chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a literature report. A 28 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "iTTP", start date: 2019 (unspecified if ongoing), notes: late 2019; "fatigue" (unspecified if ongoing); "chest pain" (unspecified if ongoing); "rash" (unspecified if ongoing); "ecchymosis" (unspecified if ongoing); "petechiae" (unspecified if ongoing); "scant vaginal bleeding" (unspecified if ongoing); "mild headaches" (unspecified if ongoing); "microangiopathic hemolytic anemia" (unspecified if ongoing), notes: On the peripheral blood smear; "admitted" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Rituximab for Immune-mediated thrombotic thrombocytopenic purpura, reaction(s): "she developed recurrent thrombocytopenia and suffered an exacerbation of iTTP"; Caplacizumab for exacerbation of iTTP, reaction(s): "but did not achieve an ADAMTS-13 activity remission". The following information was reported: THROMBOTIC THROMBOCYTOPENIC PURPURA (hospitalization, medically significant), outcome "recovered", described as "iTTP relapse"; CONTUSION (non-serious), outcome "unknown", described as "bruising on her arms". The patient was hospitalized for thrombotic thrombocytopenic purpura (hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: adamts13 activity assay: a diagnosis of iTTP; less than 2.5, notes: %; blood lactate dehydrogenase (normal high range 190): 205 IU/l; normalized; 216 IU/l; normalized, notes: on day 3; blood lactate dehydrogenase: normalized; 216 IU/l; blood smear test: she was found to be severely thrombocytopenic, notes: (platelets,17x 109/L) with evidence of microangiopathic hemolytic anemia; schistocytes; haptoglobin: undetectable; platelet count: 17 x10 9/l; 84 x10 9/l, notes: thrombocytopenia; 159 x10 9/l; 57 x10 9/l; normal, notes: on day 3. Therapeutic measures were taken as a result of thrombotic thrombocytopenic purpura. Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events Thrombotic thrombocytopenic purpura cannot be totally excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.
powder reconstituted with non approved diluent/ only diluent received; powder reconstituted with non approved diluent/only diluent received; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: The reporter reported that, they had 3 extra Shingrix powder vials.  The medical information asked reporter if they knew what happened with the missing diluents and if they believed patients received diluent only.  The reporter seemed upset about this question and said did not  even go there, did not know what happened but there was no error. The reporter said that, they did not know what happened with the vials and asked medical information if the powder could be reconstituted with a non approved diluent. The reporter did not consent to follow-up. This is 1 of 3 linked cases reported by same reporter, different patients. Additional Supportive Information: The patient received only diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case was kept valid based upon verbatim that they believed patients received diluent only.; Sender's Comments:  US-GSK-US2022AMR152100:Same reporter US-GSK-US2022AMR152101:Same reporter
Friday afternoon - swelling, heavy (lifting arm), pain in muscle, very war [applied ice]. Saturday morning - emergency room, symptoms continued 6 days.
Information has been received from a pharmacist concerning a female (age unknown) who on 05-NOV-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On approximately 05-NOV-2007, the patient experienced 3 inch long injection site reaction. Injection site is red, tender and warm. The injection site reaction persisted. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
Boostrix expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43e4t, expiry date 1st October 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 6th October 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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 patient was vaccinated with a Boostrix expired dose, which led to expired vaccine used. The reporter consented to follow up.
Headache, Myalgia, Site pain, chills, fatigue Narrative: Reports headache severe
This is a spontaneous report from a contactable nurse.   A 8-month-old female patient received on 25Apr2016, at 1 day old, the first single dose of pneumococcal 13-val conj vac (dipht crm197 protein) intramuscular in leg , first dose of hepatitis B vaccine intramuscular in leg, first dose of diphtheria vaccine, pertussis vaccine, tetanus vaccine (DTAP) , intramuscular in leg and first dose of polio vaccine (IPV) intramuscular in leg , all for routine immunization.On 24Jun2016 at 2 months, she received the first dose rotavirus vaccine orally before noon and second dose of hepatitis B vaccine intramuscular in leg, all for routine immunization. The patient medical history was not reported.  Concomitant medication included ergocalciferol (VITAMIN D) from May2016 to 24Oct2016 as supplement for breastfed babies. On 24Jun2016 the patient did not nurse well, as far as breast feeding and experienced uncontrollable crying and had only two maybe three wet diapers the first two days after receiving these injections. In 2016 HIPPA violation occurred since patient missed all of her four months vaccines and all of her six months vaccines, which were not given because events experienced with previous vaccinations. Event did not nurse well completely recovered in Jun2016 (reported as around 26Jun2016); uncontrollable crying completely recovered on 25Jun2016 and  urine volume decreased completely recovered on 26Jun2016. Events were all related to suspect  vaccines. Pfizer is the Marketing Authorization holder of pneumococcal 13-val conj vaccine in reporter's country. This may be a duplicate report in situations where another Marketing Authorization holder of pneumococcal 13-val conj vaccine  has submitted the same report to the regulatory authorities.
