chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient received an Adacel which had been frozen and thawed/No AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from non health care professional (office staff).  This case is linked to cases 2019SA196353, 2019SA224138, 2019SA224143, 2019SA224144, 2019SA224139, 2019SA224140, 2019SA224141, 2019SA224142, 2019SA224076, 2019SA224136 and 2019SA224137 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21; Lot- C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 Celsius range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C. Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated.  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 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.  Documents held by sender: none.
low grade temp 4/28, tylenol x 2 doses,  shingles rash on rt forehead, onset 4/30/2021 seen by me 5/3/2021, rx valtrex
After receiving the vaccine I had an intense headache for 3x weeks.  2 weeks after receiving the vaccine I had my first ever full blown migraine.  I thought I was having a stroke.  I was treated at an Urgent Care.  I had another full blown migraine 1x week later.  Since having the vaccine I have had 2-3 migraines a month and increased number of headaches.   I have seen my PCP about them and given migraine medication.  I have had 1 ER visit.
Approximately one week after receiving the third dose of the HPV vaccine on April 11, 2008, patient developed cramping in both calves which became increasingly severe, resulting in difficulty walking, inability to stand on the balls of her feet, and loss of reflexes in both ankles and knees as determined by a physical therapist.  Patient was seen by a neurologist several days later who found no neurological abnormalities in his exam of her and diagnosed her with "muscle strain of the backs of her legs."  Patient is continuing to experience problems with her legs, some days being better than others.  Every morning she wakes up with cramping of the calves, and some days she is able to "walk it off," and other days her legs hurt all the time.  She is a musical theatre graduate and makes her living singing and dancing.  She has been unable to dance since her calves have been affected.  Approximately two weeks after the second dose of the HPB vaccine the end of December, 2007, patient experienced ankle weakness which resulted in falling frequently, and she was seen by an orthopaedic surgeon in April 2008 when her ankles did not improve.  The orthopaedic surgeon recommended physical therapy for "floppy ankles."  It was after the third dose of the vaccine as described in the paragraph above when she experienced problems with her calves, and which led her to see the physical therapist not only for the floppy ankles, but also for the painful calves.  Because patient is not recovering, she has an appointment to see an internist who is also board certified in rheumatology.  Now that we are aware of her complications following the HPV vaccine, we will, of course, report this to the internist. 8/6/08-office notes received-patient concerned that inadequate dose was administered. Second dose administered 4/11/08 followed by 3rd dose 4/29/08 lot#1967 12/15/08-records received-consultant visit 10/23/08-C/O muscle aches dating back to march 2008 after an ear infection and vaccine. Aching in claves occur after exercise and intermittant back pain. Weakness of iliososas muscles after repetitive squatting.
17 years old and received the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the 1st dose) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the 1st dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the 1st dose) outcome was unknown. Not Provided      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 relevant concomitant medications were reported. No treatment information was provided.
Breakthrough case after two vaccines Moderna 3/26/21 Lot# 028A21A;  Moderna 4/23/21 Lot# 044B21A
RHEUMATOID ARTHRITIS FLARE UP; COVID-19; AFTER THE FIRST MODERNA VACCINATION EXPERIENCED FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    There was no reported medical history.  Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP) (seriousness criterion medically significant), COVID-19 (COVID-19) and FATIGUE (AFTER THE FIRST MODERNA VACCINATION EXPERIENCED FATIGUE). At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP) and COVID-19 (COVID-19) was resolving and FATIGUE (AFTER THE FIRST MODERNA VACCINATION EXPERIENCED FATIGUE) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.   The reporter's causality for the event(s) of after the first Moderna vaccination experienced fatigue, covid 19 and rheumatoid arthritis flare up with Humira(adalimumab) was no reasonable possibility.  Company comment: This spontaneous case concerns an adult female patient of unknown age with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) and non-serious COVID-19 (AESI) an unknown time after a dose of mRNA-1273. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient of unknown age with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) and non-serious COVID-19 (AESI) an unknown time after a dose of mRNA-1273. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Initial Side effects within 24 hours- Fever, Chills, body aches, severe headache lasting 72 hours,  Intense and frequent muscle cramping in legs beginning 4 days post injection lasting 4 weeks.  Numbness and tingling in left side of face and entire right leg beginning 27 days post injection - on going and constant 24/7 still as of today.- 1/6/2022 Severe anxiety and depression beginning 10/19 /2021 and on going now as of 1/6/2022.
