chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Syncope due to orthostatic hypotension-antihypertensive discontinued  and oral fluids pushed for 24 hours with resolution in symptoms within 48 hours.
with redness going down the side of the arm; left arm where she was injected was red and swollen; left arm where she was injected was red and swollen; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (with redness going down the side of the arm), VACCINATION SITE SWELLING (left arm where she was injected was red and swollen) and VACCINATION SITE ERYTHEMA (left arm where she was injected was red and swollen) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ERYTHEMA (with redness going down the side of the arm), VACCINATION SITE SWELLING (left arm where she was injected was red and swollen) and VACCINATION SITE ERYTHEMA (left arm where she was injected was red and swollen). On 23-Mar-2021, ERYTHEMA (with redness going down the side of the arm), VACCINATION SITE SWELLING (left arm where she was injected was red and swollen) and VACCINATION SITE ERYTHEMA (left arm where she was injected was red and swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was provided.
They had one Pneumovax 23 syringe that had leaked out completely; Her hand (skin) got wet from touching the product; Caller reported not having issues and that she washed hands afterward; This spontaneous report was received from a female patient (nurse) concerning to herself. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date in January 2022 (reported as maybe first week), noted that one syringe of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # U018632, expiration date: 11-JAN-2023) had leaked out completely (syringe issue), but it was nothing visible to determine why  this occurred. It was reported that was the last syringe in the tray and she noted that the bottom of the tray was wet. The patient reported that the skin of her hand got wet from touching the product (occupational exposure to product), but she did not have issues from this and she washed her hands afterward. The patient stated that no other physical defects were identified with the syringe and that any patient received the vaccine.
Slight temporary numbness in left arm; Odd feeling in pit of stomach; Palpitations while attempting to sleep; Sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 03Apr2021 at 17:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included glucose-6-phosphate dehydrogenase (G6PD) deficiency. The patient had an allergy to legumes. Concomitant medications included melatonin (MANUFACTURER UNKNOWN), theanine (L-THEANINE), magnesium (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (MANUFACTURER UNKNOWN) all from an unknown date for unknown indication. The patient previously took aspirin (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 18:00, the patient experienced a sore left arm where the vaccine was administered and slight temporary numbness in the left arm. The patient had an odd feeling in the pit of the stomach and had palpitations while attempting to sleep. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events sore left arm, slight temporary numbness in left arm, odd feeling in pit of stomach and palpitations while attempting to sleep were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Child became suddenly unresponsive for 1 min after waking up from a nap.  Mom stimulated her and called her name and she subsequently "snapped out of it".  Soon after, her eyes swelled and she had a rash on her chest.  She was given benadryl and after 20min the rash completely resolved and she was acting normal again.  Mom read up on reactions and states was like the descriptions of hypotonic-hyporesponsive episodes.
pt recv vax & 16MAY95 pt devel elevated liver enzymes;lab eval on that day revealed SGOT 105;lab eval 28MAY95 revealed LDh 316,alk phos 232 & SGOT 46;lab eval 21JUN95 & 13JUL95 revealed SGOT 47 & creatinine clearance 27
Patient began experiencing heat and redness when he woke up in the morning with some slight pain. Patient made PCP aware but they did not have the "time to see him" so he followed up with urgent care. They advised him to take ibuprofen and benadryl until his symptoms were resolved.
Neck and back pain that patient describes as burning, tingling from base of neck to tailbone.  Patient is treated with cyclobenzaprine.
I didn't notice anything very significant, but I did notice a rash on my hands and my body. I thought it was a heat rash and I thought it was from a new medication for my Arthritis. I went to the doctor, who advised it had to do with the vaccination and I end up with Psoriasis. It started with something small on my hands and I didn't know that was happening to me. So now she is putting me on a new medication name Cosentyx.
51 yo male seen for redness and swelling around ADACEL injection site given at this office last evening during a routine appointment - no similar reactions in the past. No systemic side effects. Plan: Will start MEDROL if worsening redness in AM will start KEFLEX.
Lump at injection site; A spontaneous report was received from a consumer concerning a 36-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lump at injection site.  The patient's medical history, was not provided by the reporter. No Concomitant medications were  reported.  On 06 Jan 2021, few hours prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) in the left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient experienced  lump at injection site. It went away soon. Treatment for the events included  ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.    Follow up: Follow-up received on 11 Jan 2021 included lump at injection site.  On 11 Jan 2021, lump at the injection site came back. Treatment included using a cold press, topical steroid cream, and an antibiotic for his side effect.  The outcome of the event, lump at injection site is 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 event, a causal relationship cannot be excluded.
Patient called on Monday (5/14/2007) and stated that redness at the injection site had developed over the weekend unresolved by 1 dose on Benadryl OTC on Sunday (5/13/07).  Area doubled in size and was warm to the touch upon waking on Monday morning.  Patient was advised the patient to visit a nearby minor care center where she was given prescriptions for a Cephalexin 500mg and Allegra 60mg.  Prescriptions were filled and patient was further counseled regarding the 10 day treatment prescribed. Patient also states she has not felt ill nor has she experienced any pain related to this event.
This non-serious event was reported by a health care professional on 13 January 2009.  This patient is one of a cluster of 20 patients; the other 19 patients are captured in case numbers 2008-03509, 2009-00153 to 2009-00162, and 2009-00164 to 2009-00171.  A patient (demographics not provided) received an injection of FLUZONE SV 2008-2009 (lot number U2762AA); however, the date, route and site of administration were not provided.  On 23 October 2008, the reporter recorded that at an unspecified amount of time after receiving the vaccination, the patient developed throbbing pain, crying and sore arm.  Part of the description of the event was illegible.  The throbbing stopped on 15 October 2008.  It was not reported whether the patient required medical intervention or received treatment.  Outcome was not reported for the other events.  Follow-up information was received from the health care professional on 13 February 2009.  The patient was 48-years-old at the time of the event.  On 23 October 2008, she received an intramuscular injection of FLUZONE in her deltoid.  Later that day she experienced severe throbbing pain in the arm, from the scapula down into the thumb.  This lasted seven hours; the events were considered to be completely resolved within 24 hours.  Treatment medications included TYLENOL and Ibuprofen.  Documents held by sender:  None
could not open her mouth almost like lockjaw; could not chew; face was hot and puffy; face was hot and puffy; might have some fever; This is a spontaneous report from a contactable consumer (Patient himself). An 82-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown, ExpirationDate: Unknown) on 30Mar2021 via unspecified route of administration at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. The patient stated the next morning she could not open her mouth, could not chew, face was hot and puffy, might have some fever also. She took a couple of Aleve, and it went away after couple of days. The patient stated she didn't know for sure if it was related to the Covid-19 vaccine or not. The day that she got the Covid-19 vaccine, later provided as 30Mar2021, she felt fine and never had a sore arm or fever. It was reported that it was almost like lockjaw, that she couldn't brush her teeth or chew. The patient reported that later in the day, the side of her face was all hot and might have been swollen and she took ibuprofen and that the inability to open her mouth went away in a couple of days. The reporter assessed the events as non-serious. The patient reported that she went to the chiropractor a couple of days later and the chiropractor said that he had heard about patients experiencing lockjaw after receiving the Covid-19 vaccine and she looked on Pfizer's website and the AE she experienced was not listed as a side effect. She is just a little concerned as she is scheduled to receive her second dose of the Covid-19 vaccine next week on 20Apr2021. She is afraid that the lockjaw might come back and might be worse. She is just curious if she is the only one that experienced the inability to open her mouth. The patient reported she does not know anyone that had this reaction and it is not listed as a side effect on Pfizer's website. The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Subsequent to inadvertently receiving Flu Shield subcutaneous, the pt developed swelling and bruising at the injection site. One day post vax a diagnosis of cellulitis was made and the pt was treated with Keflex.
