chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient' medical history and concomitant medications not reported. The patient previously received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization and experienced high temperature/fevers. On an unspecified date, patient had discomfort in the right kidney and tachycardia. Reportedly, to date he continues to present these symptoms. He mentioned the pain in the kidney is frequent and greater; while tachycardias are also more frequent and particularly when he is in motion. The outcome of the events: not recovered.
Vaccine administered at 1 p.m. At 3 p.m. patient c/o "itchy" and "rash" to both arms, left upper arm red and hot to touch, no reaction at injection site, c/o nausea, no respiratory distress. Pt received Benadryl 25 mg PO, and Pepcid 20 mg PO at 3:25.
Arm was extremely sore the night of the injection but wore off.  About a week and half after the injection my left arm started itching extremely bad and broke out in a rash.   I applied Hydrocortisone Cream to the area several times a day.    This went on for about a week and left.   I've had no further problems than the arm itching very badly and rash where the injection site was.
Developed fever on the day of vaccination; followed by seizure (febrile seizure) next day (01/11/2011). Child was evaluated and treated in E/R and discharged home.
Rash; High temperature; This case was reported by a nurse via call center representative and described the occurrence of generalized rash in a 5-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number YD5RS, expiry date 30th August 2019) for prophylaxis.   On 8th April 2019, the patient received Pediarix (intramuscular) .5 ml. On 11th April 2019, 3 days after receiving Pediarix, the patient experienced generalized rash and high temperature. On an unknown date, the outcome of the generalized rash and high temperature were unknown.   It was unknown if the reporter considered the generalized rash and high temperature to be related to Pediarix.  Additional details were provided as follows:  The patient was administered Pediarix in left deltoid. The patient developed a rash on his forehead and now he was completely covered with rash from forehead to his toes.  Patient had a temperature of 99.3 degrees F. Patient visited the doctor's office on 12th April 2019 for his rash. No further details were provided. There is discrepancy in vaccination date, as per field it was mentioned as 8th April 2019 however in source document narrative it is 4th April 2019. In worst case scenario we are considered as 8th April 2019 with lesser TTO.
No known adverse event. Vaccine given 1 day after 31-day beyond use date from transport. Vaccine expires in December but refrigerated 32 days before vaccine given.
Insomnia, acute pain in the right arm, pain in the whole body on the second day.
sometimes blackouts; vaginal atrophy; lots of dizziness; runny nose; really bad fatigue; lots of muscle aches; chills; This spontaneous case was reported by a nurse and describes the occurrence of LOSS OF CONSCIOUSNESS (sometimes blackouts) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (sometimes blackouts) (seriousness criterion medically significant), ATROPHIC VULVOVAGINITIS (vaginal atrophy), DIZZINESS (lots of dizziness), RHINORRHOEA (runny nose), FATIGUE (really bad fatigue), MYALGIA (lots of muscle aches) and CHILLS (chills). At the time of the report, LOSS OF CONSCIOUSNESS (sometimes blackouts), ATROPHIC VULVOVAGINITIS (vaginal atrophy), DIZZINESS (lots of dizziness), RHINORRHOEA (runny nose), FATIGUE (really bad fatigue), MYALGIA (lots of muscle aches) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  Company Comment : This case concerns a 40-year old, female subject with no relevant medical history, who experienced the serious unexpected event of loss of consciousness and other non-serious expected/unexpected events. The events occurred unknown number of days after the second dose of mRNA-1273 vaccine. Rechallenge is not applicable as no information about adverse event/s and its/their resolution following the first dose is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 40-year old, female subject with no relevant medical history, who experienced the serious unexpected event of loss of consciousness and other non-serious expected/unexpected events. The events occurred unknown number of days after the second dose of mRNA-1273 vaccine. Rechallenge is not applicable as no information about adverse event/s and its/their resolution following the first dose is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This case was reported by a physician and described the occurrence of elevated blood glucose in an adolescent female subject who was vaccinated with Boostrix (GlaxoSmithKline).Concurrent medical conditions included diabetes. Previous and/or concurrent vaccination included unspecified vaccines given the same day as Boostrix. On an unspecified date the subject received 1st dose of Boostrix (.5 ml, unknown). At an unspecified time after vaccination with Boostrix, the subject experienced elevated blood glucose. The reporting physician was contacted on 14 November 2007 regarding the elevated blood glucose that were not reported as severe. No other details were provided. At the time of reporting, the outcome of the event was unspecified.
