chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the Janssen COVID-19 Vaccine EUA and within 20 minutes because dizzy and had a mild headache. After about an hour, I became extremely tired and went home from work early and took a 3 hour nap. At about 11:30pm, in addition to the dizziness and headache, I got a fever and body aches, and then had bad fever chills for roughly 8 hours. The next day I had a fever, and the body and head aches remained. My dizziness was more mild, but I found it very hard to concentrate on anything. My fever remained with me for the 3rd day, and was accompanied with nausea. After day 4 arrived, my fever was much more mild, but I still had bouts of nausea throughout the day and evening along with extreme tiredness. I am at day 6, and my only remaining symptom now is the extreme tiredness.
This spontaneous report was received from a pharmacist refers to a 60 year female patient (regarding his wife). The medical history and concomitant medication were none. There was no known allergies. On 13-MAR-2016, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in the left arm. On 14-MAY-2016, the patient experienced right arm and back pain, had no blisters, rash or open areas. On an unspecified date, she saw her primary physician for the right arm and back pain. The physician called on 20-MAY-2016 and stated that the lab work tested positive for shingles. The physician prescribed ACYCLOVIR 800 mg by mouth, 5 times per day for 10days on 20-MAY-2016. The reporter stated that his wife was feeling better since the start of ACYCLOVIR. The reporter accepted VZV packet. The outcome of the events were reported as recovering/resolving. The patient sought medical attention. Additional information has been requested.
A 42 year old FEMALE who received Covid 19 vaccine today, provider was called at  monitoring site due to pt c/o headache after about 10 min of injection and  "throat tightness/scratchy", headache, palpitations. Discussed with patient current symptoms and multiple food allergies. Medications ordered STAT as below. Patient started feeling better of her pharyngeal/laryngeal symptoms after Epipen  inj applied. Headache had improved also. BP rechecked at discharge from monitoring area as below.  TODAY'S ORDERS:     EPINEPHRINE PEN INJ,SOLN   INJECT ONE INTRAMUSCULARLY STAT  Quantity: 1 Box  Days: 1 Refills: 0 *Chronic Med: NO Dispense as Written: YES Indication:  Adverse reaction to vaccine product |    METHYLPREDNISOLONE SOD SUCC INJ,SOLN  125MG/VIAL  INJECT 125MG  INTRAMUSCULARLY NOW *MED GIVEN IN CLINIC OR ER*  Quantity: 1 Vial Days: 1  Refills: 0 *Chronic Med: NO Dispense as Written: YES Indication: Edema of  pharynx |
One day after vaccinations, the pt's mother reported that her daughter developed hives at the injection site.
Thromboembolic event; This spontaneous case was reported by a consumer and describes the occurrence of EMBOLISM (Thromboembolic event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EMBOLISM (Thromboembolic event) (seriousness criterion medically significant). At the time of the report, EMBOLISM (Thromboembolic event) outcome was unknown. Not Provided  The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Thromboembolic events in younger females exposed to Pfizer Bion Tech Covid 19 vaccines or  Moderna COVID-19 vaccines. No Concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comments  This is a spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected, serious, medically significant AESI of EMBOLISM (Thromboembolic event), unknown days after receiving a dose of mRNA-1273 Vaccine in the covid 19 vaccination series. The report concerns about Thromboembolic events in younger females exposed to Moderna COVID-19 vaccines. Details of risk factors, other co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected, serious, medically significant AESI of EMBOLISM (Thromboembolic event), unknown days after receiving a dose of mRNA-1273 Vaccine in the covid 19 vaccination series. The report concerns about Thromboembolic events in younger females exposed to Moderna COVID-19 vaccines. Details of risk factors, other co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
The range of motion of my  right arm is limited. If I stretch it in a certain way, it is painful. I am concerned due to the amount of time it has been persistent .I had pain after the first shot  which lasted a while.
Menstrual spotting after first dose that repeatedly came and went.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received bnt162b2 (Covid 19, Brand Pfizer), dose 1 via an unspecified route of administration, administered in left arm on 08Apr2021 13:45 (Lot Number: ER8730) as single for COVID-19 immunization. Medical history included amenorrhoea and allergy to birth control pills from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced menstrual spotting on 12Apr2021 after first dose that repeatedly came and went with outcome of not recovered. Case reported as serious due to disability. Event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was given for event includes birth control. The patient was not diagnosed with covid prior vaccination and has not been tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Low fever, chills, body aches and pains, headache, Treatment: rest, ibuprofen
Local symptoms:  Pain-discomfort, swelling. General  symptoms: chills, fever, headaches, muscle pains, fatigue, swollen glands Narrative:
This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 59-year-old female patient who received SHINGRIX (batch number 4LP5Y, expiry date unknown) for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient had swelling in the deltoid area which was the size of a tennis ball within 24 hours of vaccination. It was associated with redness and a little pain. The events persisted for 5 to 6 days and fully resolved. There was no streaking, fever, lump or hardness observed. The reporter did not agree to be followed up and did not provide the contact details. For tolerance after 1st dose of SHINGRIX, refer case US2018GSK189804.
No adverse event; Patient received doses of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received doses of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received doses of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received doses of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received doses of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023).    No concomitant medications was provided. No treatment medications was provided. HCP wanted dosing information on patients 6 Months of Age and Older Not Previously Vaccinated with a COVID-19 Vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-721294 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721294:(Patient 2 out of 2)
I was 32 weeks pregnant, I went for my regular check up and received the Tdap shot as recommended. Almost 2 weeks later I went into preterm labor. Then had to have emergency C section due to my daughter's heart rate dropping. I had a healthy pregnancy with no issues before I received the Tdap shot. Although I have no actual proof I truly believe this caused it, after extensive research. I am reporting so late due to not being knowledgeable about vaccine reaction or VAERS.
Mom states baby with unconsolable crying for 3 hours. Started 33 hours after vaccine given. Mom did not report until in for 4 month series.
Approximately 2 hrs. after vaccine, the pain started in my upper back and spread all over body especially in my joints. The symptoms continued for 48 hours.
Information has been received from a neurologist concerning a 13 month old male with no medical history who was vaccinated with varicella virus vaccine live. The neurologist reported that, nine days after being vaccinated, the pt developed a rather severe cerebellar ataxia including a prominent symptom of opsoclonus. A MRI and EEG were both normal. Subsequently, the pt began to improve, being able to pull himself up, which he had not been able to do previously. Upon internal review, cerebellar ataxia was determined to be an other important medical event (OMIC). Additional info has been requested.
Felt very weak, Dizzy, Bad head ache, feeling cold, shaking, crying, went to acute care and was told to take Benadryl and Tylenol and check for fever or difficulty breathing.
Client received varicella and hepatitis B in left arm at about 2:45PM. Client and father returned to clinic at 4:15PM. Father states that within 5 minutes after leaving clinic, client started sneezing and complained of itching at site, around neck and eyes. Upon return to clinic, client had raised, reddened area around varicella administration site about 2cm in diameter. Neck area reddened (not raised). Clients father stated that at this time, all symptoms are much improved. Client denied any difficulty with breathing.
Patient vaccinated 10 September 2009.  Patient reported with flu like symptoms (myalgia, low grade fever, headache) 7 days later, then complained of chest tightness and heavy pressure lasting continuously for several days that was worse with breathing and coughing four days later.  Patient receives Indomethacin 25mg po TID, and Omeprazole 20mg po QD.  He was started on lovenox, asa & integrillin during ICU admittance. 10/2/09 Hospital records received DOS 9/23/09 to 9/25/09 Assessment: Vaccine-Induced Myocarditis. Patient reports substernal chest pain. Flu-like symptoms, myalgia/low grade fever. Several days of chest tightness or pressure, worse with breathing and coughing.
No issues at the time of vaccination. The day after the vaccine I experienced mild typical symptoms associated with vaccination (chills, cold-like); that night I noticed moderate lymphedema to the left axilla only which is painful. It hasn't resolved yet. Note- I'm not concerned about the symptoms but for statistical purposes wanted to report.