pink; swollen; hurts in the muscle; felt tired; Hurt; A spontaneous report was received from a consumer concerning a 64- year old-female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site discolouration,pain,injection site pain,injection site swelling and fatigue.  The patient's medical history was not provided.concomitant medications included,fexofenadine hydrochloride was reported.   On 07-jan-2021,prior to the onset of the events, the patient received their planned dose of mRNA-1273 (lot/batch unknown) through an unknown route on her arm for prophylaxis of COVID-19 infection.  On 17-jan-2021,the patient got her injection site swollen and pink and it hurts in the muscle.she initially got vaccinated she just felt tired and hurt but she got well until the reaction that appeared tonight.No laboratory data was provided.Treatment information included,ice pack was reported.  Action taken with mRNA-1273 in response to the events  was unknown. The outcome of the events  vaccination site discolouration,pain,injection site pain,injection site swelling and fatigue was considered as unknown at the time of the report.
pt felt dizzy a few minutes after receiving vaccine  felt lightheaded and feeling vision darkening and developed dry mouth then staff lowered patient to floor   pt up and was able to lay down in stretcher taken to OBS   dizzy in observation area in tredelenburg given water in OBS aftere adjusted to low fowlers position, feeling better after laying down.  DR at bedside assessing patient. vs reviewed by dr.  pt enc to breathing techniques  given more water and enc to relax. bp elevated  pt states no history but does not have a family dr due to recently moving.  dr remains at bedside   bp cuff changed to left arm and pt sitting dangling at side of bed  bp as noted   dr called clinic to schedule appointment for patient.  pt given information per dr to schedule appointment and given directions to office pt verb understanding.  pt feeling better. ambulated to exit at 1330 without diffiuclty.    vs 1309 bp179/122 hr 115 rr 20 o2 99  1312 bp 174/125 hr 106 rr 20 o2 100  1317 bp 190/110 hr 96 rr 20 o2 99  1322 bp 171/113 hr 99 rr 20 o2 98  1325 bp 155/120 hr 99 rr 20 o2 98
pt recv vax;14 hr later, devel hives, v, chills;also d & stomach ache;1oct94 recovered;27oct94, devel an afebrile resp tract infect;
VARIVAX vaccine provided 7/27/17. One day later had localized RXN of redness/swelling. Pictured on her phone. Then nausea, sore throat, "swollen nodes" (pt. is an RN). Seen today 8/1/17 (Tues) with red pharynx, mildly reddened local area at inj. site. Glands positive or negative. Vitals WNL. HRR SM. Lungs clear - no wheezes. Does not have toxic appearance.
I woke up with a fever and chills and I was dizzy. I put a ice bag behind my head by the cervical spine wrapped in a towel. I also took two aspirin, the fever broke after a few hours. I would have went to the ER or called an ambulance if the symptoms got worse. Muscle aches contained to the next day. This was the first chance I got to report it. I feel okay today.
got really sick; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "C-section" (unspecified if ongoing); "Multiple Sclerosis" (ongoing); "Allergy to band-aids" (ongoing); "Allergy to Latex" (ongoing). Concomitant medication(s) included: OCREVUS (ongoing); BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE] (ongoing); MIRALAX (ongoing). Past drug history included: Betadine, reaction(s): "Allergy to Betadine". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got really sick".  Additional information: On 01Nov2021, patient started therapy with Covid-19 Vaccine Pfizer for Covid. On unknown date, it was reported that patient experienced got really sick.  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) : 4799128
Fever 102 then down to 100 lasted for  5 days.  She also experienced weakness, slight headache, sor ethroat, coughing.  Rash occured last and it lasted for 3 days.  Pt is fully recovered after 1 week.
COVID finally got to my vessels I'm trying to deal with that; COVID finally got to my vessels I'm trying to deal with that; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: REVATIO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID finally got to my vessels I'm trying to deal with that". Clinical course: Caller called in seeking assistance with the medication Revatio. During the call caller stated. Patient was just trying to get well he have had 2 major heart surgeries since patient talked last time. The COVID finally got to patient vessels patient was trying to deal with that. Caller later stated on the call." When we took the Pfizer shot that's what we went with, you guys have helped us.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events drug ineffective and COVID-19 cannot be totally excluded.
