chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an immunization program officer, concerning an unknown number of patients who on an unspecified date, were vaccinated with improperly stored VARIVAX (Merck).  The vaccines were exposed to 8 to 17 degrees F for the past three months.  No adverse effect reported.  In follow-up information received, it was confirmed that the office may not be able to determine if any patients were vaccinated with VARIVAX (Merck) that was stored improperly.  It was explained that the office had not gone back to determine if any patients were vaccinated at the time the temperature excursions appeared to have occurred.  Although the refrigerator seemed to be holding the correct temperature, the officer reported that there may have been a few episodes of slightly variable temperatures.  At the time of reporting, there is no certainty that any patient was involved.  Follow up information has been received from a physician concerning a 72 year old female with penicillin and sulfa allergy, and no illness at time of the vaccination who on 08-JUL-2008 was vaccinated in the physician's office, with the first dose of VARIVAX (Merck) (Lot No 660325/0092X), subcutaneously, in the left deltoid.  On that same day, the patient also received the second dose of POLYVAL (Lot No 1679U), subcutaneous, in the right deltoid, and DECAVAC (Lot No U2287AA), intramuscularly.  The physician reported that the same day (08-JUL-2008) the patient experienced nausea.  The patient experienced vomiting the next day for "several days.  The patient did not seek medical attention.  The patient first contacted the doctor's office by phone on 15-JUL-2008.  The patient recovered spontaneously prior to 15-JUL-2008.  The physician reported that the patient attributes the symptoms to her vaccination.  Follow up information was received from a practice who reported that had no further information and doesn't want to receive any further inquiries.  No further information is expected.
Patient did not go see doctor to get a diagnosis, but said she got the chicken pox show up on her face about 1-2 weeks after getting her Shingrix shot. Patient said that she has puss coming out back in Aug, but it is getting better now. She is reluctant to get the 2nd dose, but is worried that she may get shingles later down the line. I told patient that she needs to talk with her doctor and decide if that is the right decision for herself. She felt better after our talk will come back in December to do the 2nd dose.
symptoms of covid include weakness leading to syncope/fall; abdominal pain, diarrhea since about 11/15/21, then tested positive for covid
Non-stop crying with a fair amount of irritability, also note formula change at time of immunizations
Headache and body ache started on 01/29/21 after the Second Covid-19 vaccine was administered on 01/28/21
Approximately 30 minutes after receiving the third dose of Hepatitis B vaccine, client states he started having pain in his right calf muscle. It was difficult and painful for him to walk around a store. He denies redness, tenderness, streaking in his right lower extremity. Denies fever. On day one post vaccine, he is still having soreness in his calf, making it hard to do his work, which requires climbing a ladder and steps. He has tried to massage it, but that does not improve the pain. It feels "ok" when he is at rest, but with movement the pain worsens.
Right deltoid - localized skin reaction 4 x 4 cm induration and erythema. Tx - BENADRYL DM, ice. Pt seen on 10/19/12 after calling in to report reaction.
Patient admitted to hospital with COVID symptoms and positive test 9/6/21-9/14/21.
Patient is here because he had an adverse reaction after getting his influenza vaccine. He had dizziness, lightheadedness, and was red in the face. It got better after a few minutes and was allowed to leave the office. He went straight to bed, did not eat or drink much last night, and was told that patient had trouble breathing, looked hot, and did not look right. He had pulse of 112 at the time. He had temp of 103.2. He had a bad headache. He was given one BENADRYL, ibuprofen, and 2 puffs of his asthma rescue inhaler. He then took some bread and butter. He laid in bed with cool washcloths. The fever broke around 2-3 AM this morning. Patient says he feels tired and lethargic right now. He has not had any known sick contacts. He was examined today and appears normal now.
Within a couple hours runny/water stools for 2-4 days. Runny nose by mid-afternoon. Wheezing by morning. Wheezing so bad by 48 hours was admitted to hospital for "asthma".
stomach pain; Joint pain; injection site pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (injection site pain) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (injection site pain) and NAUSEA (nausea). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (injection site pain) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.   Treatment information was not reported.
Erythema, swelling, warmth and tenderness below injection site spreading down the bicep.
pt vaccinated for covid.  pt tested positive for covid then eventually passed due to complications from it.
By 2/11/2021 i had developed back pain and leg numbness.  Progressed to right then left foot drop.
Pt recvd vax on 21SEP92 & later found to be pregnant; during pregnancy exp edema; 18MAY92 delivered 9lbs 4 oz baby; following delivery baby exp cyanosis & was treated w/oxygen;
30 mins after receiving the COVID vaccine I  feel tired all the time, I kneeled down and then I stand up and walked to the walk to lean on the wall for 1-2 mins. then I felt like I can walk so I walked to my car so I can drive home and laid down on my back. Since Oct. I always feel tired and before that I was fine. Now I feel like I lost my energy. I use to play tennis but since the vaccine I don't do it any more.
