chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLOOD CLOT; PULMONARY EMBOLISM; FELL; BROKE A BONE; SEVERED A NERVE; LOST A 100 POUNDS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, thoracic aortic aneurysm, sulfa antibiotics allergy (hives), abstains from alcohol, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient was no longer on blood pressure medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202S21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 61 years old. Concomitant medications included diltiazem (Cardizem). On an unspecified date in JUN-2021 (After about 2 months later), the patient started having trouble in breathing and her doctor encouraged her to go to the ER (emergency room) because she told her that she got the JNJ COVID-19 vaccine. The lung clinic doctor sent patient to the emergency room when she was having trouble breathing. On JUN-2021, the patient experienced blood clot, pulmonary embolism and was hospitalized (date unspecified). She was admitted to the hospital for 7 to 10 days and she was put on the Eliquis (apixaban) for blood clots and pulmonary embolism. On an unspecified date, the patient fell, and had broke a bone, severed a nerve and I have lost a 100 pounds and also need knee surgery. The patient wish that she had never got the COVID vaccine and had just taken her chances with COVID. The patient visited the emergency room and physician office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot, and pulmonary embolism, and the outcome of fell, broke a bone, lost a 100 pounds and severed a nerve was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20220822212-covid-19 vaccine ad26.cov2.s-blood clot. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered related. 20220822212-covid-19 vaccine ad26.cov2.s-pulmonary embolism. This event(s) is labeled per Agency and is therefore considered potentially related. 20220822212-covid-19 vaccine ad26.cov2.s-fell. 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. 20220822212-covid-19 vaccine ad26.cov2.s- broke a bone and severed a nerve. The case causality is considered NOT RELATED. Rationale: recent event of fall provides more plausible explanation.
Aches started about 4-5 hours after the shot, and about 6 hours after the shot I had a 102 degree fever that lasted 12 hours. I also felt nauseous and had chills.
Redness turning into rash that is creeping down arm; Low grade fever; Feeling achy; Headache; Redness at injection site; Pain in injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Redness turning into rash that is creeping down arm), MYALGIA (Feeling achy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain in injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. L29L20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ATENOLOL, HYDROCHLOROTHIAZIDE, ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO), ATORVASTATIN and FENOFIBRATE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (Feeling achy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain in injection site). On 27-Feb-2021, the patient experienced PYREXIA (Low grade fever). On 28-Feb-2021, the patient experienced RASH (Redness turning into rash that is creeping down arm). The patient was treated with NAPROXEN SODIUM (ALEVE) on 27-Feb-2021 for Pain, at a dose of 220mg 2 tabs. At the time of the report, RASH (Redness turning into rash that is creeping down arm) had not resolved and MYALGIA (Feeling achy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PAIN (Pain in injection site) and PYREXIA (Low grade fever) outcome was unknown.            Action taken with mRNA-1273 in response to events was not applicable.
Headache; Shivering; Fever of 101F; Fatigue; Bedridden; Quite ill; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2022, the patient received the 1st dose of Shingrix (injection, left arm). On an unknown date, 1 hr after receiving Shingrix, the patient experienced headache (Verbatim: Headache), shivering (Verbatim: Shivering), fever (Verbatim: Fever of 101F), fatigue (Verbatim: Fatigue), bedridden (Verbatim: Bedridden) and unwell (Verbatim: Quite ill). The outcome of the headache, shivering, fever, fatigue, bedridden and unwell were recovered/resolved.   It was unknown if the reporter considered the headache, shivering, fever, fatigue, bedridden and unwell to be related to Shingrix.     It was unknown if the company considered the headache, shivering, fever, fatigue, bedridden and unwell to be related to Shingrix.   Additional Information: GSK Receipt Date:15-MAR-2023  The patient self-reported this case. The reporter reported that within 1 to 6 hours (probably closer to 5 to 6 hours) after receiving his dose of Shingrix, he experienced headache, shivering, a fever, and fatigue that left him bed ridden and quite ill for 2 and half days. The reporter had not spoken with his doctor about his adverse reactions but would at his appointment later that month.  The reporter consented to follow up with health care professional.
