chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AWOKE WITH SEVERE GENERALIZED BODY PAIN, DIZZINESS, NAUSEA, TREMORS AND SLURRED SPEECH, SWOLLEN FACE, DIAPHORESIS.
Clogged Sinuses, Headache, Body aches, dizziness, weakness, general ill feeling, chest tickles, little wheezing when exhaling
He has had the following symptoms from the 4/12/2021 till present time: constant headache and fatigue.  Intermittent low fever (99F). On 4/21/2021, his primary care doctor recommended that we take him to Emergency Room because she was concerned about thrombosis as side effects from the vaccine.  His legs had some red patches on the back of the ankles area.  At ER, doctor did blood test for blood clot and result was negative. He got an IV injection less headache.
She got her vaccine, initially she just felt a little light headed, not that she could not walk or anything.  Then later in the evening about 8:00 she got a headache.  She did not sleep well, but in the morning when she woke up she had a headache, diarrhea, nausea, and then had a lot of bloating and gas.  As the day progressed she started getting asthma by the afternoon/evening, and then started coughing, and coughing up clear sputum.  That went away after a couple of hours.  She was then tired.  Day #3 she had a headache, which was on and off and still has a slight headache this morning.  She had a rash on her trunk, abdomen, arm points, groin, red rash.  Then yesterday she still had a headache and did not feel  good.  She is feeling better today, has a slight headache.  Her arm was sore, but knows that was due to the vaccine.  She has had a shingles, COVID, pneumonia and flu vaccines and has never had a reaction to any of them other than a little fatigue.  She has taken Tylenol for her headache, and Gas-X as she was gassy and bloated and uncomfortable.
This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from the (manufacturer control number: 21K-163-4116265-00).  A contactable 44-year-old female patient received bnt162b2 (BNT162B2), subcutaneous on 01Feb2021, at the age of 44-years-old, (Batch/Lot number was not reported) as DOSE 1, SINGLE, subcutaneous on 01Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to Dec2020 at unspecified dose; and subcutaneous from Jan2021 (Batch/Lot number was not reported) and ongoing, at unspecified dose for an unspecified indication.  The patient's medical history and concomitant medications were not reported.   On unknown dates, the patient experienced covid-19 and entire family caught covid-19. In 2021, the covid-19 and entire family caught covid-19 resolved.  PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Feb2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 01Mar2021, she received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. Primary reporter contact for lot number information was not available. The patient underwent lab tests and procedures which included blood test: blood count came back up on Jan2021, sars-cov-2 test: positive on 2021.  The action taken in response to the event for adalimumab was permanently withdrawn on an unspecified date.  The reporter's causality for the event ENTIRE FAMILY CAUGHT COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility.   The reporter's causality for the event ENTIRE FAMILY CAUGHT COVID-19 with BNT162B2 was possible.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, The casual association between the reported events with suspected vaccine BNT162B2 cannot be completely excluded.
Initial pain, swelling, redness....especially in the left arm. The pain and swelling involved the entire upper arm to the elbow and shoulder area. Then the stiffness started in both shoulder joints...and pain. Nighttime pain waking up to not being able to move arms...as if locked to the sides of the body. Upon rising and with slow movement am able to get both arms somewhat mobile. Each and every day inflammation continues in the arms, shoulders and neck area. The inoculation area in both arms remains very noticeable. I have felt awful since receiving these inoculations.
Nasal bleeding in left nostril that I could not stop. Required ER trip and then hospitalisation. Bleeding began about 12 hours after injection. I also had severe flu-like symptoms.  I don?t know that the vaccine caused the bleeding but I?ve never had bleeding to that extent and I?ve been taking Plavix and aspirin post heart attack since Sep 3, 2020 with nothing like this event 12 hours after second Moderna.
