chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Dose Number 1 and Dose Number 2: Moderna; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 48 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: 30155BA) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Dec2020 as dose 1, single (Lot number: 025J20A) and on 25Jan2021 as dose 2, single (Lot number: 030L20A) for covid-19 immunisation. The patient's relevant medical history included: "Tachycardia" (unspecified if ongoing); "pac/pvc" (unspecified if ongoing); "pac/pvc" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications within 2 weeks. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Oct2021, outcome "unknown", described as "Dose Number 1 and Dose Number 2: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Jan2023 to 11Jan2023.; Sender's Comments: As per the available information the causality of the events interchange of vaccine products, drug ineffective, covid-19 with the suspect can not be ruled out completely.
Patient received Janssen COVID-19 vaccine and presented to observation area. After a few minutes, complained that "her heart felt like it was racing". BP checked: 128/72, P 72 and regular. HRR. Stated she was nervous and maybe she felt like her heart was racing r/t anxiety. Sat uneventful for rest of observation period. Stated she "felt fine" after her 30 minute wait time was over. Ambulated to the parking lot. Clinic staff noticed she did not get in her car, but had her husband pick her up. Staff called patient after clinic and patient stated that "when leaving her eyes felt dizzy and she felt like she couldn't keep conscious".
Received 2nd dose of Moderna vaccine on a Thursday.  At midnight woke up with fever, severe chills, pounding headache, dizziness,  eyes hurt, pain in the lower back,  and nausea.  This continued all through Friday, unable to eat anything, lost sense of taste and bad nausea.  Saturday woke up feeling better, but noticed a rash from neck into stomach.  Called doctor and he suggested taking benedryl every six hours.  If it didn't clear up he suggested prednisone.  Nausea continued through Saturday and Sunday, along with the stomach pain and slight chest pain.  Monday, feeling better but still feverish feeling, slight chest pain.  Rash is gone.
fell to floor from chair, unconscious, face down, p/receiving flu vax from school nurse; yelled loudly, jumped up, threw chair, ran across room swinging @ things;
Improper steps prior to administration/vial was turned up and down a couple times; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PREPARATION ERROR (Improper steps prior to administration/vial was turned up and down a couple times) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (Improper steps prior to administration/vial was turned up and down a couple times). At the time of the report, PRODUCT PREPARATION ERROR (Improper steps prior to administration/vial was turned up and down a couple times) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported. Caller reported that the patient stated, when the vaccine was brought out of the refrigerator, it was not left at room temperature for 15 minutes before it was administered. Also that she felt the bottle was still cold and frosty and that the vaccine provider did not gently swirl the bottle, but they turned the bottle up and down a couple times like they do for the Pfizer Covid-19 vaccine.
11/4 Patient is a 31 year-old G6P4014 at 38.0wga. She presents to triage for contractions and vaginal bleeding. Baby in cephalic position verified by bedside ultrasound. Patient had h/o COVID in 9/2021- treated with remdesevir and steroid.  Currently asymptomatic. No need to re-isolate. Likely not reinfection given that she is asymptomatic and recent history of COVID.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced peripheral swelling ("swollen arms; 4 months ago when I got my shot; arms still swollen"), onset 2021, with outcome of not recovered. Additional information:  Patient got the Pfizer shot (unspecified shot) and his arms swelled-up (ongoing). "4 months ago when I got my shot, my arm almost swelled; and my arms still swollen." Further probing could not be done due to poor connectivity. Limited information available over the call. Expiry date of unspecified shot: Unknown. Follow-up attempts completed. Information about batch/lot number cannot be obtained. No further information expected.
Chills for about a half hour, fever reaching 102 degrees and headache lasting through the night. In the morning I took ibuprofen which brought the fever down and took care of the headache. The fever did not return, but I took another dose of ibuprofen about 5 hours after the first for a returning headache. Today is the 6th and the pain in my arm (injection site) is still fairly intense and especially to the touch.
