chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a 21 year old female who in approximately April 2007, "6 months ago", was vaccinated with the first dose of Gardasil vaccine (lot# not reported). There was no concomitant medication. In approximately April 2007, "2 days after vaccination", the patient developed bruised skin and skin atrophy at the injection site. The patient sought unspecified medical attention. No laboratory diagnostic testes were performed. Subsequently, the patient recovered from bruised skin but the indentation from skin atrophy is still noticeable on her arm. There was no product quality complaint. Additional information has been requested.
Initial information received from a consumer on 15 November 2013. A 53-year-old female patient with no medical history had received a dose of FLUZONE ID (batch number and site of administration not reported) on 12 September 2013. On 13 September 2013, patient had developed injection site reaction of swelling and a small area of induration. It was reported, that small area of induration persists 2 months later. No lab investigations were performed. At the time of this report, the outcome was unknown. List of documents held by sender: none. Follow up information received from non-healthcare professional on 05 August 2014. The patient had no illness at time of vaccination. Reporter's details were updated.
pt recvd vax & exp diarrhea; by evening of 24JAN94, vomiting; 25JAN94 diarrhea, vomiting, taken to hosp; dehydrated & dx w/rotavirus; remained in hosp 27JAN94;
Information has been received from a LPN concerning a adult female pt who was vaccinated with a first and second dose of varicella vaccine. Subsequently the pt's laboratory results indicated a varicella antibody titer of 0.2. The pt sought unspecified medical attention.
This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were  not reported. On 04-JUN-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018)(dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (degrees F) to 77 degrees Fahrenheit (degrees F) (60.33 degrees F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1807USA003177; US-009507513-1807USA003069; US-009507513-1807USA003067; US-009507513-1807USA003066; US-009507513-1807USA003065; US-009507513-1807USA003064; US-009507513-1807USA003063; US-009507513-1807USA003062; US-009507513-1807USA003061; US-009507513-1807USA003060; US-009507513-1807USA003059; US-009507513-1807USA003058; US-009507513-1807USA003057; US-009507513-1807USA003056; US-009507513-1807USA003055; US-009507513-1807USA003054; US-009507513-1807USA003053; US-009507513-1806USA012857.
Reaction after booster dose; Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction after booster dose), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction after booster dose), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, VACCINATION COMPLICATION (Reaction after booster dose), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.            The reporter wanted to report on behalf of their friend who was the patient and who experienced reaction after vaccination with booster dose of Moderna COVID-19 vaccine. It was also reported that the patient was more than 60 year old.  No Concomitant product use was reported. No treatment information was provided.   Reporter did not allow further contact
booster shot; She had a little pain after the booster shot; she is in pain; swelling/ I was swell, swollen; I have got sick; My stomach that has got the burning on; couldn't move; She is weak; I am not well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster shot"; PAIN (non-serious), outcome "not recovered", described as "She had a little pain after the booster shot; she is in pain"; SWELLING (non-serious), outcome "unknown", described as "swelling/ I was swell, swollen"; ILLNESS (non-serious), outcome "unknown", described as "I have got sick"; DYSPEPSIA (non-serious), outcome "unknown", described as "My stomach that has got the burning on"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "couldn't move"; ASTHENIA (non-serious), outcome "unknown", described as "She is weak"; MALAISE (non-serious), outcome "unknown", described as "I am not well".   Additional information: The reporter stated that, patient was not well, (not clear), got sick, was swell/ swollen, could not move and the stomach that had got the burning on.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AE reported; Caller explained ROTATEQ was administered to a patient after a temperature excursion.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 12-JAN-2023, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliters (ml) orally (lot number W020110 which has been verified to be valid, expiration date reported and validated as 13-JUN-2023) as prophylaxis. The administered dose of the vaccine was stored at a temperature of 55.0 degrees Fahrenheit (F), during a time frame of 153 hours (product storage error). There was no previous temperature excursion. No additional adverse events were reported in the patient.
On 7/16/21 Patient came into the COVID Vaccine Clinic. The 12 year old female received her first Pfizer immuzation.  At 1441 she received injection her Right Deltoid by Staff.  At 1442 Patient's eyes rolled back into head, skin color went white head relaxed back. Medical providers General impression was a syncable episode.  Patient didn't respond to verbal and was simulated by touch.  A and O 3 of 4.  Patient assisted to standing and to W/C.  Wheel Chaired to cot.  Patient on cot in a sitting position.  Three sets of vitals taken.  First two sitting and third one standing.  1445 bp 108/68 RR 14 Spo2 94 and pulse 88.  1450 BP 102/70, 97% SPO2, Pulse 85 and RR 13  1502 BP 104/58 RR 12 98% SPO2, Pulse 96.  Patient was negative for orthostatic hypotension.  Signs and symptoms dizziness, Allergies, NKDA and Allergies to food.   Medications taken include Clariton.  Past Medical history include anxiety and dizziness to injections; Seasonal Allergies.  Last oral intake was half a sandwich on 7/16/21 at noon.  Events that lead prior were anxiety about getting the injection.  Lot number to Pfizer EW0181
Motor tic, child twitching his head from left to right with a slight squinting in eye, gets worse with watching TV or videos. Sending him to neurologist for tests.
Information has been received from a 74 year old female with no drug allergies or pertinent medical history who on 08-Apr-2007 was vaccinated with a single dose of Zostavax.  Concomitant therapy included estrogens (unspecified).  On 02-Aug-2007 (a few months after vaccination) the patient developed shingles on her left side around her ear, neck, and shoulder.  Unspecified medical attention was sought.  Shingles was diagnosed.  Unspecified blood and urine tests were performed with no results reported.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
3/12/02 Started itching this morning and feeling "disoriented". Also feels 'hot and sweaty" Did not take temperature. Advised to go to ER.
Day after receiving booster vaccine I was dizzy and tired. Dizziness was intermittent that week and then on December 22nd severe dizziness, nausea, feeling like I was going to faint, vomiting that evening. Went to PCP on December 22nd was diagnosed with Vertigo and also had high BP. Next few days dizziness constant and now effecting my walking.  Right ear pain and nausea if I don't take my anti nausea medication. Went to Physical Therapist on December 27th who after testing diagnosed me with Vestibular Neuritis. Given numerous eye exercises to do.
For 6 weeks I had significant high FBS levels.  I increased my Tresiba 2 units every 2 days.  I capped out at 16 units every night. My blood sugars then began to decrease as did my tresiba dosing.
tested positive to COVID-19 but without symptoms on the first week of Jun-2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive to COVID-19 but without symptoms on the first week of Jun-2022) 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.   In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced COVID-19 (tested positive to COVID-19 but without symptoms on the first week of Jun-2022). At the time of the report, COVID-19 (tested positive to COVID-19 but without symptoms on the first week of Jun-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Positive) positive.         No concomitant drug was reported. No treatment drug was reported. Company comment: This is a spontaneous case concerns female patient of unspecified age, with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) that occurred approximately a month after the fourth dose of mRNA-1273 vaccine in COVID-19 vaccination series. SARS-CoV-2 test was Positive approximately a months after the fourth dose of mRNA1273 vaccine. The patient had received primary series and third dose of mRNA1273 vaccine on unspecified dates. No additional information is available regarding medical history and concomitant medication received and treatment details. The event outcome was unknown. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerns female patient of unspecified age, with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) that occurred approximately a month after the fourth dose of mRNA-1273 vaccine in COVID-19 vaccination series. SARS-CoV-2 test was Positive approximately a months after the fourth dose of mRNA1273 vaccine. The patient had received primary series and third dose of mRNA1273 vaccine on unspecified dates. No additional information is available regarding medical history and concomitant medication received and treatment details. The event outcome was unknown. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Severe pain lasting 4+ days. Limited use of arm and partial weakness. Continual NSAID every 8 hrs. Severe swelling and mild bruising.
Symptoms within first 6-24 hours of receiving 2nd dose: moderate pain at injection site, body/muscle aches, chills, intermittent headache and fatigue
fever; chills; joint pain; headache; tiredness; injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: unknown) intramuscularly at right arm on 11Jan2021 13:15 at single dose for COVID-19 immunization. Medical history included hashimoto's. No known allergies. There were no concomitant medications. The patient received the first dose of bnt162b2 (lot number: unknown) intramuscularly at right arm on 21Dec2020 13:15 at single dose for COVID-19 immunization. Basically, patient felt like she was hit by a mack truck. She had fever, chills, joint pain, headache, tiredness and injection site pain, all on 12Jan2021 01:00. No treatment received. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovered on an unspecified date in Jan2021.   Information on the lot/batch number has been requested.
On 4/03/2021 awoke with sharp under scapula pain with loss of power to left serratus anterior that manifested over the next weeks into severe axillary anterior and posterior spasms with tingling down left arm thumb, index and middle finger.  Numbness to fingers thereafter and then significant loss of strength came after that especially to tricep, teres major and hand.  Started dropping stuff on the floor and am unable to perform my full job duties at this time.  Treatment and pain/weakness/tingling symptoms are ongoing
Patient received expired Pfizer Covid Vaccination 5 days past expiration date.  No treatment given,  No adverse reaction reported.
This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. The patient was vaccinated intramuscularly with a 0.5 ml dose 2 of GARDASIL (lot # not reported) on an unspecified date. The nurse reported that the patient was 1 month late for her second dose of vaccine. No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
8/13, and stated that Sx, cough and HA since 8/9. The last day worked was 8/9. Will be tested 8/13.
On 07/22/19, 15 yo F presented to clinic for second HPV vaccine (HPV vaccine 9-valent IM (GARDASIL 9)). Pt received first injection on 08/10/2016 without incident. At 1426, pt was administered 0.5 mL in left deltoid (NDC: 0006-4121-02, Lot #1614897, exp: 9/20/2021). By evening-time, pt developed a diffuse pruritic rash on back of arms, abdomen and thighs. On 07/23, pt called the nurse triage line and an appointment was made for evaluation. Pt reported self-treatment with diphenhydramine with symptom relief. On return to clinic, MD exam found "extensive areas of hives both thighs, back, shoulders abdomen and anterior chest wall.  Blanching on pressure.  No sign of secondary infection." Pt was instructed to continue use of diphenhydramine as needed and given a prescription for prednisone taper. Pt discharged in stable condition.
diarrhea; nausea; Vomiting; fever of 100.2 F; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 68 years old female patient who experienced diarrhea (diarrhoea), Nausea (Nausea), vomiting (vomiting) and fever of 100.2 degree F (pyrexia) , while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included LOPERAMIDE HYDROCHLORIDE (IMODIUM AD).  On 17-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ284AB, via intramuscular route in the left arm. The patient was taking steroids for the condition of periodermangrinosa  On an unknown date, the patient developed a non-serious diarrhea (diarrhoea), Nausea, vomiting and fever of 100.2 f (pyrexia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Lab data was not reported  Final diagnosis was diarrhea, vomiting, nausea and fever.  The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM AD) and to stay hydrated.  The event outcome is reported as Recovering for diarrhea, as Not Recovered for nausea, vomiting and as Unknown for fever of 100.2 degree F.
The patient is incarcerated.  When asked if ever received a covid vaccine, patient stated, "no" When back at the clinic patient had received Moderna 4/1 Lot 044A21A, expiration 08/31/2021 and Moderna 4/29 Lot6 047A21A expired 9/1/2021
rheumatoid arthritis came back after the 3rd booster of COVID-19 Vaccine; rheumatoid arthritis came back after the 3rd booster of COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), for rheumatoid arthritis. The patient's relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: in remission. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose:1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), DISEASE RECURRENCE (medically significant), outcome "not recovered" and all described as "rheumatoid arthritis came back after the 3rd booster of COVID-19 Vaccine". The action taken for tofacitinib citrate was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My daughter developed amenorrhea and was diagnosed with PCOS (Polycystic Ovary Syndrome) 2 months after receiving the HPV (Gardasil) vaccine.
12MAY92 in PM, had t103-states off & on; 13MAY92 6AM took pt to hosp ER t104 given APAP suppositories, DPH, & Ibuoprofin & released;
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 14th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:Master case
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt woke up at 7:30 am with Left arm ,"can't feel it" the injection arm. Also from the right elbow to wrist with pain of 5-with  pain scale of 1-10. Both arms with no swelling, rash or redness. Range of motion equal bilaterally.
PATIENT SAID THAT HER LEFT ARM FELT NUMB FROM THE INJECTION SITE DOWN TO HER FINGER TIPS
Vertigo, severe, upon waking 2 days after vaccine injection. Resolved within a few hours.
15AUG95 s/s tingling of legs & face, felt weak & woozy about 12noon went to bed;16AUG95 vomited x 1;had hot flashes & clammy hands;17AUG head felt heavy, legs felt to be in slow motion, diff breathing, hyperventilating