chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: en6202), on 30Mar2021 as dose 2, single (Lot number: er8720), on 25Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 13Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Obesity" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rebound covid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient did not received other medication in 2 weeks. No known allergies. Patient received Paxlovid for COVID 19 Treatment From 29Aug2022 to 02Sep2022. It was reported that rebound covid. Patient was feeling well 01Sep to 05Sep and got sick again on 06Sep with worse symptoms than the first 28Aug to 31Aug time period.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Prolonged fever 3/14/09 - 3/18/09 with rash head to toe - rash eventually peeled. Hospitalized after 2 ER visits - had a/c for Kawasaki with cardiology consult.  5/14/09 PCP records received from 3/4/09-5/8/09. Pt did receive Rotavirus vax x 3 doses in 2008. Seen for WCC 3/4/09. Impression: Healthy. LOM. Pus noted behind L TM, otherwise normal exam. Tx with abx. RTO 3/16/09 with c/o rash. Confluent wheal and flare all over. Fussy. Referred to hospital. Cardiology consult 3/19/09 for eval of rash and fever. Dx:  Innocent murmur.  Still's murmur.  Clinical presentation does not appear c/w Kawasaki disease. 5/18/09 MR received for DOS 3/19/09 with D/C DX:  Suspected vaccine reaction.  Possible drug reaction.  Generalized exanthum. Pt admitted for eval of generalized erythematous rash with some dry areas and dry, cracked lips. Not felt to be Kawasaki. D/C for out pt f/u./pc ICD9 782.1 Non-specific skin eruption NEC.
Minimal change disease; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) in a 45-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.   No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: glomerular disease Glomerular disease.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease) to be related.    No concomitant and treatment mediations were reported.  This is a literature non-study case with reference concerning a 45-year-old female patient with no reported medical history, who experienced the unexpected serious events of Glomerulonephritis minimal lesion. The events was medically significant and occurred  on an unknown interval after receiving the second dose of mRNA-1273 COVID 19 Vaccine. Patients Biopsy kidney: glomerular disease Glomerular disease. It was reported that the outcome of the event was unknown. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-539890, MOD-2022-539891, MOD-2022-539892, MOD-2022-539885, MOD-2022-539894, MOD-2022-539895, MOD-2022-539896, MOD-2022-539897, MOD-2022-539898, MOD-2022-539899, MOD-2022-539900, MOD-2022-539901, MOD-2022-539902, MOD-2022-539903 (Patient Link).; Sender's Comments: This is a literature non-study case with reference concerning a 45-year-old female patient with no reported medical history, who experienced the unexpected serious events of Glomerulonephritis minimal lesion. The events was medically significant and occurred  on an unknown interval after receiving the second dose of mRNA-1273 COVID 19 Vaccine. Patients Biopsy kidney: glomerular disease Glomerular disease. It was reported that the outcome of the event was unknown. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
m swollen over the injection site 10/06. 10/08 on left hand and ring finger a small rash develops. Hot flashes. Sore arm.
hematoma; a purple spot; hard knot in her left arm; continues to have pain. The pain is now spreading into her chest and ribs, described as too painful to move the arm.; swelling; pain at the injection site; Initial information received on 30-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 87 years old female patient who experienced hematoma (haematoma) ,purple spot (skin discolouration) ,hard knot in her left arm (nodule) ,continues to have pain and the pain was now spreading into her chest and ribs, described as too painful to move the arm (pain) ,swelling and pain at the injection site (vaccination site pain), after vaccination with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's pain medications options were limited because she cannot take NSAIDS (Nonsteroidal anti-inflammatory drugs).  Medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 13-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious events hematoma (haematoma) ,purple spot (skin discolouration) ,hard knot in her left arm (nodule) , swelling and pain at the injection site (vaccination site pain) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date, the patient developed non-serious event of pain and the pain was now spreading into her chest and ribs, described as too painful to move the arm (pain), 6 weeks following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reports, the outcome was not reported for all the events.  There will be no information on the batch number for this case.
