chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ankylosing Spondylitis; Elevated C-reactive protein level; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4416880-00 (Company).  A 44-year-old female patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 03Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) as unk (citrate free) (Batch/Lot number: unknown) subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown"; C-REACTIVE PROTEIN INCREASED (non-serious), outcome "unknown", described as "Elevated C-reactive protein level". The patient underwent the following laboratory tests and procedures: C-reactive protein: Elevated. The action taken for adalimumab was dosage not changed. On unknown dates, the patient experienced elevated c-reactive protein level and ankylosing spondylitis. Pfizer Biontech Covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality of Humira (solution for injection in pre-filled pen) (Adalimumab) for the event (s) of Elevated C-Reactive Protein Level and Ankylosing Spondylitis was not provided. The reporter's causality of Pfizer Biontech Covid-19 Vaccine(Tozinameran) for the event (s) of Elevated C-Reactive Protein Level was not reported and for Ankylosing Spondylitis was provided as possible.  The reporter's assessment of the causal relationship of "ankylosing spondylitis" and "elevated c-reactive protein level" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162b2 to the development of events ankylosing spondylitis and c-reactive protein increased cannot be 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This is a spontaneous report from a contactable nurse through a Pfizer representative. A 16 years old female patient received TRUMENBA on an unknown date, at 0.5 ml single, intramuscular, in arm. Medical history and concomitant medications were not reported. The patient experienced headache on an unknown date immediately after receiving the vaccine. The event resolved on an unknown date. Follow-up (17DEC2015): Follow-up attempts are completed. No further information is expected.
pt recv vax 9OCT97 & 17OCT97 pt was feeling very sick (hives, h/a, ears ringing, chills & sweats & had lost 15#) & thought it was from vax;MD visit recommended & pt refused;
Breakthrough case admission after 4 vaccines Pfizer 2/2/21 lot# EM980;  Pfizer 2/24/21 lot# EN2198;  Pfizer 9/27/21 Lot# 3013SBA;  11/11/22 Pfizer Lot# GJ6665
This spontaneous report was received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of COMVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Breakthrough COVID/ Felt very sick; Lack of drug effect; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Breakthrough COVID/ Felt very sick) and DRUG INEFFECTIVE (Lack of drug effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Adrenal insufficiency (Adrenal fatigue with a very low cortisol level).   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Breakthrough COVID/ Felt very sick) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Breakthrough COVID/ Felt very sick) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment drugs were not provided. The patient's age was estimated to be 45 years.  On an unknown date, about a month ago, the patient experienced breakthrough COVID and felt very sick. The patient want to get a third or booster dose of the vaccine.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Drug Ineffective mRNA-1273, lot # unknown  with COVID-19 as associated AE. Based on the available information and based on the infectious nature of the condition, the event is assessed as unlikely related to mRNA-1273.
Period events out of range: January 21-24, February 1- Last period previous vaccination was January 11-13
Patient was given first dose of vaccine for influenza. Patient was instructed to wait in waiting room to monitor for adverse reactions. approx 10 minutes after immunization was given Patient mom told front desk personnel that her daughter had developed a rash and was constantly itching. Patient was brought back to exam room and seen by provider immediately. Patient was given 2.5ml Benadryl per Provider verbal order. Patient remained in exam room for 30 minutes for further observation. Seen again by provider and was allowed to leave with instructions from provider.
successfully avoided contracting Covid until 15Sep2022 when we both got very sick/ very ill this fall after having the first three Pfizer vaccinations; successfully avoided contracting Covid until 15Sep2022 when we both got very sick/ very ill this fall after having the first three Pfizer vaccinations; This is a spontaneous report received from a contactable Consumer (patient's wife). A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type I diabetic" (unspecified if ongoing), notes: for 60 years; "has had four bypasses", start date: 2001 (unspecified if ongoing). The patient's concomitant medications were not reported. Patient's wife reported that they successfully avoided contracting Covid until 15Sep2022 when they both got very sick. While they were taking care of each other and carefully assessing whether or not to take mitigating medication-they both came to the conclusion that without the vaccinations that they both took-they likely would have ended up in the hospital. And that is the purpose of this email. Patient's wife recalled their emotional gratitude when they finally received their first inoculation that was difficult to secure back then. They both were so grateful to have gotten that protection in such a fear-filled time. And now, having gotten very ill this fall after having the first three Pfizer vaccinations and getting to the other side of it, they simply felt how thankful they are for the brilliant scientists at Pfizer for providing them with the protection that enabled them to weather this hideous virus. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown results. Outcome of the events was unknown.   The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5, BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200088446 Same reporter/vaccine/event, different patients;
ADMISSION: 12102021 - This patient is a 74-year-old woman.  She presents for evaluation and treatment of COVID.  She has multiple sick family members at home. She has been fully vaccinated with Pfizer earlier this year, but has not had her booster yet.  She presented to Urgent Care today and was referred to clinic to get the monoclonal antibody.  When she was there, though they measured her pulse ox at 82% and sent her to the emergency room for further treatment and evaluation.  She has had cough and some mild shortness of breath. She has had poor appetite with some nausea as well.  She initially had some subjective fevers and myalgias.  PT CONTINUES TO BE INPATIENT.
fatigue, swollen lymph nodes in neck, cold sweats, chills Narrative: employee states she recieved the vaccine the pharmacy She experienced starting Saturday afternoon cold sweats, chills, extreme fatigue, stayed in bed as well as swollen lymph nodes in neck
A few hours after receiving vaccine L arm and neck began to ache, then headache, dizziness, and tightness in my ears, throat, and chest. Did not feel short of breath. Took Benadryl and went to bed. Awakened the next day with headache, tightness in neck and ears, sore throat, loss of appetite, nausea and diarrhea. Went to work began to have tightness in chest, pain in left arm and neck, was sent home. Took Benadryl went to bed. Awakened today with headache, sore throat, and fatigue. Took severe sinus tablets and feeling better.
After the patients vaccine he became dizzy, pale and extremely nauseous. After approximately 20 minutes he did experience vomiting.
Constant Dizziness for the last year. Pressure in ears. Brain fog. Balance issues. Blurry vision. Symptoms get worse when I tip my head or lay it flat.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-OCT-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M011832, expiration date 25-JAN-2018 (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 32 and 35 degrees Fahrenheit (34.4F) for 15 minutes. A digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA007834: US-009507513-1711USA007835: US-009507513-1711USA007836.
On 8th day after receiving the vaccine (4/30/2021),  experienced pain in left arm around the vaccine site. By next day, the area (at and below the injection site, between shoulder and elbow) had swelling and turned red. Looked like a rash. No itching but pain in that arm. Arm was sore. The pain and swelling reduced after icing the area and taking over-the-counter Benadryl LiquiGel capsules.  Today (5/3/2021), the area is still red but the swelling has reduced and no pain. Slight itching, but can be tolerated.  Benadryl intake: 5/1/2021 - 1 capsule at night 5/2/2021 - 1 capsule each at morning and night 5/3/2021 - Not yet taken any medication
Patient immediately developed a large, raised, red welt about the size of a quarter. Patient was not experiencing any relief from the swelling but experienced no pain or itching at 10:54a diphenhydramine 25 mg one by mouth once was administered with water. The patient then waited tell 11:06a to go to their doctor's office in which they had seen their physician and the physician noted no significant change in condition but for the patient to monitor the situation and alert both pharmacy and doctor if any change in condition occurred.
2nd dose 1 month apart instead of 6 months apart; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On an unknown date, the patient received the 2nd dose of Havrix and hepatitis A vaccine pre-filled syringe device. On an unknown date, unknown after receiving Havrix and hepatitis A vaccine pre-filled syringe device and an unknown time after receiving HAVRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 age at vaccination was not reported. The reporter stated that, the patient received 2nd dose of Havrix 1 month apart instead of 6 months apart, which led to shortening of vaccination schedule. The reporter stated that, call dropped before could collect any demographic details from patient or any other information regarding the administered vaccine such as lot number o expiration date. The reporter did not consent to follow up.
4 days p/vax pt devel right-sided facial drooping for the upper eyelid to the mouth;
nerves started firing in her arm; nerves started firing in her arm. It feels like sticking her fingers in a socket; arm muscle being inflamed; This is a spontaneous report from a contactable consumer or other non hcp.     A 61-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on 2021 as dose number unknown, single for covid-19 immunisation. Medical history included surgery, she has had multiple surgeries on her arm She clarified that the multiple surgeries and nerve damage was about 10 years ago, nerve injury. There were no concomitant medications. She has had no reaction in 15 years. She had allergy testing to see if she could get the covid vaccine and everything came back negative. Had allergy testing to see if she could get the covid vaccine and everything came back negative. It was Reported that, the patient experienced nerves started firing in her arm on 20Aug2021 with outcome of recovering, arm muscle being inflamed on 2021 with outcome of unknown, nerves started firing in her arm. it feels like sticking her fingers in a socket on Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included allergy test: negative on 2021    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
12cm x 8cm redness, swelling to injection site. Noticed same day after receiving injections. Pt being treated with antibiotics for cellulitis.
Covid arm.  now purple no soreness no bruise just discolored on 4.13.21
Received DTaP, EIPV, and MMR on 8/13/02. On 8/15/02 AM, the parent called; reported child has swollen eyelids and lips. States complaints of chest pain last night. Instructed to take to ER now.
24 yo G5P2113 given first moderna vaccine 11/18/21 at 33w1d IUFD found 11/22/21 at 33w5d 1st pregnancy - fullterm vaginal delivery 2nd pregnancy - preterm delivery at 35 weeks 3rd pregnancy - SAB with D&C at 9 weeks 4th pregnancy - fullterm vaginal delivery at 37 weeks Pt was on 17-P this pregnancy for history of preterm delivery (she recieved a dose the same day as her moderna vaccine 11/18/21 Lot 2000459 exp 12/2022 subcutaneous in left arm) she recieved a tdap vaccine 10/14/21 she was anemic this pregnancy and taking ferrous sulfate she was found to have oligohydramnios on US on 11/11/21 (AFI 4.472) she was sent to labor and delivery and was ruled out for SROM, she was IV hydrated and her AFI was repeat by MFM and found to be 9.3 she reported contractions while at the hospital and was kept until 11/13/21 she was given betamethasone for fetal lung maturity on 11/11/21 and 11/12/21 she did not make any cervical change she was treated for a suspected UTI with Keflex, her urine culture resulted no growth she was discharged home 11/13/21 She had a reactive NST on 11/15/21 and her AFI at the time was 11.06 11/18/21 she was seen for a prenatal visit and was given her 17-P and the moderna covid vaccine, she had a reactive NST this day 11/22/21 she had a prenatal appoinment and was diagnosed with an IUFD, the AFI at the time was 3.3 she was sent to L&D and the IUFD was confirmed, the pt was given cytotec for induction and delivered a male infant 11/22/21 at 33w5d, apgars 0-0, he was 2.135kg (4#11.3oz), no nuchal cord, fluid was bloody at the time of delivery placenta was sent for pathology infant was sent for autopsy
Within 1 week of receiving my 2nd dose of the Moderna COVID-19 vaccine, I started experiencing issues with anxiety.  I experienced a full blown anxiety attack for the first time in my life.  Afterwards anxiety continued and affected my sleep for a period of one month.  Since 11/01/21 I have been experiencing rapid heartbeat, vibrating feeling in my chest/heart area, pain in chest/left shoulder blade, pain in left elbow joint. I went to the emergency room on 11/01/21 due to rapid heartbeat.  EKG, labs and monitoring were all normal at the time.  I received a cardiac event monitor to wear and was prescribed a beta blocker. I am currently following up with my primary care physician and cardiologist.
I was given the vaccine at 12 noon. I waited 15 minutes. No problem. I was driving home at 12:30 PM. I stopped at stop light, I became dizzy and almost fainted, became dizzy. I stopped the car and finally got home. I was alright in an hour.
Patient came to ED with fever, shortness of breath and mild diarrhea. Admitted to hospital for COVID-19 pneumonia.
Confusion; Back muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion) and MYALGIA (Back muscle pain) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C2A1) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was Covid positive back in April of 2021) in April 2021. Concurrent medical conditions included Allergy to nuts, Allergy to animals and Penicillin allergy.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced CONFUSIONAL STATE (Confusion) and MYALGIA (Back muscle pain). At the time of the report, CONFUSIONAL STATE (Confusion) and MYALGIA (Back muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
10NOV92 1030AM pt called w/ h/a, achy, fever 104 called CDC was adv to given APAP & force fluids; fever & other sx should go away in a day;
Patient and parent are unsure of exact brand of influenza vaccine.  Patient received the vaccine on 11/14, reported having body aches starting 11/15. Then while taking a shower on 11/16 felt dizzy, laid down in her bed and briefly lost consciousness. She reports having sore throat, headache, fatigue, and fever temp max 102 also. Feeling improved on 11/17
(L) arm has multi raised red areas appox 3cm x 3cm on upper arm from site of injection to elbow pt states "painful" started appox. 1 hour after injection continued at visit today 10/10/12.
Patient developed diffuse alopecia areata 4 days after receiving her first COVID immunization.  Hair was falling out in clumps, it was an abrupt onset.  No pain or itching on the scalp.  Patient labs have been monitored since her hospitalization for MTX toxicity, last dose of MTX was mid August and has not had any since.  Her labs stabilized by discharge.
devel fever 102 on Friday noc;Saturday AM 7MAY99 9 days p/vax pt given on 28APR99;fever was reduced by giving APAP;rash broke out on chest 9MAY99 w/few small macular papular areas which spread to face;
1-2 days after vaccine, pt developed weakness, fatigue, body aches, nausea, headache and poor appetite.  Pt was admitted to the hospital on 2/5/21 and death occured on 2/6/21
14 Hours after receiving Tdap patient developed severe myalgias, followed by fever and moderate arthralgias. Patient examined 24 hours after injection. On exam temperature 101.2 F, joint exam normal without swelling. Injection site remarkable for moderate pain, minimal swelling and erythema.
Tingling on left side of body, severe pain and rash on left side of body developed Shingles
11:46: 0.5 ml yellow fever vaccine administered SC right tricep. 11:51: Pt stated throat feeling sore, not feeling like this earlier - denied throat closing. Described as tingling. Kept touching her throat. 11:53: Administered 0.3 ml EPIPEN. 11:55: Vitals BP 107/69 R 20 P 63. 12:00: BENADRYL 50 mg IM left deltoid by RN - ordered by MD - examined by MD. 12:02: BP 111/74, R 20, P 68 - pt c/o throat sore difficulty speaking, tingling. Breathing good. 12:06 transported to ER.
Headache, chills, fatigue, moderate pain at the site.  Pain lasted 4 days. I am well tolerant to medication.  Never had this type of reaction. This was experienced at the first shot also.  My wife experienced the same symptoms on the dame day with the same vaccine.  TOOK Ibuprofen, no other medication
pt. stated she had history of fainting with shots but had not occurred in over 10 years. After injection was complete pt. immediately stated she did not feel well and fainted in her chair. I was able to hold her for a few minutes and she never appeared to lose consciousness. She was sweaty, nausea, and cold. We moved her to the floor and elevated her feet with a cold towel on her face/head. Pt requested paramedics and they checked her out and said she was stable. Pt stayed in pharmacy for about 30 minutes until she went home. She was feeling better when she left.
This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates theses unspecified patients were vaccinated with improperly stored GARDASIL 9 (strength, dosing details, anatomical location, lot# and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.