Information has been received from a consumer concerning her 28 year old daughter with no pertinent medical history, allergies or drug reactions, who was vaccinated with the first dose of GARDASIL, on 29-MAY-2007 and was vaccinated with the third dose in November 2008.  There was no concomitant medication reported.  The reporter stated that in November 2008 (also reported as about a month after receiving the last dose) her daughter started experiencing pain and swelling of feet and arms, especially on her left side.  It was also reported that she woke up because of the pain in her extremities and shoulders.  She was diagnosed with rheumatoid arthritis in December 2008.  Laboratory test performed included "blood work" and "x-rays" (no results were provided).  The patient's rheumatoid arthritis persisted.  The patient sought unspecified medical attention.  Follow up information has been received from a registered nurse concerning a 28 year old female with a history of mild dysplasia cervix who on 29-MAY-2007 was vaccinated intramuscularly (IM) in right deltoid (RD) with first 0.5mL dose of GARDASIL (lot number 657736/0389U), on 07-AUG-2007 was vaccinated IM in left deltoid with second 0.5mL dose of GARDASIL (lot number 657868/0523U) and on 23-NOV-2007 (previously reported as November 2008) was vaccinated IM in RD with third 0.5mL dose of GARDASIL (lot number 659437/1266U).  There was no concomitant medication.  The nurse reported that the she did not have information about the patient rheumatoid arthritis and therefore cannot comment on her condition.  The nurse was unable to provide any information on the primary physician of the patient as she only had his/her last name.  Additional information has been requested.
tested positive for Covid-19 infection; a little over a week later tested positive for Covid-19 infection; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for 25-year-old Patient  that received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced tested positive for covid-19 infection, a little over a week later tested positive for covid-19 infection. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 2021. Caller asked when can he get his second dose. Caller states we heard 3 months and then the pharmacy said 2 weeks after positive test and has no more symptoms so we're confused and concerned and just want to know when he can get it. Response: Provided disclaimer and spoke from the attached document. Will send attached document in fulfillment via email to the email address caller provided. Referred to HCP for further guidance. Survey offered. Caller asked if he gets up and around and goes to a different state, is he able to get the second dose anywhere as long as he has his vaccination card. Caller stated the place he got his first dose is no longer there. Response: Explained that the doses were the same and he could receive second dose as long as it was the Pfizer Covid-19 vaccine. He did not get any additional shots on the day he got the vaccine; he did not go to the doctor's office or emergency room related to this other than to test for COVID. No treatments, he has just quarantine at home with his symptoms. Description of Product complaint: Warm transfer of a mom calling for son and who explained that he got his first dose of the Pfizer COVID vaccine then 1 week after getting it he came down with COVID. She would like to know when he can get the second dose. The outcome for both events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Is a hot; injection site has a big swollen area; Is itching really bad; It's sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Is a hot), VACCINATION SITE SWELLING (injection site has a big swollen area), VACCINATION SITE PRURITUS (Is itching really bad) and VACCINATION SITE PAIN (It's sore) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 016M20A and 004M20A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Is a hot), VACCINATION SITE SWELLING (injection site has a big swollen area), VACCINATION SITE PRURITUS (Is itching really bad) and VACCINATION SITE PAIN (It's sore). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Is a hot), VACCINATION SITE SWELLING (injection site has a big swollen area), VACCINATION SITE PRURITUS (Is itching really bad) and VACCINATION SITE PAIN (It's sore) had resolved.            Other treatment medicines included OTC medicine.   This case was linked to MOD-2021-368828 (Patient Link).
Ct. presented to Health Department approximately 20-30 minutes following vaccine administration with redness to vaccines sites, abdomen & face. Hives also present to these areas.
This spontaneous report as received from a pharmacist refers to a 82 year old female patient. On 13-JAN-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous. Concomitant therapies included simvastatin (manufacturer unknown), levothyroxine sodium (manufacturer unknown), potassium chloride (manufacturer unknown), hydrochlorothiazide, MAXZIDE and meclizine. On an unspecified date, in January 2014, the patient experienced a sinus infection after receiving ZOSTAVAX. Patient sought physician for sinus infection on 24-JAN-2014. The outcome of sinus infection was not reported. Patient received Prednisone and LEVAQUIN as treatment for the adverse event. The relationship between ZOSTAVAX and the event was not reported. Additional information is not expected.
moderate fatigue; mild injection site pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Nov2021 00:45 (Lot number: fh8027) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: en6203, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 23Mar2021, when the patient was 43 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: en6203, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 02Mar2021, when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021 00:45, outcome "unknown", described as "Booster"; FATIGUE (non-serious) with onset 17Nov2021, outcome "recovered" (19Nov2021), described as "moderate fatigue"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "mild injection site pain". Therapeutic measures were not taken as a result of fatigue, vaccination site pain.  Additional Information: The patient had moderate fatigue lasting 48 hours post vaccine mild injection site pain lasting 24hours post vaccine. The patient did not have covid prior to vaccination. The patient did not have known allergies. The patient did not tested covid post vaccination.   No follow up attempts are needed. No further information is expected.
Muscle soreness first at injection site and then spread up upper arm. Soreness still at three weeks post injection. Treated with tylenol
Postural orthostatic tachycardia syndrome (POTS); Fatigue; Dizziness; Headache; Autonomic Dysfunction; Orthostatic Intolerence; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 28-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome, orthostatic intolerance, autonomic nervous system imbalance, headache, dizziness and fatigue.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007594:
Patient did not experience adverse effects.  Patient was given High Dose vaccine and is not 65.  Reporting to VAERS in case of reaction.
Information has been received from a woman in a medical office concerning a 59 year old female pt who on 11/22/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (644107/0955M). It was noted that ten minutes after receiving the vaccination the pt experienced the following: got lightheaded, scratchy throat, dysphoria, and anxiety. The pt was given a nebulizer treatment and she went to an emergency room. It was noted the pt was not hospitalized and everything resolved. The reporter has requested a lot check. The records of testing prior to release of this low have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter mentioned that another pt also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES0212USA02009).
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I was ordered to take the anthrax vaccine and experienced life altering side effects from this vaccine. I took 3 of the 6 shots and after each shot I experienced joint pain which increased in severity and duration with each successive shot. I developed muscle twitching after the third shot and have been evaluated and document. I have since been separated from the guard and continue to have the muscle problems every few minutes. It is a constant reminder of this unnecessary vaccine which I was forced to take and the ongoing research that is being conducted on our troops.
An ActHIB (Haemophilus b conjugate vaccine) was mixed with a Meningococcal (Menactra vaccine) and given to the patient together.
Patient was very tired on Monday, 3/30/2021 and took a nap. When she woke up, she was covered in hives on her face, down her neck, all over her back and down her arms.  The hives up her spine were the size of quarters.  Immediately gave her 2 mg tabs of Benadryl and used Caladryl lotion to control the itching. After 1 hour, Patient took a cold shower to stop the spread of the hives and re-applied additional Caladryl.  Maintained the Benadryl dosing throughout the rest of the day into the next day continuously.  As of this writing on 3/31/2021, Patient still has hives on her arms.
The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 01Feb2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer and from a contactable medical assistant via Pfizer Sales Representative. This medical assistant reported similar events on five patients. This is the fifth of five reports. A 94-year-old female patient of unspecified ethnicity received, at the age of 93 year-old, PREVNAR 13 (lot number M20639 and expiration date 30Apr2017, NDC number 0005-1971-02) via an unspecified route of administration, on the deltoid on 17Nov2015 at 0.5 ml single. Relevant medical history was not reported and concomitant medications were none. The patient experienced cellulitis on 17Nov2015 and redness on 19Nov2015. The patient was admitted to the hospital due to the events from 28Nov2015 to 06Dec2015 and C. difficile colitis was diagnosed. The patient was treated with AUGMENTIN. The patient recovered from cellulitis while the outcome of redness was not provided.
Immunocompromised; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot numbers were not reported), via unspecified routes of administration, on unspecified dates, as dose 1, single, and then as dose 2, single, for COVID-19 immunization; and adalimumab (HUMIRA), via an unspecified route of administration, on an unspecified date, at an unspecified dose and frequency, for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient had both doses of the Pfizer COVID-19 shot and was immunocompromised on an unspecified date because the patient takes adalimumab. The patient did a test to check the antibodies and the patient had none on an unspecified date. The patient wanted to know why there wasn't a trial for people on adalimumab (HUMIRA). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Chills, fever; arm pain with beginning rash at left upper arm injection site; swelling of area above elbow 2 1/2 inches long by 1 inch wide with hardened knot below skin; slight headache; diminished appetite next day; painful lymph nodes in left armpit.
The mother first noticed on 4/27/22 in morning a 10 x 5 cm erythematous macular lesion at the left anterolateral thigh surrounding the site. This has increased slowly to the current 18 cm X 10 cm this size on 4/27/22. There is also warmth at that site.  Treatment has been ordered for pt to start taking Ibuprofen, prednisolone, and clindamycin orally.
I experienced a left sore arm, when I had my blood work, my white blood count was 15. My doctor trying to find out what it is that number. I received two boxes of azithromycin medication and after taking them my blood count went down to 13.5.
pt recvd vax 24AUG93 & 29AUG93 devel alopecia; no further details were provided;
Dizziness; Sweating; Shortness of breath; Nausea; Panic attack; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 27-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, in left arm on 30Mar2021 15:00 (Lot Number: ER8734), at the age of 27 years, as single dose for COVID-19 immunisation. The patient medical history was not reported. No known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. Patient did not receive any other medications in two weeks. On 30Mar2021 15:00, the patient experienced dizziness, sweating, shortness of breath, nausea and panic attack. The events were considered as non-serious. The events were not received treatment. The outcome of all the events was recovering.   No follow-up attempts are needed. No further information is expected.
abdominal pain got worse every day until Friday after midnight, it became unbearable so went to ER.  Did Cat scan and showed evidence that looked like kidney stones had just passed.  Today is Monday and she is still in pain on right side abdomen front and back.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications. On 03-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # M033214, expiry date 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1611USA011831: