chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme arm  soreness where injected. Sharp stabbing pains would suddenly come and go throughout my body. The sharp stabbing pains were most painful in my right kidney area and just below my sternum.  The pain below my sternum was so bad I would have to buckle over. I also had pain in right arm that mirrored the pain in the left arm where I was injected even though I had not been injected in my right arm.  The right arm pain was a constant pain and did not come and go like the other sharp stabbing pains. I also had fatigue and slight brain fog.  I had trouble thinking clearly at times and was told my reaction times were noticeably slower. This lasted about two days. The injection area pain was the last to subside. It lasted four days. I was extremely sore under my left arm and putting deodorant on was very painful all four days.
Patient received 2nd dose of Pfizer-BioNTech COVID-19 Vaccine EUA at 2:04pm , <5 minutes after vaccine administration he developed hypotension with loss of consciousness for few seconds. He was sitting in a designated chair for the protocol 15 min observation and fell from the chair to the ground, hitting the right side of his temporal - redness noted around area with skin intact. Clinic staff immediately moved patient to be lying down on the ground with cervical spine precaution and lifted his legs up on a chair. Vitals: HR 78 and BP 118/72 taken in supine position on ground with legs elevated. Patient was transported by EMS to the ED at 2:45pm. ED note: Patient has Hx of vasovagal syncope in the past with similar symptoms after blood draws..Exam and workup shows well-appearing young man, nonfocal neuro exam, normal gait, cardiopulmonary exam unremarkable, no signs of trauma other than a small hematoma to the right forehead. After evaluation, their Canadian Syncope Risk Score is -3 indicating very low risk for 30 day serious adverse events (<1%). Telemetry monitoring during their ED stay has not captured any events. Discussed next steps with patient: given their low risk for 30 day serious adverse events (including death, serious arrhythmia, MI, PE, ICH), they would prefer to be discharged to continue their workup as an outpatient, rather than admission for observation. Patient was deemed stable to discharged from the ED at 5:57pm with counseling to follow up with PCP in the next 2 days and to return to the ED with any persistent or worsening symptoms.
7 yo with DiGeorge's Syndrome but normal T cell studies, cleared by ID for MMR #2 --> rash & swelling of hands & feet 24h after vaccine.
On 3/8/2021 received 1st dose of Pfizer vaccination; 3 days later deep sharp pain from left hip down to left pinkeye toe and ring toe (which toes become numb when pain is severe), from 1st dose in March 2021 the paln has been on & off from mild to severe (assumed due to a pulled muscle from exercise, I work out 5 days a week). As of 4/2/2021 upon receiving the 2nd vaccination, the deep pain in my leg has gotten worse, at times my leg is very tender to the touch, the skin on the upper part of my thigh looks lumpy, feels tender. It's now 24 days since the last shot and symptoms have not subsided
Pericarditis and Myocarditis diagnosed 9/21/09 9/28/09 Medical records received from Date of service 9/21/09 to 9/23/09: Admit from ER for abrupt onset of chest pain increased cardiac markers, EKG changes. Patient presented to ED the previous day with malaise, fever, flu like sx but left before seen. DX: Acute pericarditis, myocarditis, Iron Deficiency anemia, . ICD9 codes: 420.90, 429.0, 280.9, 305.1
Throat swelling, congestion, rash face, chest, back and abdomen, sneezing, unusual fatigue diarrhea
dx swelling of arm rt deltoid & redness local rxn to rt deltoid secondary to hep B;rx atarax;
Vaccine at 11:30, at 12:30 he started feeling faint, light headed, heavy legs, little nausea.  Monitored blood pressure from 12:40 to 1:50, ranged 142/93 to 163/113.  Pt has high blood pressure. Had he sit and recline until he felt better.
Info has been received from a physician concerning a 4 year old female with no known drug allergies or pertinent medical history who on 3/2/02 was vaccinated, SC in the left thigh, with an 0.5 mL dose of varicella virus vaccine live (lot 640073/1146L). Concomitant therapy on the same day included a dose of MMRII and a dose of tuberculin purified protein derivative. On 1/30/06, the pt presented to the office with a mild case of chickenpox breakthrough. The onset date of the chickenpox was noted to be 1/28/06. No treatment was required and the pt was recovering. The child would be out of school for seven days. A product quality complaint was not involved. Additional info has been requested.
9/5/03 presented with redness and tenderness at injection site. Resolved with compresses and PO Keflex for 14 days.
Acute allergic rxn, cough, red swollen eyes, and face, "throat felt funny" tightness, lips swollen. Benadryl, Epi-pen Jr, ER observation for several hrs.
Multiple blood clots in urine each urination since 09/19/2021 following second Pfizer vaccination on 09/17/2021. No pain or discomfort associated.
Client given Tdap at 71 years of age, Adacel not licensed for those over 64 years of age.
Patient reports that the vaccine was painful and she is still experiencing pain from it. (It was given > 7 months ago).
sweating; Chills/Freezing; fever 103.2F; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), CHILLS (Chills/Freezing) and PYREXIA (fever 103.2F) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced HYPERHIDROSIS (sweating), CHILLS (Chills/Freezing) and PYREXIA (fever 103.2F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Mar-2021, PYREXIA (fever 103.2F) had resolved. At the time of the report, HYPERHIDROSIS (sweating) and CHILLS (Chills/Freezing) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: 103.2 (Inconclusive) 103.2F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. Treatment medication included use of Tylenol.
PATIENT STATES THEY DEVELOPED ACUTE RIGHT SHOULDER/ELBOW JOINT PAIN ABOUT 2 WEEKS SUBSEQUENT TO RECEIVING THEIR 2ND DOSE OF MODERNA VACCINE
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 29-SEP-2016, the patient was inadvertently vaccinated with an expired M-M-R II injection of therapy type recombinant human albumin (rHA) and lot # K015374 with expiry date 18-SEP-2016 (dosing details and anatomical location not known). No adverse effect reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 3:10 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 3:10 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No concomitant medications were reported.  Batch number 041L20A  underwent temperature excursion with temperature 34 degrees Fahrenheit from 08:00 to 09:00 AM. The vial was initially moved to the fridge on 08-Jan-2021 and beyond use date was 07-Feb-2021. Product moved to clinic on 12-Jan-2021. 3 vials were sent to clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
received vaccine 12/23 and on 12/31 noted hives at site of injection right arm
Severe rigors and fevers; Severe rigors and fevers; other vaccine same date product; other vaccine same date product; This is a spontaneous report from a contactable physician (patient). An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 21Dec2020 08:00 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included covid (if Covid prior vaccination: Yes/Prior to vaccination, was the patient diagnosed with COVID-19?: Yes). No allergies to medications, food, or other products. Concomitant medications the patient received within 2 weeks of vaccination included gabapentin (NEURONTIN), ibuprofen (MOTRIN), other vaccine same date product=Pfizer, other vaccine same date vaccine location was left arm. The patient experienced severe rigors and fevers on 22Dec2020 02:00.  The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of severe rigors and fevers (Tylenol). This case was non-serious. The outcome of events severe rigors and fevers was not recovered. The outcome of other events was unknown.   Information on the lot/batch number has been requested.
I only had pain like in the body ache; I started feeling something under my knee, in front of my leg under the knee, something like electric in my leg in front;  something like swelling but not swelling; On Tuesday morning, felt something on her leg under the knee, swelling and like a bruise of someone who had an injection; When I bent or when I run to in here there is like something inside, it is swelling but something is inside like it shocks me; Have an electric shock in that area when try to bend the leg.; This is a spontaneous report received from a contactable consumer (Patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EZ0196), Solution for injection, via an unspecified route of administration, administered in Arm Left on 20Jun2021 (at the age of 58-year-old) as single dose for COVID-19 immunisation. Medical history included surgery in throat in 2016 (Not on medication. It was no medical history. She only had a surgery in throat in 2016 and her thyroid hormones are no more). The patient's concomitant medications were not reported. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0186), Solution for injection, via an unspecified route of administration, administered in left arm on 26May2021 as single dose for COVID-19 immunisation. On 22Jun2021, the patient experienced pain like in the body, she started feeling something under her knee, in front of her leg under the knee, something like electric in her leg in front; something like swelling but not swelling, on Tuesday morning, felt something on her leg under the knee, swelling and like a bruise of someone who had an injection, when she bent or when she run to in here there was like something inside, it was swelling but something was inside like it shock her, had an electric shock in that area when try to bend the leg. Patient got the 2nd dose on Sunday, 20Jun2021 on the same arm (left arm), she felt body aches. On Tuesday morning, felt something on her leg under the knee, swelling and like a bruise of someone who had an injection, 'she had an electric shock in that area when she tried to bend the leg'. She had been putting ice on it. Every day, it got more and more stuff which felt like when remove glue from something, that was what she felt on the inside. The outcome of events was not recovered.  No follow-up attempts are possible. No expected further information.
Left eye twitch  after second day of receiving the vaccine. Eyelid will twitch on and off randomly all through out the day.
fractured T12; unable to walk on own; Fell; largely stopped eating and drinking; enfeebled; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: el9269), via an unspecified route of administration at left arm on 02Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included T-cell large granular lymphocytic (tCell LGL), type 2 diabetes and high blood pressure. No known allergies. No COVID prior vaccination. The patient is not pregnant at the time of vaccination. No other vaccine in four weeks. There were other medications in two weeks (unspecified). Within a week, patient was unable to walk on own. She fell and fractured T12. On 02Feb2021, she walked on her own to the car, got in the car, then out of the car, walked to the injection site, including standing in a long line, and walked back to the car. She was aware, recognized people and places, and walked from the car to her home. On 05Feb2021 12:00 (also reported as 'during 02Feb2021 thru 08Feb2021), she largely stopped eating and drinking. Within the week on 05Feb2021 12:00, she was enfeebled. At about 01:30 on 08Feb2021, she fell and fractured her back. She is now awaiting acceptance at a rehab facility. The events unable to walk on own and fractured T12 resulted to hospitalization and disability or permanent damage. The patient was hospitalized for 4 days. The events required Emergency room/department or urgent care visit. Various medical tests and treatments were administered as treatment for the events. Patient tested for COVID post vaccination. Covid test post vaccination on 11Feb2021: (covid test type post vaccination: Unknown) Negative. The outcome of the events was not recovered.
Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) 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 concomitant medication information was provided. No treatment medication information was provided.    This case was linked to MOD21-068788, MOD21-068786, MOD21-068620, MOD21-068645, MOD21-068696, MOD21-068785, MOD21-068703, MOD21-068705, MOD21-068707, MOD21-068709, MOD21-068711, MOD21-068713, MOD21-068716, MOD21-068784, MOD21-068717, MOD21-068718, MOD21-068721, MOD21-068722, MOD21-068723, MOD21-068724, MOD21-068727, MOD21-068729, MOD21-068731, MOD21-068732, MOD21-068733, MOD21-068734, MOD21-068735, MOD21-068736, MOD21-068738, MOD21-068783, MOD21-068739, MOD21-068768, MOD21-068769, MOD21-068770, MOD21-068771, MOD21-068772, MOD21-068774, MOD21-068775, MOD21-068776, MOD21-068778, MOD21-068780, MOD21-068781, MOD21-068782 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-068788: MOD21-068786: MOD21-068620: MOD21-068645: MOD21-068696: MOD21-068785: MOD21-068703: MOD21-068705: MOD21-068707: MOD21-068709: MOD21-068711: MOD21-068713: MOD21-068716: MOD21-068784: MOD21-068717: MOD21-068718: MOD21-068721: MOD21-068722: MOD21-068723: MOD21-068724: MOD21-068727: MOD21-068729: MOD21-068731: MOD21-068732: MOD21-068733: MOD21-068734: MOD21-068735: MOD21-068736: MOD21-068738: MOD21-068783: MOD21-068739: MOD21-068768: MOD21-068769: MOD21-068770: MOD21-068771: MOD21-068772: MOD21-068774: MOD21-068775: MOD21-068776: MOD21-068778: MOD21-068780: MOD21-068781: MOD21-068782:
feel awful; fatigue; headache; chills; fever (101.5°F); felt tingling in the right side of my face; I felt tingling in my tongue; A spontaneous report was received from a consumer concerning 66 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  felt tingling in my tongue (Paraesthesia oral), felt tingling in the right side of my face (facial paresthesia), chills (chills), fever of 101.5°F (Pyrexia), fatigue (Fatigue), headache (Headache) and feel awful (Feeling abnormal ).   The patients medical history was not provided. The relevant concomitant medications reported were also not provided.  On 09 Jan 2021, prior to the onset of the events, the patient received the second dose of two planned doses of mRNA (Lot number:004M20A) through unknown route of administration in the right arm for prophylaxis of COVID-19 infection.  On 09 Feb 2021, patient experienced I felt tingling in my tongue, I felt tingling in the right side of my face, chills and fever (101.5°F). The patient also felt similar events during first shot.  On 10 Feb 2021, patient experienced, feel awful, fatigue, headache and fever of 100.5°F. No laboratory data was provided. Treatment included Benadryl 25mg.  Action taken with mRNA-1273 in response to the events was not applicable.  The events felt tingling in my tongue and felt tingling in the right side of my face was resolved on 09 Feb 2021. Other events feel awful, fatigue, headache and fever of 100.5°F was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This case was considered medically important (OMIC). Information regarding Prevnar was received from an investigator regarding an 8 month old female participant in a study who developed pneumococcal bacteremia and bronchitis. The patient received her third dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. On 11/20/00, a female patient developed bronchitis. She was diagnosed with pneumococcal bacteremia after a blood culture performed on 11/20/00 revealed Streptococcus pneumoniae, serotype 19A. The assessment of the investigator and medical monitor for pneumococcal bacteraemia and drug ineffective and bronchitis were unknown. No additional information was available at the time of this report. Follow UP: Relatedness Assessment; both the investigator and medical monitor considered bronchitis penumococcal and pneumoccal bacteraemia (expected per package insert) "not related" to the study product.
Hives/itching noted slightly below injection site 7 days after  injection. The small hives then merged to one large raised red patch (approx 3 inch x 2 inch). Redness/swelling decreased after 48 hours and resolved completely within 3-4 days without treatment.
Headache, Myalgia, Arthralgia & Fever Narrative: Temp. 101.7, muscle weakness/aches, fatigue, unable to move, chills, headache. Injection site: pain, discomfort & swelling
CAN NOT WALK; MESSED ME UP; This spontaneous report received from a patient via a company representative . The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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 can't walk, and messed me up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the can't walk and messed me up was not reported. This report was non-serious.
17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    No concomitant medications were provided. No treatment medication was provided. This case contains information for the 3rd out of 17 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
Loss of hearing, feeling of pressure in one or both ears depending on day, somewhat like when flying and ears need to pop but won't. Caused my balance to be off and if there was any background noise I can't hear what people are saying. Still happening but not as bad and sometimes it seems to have cleared up. My doctor suggested using MUCINEX and FLONASE but they didn't seem to make much difference.