chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On about 12PM 10/22/2022 I received the Moderna Bivalent shot at a pharmacy, I returned home and relaxed, upon awakening on 10/23/2022 I noticed pain instability and unable to walk I took ibuprofen and used supportive aids to walk or crutches, upon sleeping I was unable due to severe pains. On 10/24/2022 I went to the emergency room and medicine and painkillers was given to me and administered. On 10/26/2022 I was still dealing with pain and was trying to work out but pain was still there so I was referred to physical therapy. On 10/27/2022 the pain was still so bad I was referred to pain management which I did not go to.
My cousin now has Myocarditis; Safety information originally reported under manufacturer case 202300047624 has been nullified and re-entered under this new manufacturer report number 202300211750.  This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "My cousin now has Myocarditis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment : This follow-up report is being submitted to amend previously reported information: (Patient's gender was removed)  Follow-up (05Jun2023): This is a follow-up report to notify that the case 202300047624 and case 202300211750  are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 202300211750.
Patient developed hives, facial swell, tight throat, angioedema 3 hrs after vaccination. Resolved with Epi, Benadryl, steroids. Mild Anaphylaxis.   11/18/09 Medical records received for DOS 10/17/09.  Final DX: Acute allergic reaction.   Presented w/swelling in face, uvuala., back of throat.  Feeling hot in neck and ears. Hives on UE. 4 hrs s/p vaccine. Steroids, epi. Resolved. D/C to home.
Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   This case was linked to MOD-2021-118750 (Patient Link).
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L018500, expiration date: 13-APR-2017) (dose and route of administration were not reported). No adverse effects were noted in any patients. Administered doses of vaccines experienced the temperature excursion of 0.4 degrees Celsius for 89 hours and 5 minutes. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected, as there was not consent to contact with the reporter.
suspected vaccination failuregot the shingles vaccine ans had a case / suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the shingles vaccine and still had a mild case. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
rash in one spot on the right side of left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash in one spot on the right side of left arm) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (rash in one spot on the right side of left arm). At the time of the report, INJECTION SITE RASH (rash in one spot on the right side of left arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that after the first dose of vaccine he has developed a number of rashes on his arms, chest and stomach.  After the second dose of vaccine the patient reported that on 19-Mar-2021 he has developed eight to nine rashes all over his body.
received / first Shingrix / on August 17, 2020 / has not had the second / yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided as follow: The age at vaccination was not applicable for this report. No Lot number or expiration date for the 1st dose of Shingrix was available. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.. The reporter did not consent to follow up.
fever is 100.9; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever is 100.9) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced PYREXIA (fever is 100.9). At the time of the report, PYREXIA (fever is 100.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2021, Body temperature: 100.9 (Inconclusive) 100.9.         Concomitant medications were not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
2/4/21 slight headache during day, tired. Cold on and off, cold feet throughout the day. 5:30pm got home from work had shaking chills, unable to get warm for 2 hours. Finally got warm but it was a hot warmth. No fever. Took Tylenol 500mg. The warmth continued and had mild headache. Took 500mg Tylenol at bedtime 11pm. I was hot throughout the night ( no sweats ) woke at 6am feeling light headed and dizzy, body aches, still hot. Felt like I had the flu. I went into the bathroom to void. I remember thinking  - I am too sick to go to work.  My husband said I was standing holding onto the door, white in color, said "i'm sick" he came to stand beside me to help me walk and I passed out. I had loss of consciousness. I do not know how long - he said he tried to shake me to wake me up about 30 seconds. He yelled to my son sleeping upstairs a few times, they got the phone and called 911. He said I vomited a few times and would not wake up.  I remember coming to - sitting on the floor with him talking to 911 .  I woke up enough to get up and walk to the living room couch with assist and gradually starting feeling better. The paramedics came and took my vital signs. Blood pressure (120/69 ), heart rate (84) oxygen saturations were all good. Blood glucose 116.  I declined ER transport.  I had continued light headedness, dizziness 2/6, 2/7/21.  Arm soreness gone at injection site on 2/7/21. I believe the dizziness is a mild concussion. I have a provider appointment 2/9/21.
Symptoms day of and next day: sore arm only  Day 3, 6am- 12 noon: Nausea, vomiting, fever,  severe headache, body aches, excessively tired.
head cold; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of 2021, patient had head cold. Patient is due to get a second COVID shot on Wednesday (10Feb2021), but she had a head cold. Patient just wanted to know if she can get the second shot. The outcome of the event was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
headaches, vomiting, body aches and headache, neck stiffness. sysmptoms started 7 hours after vaccination. T 101.5 day after vaccination. Felt better 9/3/04
tasting this salty taste on the tip of her tongue and side of her mouth, sometimes its just really intense; This is a spontaneous report from a Pfizer sponsored Program and a contactable consumer (patient) or other non-healthcare professional.  A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (age at vaccination: 66 year-old), as dose 2, single for covid-19 immunisation and patient received co-suspect as celecoxib (CELECOXIB), formulation: Capsule, hard via an unspecified route of administration from Mar2021 (Batch/Lot Number: KA 0 or O 3685; Expiration Date: 31Oct2022) and ongoing, at 200 mg, 1x/day for psoriatic arthropathy. Medical history included ongoing psoriatic arthropathy and diagnosed a couple of years ago, 2 or so years ago. The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9263), via an unspecified route of administration, administered in Arm Left on 28Jan2021, (age at vaccination: 66 year-old) as dose 1, single for covid-19 immunisation. Other products reported as No. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as none. list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as none. AE(s) following prior vaccinations reported as none. Relevant test reported as none. On Mar2021 the patient experienced tasting this salty taste on the tip of her tongue and side of her mouth, sometimes its just really intense. Patient received second dose of vaccine on 18Feb2021 and 2 weeks after the Covid 19 vaccines, patient was started a prescription of Celebrex and she said about 2 weeks after that every day since then she has been tasting this salty taste on the tip of her tongue. Patient didn't know if it's normal and It's every day, she would said it's persisting, it hasn't changed. Patient wanted to know if Pfizer had any additional information about that. The clinical outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Information has been received from a pharmacist concerning an adult patient who was vaccinated with VARIVAX (Oka/Merck). Subsequently the patient experienced a rash. It was unspecified if the patient sought medical attention. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 31 year old female with asthma and an allergy to codeine and beta blockers, currently on therapy with Ortho-Novum, and Nidrin and a history of migraines who was vaccinated with MMR II "as an infant." On 4/22/02 the pt had a measles titer drawn and subsequently, the measles titer was negative. The pt sought unspecified medical attention. The outcome of the pt's negative measles titer was unknown. Follow-up info has been received from a licensed practical nurse. The nurse reported that the pt received MMR II, and "had no problems with it." The nurse also reported that the pt needed documentation of the vaccine to continue nursing school. No further info is available.
Due to patient severe anxiety, she received her injection and monitoring in her car outside of the facility.  When vaccine was documented into her medical record, it was found that the patient came one week early.   Contacted patient 4/5/21  to  inform of the med error.  Patient states she has been having increased panic attacks since Saturday. Has appointment scheduled with her primary provider today.
Reported from father: Developed rapid heart rate on 9/9/18 after only doing mild workout that remained and caused hands to feel numb. Called EMS. Went to ER on 9/10/18 with same symptoms. Racing heart woke from sleep on 9/11 am. 9/12 went to Dr., everything was ok, no Holter monitor worn, has follow-up appointment in 6 weeks. Father reports that EKG, CXR, and labs all ok. Student returned to school 9/17/18. Student takes GHOST pre-workout supplement before workouts and has been taking for about 2 years.
12/24/ saw that the back of right arm tender and hot to touch where MMR and Varicella given pain range 5-6/10 redness and lump noted. 12/25/14 temp 99.9 nausea. Exam by myself, local inflammatory response as above. No sign of infection or systemic involvement. Pt advised ice alt heat, NSAID an continue antihistamines that she takes.
The patient was administered an improperly stored dose of ROTATEQ on 5/19/2020; This spontaneous report was received from a nurse and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies, or concomitant therapies was provided. On 19-MAY-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot # 1660941, expiration date 12-FEB-2021 (strength and dose were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 12.1 Celsius degrees (C) for 16 hours and 11 minutes. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.
Information has been received from a physician concerning a 66 year old male patient who on an unspecified date was vaccinated with the first dose of PNEUMOVAX 23 (Lot # 665904/0866Z, expiration date on 04-JUL-2011). The physician reported that the patient developed fever of 38.5C and severe cellulitis within 12 hours of receiving the vaccination. The patient may have been treated with antibiotics. The physician did not provide any information on the duration of cellulitis and fever. The physician reported that she had never seen so many adverse reactions with this vaccine and had stopped using this lot number. The physician requested an investigation of the specific lot. At the time of the report, the outcome of the patient was not reported. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (665904/0866Z) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information has been received from the physician who reported that the 66 year old male patient with neither illness at time of vaccination nor pre-existing allergies, birth defects/medical conditions who on 13-SEP-2010 was received intramuscularly at right deltoid with the first dose of PNEUMOVAX 23. On 14-SEP-2010 the patient developed high fever up to 103 F and swell local reaction- cellulitis for 6 days. The patient was treated with doxycycline and nonsteroidal antiinflammatory drugs (NSAIDS). The physician considered the patient's fever and cellulitis to be other important medical events. No further information is available.
