chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Chills; Severe arm pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 09Mar2021 at 13:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 09Mar2021, the patient experienced fatigue, chills and severe arm pain at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, chills and severe arm pain at injection site were not resolved the time of this report  No follow-up attempts are possible. No further information is expected.
paralysis in the arm receiving the flu shot; Initial information was received on 15-Sep-2020 regarding an unsolicited valid serious case from a consumer or other non-professional (patient).  This case involves an 80-year-old female patient (age at the time of report was 81 years) who experienced paralysis in the arm receiving the flu shot (monoplegia), while she received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) [PREVNAR].  Patient had history of peripheral neuropathy and brittle bone disease (5 fractures in 4 years).  The patient had been vaccinated from last 4-5 year by Fluzone HD vaccine.  Past medical treatment, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number and expiry date not reported] via an unknown route at the arm and a dose of suspect PREVNAR (not produced by Sanofi Pasteur) [lot number and expiry date not reported] via an unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious paralysis in the arm receiving the flu shot (monoplegia), either the evening of or the following day after receiving the flu shot as well as after receiving Prevnar. This event was assessed as medically significant.   The patient reported the most severe reaction last year with the flu shot for the elderly and Prevnar. Patient reported that she could not even put key in the door lock. Patient wanted to ask whether or not regular flu shot would be better for her than the HD.  Caller requested PIs (product information) for FLUZONE HD, FLUBLOK QUADRIVALENT, and FLUZONE QUADRIVALENT.    Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, the patient had recovered from arm paralysis (it was reported that symptoms lasting approximately 2 days).  Information on batch number has been requested.; Sender's Comments: This case involves an 80-year-old female patient who presented with monoplegia of the vaccinated limb after vaccination with FLUZONE HIGH DOSE and PREVNAR. The time to onset is compatible with the role of the vaccines. Patient had a history of vaccination with same suspect Influenza vaccine from last 4-5 years and experienced similar event. Patient also had history of peripheral neuropathy and brittle bone disease (5 fractures in 4 years). However, information regarding patient's condition at time of vaccination, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccines cannot be individually assessed.
H/A.  Headache started yesterday which went away w/tylenol. Pain came back this morning which is radiating to sinus area.  Denies bodyache, loss of smell, n/v/d/ URI symptoms.  Patient is a 54 year old male who presents to ED with 3/10 headache behind his eyes which started last night, then resolved and came back this morning. He reports some nausea without vomiting. No numbness, no tingling, no vision changes. He has known HTN and DM for which he takes daily medication. Past medical/surgical history, medications, allergies: Reviewed.
swollen, reddened area at injection site, approximately 3x4" on 10/20/20.  On 10./21/20, developed a pruritic rash to right hand from fingers to shoulder, as well as the right side of neck, left side of neck and left arm, worse on the right.
expired vaccine administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
no appetite; Because of this illness the patient's primary care doctor suggested that they had enough protection from the virus; dog tired,too tired to do anything; did not receive second shot in allowed time; Exposure to COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite), ILLNESS (Because of this illness the patient's primary care doctor suggested that they had enough protection from the virus), FATIGUE (dog tired,too tired to do anything), PRODUCT DOSE OMISSION ISSUE (did not receive second shot in allowed time) and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included TAMSULOSIN, LORATADINE (LOMAX [LORATADINE]), VITAMINS NOS (DAILY VITAMINS) and ATORVASTATIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (no appetite), ILLNESS (Because of this illness the patient's primary care doctor suggested that they had enough protection from the virus), FATIGUE (dog tired,too tired to do anything), PRODUCT DOSE OMISSION ISSUE (did not receive second shot in allowed time) and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19). At the time of the report, DECREASED APPETITE (no appetite), ILLNESS (Because of this illness the patient's primary care doctor suggested that they had enough protection from the virus), FATIGUE (dog tired,too tired to do anything) and EXPOSURE TO SARS-COV-2 (Exposure to COVID-19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not receive second shot in allowed time) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight decreased: 20 (Low) loss of 20lbs.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug included Cotaught and Blood pressure medication.  Treatment medication was not reported.  Patient was exposed to their grandson who tested positive for COVID-19 the day after seeing them. Patient's primary care doctor suggested that they had enough protection from the virus and did not need to continue the vaccination series. They have not received the second dose at but patient was considering at the time of this report.
Non severe allergic reaction rash on left ankle, dull chest pain, numbness of hands feet and top of head, joint pain in left knee (2011 arthroscopic release on left knee, healed and recovered), nausea, diarrhea, arm pain, very thick nasal mucus and coughing, all symptoms have happened within 24 hours of administered vaccine.
allergies with Tetanus; Initial information received on 05-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves unknown demographic patient who experienced allergies with tetanus, while received vaccine TETANUS TOXOID.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious allergies with tetanus (allergy to vaccine) (Unknown latency) following the administration of TETANUS TOXOID.  (Other relevant tests included no lab data.) Final diagnosis was allergies with tetanus.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for allergies with tetanus.  Information on the batch number was requested.  List of documents held by sender: none.
Rapid heart rate - right away and still experiencing went to emergencyroom and now cardiologist ,  hot rush - right away lasted 2 minsthrough body, tightness breathing  lasted a week. Went to urgent care and used inhalers,  itchy throat. Lasted the day
vaccine_brand_other=J&J, vaccine administration date: 06Apr2021/vaccine_brand_other=Moderna, vaccine administration date: 15Sep2021; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Sep2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine_brand_other=J&J, vaccine administration date: 06Apr2021/vaccine_brand_other=Moderna, vaccine administration date: 15Sep2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: days since my first dose and I still am testing positive (have never tested negative during or after the course of treatment). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Brand Paxlovid treatment start date was 03Mar2023 and treatment stop date was 08Mar2023,Indication reported Treatment of COVID-19. Other medication in 2weeks was reported as yes.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Administered 8/16/16. Tuesday night pain and redness started in arm. Wednesday pm fever started: pt reports 100.4. Pt administered TYLENOL immediately and fever subsided. Current temp 97.8.
stuffed up; runny nose; cough; sore arm; not immunocompromised, but received a full dose; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (not immunocompromised, but received a full dose), NASAL CONGESTION (stuffed up), RHINORRHOEA (runny nose), COUGH (cough) and VACCINATION SITE PAIN (sore arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A, 012M20A and 014F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced OVERDOSE (not immunocompromised, but received a full dose). On an unknown date, the patient experienced NASAL CONGESTION (stuffed up), RHINORRHOEA (runny nose), COUGH (cough) and VACCINATION SITE PAIN (sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. On 22-Oct-2021, OVERDOSE (not immunocompromised, but received a full dose) had resolved. At the time of the report, NASAL CONGESTION (stuffed up), RHINORRHOEA (runny nose) and COUGH (cough) had not resolved and VACCINATION SITE PAIN (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The contact is not immunocompromised. Concomitant medication use was unknown   This case was linked to MOD-2021-363393, MOD-2021-363403 (Patient Link).
has been having progressive shortness of breath and cough for the past 3 days and have been running intermittent fevers but was unsure of the actual temperature.  He felt that his shortness of breath and cough have been getting progressively worse and occasional productive of yellow sputum.
TOOK TWO DOSES IN A ROW; This case (PVX2019-2213) was received from a nurse on 29-Aug-2019. It described a male consumer who "took two doses in a row" (PT: Inappropriate schedule of product administration), while being oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took two doses of Vivotif in a row on 28-Aug-2019 and 29-Aug-2019, respectively.  Action taken with Vivotif with respect to the events was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Received the Shingrix (Shingles vaccine) and within 2-3 hours had extreme side effects. eg; headaches, spaciness, and violent shaking.
Breakthrough menstrual  bleeding occurred within 2.5 weeks of my last period, which I was on the 4th day of at the time of this 2nd injection. I?ve NEVER EVER had a period within 2.5 weeks of my last one & the flow was heavier than usual also
Patient was given the wrong dose at time of vaccination. He was given a dose for 65+ (High Dose) instead of the regular dose.
Fatigue & hives the next day & most days since. I?m not sure if it?s caused by my autoimmune disorders or the vaccine.  My nurse friend encouraged me to report the symptoms.
I had horrible headache, sore throat, terrible congestion, and body aches. I tested positive for COVID-19 at home. I talked to my doctor, and they prescribed me PAXLOVID. I was sick for 4 days and then I started feeling better. Then after a couple of days I got sick again. I had the same symptoms, and they were milder.
