chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left Arm Tendonitis; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 (Lot number: FF8841) at the age of 49 years as dose 2, single for covid-19 immunisation at pharmacy or drug store. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FE3592, Location of injection: Arm Left), administration date: 29Aug2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: TENDONITIS (non-serious) with onset 25Oct2021, outcome "not recovered", described as "Left Arm Tendonitis". Therapeutic measures were not taken as a result of tendonitis.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up (14Dec2021): Follow-up attempts are completed. No further information is expected.
6/8/2022 tested positive with an at home rapid COVID 19 test.  Chills; body aches; sore throat.  Only sore throat after 6/8, with occasional hot sweats corresponding to physical activity.    6/23 visited Urgent Care.  Diagnosed with bronchitis, prescribed Z-Pack.  Still coughing as of 7/1.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Severe, Systemic: Hypertension-Severe, Systemic: Hyperventilation-Severe, Systemic: Nausea-Severe, Systemic: Tachycardia-Severe, Systemic: Vomiting-Severe
This spontaneous report was received from a physician refers to an approximately 51-year-old female patient (reported as over 50 years). Patient had a history of shingles. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). The patient developed shingles after receiving a dose of ZOSTAVAX on an unknown date. The patient recovered on an unknown date. It was unspecified whether lab diagnostic studies were performed or whether patient sought medical attention. Additional information has been requested.
headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In 11th July 2019, the patient received shingles vaccine. The patient experienced headache after receiving the vaccine.
STOMACH ACHE THAT FELT LIKE CRAMP IN STOMACH; INCREASED HEART RATE; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight was 57.7 kilograms, and height was not reported. The patient's concurrent conditions included: secondary pulmonary hypertension. The patient received selexipag (tablet, oral, batch number: 1223186, and batch number: 1223186 expiry: 31-JUL-2022) 800 ug, 2 times every 1 day from 07-SEP-2021 to 07-OCT-2021 for secondary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included macitentan for drug used for unknown indication, and sildenafil citrate for drug used for unknown indication. On OCT-2021, the patient experienced increased heart rate. Laboratory data included: Heart rate (NR: not provided) 102 {beats}/min. On an unspecified date, the patient experienced stomach ache that felt like cramp in stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of selexipag was not changed. The patient had not recovered from increased heart rate, and the outcome of stomach ache that felt like cramp in stomach was not reported. This report was non-serious.
Developed fever up to 102.4 F. and fever continued for 48 hours. Developed body aches and chills for same amount of time. Also developed extreme fatigue that is slowly resolving. The day after the fever resolved, developed multiple sores in the mouth treated with salt water rinses.
Information has been received from a pharmacist concerning a patient who an unspecified date was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported). The Pharmacist reported that a physician called and reported that the patient who received a dose of VARIVAX (Oka/Merck) was now non-immune to VARIVAX. It was unknown if the patient sought any medical attention. The outcome of the patient was unspecified. No further information is available.
Patient came into Pharmacy with complaint of Rash on left wrist, at injection site, and on left shoulder. Complained of itching.
severe chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (severe chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (severe chills). At the time of the report, CHILLS (severe chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.   This case was linked to MOD-2021-302223 (Patient Link).
Ovarian pain on my right side including twisting/tightening that continued until 1/23/21 with added pain across my lower abdomen and back pain. To date, this aching pain in abdomen and back is still noticeable.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Mild, Additional Details: Patient temp at time of incident was 96.8. About 8 mintues after vaccination was given patient became pale and passed out for several seconds. Patient was dizzy and vomited. No other symptoms. Called paramedics to make sure patient was okay. Gave patient some water and spoke to patient until the paramedics arrived. Paramedics took her vitals and after while they cleared her. She was able to walk out on her own and went home with her father and brother.
Dose 1 in 2019 and dose 2 in 2022; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (1st dose was received in 2019).  In DEC-2022, the patient received the 2nd dose of Shingrix. In DEC-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Dose 1 in 2019 and dose 2 in 2022). The outcome of the drug dose administration interval too long was unknown.  Additional Information: GSK Receipt Date: 07-APR-2023 The patient reported that he received the second dose in December 2022.  Education was provided to patient. The reporter had denied consent to follow-up. The patient had received the second dose later than the recommended interval, which had led to lengthening of vaccination schedule.