According to the death investigation report, this 2 month old white female infant was transported to the hospital ER at about 21:21.  CPR was performed by ER service for 30 minutes.  The patient was found unresponsive by her mother at about 20:30 after being put down for a nap on the parent's bed at about 18:30.  The infant was pronounced dead at 21:30 by the doctor.  The doctor estimated the length of time that the infant was unresponsive was from 30 minutes to 2.5 hours.  The said decedent died of Sudden Infant Death Syndrome.  Children in the early months of infancy can often die without any pathological changes seen at autopsy.  The only injury seen at autopsy was a very small dot-like purple abrasion of the chin to the left of the midline.  This injury was the result of blunt trauma and did not contribute to the patients death.  Postmertem blood alcohol test and drug screen were negative.  The manner of death is classified as Natural.
Fever started she was a little fussy & that lasted 3-4 days. Then on 5th day she broke out in rash all over her body & her behavior changed dramaticlly. She screams & is unconsolable. It is a definate im in pain kind of screaming. I have been trying pain relievers but dont seem to help much.
No additional AE/no PQCs.; Nurse reported PROQUAD was administered after TE; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not reported.  On an unknown date in 2023, the patient was vaccinated with an incorrect storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dose, (lot # reported as X007537, which was an invalid lot # for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported as 08-SEP-2024), administered as prophylaxis (strength and route of administration were not provided).  On 19-SEP-2023, the vaccine was exposed to a temperature excursion of 8.1°F, during a time frame of 3 hours. There was no previous temperature excursion. No additional adverse events (AE), no product quality complaint (PQC) were reported.
Fever and Shivering started at 8:00pm on 03/02/2019 (Day 1). Nausea and vomiting started at 8:00pm on 03/03/2019 (Day 2).
p/recv vax pt devel generalized rash, stridor & wheeze; blood in stool; @ time of admit, stridor  intermittent & resolved w/o specific treatment; rash resolved by 24hrs; took enfamil w/iron x2 feeds. prior to 7/16 only breast
Bronchospasm started 1/16/2021 morning, tested with albuterol. Basically resolved by 1/17/2021 evening. Accompanied by aches and fatigue. Covid antigen PCR test NEGATIVE on 1/17/2021.
Fever, irritability, vomiting, poor feeding. Symptoms had onset the day of immunization and have now lasted for 9 days. Required 2 emergency department visits, IV fluids, septic workup and now hospitalization.
Severe chest and left shoulder pain, worse on breathing and leaning forward. Five physicians heard a rub. Responded to Motrin and Colchicine.  Lasted two weeks.
Only had a mild arm discomfort the next day but 5 days later on Tuesday had a general feeling of not feeling well and had an itchy right eyelid. Also got a migraine that evening. The next day I started getting various itchy spots all over my body, mainly distal arms and legs but a few on upper arms and legs and a few on torso. They were intensely itchy spots and I still have one or two pop up now. They seem to disappear quickly especially if they blister and get itched. The injection site never got itchy or red.
10/7/2022 The night after my vaccine I had sweats, headache, nausea and vomiting into the next morning. I was in bed for three days with these symptoms. I called the doctor on 10/8/2022 and my COVID and Flu tests were both negative. I was told to drink a lot of fluids, rest and TYLENOL for headaches. I felt better by 11/13/2022.
Child experience ataxia and jitteriness 3 to 7 days after receiving varicella and MMR vaccinations. This started on 12/25/04. Child was seen in the ER on 12/31/04 and diagnosed with acute cerebellar ataxia, which is improving.
Itchiness and redness on injection site; Itchiness and redness on injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 24Feb2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced itchiness and redness on injection site and he wanted to know if this was normal after getting the vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
13 year old client in for vaccines. Reviewed record and discussed MCV4 vaccine. Family agreed for child to have vaccine. Vaccine drawn up and administered. After vaccine administered was reviewing record with family and noted that child had MCV4 dose 2014 so this was given in error. Informed family right away when mistake was noted. Let them know that client will still need booster dose at 16-17.
Lots of crying. Very red thigh area. Not sleeping very much. Wakes up through the nights
Client received Moderna, 0.5ml, IM in the left deltoid as a Booster dose.
I got the shot and got a very mild case / suspected vaccination failure; got a very mild case; it was so painful??; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient got the shot and got a very mild case of shingles and it was so painful. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible, as no contact details were available.
