chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial misuse report received from a non-healthcare professional on 09 January 2014. A female patient (no information was provided regarding the patient(s) had received a dose of FLUZONE on an unspecified date and then it was found that the patient had received a does of FLUZONE on an unspecified date in November 2013. No adverse event was reported. Documents held by sender: none.
Approximately 12 hours after receiving immunizations patient developed diffuse urticaria and fever.  Subsequently his feet became swollen and he was unable to walk.  See in ED and treated with Zyrtec and Hydeoxyzine.  All symtoms resolved within 96 hours.  2/22/07 Received medical records from hospital which reveal patient experienced pruritic rash for approx 2 days w/fever, crankiness & difficulty walking.  Derm consult done in ER.  Had already been treated by PCP w/Benadryl & Zyrtec.  Exam revealed diffuse, erythematous confluent rash & scattered targetoid lesions sparing palms & soles FINAL DX: Urticarial hypersensitivity reaction, probably viral, less likely vaccinations.
FEVER, FATIGUE, COUGH, CONGESTION, ST, RHNORRHEA, BODY ACHES
Redness below injection site; Warmth below injection site; Swollen area; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number L7SY9, expiry date 4th July 2021) for prophylaxis.   On 29th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st July 2019, 2 days after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix in left arm on Monday before reporting date. On Wednesday before reporting date, the patient noticed redness and warmth about 1.5 to 2 inches below the injection site. The reporter saw the area and noted that the area was also swollen. The reporter was unable to obtain additional information.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 59-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date unknown) for prophylaxis. The patient's past medical history included shingles. Previously administered products included SHINGRIX (1st dose received with batch number XC534). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, shingles and paresthesia. On an unknown date, the outcome of the fever and shingles were recovered/resolved and the outcome of the paresthesia was unknown. The reporter considered the fever, shingles and paresthesia to be possibly related to SHINGRIX. Additional details were provided as follows: The expiration dates were unknown. The patient experienced a sensation of reactivation of shingles. The healthcare professional further clarified that the reported reactivation of the shingles as, a stabbing sensation in her left side and back kidney area, where she previously had shingles. The reported symptoms resolved after a couple of days following administration. This case has been linked to US2018140187, reported by the same reporter.
Child appears with 2.8cm x 2.5cm erythema, warmth, swelling, firm. Tender to touch. Afebrile on presentation. Child refused ice to area per mom.
I experienced nothing but a sore and swollen arm on September 15th but on Saturday the 18th of September I started experiencing tightening of my thigh, calf, and leg muscles. The tightening is persistent and is most uncomfortable when I'm trying to relax and especially after I wake up after being sleep for several hours.  I'm still experiencing this daily.
COAGULOPATHY, UNSPECIFIED TYPE ACUTE NON ST ELEVATION MI CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Information has been received from a physician referring to a male patient of unknown age who participated in a market research that was conducted by agency. The patient's medical history or concurrent condition were not provided. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (strength, lot#, dose, route and duration were unspecified). No concomitant therapy was provided. On an unknown date the patient experienced unspecified adverse event. The physician considered the adverse event to be non-serious and not related to ZOSTAVAX. The outcome of the adverse event was unknown. Additional information is not expected as the doctor was not willing to be contacted.
I have had mild dizziness each morning and evening with positional changes. This last for about an hour after waking up in the morning. When I arrive home after work and sit down on the couch to rest and lean my head back, I am dizzy upon standing. This has happened for the past couple of days and seems to be slightly lessening. I am still able to work, but note this is not a normal symptom and have never had dizziness prior to the shot.
About 20 seconds after administering HPV in R delt pt felt "dizzy" pulse 58 and BP 98/52 w/anxiety and orthostatic hypotension.  After 30 min pt felt much better B/P 110/72 and was able to walk out unassisted.  Pulse OX 98-99%.  After lying down.
Vaccine recipient received vaccine on 1/8/2021. The site of injection was sore and had redness for 2-3 days. On 1/14, he reported that he developed itchiness all over his body. He reported that the site of injection was raised and looks like a bullseye and about the size of an orange. He was advised to seek follow-up with occupational health.
No adverse effects reported; patient received one dose of VAQTA (lot number R013857, expiration date 4/22/2019) on 05/06/2019; This spontaneous report was received from a medical assistant (inconsistent information as it was also reported as nurse), concerning a patient of unknown age or gender.  The patient's medical history, concurrent conditions, drug reactions or allergies were not provided.   On 06-MAY-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # R013857 with expiration date 22-APR-2019, administered intramuscularly (strength, frequency, dose, and anatomical location were not provided) for prophylaxis.  No adverse effects were reported.
Experience taste of vitamin B 12 in her mouth; dizzy; Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Experience taste of vitamin B 12 in her mouth), DIZZINESS (dizzy) and SOMNOLENCE (Sleepy) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (Experience taste of vitamin B 12 in her mouth), DIZZINESS (dizzy) and SOMNOLENCE (Sleepy). At the time of the report, TASTE DISORDER (Experience taste of vitamin B 12 in her mouth), DIZZINESS (dizzy) and SOMNOLENCE (Sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
12 hours after receiving vaccination I woke up with severe cold chills, heart burn, and body aches. I took Tums, Pepto, and other prescriptions to try and alleviate those pains. None of those worked so around 5:30- 6pm (4/25/2021), I went to ER. When I went in they took blood work, a urine sample, and then gave me Iv fluids, and other medications. The Dr. confirmed that I was dehydrated, and I had a normal reaction to the shot. I was in the ER for about 2-3 hours, and then they let me to go home. I went to work the next day.
On 11/06/2003 in the PM, I returned patient's call.  She stated she went to clinic for temperature 103 and swollen glands.  Was on antibiotic.  Patient was given appointment on 11/07/2003.  She no showed.  Certified letter sent home.
Initial report was received from a healthcare professional on 15 November 2013. A 14-year-old male patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH906AE, on 11 November 2013 and 24 hours later complained of body aches and developed shingles. The patient had no illness at the time of vaccination and no past medical history. Outcome was not recovered. Documents held by sender: None.
Developed a fever mid-day May 27th.  By 3pm on May 28th the fever reached 107degF, at which point I called her physician's office and administered Children's Tylenol (tylenol).  Her fever stayed at 102degF while on tylenol, but ramped up again around 8pm to 104degF.  I gave her one more dose of tylenol before she went to sleep.  She awoke the next morning with a temperature of 101degF, which persisted throughout the day, ramping up again toward the evening to 102degF.  She awoke Tuesday morning May 30th with a normal temperature of 97.8degF.  Throughout the fever, her sleep had been fitful.  In addition, she experienced irritability within 24 hours of receiving the vaccine, which persisted until the morning of May 30th.  My daughter had the same reaction within a week after receiving her first set of immunizations on February 25, 2006.
Case was observed for standard 15 minutes. Was released, then fainting heading out to her car to leave.
THE INITIAL DOSE GIVEN TO THE RECIPIENT WAS 1/2 THE NORMAL DOSE.  THIS WAS DONE IN CONFUSION DUE TO THE PREVIOUS BOOSTER DOSE OF MODERNA BEING 0.25ML AND THE NEWER BIVALENT DOSE BEING 0.5ML.   THERE HAS BEEN A SECONDARY VERIFICATION ADDED TO THE PROCESS AT THE FACILITY TO VERIFY THE CORRECT DOSE WITH THE VACCINE BEING GIVEN BY ANOTHER STAFF MEMBER. THE RECIPIENT WAS CALLED BACK TO THE FACILITY AND RECEIVED THE REMAINING 1/2 DOSE TO COMPLETE THE DOSE OF THE BOOSTER VACCINE.
day after dose 1: mild-moderate body aches, especially in joints, severe fatigue; day after dose 1: mild-moderate body aches, especially in joints, severe fatigue; day after dose 1: mild-moderate body aches, especially in joints, severe fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 39-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration, administered in left arm on 01Apr2021 16:00 (at the age of 39 years old) as dose 1, single dose for covid-19 immunization. Patient was not pregnant at the time of vaccination. No covid prior to vaccination. The patient's medical history was not reported. The patient's concomitant medications included prenatal vitamins (ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide) and probiotics taken for an unspecified indication, start and stop date were not reported. Patient took no other vaccine in four weeks. On 02Apr2021 at 09:00, after dose 1, the patient experienced mild moderate body aches, especially in joints and severe fatigue. Patient not tested for covid post vaccination. No treatment received for the events. The outcome of the events was recovered with sequelae.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
she has COPD, diabetes, and cirrhosis of liver, and her symptoms of these seem worse after; chills; fatigue; sore muscles; aches; head stuffiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), HEAD DISCOMFORT (head stuffiness), CONDITION AGGRAVATED (she has COPD, diabetes, and cirrhosis of liver, and her symptoms of these seem worse after), CHILLS (chills) and FATIGUE (fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Diabetes and Cirrhosis of liver. Concomitant products included INSULIN GLARGINE (LANTUS), LOSARTAN, CARVEDILOL, LOVASTATIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN, MECLIZINE HCL, CALCIUM, PROBIOTICS NOS, MULTIVITAMINS [VITAMINS NOS], FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), IPRATROPIUM BROMIDE, AZELASTINE HYDROCHLORIDE (ASTELIN [AZELASTINE HYDROCHLORIDE]), SODIUM CHLORIDE (SALINE NASAL SPRAY), IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT), SIMETHICONE, ZINC and DICLOFENAC SODIUM (DICLOFENAC 1A PHARMA) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (aches), HEAD DISCOMFORT (head stuffiness), CHILLS (chills), FATIGUE (fatigue) and MYALGIA (sore muscles). On an unknown date, the patient experienced CONDITION AGGRAVATED (she has COPD, diabetes, and cirrhosis of liver, and her symptoms of these seem worse after). At the time of the report, PAIN (aches), HEAD DISCOMFORT (head stuffiness), CONDITION AGGRAVATED (she has COPD, diabetes, and cirrhosis of liver, and her symptoms of these seem worse after), CHILLS (chills), FATIGUE (fatigue) and MYALGIA (sore muscles) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On follow up patient mentioned that she is totally fine now.  No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up received on 20-APR-2021,Patient said she was doing fine and refused to disclose further contact details and refused further FU.
On first day had chills, sore throat, both minor.  Second day had fatigue, moderate joint and muscle pains.  Third day, some muscle pain.
Pt. states that after receiving the 1st dose of High Dose Influenza 11/05/2021, started experiencing symptoms that evening of chills, uncontrollable shaking, and fever (100.0), Lasting 24 hours before subsiding.  PCR Test - Negative, Primary visit.
received the first dose of the Pfizer covid vaccine on Aug 9 and she was diagnosed with covid on august 15; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 09Aug2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she received the first dose of the Pfizer COVID vaccine on 09Aug2021 and she was diagnosed with COVID on 15Aug2021. The patient underwent lab test which included COVID-19 test (Sars-cov-2 test): positive on 15Aug2021. The patient wanted to know when she will be eligible to get the second dose of the Pfizer COVID vaccine. Her doctor told her not to take the second dose and she did not need it. The outcome of the event was unknown.   Information about lot/batch number has been requested.
fever 103.5 with chills, pounding headache, insomnia at first transitioning into extreme fatigue.  bp 129/93 heart rate 115. Headache with flush face and arms and legs super heavy feeling on Sunday. Tuesday night experienced facial and head swelling, started in the middle of my forehead gradually filling up my entire head and face. Wednesday my whole face/eyes and head swollen, with tightness on my chest. My primary care provider prescribed methylprednisolone tablets USP Dosepak 4mg.  I did take Benadryl  and tylenol Tuesday. I also applied ice packs to my head and face. Headache still comes and goes with brain fog. Slight swelling remains on my forehead and eyes.
PT PASSED OUT DURING 15MIN MONITORING PERIOD OUTSIDE OF PHARMACY.  AND PT RECOVERED QUICKLY.  PT'S MOM SAID PT HAD SEIZER.  HOWEVER, I DIDN'T SEE THAT.
I got a high grade fever (103.2 F), and got severe chills. Took some Advil, hot shower, and laid down. Woke up fever was gone, and I?m fine.
BAD SKIN REACTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced bad skin reaction. The action taken with covid-19 vaccine was not applicable. The outcome of bad skin reaction was not reported. This report was non-serious.
increased my anxiety reactions, actually had an anxiety attach and what felt like heart attack conditions since the booster, peaked on Christmas eve and went to emergency room, checked in, but they said there was no "heart event" after ekg and blood work.  They did not ask about my date of booster.  3 weeks now from the booster and the effects are lessening but still here somewhat.
About 5 minutes post vaccination, the patient started vomiting. She said her hands were sweaty and they were shaking. She also deficated. Her mom was there and said she has a vomiting syndrome and diabetes. She also did not eat all day. She sat for about 20 minutes and was still feeling sick so her mom was going to take her to the ER because she thought it was from one of her other illnesses.
Patient reported sore shoulder, unable to raise arm. Reported to Pharmacy on 9/28/2019 treated with tylenol and ice. Patient staed doctor advised to use claritin until visit to doctor on 10/01/19. Patient was examined received prednisone. Patient reported arm feeling much better on Monday and Doctor could not find any injury, swelling or inflamation. Patient also received imaging which was inconclusive. Follow up call was held with patient on 10/02/19 patient reported arm feeling much better and doctor could not determine what was cause of shoulder pain.
This is a spontaneous report from contactable Other HCP via a Pfizer sales representative. A 17-year-old male patient of unspecified ethnicity received first dose of TRUMENBA via an unspecified route, at single dose on 15Aug2016. No medical history or concomitant medications were reported. After administration of vaccine the patient experienced headache, chills, nausea, fever 100.9 Fahrenheit, sore throat and congestion. The outcome of the events was unknown. Follow-up (14OCT2016): Follow-up attempts are completed. No further information is expected.
Patient slumped in chair, began seizure - like activity, became pale, then after I tried to get a response from her began crying and stated she was scared.
body aches; arm is so painful; diarrhea little bit.; chills; fever of 99 degree; nausea; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PAIN IN EXTREMITY (arm is so painful), DIARRHOEA (diarrhea little bit.), CHILLS (chills) and PYREXIA (fever of 99 degree) in a 35-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.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN (body aches), PAIN IN EXTREMITY (arm is so painful), DIARRHOEA (diarrhea little bit.), CHILLS (chills), PYREXIA (fever of 99 degree), NAUSEA (nausea) and VOMITING (throwing up). At the time of the report, PAIN (body aches), PAIN IN EXTREMITY (arm is so painful), DIARRHOEA (diarrhea little bit.), CHILLS (chills), PYREXIA (fever of 99 degree), NAUSEA (nausea) and VOMITING (throwing up) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Pyrexia: 99 (Inconclusive) patient reports fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient asked whether she can take Tylenol and Advil for her body aches.   Reporter did not allow further contact
Swollen and tender lymph nodes on left side of body under clavicle.; Off-label use (due to interchange); Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 11:15 (Lot number: FJA762) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine rha 4v (baculovirus) (FLUBLOK QUADRIVALENT), administered in deltoid right, administration date 09Dec2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROPRANOLOL; DICLOFENAC; DIPHENHYDRAMINE; ACETAMINOFEN. Past drug history included: Pcn, reaction(s): "Known allergies". Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 042B21A, Location of injection: Arm Left, Vaccine Administration Time: 12:45 PM), administration date: 15Apr2021, when the patient was 42 years old, for Covid-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 003A21A, Location of injection: Arm Right, Vaccine Administration Time: 12:45 PM), administration date: 18Mar2021, when the patient was 42 years old, for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 09Dec2021, outcome "unknown", described as "Off-label use (due to interchange)"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 09Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset 11Dec2021 18:30, outcome "unknown", described as "Swollen and tender lymph nodes on left side of body under clavicle.". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information:  Patient was not pregnant at time of vaccination. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.   No follow-up attempts are possible. No further information is expected.  Follow-Up (23Dec2021): Follow-up attempts are completed. No further information is expected.