chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination adverse reaction; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) and COVID-19 (COVID-19) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction) and COVID-19 (COVID-19). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) and COVID-19 (COVID-19) outcome was unknown.            No concomitant medication information provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication information provided.  Company Comment: This spontaneous case concerns a 55-year-old patient (gender not specified) with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old patient (gender not specified) with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
pt. recvd. vax & previously suffered needle stick injury & recvd. tetanus vac & hep B immune globulin (human).
Red, warm to touch, and itchy only on the injection site; Red, warm to touch, and itchy only on the injection site; Golf ball size swelling; Red, warm to touch, and itchy only on the injection site; Pain and bruising on the injection site; Pain and bruising on the injection site; A spontaneous report was received from a nurse who was also a 32-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced pain and bruising on the injection site, golf ball sized swelling, red, warm to touch, and itchy only on the injection site.  The patient's medical history was not provided. Concomitant product use was not provided.  On 22 Dec 2020, the day of the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011I20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 22 Dec 2020, the patient experienced pain and bruising on the injection site.  On 29 Dec 2020, the patient experienced newreactions at the injection site that included golf ball sized swelling, redness, warmth, and itchiness. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, pain and bruising on the injection site, were considered resolved on 23 Dec 2020.  The events, golf ball sized swelling, red, warm to touch, and itchy only on the injection site, were considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
He got COVID-19 on 09/22/2023 fever, cough, runny nose, stuffiness.  We had a virtual visit with provider. Then on 11/23/2022 he had mild fever, runny nose. We had a virtual appointment again with provider but did not test positive for COVID-19. Then again on 02/02/2023 he tested positive for COVID-19. He had a high fever of 103.5, lost of appetite.  Also he had conjunctivitis in both eyes. Did another virtual visit and provider prescribed ibuprofen.
The evening that I got the vaccine I noticed tingling in my legs. The next evening I noticed it again including involuntary muscle spasms. Over the course of the week it spread to my arms, back, scalp and face. It was worse when I was at rest but became bothersome all throughout the day. Muscle spasms, tingling and numbness peaked at 7 days after the shot and slowly started to subside. The symptoms are still present present at day 13.
patient got dose one of Shingrix in November of 2022 and has not received dose two.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in November 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient got dose one of Shingrix in November of 2022 and has not received dose two.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-NOV-2023 Pharmacy intern reported that the patient had not received dose two of Shingrix. The healthcare professional could not provide the lot number and expiration date or exact date of vaccination. The reporter consent to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Accidently received 2.5 ml instead of 0.25 ml of Moderna Booster vaccine; Not feeling well; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Not feeling well) and ACCIDENTAL OVERDOSE (Accidently received 2.5 ml instead of 0.25 ml of Moderna Booster vaccine) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2.5 milliliter. In November 2021, the patient experienced MALAISE (Not feeling well). On 17-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Accidently received 2.5 ml instead of 0.25 ml of Moderna Booster vaccine). On 17-Nov-2021, ACCIDENTAL OVERDOSE (Accidently received 2.5 ml instead of 0.25 ml of Moderna Booster vaccine) had resolved. At the time of the report, MALAISE (Not feeling well) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was administered the vaccine on left arm with 2.5 mL instead of 0.25 mL No concomitant medication were provided. No treatment information were given.
Incidental diagnosis of thrombocytopenia during routine physical.  Menorrhagia (excessive menstrual bleeding) Start: 11/15/2004
Light intermenstrual bleeding 10 days after second shot. One day after second shot experienced fatigue and body aches.  Developed a large, swollen circular rash, warm to the touch at injection site, with arm pain.  Pain lasted about 3 days, rash cleared after 7 days.
The morning after having the shot I was up for  about an hour. A pain started in my middle back, left side. It continued for about half an hour, getting more painful, like a badly pulled muscle.  Within 10 minutes my bladder started to feel the pressure that comes with a bladder infection. Urgency to urinate without anything there. It was painful enough to double me over. It continued for about an hour before I went to the local pharmacy and bought AZO, urinary pain relief medication. It has relieved the painful bladder, the pain in my back is still there two hours later.
pt had severe maylagia and fatigue lasting 6 weeks after 1st vaccine.  states symptoms starting to wane and then became severe again after 2nd dose on 3/4/2021.  the symptoms resolved after prednisone was initiated on 03/26/2021
Information has been received concerning a 17 month old male patient with no known allergies, and history of chronically elevated "white count", who on 09/10/2002 at 13:00 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 641720/0351M), and a dose of Haemophilus B conjugate vaccine (manufacturer unknown).  On 09/11/2002 at 16:00 he developed an "allergic reaction (hives)" on his trunk, and had a red warm mass at the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) injection site.  It was reported that over the next 24 hours the hives spread and involved the rest of the trunk, the arms, and face.  The local injection site reaction decreased and consisted of only a "series of small bumps similar to insect bites" within 24 hours.  It was noted he had a very mild fever during this episode.  The hives cleared within 3 days (approximately 09/13/2002).  It was noted the mother has a strong allergic history.  Unspecified medical attention was sought.  Additional information has been requested.
Dry, red area at injection site-25x20 mm. Upper Respiratory Infection symptoms. Body aches. Vesicular reaction-told to keep clean and dry, contact personal physician for further evaluation if needed. Area appears to be healing. Clients symptoms have improved.
angioedema; swollen glands below the jaw; dry mouth; canker sores; thrush; a metal taste in his mouth; swelling of lips, tongue and gums; Rash; A spontaneous report was received from a consumer concerning a 51-year-old, male patient, who received Moderna's COVID-19 vaccine and experienced angioedema, swollen glands below jaw, dry mouth, canker sores, thrush, metal taste in mouth, swelling of lips, tongue and gums.   The patient's medical history was not provided. Concomitant product use was not provided  by the reporter.  0n 06 Jan 2021, prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: unknown)  for prophylaxis of COVID-19 infection.   The patient developed symptoms after the first dose like dry mouth, canker sores, swollen glands below the jaw, swollen tongue, thrush, a metal taste in his mouth, and swollen lips.   On 05 Feb 2021, the patient received the second dose of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. Nothing new happened after the second dose.  On 29 Feb 2021 (the date will be confirmed) he went to ER received steroids, Benadryl and Pepcid. They treated him for angioedema. Most of the symptoms went away except for the swelling of the gums, rash and metallic taste.  The outcome of the events, angioedema, swollen glands below jaw, swollen tongue and lip, dry mouth, canker sores, thrush, swelling of lips, tongue and were resolved. The outcome of the events metal taste in mouth, gums and rash were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Morbid obesity" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient received other medication in 2 weeks. The patient received paxlovid as treatment for covid-19. Treatment start date was 07Jun2022 and stop date was 12Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
10 hours after injection developed redness down Lt arm & tingling Lt. hand - this resolved later at home. The next morning awoke with nausea & vomiting & fever of 101 degrees oral. Parent is giving pt TYLENOL. Dr advised BENADRYL 25 mg Q 6 hr x 24 hrs. Symptoms resolved 1-17-13.
felt tired, had terrible muscle pain, a headache, shivering, fever,  nausea (currently still  not feeling 100% and it's 3 days later)
Pt started Moderna series at clinic. Started and completed Pfizer series at clinic (#05 OH7625)
MD called pharmacy to report redness 3" in diameter under injection site. Pt. reported no fever. I have not seen Pt. Injection was administered in (L) deltoid. Pt. had no reaction to 1st injection. Patient presented to MD office, as reported by Dr. with redness 3" diameter under injection site. The patient had no fever. Since I did not examine patient unsure if actually under injection site. I administered shot and administer all IM shots on lower deltoid to avoid most nerve endings. Patient was advised to monitor over weekend and report any fever to Clinic. RPh.
Patient is a 64 y.o. male patient of CNP with history of hypertension, hyperlipidemia, type 2 diabetes mellitus, diabetic neuropathy, morbid obesity, obstructive sleep apnea, diastolic congestive heart failure, bilateral lower extremity venous insufficiency, severe degenerative disc, lumbar spinal stenosis, right hip osteoarthritis, restless leg syndrome, migraine presented to Hospital with chest pain.   Acute kidney injury Patient had a heart catheterization 9/15 resolved    Cough-  Shortness of breath - resolving COVID-19 infection COVID-positive on admission CTA chest shows mild emphysema, negative PE Isolation S/p remdesivir S/p decadron On RA, no acute signs of respiratory decompensation   Covid-19 Virus Infection Date of onset of symptoms: week prior to 9-12-2023 Symptoms present on admission: SOB chest pain  Date of covid positive test: 9-12-2023 Vaccination status: unknown Imaging: negative  Oxygen requirements on admission: no Current oxygen requirements: weaned  Medical therapy: remdesivir   Episode of nonsustained V. Tach S/ left heart cath - no chest pain Recurrent episode of nonsustained V. tach  Given concern of NSVT and chest pain 30-day event monitor ordered   Chest pain resolved History of HF  Unsure chest pain from cardiac origin versus COVID Troponin negative EKG WNL Continue Bumex 1 mg, metoprolol, lisinopril On 9/15 cardiac cath showed nonobstructive coronary disease and normal LV filling pressures Type 2 insulin-dependent diabetes mellitus Insulin home dose  Keep BG between 140-180    Right hip osteoarthritis Severe physical deconditioning Chronic fatigue syndrome PT OT Tylenol as needed   Hypertension Lisinopril   Dyslipidemia Statin     Restless leg syndrome Requip     morbid obesity Body mass index 49 OSA CPAP   CKD stage IIIa Baseline creatinine 1.6    monitor
Terrible headache. She had very bad aches and pains and the feeling of collapsing. Caller stated that she became very weak and fatigue. Went to urgent care.
Bbeathlessness/gasping for air, slight fever (~1 degree), flushing, amnesia reported for 3-4 days follow shot, eventually had to call 911 due to being unable to breath.
