chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-JAN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # R019235 and expiry date 04-JUL-2020) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. There was involvement of Digital data logger was involved. There was no involvement of Product quality complaint (PQC). This is one of the several reports received from the same reporter.
A week of intense neuropathic pain in the left side of his face mapping to all 3 branches of the trigeminal nerve. He saw his dentist out of concern for a dental abscess but nothing was found. His exam in my office was remarkable only for hyperesthesia in the left V1-3 distribution--no rash.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (the pain appear in the arm), FEELING ABNORMAL (feels like a piece of my arm was removed), PAIN (never felt this kind of pain,it's like it's in the bone), MALAISE (feeling sick) and FEELING ABNORMAL (Make my life horrible) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PAIN (never felt this kind of pain,it's like it's in the bone). On an unknown date, the patient experienced PAIN IN EXTREMITY (the pain appear in the arm), FEELING ABNORMAL (feels like a piece of my arm was removed), MALAISE (feeling sick), FEELING ABNORMAL (Make my life horrible), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't take a shower), PAIN (terrible pain), COVID-19 (Got COVID) and ILLNESS (little bit sick for 5 days). At the time of the report, PAIN IN EXTREMITY (the pain appear in the arm), FEELING ABNORMAL (feels like a piece of my arm was removed), PAIN (never felt this kind of pain,it's like it's in the bone), MALAISE (feeling sick), FEELING ABNORMAL (Make my life horrible), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't take a shower), PAIN (terrible pain), COVID-19 (Got COVID) and ILLNESS (little bit sick for 5 days) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive. 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 and treatment medications were not provided by reporter.
SEVER BODY AND JOINT ACHE [ONGOING] HEADACHE - INTERMITTEN SHARP PAINS [ONGOING] PAINFUL SORENESS IN ARM - REDNESS, ITCHING, SWEELING [ONGOING] MILD FEVER 100.8  FATIGUE TIRENESS AND LIGHTHEADED [ONGOING]
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination for STEMI.
CONTINOUS GRADE 3 FEVER OF 102 TO 103; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (CONTINOUS GRADE 3 FEVER OF 102 TO 103) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (CONTINOUS GRADE 3 FEVER OF 102 TO 103). At the time of the report, PYREXIA (CONTINOUS GRADE 3 FEVER OF 102 TO 103) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: unknown (High) 102 TO 103.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported.  No treatment information was provided.
Irritability, left leg swollen, did not want to walk due to pain. Gave ibuprofen, distracted him with cold pack. An hour later, gave TYLENOL. Symptoms gone by next morning.
patient received the J&J vaccine at 9 am and was monitored for 15 minutes. She is a store associate. Patient returned to work. At 1:30 patient was moving a lot of items from the pallet shipper. Patient felt dizzy and reported that she may need to faint. Patient was monitored by the pharmacist. She was counseled to drink water.  We took blood pressure at 129/85 and 133/80. Patient was alert and oriented. Patient was sent home to rest. Follow up counsel on 05/26/2021
Moderna 6/11/21, 7/9/21, 1/21/22. Positive on 3/29
Break out in hives again; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Break out in hives again) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21H, 041L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Break out in hives again). At the time of the report, URTICARIA (Break out in hives again) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that patient had hives again which was not that significant and did not itched. It was also reported that hives took a little time to disappear.   This case was linked to MOD-2021-409888, MOD-2021-409900 (Patient Link).
Immunizing pharmacist noticed that vaccine had expired on 06/18/2022 after it was administered. We contacted the manufacturer (GSK) and per "results from in-house analytical potency testing have shown that the vaccine remains within the approved specifications for up to 30 days following the expiration date of the vaccine". Immunizing pharmacist informed patient about incident and patient denied any side effects. Also, she informed incident to provider's office, who documented it in her file and will answer questions that patient may have.
dizziness described as spinning while in bed on Tuesday morning associated with episodes of diaphoresis, and chills.    This morning she awakened and noted left facial swelling and left lip swelling
Two-3 hours after shots, whole body and head curled to right and stiff, eyes rolling, dazed, slurred vocalizations.
Mom called on 10/30. Said patient complained of severe chills at midnight, and felt very over-heated. He also blacked out. This morning (10/30) he is primarily complaining of sore muscles. I asked Mom to request patient to go to student health or ER or PCP.
Pt recvd vax on 28FEB92 & 1 wk following vax devel nausea, exacerbation of the arthritis, circulating immune complex; devel asthma & bronchitis; lab eval on 4AUG92 revealed ESR 29, Rheumatoid factor 28, C reactive protein 2.5;
Wa supposed to be given the new bivalent booster, 4th shot in the series. Confirmed with technician while he has the syringe that it was the bivalent booster he was going to give me. He said yes. 20 minutes after the appointment I got a call from Pharmacy apologizing saying that while everything said updated, they actually gave me a covid 19 monovalent ahot
Back pain; Pelvic pain upto neck; Sick to her stomach; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PELVIC PAIN (Pelvic pain upto neck), ABDOMINAL DISCOMFORT (Sick to her stomach) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D30L20A) for COVID-19 vaccination.     Patients medical history was not provided.  Concomitant products included ROSUVASTATIN, LEVOTHYROXINE and AMLODIPINE for an unknown indication.  On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 29-Jan-2021, the patient experienced CHILLS (Chills). On 03-Feb-2021, the patient experienced BACK PAIN (Back pain), PELVIC PAIN (Pelvic pain upto neck) and ABDOMINAL DISCOMFORT (Sick to her stomach).   The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 30-Jan-2021, CHILLS (Chills) had resolved.   On 05-Feb-2021, BACK PAIN (Back pain), PELVIC PAIN (Pelvic pain upto neck) and ABDOMINAL DISCOMFORT (Sick to her stomach) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Day after influenza vaccination client stated felt "punky" not great - noticed arm had "rash" - 48 hours after rash all over 60% - groin, under arms, sides of body (under arms) back of shoulders - not itchy.
After 6 month appt, mother expressed concerns of adverse reactions to his 4 month vaccines including rash on legs, redness, irritability, and fevers. These are common reactions which were discussed by provider, but mother wanted to report incident.
SARS-CoV-1 test positive.; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-1 TEST POSITIVE ( SARS-CoV-1 test positive.) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced SARS-COV-1 TEST POSITIVE ( SARS-CoV-1 test positive.). At the time of the report, SARS-COV-1 TEST POSITIVE ( SARS-CoV-1 test positive.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  Patient was scheduled for dose 2 on 11-Aug-2021
5 minutes post vax, c/o itching at inject site, redness noted surrounding site, involved 3/4 of area of upper arm.  Raised area at inject site.
Patient was inadvertently given an IPV when IPV is contained in the combination vaccine which resulted in a double dose of IPV being given in the same visit.
I have ringing in my right ear.  Tinnitus. It has become unbearable after the shot.
Hot, clammy, light-headed. 31 weeks pregnant. Vitals wnl.
devel abd cramping/pain w/diarrhea & pain in lt hand for 3 days;
After injection approximately ten minutes later complained of chest pain and cough. Further described feeling like something sitting on his chest. EMS on site performed EKG which showed normal sinus rhythm. Patient continues to c/o chest pain and pt was transported to hospital for further evaluation
Her left arm was starting to get numb; pain, Two days in a row she's been sore; swelling/red swelling, not a bump, just swelling at her injection site; chills; her left arm hurts because of the injection, had pain all in her legs and everywhere; swelling; swelling/red swelling, not a bump, just swelling at her injection site; breathes real hard she can feel it in her chest; her test was positive; This is a spontaneous report from a contactable consumer (patient). A 65-year-old Female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Apr2021 at 14:15 at single dose in left arm for COVID-19 immunisation at the age of 65-year-old. Lot number was ER8731. Medical history included high blood pressure, enlarged heart, diabetes and concomitant medications included ongoing metformin hydrochloride (METFORMIN N), carvedilol (CARVEDILOLO). On unknown date, left arm was starting to get numb, and the patient experienced pain, Two days in a row she's been sore, swelling/ red swelling, not a bump, just swelling at her injection site, chills, her left arm hurts because of the injection, had pain all in her legs and everywhere, swelling. On 20Apr2021, the patient underwent sars-cov-2 test and it resulted positive, patient breathed real hard she could feel it in her chest. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
Rash developed around injection site approx 5 days after injection. It resolved 4-5 days later. It included a site 0f 5-6 inches in diameter, and caused redness, slight inflamation ,and minor itching.
headache; body aches; fatigue; injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Sep2021 16:15 (Batch/Lot number: unknown) at the age of 45 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "known allergies: juniper" (unspecified if ongoing), notes: known allergies: juniper; "known allergies: nickel" (unspecified if ongoing), notes: known allergies: nickel. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 16Sep2021, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 16Sep2021, outcome "not recovered", described as "body aches"; FATIGUE (non-serious) with onset 16Sep2021, outcome "not recovered", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 16Sep2021, outcome "not recovered", described as "injection site soreness". Therapeutic measures were not taken as a result of headache, pain, fatigue, vaccination site pain. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. This case seriousness was reported as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
LOSS OF APPETITE; FEVER; FATIGUE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced loss of appetite, fever, fatigue, and nausea. The action taken with covid-19 vaccine was not applicable. The patient recovered from loss of appetite, fever, fatigue, and nausea. This report was non-serious.
It was sore the first time; bad fall three weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of FALL (bad fall three weeks ago) and VACCINATION SITE PAIN (It was sore the first time) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 258E21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (arthritis and scoliosis in the spine), Scoliosis (arthritis and scoliosis in the spine), COPD and Smoker (has been smoking since the patient was 13 years old).    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced FALL (bad fall three weeks ago). On an unknown date, the patient experienced VACCINATION SITE PAIN (It was sore the first time). The patient was treated with CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) on 14-Oct-2021 for Adverse event, at a dose of 150 mg twice a day. At the time of the report, FALL (bad fall three weeks ago) and VACCINATION SITE PAIN (It was sore the first time) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. The patient got epidurals for the pain.  The patient did not have the lump and the itching after the first dose.   This case was linked to MOD-2021-354671.
The patient reports that while she was working on the morning of 11/13, she developed hives behind her left ear which spread down her neck. She was very itchy. She took Benadryl 12.5 mg and the hives improved after about 30 minutes. That evening, the hives came back, so she took Benadryl 25mg, which helped after about 30 minutes and she was able to sleep. The following morning, the hives were present again, so she took Benadryl 25 mg with improvement. That day, she ran a race. She took Benadryl 25 mg on her way home from the race because she felt that the hives were coming back. That evening, she noticed that the rash was starting again on her neck, ears and scalp. She went to the ED and was prescribed Benadryl, Pepcid and prednisone. The rash recurred again while at work the morning of 11/15 but was more diffuse, covering her whole body. After her shift she went back to the ED. At that time, she had hives to her right ear, neck, trunk, and legs. She was treated again in the ED with prednisone and Benadryl. During her observation, her upper lip became swollen and her tongue became itchy. She was treated with IV Benadryl and IM epinephrine. She had immediate relief after the epinephrine, but the hives came back after about an hour, so she was treated with additional Benadryl and Pepcid with improvement. Her hives and swelling were resolved at discharge.   She had been taking Benadryl when she notices the hives starting up, Pepcid 20 mg once daily scheduled in the morning, and prednisone taper as prescribed   Yesterday at work, she developed hives on her hands while wearing gloves. She also developed hives and swelling on her feet. She also had them on her trunk and in her axillae. She was seen in occ med yesterday afternoon. She started cetirizine 10 mg yesterday afternoon and also took cetirizine 10 mg this morning. She continues to take famotidine 20 mg once daily and prednisone as prescribed. She has an epinephrine autoinjector.    She reports that this morning, her hives are better than previously, but she still has hives on her hands and feet. They are very itchy and feel hot. She has not had lip swelling but has maybe had some red patches on her lips which were transient. She denies throat tightness, dyspnea, and wheezing. Yesterday morning she had a different sensation in her throat which resolved after drinking water.   The patient likely has acute urticaria, which may related to an immune response to her recent Moderna COVID-19 vaccine. The ongoing symptoms make this unlikely to be an allergic reaction. Her symptoms may persist for several weeks.   Plan cetirizine 20 mg twice daily scheduled, famotidine 20 mg twice daily scheduled, complete prednisone taper as prescribed. We discussed risks of sedation associated with antihistamines, and she was counseled not to drive/operate heavy machinery if feeling drowsy.
Marked local reaction on arm with axillary tenderness, no node increase, redness measuring 3" long x 2" wide, area raised and warm. Denies fever/malaise. Has Hx "other" allergies. 1st flu vaccine! Tx: Zyrtec tabs given by Corp Health MD. Seen by MD for discomfort. Follow up on 12/10/03: "Less than 24 hours after vaccination, began AM of 10/30/2003."
Pt received flu shot. Next morning area red and sore. Tolerated it for 1 day and then began feeling fluid move about in the shot area. Knot became grapefruit-sized so went to MD and he placed her on Keflex. Arm continued to feel worse and had aches all over body. Temperature was 100F-101F. Was advised by MD to go to ER. Admitted to the hospital for 2 days for IV antibiotics. Could not return to work until 1/4/01.
COPD      Increased SOB that started this morning. Also states she can feel a "lump" on her left side.      HPI 87-year-old female chronic respiratory failure COPD hypertension presenting to the ER with chief complaint of shortness of breath over the last week worsening this morning. She notes cough and worsening shortness of breath. She has yellow sputum. She notes she has been wearing her oxygen and hasn't increased. She has intermittent nosebleeds 1 reaction. She states she is Covid actually. As a sick contacts. She is taken nitroglycerin recently with improvement in chest pain. She did stop smoking 5 years ago.    Review of Systems  Constitutional: Negative for chills, fatigue and fever.  HENT: Negative for ear pain, rhinorrhea and sore throat.   Eyes: Negative for visual disturbance.  Respiratory: Positive for cough, shortness of breath and wheezing.   Cardiovascular: Positive for chest pain. Negative for palpitations and leg swelling.  Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria, hematuria and urgency.  Musculoskeletal: Negative for arthralgias, neck pain and neck stiffness.  Skin: Negative for rash.  Neurological: Negative for dizziness, weakness and headaches.
10 patients receive vaccine after temperature excursion reaching 68 degrees F; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (10 patients receive vaccine after temperature excursion reaching 68 degrees F) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (10 patients receive vaccine after temperature excursion reaching 68 degrees F). At the time of the report, PRODUCT STORAGE ERROR (10 patients receive vaccine after temperature excursion reaching 68 degrees F) had resolved. 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 Treatment medications were provided No  Concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information received on 29-JUNE-2021, included no new information
Patient collapsed & died 48 hrs. after receiving vaccine. He was shopping at local CVS store & collapsed without warning. Two nurses on scene at Clinic performed CPR immediately & applied AED. EMS arrived within 5 min. There was never a heart rhythm & after 35 min. of CPR was DOA at hospital ER. He had gone to the gym earlier at 7am & was having a normal day. He had not mentioned any complaints of not feeling well.