Soreness of injection sight-48 hours Diarrhea-72 hours Fatigue/Malaise-48 hours
HAD DTAP ON 7-16-2008, SEEN 7-17-2008 SWELLING,ERYTHEMA AT SITE(19CM BICEP AND 5CM ABOVE ANTICUBITAL SITE) FEVER
On 03/06/2021, that evening my throat was itchy, my face started swelling and getting red and was hot to the touch. The symptoms lasted 3 or 4 days. I called the doctor on 03/07/2021 and he told me to take Benadryl. The Benadryl subsided the itching but the swelling lasted a week or 2. It was slowly going down.
Persistent tingling in my head, face and extremities (pins and needles sensation) and numb lips began the day after the vaccine and are still present a week later. I also experienced a headache for the first two days and discomfort in the injection site for 3 days.
This spontaneous report was received from a nurse and refers to an adolescent patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 25-SEP-2015, at the age of 14 years, the patient received the first dose of GARDASIL injection (dose, route of administration, lot # and expiration date were not reported). On 28-APR-2017, the patient was vaccinated with the second dose in the HPV vaccination series, which was GARDASIL 9 injection (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported.
Phantom smell & phantom taste of a distinct strange odor/taste. Smell/taste is best described as a mix of onion + dirty socks.
Approx 3 inch long, 2 inch wide red/hot/swollen local reaction.
his is an initial report of a pregnancy, received on 21 OCT 2014. Subject number: 2014-031068/KE, a 36-year-old female received FLUBLOK, intramuscularly on 20 OCT 2014. On day 2 of receiving FLUBLOK, 21 OCT 2014 (FLUBLOK was administered on OCT 2014) (lot # 441253F) the pharmacist contacted the call center to inform that the above reference subject was pregnant. No information on previous pregnancy history, medical history or concomitant medication provided. Causality information was not provided. Since it is a one time dose, action taken, outcome, de challenge and re challenge has been reported as not applicable.    Company assessment: based on the initial information received 21 OCT 2014, that the FLUBLOK was administered  to the subject who was pregnant, the company assessment of causality between the event and FLUBLOK is not related.
first Twinrix on 11/17/21 later Engerix 12/17/21; first Twinrix, a month later Engerix, mix up; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 49-year-old male patient who received HBV (Engerix B adult) (batch number L5C49, expiry date 17th May 2022) for prophylaxis. Co-suspect products included HAB (Twinrix adult) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX ADULT). On 17th December 2021, the patient received Engerix B adult. On an unknown date, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 17th December 2021, unknown after receiving Engerix B adult, not applicable after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device and an unknown time after receiving TWINRIX ADULT, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the wrong vaccine administered and incomplete course of vaccination were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported for Engerix B vaccine. The age at vaccination was not applicable for Twinrix adult. The patient received 1st dose of Twinrix adult on 17th November 2021, batch number 3Y7NL and expiry date 24th May 2022. The patient received Engerix B vaccine instead of Twinrix adult, which led to wrong vaccine administered. The patient did not receive 2nd dose of twinrix adult as per recommended vaccine schedule, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Chills, body ache, headache, fever for approximately 3 1/2 hours, then chills and body ache throughout the day April 1.  All cleared up by April 2.   These conditions were identical to the reactions to Shot #1 on March 8, 2021.
