chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion that occurred several days ago in the Freezer.; No adverse event; patient received vaccine from vaccine that underwent a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer.) and NO ADVERSE EVENT (No adverse event) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer.) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer.).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. the excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
Flu like symptoms; Severe body aches; Chills; Low grade fever,; Lingering headache; This is a spontaneous report from a non-contactable consumer, the patient and also from a contactable consumer. An adult non-pregnant female patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had received any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient experienced flu like symptoms, severe body aches, chills, low grade fever and lingering headache. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu like symptoms, severe body aches, chills, low grade fever and lingering headache was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mom called today (1-10-12) & states that child became ill feeling & nauseated within 1-2 hrs after injection. At 3AM (1-10-12) woke up vomiting, broke out in beaded sweat. Mother states that her 11 yr old younger son had a severe reaction to his vaccines that he got of Hep A & HPV - given at same time & he broke out in hives all over even inside his mouth. Does not want either child to get the HPV vaccine again.
Patient verbalized previous episodes of syncope after vaccination.  She has a fear of needles and even fainted after having her ears pierced as a child.  After vaccination, she began to have concern that she was going to faint.  After trying to lower hear head between her legs, she fainted while being comforted by her husband.  We lowered her to the floor and elevated her legs allowing the bloodflow to quickly return to her upper body.  She was only unconscious for around 10-15 seconds.  She awoke and felt much better.  She sat for another 10+ minutes but felt better and was fine.  We called EMS to fully check her out but she refused care.
On Saturday April 24, 2021, I began experiencing severe headaches, eyeball pain, light-headiness, weakness and lack of energy, pain at the injection site and flu like symptoms.
Dizziness and headache for 15 minutes after receiving the vaccination Rash medial to the vaccination site
Chills, severe headache, fatigue, nausea, 101.5 fever
Patient was admitted to a facility on 01/18/2022 for acute hypoxemic respiratory failure 2/2 to Covid-19, acute toxic metabolic encephalopathy, acute kidney injury, dehydration and polypharmacy, severe sepsis secondary to COVID 19, transaminitis and hyperbilirubinemia.  While in the hospital the patient received Decadron, and respiratory status continued to worsen to need to be placed on Bipap, and could not be weaned off.  The patient was made comfort care and passed on 01/22/2022.
Left arm only. Enduration around vaccine sight about 1 1/2" x 2", red & hot to touch. Gave MOTRIN & BENADRYL, iced area. Fever 102 & headache. Mild itching fever & headaches resolved today - 3-24-10. If not better next 24 - 48 hrs, to be seen. Continue BENADRYL & cold compresses.
The patient developed back pain in March, 2019 (two months after the vaccine) and was diagnosed with constipation.  His symptoms persisted and he was ultimately diagnosed with Crohn's Disease in June, 2019
extreme muscle pain in right upper arm .  body aches all over flu like feeling,  feverish, chills, felt like "hit by truck"   joint pain throughout body
I couldn't sleep the night of my shot. I felt like l had the flu. No fever but just so sick and because of the myesthenia my breathing was compromised.  On the oxymeter it showed 92 and 93 at times. Today, the 22nd February l feel better but weak and tired and my head feels funny   Hard to describe.  I still feel it's difficult to take a deep breath
all of the vaccinated I know ALL are getting covid-19; all of the vaccinated I know ALL are getting covid-19; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's 1st daughter).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller reported that all the vaccinated people the reporter knows were getting covid-19 including reporter's two daughters and two granddaughters. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. the outcome of events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101281144 same reporter, different patient
it felt like it was a little lumpy at the injection site; itchy and red at injection site; itchy and red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (itchy and red at injection site), VACCINATION SITE PRURITUS (itchy and red at injection site) and VACCINATION SITE MASS (it felt like it was a little lumpy at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (itchy and red at injection site), VACCINATION SITE PRURITUS (itchy and red at injection site) and VACCINATION SITE MASS (it felt like it was a little lumpy at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (itchy and red at injection site), VACCINATION SITE PRURITUS (itchy and red at injection site) and VACCINATION SITE MASS (it felt like it was a little lumpy at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported. On 23-Jan-2021 feeling much better; it was faded a lot.   Reporter did not allow further contact
I have red sore spots on my toes on both legs. They are red and tender and painful to touch and walk. They seem to vary a bit from day to day. I did not visit a doctor. I never had something like this before and nothing changed in my behavior or shoes. Just concerned about what they are and how to treat them.
1st noc of vax t100?, 3 noc later flu sx aching, tired,sick to stomach x 4 days;could not play soccer game d/t chest pain/pressure x 2 wk;tired no energy;bronchitis x 1wk;christmas-FEB couldn't sleep, tired, sinus, dizzy, h/a
Prevnar given IM, LAT, on 5/9/01. Area bruised with a knot right away. Hard area lasted 6 months. Muscle atrophy noted on 12/1/01 measuring 2.5cm X 2cm. Initially documented by another MD.
I started hearing a motor running to the beat of my heart in my left ear. If my heart rate increased, the motor sound would increase. This started in January 2023. I have it every day, but it never happens at the same time.
administered with MMRII during pregnancy; This spontaneous prospective pregnancy report was received from a medical assistant and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA), lot # R031681, expiration date 01-NOV-2020 (dose and route of administration were not reported) for prophylaxis. The patient was 24 weeks and 6 days pregnant at time of administration. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) were not known and could not be calculated. The pregnancy outcome was pending.
Hard, baseball sized bump under vaccine site and round red circle appeared approximately 8 days after getting the injection, which two days later turned into a large, splotchy red rash that traveled down my arm along with itchy hives
This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach was upset like nausea), DIZZINESS (lightheaded/somewhat dizzy), NAUSEA (stomach was upset like nausea) and HEADACHE (headaches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Chronic kidney disease stage 3 and Spinal stenosis. Concomitant products included TRAMADOL for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach was upset like nausea), DIZZINESS (lightheaded/somewhat dizzy), NAUSEA (stomach was upset like nausea) and HEADACHE (headaches). At the time of the report, ABDOMINAL DISCOMFORT (stomach was upset like nausea), DIZZINESS (lightheaded/somewhat dizzy), NAUSEA (stomach was upset like nausea) and HEADACHE (headaches) outcome was unknown. Treatment details were provided by reporter. She did not take any medications for her symptoms but limited her diet to applesauce, bananas, and rice. She watched her diet to try and help with those symptoms as well. This case was linked to MOD-2021-289553.
still has red blotches all over; Vagina had an itch; red rash; black rash on legs,feet are black, her toes are black, her nails are black; so hot to touch; peel; arm is swollen and hot; This spontaneous case was reported by a consumer and describes the occurrence of VULVOVAGINAL PRURITUS (Vagina had an itch), RASH ERYTHEMATOUS (red rash), RASH (black rash on legs,feet are black, her toes are black, her nails are black), INJECTION SITE WARMTH (so hot to touch) and SKIN EXFOLIATION (peel) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VULVOVAGINAL PRURITUS (Vagina had an itch), RASH ERYTHEMATOUS (red rash), RASH (black rash on legs,feet are black, her toes are black, her nails are black), INJECTION SITE WARMTH (so hot to touch), SKIN EXFOLIATION (peel) and PERIPHERAL SWELLING (arm is swollen and hot). At the time of the report, VULVOVAGINAL PRURITUS (Vagina had an itch), RASH ERYTHEMATOUS (red rash), RASH (black rash on legs,feet are black, her toes are black, her nails are black), INJECTION SITE WARMTH (so hot to touch), SKIN EXFOLIATION (peel) and PERIPHERAL SWELLING (arm is swollen and hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2021: Follow up information was received and events were added.
During administration of vaccine when nurse push plunger to inject vaccine all leaked out around hub of needle. Physician on site was contacted assessment was that client didn't receive a dose of the covi-19 vaccine. Physician advised nurse to give a second injection. Client stated she felt the vaccine in her arm with the second shot whereas nothing was felt during first injection.  Observed client for 30 minutes and released without incident.
Immediately after receiving vaccine, patient complained of pain to right deltoid. Continued pain, low grade fever, fatigue, back and body aches.
Patient had swelling and redness at site of the shot. Patient said had cramping and diarrhea around 3 hours after receiving the shot.
Caller mentioned that she thinks the COVID booster shot that she received 2 years ago messed up her brain.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 Immunization. The following information was reported: CEREBRAL DISORDER (non-serious), outcome "unknown", described as "Caller mentioned that she thinks the COVID booster shot that she received 2 years ago messed up her brain.".  Additional information: Reporter mentioned that she thinks the COVID booster shot that she received 2 years ago messed up her brain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received 3rd Hepatitis vax, and the following day developed a red "knot under skin" at site of injection; experienced serous drainage and then pus from site; no fever; no red streaks above or below site; no rash; no respiratory difficulties. As of 08/02, "knot" has softened and site has a scab with no additional drainage.
