chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started feeling bad on January 7, 2023, was tired just wanted to lay around, I had a headache. I started to get a fever on the 9th of January so I took a home COVID-19 test that came back positive very fast. I called my doctor's office to let them know I had tested positive. My doctor called in a prescription of molnupiravir antiviral medication that I started taking that evening. By Thursday I was feeling better and gradually everyday it just kept getting better.
No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 28-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA001345: US-009507513-2207USA004690: US-009507513-2207USA004691: US-009507513-2207USA004697: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
within minutes warm sensation from head to toes - 163/100 was BP - felt like she was going to faint went to urgent care - NP saw her and said recommended to go home and take Benadryl and drink lots of fluids - the next day had low grade fever and HA, felt exhausted, alternated Tylenol and Advil. for aching pain in arm and neck.  felt slightly better on Sunday the second day after vaccine.  Monday still wasn't feeling much better, and had stomach and back pain.
red purpura rash started to appear on lower parts of legs - not itching or painful at all; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 2, single (Lot number: EN6204) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN oral taken for blood cholesterol, stop date: Apr2022; CLOPIDOGREL oral, stop date: Apr2022. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6205; Route of administration: Intramuscular; Anatomical site of injection: Arm Left), administration date: 24Feb2021, for Covid-19 immunization. The following information was reported: PURPURA (non-serious) with onset Jun2021, outcome "unknown", described as "red purpura rash started to appear on lower parts of legs - not itching or painful at all".
Night Sweats; Dizziness/Light headed; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night Sweats), DIZZINESS (Dizziness/Light headed) and FATIGUE (Fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced NIGHT SWEATS (Night Sweats), DIZZINESS (Dizziness/Light headed) and FATIGUE (Fatigue). At the time of the report, NIGHT SWEATS (Night Sweats), DIZZINESS (Dizziness/Light headed) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment information was not provided
Possible infection with rash or cellulitis at injection site. Patient was prescribed clindamycin for treatment.
Narrative: Patient presented to COVID tent requesting test which was required prior to his procedure on 7/28/2021. COVID test performed. Patient denied any symptoms. Patient tested positive for COVID 19 ON 7/27/2021.
Received nasal vaccine and told to sniff, nausea and stomach ache x 1 day, missed 1 day of school.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4498662-00 (Company).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 06May2021 as dose 1, single (Batch/Lot number: unknown), on 16Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 08Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovered" (2022) and all described as "COVID-19". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "covid-19" related to BNT162b2.  Clinical course: The reporter's causality for HUMIRA for the event(s) of COVID was not provided. Causality for Pfizer Biontech COVID-19 Vaccine reported as Causality as per reporter (Drug/Vaccine) : Possible. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. There was no reported medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Sore arm, then swelling, hardening, redness & a lot of heat in upper arm in about a 5" circle around infection site that lasted about a week.
Confirmed breakthrough  COVID-19 (Pfizer) 1 02/11/2021 Pfizer EM9810   COVID-19 (Pfizer) 2 03/04/2021   Pfizer EN6201   COVID-19 (Pfizer) 3 10/13/2021 Pfizer FF2590
Pt recvd 3 doses Engerix-B & did not seroconvert; Booster doses were administerd; no tx was given;
Six hours post vax pt developed an injection site reaction characterized by a 30mm area of redness and induration and inability to move the arm. The pt experienced nausea and vomiting and developed a fever of 101F. The symptoms resolved within a few days. No further info was available at the date of this report. The reporter indicated that 4 pts experienced these events following receipt of Pnu-Imune 23 vaccine, lot 469-401. See HQ1777307JUN2001, HQ1777407JUN2001 & HQ1777507JUN2001.
association with myopericarditis after getting the vaccine; This is a spontaneous report from a contactable physician. This physician reported for a patient that: A patient of an unspecified age and gender received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as Dose number Unknown, Single for COVID-19 immunization. The patient's medical history was not reported. The patient concomitant medications were not reported. The patient had association with myopericarditis after getting the vaccine. On an unspecified date patient experienced myopericarditis (myocarditis). Pfizer employee states that she gave the physician the name of the person at the state and that is why she was cc'd on the email. Physician was emailing the (State withheld), asking about the vaccine and its association with myopericarditis. There is no patient specific information to provide or product information to provide. In the email, the physician asked if he were to provide the names of individuals who developed temporary associated myopericarditis after getting the vaccine, could he be provided with the lot numbers used. They are putting together a case series from  that patients did well, and many pediatricians are now hesitant to vaccinate. It was reported that she has no other information and does not know this physician. It was reported again clarified that she has no patient information, just that she knows the patients are adolescents. Again, clarified the details previously stated from the email. They are putting together a case series at (name withheld). They all did well thankfully. He needs information to help move the needle on this. The data will show he assumes that the incidence is very low, outcome is very good, and no specific lot number was a problem. The physician had asked if there was a website or specific literature. Pfizer employee states she has no other information to provide. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported event of myocarditis.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
About 48 hours after the vaccine, the injection site began to itch as well; Injection site bruising; Injection site bruising, redness, and swelling within an area about two inches in diameter.; Injection site bruising, redness, and swelling within an area about two inches in diameter.; General arm soreness over the next couple days; Tenderness at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28May2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), hydroxyzine (MANUFACTURER UNKNOWN) and methylphenidate (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28May2021, the patient experienced injection site bruising, redness, swelling within an area about two inches in diameter, general arm soreness over the next couple days and tenderness at the injection site. On 30May2021, about 48 hours after the vaccination, the patient experienced injection site began to itch. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events injection site bruising, redness, swelling within an area about two inches in diameter, general arm soreness, tenderness at the injection site and injection site began to itch was not resolved at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Patient came to pharmacy on 7/31/20 complaining of a rash after receiving the shingrix vaccine on 7/28/20.  He stated 8 hours after receiving the vaccine 3 rashes began to form on his torso.  On 7/31/20 he presented with multiple rashes on his torso with one appearing to have previously blistered.  He was told to see his doctor because the rashes appeared to be shingles.
I just kept getting sicker and sicker after the shot.  I ended up starting to miss work a few weeks following the shot, was out of work entirely by mid-November, and missed work for five months.  Was diagnosed with chronic fatigue in December of 2008.  I'm still not well.
Description of adverse event verbiage: Per the clinical lead the Influenza vaccine was transported to clinic in the brown portable cooler. A vaccine excursion occurred with the brown portable cooler. The temperature on the data loger attached to the brown portable cooler went out of range according to GlaxoSmithKline Biolocicals manufacturer recommendations. The portable cooler was reconditioned and the Influenza vaccine was administered to the patient. Manufacturer contacted by Health Department representative. Per the Health Department they were advised by  GlaxoSmithKline that the Influenza vaccine was not viable and the patient needed to be revaccinated.
Patient received a flu shot from grad intern. He immediately went into a seizure (shaking), was unconscious, and threw up when he regained consciousness. Patient and his father, who was also there at the time, reported patient had no history of seizures nor diabetes. 911 was called and EMS came in 10 minutes.
Approximately 40 minutes following the injection, I experienced an increase in heart rate.  Not painful but noticeable.  Stopped activity and returned to normal within 30 minutes
Returned 3-10-10 a.m. with reddened, indurated injection site approximately 4" diameter; but is afebrile today; walking no problems; active; not fussy. Eating well. Advised cool compresses; antihistamine. To call us on 3-11-10-attempted to call him 3-12-10, 3-15-10 no answer.
This spontaneous report was received from a Registered Nurse (R.N.) referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions and concomitant therapies were provided. On an unknown date the patient was vaccinated with M-M-R II. Dose, route, anatomical location and lot # were not reported. Then, 11 days after vaccination (unknown date), the patient was vaccinated with VARIVAX, 0.5 ml, subcutaneous. Anatomical location and lot # not reported. No adverse effects were reported. It was not a product quality complaint involved. Additional information has been requested.
Headache (first and second day post vaccine) Sore throat (first and second day post vaccine) Fever (first and second day post vaccine) Nausea (first day post vaccine) Vomiting (first day post vaccine)  Chest tightness/ difficulty breathing (beginning on second day post vaccine)
Right thigh had redness and cellulitis of size 20 x 20 cm. Small abrasion overlying with a scab. Warm to touch, mildly tender.
Original side effects were chills, fever, headache, and cough. Current side effects are swelling of armpit region and stiffness of joints.
Pfizer-BioNTech COVID-19 Vaccine EUA 64-year-old female presents as a rapid response team patient status post immunization her second shot was done on Tuesday 2 days ago.  She had some diarrhea last night and had some body aches in her arms following the rules today she woke up did not eat breakfast which is not abnormal for her did have some coffee came to work describes some myalgias and felt sweaty felt chilled so she went downstairs had a glass of orange juice to see if that would help had a small helping of hashbrowns did not help she was so she went to employee health in the then was sent here for further evaluation.  Patient denies any heart or lung problems high blood pressure diabetes has URI symptoms. No history of PEs or DVTs denies hypertension she fell your blood sugar is low but has no documented history of hypoglycemia is not on any hypoglycemic medications.  No history of PEs or DVTs no travel or surgeries.  No nausea or vomiting with the diarrhea.  Also complains of body aches.BP 120/69  | Pulse 76  | Temp 37 °C (98.6 °F) (Oral)  | Resp 21  | Ht 1.676 m (5' 6")  | Wt 198 lb (89.8 kg)  | SpO2 95%  | BMI 31.96 kg/m² Labs reviewed on the chart are normal symptomatically she feels better offered Toradol for myalgias she refused she I suspect is having a reaction/side effect not an allergic reaction to her vaccination she received. Patient discharged.
hard time moving her fingers; painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (002591).  An 88-year-old female patient received tofacitinib citrate (XELJANZ XR), (Lot number: EH9981, Expiration Date: Jan2023) at 11 mg 1x/day, oral for rheumatoid arthritis; BNT162b2 (BNT162B2), as unk unk, single (dose 1, single) (Batch/Lot number: unknown), as unk unk, single (dose 2, single) (Batch/Lot number: unknown) and as unk, single ((dose 3 single) (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "neuropathy" (unspecified if ongoing); "Weight loss" (unspecified if ongoing); "not being able to walk" (unspecified if ongoing). Concomitant medication(s) included: FOLIC ACID; ATENOL. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "hard time moving her fingers"; PAIN (non-serious), outcome "unknown", described as "painful". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for tofacitinib citrate was unknown. Additional information:  Patient stated her height has been shrunk. she lost a lot of weight, and she was real good at the time and ended up not being able to walk.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
LOCAL REATION OF LEFT ARM. ARM IS SWOLLEN& RED FROM TOP OF LEFT SHOULDER TO ELBOW (18 CM). CIRCUMFERENCE ABOVE LEFT ELBOW 20 CM VERSES 16CM ON RIGHT. MT REPORTS A LITTLE FEVER YESTERDAY BUT DID NOT TAKE READING.
Tight, painful chest, upper middle back pain, headache, body aches, chills, temp between 95 & 97 degrees, fatigue, nausea.  Still sick today (11/8/2011) although symtoms less severe.
Difficulty breathing; Low blood pressure; This is a spontaneous report from a contactable consumer (patient). This 90-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201) via an unspecified route of administration in the right arm on 25Feb2021 at single dose for COVID-19. Medical history included Known allergies: Sulfa drugs, Afib, Diabetes, Meniere disease. The patient had COVID prior vaccination. Concomitant medications included amlodipine, celecoxib (CELEB), metformin, pravastatin, warfarin. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318) in the left arm on 04Feb2021 12:00 PM for COVID-19. The patient experienced difficulty breathing, low blood pressure on 26Feb2021 02:30 AM. The patient was admitted to Hospital. Life support IV in neck to maintain blood pressure. Treatment including high flow oxygen, life support IV to maintain BP was received for events. AE resulted in: emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient had no COVID tested post vaccination. Outcome of the events was unknown.
The evening I received the shot I spiked a fever and my body started aching really bad. The next morning my head hurt and my body ached. I took some ibuprofen which seemed to help but that evening I spiked another fever and my body ached again.
Patient got a MODERNA COVID-19 vaccine late evening 01/4 and began to have increased heart rate between 108-117, severe headache, and some dizziness
Raised red swelling under skin at or near injection site, about the size of a dime. Still present at this time. Saw health care on 7/25/2022.   My health care provider did not seem concerned and treated the spot with steroidal cream, The cream did not have any effect on the area. I do not experience other symptoms except for the raised red area on my upper arm.
Leg heaviness, cold legs and feet, right side facial numbness, tingling across back, full body shakes began 3 days post vaccination and continued for approximately 24 hours. Dizziness/lightheadedness, headaches and heart palpitations also began during that time frame. Dizziness subsided within 1 week. Heart palpitations and headaches have continued for 3 plus weeks. Feelings of panic and depressive lows began for the first time in patient's life during this time frame and have continued to this point.
- Acute Saddle Pulmonary Embolism. - Deep Vein Thrombosis, lower extremity, proximal, acute, left. Shortness of breath started 04/25/2022 and got progressively worse along with mid and lower back pain until left leg started swelling up on 06/08/2022 which sent me to the ER where they diagnosed the Acute Saddle PE and Left Leg DVT. Placed on IV blood thinner while in hospital. Released and put on prescription of ELIQUIS 5 MG tablets twice per day for at least one year for treatment of unprovoked PE and DVT events. No prior history of Blood Clots and subsequent blood work showed no genetic predisposition to blood clots. Had seasonal Flu vaccine and 1st dose of Shingles Vaccine on 01/10/2022. Had 2nd dose of Shingles vaccine on 06/04/2022 and the left leg pain started on 06/05/2022 and continued with leg swelling starting 06/08/2022 which is when I went to the ER as I suspected I had a blood clot in my leg. It was a surprise to find out I had the PE as well.