4:49PM 'FEELS JITTERY - HAVING A PANIC ATTACK'.  A/O, PINK, W/D, RESP WITH EASE. BP 115/77, HR 10,5 R20, 02 SAT 99%.  5PM 'FEELS BETTER'. AMBULATORY TO EXIT - GAIT BRISK AND STEADY. NO ACUTE DISTRESS.  HR 90.
Woke at 4AM with severe itching on March 24. Big splotchy red rash appears on upper thighs, torso, back and upper arms.  Began taking allergy medicine (chlorpheniramine maleate 4 mg tabs) every 4-6 hours for next 3 days. This is the third day and seems a bit better...
Information has been received from a physician concerning a pt (age and gender not given) with an egg allergy who was vaccinated on an unknown date with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not given). Subsequently the pt experienced an adverse event that was not otherwise specified. It was unknown if the pt sought medical attention. Additional info has been requested.
This dose is one week early was due to be given 6/9 dose one Pfizer EW0179 5/19/21 at RCSJ Mega Site only sending this report for documentation at this time.
"Received second at 1520 on 3/24/2021.  At 3/25/2021 at 1600 spike a temp at 101, fever, chills, and mild nausea.  Pt. took 1gm of Acetaminophen.  Repeated at 0030 on 3/26/2021, "fever never broke." temperature went to 101'F and took another 1gm at that time.  0700, fever was back to 101, took a tepid shower, notice rash mid-sternal to nipple line of each breast, red and blotchy, raised, no pruritus.  At 0715 took Benadryl 25mg po, and 1gm of Tylenol again.  Noticed a blanched patch after another a2-3 hours later.  5-6 hours symptoms to start to resolve so no further Acetaminophen taken. No breathing difficulty noted throughout the event.  3/27/2021 everything was resolved, no further issues or Acetaminophen taken."
(R) anterior thigh redness, tenderness, swelling and clear vesicles. Cellulitis of (R) thigh - today Dx of otitis media.
Patient went home, and shortly after arriving at home sat down. While resting, he felt sharp, needle-like pain for a couple of minutes. These were sudden, and dissipated shortly thereafter. Then he noticed his resting HR to be increased by about 20 bpm. He experienced this a few times after this, but none since the second day after the shot. After the second day post vaccine, he started to feel pressure in chest, as if he exited a room temp building and walked out on a hot, humid, summer day. He has experienced this a few times since then.
Significant, warmth, redness, tenderness of (R) arm from elbow to Deltoid.
42 hrs p/shot woke up from sleep screaming & suddenly became limp & felt back asleep; also had a high pitched scream;
Chills; This is a spontaneous report received from a contactable reporter (Consumer).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sinusitis" (unspecified if ongoing), notes: always had allergies before, he probably had allergies before, because he has sinusitis, uses Flonase; "allergies" (unspecified if ongoing), notes: always had allergies before, he probably had allergies before, because he has sinusitis, uses Flonase. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021266075 same reporter/drug/event; different patient
3/18 received Pneumovax, left arm flexor, SQ. That p.m. chills, headache & fever, site warm, red, sore, swollen, achy. Pt complains of bad taste in mouth & lethargy. Motrin, Tylenol & cool compresses at site. Lethargy & "tingling" at times at site continues to date (3/26)
Woke up the day after receiving Moderna 1/2 dose booster with moderate hives on my chest and arms.   Treated with antihistamine and Benadryl gel
New onset seizure disorder/epilepsy. Hospitalized after a MVA caused by a seizure, was in status epilepticus, started on IV keppra, discharged home on PO keppra, now scheduled to follow up with neurologist.
The pt developed a local reaction to the DTaP and MMR consisting of redness and itching. The pt also experienced herpes zoster and dermatomes.
