chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 2 days after his second Moderna Covid vaccination, the patient experienced splotchy, rash-like redness extending from area around site of injection down the muscle towards the elbow.  He stated it was itchy but not raised or bumpy and that his arm was slightly swollen.  When he contacted the pharmacy to let us know his symptoms he had been having the reaction for about 4 days total thus far.  He was advised to take an anti-inflammatory and an antihistamine, and to contact his doctor if the reaction worsened or did not improve over time.
diplopia rt trochlear paralysis; 2-3 days p/inject diplopia cleared in MAR93;
Narrative: 08/31/2020 COVID swab, result: not detected COVID infection following COVID vaccine series 01/28, Pfizer, dose#1 04/12, Pfizer, dose #2 administered non-facility 08/05 COVID swab, result: detected 08/05 pt cc; rhinorrhea exposure: unknown 08/05 SARS-COV-2 LINEAGE result: B.1.617.2 08/05 SARS-COV-2 clade result: 21A DELTA
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
EXTREME BREAK OUT OF COLD SWEAT; BEE STING-LIKE PAIN; NERVE PAIN; LOW BLOOD PRESSURE; IRRITABLE; RASH TROUGHOUT BODY; CHILLS; SWELLING AT SITE OF INJECTION; FEVER; NO STRENGTH TO STAND UP; ITCHING; BODY ACHES; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included sepsis, and concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 12:30, in the left arm, for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced no strength to stand up. On 18-MAR-2021, the subject experienced extreme break out of cold sweat. On 18-MAR-2021, the subject experienced bee sting-like pain. On 18-MAR-2021, the subject experienced nerve pain. On 18-MAR-2021, the subject experienced low blood pressure. On 18-MAR-2021, the subject experienced irritable. On 18-MAR-2021, the subject experienced rash throughout body. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced swelling at site of injection. On 18-MAR-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) Low. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 19-MAR-2021, had not recovered from extreme break out of cold sweat, chills, low blood pressure, swelling at site of injection, rash throughout body, bee sting-like pain, nerve pain, and irritable, and the outcome of itching, no strength to stand up and body aches was not reported. This report was non-serious.
Fever 100.4 on 12/22/20 13:33 and vomited x 1 on 12/22/20 s/p COVID-19 vaccine received on 12/21/20 @ 15:22. Acetaminophen 650mg administered 12/22/20 @ 17:44 with resolution of symptoms w/in 1-2 days; Vancomycin 1 gm once and Ceftazidime 2gm once post dialysis also given empirically. Fever & NauseaVomiting. ACETAMINOPHEN 650 MG ONCE, VANCOMYCIN 1 GM ONCE POST DIALYSIS ,CEFTAZIDIME 2 GM ONCE POST DIALYSIS
Pain, inflammation of entire upper arm, joint pain in whole arm, redness. Pain lasted 10 days and then the injection site became itchy. As of 8 June, injection site still red, but there is no pain nor itchy.
Severe body aches so much so it was difficult to walk and even to roll over in bed when trying to rest.  Had a terrible headache that lasted most of the day into mid evening hours. Took 1000mg of Tylenol once in the morning then again early afternoon.
This spontaneous report was received from a physician and a licensed practical nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 28-JUL-2017, the patient was vaccinated with a dose of VARIVAX lot # M046926, expiration date: 28-NOV-2018 (dose and route of administration were not reported) which was reconstituted with sterile diluent (lot # L025374, expiration date: 27-MAR-2018), instead of a dose of ZOSTAVAX vaccine. No adverse effects were reported. Product quality complaint was not presented.