Light headiness and dizzy, along with typical side effects..  This dizziness and light headedness lasted approximately 7 days and went away for 10 days.  It then returned for 2 days.  Now it's been happening 2-3 times weekly.
Fever of 102, 101, 100; chills; body aches; headache; severe cough; Sore arm at injection; shortness of breath; This is a spontaneous report from a contactable consumer reporting for herself. A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EP7533/expiration date: not provided), via an unspecified route of administration, on 09Apr2021 at 09:45 (at the age of 63 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6204/expiration date: not provided), via an unspecified route of administration, on 12Mar2021 at 09:30 (at the age of 63 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included hypertension and hypothyroidism. The patient had known allergies to hydromorphone (DILAUDID). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Apr2021 at 18:00, the patient experienced fever of 102, 101, 100, chills, body aches, headache, severe cough, sore arm at injection and shortness of breath. The patient did not receive treatment for the events and did not require hospitalization or a physician's visit. The outcome of the events fever of 102, 101, 100, chills, body aches, headache, severe cough, sore arm at injection and shortness of breath was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
Received Pfizer vaccines on  3/4/21, 3/25/21, 10/27/21 Tested positive for COVID by PCR on 3/7/22. Admitted to hospital on 3/12/22 for COVID pneumonia (transferred from Hospital) underlying h/o heart transplant, Type 2 DM, obesity. In ICU, on hi-flow NC as of 3/13/22.
Prostate swelling; Unable to urinate/Zero flow/ haven't urinated since May 31st; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY RETENTION (Unable to urinate/Zero flow/ haven't urinated since May 31st) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LIOTHYRONINE and LEVOTHYROXINE for Thyroid disorder.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced URINARY RETENTION (Unable to urinate/Zero flow/ haven't urinated since May 31st) (seriousness criterion medically significant). On an unknown date, the patient experienced PROSTATOMEGALY (Prostate swelling). The patient was treated with TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URINARY RETENTION (Unable to urinate/Zero flow/ haven't urinated since May 31st) and PROSTATOMEGALY (Prostate swelling) had not resolved.            Treatment included pain medications. The patient went to the hospital and got a catheter inserted.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received added a new event.; 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. Further information has been requested
11 days after the first COVID-19 vaccine a rash developed on upper extremities, bilat, medial from the elbow up with pruritus, redness, raised hives "like a whelp".  The benedryl and hydrocortizone cream relieved the itching. The next morning she had "a little itching and a few hives."
This spontaneous case reported by a consumer, describes the occurrence of dyspnea (labored breath/trouble breathing) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 050C21A) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced dyspnea (labored breath/trouble breathing). At the time of the report, dyspnea (labored breath/trouble breathing) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use and treatment information not provided. On an unknown date, around 10 or 12 days ago, patient received first dose. On an unknown date, about 10 days ago, symptoms started according to the patient.
Woke up with fever, slight headache, hardly any energy (I'm normally brimming with energy), very sore left arm (where injection was administered). 24 hours later, the fever was gone, but still wasn't 100% energy-wise. It took 3 - 4 days before the sore arm was resolved. The skin at the injection site was noticeably red and inflamed for 3 - 4 days.
Dizziness; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and VERTIGO (vertigo) in a male patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and VERTIGO (vertigo). At the time of the report, DIZZINESS (Dizziness) and VERTIGO (vertigo) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-100611 (Patient Link).
have insomnia; Panic attacks; had anxiety; Blood pressure elevated and hard to control; This case was reported by a consumer via call center representative and described the occurrence of insomnia in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included losartan potassium (Losartin), nebivolol hydrochloride (Bystolic) and amlodipine.   On 27th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced insomnia, panic attack, anxiety attack and increased blood pressure. On an unknown date, the outcome of the insomnia, panic attack, anxiety attack and increased blood pressure were not recovered/not resolved.   It was unknown if the reporter considered the insomnia, panic attack, anxiety attack and increased blood pressure to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's blood pressure elevated and hard to control after receiving Shingrix. She also had anxiety, panic attacks and insomnia. The reporter statd her blood pressure was better controlled since she was started on blood pressure medications and that these might be why the patient was having insomnia.
13Aug90 pt vax w/ hepta B. along w/ Attenuvax.  22Aug90 pt devel bilateral knee pain. 04Sep90 pt devel rash on lower legs, which were sore and tender. pt tx w/ pres drug.
