chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got the Flu; Initial information received on 10-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who got the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, route, frequency, lot number and expiry date was unknown) not  in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date the patient developed a non-serious event "got the flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" I got mine and immediately got the Flu and wish I had never gotten it , it was definitely terrible."   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got the Flu).  At time of reporting, the outcome was Unknown for the event got the flu.
New onset, intermittent vertigo that sounds most consistent with Benign Paroxysmal Positional Vertigo.
Initial misuse report received from a healthcare professional on 21 October 2013. The cases were received on 21 March 2014. A 65 year old patient had received unknown dose of FLUZONE HD (No other information was provided regarding the patient). No adverse event was reproted. List of documents held by sender: none.
Pt experienced seizure-like activity with clonic tonic movements of all extremities directly following the administration. Pt did not lose consciousness and was not incontinent during the event. Pt complained of felling fatigue - challenge to keep her eyes open. EMS arrived in 4 minutes and took patient to ER
Information has been received from a physician who saw a local news report about a female patient who on an unspecified date was vaccinated with a dose of GARDASIL and experienced an unspecified autoimmune disorder.  It was unspecified if the patient sought medical attention.  At the time of the report, the outcome of the event was unknown.  Attempts to verify the existence of an identifiable patient have been unsuccessful.  No further information is available.
Within about 45 minutes after receiving the second Pfizer vaccine, I started feeling like I was day dreaming.  My head became heavy and it was almost as if I was frozen in time. When that happened, I fell into a drainage ditch at the edge of my yard, which caused my left femur to break completely in-two.  My neigbor called an ambulance and I was taken to Hospital where I had surgery the following day.  They couldn't do the surgery any earlier because I take Eliquis blood thinner.  I stayed from Saturday until Wednesday in the hospital.  Then, I was transferred to Nursing Home for three weeks of therapy.  After I was discharged from the nursing home, Home Health continued to give me physical therapy at my home for several more weeks.
After my second Pfizer covid vaccine, three weeks to the day I experienced sudden hearing loss in my left ear.   Doctor stated it is idiopathic reason.
Temp 101.4  F within 7 hrs lasting 21 hrs.; Body aches; Headache lasting 48 hrs; Soreness at injection site; This is a spontaneous report from a contactable Nurse reported for herself. A 72-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 12:00 (age at vaccination 72-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included seasonal environmental allergies and known allergies: walnuts, known allergies: peaches, known allergies: eggplant. Concomitant medication(s) included as other medications in two weeks, fluoxetine (FLUOXETINE) as 30 mg. The facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took azithromycin and experienced known allergies: azithromycin. On 11Mar2021 at 19:00, the patient experienced Temp 101.4 F within 7 hrs lasting 21 hrs., body aches, headache lasting 48 hrs and soreness at injection site. The patient underwent lab tests and procedures which included body temperature which showed 101.4 Fahrenheit (Temp 101.4 F within 7 hrs lasting 21 hrs.) result on 11Mar2021. No treatment was received for the adverse events. The outcome of the events was recovered with Sequel on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
t104 starting 2hr p/vax;pt seen in MD office on 7JAN97 w/t102;had a sz lasting 1hr & 15min was taken by amb to hosp;IV phenobarb stopped sz, was in hosp 2 days; devel red spotty rash;
Pt reported she broke out in a rash and had sores all over which lasted 2 or more weeks.
Expired vaccine was administered to the patient, no AE; Initial information regarding an unsolicited valid non-serious case was received from the pharmacist inbound (reference number- 00558166) and transmitted to Sanofi on 12-Apr-2021.  This case involves an expired vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number: not reported; expiry date: unknown Feb-2021) that was administered via unknown route in unknown administration site for prophylactic vaccination on 12-Apr-2021 to a patient (demographics not reported) (expired product administered).  Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (latency same day).  The reporter stated that patient received an expired TENIVAC. At the time of reporting, the reporter wanted to know the recommendations as to what should be done moving forward. Also, the reporter wanted to know if there was a recommended time frame to wait prior to revaccination of TENIVAC. The reporter also queried whether they need to wait four weeks or if that was only for live vaccines.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Patient reported 7/6/04 she had rash on legs, ringing in ears and dull headache since 6/20/04. Pt related symptoms staring after Pneumovax given.
Fever (around 101 F on 5/5/2021--resolved within 6 hours on 5/5/2021), Severe Headache (started 5/5/2021 about the same time as the fever.  Headache has downgraded to minor headache by 5/7/2021) Swelling of  lymph nodes in Left side arm pit (started 5/6/2021 and mostly resolved by 5/7/2021)
Received vaccine in left deltoid on day 1.  No immediate adverse reaction.  On day 3, woke up with moderate fatigue, spent most of the day sleeping.  On day 4, woke up with severe headache and severe fatigue.  Slept most of the day.   Woke up in afternoon/early evening of day 4 with sore left arm and shoulder.  Could not lift arm beyond 45 degrees.  By day 5, having joint pain all over, especially in shoulders, hips, and knees.  Severe fatigue continuing.  Mild muscle aches now present.  By day 7, fatigue is essentially resolved, muscle aches resolved, headache resolved, and joint pain resolved except for left shoulder.  Now on day 32, continue to have mild to moderate left shoulder pain with inability to raise arm.
mild anaphylaxis. Began with flushing about 5-10 minutes after vaccine. Proceeded to stomach cramping with diarrhea and itching in throat and of tongue. I took 2 diphenhydramine 25mg capsules and famotidine 20mg.  Proceeded to the ED with the administering RN, Received 1 dose epipnephrine IM, SoluMedrol and famotidine IV. Coughing, itching and cramping subsided in about 10 minutes. Discharged on 60mg prednisone QD for 5 days after ED monitoring until vitals were stable.
Breakthrough case admission after 4 vaccines Moderna 2/23/21 lot# 031M20A;  Moderna 3/23/21 lot# 044A21A;  Moderna 12/7/21 lot# 077C21B;  Moderna 6/15/22 lot# 014B22A
The pt developed itchy maculopapular rash on nect and upper chest 48 hrs post vaccination. Mother denies treatment. States will use Benadryl to relieve itching.
Mother reported that she developed a full body rash 12 days after the vaccine was administered. She reported that the rash lasted 24 hours and did not seem bothersome.  Denies any other symptoms.
Aug 18-Slight rash on Left arm, 19th more rash noted, swollen lymph nodes in groin, 20th- eyes swollen, chin itchy, visited ER, given IV epinephrine, prednisone, and benedryl, 21st- feeling better, 22nd- itching and rash, face swollen, got medrol dose pack at student health, 25th- couldn't sleep with hands and feet tingling.  Resolved by 26th.
I had a headache, nausea, muscle soreness and stiff joints on the first day and the second day fatigue.
Pain in legs; leg cramps/cramping in right leg; Face swelling; Lips swollen; Felt weird and strange; Really heavy legs legs; Vomiting; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in legs), MUSCLE SPASMS (leg cramps/cramping in right leg), SWELLING FACE (Face swelling), LIP SWELLING (Lips swollen) and FEELING ABNORMAL (Felt weird and strange) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) and TOPIRAMATE (TOPAMAX) for Migraine.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced PAIN IN EXTREMITY (Pain in legs), MUSCLE SPASMS (leg cramps/cramping in right leg), SWELLING FACE (Face swelling), LIP SWELLING (Lips swollen), FEELING ABNORMAL (Felt weird and strange), LIMB DISCOMFORT (Really heavy legs legs), VOMITING (Vomiting) and MYALGIA (Muscle pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 20-May-2021, VOMITING (Vomiting) had resolved. On 21-May-2021, SWELLING FACE (Face swelling) and LIP SWELLING (Lips swollen) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in legs), MUSCLE SPASMS (leg cramps/cramping in right leg), FEELING ABNORMAL (Felt weird and strange), LIMB DISCOMFORT (Really heavy legs legs) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
hot flash sensation on right side body under her arms down side of her body; This is a spontaneous report from a contactable pharmacist (patient). This 45-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3302; dose 1) via an unspecified route of administration on 26Jan2021 (at the age of 45-years-old) as a single dose in the arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced hot flash sensation on the right side of her body. The patient stated she got the vaccine "today" (26Jan2021) and wanted to find out if the kind of side effect she was having would resolve or if she needed to contact her physician. She had been experiencing a hot flash sensation on the right side of her body under her arms and down the side of her body on 26Jan2021. The outcome of hot flash sensation on the right side of her body was not recovered.   No follow-up attempts are needed. No further information is expected.
p/vax pt c/o pain p/full dose last year;lt arm red, swollen, sore & c/o tired;DPH given;
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On 07-AUG-2014, the patient was vaccinated with GARDASIL (0.5 ml, lot#J011272, expiration date: 21-APR-2016) intramuscularly which underwent a temperature excursion. No adverse events were reported. At the time of the report action taken with GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.
PATIENT HAD RECEIVED 1ST DOSE MODERNA AT OUR FACILITY, THEN WAS HOSPITALIZED DUE TO MALIGNANCIES AND OTHER MEDICAL CONDITIONS. SHE WAS CONFUSED AND MISPLACED HER VACCINE CARD. SHE CAME BACK TO OUR FACILITY TO GET HER 2ND DOSE, BELIEVING SHE HAD RECEIVED PFIZER AS HER 1ST DOSE. PHARMACIST ON DUTY WAS A TEMPORARY FLOAT PHARMACIST FILLING IN FOR THE DAY. SHE DID NOT CHECK IMMUNIZATION RECORD. PT DID NOT HAVE HER VACCINE CARD WITH HER. PHARMACIST GAVE HER PFIZER AS REQUESTED FOR 2ND DOSE.
Vaccine 10:30 a.m. on 10/17/07 "Could hardly wake up" on morning on 10/18/07. "It was like I took a sleeping pill, and I had a strange headache." felt hot and cold. (Did not take temperature.) "Dizzy" on 10/19/07 and stayed home from work. 10/22 at work and feels fine.
Fever; feeling very sleepy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Fever) and SOMNOLENCE (feeling very sleepy) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Two weeks after the first shot she had Covid) in January 2021. Previously administered products included for Product used for unknown indication: Flu shot (given within 1 month prior to Moderna vaccine). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Allergy to antibiotic (Erythromycin) and Drug allergy (Codeine). Concomitant products included ALPRAZOLAM, AMLODIPINE, ATORVASTATIN and ESOMEPRAZOLE for an unknown indication.    On 11-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 12-Oct-2022, the patient experienced PYREXIA (Fever) and SOMNOLENCE (feeling very sleepy). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) and SOMNOLENCE (feeling very sleepy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Positive.         The patient received fist dose of Moderna vaccine with lot number 042L20A on 15-Jan-2021 in deltoid (shoulder) muscle via intramuscular route.  The patient received second dose of Moderna vaccine on 24-Apr-2021 in in deltoid (shoulder) muscle via intramuscular route.  The patient received first booster dose of Moderna vaccine on 08-Nov-2021 with lot number 071F21A in deltoid (shoulder) muscle via intramuscular route.  On 11-Oct-2022, the patient received second booster dose of Moderna COVID-19 bivalent vaccine.  The patient received a couple of Tylenol. The reporter wanted to know if it was normal to have fever after receiving the vaccine. The patient was taking other medication and the healthcare provider was aware of the side effects.   This case was linked to MOD-2022-658050, MOD-2022-658051 (Patient Link).
the arm was killing him and I could not lift it; allergic reaction; soreness in his arm; looks like a giant walnut where she put the shot/arm is still swollen with "a giant walnut on my arm".; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 25Feb2021 (at the age of 66-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient had a major allergic reaction. He received his first shot on 25Feb2021 and reported that after getting the shot in his upper arm "the arm was killing him and I could not lift it".  The patient went to the hospital for the soreness in his arm and what "looks like a giant walnut where she put the shot". Patient reported that he planned to go back to the hospital in 30 minutes to have his arm looked at again and to get another shot because his arm was still swollen with "a giant walnut on his arm".  The patient stated also that he could not move his left arm. He believed that the nurse stuck the needle into his muscle. He stated, received the vaccine in his upper arm and at the time of reporting that was so sore he cannot lift it and he just said that there was no logic because the nurse hit his muscle, that's what he said to the afterhours services. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Narrative: hospitalization for COVID-19 after receipt of vaccination approximately 3 months prior.
The patient cried for 3 hours after administration of the vaccines (DTap, Prevnar, IVP, Hib, andHep B#2). The infant could not be consoled, cry was shrill. No fever.
loss of taste; This is a spontaneous report from a contactable HCP. This HCP reported for unknown (patient). A male patient with an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: unknown) via unknown route of administration on 09Mar2021 as DOSE 1, SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: unknown) via unknown route of administration on 27Mar2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The experienced loss of taste after the first dose of the vaccine. The lab data included covid test with negative result on 07Apr2021. At the time of this report outcome of the event was unknown.  No follow-up attempts were needed, information about lot/batch number cannot be obtained.
7NOV95 devel red blotches & rash over body, hands were extremely itchy-no temp BP 155/65 some achiness; called MD who advised cortisone cream;denies allergies prev known;had flu shots prev yrs & no rxn;
No Additional AE; she inadvertently administered a 2nd dose of PROQUAD today, 05/08/2023 after a first dose of PROQUAD was administered on 03/14/2023; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 14-MAR-2023, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (strength, lot, expiration date and route of administration were not provided). On 08-MAY-2023, the patient was inadvertently administered a 2nd dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #W017568, expiration date: 29-NOV-2023, for prophylaxis (strength, and route of administration were not provided (Inappropriate schedule of product administration). No additional information was provided.  No Additional adverse events, no product quality complaints.
Instant hives. Pt was given Diphenhydramine HCL 3.75 mg.
Received a 0.25mL dose of the Moderna Covid-19 Bivalent vaccine instead of a 0.5mL; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid-19 Bivalent vaccine instead of a 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid-19 Bivalent vaccine instead of a 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid-19 Bivalent vaccine instead of a 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid-19 Bivalent vaccine instead of a 0.5mL).    No concomitant medications were reported. The healthcare provider reported that they had mistakenly provided patients with 0.25 mL doses of the Moderna Covid-19 bivalent vaccine instead of 0.5 ml doses. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646302, US-MODERNATX, INC.-MOD-2022-646303 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646302:Patient 3 US-MODERNATX, INC.-MOD-2022-646303:Patient 2
Within 2 weeks I was breathless,  chest pains, loss of appetite fatique, unable to work, muscel pain, neck pain, blurry vision, anxiety
Four days following administration of the vaccine we were made aware that due to a temperature excursion the vaccine that was administered to the patient was "not viable" per the manufacturer.  CDC recommendations are that the vaccine be repeated.
Redness down half of arm to elbow. Swollen and a little sore. Felt a little nauseated and chills the day after receiving vaccine. Said they felt ok today.
Patient stated the shot was given on the side of her bicep muscle which caused her arm to swell, soreness and a red rash which was tender to touch. She applied ice and took TYLENOL OTC.
Patient has had severe pain in shoulder and has had sharp shooting pains it has not stopped . it has now radiated to back side of shoulder in same spt.  In left arm pain has radiated down to elbow and to hand with radiating pain
3 cm X 1 cm erythema and induration with 1 mm pustule in center
Very Dizzy right after injeection. Fatigued for several days. More severe symptoms arose one week later, same symptoms I had when I had Covid in December 2020. Very stiff neck, fatigue, skin tenderness like from fever, but no fever., bad headache. To date 04/19/21 I am still dealing with a very stiff neck, headache and fatigue. My second shot is in 4 days April 23, 2021