Knocked him out; when someone was talking to him about something he could not remember what they were talking about; messing with his head so bad/ wiped him out mentally; takes away his ability to concentrate; He will need to sleep it off over the weekend; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "takes away his ability to concentrate", "knocked him out", "when someone was talking to him about something he could not remember what they were talking about", "messing with his head so bad/ wiped him out mentally", "He will need to sleep it off over the weekend". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Knocked him out"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "when someone was talking to him about something he could not remember what they were talking about"; MENTAL DISORDER (non-serious), outcome "unknown", described as "messing with his head so bad/ wiped him out mentally"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "takes away his ability to concentrate"; SOMNOLENCE (non-serious), outcome "unknown", described as "He will need to sleep it off over the weekend".  Additional information: The First year the vaccines came out (2021), he works at a level 1 trauma center. The first dose knocked him out and stated that he had to go home from work. When he got the first shot, a hour afterward he said that when someone was talking to him about something he could not remember what they were talking about. He had the same problem with the second dose. Last year (2022) booster wiped him out mentally. It takes away his ability to concentrate. These vaccines are messing with his head so bad. It wipes out his ability to concentrate. It seems to only be happening to him. He said that 4 for 4  of his doses have had exact same thing. He will need to sleep it off over the weekend.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300355612 same patient/drug/AEs and different dose;
At 9:40 pm on 11/30/2021, I started experiencing extreme fatigue and chills. I took tylenol and went to bed. At 1:30 am, I woke up with a temperature and a very fast throbbing heartrate. My fitbit measured it between 119-138 bpm throughout the entire night. I was burning up and the temperature was above 100. I used cold compresses to try to bring the heat and pulse rate down. I slept for a total of 1:30 hours and as of 12/01/2021, I am still feeling very fatigued and had extreme chills an hour ago. Since last night, I have been alternating tylenol and ibuprofen. My current heart rate is between 90 - 110 bpm.
they have given a patient an extra dose of Adacel, with no reported adverse event; Initial information received on 02-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 17 years old male patient who was given an extra dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine conj (Meningococcal Conjugate); and HPV vaccine for Prophylactic vaccination.  On 24-May-2023, the patient received an extra 0.5 mL dose 2 of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (Strength: Standard) (batch number: U7548AA; expiry date: 14-Oct-2024) via intramuscular route in the left deltoid for immunization with no reported adverse event (extra dose administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event they have given a patient an extra dose of adacel, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
FEVER; Chills; headache; It knocked on my but; she felt exhausted/she's still really tired; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection), dose 2 via an unspecified route of administration on 02May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took bnt162b2 for covid-19 immunisation and cosentyx. The patient experienced fever, chills, headache, it knocked on my but, still really tired. Patient reported she received her second dose a Pfizer COVID-19 vaccine this past Sunday 02May, the day after taking her cosentyx dose, it knocked me on my but, she went on to explain she experienced fever, chills, headache, and she felt exhausted she reported her symptoms are improving but she's still really tired and having some chills headache. In addition she mentioned she took care passed a dose of her cousin takes a few days late because she forgot to take it and she felt a tingling in her scalp, reported this fully resolved after she took the dose. She also mentioned that she does continue to experience an itch as yet warning sign before her next maintenance dose is due. Outcome of exhaustion was unknown and for all other the events it was recovering.   Information on the lot/batch number has been requested.
chills; headache; fever; This is a spontaneous report from a contactable physician (parent). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered in arm left on 09Jun2021 07:30 (Batch/Lot Number: EW0186) (at the age of 12-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 dose 1, intramuscular (lot number: EW0179) on 18May2021 07:30 AM for COVID-19 immunisation. The patient had no other vaccines within four weeks. The patient had no covid prior vaccination. He had not tested with covid post vaccination. The patient experienced chills, headache and fever on 09Jun2021 19:30 with outcome of recovered on 10Jun2021 14:00. It was reported that 12 hours after receiving the vaccine, the patient started having chills, headache and fever (38.5 degrees Celsius). Ibuprofen 300 mg was taken once. The following morning (June-10) around 9 am another dose of Ibuprofen 300 mg was taken. The events resolved by 2 pm the same day. Therapeutic measures were taken as a result of chills, headache and fever.  No follow-up attempts are possible. No further information is expected.
"Moderna COVID- 19 Vaccine EUA" Patient presented to the vacccination site to receive 2nd dose of COVID vaccine.  The patient missed her original return date and showed up at the location site after the call center staff instructed her to just show up onsite to receive her 2nd dose.  The day the client came the site was administering Moderna.  No complaints or adverse reactions reported by the patient.
