chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatoid arthritis flare up; Fatigue; Arm deformity; Eczema; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4210232-00 (Abbvie).  A 69 year-old female patient received BNT162B2 (BNT162B2), intramuscular, administration date 06Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovered", described as "Fatigue"; LIMB DEFORMITY (non-serious) with onset Mar2021, outcome "not recovered", described as "Arm deformity"; ECZEMA (non-serious) with onset Mar2021, outcome "not recovered", described as "Eczema"; RHEUMATOID ARTHRITIS (medically significant) with onset Mar2021, outcome "not recovered", described as "Rheumatoid arthritis flare up". The action taken for adalimumab was unknown. Clinical course: a 69-year-old female with events of non-serious COVID vaccine made fatigued, left arm fused together, eczema and rheumatoid arthritis flare up with HUMIRA (adalimumab). There was no reported medical history. On unknown dates, the patient experienced left arm fused together, eczema and rheumatoid arthritis flare up. In Mar2021, the patient experienced COVID vaccine made fatigued. In 2021, the COVID vaccine made fatigued 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 06Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 06Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech.  Causality for HUMIRA (ADALIMUMAB) and PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): The reporter's causality for the event(s) of COVID vaccine made fatigued, left arm fused together, eczema and rheumatoid arthritis flare up was not provided.  The reporter's assessment of the casual relationship of the events 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 information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   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.
Received both Fluzone and Pneumovax in top left arm one below the other on 6:45 pm 10/18/06.  At 1 am, I woke up and could not catch my breath. My left Arm hurt very bad, it was hot, swelled, and was sore and same arm broke out in welts below shot area above the elbow on 10/20/06. I took Tylenol every 3.5 hours for pain. The pain was so bad I could not move my arm if the Tylenol was not taken. I felt very congested and tired after the shot. It should be noted my arm hurt badly and I not able to sleep. Today 10/21 6:45 am the pain has lessened but the welts are still on my arm and very hot to touch. There are two welts about the size of a quarter each.  I have had taken many flu shot in the past and never had an allergic reaction. I believe I am reacting to the Pneumovax injection.  I am allergic to several drugs Norvasc Tabs 5 mg, Nifedipine 60 mg.   Currently I am being treated for high blood pressure. I take the following medications:  Lisinopril  5 mg 1 Daily Hychlochlorot 25 mg 1 daily, and for allergies Rhinocort Aqua Spray 32 mcg 1 sprays each nostril 1 daily. In September I was diagnosed with mild sleep apnea. My blood pressure is under control.  My other vitals are perfect. My last blood pressure checked on 06/27/06 and was 132/76. That is about the normal range when it is checked.    This 1.5 past years, I have has many health issue:  July 19, 2005 Surgery for Prolapsed Rectum  Surgery for Abdominoplasty  February 28, 2006  Bladder Surgery.  I was unable to take the  RX pain medications because I felt like I was unable to breath.   I hope this helps your studies on these drugs for allergic reactions. I am fine now. My arm is just a little sore today.  I did not report this to my Doctor. I will tell him about it when at my next appointment on December 18, 2006.
About 36 hours after vaccine, nausea and severe gastrointestinal distress occurred. Patient diagnosed with acute pancreatitis and hospitalized for 2 days
Soreness at injection site. Stiffness and pain in neck and back on same side as injection. As of today pt says is better not completely gone.
This spontaneous report as received from a registered nurse refers to a 67 years old patient of unknown gender. On 16-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K003600, expiration date verified as 10-MAR-2015 (also reported 19-MAR-2015) 0.65 ml dose once, subcutaneous (dose number was not reported), that ws exposed to 19.5 F for hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
I woke up 8 days later and my left arm was itchy. I felt that it was very hot. It was swollen and the injection sight was raised. it was itchy hot and I iced it and it went away after about 2 days.
PATIENT CALLED TODAY TO REPORT THAT HE IS STILL EXPERIENCING VERY PAINFUL ARM AND SHOULDER PAIN  A MONTH AND A HALF AFTER RECEIVING HIS FIRST SHOT OF SHINGRIX.  HE VISITED HIS DOCTOR A FEW WEEKS AFTER THE SHOT AND HE WAS GIVEN CORTICOSTEROID PRESCRIPTION WHICH HELPED TEMPORARILY.  LAST NIGHT WHILE HE WAS ASLEEP, EXCRUCIATING PAIN JOLTED HIM AWAKE.  HE STATED THAT HE DOES NOT HAVE ANY HEART PROBLEMS.