Swelling at injection site; redness; painful at injection site; warm to the touch; This is a spontaneous report received from a contactable consumer or other non hcp. A 45-years-old female patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 19Feb2021 12:15  as Dose 1,single for covid-19 immunization.Medical history included anxiety,depression, restless legs syndrome and covid-19 from an unknown date and unknown if ongoing. Concomitant medication(s) included ropinirole, ondansetron (ZOFRAN),prochlorperazine edisylate (COMPAZINE)taken for an unspecified indication, start and stop date were not reported.The patient previously took gantrisine and experienced drug hypersensitivity.The patient experienced swelling at injection site,redness, painful at injection site and warm to the touch on 20Feb2021 06:30.The outcome of the events was not recovered.The patient was diagnosed with covid prior vaccination and not tested for covid19 post vaccination.The patient had not received any other vaccine within 4 weeks.
Nauseous, and headache called her family doctor right after, and was advised to come to his clinic. Was given an IV medication and performed blood work. Was asked to stay in the clinic for 2 hours for observation, then was feeling better after.
Pt received MMR and Varicella vaccine 5/9/11, developed a fever 5/12/11 102.7, had 2 seizures, one last 10 minutes the other 7 minutes. Taken to nearest ER via rescue.
Right wrist pain that resolved.  On Sunday started to have left wrist pain.  Got worse.  Family called said having pain in arm due to shots.  Diagnosis carpal tunnel syndrome.  Patient finish large project for school and was typing a lot.
During rounds at 10pm, CNA observed resident unresponsive. Nurse was immediately called, who in turn call the code. Nursing staff responded and started CPR. A total of 16 rounds of compressions and shocked x 2, prior to Paramedics taking over 10 minutes later. They continued CPR for another 10 minutes before resident was pronounced dead.
Patient called stating that his arm hurt terribly from his flu shot and that he feels like a nerve was hit
Had a tingling cold sensation in the left ear to the left side of her neck; Had a tingling cold sensation in the left ear to the left side of her neck; Pain from elbowto wrist and hand/Pain from elbowto wrist; Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (Had a tingling cold sensation in the left ear to the left side of her neck), FEELING COLD (Had a tingling cold sensation in the left ear to the left side of her neck), PAIN IN EXTREMITY (Pain from elbowto wrist and hand/Pain from elbowto wrist) and PAIN IN EXTREMITY (Sore arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced PARAESTHESIA (Had a tingling cold sensation in the left ear to the left side of her neck), FEELING COLD (Had a tingling cold sensation in the left ear to the left side of her neck), PAIN IN EXTREMITY (Pain from elbowto wrist and hand/Pain from elbowto wrist) and PAIN IN EXTREMITY (Sore arm). On 16-Sep-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, PARAESTHESIA (Had a tingling cold sensation in the left ear to the left side of her neck), FEELING COLD (Had a tingling cold sensation in the left ear to the left side of her neck) and PAIN IN EXTREMITY (Pain from elbowto wrist and hand/Pain from elbowto wrist) 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 relevant concomitant medications were reported.  No treatment information was provided.
Fatigue ,Neuropathy in feet and hands aggravated everything is on fire (much more pain). Breast implants nerves on fire (Severe pain). Started 2-3 days after 2nd shot as of today still same pain
Painful inflammation at injection site (left deltoid), advised to take Advil and use local heat.
After the vaccine I had a light headache. Around 3:00 in the morning my feet got really cold and my hands became really cold. I was shivering, and I started to shake. This last until about 7:00 in the morning. I had a fever and body aches. After the body shaking the fever and the headaches continued. The shaking wasn't like shivering, I experienced uncontrollable shaking.
got the shot on Sunday and on Monday I could not walk without a lot of pain in my knees
Patient died on April 12th 2021. Not sure exactly what the cause of death but that he was losing blood in in his somewhere. He resided in a nursing home, and was taken to the hospital where he later died
At night same day as shot. Both knees sore and arms and legs were sore as well. Too OTC pills for the pain. Generic brands. Took a pill every 4 hours as recommended until it no longer hurt.
Intermittent racing heart for the next 24 hours.  Contacted family doctor (who was on vacation), doctor's office suggested contacting health dept, who advised rest, fluids and Tylenol.  Resolved in ~ 24 hours