chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm is killing like with the other 3 injections; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm is killing like with the other 3 injections) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no allergies for medications, food and other products. Patient has never been diagnosed with Covid.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is killing like with the other 3 injections). At the time of the report, PAIN IN EXTREMITY (Arm is killing like with the other 3 injections) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided.  Patient did not received other vaccine given within 1 month prior to Moderna COVID-19 vaccine.  No treatment medications were provided.   This case was linked to MOD-2022-532671, MOD-2022-532675, MOD-2022-532374 (Patient Link).
warmness around the injection site; Red circle around injection site; Red circle around injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warmness around the injection site), VACCINATION SITE RASH (Red circle around injection site) and VACCINATION SITE ERYTHEMA (Red circle around injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  The patient's past medical history included Congestive heart failure. Concomitant products included METFORMIN and APIXABAN (ELIQUIS) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warmness around the injection site), VACCINATION SITE RASH (Red circle around injection site) and VACCINATION SITE ERYTHEMA (Red circle around injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warmness around the injection site), VACCINATION SITE RASH (Red circle around injection site) and VACCINATION SITE ERYTHEMA (Red circle around injection site) 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 medications for Congested Heart Failure; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Initial information received on 10-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 39 years old female patient who was laying down and all of a sudden and had trouble swallowing and breathing, mouth kept filling up with saliva, injection site reaction and muscle aches in legs, while she received vaccine FLUBLOK QIV. The patient's past vaccination(s) included FLUBLOK with no reactions. The patient's past medical history, medical treatment(s) and family history were not provided. On 07-Dec-2018 at 3:30 PM, the patient received a 0.5 mL dose of suspect Influenza Quadrivalent Recombinant Vaccine lot number not reported via intramuscular route in the left deltoid. On 07-Dec-2018 between 10:00 pm and 11:00 pm, the patient developed a non-serious trouble swallowing (dysphagia), trouble in breathing (dyspnoea), mouth kept filling up with saliva (salivary hypersecretion), injection site reaction (vaccination site reaction) and muscle aches in legs (pain in extremity) on same day following the administration of Influenza Quadrivalent Recombinant Vaccine. (Other relevant tests included no lab data.) Final diagnosis was muscle aches in legs, injection site reaction, mouth kept filling up with saliva, trouble in breathing and trouble swallowing. The patient was treated with two BENADRYL and Ranitidine. On an unknown date, the patient recovered from the events (outcome considered based on sentence I am fine now and injection site reaction is down to normal). Documents held by sender: none.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 17-AUG-2017 the patient was vaccinated with M-M-R II for prophylaxis. Concomitant therapies included sterile diluent (MRK INJ). On 17-AUG-2017, 1 day after onset of therapy the patient experienced incorrect dose administered and syringe issue.  On an unknown date the patient experienced no adverse event. Sender's Comments: US-009507513-1708USA008322.
Sore arm.; This is a spontaneous report from a non-contactable pharmacist. A non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Feb2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 25Feb2021, the patient experienced sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event sore arm was resolved on an unknown date in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no energy/weakness; upset stomach; chills; headache; body ache; fatigue; nausea; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy/weakness), ABDOMINAL DISCOMFORT (upset stomach), CHILLS (chills), HEADACHE (headache) and MYALGIA (body ache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced ASTHENIA (no energy/weakness), ABDOMINAL DISCOMFORT (upset stomach), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (joint pain). At the time of the report, ASTHENIA (no energy/weakness), ABDOMINAL DISCOMFORT (upset stomach), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
"off-label" use of quadrivalent HPV-L1 vaccine (Gardasil) for HPV-HR positive gynecological malignancies;   This literature marketed report was received from the authors in a published literature article titled as stated above, concerning a 41-year-old female patient, diagnosed with stage IIIB, HPV-HR positive, moderately differentiated squamous cell carcinoma of the cervix. The patient was treated with pelvic irradiation (4500 cGy) with concurrent cisplatin (40 mg/m2) followed by two low-dose-rate cesium brachytherapy implants (total 8500 cGy to Point A). By the second tandem and ovoid application, the cervical tumor had completely resolved. Four weeks (also reported as three weeks) after her second cesium application, the patient presented to the office complaining of vaginal discharge. An exam found a 3 to 4 cm recurrent, grade 1, squamous cell carcinoma. Positron emission tomography and computerized tomography (PET/CT) imaging documented an isolated central cervical cancer recurrence with no evidence of metastatic disease.   On an unknown date, 4 weeks after second cesium implant, the patient received the first intratumoral vaccination of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) 0.5 mL, using 0.25 mL of the vaccine diluted with 2.75 mL saline (total volume 3 ml) injected evenly throughout entire recurrent tumor, administered for with stage IIIB, HPV-HR positive, moderately differentiated squamous cell carcinoma of the cervix (Off-label- use) (lot #, and expiration date were not provided); which was was given followed by intravaginal 0.2% imiquimod suppositories every night until the second intratumoral injection 14 days later. On day 15, the patient received the same treatment as cycle # 1 (lot #, and expiration date were not provided). In addition, she received a subcutaneous injection in the right shoulder as a "booster" (dose, lot #, and expiration date were not provided). The patient received only 2 cycles, which she received 8 days before a planned exenterative surgery which was aborted.   A copy of the published article is attached as further documentation of the patient's experience.   This is one of two reports from the same literature article.; Sender's Comments:  US-009507513-2201HUN002212:
Dizziness; Night sweat; Fatigue; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NIGHT SWEATS (Night sweat), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 01-Feb-2021.    On 08-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021 at 4:30 PM, the patient experienced DIZZINESS (Dizziness), NIGHT SWEATS (Night sweat), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness), NIGHT SWEATS (Night sweat), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
ROTARIX via injection in the left thigh; This case was reported by a consumer via call center representative and described the occurrence of inappropriate route of vaccination in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 24th March 2022, the patient received Rotarix lyophilized formulation (injection) and Rotarix Oral Applicator Device. On 24th March 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022054975   Additional Information: GSK Receipt Date: 24-MAR-2022 Reporter's Comment:  The patient's mother reported on behalf of her child. The reporter reported that the nurse at the facility administered Rotarix via injection in the left thigh of her baby instead of giving the vaccine orally. The reporter would like to know if she needed to look out for any side effects , so information provided to her, telephone number for HCP (health care professional) to call.  The consent was obtained to contact reporter and HCP for follow-up but she declined to provide her contact information and her Childs name.  Additional supportive information: The Rotarix dose was given via injection instead of giving it orally, which led to Inappropriate route of vaccination.
pt recvd vax;rash 22jan95,on face,neck,chest & back;seen in er;23jan95 T 98.5; crusty yellow nasal discharge, no cough; dx:probable acute measles; ?secondary to vax;
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 at 09:00 as dose 1, single (Lot number: En6207), in left arm, on 09Apr2021 at 09:00 as dose 2, single (Lot number: Ew0158), in left arm, on 03Dec2021 at 09:00 as dose 3 (booster), single (Lot number: Fj8762), in left arm and on 05May2022 at 09:00 as dose 4 (booster), single (Lot number: Fj4991), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient was treated with Anti viral Paxlovid from 08Aug2022 to 12Aug2022 for the treatment of COVID-19. The patient did not received any other medication in 2 weeks.
4 hours after shot - mild malaise developing, 7 hours after shot- fever and severe chills (chills and shaking was worse than the worst malaria attack I ever had; by hour 9 temperature was 103.5F.  By morning fever low 101's, some aches. symptoms diminished during the day and were gone by the following day.
Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever
pt states getting J&J yesterday at 1500 and at 2300 felt fever and chills upon waking noticed hives on arms pt denies N/V/D pt denies change in soap, detergent.
dizzy after covid vaccine. After a few moments patient says felt better. 126/66, 65,18, 97% RA, refused EMS transport to ED
heart attack after the shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 45 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation.  The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack after the shots". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results. The clinical course of events was as follows: How can you test detected on a covid test if you are vaccinated.. and also how my wife had a heart attack after the shots and can't work for now..when we documents she has a healthy heart for her 45 yrs.. and now... The lot number for bnt162b2 was not provided and will be requested during follow up.
I had swollen lymph nodes in my neck and other areas of my body for 7 months or more after the booster shot.  I had to get 2 or 3 MRIs and at least two CT scans because the lymph nodes were bigger than normal.  The doctor did not do anything.
gave pt janssen covid vaccine.She was anxious to begin with. She went to sit down after vaccination and was doing fine. I checked in with her 5 minutes into her wait and she said she was fine. Then she complained she was dizzy. I asked her if she had eaten yet (1230pm) and she said no. I had her sit down and drink some orange juice. She then said she wanted to lay down, so I took her back into the booth and she stretched out over a few chairs and boosted her legs up. She said her hands and arms were getting tingly and she started to panic. I took her phone and dialed her husband who was outside and told him to come in. She asked me to call 911, I did. I applied an ice pack to her forehead neck and shoulder areas and she said she was feeling better. I gave her another juice bottle an verified any meds she was on. She wasnt taking any meds. I called mngt also to take a statement. her husband came in and told her to calm down she was just anxious and didnt eat. When the paramedics finally showed up she was feeling much better. they took her out the the ambulance to check her over. They asked her if she wanted to go to the hospital, and she said no. I will call her later to check in on her.
twitching face muscle on left side of lips has been twitching every 1-2 seconds since 3 days after the shot and the next 4 days so far. it is currently day 7 after the shot with no relief from symptoms
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On unknown dates unknown number of patients were vaccinated with (Merck) VARIVAX (dose, lot no and route unknown). No concomitant medication was reported. The patients were inadvertently administered vaccine that had been improperly stored. No adverse effects were reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
43 yr old male sitting in observation area after receiving 1st Covid  vaccine injection felt faint and dizzy as well as nauseous. Pt appeared to be pale and skin cold,clammy, and diaphoretic and was moved to medical 2 for observation. Pt was placed in trendelenburg position and vs were taken. Pt bp was 102/62, hr 58, 98% ra and 18 reps. Led clear bil. Pt was allowed to rest for several minutes and vs were retaken and improved. Pt felt better and adverse symptoms subsided. Vs were normal at bp 110/70, hr 65, resp 18, spo2 was 100% ra. Pt felt like he can go home and doesn?t need t/p to hospital Er. Pt signed a refusal for transport and went back to observation room t rest.before returning home
This spontaneous report was received from a Nurse refers to a 3 month old female patient. On an unknown date, the patient was vaccinated with M-M-R II (dose, route and frequency were not reported) and VARIVAX (merck) (dose, route and frequency were not reported). Concomitant medications included ROTATEQ and PREVNAR 13. No adverse effects were reported. No further information reported. Additional information has been requested.
12/29/09 - Hives and itching (minimal) in evening 12/30/09 - Increase in hives/itching, contacted doctor. Told to take BENADRYL ore ZYRTEC when she goes home.  12/31/09 increase hives, itching, severe body aches - went to see doctor received CORTISONE injection 1/4/2010 returned to work given FLEXARIL for body aches
15 minutes after injection, started feeling of impending doom, tachycardia (190), confusion, dizziness, and shortness of breath.
no adverse event; HBP calling to report the administration of an expired dose of GARDASIL 9 to a patient on 10/17/2023.   Caller confirmed no previous temperature excursions for this product and stored in the recommended range.  HBP states there are no symptoms or fur; This spontaneous report was received from other health professional and referred to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 17-OCT-2023, the patient received an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe injection (valid lot #U008899 with reported expiration date: 12-AUG-2023) (strength, dose description, and route of administration not provided) for prophylaxis by a health professional. There were no previous temperature excursions for this product and stored in the recommended range, and there were no symptoms reported (no adverse event).
Mom phoned on 04/08/05 in AM to report child was lethargic, not eating. Was instructed by nurse to take child to MD for evaluation. This nurse called to f/u and mom was not home. When mom returned she called the clinic. I answered and spoke with mom. MD evaluated child " she checked her ears, nose, and throat, and noticed that her throat was red and swollen" MD RX for Amoxicillin and Motrin. F/U appt for 4/11/05. Mom stated DR said it had nothing to do with the shots. Mom also advised to increase fluids for child and monitor output.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Headache-Severe
Developed headache, tachycardia, painful heartbeat / strong feeling of heart beat in upper chest/throat, moderate nausea, sore injection site.   Symptoms cleared after 48 hours, except for sore injection site, which cleared after 72 hours. Moderate nausea was treated with Zofran ODT during the first 48 hours of symptoms, prescription from urgent care.
This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 17th July 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site warmth were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The reporter was receptionist and called to report her own personal experience. The age at vaccination was not reported. The patient did not experience any side effects with her 1st dose 2 months before the 2nd dose. The patient experienced increased swelling larger than a quarter size and fever to the touch at the injection site. The reporter did not agree to follow up from GlaxoSmithKline.
Panic attack, felt like I couldn't breathe, Hot, got rash, but not like Shingles. Had Shingle shot 4 days before. Has lasted over 4 months, but is fading.
Child experienced a febrile seizure lasting approximately five minutes. Child also experienced fevers for several days after shot administered, as well as rashes on the body.
Prior to getting the shot I would have migraines for about 4 years but since then I have not had any headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Lot number: EN6203) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: migraines for about 4 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st shot, lot: EL9264), administration date: 18Feb2021, for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Prior to getting the shot I would have migraines for about 4 years but since then I have not had any headaches".  Additional information included as he received Covid vaccine both shots and he had a benefit from it. Prior to getting the shot he would have migraines for about 4 years but since then he has not had any headaches, not as frequent not as nothing. He didn't expect this.   No follow-up attempts are possible. No further information is expected.