2/4: Sore at injection site on R arm + mild dizziness & nausea.  2/5: R arm became very painful from shoulder to elbow, continued mild dizziness. Took Aleve & Advil  didn't help. Pain continued all day. NOTE: Comorbid Congenital Myopathy (excessive muscle reactions  to trauma), but no prior adverse reactions to vaccines or shots, incl allergy, XoLair, & Pneumovax23.  Concerns about effect of Pfizer Vaccine on heart & lungs due to Congenital Myopathy, Dysautonomia, &  chronic reduced lung capacity (60%). 2/6: R arm pain less intense, but expanded from shoulder to wrist. 2/7: R arm pain less intense, but now it affects whole R arm & fingers are numb. 2/8: same as 2/7.
Aches; Radiating nerve pain down arm and leg; Shoulder pain; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Aches), NEURALGIA (Radiating nerve pain down arm and leg), ARTHRALGIA (Shoulder pain) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-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 PAIN (Aches), NEURALGIA (Radiating nerve pain down arm and leg), ARTHRALGIA (Shoulder pain) and CHILLS (Chills). At the time of the report, PAIN (Aches), NEURALGIA (Radiating nerve pain down arm and leg), ARTHRALGIA (Shoulder pain) and CHILLS (Chills) 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 concomitant medication was provided.  No treatment information was provided.   This case was linked to MOD-2021-294679 (Patient Link).
The normal side effects listed however , symptom started after completion of the Vase check in.  Moderate nauseous and vomiting
2nd shot hurt going in, and coming out!; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter stated that the second dose was a doosie. The reporter reported that the patient experienced second dose hurt going in and coming out. The reporter stated so hold your breath and hold on to your seat when you get that one shot and do not forget to exercise your arm, right a way as well. Follow up would not be possible as contact details were not provided.
White, red and GR cells are all abnormal; White, red and GR cells are all abnormal; White, red and GR cells are all abnormal; Blood work and the numbers are all out of my norm; This is a spontaneous report from a contactable consumer (who is also the patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced "blood work and the numbers are all out of my norm." and "white, red and GR cells are all abnormal". The patient stated, "I donated some blood. It was shown that I was COVID reactive but not positive. I did some blood work and the numbers are all out of my norm. My white, red and GR cells are all abnormal. Normally these numbers indicate anemia or cancer of the blood. I have none of that. I have these side effects, which potentially is reported in limited amount of people. I also read an article of 254 people in (place name) which developed bleeding disorder or blood clot after getting the vaccine. They didn't identify which vaccine it was." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Initial report received 19 June 2009 from a health care professional. A 17-year-old female patient with no known drug allergies, had received a first dose intramuscular left arm injection of MENACTRA, lot number U2822AA and a subcutaneous left forearm injection of TUBERSOL, lot number C3036AA and 12 hours later, she developed inflamed and swollen lymph nodes and fatigue. The patient was evaluated by her physician (date not reported) and she received an unspecified steroid which "somewhat" decreased the lymph node swelling. The patient was also reported to have had positive mono and Lyme's disease test results (dates not reported). She had not received any other vaccines within four weeks of MENACTRA and TUBERSOL, and she had not been taking any concomitant medications at the time of vaccination. At the time of the report, the patient's recovery status was unknown. Documents held by sender: None.
10 days post vax, pt developed a red rash around the collar of his neck and fever of 101.5.  By March 3 the rash had propagated to his entire body from his scalp to the groin area (head, neck, trunk, and arms) except for his legs.  Pt was diagnosed with rubella infection due to viral shedding and transmission through breast milk.  Pt red rash persisted at the time of this report.