Patient was given HPV, patient stated her last period was on 2/20/2018 but stated she was on birth control. Doctor ordered a pregnancy test after the HPV was given and it was positive.
Appendectomy 3/5/2021  - surgery to remove appendix   C.difficile 6/10/2021  - Vancomycin 10 day C.difficile 7/1/2021 - relapse Vancomycin 10 day
COVID test this morning, and found out that she was positive; fever; shaking and chills; nauseated; possible body aches; shaking and chills; all my bones hurt; real sore right arm; felt little sluggish; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (real sore right arm), SLUGGISHNESS (felt little sluggish), TREMOR (shaking and chills), BONE PAIN (all my bones hurt) and SARS-COV-2 TEST POSITIVE (COVID test this morning, and found out that she was positive) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia, Arthritis and Autoimmune disorder. Concurrent medical conditions included Diabetes.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (real sore right arm) and SLUGGISHNESS (felt little sluggish). On 06-Apr-2021, the patient experienced TREMOR (shaking and chills), BONE PAIN (all my bones hurt), PYREXIA (fever), CHILLS (shaking and chills), NAUSEA (nauseated) and MYALGIA (possible body aches). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (COVID test this morning, and found out that she was positive). At the time of the report, PAIN IN EXTREMITY (real sore right arm), SLUGGISHNESS (felt little sluggish), TREMOR (shaking and chills), BONE PAIN (all my bones hurt), PYREXIA (fever), CHILLS (shaking and chills), NAUSEA (nauseated) and MYALGIA (possible body aches) had not resolved and SARS-COV-2 TEST POSITIVE (COVID test this morning, and found out that she was positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101-102 degree Celsius 101-102 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       the concomitant history was not reported.  the treatment taken by the patient was Tylenol (paracetamol).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: No specific follow-up information recorded.
Patient had some dizziness and flushing post vaccine administration, but she declined calling the rapid response team. This resolved within 5 minutes without intervention. Closely monitored for 30 minutes.
Patient was  given  second dose of Moderna vaccine at 1 21 day interval not 28
Initial reaction was swelling, lightheaded, and pain at injection site. Within 48 hrs had feeling of burning throughout body and lost consciousness and had to be taken by ambulance. Within the next week began experiencing abdominal pain and swelling, fatigue, and memory problems. Within the year began experiencing tremors that come and go, short term memory, crippling fatigue, severe gastrointestinal problems such as nausea, bloating, alternating constipation and diarrhea, intestinal cramps and spasms, balance problems, increase in allergic reactions and items allergic to, depressed immune system, depression, joint pain, rashes, malabsorption, migraines, and nerve pain. Exact date and time of vaccination cannot be recalled and service records with vaccination report cannot be located. But vaccination was given June of 2000.
ON 19 AUG 09, PT COMPLAINED TO MOTHER THAT INJESCTION SITE HURT AND ITCHED. REDDENED WITH INDURATION NOTED ON LEFT LATERAL THIGH MEASURING 45MM X 30MM.
Information has been received from a 36 year old male who was inadvertantly vaccinated with the 1st dose each of Hep-B vaccine recombinant (MSD) and Hep-A vaccine (Havrix), in the left and right arms, that were improperly stored for 3 days at 15 degrees C. Approximately 1 month, post vax, the pt experienced a "six month fluctuation of his liver enzyme level." The pt received the 2nd and 3rd doses of Hep-B vaccine recombinant and Hep-A vaccine (mfr unknown) according to schedule. Subsequently, his liver enzyme level returned to normal. No further information is available.
PT COMPLAIN OF FEELING BAD THE DAY OF THE VACINE. NECK GOT STIFF AND HURT. WHEN HELD HEAD BACK SHE HAD PAIN. ALSO HAD HEADACHES AND NAUSEA. DENIES FEVER. ENERGY LEVEL DROPPED ON 10/22/05. CONTINUED WITH ENERGY DECREASE. FATIGUE AND STIFF NECK WORSENED. LASTED ABOUT 2 WEEKS.
Continued enlarged lymphs nodes in right side of torso. Repeated for 5 months, different lymph nodes each time for approx 1-2 weeks each episode. In abdomen, neck, left armpit, left upper back. Lymph nodes will painfully enlarge then graddually decrease in size when another will enlarge. First symptoms beg or April continuing to today.