This spontaneous report was received from a registered nurse and refers to multiple patients of unknown age and gender. The patients' concomitant medications, concurrent conditions and medical histories were not provided. On unknown dates, the patients were administered doses of improperly stored VARIVAX injection, lot # M039316 with expiration date on 20-SEP-2018 (doses and routes of administration were not reported). The administered doses of VARIVAX were reconstituted with sterile diluent (manufacturer unknown) (lot # and expiration date were reported as unknown). Administered doses of vaccines experienced a temperature excursion from -9 degrees Celsius to 8 degrees Celsius, which lasted for 3.5 hours. No previous temperature excursion was reported. A digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA002377.
pt recv vax 1AUG97 shortly p/left the office slept for 12hr-waking only for 20min;pt was not arousable w/stimulation;even the police were unable to arouse pt;
Vaccine administered  to out of age group. Pt was only 17 at time of injection. Pts screening form had incorrect date of birth leading to the mix-up. Pt reporting no ill effects as of yet.
Soreness & redness to lt mid arm; c/o itching; no other complaints; MD told pt to report as adverse side effect; Did not see MD only called;
pt recv vax & 4SEP97 contracted chickenpox from vaccinees;it was reported that the pt had less than 10 lesions;
felt "drowsy" for 5 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (felt "drowsy" for 5 days) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (felt "drowsy" for 5 days). At the time of the report, SOMNOLENCE (felt "drowsy" for 5 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Patient presented to MPX site for 1st dose of Jynneos vaccine. At 5:54 PM, patient received intradermal injection in his right arm by RN Lot #FDP00015 exp 12/14/2022. After proceeding to the observation area, patient reported to RN that he felt dizzy. RN alerted PHN Lead and PHN Co-Lead. At 6:04 PM, patient was advised to stay seated and was handed a bottle of water. Patient states he has no allergies and has been diagnosed with hypertension. He takes metoprolol daily. A first set of vital signs is taken at 6:04 PM: BP: 165/92, O2: 98%, R: 18, and HR: 71bpm. Patient stated that his baseline is normally around 140/90. Patient was encouraged to drink more water. At 6:07 PM patient was helped into the gravity chair and leaned back. Patient states dizziness has not improved or worsened. At 6:09 PM, a second set of vitals were taken, and BP: 166/82, HR: 86 bpm,R: 17, and O2: 98%. Patient is reclined on the gravity chair and his feet are elevated. Patient finishes water bottle and is handed an additional water bottle. Patient was offered and declined a snack. At 6:16 PM patient states he no longer feels dizzy. Patient stated that he drove to the site. Nurses verbalized that we will need to make sure he is safe to drive. At 6:18 PM patient was assisted to the standing position. Patient states he continues to be free of dizziness and feels he is safe to drive. Patient asked to wait to be sure the dizziness does not return. At 6:23 PM patient states he is still not feeling dizzy and is ready to walk to the car. RN and another RN walked with patient to his car. Patient safety ambulated to car and left site in stable condition.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with her first dose of GARDASIL, (dose, route, lot number and expiration date not reported). Then, approximately in 2008 (reported as "about 7 years ago") the patient received her second dose of GARDASIL, (dose, route, lot number and expiration date not reported). On 14-JAN-2015 (reported as currently), the patient was at pharmacist's office to receive her third dose of GARDASIL, (dose, route, lot number and expiration date not reported). No adverse effect reported. Additional information has been requested.
The patient was given Td injection in the left arm, IM, on 8/20/04. The patient called in on 8/23/04 complaining of swelling, redness and pain at injection site.
moderate injection site pain; headache; chills; joint pain; muscle pain; very slight nausea; tiredness; This is a spontaneous report from a contactable other HCP (patient) reporting herself. A 75-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6203; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 21Feb2021 10:30 as single dose for COVID-19 immunization. Medical history included moderate atherosclerosis, drug hypersensitivity; penicillin allergy from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (ATORVASTATIN), lisinopril (LISINOPRIL) and colecalciferol (VIT D3) taken for an unspecified indication. The patient previously took cephalosporin c and experienced drug hypersensitivity. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN5318; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 31Jan2021 10:15 as single dose for COVID-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. It was reported that on 22Feb2021 04:00 patient experienced moderate injection site pain, headache, chills, joint and muscle pain, very slight nausea, tiredness within 18 hours after the second dose. Patient had not received any treatment for the adverse events. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was recovered, after the 8 hours of onset.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
was having longer RA flares than usual; wasn't sure if this fell under potentially decreasing efficacy; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASP2021077167), license party for etanercept (ENBREL).  This serious spontaneous report (USASP2021077167) was reported to Amgen on 15/MAY/2021 by a consumer and involves an adult female patient who was having longer RA (rheumatoid arthritis) flares than usual [PT: rheumatoid arthritis], was not sure if this fell under potentially decreasing efficacy [PT: therapeutic product effect decreased] while receiving Enbrel. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medication included Adderall (amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate) and Covid-19 Vaccine. The patient began Enbrel on an unknown date. On an unknown date, the patient stated that she was having longer rheumatoid arthritis flares than usual even though she was still taking Enbrel as prescribed. The patient stated that this might or might not have anything to do with her recent COVID-19 vaccine or from an increase in Adderall (amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate) dosage. The patient also stated that she was not sure if this fell under potentially decreasing efficacy. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as not recovered/not resolved. The outcome of the event therapeutic product effect decreased was reported as unknown. Action taken with Enbrel was continued for the events rheumatoid arthritis and therapeutic product effect decreased. The consumer reported that the event therapeutic product effect decreased was possibly related to Enbrel. The causal relationship between the event rheumatoid arthritis and Enbrel was not provided by the consumer. Follow up has been requested for the lot number only.  Amgen comment: This safety report does not necessarily reflect a conclusion by Amgen that etanercept caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022.; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022 at 12:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022 at 12:09 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The ethnicity of the patient was reported.  No Concomitant product use was reported.  The patient received vaccine past its 30 day expiry date The vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021. The vaccine was administered up until it manufactured expiry date of 04-Apr-2022. The patient received booster dose.  No treatment information was provided.
Round red rash has appears on my left arm That is hard, raised and itchy . Approximately 2-3 inches wide
Area initially noted to be red and warm by the client on the night of the injection.  It has progressed and is now an area 12.5cm x 9 cm in size in the bicep area of her left arm.  Area is red and warm to the touch and the distal edge is ecchymotic.  Injection site is visible approximately 2cm above the area in the deltoid area.
Chest x-ray showed really bad scarring on both lungs; Diagnosed with COVID-19 for second time; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY FIBROSIS (Chest x-ray showed really bad scarring on both lungs) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M204 and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced PULMONARY FIBROSIS (Chest x-ray showed really bad scarring on both lungs) (seriousness criterion medically significant) and COVID-19 (Diagnosed with COVID-19 for second time). At the time of the report, PULMONARY FIBROSIS (Chest x-ray showed really bad scarring on both lungs) and COVID-19 (Diagnosed with COVID-19 for second time) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, COVID-19: (Positive) diagnosed with COVID-19 for second time. On 03-May-2021, Chest X-ray: scarring on both lungs, really bad. On 03-May-2021, Echocardiogram: (Negative) Negative. On 03-May-2021, Electrocardiogram: no indication of heart attack.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided.  .  No treatment information provided. Action taken with mRNA-1273 in response to the drug was not applicable.; Sender'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.
Vaccine received was Fluzone High dose-Thimerosal free; preservative free: Prolonged pain in the arm for 5 weeks and still counting.  Tried arm stimulation and light exercises first with ice, later with heat and no relief to present time. Husband has same problem (and also other people we know). Have also been to chiropractor with no success. Gave us exercises which we are still doing.  Have talked to other nurses and they have told me they have had some calls with same problem.
feel tingles on your hands; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (feel tingles on your hands) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (feel tingles on your hands). At the time of the report, PARAESTHESIA (feel tingles on your hands) outcome was unknown.            No concomitant medication information provided. No treatment information given. Reporter gave consent for safety follow up.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 19-APR-2016, the patient received an expired dose of ZOSTAVAX lot # L000461, expiry date 08-MAR-2016 (dose, route and site of administration were not reported). Additionally, the ZOSTAVAX had been exposed to a temperature excursion prior to administration (10 minutes, temperature 77 Fahrenheit). No symptoms reported. Additional information has been requested.
Narrative:  Patient received COVID-19 Moderna Vaccine dose 1 on 01/22/2021 and dose 2 02/19/2021. Patient admitted to the hospital on 5/26/21 with chest pain and positive covid-19 test. Patient not requiring oxygen at time of admission. On 5/27/21, patient decompensated, desaturating to 87% SPO2 on room air requiring initiation of oxygen. Patient initiated on dexamethasone and remdesevir at that time. Currently hospitalized.
Vaccine was administered 3 days outside of the BUD (while under refrigeration). Error was discovered after administration. Patient notification is being attempted and the patient will be given further guidance upon contact. No adverse events reported at this time.
1St Dose COVID 19 Vaccine Patient Fainted in chair 5 minutes after vaccine administered
2 days after the first vaccine I started having symptoms of a urinary tract infection. Called doctor and they prescribed me Nitrofurantoin for 5 days.  I completely recovered.  Now at almost 2 days after the second vaccine I'm showing some symptoms of a urinary tract infection - lower back pain; some pain in when urinating.
On 10/22/2022, I woke up with a low-grade fever of around 99.4 degrees. I had chills, fatigue, slight cough, and head congestion. I ran a fever for the next few days. I treated that with TYLENOL cold medication. I took an at home COVID-19 test that same day and it was negative. However, the next day, 10/23/2022, I tested again and was positive. I spoke with my doctor on 10/25/2022. She did not advise any antiviral treatment as my symptoms were minor. She instructed me to treat myself with over-the-counter medication and call her back if I got worse. I went to a local pharmacy on 10/29/2022 for a COVID-19 test and that confirmed my positive results. My symptoms gradually improved on their own and I tested myself again on 11/01/2022, the results were negative.