Discoloration of the arm; Experiencing achiness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Discoloration of the arm), PAIN (Experiencing achiness) and FATIGUE (tiredness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Celiac disease. Concomitant products included VITAMINS NOS, FISH OIL and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced SKIN DISCOLOURATION (Discoloration of the arm), PAIN (Experiencing achiness) and FATIGUE (tiredness). At the time of the report, SKIN DISCOLOURATION (Discoloration of the arm), PAIN (Experiencing achiness) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Added outcome of events.
Burning, frequent, bleeding, spasms during urination pelvic pain weakness all over stiffness all over
Severe adverse reaction; This case was reported by a physician via sales rep and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional information was provided as follows: Field rep was the reporter and was notified of the event last night from the reporting date. The age at vaccination was not reported. No patient identifiable information provided in the e-mail. The age group was captured as an adult as per vaccine indication. The patient complained of unspecified severe adverse reactions. The severe adverse reactions are unknown. This case had been linked with US2020AMR042482, reported by same reporter.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unspecified date in 2016, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported), to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the healthcare professional. On or about 07-JAN-2017, the patient experienced shingles and was treated by a physician at a hospital. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages, as a result of patient's injuries on unknown dates. The patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The relatedness between ZOSTAVAX and the aforementioned events was assessed as related by the reporter. The reporter determined all the events to be serious due to disability, life-threatening and medically significant.
Patient's arm became swollen at the shoulder and very painful. Patient could not lift arm on day 2 after the vaccine was given. Patient went to her family MD on day 2 after the vaccination, and was given a cortisone shot. It is much better today (3 days after vaccine).
Patient complains of memory loss,  specifically trouble remembering recent events , "brain fog" onset a couple of days after receiving the first dose in the vaccine series. He completed the series but reported the memory issues to provider afterwards. He states he never had problems with memory before
no symptoms; temperature excursion for multiple products/ PROQUAD being administered to one patient; This spontaneous report was received from an office manager and refers to a 4-year-old male patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 04-MAY-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 ml / once, lot #W030849, expiration date reported as 04-MAR-2024 but upon internal validation established as 26-MAR-2024, administered subcutaneously for prophylaxis (strength was not provided). No symptoms were reported (no adverse event).  The temperature excursion was 2 and a half hours as recorded by a data logger. There was no previous temperature excursion reported.
Went to Facility on 12/15/22  for pain behind ear and down to lower jaw, numbness in tongue and mouth and paralysis of the right side of the face. Was diagnosed with Bells Palsy.   Told nurse that I recently received the Pfiser Booster and had side effects a few days later.  Told nurse that after receiving the second pfiser August of 2021, I had swollen lymph nodes causing pain in armpit and my first case of shingles. Nurse asked why I wanted to get the booster after having those side effects.
joint pain; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain) and FATIGUE (felt tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included AIDS (diagnosed in the 1980s.).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced ARTHRALGIA (joint pain) and FATIGUE (felt tired). At the time of the report, ARTHRALGIA (joint pain) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Following COVID19 vaccine employee returned to work and began to feel dizzy/lightheaded/shakey. Went to ED for further eval.
Redness at the injection site and has swelled and became large over time, about the size of a quarter.  Fatigue and dizziness. Severe pain under rib.
OFF BALANCE; DIZZINESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-JUL-2021, the subject experienced off balance. On 09-JUL-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from off balance, and dizziness. This report was non-serious.
Severe pain in my jaw bone in my ears, my temple area like my upper neck all the way to up to my head.; Light headed/Dizzy; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe pain in my jaw bone in my ears, my temple area like my upper neck all the way to up to my head and light headed/dizzy on an unspecified date. Consumer stated, "I had just gotten a Pfizer shot about an hour ago and I was looking up with the side effects. I am having like severe pain in my jaw bone in my ears, my temple area like my upper neck all the way to up to my head. Is that something I need to get checked out?". When clarified the name of the product as Pfizer Covid-19 Vaccine, consumer stated, "Yes, then I called here. I had just taken it about an hour ago, hour and a half." When asked to file a safety report, consumer stated, "No, I am thinking of to go to the Doctor because I am lightheaded and dizzy." Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
The day after I received the shot (2/19), I began to feel a lump under my left arm (armpit). By the next day (2/20), the swelling had increased substantially and I was unable to completely put my arm down due to the swelling and pain. I applied a hot compression and took a Tylenol for the pain. It's now 2/21, two days since I've received the vaccination, and I am still applying the hot compress.