Nauseous all day after dose, went away with time  Sore arm for 2 days, took ibuprofen every few hours
Case number PHEH2014US025130, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 78-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 21 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursions began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
7/14/2023 - 7/22/2023 (8 days) Presented to the ED due to weakness, confusion of one day duration.  Admitted and started on iv rocephin /zithromax, ivf,  iv remdesivir and systemic steroids along with bronchodilators GL0446 11/18/2022 11/13/2021 FG3527 3/20/2021 ER8727 EN6198 2/27/2021
Wrist and Hand on arm of injection was swollen for 3 days after the injection; Wrist and Hand on arm of injection was swollen for 3 days after the injection; This is a spontaneous report from a contactable consumer (reported for herself). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265 and expiry date was not provided), via an unspecified route of administration, in arm right, on 31Jan2021 08:00, as a single dose for Covid-19 immunization, at hospital. Patient's medical history included Parkinsons and allergies to penicillin. Concomitant medications included carbidopa, levodopa and diltiazem (within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 01Feb2021 03:00 AM, the patient had wrist and Hand on arm of injection was swollen for 3 days after the injection Patient was received no treatment for the adverse events. Outcome the event was recovered on an unknown date in Feb2021.
ALL JOINTS ACHE; MUSCLE ACHE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced all joints ache. On MAY-2021, the subject experienced muscle ache. Treatment medications (dates unspecified) included: tramadol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle ache and all joints ache was not reported. This report was non-serious.
I woke up the next morning after my vaccination with severe vertigo. On my 6th day of Vertigo I started physical therapy. I had it on both sides. It took numerous treatments (Epley  maneuver ) and 2 weeks to get rid of it. I had my 2nd vaccine 3/10/21 and woke up dizzy and nauseous and ended up with Vertigo again. I start physical therapy again on 3/18/21.  Two vaccinations and two bouts of vertigo.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 2:17 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that on 24-Sep-2021, patient received the Moderna vaccine which expired on 22-Sep-2021. The patient did not have any adverse events and did not required any medical attention. No problems were reported by the patient.  No concomitant medication was reported. No treatment information was reported.
Severe stomach cramps and diarrhea  Very strong right leg cramps  started at 11pm on 4/8/22 and continued until 10 pm on 4/9/22
Chills; fever; body aches; painful lump in armpit; chest fullness/discomfort; hard to take a deep breath; fatigue.
PT did not seroprotect p/3 vaxs (20mcg, del) given on unspecified date for 1st inject, APR90, & 27JUN90; PT still did not seroprotect p/14SEP90 inject; plan to give a 5th inject;
Pt received the 2nd dose of the COVID vaccine on Sunday 1/17/21 and developed a sore arm, but otherwise had no symptoms. By Tuesday 1/19/21, he was having shooting pains through his shoulder and down to his elbow. By late Wednesday, he had started to develop hives on his palm, between his fingers, and up to the elbow. Pt states he has a history of a pinched nerve in his neck and elbow, but this pain is nothing like his usual pain.  On 1/22, pt presented to the ED for left uper arm pain and rash. He denied new detergents, foods, clothes, wooded area exposure. Denied decreased ROM in shoulder, but ROM makes his shoulder sore. BP 161/82, otherwise vitals normal. Rash did not apear infectious. No evidence for DVT. Pt received ketorolac 30 mg IM x 1 in ED and was prescribed hydrocodone-APAP 5-325 mg tabs PO Q6h PRN #8. Pt was instructed to follow up with PCP in 1-2 days.  By 1/25/21, pt reports the hives have become dark purple, like bruises. He states he has trouble making a fist and is not using his left arm at all - when this writer spoke to him, he said it was "gimpy." Pt stated during the phone call that he was about to call his PCP for a follow up appointment.
CDC reports: 3 mo infant received DTP/OPV on 11OCT89 and died 13OCT89.
Information has been received from a physician concerning a 12 year old female who in February 2008, was vaccinated with a dose of GARDASIL (lot number, injection site and route not reported). On the same day, the patient experienced headache and after several days she started with blurred vision, and was seen by an ophthalmologist that diagnosed Pseudo tumor Cerebri. The Pseudo tumor Cerebri was confirmed by an MRI of brain. Upon internal review, brain neoplasm was determined to be an other important medical event. Additional information has been requested.
This non-serious medically confirmed report (initial receipt 09-OCT-2014) concerns a 55 year old female patient who had no known relevant medical history. On the 09-OCT-2014, the patient received AFLURIA (batch number R52006m expiry date 19-JUN-2014) 0.5 ml via the intramuscular route. The patient inadvertently was administered the dose of expired AFLURIA. No adverse reaction had been reported. Outcome was recovered. Reporter comments: The reported stated the case to be non-serious.
Started feeling flu-like symptoms the next morning with a temperature of 101.7. Took Ibuprofen and laid down around 12:00 PM, woke up in a sweat around 4:00 PM with temperature of 99.5. Felt better soon after.
After completion of vaccinations, patient passed out. Patient came back to very prompt and was evaluated by provider and deemed safe to return home.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 23-AUG-2017, the patient was vaccinated with an expired dose of GARDASIL lot # L012190, expiration date 13-APR-2017 (dose and route were not reported), for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
.7cm X .7cm knot in left arm first noticed 4/18/00. No redness. No warmth at site. 2cm long bruises X 2 on right arm, noticed on 4/14/00. Normal behavior with localized reaction.
