chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Coughing and feeling pain in my throat.; Coughing and feeling pain in my throat; This is a spontaneous report from a contactable consumer. This is the second case of two split cases.  A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173) via an unspecified route of administration on 08May2021 as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0180) via unspecified route of administration on 24May2021 as dose 2, single for COVID-19 immunization. Medical history included hypertension and blood cholesterol increased. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for blood cholesterol increased, start and stop date were not reported; simvastatin (SIMVASTATIN) taken for blood cholesterol increased, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for blood cholesterol increased, start and stop date were not reported; losartan (LOSARTAN) taken for hypertension, start and stop date were not reported. On 10Jun2021 patient started coughing /coughing is so annoying and feeling pain in throat. Still experiencing side effect: whole time in morning and when he goes back in 8 PM start experiencing the worse. Patient didn't receive any treatment for adverse events. The clinical outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
Fatigue, muscle pain, head ache, nausea, stomach pain, abdominal bloating, kidney pain
states sz eve before & again in AM;advised seek medical attention immed;f/u phone call reveal child seen @ hosp;MD state it's possible DTAP could have caused sz;father states has sz this time every year & should have reported to clinic;
extreme swelling around injection site; redness around injection site; pain around injection site; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient reported and adverse event with Shingrix and was looking to receive the 2nd dose when due but the patient want to try to determine if there was potential risk to the patient in receiving the 2nd dose. The patient had redness, extreme swelling, and pain around the injection site. The reporter saw the site about 6 days after the administration and the site was still red and mildly swollen in about a 5 inch x 4 inch area of the bicep area of the arm where the injection was given.
No strength; Shakes; Shortness of breath; Hair loss; Where she is in space feels screwed up; Joint pain; chills; Muscle pain; Absolutely debilitating fatigue; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No strength), TREMOR (Shakes), DYSPNOEA (Shortness of breath), ALOPECIA (Hair loss) and FEELING ABNORMAL (Where she is in space feels screwed up) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced ASTHENIA (No strength), TREMOR (Shakes), DYSPNOEA (Shortness of breath), ALOPECIA (Hair loss), FEELING ABNORMAL (Where she is in space feels screwed up), ARTHRALGIA (Joint pain), CHILLS (chills), MYALGIA (Muscle pain), FATIGUE (Absolutely debilitating fatigue) and FATIGUE (Tired). At the time of the report, ASTHENIA (No strength), TREMOR (Shakes), DYSPNOEA (Shortness of breath), ALOPECIA (Hair loss), FEELING ABNORMAL (Where she is in space feels screwed up), ARTHRALGIA (Joint pain), CHILLS (chills), MYALGIA (Muscle pain), FATIGUE (Absolutely debilitating fatigue) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment The consumer is taking Tylenol for these symptoms.
COVID 19 Treatment/ Contracted COVID-19; COVID 19 Treatment/ Contracted COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 68 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9262), on 17Feb2021 as dose 2, single (Lot number: EN6200), on 29Sep2021 as dose 3 (booster), single (Lot number: FF8841) and on 03Apr2022 as dose 4 (booster), single (Lot number: FK9895) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: FOSAMAX, start date: 18May2018. Past drug history included: Known allergies: lomotil, reaction(s): "Known allergies: LOMOTIL", notes: Known allergies: LOMOTIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Feb2023, outcome "recovering" and all described as "COVID 19 Treatment/ Contracted COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid taken from 25Feb2023 to 02Mar2023.
Five days after the shot, I started getting constipated really bad. I couldn't go to the bathroom for 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of Five days after the shot, I started getting constipated really bad. I couldn't go to the bathroom for 3-4 days in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032B21A) for COVID-19 vaccination.     No medical history reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced Five days after the shot, I started getting constipated really bad. I couldn't go to the bathroom for 3-4 days. On 01-Apr-2021, Five days after the shot, I started getting constipated really bad. I couldn't go to the bathroom for 3-4 days had resolved. Not Provided.          No concomitant medications listed.    This case was linked to US-MODERNATX, INC-MOD-2021-098138. Sender's Comments:  US-MODERNATX, INC-MOD-2021-098138.
BELLS PALSY; This spontaneous report received from a patient via a company representative and concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s. The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had bells palsy (Dose number in series 2). It was reported that shot was not tested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220400821-covid-19 vaccine ad26.cov2.s-Bell's palsy. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
This is a spontaneous report from a contactable pharmacist via Pfizer representative. A patient of unspecified age and gender received PREVNAR 13, on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced lymphadenoma in arm at the injection site on an unspecified date with outcome of unknown.
Patient received Pfizer COVID-19 vaccine which was beyond the manufacturer recommended use time of 31 days at the refrigerated temperature. Organization has been in direct contact with the vaccine manufacturer regarding this issue. Pfizer has data to support the stability of the vaccine up to 45 days at refrigerated temperatures. The vaccine given was within this range which is supported by the above data. No known adverse outcomes. Patient received Pfizer COVID-19 vaccine which was beyond the manufacturer recommended use time of 31 days at the refrigerated temperature. Organization has been in direct contact with the vaccine manufacturer regarding this issue. Pfizer has data to support the stability of the vaccine up to 45 days at refrigerated temperatures. The vaccine given was within this range which is supported by the above data. No known adverse outcomes.
Light Headedness, scratchy throat. Problem persists with constant headache and unable to focus. Its Been one month already.
INCREASED STIFFNESS AFTER COVID VACCINE. MODERNA COVID-19 VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (INCREASED STIFFNESS AFTER COVID VACCINE. MODERNA COVID-19 VACCINE) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (INCREASED STIFFNESS AFTER COVID VACCINE. MODERNA COVID-19 VACCINE). At the time of the report, MUSCULOSKELETAL STIFFNESS (INCREASED STIFFNESS AFTER COVID VACCINE. MODERNA COVID-19 VACCINE) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not reported.
Patient complained of hives on his face, treated with Benadryl and Tylenol. Complains rash exist one week after vaccination
Severe chest pain for 5 hours on January 3rd starting at 1 am. Tachycardia for a day and a half.
This case was reported by a pharmacist via sales rep and described the occurrence of extensive swelling of vaccinated limb in a elderly female patient who received SHINGRIX. On 13th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, erythema and pruritus. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema and pruritus were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema and pruritus to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced raised redness, swelling around the entire arm located 1 inch below the injection site and itching. These symptoms persisted at the time of reporting. The reporter agreed to be followed up.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 29-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds .5 mL Vls 10 SDV, which had the lot # K008409, with expiration date 04-MAR-2016 (dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced different temperature excursions of 88, 64, 320, 152, 184 and 264 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius degree), 33 F (0.555555556 Celsius degree), 31 F (-0.555555556 Celsius degree), 30 F (-1.111111111 Celsius degree), 29 F (-1.666666667 Celsius degree) and 32 F (0 Celsius degrees) respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.
PT REPORTED TO PHARMACY MORNING AFTER VACCINE TO SHOW RPH ARM.  IT APPEARS THAT SHINGRIX MAY HAVE BEEN INJECTED INCORRECTLY IN BACK OF ARM VS DELTOID. IT APPEARED RED, SWOLLEN,  AND WARM TO TOUCH.  RPH ON DUTY RECOMMENED PT SEE HER DR TODAY. ERROR WAS REPORTED TO UPPER MANAGEMENT SO FLOATER PHARMACIST CAN BE RETRAINED.
Arthritic feeling in legs/ ankles hurt a little; Low fever; Chills; Weak legs; Like arthritic-y and her ankles felt heavy like 100lbs each; Stood up after sitting down it felt heavy; Legs felt heavy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak legs), JOINT SWELLING (Like arthritic-y and her ankles felt heavy like 100lbs each), SITTING DISABILITY (Stood up after sitting down it felt heavy), ARTHRALGIA (Arthritic feeling in legs/ ankles hurt a little) and PYREXIA (Low fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced JOINT SWELLING (Like arthritic-y and her ankles felt heavy like 100lbs each), SITTING DISABILITY (Stood up after sitting down it felt heavy) and LIMB DISCOMFORT (Legs felt heavy). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Weak legs), ARTHRALGIA (Arthritic feeling in legs/ ankles hurt a little), PYREXIA (Low fever) and CHILLS (Chills). At the time of the report, ASTHENIA (Weak legs), JOINT SWELLING (Like arthritic-y and her ankles felt heavy like 100lbs each), SITTING DISABILITY (Stood up after sitting down it felt heavy), ARTHRALGIA (Arthritic feeling in legs/ ankles hurt a little), PYREXIA (Low fever) and CHILLS (Chills) outcome was unknown and LIMB DISCOMFORT (Legs felt heavy) had not resolved.            Concomitant product use was not provided by the reporter.  On 23-Mar-2021, the patient had ankles hurt a little.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: follow-up information received on 11-May-2021, contains no new information.