PATIENT RECEIVED J&J COVID VACCINE AT 11:15AM ON 5/29/21. WHILE WAITING FOR 15 MINUTES PERIOD AFTER VACCINATION, HE WAS FAINTING AND SAT DOWN ON THE FLOOR IN FRONT OF PHARMACY AT 11:20AM. PATIENT WAS SHAKING. HIS BODY TEMPERTURE TURNED COLD. HIS SKIN TURNED PALE.
intermittent headaches; tiredness; hard lump the size of an egg at the; the injection site is red; injection site is itchy; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse drug reaction (received 1st dose on an unknown date and experienced all the common side effects).   On 31st December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache, tiredness, injection site lump, injection site erythema and injection site itching. On an unknown date, the outcome of the headache, tiredness, injection site lump, injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the headache, tiredness, injection site lump, injection site erythema and injection site itching to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination had headaches, tiredness, a hard lump the size of an egg at the injection site, and the injection site was red and itchy but not blistered. The patient asked whether it is safe to be around 3 month old grandson who was born a few weeks early weighing just over 4 lbs, but was quite healthy. The patient asked how long expect the side effects to last or if necessary at all remain isolated from infants. This case has been linked to US2019AMR238653, reported by the same reporter.
pt experienced severe itching around her face and on the vaccinated arm, the itching became worse over ten minutes and progressed to the inside of her mouth around her lips, she was given 25mg of benedryl and the itching resolved within 45 minutes.
Low grade fever, headache, arthralgias, then swelling, warmth, induration, erythema at the site of administration of vaccine.
pt recvd MMR vax 31MAY91 & following vax pt devel a rash; no further details were provided;
covid test result: Positive; covid test result: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from regulatory authority.  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 15Oct2021 (Lot number: FF2589) at the age of 53 years as dose 3 (booster), single, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and administration date 26Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "covid test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of rhinorrhoea.  Clinical information: Facility where the most recent COVID-19 vaccine was administered workplace clinic. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, patient was tested for COVID-19. Covid test post vaccination. Covid test type post vaccination was unknown. Covid test name post vaccination was home Ag. Device date was 18Jan2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Vaccination Failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and Vaccination failure is : expected. The case will be reassessed further upon receipt of additional information.
Immediately following shot I was fine, next day felt nauseous and extremely exhausted. Lasted for several days. Never felt quite ?normal? until several weeks later. Then end of September my tooth was throbbing. When I finally got in to dentist, end of October, had infection in tooth and needed a root canal. Dentist put me on penicillin for infection. Started the penicillin and got in to endodontist on November 4th. Prior to appointment I noticed rash in my mouth and thought I was having reaction to penicillin but it was not, it was strep throat (while I was on penicillin). Went on Z-pac for strep, got a little better but never fully and went back to walk in and was tested positive again for strep. Put on cefzil. A week later, not feeling well and once again tested and positive again for strep. All measures were taken (never re-used tooth brush, got rid of lipsticks, etc?) Now put on Cefdinir. Just got off 2 days ago and not sure if it?s done what it should be doing. Only time will tell, but what seems to be the case is, once I?m done with prescription, I get tested again because I?m having symptoms and then I have strep once again. Why can I not get this out of me? I had my tonsils removed when I was 20 years old, never had strep since then. Why at 57 am I getting this and can?t seem to get rid of it? Only coincidence is that I had this vaccine. Can you tell me if there could be some correlation?
intern came to help out with the vaccines and processing them, at the store I was floating to. I took out the vaccine from the refrigerator to thaw. I indicated to her as such. But  there were 2 vials( 1 Pfizer+ 1 Moderna) left over from yesterday(12/13) sitting on the other side of the back counter, with a sticker on the bottom indicating the time and date. She thought I already prepared the vaccines and ready to go. So she started giving  vaccines from those vials.  After giving the 3 Pfizer and 2 Moderna vaccines, she realized that it was a bottle from yesterday. She alerted me as such .  None of the patients called back reporting any adverse effects. we reported to out patient care services manager