Three weeks after my initial shot (late March 2021), I started to experience vertigo and a thrumming, vibrating sensation in my ears. The vertigo is not the room spinning-type but a bobbing up and down and side to side sensation as if one is on a boat. I continued with my 2nd vaccine shot the following week. The symptoms continue to this day, 7.5 months after my first vaccine shot. None of these symptoms existed prior to receiving the vaccine. Initially, I reached out to my GP in late April 2021 My GP ordered a complete blood work-up and suggested I schedule a visit to an ENT. All of the blood work came back normal. I saw an ENT in May 2021. The ENT initially prescribed a 10-day prednisone treatment along with a 30-day treatment of fluticasone.  Neither resolved the issue. The ENT then referred me to an audiologist who conducted a series of vestibular tests, all of which returned normal results. The tests done in July 2021. The ENT then recommended vestibular therapy. After 3 sessions the therapist terminated my therapy as she was unable to reproduce the symptoms based on the tests available to her. The therapy occurred in late August and early September 2021. In late August 2021, I visited my GP again for further guidance. Another round of blood work was ordered. My GP did notice that my left sinuses were clogged and prescribed a 10-day course of antibiotics and a 5-day course of prednisone. None of these resolved the vertigo or the thrumming sensation in my ears. All blood work came back normal. Upon returning to my GP in October 2021, my GP prescribed an MRI, which was completed in November 2021. I have yet to receive the results of the MRI. My GP also prescribed a 30-day alternating treatment of meclizine and clonazepam. This treatment is going with no meaningful impacts to date.
Malignant Otitis Externa with facial cellulitis with no history of the same and no notable hyperglycemia. Not on Insulin.
This spontaneous report as received from a healthcare worker, (medical assistant (M.A.), also reported as registered nurse (RN)) refers to a patient of unknown age and gender. Medical history and drug reactions or allergies were not specified. On 25-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) injection, lot number K007158, expiration date 12-NOV-2015, 0.5 ml once, subcutaneously, that was stored at 42.9 (also reported as 73) degrees Fahrenheit for 744 hours (temperature excursion date reported as 25-AUG-2014). No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same source. Additional information has been requested.
Patient received injection and sat down in the waiting area with her Mom. Less than 5 minutes after the injection she fainted and appeared to have a small seizure , her mother shouted at her and shook her and she became conscious and vomited. 911 was called , they evaluated the patient and she went to the hospital.
Petechial rash onset bilateral lower extremities 2 days after 2nd vaccine. Labs pending.
Patient reported that about 1 hour after vaccine, he had dizziness, sweating, shaking, weakness and aches. It took almost 24 hours to feel back to normal.
Awakened in AM with hives. The pt saw the doctor on 03/12/2002 and was given Decondron, Medrol dose pack and was agian seen in the office on 03/14/2002 with still visible hives. The pt stated weakness and tiredness. Pt has multiple allergies and is followed by the allergist. Follow up states it is not possible to determine whether this reaction was related to hepatitis A vaccine or not since there is no current recommendation for booster vaccination and patient has received 2 dose of vaccine. Revaccination
Pt received ZOSTAVAX injection 6/17/11 then came down with shingles approximately 3 weeks later on right back. She originally thought it was bug bites.
Initial report was received from another manufacturer on 14 November 2013 under reference number PUS2013US118465 who received the case from a healthcare professional. A patient (gender and age not reported) had received an injection of FLUZONE (lot number, route, site and date not reported) and 1-2 weeks later experienced a seizure. Exact date of seizure was unknown. No other information was provided. Outcome was not reported. Documents held by sender: None.
First dose back in February; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose back in February) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose back in February). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose back in February) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medication provided.
Patient described that a rash started on her face on 06/27/19 in the evening. The rash spread to her left arm and to her calves. Her injection site was red, swollen, and warm to the touch.  Patient reported the rash to the health department on 07/01/19. She stated it no longer appears to be spreading, and she planned to make a doctor appointment on 07/01/19.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild
COVID tested and had COVID; COVID tested and had COVID; Didn't feel well; Upset stomach; Chills; The worst headache of his life; no energy; This is a spontaneous report from a contactable consumer (patient's spouse) under the same suspect products for 2 patients. This is one of the 2 reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the shot on 18Mar2021 and didn't feel well from it over the weekend. The patient started to feel worse and worse. On an unspecified date, the patient got COVID tested and had COVID. Somewhere around the time the patient got his first shot he had been exposed to COVID. He had COVID for 2 weeks. He didn't have to be hospitalized and his oxygen levels were fine. He had all other symptoms except fever, diarrhea, and oxygen depletion. The vaccine was scheduled out far enough and he was past COVID so he could come and get second dose. With the first dose, it is hard to tell what a reaction to the shot was when it was actually coming down with COVID. He did have an upset stomach and chills and the worst headache of his life on an unspecified date. He also had no energy on an unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021461372 same reporter, drug , event; different patient