Feeling dizzy, nausea, vomiting, flushing BP 100/60 pulse 114 Temp 97.9 resp. 18 monitored and sent home.
elevated temperature excursion; Initial information received on 10-May-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  It was linked with 2019SA130411, 2019SA130377 and 2019SA130410.  This case involves a 2 months old female patient who that was exposed to a temperature excursion, while he received 0.5 ml vaccine IPV (VERO) [IPOL] on 24-Apr-2019 (lot: P1A242M)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; HIB VACCINE (HIB) for Immunisation; and Prevnar for Immunisation.  It was of actual medication error due to incorrect product storage.  It was unknown whether adverse event was experienced.  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.  List of documents held by sender: none.
12 year old patient was given the pediatric dose for 5-11 year old. No symptoms noted. Mother was notified and she verbalized understanding.
very tired; Nausea; tired; threw up; Dizzy; Abdominal pain; very pain and cold; very pain and cold; blood pressure went up little bit; sweating a lot; mouth change of color kind like purple or blue; weird episode that never had before; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ABDOMINAL PAIN (Abdominal pain), PAIN (very pain and cold), NASOPHARYNGITIS (very pain and cold) and BLOOD PRESSURE INCREASED (blood pressure went up little bit) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003ACIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included PANTOPRAZOLE for Reflux esophagitis.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (Dizzy), ABDOMINAL PAIN (Abdominal pain), PAIN (very pain and cold), NASOPHARYNGITIS (very pain and cold), BLOOD PRESSURE INCREASED (blood pressure went up little bit), HYPERHIDROSIS (sweating a lot), ORAL PIGMENTATION (mouth change of color kind like purple or blue), ADVERSE DRUG REACTION (weird episode that never had before), NAUSEA (Nausea), FATIGUE (tired) and VOMITING (threw up). On 20-Mar-2021, the patient experienced FATIGUE (very tired). On 19-Mar-2021, DIZZINESS (Dizzy), ABDOMINAL PAIN (Abdominal pain), PAIN (very pain and cold), NASOPHARYNGITIS (very pain and cold), BLOOD PRESSURE INCREASED (blood pressure went up little bit), HYPERHIDROSIS (sweating a lot), ORAL PIGMENTATION (mouth change of color kind like purple or blue), ADVERSE DRUG REACTION (weird episode that never had before), NAUSEA (Nausea), FATIGUE (tired) and VOMITING (threw up) had resolved. At the time of the report, FATIGUE (very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported.
Pt received vaccination at 24 hours later developed a 1-2 mm erythematous blanching discreet rash on knees.  The following day spread to elbows. 7 days status post vaccination, erupted on face and shoulders.
Nerve pain to L arm soon after injection;  Moderate muscle/joint pain, especially L arm accompanied with moderate chills next day.   No fever.
On the 5th day 12-15-2021, I woke with Shingles.  I started taking Valtrex on 12-17-21 and have been using calamine lotion.  With the treatment the shingles area is now starting to scab over.
Chest pain with increased deep pain associated with every heart beat. Started at around 0700 the morning after the booster and progressively worsened throughout the day. It is definitely associated with each heart beat. It improves with 600-800mg ibuprofen doses. There are no rhythm changes or severe SOB. I am a cardiac anesthesiologist.
Wellness visit on 3/23/21 indicated platelet count of 55,000.  Previous counts were always above 150,000.  No other symptoms.  Lab work repeated and count still low.  Referred to oncologist and determined not leukemia or lupus.  Vitamin B12 very low also.   He mentioned could be one of three things, one of which was ITP.  Treatment at this time - B12 shots.  Rechecked labs in July with platelet count still low.  Will recheck again in August and see oncologist in November.  Doctors don?t indicate caused from vaccine but suspicious to me.
Fever, Chest pain, presented to the ER and now admitted to the cardiac stepdown unit with myocarditis
This spontaneous report was received from a office manager regarding a 12 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The patient was vaccinated with GARDASIL 9 on 06-JUL-2016 (M007764, exp 01/30/2018); on 08-SEP-2016 (M021407, exp 30-APR-2018); and on 29-SEP-2016 (M024261, exp 30-JUL-2018) intramuscularly (dose, strength, indication were not reported) (inappropriate schedule of drug administration). It was reported that patient was not experiencing any adverse effects as result of the vaccination. There was no product quality complaint involved. Additional information has been requested.
Mother called HD on 4/27/01 to report that child had a reaction to MMR given on 4/4/01. She states she took child to MD who was initially doubtful that symptoms were from vaccine. Symptoms of temperature of 104F X 4 days and poor appetite with weight loss during event (small amount of 2 lbs). Onset of symptoms was on 4/10/01.
Patient had first COVID vaccine shot on 4/22/21. Throughout the month she felt stuffiness in the left sinus passages. On 5/18/21 she developed pain in the left ear and jaw area. On 5/20/21 she had second COVID vaccine shot. On 5/21/21 she developed jaw/ear pain worsened and she developed left arm pain. On 5/22/21 she developed left numbness/tingling and left facial numbness/tingling. On 5/24/21 she went to the ER for left facial drooping. She had MRI brain which did not show evidence and stroke and she was diagnosed with Bell's palsy.  A week later she noticed numbness/tingling in the right hand and shortly after in the feet. She developed imbalance. Symptoms seemed to plateau after 2 weeks. On 6/28/21 she had an EMG/NCS which confirmed diagnosed of Guillain Barre Syndrome (GBS). Given relatively mild and improving symptoms she was not treated with IVIG. It is unclear if the COVID vaccine was related to the GBS.
fever; woke up in sweats; headache; muscle pains; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received first shingle vaccine months ago on an unknown date with no side effect).   On 25th May 2021, the patient received the 2nd dose of Shingles vaccine. In May 2021, 1 day after receiving Shingles vaccine, the patient experienced fever, night sweat, headache and muscle pain. On an unknown date, the outcome of the fever, night sweat, headache and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the fever, night sweat, headache and muscle pain to be related to Shingles vaccine.  Additional details provided were as follows: The age at vaccination was not reported. The patient received 2nd dose of shingles vaccine and experienced night sweats,headache,fever and muscle pain. The patient denied to disclose any personal information.
, he is a 27 year-old who had his Moderna COVID-19 mRNA booster 11.12.2021. He had some muscle pain in his back the day after receiving the vaccine. On 11.23.2021, he developed hives on the back of his head and neck. The next day, they spread to much of his body. He had a telemedicine appointment and was given prednisone 60 mg and hydroxyzine. It initially helped, but he was still severe two days later. He developed muscle pain and swelling in his upper and lower extremities. He received a steroid shot from his PCP. The following day, he still had severe hives, lip swelling and feet swelling. He went to the ER, and he was given a IV solumedrol as well as more oral steroids. He is now on 40 mg daily. He still has dermatographic and spontaneous urticaria. He is taking cetirizine 10 mg bid. His feet are still uncomfortable to walk on and swollen. He had some shortness of breath last night. Albuterol helped his symptoms. He has no chest pain. He had a negative COVID test last week. He had no sick contacts. He saw a Rheumatologist earlier in the weed.
Vomiting and Diarrhea, poor feeding, feeding intolerance, dehydration, worsening over the course of 4 days, admitted to hospital for fluid resuscitation for 24 hours. Vomiting stopped after 4 days, diarrhea reduced after 5 days.
11/16/02 seen in clinic for diarrhea, vomiting, jaundice, elevation of liver enzymes. 11/17/02 hospitalized for severe hypoxia, tachycardia, fever 104, rash, diarrhea. On ventilator for respiratory failure.
She said she had pain in the muscle at the injection site. She developed hardness under the skin. There also developed surrounding redness and soreness. No hives or other raised lesions. Erythema multiform. Cephalexin 500 mg tid.
This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M008551 and expiry date 02-JUN-2018 (dosing details not provided). The vaccine had unspecified temperature excursion on 19-JUL-2016. No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested