chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with covid; diagnosed with covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-202101886107 (pfizer), US-PFIZER INC-202200000007 (pfizer).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "shoulder surgery" (unspecified if ongoing), notes: had shoulder surgery last year or early this year to treat a longstanding injury. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with covid". Patient diagnosed with covid. Males all mid -late 20s. They reside in withheld. This is a recent event. Not sure what vaccines are provided in withheld, but they are likely all vaccinated.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101872620 same reporter/vaccine/event, different patient;US-PFIZER INC-202101872619 same reporter/vaccine/event, different patient
Client complained of feeling dizzy and light headed after receiving the vaccine,   He reports an allergy to Bananas which causes anaphylaxis.  He does not carry an Epi Pen.  Vasovagal event with no syncope.  Blood pressure 87/41 pulse 78 with 02 saturation 96%.  Se4cond set of vitals in 5 minutes was blood pressure 116/70  with pulse 75 and o2 saturation 98%  .  Released by Dr after second vitals by EMS on site.  Advised to seek medical attention later if needed.  Client stated understanding.
Vial was not diluted, so patient was given 0.3 mL of undiluted Pfizer vaccine for his second dose. Patient was then contacted about 1/2 hour after his dose. He was still feeling fine and reported he had very few symptoms after his first dose. Encouraged patient to see care if he feels unwell. Anticipated adverse effects patient was educated on include a localized reaction and strong immune response. Patient verbalized understanding and had no further questions or concerns.
Severe allergic reaction to HPV vaccine immediately after injection including hives, swelling of throat, wheezing, paleness and increased heart rate.  Given Epi injection with improvement.  Taken to ER via ambulance and was observed for several hours.  Started on Prednisone for the next 4 days and given an Epipen.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Headache-Medium
My menstrual cycle is always on time and usually last only a few says. Since Ive gotten the vaccine my cycle started a week early.
He was sleeping, and on 11/16/21  around 6am all of sudden He started shaking, eyes rolled up and foam was coming out of mouth. I called 911 and they took him to hospital. They said he got grand mal seizure. He also got same reaction after 2nd dose of Moderna Covid Vaccine
Starting 2-3 weeks after 3rd Moderna shot, I started breaking out in chronic, spontaneous hives. The hives appear anywhere on my body within 5 minutes of light skin irritation or scratching, remain itchy for 10 minutes, and then disappear after another 10-15 minutes. I tried taking Benadryl, but symptoms persisted.  When hives appear, applying Cortaid cream relives the itching. This has been occurring for the past 5-6 weeks, with no noticeable change in frequency or severity.
Strong flu-like symptoms since Friday night. Wake up 230 Am Extreme headache, nausea, joins pain, lost of appetite
C/O Respiratory Distress Hx of asthma, no inhaler available, 911 phoned taken to ER
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-OCT-2016, the patient was vaccinated with the improperly stored (7.5F for 3 hours) dose of VARIVAX (lot # reported as M033904, expiration date 20-JUL-2018; dose and route of administration was not provided) for prophylaxis. The call was made because of the digital data logger. No previous excursion was reported. Additional information has been requested.
Running fever for 2 days (off & on); rash devel 3rd day-no more fever p/rash devel;
Patient presented to the ED via MMR accompanied by her grandson for evaluation of increased shortness of breath.  According to her grandson patient was diagnosed with COVID-19 last week and started with some congestion, cough, headache, body aches fatigue, decreased appetite and shortness of breath which has worsened in the last few days and decided to come to ER for further evaluation.  Per her grandson patient was admitted overnight 7 days ago at hospital where she was started on steroid and oxygen and discharged home but patient continued having symptoms and he brought her for further evaluation.   No recent fall or injury.  Patient denies any chest pain or leg edema.  Denies any history of coronary artery disease or congestive heart failure.  Upon arrival to ER patient was hypoxic in the 80s and was placed on oxygen  Her vitals shows blood pressure 172/70 heart rate 64 temperature 99.8° respiratory rate 18 pulse ox improved to 94% on room air  Chest x-ray showed COVID-19 pneumonia  Her lab showed white count at 7.4 hemoglobin. She was diagnosed with sepsis due to covid pneumonia with associated acute hypoxic respiratory failure at time of admission.  Patient was admitted on 3 L of oxygen via nasal cannula.  Breathing declined and oxygen demand maxed at 6 L via nasal cannula. she was tapered to 1L via NC after high-dose steroids and Remdesivir.  She declined Baracitinib.  She continues on Decadron which has been tapered to 2mg po daily and can be tapered off this week.   Patient's oxygen saturations with demand plateaued at 6 L for approximately 4-5 days.  Subsequent CTA for evaluation of PE showed incidental finding of thyroid mass which needs further follow-up outpatient.  The patient has been advised.  There was no findings of PE.  Echocardiogram also completed without any significant abnormalities nor acute findings.  LVEF is preserved. Again incidental finding during chart review of hepatocellular disease  On 11/2020 imaging without known history of liver affected cancer.   Patient is medically cleared for discharge to skilled nursing facility for continued multi disciplinary care in improved condition.