Patient got first dose of Covid vaccine (Prizer) on 04/02/21 around 11:00am. Patient started develop adverse effects of dizziness, cold and low blood glucose. He almost passed out. He refused us calling 911. However after 20 minutes, symptoms get worse . We call 911 and AMR arrived.
The evening of 05/02/00 left arm became red and swollen. Cool pack was applied-area swollen form shoulder to elbow. 5/3/00 warm pack applied. Child observed by RN on 5/3 & 5/4/00. 5/4/00, red raised area noted around site, redness and swelling decreased-child active and alert, eating and drinking. Advised 5/4/00 to contact MD. 5/11 RN to mother used Benadryl gel on rash.
pain in the first week followed by tingling and numbness that has continued into present day in the left arm
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received COVID-19 treatment from 13Oct2023 to 17Oct2023. No known allergies.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
noticed soreness and itching in the evening but by the morning, felt area with warmth and swelling and redness; no fever
Child (2.5 years) was given Adacel inadvertently by HCP with no reported adverse event; Initial information received on 23-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 28 months old female patient who was given adacel inadvertently by health care professional with no reported adverse event, after  receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Aug-2022, the patient received a  total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE( lot U7461AA) at 0.5ml once via intramuscular route in unknown administration site for Immunization..  On 23-Aug-2022(latency: same day), the patient was given adacel inadvertently by health care professional with no reported adverse event (product administered to patient of inappropriate age)(latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: unknown   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 the guidelines. 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.
URINARY TRACT INFECTION; pink in my urine; Little bit of Pain after injection in left arm; A spontaneous report  was received from a 71 years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection (urinary tract infection), pink in my urine (chromaturia) and little bit of pain in arm of injection (pain in extremity).  The patient's medical history was not provided. The relevant concomitant medications were also not provided.  On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number:013M20A ) through intramuscular route of administration in the left arm for prophylaxis of COVID-19 infection.  On 02 Feb 2021, patient experienced little bit of pain in arm of injection.   On 23 Feb 2021, patient experienced pink in urine. The patient subsequently visited the urgent care on 26-Feb-2021 and was diagnosed with  a urinary tract infection. Treatment for urinary tract infection included ciprofloxacin 500 mg twice daily for 7days.  No laboratory data was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event little bit of pain in arm of injection was resolved 03 Feb 2021. The event pink in urine was resolved on 01 Mar 2021. The outcome of the event urinary tract infection was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (vaccination site pain) a causal relationship cannot be excluded. However, for the events - chromaturia and UTI, a very limited information has been provided at this time. Further information has been requested.
Information has been received from a pharmacy Intern referring to two unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On 12-OCT-2016, the patients were administered doses of PNEUMOVAX 23 syringes (lot number M020521 with expiration date 17-NOV-2017; dose was unknown) intramuscularly. On an unspecified date in October 2016, after administration, the patients experienced "redness, and swelling from the shoulder to the elbow on the arm, where PNEUMOVAX 23 was administered". Both the patients also experienced the area being "hot to touch". No treatment was given for the events. These symptoms lasted for an unspecified amount of time, and the current status of the unspecified patients was unknown. The pharmacy intern requested a lot check for this lot of PNEUMOVAX 23. The causal relationship between the events and PNEUMOVAX 23 was unknown. Additional information has been requested.
Six days post vax, the pt was found to have SGOT=193 (0-42). No treatment was given. The most recent information received reports the condition of the pt is ongoing.
Widespread myalgia starting upon waking up the next morning.  After waking up the following morning, the pain was gone.