At 10PM  (8 hours after getting the JnJ vaccine) pt developed chills and pulsate headache.  Pt was able to sleep. Next day in the morning by 7:40AM she went downstairs and got dizzy and fall gradually on the floor.  Pt got help, but when she was trying to get up she got lightheaded/passed out again bumping her head on the wall.  Pt reacted, fluids were given.  Pt slept all morning. At 2PM she got up from bed. No pulsate headache, just "mild headache."  Today, 48 hours later, pt reported light headache.  Denies abdominal pain or pain in extremities.  Pt  and parents of pt were encouraged to report to patient's PCP.
This spontaneous report was received from a register nurse, refers to a three patients of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date, the patients were inadvertently vaccinated with ZOSTAVAX intramuscular, (dosage, lot # and expiration date were not reported). Concomitant therapy was not reported. There was not adverse effects reported. Additional information has been requested.
Pt developed apparent shingles of the central compartment of the dermatome on the right.
Patient presented to the ED on 3/7/23 with weakness, fatigue, nausea, vomiting, and diarrhea. A COVID-19 PCR test performed in the ED resulted positive. Ultimately he was admitted 3/7/23-3/9/23 for COVID-19 and dehydration. He was not treated with steroids or antivirals during his admission. During admission he had improvement of symptoms. Of note, the patient has received the primary COVID vaccine series and three boosters.
Patient presents and is admitted to a local hospital with cough, congestion, fever, and shortness ofbreath. Hx of copd. States she is vaccinated for covid 19. Hypoxic on ems arrival in the 60s. 84% on room air
Soreness in injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in injection site left arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in injection site left arm). At the time of the report, VACCINATION SITE PAIN (Soreness in injection site left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported.   This case was linked to MOD-2021-368929, MOD-2021-368930 (Patient Link).
Booster; We not feeling great; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; lenvatinib mesilate (LENVIMA) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; MALAISE (non-serious), outcome "unknown", described as "We not feeling great". The action taken for lenvatinib mesilate was unknown.  Additional information: This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-104219), for bnt162b2. Initial Report: Reporter spoke with patient wife who stated "We not feeling great, because we just had the covid-19 booster shot". No further information was provided. Prescribing HCP Diagnosis on enrollment form Lenvima 12mg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101732774 Same reporter/drug/event for different patients
Raised injection site welt. 2.5 inches. Red and itching. Started 7 days after initial injection. Warm to touch.
Site: Pain at Injection Site-Mild, Systemic: PT SAID HE IS VERY WARM AFTER INJECTION AND STARTED SWEATING. THEN HE SAID THINS ARE VERY BLURRY AND WE CALLED 911. THEY CAME AND CHECKED ON HIM AND THEN TOOK HIM WITH THEM.-Severe, Systemic: Flushed / Sweating-Severe
Slept all day; very tired; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 07Mar2021 08:00 as dose 1, single, and via an unspecified route of administration, administered in Arm Left on 28Mar2021 (Lot Number: EP6955) as dose 2, single for Covid-19 immunisation (Vaccinated at 77years of age). Medical history and concomitant medications were not reported. No family medical history relevant to adverse events reported. The patient slept all day, very tired on 09Mar2021. Patient reported that she received her first dose on a Sunday(07Mar2021) and was tired on Tuesday(09Mar2021) and just slept all day and by the 3rd day(10Mar2021) she was up and fine. The patient said that the tiredness was with her first dose. She stated that the tiredness was just for 1 day. Her vaccines were received 2 weeks apart and thought they were in May. Patient clarified that they were actually 3 weeks apart and she received them in Mar2021. NDC number of Pfizer Covid-19 Vaccine was Unknown. AE(s) did not required a visit to Emergency Room or Physician Office. There was no Prior Vaccinations within 4 weeks. There was no AE(s) following prior vaccinations. No relevant tests. The outcome of events were resolved on 10Mar2021.   Follow-Up (14Jul2021): Follow-up attempts are completed. No further information is expected.
Pt is on chemotherapy & exp a nosebleed p/receiving the flu vax;