Just like my 1st dose, this 2nd dose made my arm from my elbow to my shoulder very sore starting about 2 hours after the injection. The soreness lasted for 2-3 days, gradually lessening each day. Unlike my 1st dose, this 2nd dose made my whole body experience soreness.  It started with soreness in my neck, lower back, and elbow and knee joints around 10pm (8 hours after the injection). When I woke up the next morning, I struggled to get out of bed and had to call my employer because I couldn't work that day. It was effecting all of my muscles from my neck to my calves. On 2 occassions,  I reached for an item with my right arm (non-injection arm) and had strong cramps where the tricep and shoulder muscle meet. I had to massage the cramps out. I felt like my body had been jolted in a car crash 1-2 days before. This lasted throughout the day and I felt like the soreness, cramping and immobility started to ease up around 9-10pm, So approximately 23-24 hours after it started. The next day (2 after the injection) I hopped out of bed and felt no residual effects, as if nothing had happened the day before. Throughout the day of .muscled soreness and fatigue, I experienced NO fever, chills, or nassea.
head like spinning round and round and like the room is spinning really really fast; Getting really really dizzy and it was hard to even move on that first day, I couldn't even turn my head/couldn't move her head, couldn't turn her tv on; Getting really really dizzy and it was hard to even move on that first day, I couldn't even turn my head; Sick; nausea; I couldn't lay down and I couldn't even get any rest without just getting sick all over again; sick stomach/Upset stomach; Headache; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6200 and Expiration date and NDC number was unknown), via an unspecified route of administration on 18Feb2021 as dose 1, single (at the age of 73-years-old) for covid-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication(s) included moexipril taken for blood pressure measurement, start and stop date were not reported. On 19Feb2021, the day after, the Friday, patient woke up with my head like spinning round and round and like the room was spinning really really fast. Patient was really really dizzy, and it was hard to even move on that first day. Patient stated that it was scary, and patient could not move/turn her head, could not turn her tv on, could not lay down and could not even get any rest without just getting sick all over again. On an unspecified date of 2021, patient experienced nausea and sick stomach/upset stomach. Patient asked if that was normal like she could not lay down to sleep or anything for few days finally, morning she could but she still talks to these other people. But at least patient was able to lay down her head a little bit and get some rest. But she had not been able to do that because she had been so sick and every time, she tries to put any pressure, put her head down to get some, it starts spinning. Patient asked if it was normal and should she receive the second dose, as patient mentioned that she heard that patients had more severe reactions after receiving the second dose. Patient also asked that does the first dose had some antibodies/some protection and would she be able to receive only one dose. Patient was probably 4 foot 9, well let's say 5 feet. Patient used to be 5 foot 2 so she does not know after she get older, but her weight was probably right about a 100 pounds. On an unspecified date of 2021, patient had headache. Patients stated that she does not take treatment for headache, but she does like Tylenol and the Excedrin because she kind of had a headache too and then she took Gaviscon for my upset stomach she took a couple of those. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to an adult patient of 60 or 61 years old (gender was not reported). Concurrent or medical conditions were not reported. On an unknown date, the patient received an improperly stored dose of ZOSTAVAX (dose, strength, route and lot number were not reported). No adverse effects reported. No product quality complain was reported. This is one of two reports from the same source. Additional information has been requested.
Max experienced Angioedema shortly after dinner. Was perscribed 40 mg Prednisone.  The meal was pizza which we have weekly. He does suffer from occasional hives with unknown cause but this is the first event of angioedema.
Extreme fatigue, severe dizziness, possibly fainted for unknown amount of time or fell, nausea, headache, unable to stand without holding on to something.  Symptoms lessened the next day and where gone after 2nd day. Thimerosal free shot was the one administered.
Patient tested positive for COVID-19 after completing the full Pfizer vaccine series, 77 days after 2nd dose.  Patient received 2nd dose of COVID vaccine on 1/17/21.  Tested positive for COVID on 4/4/21.  NOT hospitalized. Likely was exposed through daughter who tested positive for COVID recently.
8/15/18 - 8/19/18 : Agitation, insomnia, screaming in sleep once patient does fall asleep. 8/20/18 - 8/21/18: Agitation, insomnia, screaming in sleep once patient does fall asleep, lack of appetite, rash around neck and scalp, abnormal behavior - banging head against wall. 8/22/18: Agitation, insomnia, screaming in sleep once patient does fall asleep, lack of appetite, rash around neck and scalp, diarrhea. Patient was taken to the clinic 8/22/2018 with complaints of the above symptoms, physical exam was given, Dr. didn't feel medical treatment was necessary. Refused to acknowledge this vaccination has reactions and would not treat patient or run lab tests.
significant swelling, pain, itching in left arm. cough same day sore throat next day