Sore, swollen arm; Sore, swollen arm; Tired; This spontaneous case was received on 23-Oct-2021 from other non-health care professional (consumer) via the Regulatory Authority  (reference number: SEQW21-04460) and concerned a 74-year-old, female patient.  The patient's concurrent conditions included Grave's disease, hypertension, arthritis,  leaky valve and the patient was allergic to formaldehyde. The patient's concomitant medications were unknown.  On an unspecified day in Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number was not reported.   On an unspecified day in Sep-2020, after receiving Flucelvax Quadrivalent, the patient became tired and her arm was sore and swollen for eight days. The patient did not receive any corrective treatment.  On an unspecified day in 2020, the patient recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  Company comment: A 74-year-old female patient experienced arm pain and swelling along with fatigue after vaccination with Flucelvax Quadrivalent. Due to the lack of information regarding chronology, causality for the reported events is unassessable.; Sender's Comments: A 74-year-old female patient experienced arm pain and swelling along with fatigue after vaccination with Flucelvax Quadrivalent. Due to the lack of information regarding chronology, causality for the reported events is unassessable.
Complex febrile seizure: clenching of mouth, stiff arms, eyes rolled up, with fever of 103.
This case was reported by a healthcare professional and described the occurrence of erythema in a 4-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. Concurrent vaccination included live attenuated measles, mumps and rubella vaccine, live attenuated oral poliomyelitis vaccine (left arm) and varicella virus vaccine all given on 28 March 2007, same day as the 5th dose of Infanrix. On 28 March 2007 the subject received 5th dose of Infanrix at 0.5 ml in the left arm. Two days after vaccination with Infanrix, on 30 March 2007, the subject experienced erythema, swelling and warm to touch at the injection site. The subject was treated with diphenhydramine hydrochloride (Benadryl), acetaminophen and cold compresses. At the time of reporting the events were resolved. The healthcare professional considered the events were related to vaccination with Infanrix. Of note, the reporter had concerns that the events were related to this particular lot of Infanrix.
45-year-old female RN was received a flu shot and COVID shot on 10/05/2021. She reports she after the she developed pain with subsequent drowsiness and intense burning on the ventral surface of her proximal her upper extremities (in the proximity of the biceps brachi) and axilla?s She felt that she felt that her lymph nodes were swollen as well.  She fells that he area is warm as well. She had not had reactions to immunizations previously. She tells me that she has been using Tylenol and Ibuprofen 800. She denies fevers or recent illness. She reports a Hx of Migraine  headaches and uses Rrizatriptan,  Emgality and drospirenone-ethinyl estradiol OCP. She denies possibility of pregnancy or allergies.  She reports a 5/10 constant burning pain with no aggravating factors on the left and a 2/10 constant burning pain with no aggravating factors on the right.
48 hours after injection , site  turned bright red  approx 2? diameter redness,   itchy and painful.  Applied neosporin and symptoms subsided within 8 hours. BUT THEN ON JAN 23  I FELT A SMALL GRAPE SIZE MOVEABLE LUMP ON MY LEFT CLAVICLE,  VACCINE GIVEN IN LEFT ARM. I MADE AN APPT WITH MY INTERNIST WHO ORDERED MULTIPLE TESTS LISTED BELOW
immediately had a seizure within a few minutes after the injection (~5mins). seizure lasted approximately 1 minute and was witnessed by the patient's long-term partner.
Dizziness & NauseaVomiting Narrative: C/O NAUSEA, ASSIGNED TO BATHROOM, VOMITING NOTED; C/O DIZZINESS, BECAME DIAPHORETIC. VITAL SIGNS: BP 151/83 HR 86 O2 100% C/O ACID REFLUX AND NAUSEA; TOLERATED 4 MG PO ZOFRAN
Macular erythematous 1-2mm lesions on trunk, face, extremities;
Started showing redness and a little swelling noted 5/4/16 around noon. Was itching after shot was administered as per mom. Able to have full mobility of (L) upper arm.