Fever of 101.3 degree F/fever of 100.6 degree F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.3 degree F/fever of 100.6 degree F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Patient takes medication twice a day for hypertension). Concomitant products included VALSARTAN, HYDRALAZINE, HYDROCHLOROTHIAZIDE and ATENOLOL for an unknown indication.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced PYREXIA (Fever of 101.3 degree F/fever of 100.6 degree F). The patient was treated with PARACETAMOL (TYLENOL) on 23-Oct-2021 for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 101.3 degree F/fever of 100.6 degree F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2021, Blood pressure measurement: 160/96 (High) BP was160/96 mmHg. On 23-Oct-2021, Body temperature: 101.3 (High) 101.3 Degree Fahrenheit and 100.6 (High) 100.6 Degree Fahrenheit after an hour of taking Tylenol. On 23-Oct-2021, Heart rate: 96 (High) 96 beats per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had reported that on October 23 2021 blood pressure was 160/96 mmHg  and his pulse was 96 beats per minute which was not typical for him. Patient also had a fever of 101.3 degree Fahrenheit, so they took some Tylenol and then after an hour, it was 100.6 degree Fahrenheit.    This case was linked to MOD-2021-361891, MOD-2021-361949 (Patient Link).
Myalgia; flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of myalgia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia and influenza-like symptoms. On an unknown date, the outcome of the myalgia and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the myalgia and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experianced myalgia and influenza-like symptoms. For the tolerance of 2nd dose, refer linked case US2020AMR172256. This was 1 of 3 linked case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR172064:same reporter US-GLAXOSMITHKLINE-US2020AMR172256:2nd Dose, same patient
Information has been received from a RN concerning a pt who's 4 year old female sibling was vaccinated with a dose of varicella virus vaccine live (Lot # 630678/0426J) on 02/02/00.  The pt had never been immunized against chickenpox and developed a "classic case" of chickenpox on approximately 08/04/03.  The child's chickenpox was noted to be a "full case". Because the pt's sibling had some lesions in her hair some time in August 2003, it was assumed that the disease was transmitted to the pt. Additional information has been requested. The nurse also reported a case of chickenpox in the pt's sibling after being vaccinated with a dose of varicella virus live (WAES  #03090USA02503).
Patient fell faint and passed out for 2 minutes after administration of all 3 vaccines. EMS came and took patient's vitals and cleared patient as okay.
URI, h/a, fever, cough starting on E-Mycin 13DEC;
Pounding in chest with rapid heart rate variable up to 180 bpm. I  first noticed a faster heart rate at approximately 6:00 p.m., 10/19/208. It reached its peak around 11:00 p.m., 10/19/208 and continued until approximately 3:00 a.m., 10/2-/2-18., when I finally fell asleep. My normal resting heart rate is 59 bpm. I thought about going to the hospital during the night, but didn't and it is now back to normal  range. I never had a rapid heartbeat like this before.
p/vax pt reports some soreness in muscle a few days;Today (20 days later) woke up this Am & arm started hurting again;when presses where shot was given it is tender & feels swelling under tissue;pt does not think arm is warm than other;
Stiff neck; sore arm at injection site; This is a spontaneous report from a contactable consumer (patient's wife). The 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP6955 expiry date: unknown) via an unspecified route of administration in right arm on 17Mar2021 01:15 PM, as a single dose for Covid-19 immunisation. Medical history included high cholesterol. The patient has no known allergies medications, food, or other products. Concomitant medications in two weeks included fexofenadine hydrochloride (ALLEGRA); atorvastatin (LIPITOR [ATORVASTATIN]). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Facility where COVID-19 vaccine was administered was at a clinic. Patient not tested for COVID-19 prior to vaccination. On 19Mar2021, the patient experienced stiff neck and sore arm at injection site. He did not receive treatment for events. Patient not tested for COVID-19 after the vaccination. The outcome of the events of stiff neck and sore arm at injection site was reported as recovering.  No follow-up attempts were needed. No further information was expected.
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. SORE ARM AFTER 1ST VACCINATION.
Second day after receiving vaccine, felt fatigue and slept most of day.  Had some muscle and joint pain and loss of appetite.  Never had a fever.  Only symptoms to this date are fatigue and appetite loss.  ON Thursday January 21 tested positive for Covid 19.  No real bad problems never had a fever.
Woke up with a full body rash and fever - pt taken to hosp. for urticaria. Also has with peanut butter.
Headache, Fatigue, Sleep Disturbance, Joint Pain, Body Aches, Elevated Liver Enzymes, Deep Grooves in Thumbnails, Abdominal Swelling, Hand Tremor
Myalgia, Arthralgia, NauseaVomiting, chills/ fatigue Narrative:
C/O vomiting, diarrhea, abdominal cramping, body aches, right flank pain.
This spontaneous report was received from a pharmacist referring to an unspecified number of 30 year old patients. The patients' had no medical history, concurrent condition, drug and allergy history to be reported. On an unspecified date, an unspecified number of patients were vaccinated with GARDASIL 9 (strength, dose, lot #, expiration date were not reported) for prophylaxis. No adverse effects reported. Additional information has been requested.
Within four hours = sore arm, "heavy head"  24 hours = sore arm, headache, stomach cramps, headache, sore jaw, muscle aches  36 hours = all of the above with a fever not to exceed 100.7 48 hours = no symptoms  72 hours = cold symptoms, runny nose/congestion, chills, no fever
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 03-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 828 hours (sum of hours in excursion). The vaccine status was reported and "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No medical history, concurrent conditions or concomitant therapies were reported. On 28-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA lot # L009445, expiration date 01-JUN-2017 (dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccinated with Jannsen vaccine, developed COVID 19 and admitted to hospital on 7/10/2021
Patient reports she had her vaccine on 1/13/21. On 1/14/21 at approximately 9 or 10 am she felt achy muscles, painful joints and all over pain.  She reports the pain progressively worsened on Friday and Saturday and Sunday to the point where she was unable to sleep or move from the bed or sofa.  She notes she ran a low grade fever up to 99.6 and she also had a headache throughout this time.
After vaccination I developed rash on my right and left elbow. It appeared to be dry patches. No pain affiliated with rash.
In January in the evening I went to the gym and was working out and I felt ok and when I got home I started to feel under the weather and I went to bed and I felt sick and tested positive at my doctors office, normally I wouldn't have thought much of it and after a few days I felt ok.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 09:00 as dose 5 (booster), single (Lot number: C55343) at the age of 55 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 at 13:00 as dose 1, single (Lot number: EL9263), in right arm, on 11Feb2021 at 13:00 as dose 2, single (Lot number: EM9809), in right arm, on 04Oct2021 at 08:00 as dose 3 (booster), single (Lot number: 301358A), in right arm and on 30Mar2022 at 09:00 as dose 4 (booster), single (Lot number: IK9896), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive on Day 4.  Therapeutic measures were taken as a result of vaccination failure, covid-19.
Information has been received from a licensed practical nurse concerning an unidentified patient with asthma who was vaccinated with a dose of PNEUMOVAX. It was reported that the patient had a reaction after getting PNEUMOVAX. The patient had an asthma attack after getting PNEUMOVAX. No details were available on this patient. This is one of two cases from the same source. Additional information has been requested.
Initial misuse report received from a healthcare professional on 08 OCTOBER 2013. A 4-year-old female patient had received ADACEL instead of KINRIX last week. List of documents held by sender: none
Hives, joint pain, elevated B/P, elevated HR, flushed upper body and tingling
Headache, Myalgia, Arthralgia, chills Narrarive:
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of M-M-R II (6 doses of lot # L001336 and expiry date: 13-JAN-2017). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
On 10/5, pt developed a fever to 103. Pt developed a maculopapular rash on face and trunk onset 10/8/01.
I stood up And wAlked About 15ft And Felt dizzy, I thought it WAs my blood sugAr, Didnt tell facility.  Ate + Felt better 3 hours exActly lAter Dizzy w/confusion Still hAving this off And on bAd todAy. I hAve stAggered, slurred, forget whAt I'm tAlking About. I get the shAkes + heAdAches Also.
redness at injection site; symptoms of swelling at the injection site and a ring around the injection site; This is a spontaneous report received from contactable reporter(s) (Nurse and Other HCP) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GM9409, Expiration Date: 31Aug2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness at injection site"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "symptoms of swelling at the injection site and a ring around the injection site". Additional information: It was reported that two patients had symptoms of swelling at the injection site and a ring around the injection site, also redness at injection site in the same batch of Prevnar 20.  No follow-up attempts are possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300082584 same drug and AE, different patient;
Sore arm; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mocalopopular mark-Trumcal ienopounie to Foratacetive/Benadryl. Given Methylpredinalone 40 mg on 09/26/07
Upset stomach; Injection site pain; Soreness in right arm; Tiredness; Headache; Chills; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 06Apr2021 at 15:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included Factor V Leiden, Raynaud, sleep apnea and COVID-19. Concomitant medications included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D3), calcium (MANUFACTURER UNKNOWN), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC) and Multi vitamin; all for an unknown indication and from an unspecified date and unknown if ongoing. The patient previously received nitrofurantoin (MANUFACTURER UNKNOWN) on an unknown date for an unspecified indication and experienced drug allergy. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Apr2021 at 10:00, the patient experienced injection site pain, soreness in right arm, tiredness, headache, chills, feeling unwell and upset stomach. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events Injection site pain, soreness in right arm, tiredness, headache, chills, feeling unwell and upset stomach were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.