Dry mouth and weird sensation on tongue approximately 2 days after second vaccine. It still continues.  2 months later I developed numbness in my mouth, lips and part of tongue. It still persists.  3 months after the vaccine I experienced loss of taste. It still persists.
Pain at injection Site Right Arm after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection Site Right Arm after first shot) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 vaccination.     The patient's past medical history included Cat bite (on the left hand) on 28-Feb-2022 and Surgery (left hand) on 14-Mar-2022. Previously administered products included for Cat bite: Rabies shot (right arm). Past adverse reactions to the above products included No adverse event with Rabies shot. Concurrent medical conditions included Asthma.    On 09-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Apr-2022, the patient experienced VACCINATION SITE PAIN (Pain at injection Site Right Arm after first shot). In April 2022, VACCINATION SITE PAIN (Pain at injection Site Right Arm after first shot) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications included asthma medications.  At the beginning of Mar-2022, prior to vaccination, the patient was at hospital for cat bite.  The patient had pain at injection site and the pain lingered for about 2 weeks.  No treatment medication was provided.   Reporter did not allow further contact
Patient received the vaccine on 6/6/2021 at 4 pm. This morning (6/7/2021) the patient woke up with a fever and chills. She got up to go to the bathroom and experienced a seizure. Patient reports that her husband was home during the seizure and he reports that it lasted for 4 minutes. Patient hit her head on the floor at the beginning of the seizure and reports having a horrible headache and sore neck currently. Advised patient to go to the doctor to be checked out.
Child has moderately severe swelling and redness of the left deltoid region to 3/4 of the forearm.  Full mobility of shoulder.  No fever.
Patient received 0.3mls of Janssen J&J instead of the intended 0.3ml of the Pfizer for her booster dose.
lump at the injection site; redness and a lump at the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump at the injection site) and VACCINATION SITE ERYTHEMA (redness and a lump at the injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE MASS (lump at the injection site) and VACCINATION SITE ERYTHEMA (redness and a lump at the injection). On 10-Mar-2021, VACCINATION SITE MASS (lump at the injection site) and VACCINATION SITE ERYTHEMA (redness and a lump at the injection) had resolved.        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.
urticaria to whole body, moderate relief with antihistamines. Started on 01/17/2022 and is still occurring as of now, 01/21/2022
Coughing, followed by 102 degree temperature.  Coughing lasting for 1-2 hrs, temp for 3 hrs+.
Swollen arm (could not use for 5 days), no redness Shiver/fever next morning Overnight vomitting and diarrhea for 2.5 days Extra fatigue
Patient received prevnar 13 and the next afternoon patient started to with rash spreading down towards her elbow, warm to touch and 5/10 discomfort.  Patient was treated with Cephelexin 500 mg twice a day for 10 days.
hemoptysis; short breath; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262), via an unspecified route of administration (left arm), on 21Jan2021 18:00, at single dose, for covid-19 immunization. Medical history included osteoporosis; there were no known allergies. There were no concomitant medications. The patient had no Covid prior vaccination. The vaccine was given at the hospital. The patient stated that on the next day after having the Pfizer-BioNTech Covid-19 vaccine, on 22Jan2021 15:00 the patient had short breath. On the 2nd day, 23Jan2021, the patient had hemoptysis. The patient does not know whether hemoptysis has something to do with the vaccine injection. The patient never had short breath nor hemoptysis in her life. These adverse events resulted in emergency room/department or urgent care visit. No treatment was received for the adverse events reported. At the time of the report, the patient had not recovered from the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was Covid-tested post vaccination via nasal swab PCR on 25Jan2021 with results of negative.
No adverse experiences; Administration of improperly stored vaccine; Information has been received from a medical assistant concerning to a patient (age and gender not reported). No medical history, concurrent conditions nor concomitant medications were reported.   On 03-NOV-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml (route of administration not reported) (Lot number T014309, expiration date: 24-APR-2022), as prophylaxis. The patient did not report any additional adverse experiences as a result of receiving the improperly stored vaccine.  The reporter stated that the vaccines were supposed to arrive on 27-OCT-2020 but it arrived on 29-OCT-2020. The caller stated that when she first received the vaccines, for some reason thought the current date of receipt was 27-OCT-2020 and not 29-OCT-2020 and that the product was received on time. The reporter immediately placed the product into the freezer. The product was received 2 days late.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2011USA013581: US-009507513-2011USA013379: US-009507513-2011USA013163: US-009507513-2011USA013620: US-009507513-2011USA013293:
Client called us indicating that her arm swelled, and exhibited hives.  She called her physician and us to report the incident.
By 8:30pm the day of receiving my booster, I was feverish, with an upset stomach. Low grade fever, full body aches, headache, and upset stomach continued through the next day. Twenty four hours after the vaccine booster, my fever increased with joint aches and chilling. All symptoms resolved upon waking up this morning, 36 hours after the booster was given.
Vaccinator, RN, was speaking with the client immediately after vaccination when she realized his eyes were closed, chin was down, and his flexed legs became extended. RN, called for assistance. Lead RN, came over to assess. Client was unresponsive, his eyes were closed, and he was leaning forward. Lead RN, attempted a sternal rub without any response from the client. The client was unresponsive from stimulus. Called for Co-lead RN, to call 911. At 1227, RN, called 911. At 1226, the client became responsive. He was shocked when he opened his eyes and did not immediately know where he was. Within 30 seconds, the client became oriented. Client is AOx4. Client sweaty in appearance. At 1228 EMT, checked vital signs. BP: 121/55, HR: 57, SPO2: 100%, RR: 16. At 1229, client asked to lay down. EMT, and RN, assisted client into the anti-gravity chair. Client reports no medical history. No history of allergies. Client self reported that he has become unresponsive before when giving blood approximately 2 years ago. He reports he did not eat breakfast. At 1234, vital signs re-checked. BP: 125/68, HR: 68, SPO2: 100%, RR: 16. Client provided with water, juice, and a snack. He consumed all of the juice and majority of the snack when EMS arrived. EMS arrived at 1236. Per the paramedics, all of the client's vital signs were within normal range. Paramedics checked the client's blood sugar. Blood sugar was 84. Client refused to go with the ambulance and signed AMA. Client remained in the anti-gravity chair. Vital signs checked again at 1248. BP: 124/55, HR: 59, SPO2: 100%, RR: 16. Client asked if he could walk around outside in the sun. Client stood up without assistance. Lead RN, observed the client walking with a steady gait. RN, monitored the client while he walked around outside. Client reports he "feels good". Client sat down in chair. Another set of vitals taken. BP: 134/75, HR: 64, SPO2: 100%, RR: 16.
She was admitted to the hospital 6/21/21 with lethargy and was intubated due to low oxygen levels.  She developed a blood clot in her left arm around 4 am 6/24/21.; She was admitted to the hospital 6/21/21 with lethargy and was intubated due to low oxygen levels.  She developed a blood clot in her left arm around 4 am 6/24/21.; She was admitted to the hospital 6/21/21 with lethargy and was intubated due to low oxygen levels.  She developed a blood clot in her left arm around 4 am 6/24/21.; This is a spontaneous report received from a contactable male consumer. A 70-year-old female patient (non-pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0180), via an unspecified route of administration on arm left on 17Jun2021 (Age at Vaccination: 70 years) at single dose for COVID-19 immunization. The patient medical history included Alpha-1 Antitrypsin deficiency, emphysema, depression/anxiety, chronic kidney disease and known allergies to Medication-Paxil. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The device date was reported as 25Jun2021. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient Concomitant medications were not reported. On 21Jun2021 15:00 PM, the patient was admitted to the hospital with lethargy and was intubated due to low oxygen levels. On 24Jun2021, around 4 am, the patient experienced blood clot in her left arm.  The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The relevant lab tests included Test: Covid test, result: Negative on 21-JUN-2021. Therapeutic measures were taken and treatment included Heparin IV medication. The outcome of the events was Not recovered.   Follow-up attempts are completed. No further information is expected.
None at present time.  Just was given flu mist when pregnant. 1/6./2010 OB-GYN records 11-12/18/2009, pregnant,  EDC 1/6/2010, no adverse reactions noted.
Pt reported feeling "dizzy" 5 min s/p vaccine. Initial vitals were: 153/117 HR52. at 15 minute post 191/68 HR 46. and 30 min post 181/68 HR 52. Pt ambulated with only standby assistance to to restroom to void times 2 during his 30 min stay. Pt stayed a total of 60 minutes total at which time he stated he felt much better and ambulated to his vehicle. While monitoring pt stated he was diabetic and didn't have breakfast but "felt better" after some juice and blueberry muffin cookies.
One week after second vaccine had a headache; Nausea; This is a spontaneous report from a contactable Consumer. A 68-years-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9263, Expiration date: Unknown), dose 2 via an unspecified route of administration in the right arm on 26Jan2021 at 2:00 PM (68-years age) 2nd dose single for COVID-19 immunization and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266: Expiration date: Unknown),dose 1 via an unspecified route of administration on the left arm on 17Feb2021 at 12:00 PM 1st dose single dose for COVID-19 immunization. Patient experienced vomiting and headache after one week after first vaccination. Other Medical History included mitral valve repair in 2018 and the patient allergic to Demerol codeine walnuts. Concomitant medication(s) that patient received in two weeks included atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]); valaciclovir hydrochloride (VALTREX); bazedoxifene acetate, estrogens conjugated (DUAVEE [BAZEDOXIFENE ACETATE; ESTROGENS CONJUGATED]); calcium (CALCIUM); ergocalciferol (VIT D); famotidine (PEPCID [FAMOTIDINE]). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 19Oct2020 the patient underwent Covid-19 nasal swab test which resulted as Negative. On 23Feb2021 at 05:00 PM the patient experienced headache for 2 days and nausea most of the 2 days. No treatment received for reported adverse event. The Outcome of the Events were Recovering.
Client complained of SOB, nasal congestion, and itching all over her body.  Client was given Benadryl 50 mg IM in RT Deltoid.  She was sent to the ER for evaluation.
Low grade fever; Congestion; Sore Throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 13Nov2021 (Lot number: FK5127) at the age of 11 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 15Nov2021, outcome "unknown", described as "Low grade fever"; NASAL CONGESTION (non-serious) with onset 15Nov2021, outcome "unknown", described as "Congestion"; OROPHARYNGEAL PAIN (non-serious) with onset 15Nov2021, outcome "unknown", described as "Sore Throat". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pyrexia, nasal congestion, oropharyngeal pain. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. No follow-up attempts are possible. No further information is expected.
It was reported that a female pt received an Imovax Rabies ID vaccination on 4/23/01. Reportedly, sometime after the receipt of the vaccination (date not specified), the pt developed hives over her neck and arms, itching and a headache, which lasted for 6 days. The symptoms resolved except for a "dollar-size" rectangle area in forearm.
Per family member "his arm has been sore since he got the shot"  Denied redness, swelling, warmth, etc.
The same afternoon, about 3 hours later, I got a low temperature. As the night went on, my temperature got higher and higher. I started taking Tylenol to keep the fever under control. It lasted for about 3 days and then I was back to normal. I had no other symptoms, just the fever. I was so hot, my wife had to get out of the bed with me because she said it felt like I was burning her.
This spontaneous report as received from a medical assistant refers to 18 month old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 16-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1610USA004609:
This spontaneous report was received from a pharmacist, referring to an adult patient of unspecified age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the adult patient was vaccinated with RECOMBIVAX HB 5/0.5 mcrg/ml (anatomical route of vaccination not reported) with a reported lot # M037348 with expiration date on 21-FEB-2019 for prophylaxis (drug administered to patient of inappropriate age). Furthermore, no adverse events were reported and no product quality issue was involved. Additional information is not expected as consent to follow up was not provided.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Pt. began to feel dizzy after receiving the shot. He states that this is a normal reaction for him and he always feels dizzy and anxious after receiving an injection. Pt. laid down on the floor and elevated his legs shortly after announcing he was dizzy. He was given water to drink. He got back up several minutes later and was fine.