Moderna COVID vaccine dose 2 received 1/25/21. Started experiencing L arm pain, fatigue, HA, chills, body aches, chest pressure and SOB on 1/26/21. Could not say whether or not chest pressure and SOB were related to vaccine. Sent to ED same day. ED returned person to work on 1/29/21.
I am currently breastfeeding feeding and since receiving my daughter has a bad eczema flair. I have pictures if needed.
That evening, I began to have difficulty breathing as I did after out of quarantine from COVID. I used my inhaler prescribed to me from having covid in November of 2020. That helped. Then about a week later I started to have leg pain. Not sharp pain, but achey pain in both legs that can not be controlled by Tylenol or Ibuprofen. It has been occurring every few days and some nights like last night are bothersome and I can not sleep well. Also after about a week, I had dryness and redness on the bottom part of my mouth and chin.  In the last week I have had flush on my neck and chest.  It is hot, sometimes causes dryness and pealing and is sometimes itchy.
he has had quite a reaction to it which he did not have to the Moderna shot; He is only 4 years 10 months old but I think they may have provided him the Bivalent booster; overdose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 4-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Jan2023 as dose number unknown (orange cap; booster), single (Lot number: GK1657) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization complete but manufacturer unknown), for COVID-19 Immunization.  The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 28Jan2023, outcome "unknown", described as "He is only 4 years 10 months old but I think they may have provided him the Bivalent booster"; OVERDOSE (non-serious) with onset 28Jan2023, outcome "unknown"; IMMUNISATION REACTION (non-serious), outcome "unknown", described as "he has had quite a reaction to it which he did not have to the Moderna shot".  Additional Information: Reporter stated, "I need to check with you what type of vaccine my son got yesterday at a (facility name withheld). He is only 4 years 10 months old but I think they may have provided him the Bivalent booster and so, I have the LOT# and I am hoping you can check that for me to tell me what kind of shot he did receive and then if in fact it was done incorrectly, then I want to not that for your record.". Reporter stated, "I am sorry, so you can't look that up in your line because if in fact he was given the wrong, then it would be a vaccine safety issue because he has had quite a reaction to it which he did not have to the Moderna shot (COVID-19 Vaccine). So I followed the information in the PDF that I found online to call you. So I just wanted to confirm that I am not going to talk to them and then they are going to make me call you guys tomorrow." So again, on a recorded line I am telling you that I am only filing a safety report if I know what was injected into my son and you are telling me that you are not able to look up for the information which I fully understand. You only have what is available on the screen in front of you. So I will now make another call to Pfizer tomorrow morning and get that information  No follow-up attempts are possible. No further information is expected.
The next day after the shot I took the Band-Aid off and it was red and raising up and oozing so I put steroid cream on it and it took 3 days to dry it out.
This spontaneous report was received from a pharmacy student refers to an 81 year old female patient. The patient had no pertinent medical history and no drug reactions/allergies. On 20-OCT-2016, the patient was vaccinated with PNEUMOVAX 23, intramuscularly, once, lot # M00431 with expiry: 12-OCT-2017. Concomitant therapies included PREMARIN. Subsequently, shortly after vaccination, the patient experienced excessive swelling and redness at the injection site. On 22-OCT-2016, two day post vaccination, the patient sought medical attention - visited physician, and she was given treatment for the events. Outcome of the events and causality were not reported. The lot# M00431 has been verified to be invalid lot number for PNEUMOVAX 23. Additional information is not expected as the reporter did not wish to be contacted.
It definitely packed a punch for me. I'm over the side effect; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (It definitely packed a punch for me. I'm over the side effect) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 3) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 21-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (It definitely packed a punch for me. I'm over the side effect). At the time of the report, IMMUNISATION REACTION (It definitely packed a punch for me. I'm over the side effect) had resolved.            No concomitant medication details was reported.  No treatment medication details was reported.