This spontaneous report as received from a licensed practical nurse refers to a 23 years old female patient. The patient was vaccinated with dose 1 of GARDASIL (lot #, dose and route not reported) on an unspecified date and was vaccinated intramuscularly with a second 0.5 ml dose of GARDASIL (lot # not provided) last week (approximately on 05-SEP-2012). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient experienced reactions after both her 1st shot and 2nd shot of GARDASIL. After the first dose, the patient experienced a drop in blood pressure and fainted. She was weak and had slurred speech. She recovered in 30 minutes. The patient received the second dose and again experienced a drop in blood pressure and felt weak last week (approximately on 05-SEP-2012). The patient was seen in an urgent care office. No treatment was given for the events. The vaccine series was discontinued. It was reported that drop in blood pressure and felt weak was (after second dose) had improved after therapy was stopped. The relatedness for the reported events was not provided for GARDASIL. Additional information has been requested.
Patient reported itching on upper right arm yesterday, Nov 1st, and waking today with erythemia, mild  inflammation, and warmth to touch over injection site, about 4inx3in. Claims she did not scratch using fingernails. May have been feverish, felt "lowsy". I advised to go to urgent care, will likely require antibiotics.
Adverse event; did not receive second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (Adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (did not receive second dose). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not receive second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was interrupted on an unknown date.       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. Further information has been requested.   Reporter did not allow further contact; 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. Further information has been requested.
Fever ranging from 99.4 to 101.8,  extreme chills and shivering, complete body aches, fatigue, headache.  Lasted 24 hours
approx 2 1/4 hr p/vax pt began screaming in high pitched, unusual sound;crying cont throughout noc & stopped by 9AM;parent called MD during noc;
received their Shingrix vaccines 3 yrs ago, late dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follow: The case was reported by consumer itself. The patient received 1st dose of Shingrix 3 years ago. The patient was late for 2nd dose of vaccination and led to incomplete course of vaccination. The information regarding 2nd dose administration was not provided. No further information was provided. This case is linked with US2021AMR084088 with same reporter for different patient (husband). The consumer did not consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR084088:same reporter (Husband´s case)
Swelling entire lateral aspect lt upper arm; next morning general aches, weakness, like fainting while in shower; Pt admitted to Hosp 8MAY-9MAY then re-admitted 20MAY-24MAY for chest pain;
Sore arm; Felt sleepy; Achy; Midnight being sweaty; Low grade headache; Kind of ran down, stayed in bed most of the day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Felt sleepy), PAIN (Achy), NIGHT SWEATS (Midnight being sweaty) and HEADACHE (Low grade headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (Medical history reported as mild asthma) and Seasonal allergy (Medical history reported as seasonal allergy). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Felt sleepy), PAIN (Achy), NIGHT SWEATS (Midnight being sweaty), HEADACHE (Low grade headache) and FATIGUE (Kind of ran down, stayed in bed most of the day). At the time of the report, PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Felt sleepy), PAIN (Achy), NIGHT SWEATS (Midnight being sweaty), HEADACHE (Low grade headache) and FATIGUE (Kind of ran down, stayed in bed most of the day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
pt recvd vax & APAP given prior to inj;pt slept until 830PM 8JAN96;upon awakening t101-102;attempts to give APAP again resulted in pt vomiting x 2;began shaking-jerking, eyes glassy, dec responsiveness;MD called;dec appetite & not self
Pt recv vax on 1/12/99; on 1/13/99 pt exp red areas on legs, right thigh erythema, hot, left thigh erythema; tx=Benadryl
Right arm is red, slight swollen and itchy. Patient has FROM to arm, no other concerns. Mom to apply ice pack and Benadryl OTC prn. Call back if worsens or no improvement by 24hrs.
The patient may have been administered a dos eof M-M-R II via the intramuscular route rather than the recommended subcutaneous route; No adverse effects were reported; This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.   On unknown date (reported as "couple of weeks ago"), the patient may had been administered a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dosage, frequency, lot number and expiration date were not reported) for prophylaxis via intramuscular route rather that the recommended subcutaneous route (Incorrect route of product administration).No adverse effects were reported.
Vaccine Administered at 3:30 PM 5/23/18 approximately 12 hours later patient developed a painful and swollen upper right arm in the tricep area.