Patient said he had an extreme headache and slight difficulty breathing and his heart racing within 2 minutes of being vaccinated. His blood pressure was taken and was 164/94, and he was given water to drink. Within 5 minutes, the headache was beginning to subside and his blood pressure returned to normal levels at 129/64. After 10 minutes the headache was gone and the patient said he was feeling much better. He was monitored for another 15 minutes before being released to go home.
Fever; Chills; joint aches; upsettummy; runny nose; head congestion; headache; This is a spontaneous report from a contactable consumer, the patient. A 52-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 18Jul2021 at 14:15 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid (VITAMIN C) and colecalciferol (VITAMIN D3) and MULTIVITAMIN. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 28Jun2021 at 17:00 (at the age of 52-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. On 19Jul2021 at 00:00 the patient experienced fever, chills, joint aches, upset tummy, runny nose, head congestion and headache. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events fever, chills, joint aches, upset tummy, runny nose, head congestion and headache were recovering at the time of this report.
Rash on right arm - Treated with 2 Benadryl and some cream to rash.
Initial unsolicited report received from a nurse on 23-Mar-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date (reported as 10 years ago). Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at the time of vaccination were unknown. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date (reported as 10 years ago), following the vaccination, the patient developed a large local red reaction (vaccination site reaction) and headache with sweating. Patient required emergency room (ER)/ doctor visit with systolic BP in 80s and PVCs on a rhythm strip. Laboratory investigations were not reported. Corrective treatment were not reported. The outcome of events were unknown. List of documents held by sender: none.
I continue to experienced chronic fatigue, so tired all the time, heart palpitations, dizzy, have a cough and got memory confusion since I had covid and these symptoms are not going away. I've had labs done, had a heart echo done, sent to a pulmonologist, lung test, EKG done and it all comes back as inconclusive.
side effects; This case was reported by a consumer via call center representative and described the occurrence of stomach flu in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, couple of weeks after receiving Shingrix, the patient experienced stomach flu. On an unknown date, the outcome of the stomach flu was unknown.   It was unknown if the reporter considered the stomach flu to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the Shingrix a couple of weeks ago experiencing those side effects. The reporter thought it might be a flu bug but then remembered the vaccine a couple of weeks ago.
"About 4 hours after the vaccine I felt fuzzy headed, flu like and body aches."
Two weeks after vaccination (3/15), I developed a headache which is mildly grinding and it's 24/7.  Still going. Three weeks after vaccination (3/21), I woke up and heard high pitched hiss in both of my ears. It's 24/7 and still going.
Blanching 1/2 circular areas erythema on anterior thighs and slightly below axillae, slightly itching. Began 2-3 days after Dtap and Hib were administered RX Benadryl 12.5 mg tsp 1tsp Q 6 hours PRN.
Pfizer bivalent was accidentally administered as the 1st dose in patients primary series. Patient was notified.
Noticed a few hours after I got vaccine. Not exactly sure exact time because work nights and came home and went to sleep after vaccine .  Achy spine, front of my head hurt, nauseous. Same 2nd day. 3rd day just achy spine. Slept on and of last few days.  Did not call Dr.  Or go into office because symptoms didnt worsen. I work in hospital and kept in contact with EHO on monitoring steps i needed to take.
Fever of 102 degrees Farenheit lasting 14 hours. Dizziness, muscular aches and weakness, body tremors lasting 40 hours. Persistent headache lasting 4 days.
pt recv vax 7NOV97 & 3hr p/vax pt exp dizziness, then hands swelled, felt prickly (like asleep) & both hands are bright red;
Pt recv vax on 1/8/99; on same day pt exp diarrhea x 3 day
Almost immediately after receiving the vaccine, I felt tingling in my lips and the tip of my tongue.  One week later, I developed large inflamed patches on the inside of my lips.  I still have them (almost two weeks later).
One day post AVA # 3 he began to experience tremors in all hands.  Initially severe and intermittent and mild.  No md evaluation.  Received AVA # 4 in 2007 without increase in tremors.
Started not feeling right- her stomach was bothering her; diarrhea; Her face turned red; Face and chest felt like they were on fire; Freezing and could not warm up; She was very crampy; nauseous; Left arm soreness; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247) solution for injection intramuscular in the left arm on 19Jan2021 (at the age of 80-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. On 19Jan2021, the patient started not feeling right- her stomach was bothering her, diarrhea, her face turned red, face and chest felt like they were on fire then freezing and could not warm up, she was very crampy, nauseous and left arm soreness. The outcome of the events stomach discomfort, diarrhea, feeling hot, feeling cold, very crampy and nauseous was recovered on 19Jan2021. The outcome of the event face turned red was unknown. The outcome of the event left arm soreness was not recovered.
Exactly one week after my shot, I have been experiencing the longest and worst period I have ever had. I did not connect the two at the time. But I now feel this was a reaction to the vaccination. I am passing blood clots, undergoing blood tests and having a ultrasound on my uterus because it is so out of the ordinary.