Headache, Fever, joint pain, muscle pain,shooting pain through both  ears Narrative:
Two weeks after MMR child ran 103 T. He was on Augmentin for an eye infection the week before. In the evening of 06/13/02 his T rose above 104. Was taken to ER. No cause for fever was found.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 54 year old white and non Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 11-SEP-2021) dose was not reported, 1 total, administered on left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-AUG-2021, the patient tested positive for Covid-19 (suspected covid-19 infection and suspected clinical vaccination failure) and was quarantined. Patient lost taste and was fatigued. On 05-SEP-2021, at about midnight and at 15:00, patient went to the bathroom. The patient reported no muscle pain and no bunion pain. The patient had lost taste and smell again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210908708-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient states that immediately after receiving the flu shot she started having pain in her arm and shoulder.  She states that she thought it would get better in 2-3 days but it didn't.  She didn't come to the pharmacy to discuss this until 3 months after receiving the shot.  She describes the pain as one that radiates from her shoulder to her neck.  Patient denies any numbness or weakness in the arm.  She states that she does get better after taking an NSAID or using topical creams like Aspercreme and then applying the Salon-Pas patches.  Instructed patient to see her doctor about it but she stated that she doesn't have an appointment with her PCP until late January.  I advised her to go to the urgent care which she did on 12/28/20.  They did an X-Ray and told the patient that they couldn't see anything on the X-Ray.  They recommended that she see a surgeon to get a MRI. The patient stated that she will call her PCP today and try to get in sooner than her next appointment.
Patient did not experience any adverse reactions to this immunization. Patient was administered a vaccine that expired in 20 Jan 2020. When I originally keyed the vaccines in stock into ASIM's I keyed in 20 Jun 2020. I spoke with the patient 15 minutes after administration and there were not any signs and symptoms of an adverse reaction, but I did notify her that I had administered an expired vaccine and to report any abnormalities in that area.
Foot tingling started about 8 days after injection, quickly went up entire leg (left) went to ER, afterwards noticed same sxs in (R) leg eventually went up both legs to the waistline. No feeling and unable to urinate. Hospitalized 3/22/13.
PATIENT EXPERIENCED HIGH FEVER(103), CHILLS, DIZZINESS, BODY ACHES, NAUSEA ONE DAY AFTER VACCINATION AND ANOTHER EPISODE OF SAME SYMTOMS ONE WEEK LATER. PT TOOK A COVID TEST TO ELIMINATE COVID IT WAS NEGATIVE. SHE HAD A VIRTUAL VISIT WITH MD NEXT DAY. MD LOOKED UP ADVERSE EVENTS ON SHINGRIX AND IT LISTED PATIENTS HAVING THESE TYPE OF SYMPTOMS SHORTLY AFTER VACCINE WITH ADDITIONAL EPISODES UP TO TWO WEEKS AFTER VACCINE.  MD SUGGESTED TO NOT GET THE SECOND DOSE OF SHINGRIX.
pt recvd vax & approx 1 min later pt stated "I dont' feel right - given NH3, however pt lost consciousness (approx 5 mins) & appeared to have petite mal sz;
patient received Kinrix instead of Boostrix.; inappropriate age at vaccine administration; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 51-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 24-AUG-2023, the patient received Kinrix. On 24-AUG-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: patient received Kinrix instead of Boostrix.) and inappropriate age at vaccine administration (Verbatim: inappropriate age at vaccine administration).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 28 Aug 2023: The nurse informed that a 51 years old patient received Kinrix instead of Boostrix.  No side effects reported in the email. The consent to contact reporter was not provided in the email.  51 years old patient received Kinrix instead of Boostrix which led to wrong vaccine administered and inappropriate age at vaccine administration.
influenza vaccine administered approximately 8 pm on 9/25.  At approx. 1 AM on 9/26 Ivette felt warm and dizzy she had frank syncope and also vomited. In the emergency room she was found to be in rapid atrial fibrillation (150/min.)treated with fluids and a cardiazen drip.  She converted to sinus rhythm. 10/5/09 Hospital records and DC summary received for dates 9/26/09 to 9/27/09. DC Diagnosis: Syncopal episode, Atrial Fibrilation with rapid ventricular response.  Presenting symptoms: Pt received flu vaccine. Several hrs later pt. felt flushed, dizzy, and had a syncopal episode lasting several minutes. Pt vomited x1, then felt nausea. In ER pt. found to be in A-fib. Pt tx in ICU. Pt improved and DC the following day. ICD9 codes: 427.31, 276.8, 780.2, 288.60, 272.4