in same exam room; both due to receive HPV vaccine and Menactra. 12 y/o patient received 1 dose of HPV vaccine in each arm, I'm simultaneously, instead of 1 dose HPV and 1 dose Menactra.
Patient is fully vaccinated. COVID positive on 5/13/2022 at ED visit.  44-year-old female who presents complaining of cough, congestion, sore throat and fatigue.  Patient states that she has been sick for approximately 1 day.  Denies any nausea or vomiting.  Denies any chest pain, leg pain, leg swelling, shortness of breath.  Unknown if any sick contacts. no fever. VSS. SpO2 100%Patient was given Decadron, Toradol, and viscous lidocaine with some relief.She was given prescription for Motrin and Zofran for home.  Quarantine instructions given.  Discharged home.
3.0cm x 3.0cm slightly raised red, hive-like area. States itches slightly warm to touch. No temp.
Low grade temp, Chills, Cramps, feeling tired and week. Took 3 Advil liquid gel and went to bed. No reaction the next day (back to normal).
Side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received and experinced adverse event.
Chills, low grade temperature, headache, very tired, arm soreness for days, body aches, bloody nose(the day after vaccine I had pinkish discharge from left side of nose that lasted 8 days. On day 11 I had a bloody nose on right side that took approx 15 minutes to stop. Also starting day after vaccine,  breast tenderness and fullness in both breasts..have had this everyday since and still have this.
I spent the first 24 years of my life totally healthy! I lived a very active,  healthy and full life with my husband and 2 dogs.  My health started to decline after my first and second gardasil vaccination but I never questioned that the vaccination caused my problems, I just thought it was a coincidence that the time lines matched up.  I developed Celiac Disease, Hashimotos Disease, severe stomach problems, motility issues, heart burn, anxiety, and neurological problems like neuropathy and parethesia.  After my third and final vaccination I woke up the next morning and had a severe profound fatigue that left me bed bound.  That fatigue never went away.  This time I new it was indeed the vaccination. It has been almost 1.5 years since my last vaccination and my life is completely ruined.  I quit my job, quit school, and spend 90% of my time in bed too tired to even watch TV.  My immune system has been completely ruined and now I have several other bacterial and viral infections I live with.  The gardasil vaccination ruined my, I would give anything to go back in time and undo it.  I think it is also worth noting that when I was 17 years old I had the first and second round of the gardasil vaccination, but I never went back to receive the third.  Then, 7 years later I was told I should restart and get all 3 vaccinations in the 6 months timeline that is recommended.  So I have actually had 5 gardasil vaccinations.
URI 1-2 wks before this started. About October 29 started with leg pain, left first. Seen in ER 11-4-12 with leg pain & limping. Xrays normal -> given MOTRIN. Seen in this office 11-5 and unable to walk at school. Xrays, throat culture obtained. Seen ER 11-9-12 with inability to move muscles without pain sent home. Seen here 11-12-12 - pt incontinent as too much pain to sit & urinate.
Patient reported nausea at 1530 and cold sweats, aches, chills starting at 0200 5March2021.  For 2nd shot in series (8April2021 at 0830am): patient reported nausea at 0430, and cold sweats, aches, chills starting at 0300 on 9April2021).  Patient reports symptoms resolved but continued 'on and off headaches' as of 10April2021.
Information has been received from a published article. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB vaccine, manufacturer batch number, route and site not reported, on unreported dates. This report concerns patient # 28 of 32, a year old male. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A one year old male on an unspecified date was vaccinated with a dose of RECOMBIVAX HB vaccine (lot number, route and site not reported). There was no concomitant medication. On an unspecified date after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of arthritis and injection site reaction. The authors stated the RECOMBIVAX HB vaccine may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB vaccine (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02352, WAES 1004USA02354 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
I received the J&J - Janssen vaccine on July 13, 2021 . In mid August, overnight, I awoke to find my left thumb appearing to b bruised, for no reason... not bluish, but reddish and painful. Didn't give it much thought, but I did snap a pic. In Sept 2021, I awoke again, with excruciating pain in my left foot, inner arch. With the ER's crowded in (LOCATION), I didn't go have it checked, but it also appeared reddish bruised. took 5 weeks to heal, but again, I didn't think of a blood clot. In November, 2021, again, overnight, I awoke with pain in my bum. In going to the bathroom, It appeared to be a soft lump, a hemorrhoid, which I've never had, ever.. and this is when I put all 3 together.
Patient arrives to be seen for tachycardia from the clinic.  Patient was actually there to get seen for hives that she gets occasionally with no known onset because.  Patient says that she gets these hives to go self-directed steroid pack and then go away.  When they were doing her vitals there they noticed that her heart rate was 150.  Patient has no known history of A. fib.  Patient arrives here and seen to be in A. fib on the monitor.  Patient denies chest pain or palpitations but notes that she has been more short of breath with activity recently.  Patient denies history of heart attack cardiac stent or CABG.  Associated Symptoms: itching, rash, shortness of breath
Patient inadvertently received 2 doses of Pfizer COVID-19 < 21 day interval (01/08/2021 and 01/21/2021).
Pain; Swelling; Afraid of Vaccine effects/ Fear of disease; Afraid Vaccination effects; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SWELLING (Swelling), FEAR OF DISEASE (Afraid of Vaccine effects/ Fear of disease) and VACCINATION COMPLICATION (Afraid Vaccination effects) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) . On an unknown date, the patient experienced PAIN (Pain), SWELLING (Swelling), FEAR OF DISEASE (Afraid of Vaccine effects/ Fear of disease) and VACCINATION COMPLICATION (Afraid Vaccination effects). At the time of the report, PAIN (Pain) and SWELLING (Swelling) was resolving and FEAR OF DISEASE (Afraid of Vaccine effects/ Fear of disease) and VACCINATION COMPLICATION (Afraid Vaccination effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  It was unknown if patient was enrolled in clinical trial.  Indication for HUMIRA reported as RHEUMATOID ARTHRITIS, with daily dose. The causality with respect to Humira for the event Fear of disease, Swelling and Pain was reported as Not Reported.  No treatment drug information was provided.
Headache, Diarrhea, NauseaVomiting, tired, chills, left arm pain at injection site Narrative:
patient presented with atypical chest pain, stress test completed and was normal.  tested positive for covid 19 on admission, no treatment required
On 14APR2014, information was received from a consumer on behalf of his cousin. The reporter stated that his male cousin had received the Anthrax vaccine (date, dose, lot# not reported). On an unspecified date he experienced high liver enzyme levels. Subsequently, he died. Date of death, unknown. Cause of death, unknown. Follow up information has been requested.
Swelling of supraclavicle lymph node on left side of body. Lymph node swelled to the size of a pea roughly. It was a bit sore to the touch the first 2 days but over the course of a few days the pain stopped. After about a week and a half the lymph node "disappeared" and went back to normal size. It was no longer visable or feelable through the skin.
Headache, Flu like symptoms, Sore red raised bump on arm at injection site.
9/26/20 received flu shot and developed pain to  left shoulder . Employee called employee health services On 10/15/20 to make and appt to be seen.  Pt dx with left sub deltoid  burtitis on 10/27/20
No adverse effect; Improperly stored vaccine administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUL-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, lot # S003326, expiration date: 02-AUG-2020 (exact dose, site and route of administration were not reported) for prophylaxis. No adverse event was reported. The vaccine experienced a temperature excursion from -9 degrees Celsius to 8 degrees Celsius (-0.4 degrees Celsius) for 20 hours. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001776: US-009507513-1907USA010133:
mildly swollen upper and lower lips, 24 hour onset after vaccine. Also having mild left axillary node enlargement and mild localized redness at the left delt injection site.  Pt received lip fillers slightly over one year ago. She does not remember which brand of name of filler.
Patient notes having chest pain 2/10 after getting vaccination. Vitals were stable, no other symptoms noted. She was observed for 30 minutes and during this time pain completely resolved.
Skin abscess: boil (Right) leg; This spontaneous case was reported by a pharmacist and describes the occurrence of FURUNCLE (Skin abscess: boil (Right) leg) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced FURUNCLE (Skin abscess: boil (Right) leg). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) at an unspecified dose and frequency. On 06-Mar-2021, FURUNCLE (Skin abscess: boil (Right) leg) had resolved.        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 concomitant medication was provided.    This case was linked to MOD-2021-036790 (Patient Link).; Sender's Comments: Bacteria typically cause a furuncle,.  Hence, based on biological implausibility, a causal association with  administration of mRNA-1273 is assessed as unlikely.
Whelps over entire body with itching  1st Benadryl OTC 2nd Steroid injection Dytan bid; medrol dose pack TAD
screaming episode lasting > 3 hrs 500 pm-900 pm on 5Dec90
Heart rate went up right after vaccine injection, presented to the Dr office five days later and pulse from ekg reported 104, 107.  Extreme fatigue, head pressure and diarrhea persisted. Shortly after, facial spasms developed. I experienced fall accident due to the vertigo spells.. i went to the ER on 9/11/21 related to fall. On 9/16, I presented to the ER with head pressure, facial spasm, and weakness. I was given toradol for pain, fluids, decadron for inflammation and magnesium due to loss of electrolytes from diarrhea. It is now almost 4 weeks later, I am still experiencing constant diarrhea, head pressure, vertigo, facial spasm on left side, weakness and fatigue.
On 1/31/2011 received vaccines Varicella, TDAP, Meningitis, seasonal FLUMIST - Mom reported child had chickenpox disease & was req. by school to have vaccine. Lt. upper arm, swollen & reddened size of golf ball hard swelling.
LARGE RED SWELLING, ITCHING AND DISCOMFORT AT SITE LOTS OF COUGHING AND ASTHMA ALL NIGHT THROAT BASE PAIN ACID REFLUX LASTING THROUGH MONDAY.
PATIENT RECEIVED MODERNA VACCINE AND WAS NOT 18 YEARS OLD, SHE WAS 17
Information has been received from a nurse practitioner concerning a couple of patient 's who on an unspecified date was vaccinated with the second dose of VARIVAX (Merck). The nurse practitioner reported that the patients experienced a chicken pox breakthrough. The patients sought unspecified medical attention. Additional information has been requested.
Pt presented to the clinic for 2nd HPV vaccine on 6/22/2022. Checklist reviewed with pt.  Allergy to Motrin was noted at the visit. Pt denied pregnancy at visit. Pt presented to clinic 7/1/2022 stated that they had an at home positive pregnancy test on 7/1/2022.
Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 57-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 397B5) for prophylaxis.   On 30-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter