chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Whenever I lie down to go to bed, after about 10 or 15 minutes, I'll hear a sound & it goes across the back of my head.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Whenever I lie down to go to bed, after about 10 or 15 minutes, I'll hear a sound & it goes across the back of my head.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 007M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Joint replacement (Multiple orthopedic joint replacement surgeries). Concurrent medical conditions included Immunocompromised.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In September 2021, the patient experienced TINNITUS (Whenever I lie down to go to bed, after about 10 or 15 minutes, I'll hear a sound & it goes across the back of my head.). At the time of the report, TINNITUS (Whenever I lie down to go to bed, after about 10 or 15 minutes, I'll hear a sound & it goes across the back of my head.) had not resolved.            No concomitant medications were reported.  One week after the third dose the patient whenever lied down to go to bed, after about 10 or 15 minutes, patient would hear a sound and it went across the back of head. It kept going, unless patient sat upright. Had to sleep sitting upright in the living room. And if patient tried to sleep on  left side, it would start up right away. Went to see 4 different doctors, but everything was fine. It was unknown if the patient had allergies. It was unknown if the patient had been diagnosed with COVID or tested positive. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine  was unknown.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up document contains no new information.
Pt had seizure in bathroom, mom found her limp and unresponsive. EMS on scene gave Zofran during post-ictal state since pt was nauseated. Pt taken to ER for labs.
This spontaneous report was received from a medical assistant who refers to a 16 year old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication provided. On 21-JAN-2019, the patient was vaccinated with an adult dose of VAQTA lot # R022122, expiration date 09-AUG-2019 (exact dose and route of administration were not reported) for prophylaxis. No adverse effects were reported.
alopecia; Inappropriate route of vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  An adult male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) intravenous for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate route of vaccination".  Additional information: Reporter stated so both reporter (daughter) and her father developed what appears to be alopecia after being vaccinated. Now Pfizer was introducing a new drug for alopecia. Just curious if anyone else developed this after being vaccinated, patient wants to know exposure. Reporter considered event as caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient's arm has become warm, red, and swollen the size of a baseball and is keeping her up at night. She has required ice packs for several days.
Fever Tmax 101.1 Weakness Dizziness Chills Hot flashes Body aches L arm weakness and pain Nausea Sore throat Congestion
The patient is a 79 y male presenting to the ED via EMS with complaints of shortness of breath for the past week that has worsened today. EMS report the patient was 72% on room air and they placed him on a nonrebreather. He reports a productive cough with chest pain. He denies any radiation of his chest pain to his arm or back. The patient reports previously smoking 3-4 cigarettes daily.  Patient was diagnosed by infectious disease specialist with pneumonia due to COVID-19 with elevated CRP.  Patient's D-dimers are elevated.  Patient's procalcitonin is also elevated.  Patient continues to be very weak lethargic and fatigued as.  Patient continues to have respiratory distress and insufficiency. , placed in isolation. ID consulted and started on IV abx , cefepime, micafungin, and solu medrol, he was also receiving supplemental oxygen, on nasal cannula 6L 1/18 weaned down to 4L NC 1/20.. Pt stable and will be discharged back to AFC.
Pregnant at time of vaccination; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant at time of vaccination) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 037B21A) for COVID-19 vaccination.     The patient's past medical history included Embryo transfer (paternal history, so child was conceived using IVF) on 20-Dec-2020. Concurrent medical conditions included Allergic asthma (Asthma (allergy-related)) since 01-Jan-1992, Egg allergy (Very mild egg yolk allergy), Dust allergy, Allergy to animals (cats) and Allergy (trees). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], THERANATAL PLUS from 02-Jan-2021 to an unknown date and BUDESONIDE (PULMICORT FLEXHALER) from 02-Nov-2020 to an unknown date for an unknown indication.   On 12-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Nov-2020 and the estimated date of delivery was 07-Sep-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant at time of vaccination). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy. The delivery occurred on an unknown date.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant at time of vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Prenatal screening test: no chromosomal abnormalities detected/normal (normal) No chromosomal abnormalities detected/normal. On 24-Mar-2021, Alpha 1 foetoprotein: normal/not elevated (normal) Normal/not elevated. On 22-Apr-2021, Ultrasound foetal: normal/no abnormalities detected (normal) Normal/no abnormalities detected.         Additional concomitant medications include Homacort.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: initial additional
Hypersensitive nerves (putting on clothes, or rubbing of skin is painful); Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 at 10:30 (at the age of 22-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) 15 mg and bupropion (MANUFACTURER UNKNOWN) 150 mg; both for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 27Mar2021 at 10:30 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 10Apr2021 at 22:00, the patient experienced hypersensitive nerves (putting on clothes, or rubbing of skin is painful), fever and chills. On 07Apr2021 (post vaccination), the patient underwent PCR (nasal swab/rapid antigen) and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events, hypersensitive nerves (putting on clothes, or rubbing of skin is painful), fever and chills was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
L distal bicep erythema of 13 cm not indurated, distal arm look good. No fever, no cough. Local reaction representing resolved immunity.
Between 30-45 minutes after receiving the vaccine I noticed jaw muscle tension, and then for about 10 minutes numbness in the left side of my face, making it hard to form words and having an uneven smile. At about the same time I noticed a strong metallic taste in my mouth that lasted for the rest of the day, and a subtle metallic taste in my mouth has been ongoing
Was diagnosed with the flu/the same thing happened to them; This spontaneous case was received on 02-Nov-2020 from other non-health professional (consumer) via agency (reference number: SEQW20-04654) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location and indication not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving with influenza virus vaccine polyvalent, the patient developed flu.   The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The event of flu was considered to be medically significant by a Physician within agency.  The case is linked to case 202005984 and 202005986 (the same reporter).  Company comment: The patient developed influenza on an unspecified date and an unknown amount of time after receiving suspect product, influenza virus vaccine polyvalent. Chronology is unclear. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship is assessed as unassessable due to lack of information regarding onset latency.; Sender's Comments: The patient developed influenza on an unspecified date and an unknown amount of time after receiving suspect product, influenza virus vaccine polyvalent. Chronology is unclear. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship is assessed as unassessable due to lack of information regarding onset latency.
Two of them are now fatally sick with COVID, confirmed COVID cases, vaccine failure; They are sick after booster (COVID Vaccine); People were sick; Two of them are now fatally sick with COVID, confirmed COVID cases, vaccine failure; They are sick after booster (COVID Vaccine); People were sick; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Two of them are now fatally sick with COVID, confirmed COVID cases, vaccine failure; They are sick after booster (COVID Vaccine); People were sick"; IMMUNISATION (medically significant), outcome "unknown", described as "booster".  Additional Context: Pfizer representative stated that, "I am Pfizer colleague (Pfizer representative), so I am trying to be in compliance on reporting an adverse event. So my daughter visited us this weekend and she then mentioned to me that she works at a small clinic in withheld and all the staff there, the small staff have received the Pfizer COVID Vaccine. She reported me that two of the people that received the COVID Vaccine and they were given about the same time, I think that they schedule to have all the staff vaccinated same time and two of them are now fatally sick with COVID, confirmed COVID cases (Split not made). So I do not know, you know I understand that we have vaccine failure, so I felt like I needed to report this to you guys because it is this small group receiving a same potentially same LOT of the vaccine and wanted to make sure that there was 'that' awareness reached." Is there a Product Complaint: Yes  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101798432 same reporter/drug/event, different patient
Child received MMR, IPV, DTaP and HAV vaccines on same day. Next AM awoke with red, swollen, and itchy left arm. MOC applied ice compressed and warm compresses and gave child Ibuprofen for discomfort and swelling, came down. Continued with warm compresses, butter today 8/30/02. Child received MMR and HAV in left arm.
This patient was in hypotensive shock: hypotension 124/96 - 70/40, Pulse 82/46, diaphoresis, pallor, bradycardia. Treatment with IV fluids. A question of 2 degree vasovagal syncope.
Fatigue- ongoing Light headness- ongoing Muscle aches- first 5 days Pain at injection site- first 3 days Nausea- intermittent, ongoing
Patient received his 2nd Pfizer COVID vaccine on Tuesday 4/27/2021; he had low grade fever (100.3 deg F) on Wed 4/28/2021. On Thursday 4/29/2021, he developed "heartburn", and on Friday 4/30/2021 he developed chest pain that radiated to his jaw and left arm. He presented to Hospital on  late 4/30/2021 or early 5/1/2021 for evaluation; initial labs showed a CRP of 1.23, POC troponin of 6.56 ng/mL (03:18 on 5/1) and lab level of 17.6 ng/mL  (03:05 on 5/1) that increased to 24 ng/mL later in the morning on 5/1. COVID-19 PCR was negative. He was transferred to another Hospital mid-day on 5/1/2021 due to concerns for myocarditis/myopericarditis. He was started on NSAIDs. His troponin level improved, had decreased to 9.69 ng/mL on 5/2/2021; at that point as his chest pain had improved and labs were improving, parents requested that he be discharged from the hospital. He had 2 echocardiograms at PCH which reportedly showed normal biventricular systolic function. He had an echo at the hospital on 5/2/2021 which showed normal biventricular systolic function, no pericardial effusion, and normal valves.   As an outpatient, he had repeat troponin-I levels: 2.49 ng/mL on 5/3; 0.31 ng/mL on 5/5; the troponin level was reportedly normal on 5/10/2021 per his primary cardiologist
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 26-APR-2017 the patient was vaccinated with ZOSTAVAX (dosing details were not reported) (lot # M037015, expiry date: 22-NOV-2017) for prophylaxis. Other suspect therapies included sterile diluent. The reporter stated that during administration of a dose of ZOSTAVAX, the needle 'retracted too early' causing some of the ZOSTAVAX to leak out of the injection site onto the patient's skin, resulting in a potential partial dose of ZOSTAVAX. No adverse effect reported. There was no product quality complaint involved. Additional information has been requested.
Patient was found unconscious laying back in her chair shortly after receiving her Covid-19 vaccine.   Patient was awoken with a light shake on the shoulder, but not to noise.  The patient stated they had difficulty hearing, along with nausea and light headedness.  The patient denied any other symptoms, including difficulty breathing, abdominal pain, and body soreness.  Nothing was administered on the pharmacy's end.  The paramedics arrived shortly after and took the patient as she was going in and out of consciousness.  Patient was contacted after the incident, in which she said that she was told she had vasovagal syncope.  The patient is fine now.
Patient started vomiting on 12-10-09 and went to ER. Started coughing, runny nose and breathing hard on 12-11-09. Pt wheezing at doctor's office then given several breathing treatments. Pt got worse at office then sent to hospital. Then transported to another hospital on the same day.
Information has been received on 28-OCT-2015 from a representative (field employee) who was informed by a physician that a 17 year old female developed "hypotension" (confirmed with the representative that the physician reported hypotension and not hypertension) and postural orthostatic tachycardia syndrome "two weeks" (specific date not reported) after receiving her second dose of GARDASIL (dose and date not reported). Outcome of events was reported as recovered (date unspecified). No further information was provided. Additional information has been requested.
Patient received vaccine, was requested to wait in the lobby for 15 minutes for post-vaccination monitoring. Approximately 10 minuets into  waiting period, patient attempted to stand up and fell. He hit his head against our wall. He was alert and responsive, we called ems, after their evaluation they said patient was okay to leave. We requested the patient to have family member to come pick him up but he insisted to drive back and left.
Throbbing in my arm after the injection; A spontaneous report was received from a physician concerning a 65-years-old, female patient who experienced throbbing in arm after injection.   The patient's medical history included diabetes, borderline high cholesterol levels, high blood pressure and migraines. Concomitant products were Metformin for diabetes, Rosuvastatin for cholesterol levels, Propranolol for migraines and an unknown medication to control blood pressure.   On 02 JAN 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient reported throbbing in arm after the injection. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event, throbbing in arm after the injection was considered recovered on 03 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient reported numbness / tingling (site; leg); numbness in face; increased HR, dizzy, sweat/fevers after 1st dose.  1st COVID vaccine on 1/27. She immediately had numbness/tingling of the injection site. Shortly after that her left leg had numbness and tingling. She states it progressed to her left face and neck. She states she had some minor swelling of the left leg and face. Denies swelling of her throat or breathing difficulties. She reports her face like she had gotten Novacaine. She also reports elevated heart rate, dizziness, and sweats/feverish within the first few days of getting the vaccine. She states all of her symptoms have resolved except for tingling in her left leg. She states her left leg is no longer swollen and the tingling is minimal and intermittent and vastly improved compared to last week. Denies weakness or numbness of either side of her body.   Consult Visit with Allergy:  History of adverse reaction to Pfizer COVID vaccine: I have seen over a dozen patients with complaints of numbness tingling. None had recurrence with the second dose. The mechanism is unclear, but think this is due to irritation from the vaccine.  Angioedema can be seen after the COVID vaccines. It is the same mechanism as viral induced hives- it is from activation of the immune system and lasts several days. It is not allergy. She is not considered at increased risk of anaphylaxis and should get the second dose with no special precautions. Letter of clearance written. I do recommend cetirizine or fexofenadine pretreatment to limit angioedema (take one at least one hour prior and then BID for 3 days). Patient nervous for 2nd dose - has not received yet.
per mom pt cried a lot 12JUl-14JUL94-screamed x 7 hrs 14JUL94;
Mild fever; body aches; This is a spontaneous report from a contactable consumer (patient). A 31-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and expiration date were not reported) via an unspecified route of administration in left arm on 24Feb2021 (age at vaccination 31 years old) as single dose for COVID-19 immunization. Medical history included kidney disease. No known allergies were reported. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (lot unknown reason Misplaced/discarded, administration date was 28Jan2021 at 12:30 PM, vaccine location was Left arm) for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. On 25Feb2021 at 04:00, patient experienced mild fever and body aches. Patient did not receive treatment for events. The outcome of events was recovered.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained. .
The patient reported minor facial swelling that started sometime the evening after receiving her first dose, and resolved about 8 hours later.
The patient was given a pediatric Pfizer dose. Tolerated well, no adverse reaction.
Patient reports sharp pain/ache in left arm that comes and goes since receiving the vaccine. Pain is from injection site and down towards elbow. Patient reports no redness or swelling at injection site. He has not taken anything for the pain. Incident was reported to pharmacy 4 days after receiving vaccine. Patient did not follow up with doctor yet but will be contacting doctor if pain continues.
Swelling; Warmth to deltoid; swollen axillary lymph nodes to the same arm; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (Swelling), VACCINATION SITE WARMTH (Warmth to deltoid) and LYMPHADENOPATHY (swollen axillary lymph nodes to the same arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling), VACCINATION SITE WARMTH (Warmth to deltoid) and LYMPHADENOPATHY (swollen axillary lymph nodes to the same arm). At the time of the report, SWELLING (Swelling), VACCINATION SITE WARMTH (Warmth to deltoid) and LYMPHADENOPATHY (swollen axillary lymph nodes to the same arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and medication information provided.  No treatment information provided.