pain she got after both shots/arm pain where she thought she slept on her arm bad/it is just painful/feel the pain when they injected her; She cannot lift her hand/she cannot lift her arm; sometime it goes numb/she cannot use it; she has to drive with her left arm due to the pain; second shot outside recommended time interval; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain she got after both shots/arm pain where she thought she slept on her arm bad/it is just painful/feel the pain when they injected her), HYPOKINESIA (She cannot lift her hand/she cannot lift her arm), HYPOAESTHESIA (sometime it goes numb/she cannot use it), IMPAIRED DRIVING ABILITY (she has to drive with her left arm due to the pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot outside recommended time interval) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (pain she got after both shots/arm pain where she thought she slept on her arm bad/it is just painful/feel the pain when they injected her), HYPOKINESIA (She cannot lift her hand/she cannot lift her arm), HYPOAESTHESIA (sometime it goes numb/she cannot use it), IMPAIRED DRIVING ABILITY (she has to drive with her left arm due to the pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot outside recommended time interval). The patient was treated with IBUPROFEN for Pain, at a dose of 1 dosage form. In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot outside recommended time interval) had resolved. At the time of the report, PAIN IN EXTREMITY (pain she got after both shots/arm pain where she thought she slept on her arm bad/it is just painful/feel the pain when they injected her), HYPOKINESIA (She cannot lift her hand/she cannot lift her arm), HYPOAESTHESIA (sometime it goes numb/she cannot use it) and IMPAIRED DRIVING ABILITY (she has to drive with her left arm due to the pain) had not resolved.            Concomitant medications were not provided Patient made an appointment with the doctor.
I awakened with teeth chattering chills and was incontinent on the way to the bathroom to void. When I awoke around 7:15 I was feverish. I took Acetaminophen. My back ached left of middle back; ER on 05/08/2016 diagnosed UTI, ER on 05/09/2016 admitted due to sepsis; ran several tests to find source of staph infection; 05/12/2016 diagnosed MSSA pneumonia; discharged 05/15/2016; continue to have back aches- wearing Fentanyl patch  and taking Aceteminophen to manage pain.
Initial unsolicited report received from a pharmacist on 20-Mar-2017. This case involves a 66-year-old female patient who was vaccinated with a dose of ADACEL (batch number, expiry date dose form, frequency and site of administration not reported) via intramuscular route on 21-Feb-2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) were reported as unknown. Illness at the time of vaccination was reported as unknown. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 21-Feb-2016, the same day following the vaccination the patient experienced numbness in lip and lower face. The patient was seen by a physician on an unspecified date. Relevant laboratory investigations were not reported. The patient received Steroid pack (unspecified) as corrective treatment. The patient had not recovered from the event. Follow-up report received from a pharmacist on 16-May-2017. Batch number of Adacel was reported as "45607AA" and expiry date was reported as 29-Mar-2019. List of documents held by the sender: None.
Hard, swollen arm with baseball sized rash over the site; that went away after a week, then hives developed and ongoing for about a week now.
there have only been 3 of us (Further clarifications unknown) that this is happened to/already reported this to Safety and then she gave all the information about myocardia and not been able to walk.; there have only been 3 of us (Further clarifications unknown) that this is happened to/already reported this to Safety and then she gave all the information about myocardia and not been able to walk.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), GAIT INABILITY (non-serious), outcome "unknown" and all described as "there have only been 3 of us (Further clarifications unknown) that this is happened to/already reported this to Safety and then she gave all the information about myocardia and not been able to walk.". Additional information: Reporter mentioned that she already reported this to Safety and then she gave all the information about myocardia and not been able to walk. She wanted compensation for the medial part that haven't been paid and an appointment. She did give this to an attorney. She did state that there have only been 3 of them (further clarifications unknown) that this happened to and reporter did not understand why they do not want to meet with her or why Pfizer does not meet with her. Reporter stated that she filed the adverse event about a year and a half ago because the day after she got the shot, she went to the hospital.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201387564 same reporter/ product/ event; different patient;
Immediate onset after vaccination. Inconsolable screaming. Could not settle him. Drove home with him screaming, which stopped abruptly after 10 minutes or so. Took him from car seat, did not wake up. Put down for nap at 10am (when usually would wait till afternoon). At 12 noon, I tried to wake him up, could not stir him. Pulled up blind, turned on lights, made noise, still no response. At 3pm, he finally was able to respond and sit up, but then eyes rolled back and collapsed on his side. By 5 pm, he was more cognizant of his surroundings. I believe he was experiencing seizures. He subsequently stopped calling for me in the mornings, stopped word approximations, development slowed. He should have been in the hospital on the day of immunization, but it was my second child and I thought it would be better to wait it out at home rather than have 2 small children in the emergency room. Other subsequent diagnoses are epilepsy, autism, central auditory processing disorder, visual processing disorder, apraxia. His right side of his body presents more like a person with cerebral palsy, than autism.