Flu shot administered 10/17/15 at 3PM. By 11 PM chills, fever (100.1) general weakness were experienced. Weakness lasted five days along with pain in left arm. Arm extremely sore and felt very heavy.
Patient got covid-19 disease 5 months after he received his Pfizer Covid vaccines; Patient got covid-19 disease 5 months after he received his Pfizer BT Covid vaccines.; This is a spontaneous report from a contactable consumer (patient) via medical information team.  A 66-year-old male patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: not reported) via unspecified route of administration on unspecified date in 2021 as dose 2, single and on 03Mar2021 as dose1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported that patient got covid-19 disease 5 months after he received his Pfizer Covid vaccines. He had his 1st vaccine dose on 03Mar2021. 2nd dose after that. Reporter querying if the efficacy of the Pfizer covid vaccine was 80% up to 6 months after receiving the vaccine series and queried for why he got COVID-19 disease. Patient queried for what are the 6 months topline analysis results of the Pfizer-BioNTech COVID-19 Vaccine. In response to patient query provided information as on 01Apr2021, Pfizer and BioNTech announced an updated topline analysis up to 6 months following second dose of COVID-19 Vaccine Study. on analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) is effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to 6 months after the second dose vaccine was 100% effective in preventing severe disease as defined by the U.S. Centers for Disease Control and Prevention (CDC) and 95.3% effective in preventing severe disease as defined by the U.S. Food and Drug Administration (FDA) on vaccine was 100% effective in preventing COVID-19 cases. where the B.1.351 lineage is prevalent vaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second dose Pfizer and BioNTech plan to share these results with worldwide regulatory agencies soon. The press release is available at:(mail) Please note that the Pfizer-BioNTech COVID-19 Vaccine - Antibody Persistence and Duration of Immunity, has been updated to include the Press Release information. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
CDC VIS was given to EE and consent signed by EE prior to vaccination. MMR given to LUA SQ without difficulty at 1120am. EE stated immediately she felt some shooting sensation up her arm into her neck. EEAAOX4 at this time in NAD. EE remained in nurse office x20 minutes post vaccination; EE talkative, alert during the 20 minute period.  O: At 1142, EE stated "I feel funny"; stated her throat as feeling "tight" and "tongue tingling". O2 sat RA 100% at this time. EE pointed to throat stating beginning to feel pain in her throat area and c/o "metallic taste", feeling "shaky and weak". 1145: BP 153/79 P67 O2Sat 100% RA. EHS Emergency med box available. 1147: 911 called.  1153: BP 132/87 P 61 O2 sat 100% RA; EE remains alert and anxious stating she doesn't feel right, feeling light-headed.  Approx 1155 EMS arrival; EE able to walk with assistance to stretcher. Report given to EMS; EE agreed to EMS transport to ED for further evaluation and tx.
Patient was given a Hep A vaccine at 5 months of age. No adverse reaction was observed.
Went to give patient covid shot, ancillary needle provided wouldn't pierce patient skins. Gave patient the 'husband's' dose and went to go get a new needle for husband's shot. Re-entered pharmacy, got needle, and accidentally gave the patient the second dose intended for husband to her. No signs or symptoms as of 3 hours later from event, had patient sit for 30 min to make sure no reaction - but patient reports none. Will follow up with patient tomorrow approximately 24 hours after event.
Information has been received from a nurse practitioner concerning a 12 month old pt who about 4.5 weeks ago, on approx 10/26/06 was vaccinated with a 0.5ml dose of MMR II/Varicella vaccine. Ten days after receiving the shot on approx 11/5/06, the pt experienced a CVA (stroke) and was hospitalized for three weeks. The pt was released from the hospital on 11/28/06 with a feeding tube, At the time of the report, the pt was recovering. No product quality complaint was involved. The reporter considered the pts stroke to be life threatening and disabling. Additional information has been requested.