Breakthrough case admission after 3 vaccines Pfizer 4/2/21 Lot# Ew0150;  Pfizer 4/24/21 Lot3 Ew0150;  Moderna 12/20/21 Lot# 067H21A
Moderna COVID-19 Vaccine EUA:  - DIZZINESS/WEAKNESS (01/08-01/10) - VOMITING (01/08-01/09) - HEART PALPITATIONS (01/08-01/10)
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 at 15:00 as dose 3 (booster), single (Lot number: FD7218) at the age of 58 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Low thyroid" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin", notes: known allergies: amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Therapeutic measures were taken as a result of events with Paxlovid.   No follow-up attempts are possible. No further information is expected.
idiopathic transverse myelitis; This is a literature report. This is a literature report based on a Health Authority database analysis.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 10Jan2021, outcome "unknown", described as "idiopathic transverse myelitis". Adverse event summary reported as left side numb three days after vaccination in the left arm; right side weak three days after 2nd vaccine (unknown manufacturer) injected in the right arm. Diagnosed as idiopathic transverse myelitis. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging spinal: T2 signal abnormalities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and temporal relationship, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event Myelitis transverse. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/ drug/event and different patient;
20ARP92 recvd 1st dose of Engerix-B @ 930AM; 1030AM became sick c/o of nausea & chills; 1230PM went home from work; recovered fully & returned to work in 2 days on 22APR92;
Site: Pain at Injection Site-Mild, Systemic: Arm Shaking after-Mild, Additional Details: Arm shaking told patient to do cold compress
Information has been received from a nurse practitioner concerning a 17 year old female with a penicillin allergy who on 06-APR-2007 at 15:00 was vaccinated IM into the right deltoid with the first 0.5 ml dose of the Gardasil. Concomitant therapy included Yaz. Subsequently, the patient fainted. She recovered on an unspecified date. On an unspecified date, the patient was vaccinated with the second 0.5 ml dose of the Gardasil. Subsequently, the patient fainted. She recovered on an unspecified date. Additional information has been requested. Follow-up information indicated that on 06-APR-2007 at 19:00 "three hours after vaccination",  the patient complained of tingling from head to toe, and a "warm feeling" in her head followed by body chills. It was reported that it lasted only seconds. No diagnostic laboratory studies were performed. Additional information is not expected.
Large red rash at injection site, rash was hot and itchy and lasted for 2 weeks
Watery Diarrhea started on 3/19 and continues to go on each morning, up to twice, since 3/19. Contacted Dr. and started taking Imodium AD to see if it helps. I took two pills yesterday, one pill this AM per the directions. Experienced one additional watery bowel movement this morning. Stomach is bloated and uneasy. Watery stools up to twice in am since 3/19. The watery stools are the only issue, with bloating. Still has appetite and feels otherwise, normal. Stomach is the issue.
Patient was given the covid vaccine on mistake, not what he had been consented to be given.  No adverse event noted.  Patient's guardian was contacted and gave consent for him to have received the covid vaccine.  This consenting happened after the fact.
Vaccine was administered at 9:27. Donor was sitting on examination bed in the medical room when the donor had LOC and fell forward from the exam bed and onto the floor. Donor recieved one laceration to his forehead, one to the top of his nose, and a broken tooth. Donor was given ice, and donor was able to put pressure on his nose. The medical staff cleaned the laceration areas, and applied two butterfly strips to the forehead and covered the area with a bandage. The donor refused EMS transport, stated that he will see a dentist/doctor when he leaves the center. Donor stated that he has an incident of LOC while getting his lip peirced on 7/7/13. On initial observation of arm there were no adverse reactions. Donor was able to leave the center unassisted.
Patient had some arm swelling that she stated was about the size of a lemon. Patient returned to pharmacy on 8/8/09 and swelling had gone down.
Lump under skin at vaccination site, red rash around vaccination site (itchy and sore), swollen, sore lymph nodes under left arm. I noticed the swollen lymph nodes a few days before the rash appeared.
On an unspecified date, the pt received 3 injections of Lymerix. It was noted that the pt received the injections on an accelerated schedule (all 1 month apart). Some time later, the pt developed 2 areas of erythema migrans, requiring either an ER or doctor's visit. She received unspecified treatment for Lyme disease. The most recent information received on 6/13/2000, reports the outcome of the event as unknown.
Large area of swelling and erythema in right thigh noted 2 days post adminstration.  Patient unable to bear weight.  Fever X 1 day.
10/4/07 2 hives on chest, 2 hives (L) hand. Took Benadryl 25mg and at night took 25 mg. 10/7/07 To ER trouble swallowing, light headed took Benadryl, Rx Epi pen. More hives 10/8 (5) (L) leg. Still taking Benadryl.
Facial swelling, itching - face, neck itching, erythema neck et face.
This spontaneous report was received from a pharmacist refers to a 23 year old patient. On 25-JUN-2013, the patient was vaccinated with an expired dose of 0.5ml GARDASIL. (lot # 666162/0565Z, expiry date 15-SEP-2012, route was intramuscular). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
The patient received Moderna for the first two doses of the COVID-19 vaccine series and presented to the pharmacy to receive a booster dose of Pfizer BioNTech COVID-19 vaccine.  Patient received the Pfizer BioNTech COVID-19 vaccine for the 3rd dose, so this form is being submitted due to the error of not receiving the primary series of the Pfizer BioNTech COVID-19 vaccine prior to receiving the Pfizer BioNTech COVID-19 booster.
Pt. had 4 inch diameter redness and right deltoid urticarial looking lesion where meningococcal and flu vaccine had been administered. Lesion was pruritic. No respiratory symptoms. Treated with BENADRYL.
Redness, swelling, 95mm by 60mm.  Patient denies nausea/vomiting/diarrhea.  Tender, pain in armpit.
I am currently pregnant with my 5th child, due 01/22/2022. A week after receiving the first dose of the moderna vaccine, my right arm became swollen and itchy ( with a rash present) at the injection site.
Fever 101.5 starting in the evening after receiving immunizations earlier that same day. Treated with Tylenol.
After the Pfizer vaccination, I felt fine for approximately 2 weeks. However, starting around 2 weeks after the shot I experienced severe generalized anxiety along with occasional bouts of panic attacks. The symptoms also included insomnia, difficulty concentrating, feelings of fear and dread. The symptoms peaked for the next 2 weeks and slowly resolved over the next 4 months. After the first Pfizer vaccine, similar symptoms also occurred but at a much lower level. These symptoms caused me to delay my second shot by 6 months.
patient returned to pharmacy to show a localized redness welp on back of arm from injection on friday. advised to put cold compresses on arm and call us if no resolve within 24 hours
Hallucinations, Headache, Arthralgia, Fever, ErythemaMultiform, NauseaVomiting, lower back pain, colored floaters in vision, fatigue, diaphoresis, knot in injection arm Narrative:   Other Relevant History:
Red, itchy, full-body rash with hives starting at the left arm near injection site on Tuesday afternoon and spread overnight progressively from neck to feet.  Worsening throughout Wednesday,  sought Medical treatment on Thursday.  Itching  was maddening.  Prescribed methylprednisolone in a Dosepak and diphenhydramine HCL.
Had a tightness in her throat.; Feeling anxious; Shortness of breath; Fever; Nausea; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Had a tightness in her throat.), ANXIETY (Feeling anxious), DYSPNOEA (Shortness of breath), PYREXIA (Fever) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson COVID-19 Vaccine (Covid-19 vaccine by intramuscular injection (lot number 1805022)) on 12-Mar-2021.  Past adverse reactions to the above products included No adverse event with Johnson and Johnson COVID-19 Vaccine.   On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROAT TIGHTNESS (Had a tightness in her throat.), ANXIETY (Feeling anxious), DYSPNOEA (Shortness of breath), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Felt tired). The patient was treated with IBUPROFEN on 24-Dec-2021 for Adverse event, at a dose of 2 extra strength. At the time of the report, THROAT TIGHTNESS (Had a tightness in her throat.), ANXIETY (Feeling anxious), DYSPNOEA (Shortness of breath), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Felt tired) outcome was unknown.     No Concomitant medication reported. Patient did not experience any side effects after receiving the J and J vaccine. She felt she had been anxious which had made the throat tightness worse. This tightness felt like someone's hands were around her throat. She took  ibuprofen for her symptoms, which made her feel better. She noted that symptom felt worse when she was stressed.
swelling in lymph nodes under left arm, and tissue around collar bone and shoulder. Pt c/o intermittent numbness in entire left arm.
heart palpitations,  pain/twitching/tremors in body (more prevalent on left side of body) dizziness, tingling/feeling of pins and needles (sensation) in  bilateral hands and feet. Tingly/ itchy feeling in face, headache and chills.
Patients mother reports she developed facial numbness and weakness of arms and legs. Evaluated by neurologist, results unknown.
BREASTFEEDING EXPOSURE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, transmammary, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-MAR-2021, the patient experienced breastfeeding exposure. The reporter was not informed that the mother of the patient was lactating, The reporter received a call on 10-Mar-2021 and was informed that the mother of the patient is breastfeeding and would like to know if she could continue breastfeeding after getting vaccinated. No side effect were reported  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breastfeeding exposure was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and breastfeeding exposure as related. Company causality between covid-19 vaccine ad26.cov2.s, and breastfeeding exposure was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210320488-covid-19 vaccine ad26.cov2.s-Breast feeding exposure. 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
Whole left arm was red; This spontaneous case was reported by a pharmacist and describes the occurrence of ERYTHEMA (Whole left arm was red) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Whole left arm was red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Whole left arm was red) outcome was unknown.        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 medication information was reported.
One week following first dose I broke out in a rash covering my entire back. Hydrocortisone was applied to treat. Shortly after the tingling of my hands and feet and burning sensation began. It progressively got worse and moved up the legs and arms sometimes there is tingling around my mouth and cheeks.  A lot of pain in all joints including fingers and toes elbows knees hips.  It has progressively gotten worse. I can?t complete simple daily tasks. When there is activity the symptoms are much worse. Most recently tried Duloxetine. Which got rid of the pain. For about 2 weeks. Now it isn?t working. The rheumatologist  has increased dosage and it  isn?t working. Nothing is working and pain is increasing as of today 8/13/2021
States she felt like she had Covid; felt terrible; very sick to stomach; bad headache; chills; increased temperature; diarrhea; sore arm; she got too sick after the first dose; body aches; reaction; This is a spontaneous report from a contactable consumer (herself). A female patient of unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 29Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The caller stated that she had a reaction after receiving the first dose. On 15Apr2021, she did not want to get the 2nd dose because she was scared. the patient stated that she experienced adverse events like headache, chills, increased temperature, diarrhea, sore arm, and covid-like symptoms. States she felt like she had Covid, states she had Covid 19 around the end of November 2020 and now she knows exactly what it feels like. Started three hours after the first dose, had a bad headache and very sick to stomach, after that she got diarrhea, chills and body aches, felt terrible. Lasted for 7 days. She wanted to do the right thing and cancel the appointment instead of just not showing up. Patient asked she went on the computer and read that if you have had covid, you only need one vaccine, is this true. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Spinal stenosis became so bad that I rapidly became immobile; TSH went up; Spinal stenosis became so bad that I rapidly became immobile; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 28Mar2021 as 2nd dose, single for covid-19 immunisation. Medical history included spinal stenosis from 2009,  thyroid cancer from 2013. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 Immunization. The patient stated, he did not know if there is direct relationship or coincidence. But right after second shot, his TSH went up on 01Apr2021 and he needed to increase his synthroid dose. And his spinal stenosis became so bad that he rapidly became immobile on 01Apr2021. There is no other vaccine in four weeks, no known no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Pt. reported tingling in left palm of hand and fingers on left hand after receiving Hepatitis B vaccine. Pt. advise tingling started about 5 minutes after vaccine administered. Pt. first reported tingling to hand and fingers approx. 6 hours after onset. Treatment by outside healthcare provider offered. Declined.