20OCT95 flu vax given;23OCT95 rash appeared on obth arms from shoulder to wrist
dose 1- ARM PAIN ON DAY 1 AND DAY 2 dose 2- day 1-2 mild arm pain.  Narrative: dose 1-ARM PAIN ON DAY 1 AND DATY 2 dose 2-day 1-2 mild arm pain.
At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck. The next day this continued with a  fever of 99-100, malaise, and chest discomfort. At the 48th hour, today?s date, fever still present, body aches are improved, but my head feels hot and now with a stiff neck. I feel very tired and mental status seems ?foggy?
No additional AE; Nurse administered PFS into deltoid of patient and while pushing against the plunger rod with her thumb to administer, her thumb slipped and cut against the broken finger flange causing a cut. Patient received full dose of vaccine with no side effect; her thumb slipped and cut against the broken finger flange; This spontaneous report was received from an office manager and refers to a 13-year-old male patient. No information on patient's medical history and current conditions was provided. Concomitant therapies included minocycline and ondansetron.         On 14-JUL-2023 the patient was vaccinated with poor quality device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # W026150 and expiration date 20-OCT-2024, intramuscular in the left deltoid for prophylaxis (exact dose and dose number were not provided) (poor quality device used, syringe issue and no adverse event).
Hives started on my abdomen on day 3 and are spreading to upper arms and legs.  Tried Benedryll first then Zyrtec. Went to see doctor on day 6 and was given a Solu-Medrol injection and prescription for a Medrol dose pack. On day two of dose pack currently.
This case was reported by a pharmacist and described the occurrence of swelling of tongue in an adult subject of unspecified gender who was vaccinated with influenza vaccine (Fluarix) for prophylaxis. On an unspecified date in October  2006, on or before 26 October 2006, the subject received unspecified dose of Fluarix. On an unspecified date in October 2006, less than one month after vaccination with Fluarix, the subject experienced swelling of tongue and injection site irritation. The subject was seen at a physician's office. the subject was treated with oral diphenhydramine hydrochloride (Benadryl). At the time of initial reporting, 26 October 2006, the tongue swelling had resolved. The outcome of the injection site irritation was not reported.
went to work after vaccination post injury.  Left early and developed fever to 101 F.  Slept for 32 hours essentially straight through.  Had generalized fatigue and headache.  Missed about one day of work in total as result. Considered ER visit but ended up not going.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On an unknown date the patients were vaccinated with GARDASIL (lot # K010215, expiration date 05-MAY-2017) (dosage, strength and route were not reported). There was no concomitant medication reported. At the time of the report, no adverse event was reported. This is one if several reports received from the same reporter. Additional information has been requested.
pt recv vax 25MAR97 & on 3APR97 pt devel fever of 105 father reported on 22APR97;
Patient got FluBlok on 01Oct2020 and by mistake a 2nd dose of FluBlok on 09Oct2020 with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via the agency (Reference number- 00353266) and transmitted to Sanofi on 10-Nov-2020.  This case is linked to case 2020SA317927 (same reporter) (male patient).  This case involves a 59 years old female patient who got  first dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] on 01-Oct-2020 (lot number and expiration date was not reported) and by mistake got the 0.5 mL second dose of same vaccine (lot QFAA2009 and expiration date: 30-Jun-2021) via intramuscular route in the left deltoid (extra dose administered) on 09-Oct-2020.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to extra dose administered (latency on the same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  There will be no information on the batch number for this case.
pt recvd vax & 2 days p/dose exp hives-like rash; pt was not seen by MD;
Vaccine dose number 2 received on Saturday 06/05 and reoccurring and ongoing headache started Monday, 06/07. Treated with hydration rest, Tylenol and Ibuprofen. Some relief, but never fully went away. Persisted until at least Sunday, 06/14.
His eyes turned red and swole completely shut, skin had red spots on his chest and back. Congestion