unable to get adequate blood flow; cord was not attached as it should; babies were in the same sack; Maternal exposure during pregnancy; Birth weight low; premature birth; Live birth; This case was reported by a nurse via call center representative and described the occurrence of cardiovascular insufficiency in a male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) (batch number D4E29, expiry date 30th June 2019) for prophylaxis.   On 26th October 2018, the patient received Fluarix Quadrivalent 2018-2019 season (transplacental) .5 ml. 118 days after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced birth weight low, premature birth and live birth. On an unknown date, the patient experienced cardiovascular insufficiency (serious criteria GSK medically significant), umbilical cord abnormality, monoamniotic twin pregnancy and maternal exposure during pregnancy. On an unknown date, the outcome of the cardiovascular insufficiency, umbilical cord abnormality, birth weight low, premature birth, live birth, monoamniotic twin pregnancy and maternal exposure during pregnancy were unknown.   It was unknown if the reporter considered the cardiovascular insufficiency, umbilical cord abnormality and birth weight low to be related to Fluarix Quadrivalent 2018-2019 season. The reporter considered the premature birth to be unrelated to Fluarix Quadrivalent 2018-2019 season.     See case US2018199479 for details regarding the baby case.   Additional details were provided as follows: The patient's mother did not had any known medical history. One hundred and eighteen days after receiving the vaccine to the patient's mother, premature delivery led to premature birth. The Nurse reported that the twin babies were in same sack and one twin did not get adequate blood flow also there was reverse blood flow to one twin. The reporter considered that the event premature birth was not due to the flu shot. It was unknown, if the reporter considered the event cardiovascular insufficiency was related to Flu Seasonal QIV Dresden. The VARS details were updated. This is 1 of 3 cases linked for parent-child cases.
1 hour and 40 minutes after vaccine was administered pt returned with a red rash spaced sporadically over her body. She was scratching at the rash covered areas. Her eyes were red and tear filled. No difficulty breathing noted. MD called and ordered 1.5 tsp liquid Benadryl/PO and 1 tsp Q6 PRN.
A few minutes later after given covid vaccine, patient felt a slight headache and pharmacist gave him a bottled water.  Pharmacist asked if he felt "hot" and pt said "a little."  Pharmacist took a few steps to grab an instant ice pack then turned her head and ran to the patient as she saw him lean to the right. Patient fell to the floor, hitting his head.  a few seconds later he became alert and he said he was ok.  911 was called and Paramedics arrived to triage the patient.
REDNESS, SWELLING AND INDURATION IN INJECTION SITE, ERYTHEMATOUS PAPULAR RASH ON CHEST, MYALGIAS, FATIGUE, NECK PAIN.
This spontaneous report was received from an other referring to a 15 month old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 09-NOV-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA008334.
Large circular rash at injection site 8 days after first injection. Rash is itchy and slightly warm. There is some slight tingling in the hand/fingers on that side of body (left).
shortness of breath, cough, and dizziness. vertigo, pre-syncope, AKI/CKD , covid -19 w no hypoxia, positive for arrhythmia
Information has been received from a 67 year old female with high blood pressure and no drug reactions/allergies, who on a Friday in December 2007, was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included TOPROL XO TABLETS, calcium (unspecified), vitamins (unspecified) and OMEGA-3 MARINE TRIGLYCERIDES. The patient reported that on her left arm, she had redness at the injection site right after receiving the vaccine. She also reported that the next Wednesday in December 2007, she got sick, felt achy and had flu like symptoms and then a couple of days after. She started to itch really bad on her arms above the elbows, the top of her ears, on the bottom half of the scalp, her chest and back. The reporter states that she saw her primary care physician who did blood work but they all came back fine. She also saw an allergist who did blood tests and she was not allergic to anything, and then she saw a dermatologist who said she was itching from the inside out. The patient stated that they did not know if it was from the vaccine and they did not know what is causing her itching. The patient said she still itches, but the itching on her scalp went away and she can sleep a lot better. At time of reporting, the patient was recovering. Additional information has been requested. This is in follow-up to report(s) submitted on 09/24/2008. Follow-up information was received from a licensed Piratical Nurse who reported that on 14-DEC-2007 the patient received a first dose of ZOSTAVAX (Oka/Merck) (lot # 658396/0947U) IM, into her left arm. It was reported that the patient moved and was treated there on 19-DEC-2007 for "achey and flu symptoms" which lasted 1 day. On 25-DEC-2007 a "random body itch started". Additional information is not expected.