chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left calf pain started around 4/12; went to Total Access Urgent Care on 4/28 as pain had increased with minor swelling and Ultrasound showed DVT.; swelling; Ultrasound showed DVT; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Apr2021 (Lot Number: er8733, at age of 41 years old) as single dose for COVID-19 immunisation. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included: Levonorgestrel; Pravastatin. The patient previously received Penicillin, dairy products. Left calf pain started around 12Apr2021; went to Total Access Urgent Care on 28Apr2021 as pain had increased with minor swelling and Ultrasound showed DVT (Deep vein thrombosis) in Apr2021. The adverse event result in Emergency room/department or urgent care. The patient received treatment for the adverse event: On Eliquis blood thinner for 3 months. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contribution of the suspect drug administration to the event deep vein thrombosis cannot be excluded, due to a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Info has been received from an RN concerning an 8 year old white female, with no pre-existing allergies, birth defects or medical conditions, who on 9/15/97 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccinations given on the same day included: the 3rd dose of poliovirus vaccine live oral (Orimune), given orally and the 1st dose of tuberculin purified protein derivative (Tubersol) given SC. There was no illness at the time of the vaccination. On 3/24/05, also reported as 3/25/05, the pt developed approximately 10 varicella lesions. It was also noted that the pt developed 12 diffuse chickenpox lesions on belly and ankles after immunization. The strep was treated with Amoxil. The pt was seen in the office on 4/2/05 for strep. It was reported that the pt recovered from varicella. No relevant diagnostic studies or laboratory tests were performed. Unspecified medical attention was sought. There was no product quality complaint involved. There were no adverse events following the vaccination of pts or siblings. Additional info is not expected.
administered 28-hours after a vaccine vial was removed from the refrigerator; administered 28-hours after a vaccine vial was removed from the refrigerator; administered 28-hours after a vaccine vial was removed from the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 28-hours after a vaccine vial was removed from the refrigerator), PRODUCT TEMPERATURE EXCURSION ISSUE (administered 28-hours after a vaccine vial was removed from the refrigerator) and PRODUCT STORAGE ERROR (administered 28-hours after a vaccine vial was removed from the refrigerator) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 28-hours after a vaccine vial was removed from the refrigerator). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered 28-hours after a vaccine vial was removed from the refrigerator) and PRODUCT STORAGE ERROR (administered 28-hours after a vaccine vial was removed from the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 28-hours after a vaccine vial was removed from the refrigerator), PRODUCT TEMPERATURE EXCURSION ISSUE (administered 28-hours after a vaccine vial was removed from the refrigerator) and PRODUCT STORAGE ERROR (administered 28-hours after a vaccine vial was removed from the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vial was moved from freezer to refrigerated on 16-May-2022.   Max temperature reached: Room Temperature 72F.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Follow-up  received significant information  as vaccine administration date and Lot number updated
Pressure  headache, chills, joint pain , muscle cramps , rash at the injection site
Expired Engerix-B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 14-year-old male patient who received HBV (Engerix B) (batch number MY3RA, expiry date 21st September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th September 2022, the patient received the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 27th September 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comments: The medical assistant reported that the patient was administered expired dose of Engerix-B series. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
sore arm; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional and consumer or non-healthcare professional in the .  This case involves patient (unknown demographics) who experienced sore arm (pain in extremity), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.   It is unknown if the patient had any medical history, concomitant disease or risk factor.  Patient concomitant medication include vitamins as he took since decades.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  Patient was saying as your age, you'll find out you've been having a mild case of the flu. It's easy to transmit the flu to others. The 1918 flu was delay for people with good immune systems which killed them. Most employers prefer it, some require it. But he do it because some of his friends are vulnerable. Why kill a buddy over a day. It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine not provided.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pain in extremity.  There will be no information available on the batch number for this case.
Information has been received from a pharmacist concerning a 66 year old female patient who in 1997 or 1998 was vaccinated with a dose of RECOMBIVAX HB. The reporter reported that patient had a reaction to RECOMBIVAX HB and she did not know what the reaction was. She did not have any other information on the patient and the event. The outcome was unknown. Additional information hs been requested.
Patient started having a minor seizure immediately after the flu shot was injected. He was shaking, dizzy, and his skin began to feel clammy and cold. The shaking would stop and start again. He was breathing and upright the whole time. The ambulance was called right after the reaction began. When paramedics arrived they tested the patients blood glucose, which was normal. His blood pressure was very low, but I don't know the exact numbers. They monitored blood pressure for several minutes and said they weren't leaving until his blood pressure came up. The patient said he was not on any medications and had not had anything to eat since breakfast. He admitted that he was not very well hydrated. He said he had a similar reaction to one of his Gardasil shots, but has never had a reaction to any other vaccine including the flu shot. The patient eventually left the pharmacy area on his own will after about a half an hour, the paramedics said that they needed his brother to take him to urgent care right away since he did not want to go in the ambulance. That is all the information I have at this time.
vivid dreams; fatigue; headache; rash on my neck; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to an unknown date Had COVID in Dec and recovered, autoimmune disorder from an unknown date and unknown if ongoing, illness from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date the patient experienced vivid dreams, fatigue, headache, rash on my neck. Patient wanted to know whether she can receive the second dose of vaccination. The outcome of the events abnormal dreams, fatigue, headache, rash was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
4 shots given. Child fainted then had decreased pulse. Sycope episode with seizure like reaction. Fine after 30 minutes.
The patient had noted increased bruising at her insulin injection sites within weeks after the vaccine. She had routine labs on May 18, 2021 that showed isolated thrombocytopenia with a platelet count of 12 thousand. This was confirmed in hospital with a platelet count of 13 thousand the same day. She was admitted to Hospital and seen by hematology. She was treated with glucocorticoids and discharged when her platelet count rose to around 20 thousand. Thus far, she has not had thrombotic events. None of her medications are new. All are stable.   We have prior complete blood counts that showed perfectly normal platelet counts in 2020 and earlier.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 85-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in June 2018 with no adverse events). In September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced shingles, itchy upper limbs and blistery rash. The patient was treated with Cream (Medication Unknown). On an unknown date, the outcome of the shingles, itchy upper limbs and blistery rash were recovered/resolved. It was unknown if the reporter considered the shingles, itchy upper limbs and blistery rash to be related to SHINGRIX. Additional details were reported as follows: Approximately 1 week after receiving the 2nd dose of SHINGRIX, the patient noted rash with blisters on both arms and one knee. The patient saw a dermatologist who diagnosed shingles. The patient was prescribed an unspecified cream and symptoms improved at time of report. The reporter gave consent to follow up. The reporter gave permission to send letter asking for permission to contact doctor for further follow up.
Consumer missed her 36 days mark for 2nd dose; UTI; Hives from bactrim; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI), URTICARIA (Hives from bactrim) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Consumer missed her 36 days mark for 2nd dose) in a 76-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 Stent placement. Concurrent medical conditions included Asthma chronic, Urinary tract infection and Heart disease, unspecified. Concomitant products included NITROFURANTOIN for UTI, NITROGLYCERIN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced URINARY TRACT INFECTION (UTI) and URTICARIA (Hives from bactrim). On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Consumer missed her 36 days mark for 2nd dose). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for UTI, at an unspecified dose and frequency. On 08-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Consumer missed her 36 days mark for 2nd dose) had resolved. At the time of the report, URINARY TRACT INFECTION (UTI) was resolving and URTICARIA (Hives from bactrim) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient medical history included blood pressure. It was reported that on 17-Mar-2021 UTI was subsided.; Sender's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot#036A21A with AEs of Urticaria and UTI. 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.
Child was seated in a chair for observation after vaccine administration.  Two minutes later child c/o dizziness. Child then had a change in LOC and paramedics were called.
The first night I had sever kidney pain on my right side, I thought I was going to have to go to the hospital. Since then, I have had Chills and a headache and severe nausea.
At 5PM, patient started to feel lightheaded while walking to the check out counter. She had lunch. She is diabetic type II (with diet control). On Metformin and BP meds. Patient here for first Covid 19 vaccine dose. VS taken: B/P 110/80, HR 94, O2 Sat 98%. At 5:05 PM he reported feeling better. VS before departure: B/P 120/80, HR 84, O2 Sat 98%.
Information has been received from a female physician's assistant who may have had a mild case of chicken pox as an infant  (developed 3 "spots". The physician's assistant reported that 2 years ago, in 2000, she was vaccinated with Varivax. she reported that she did not have an injection site rash or any other rash within 42 days of the vaccination. On 01/10/02, she developed herpes zoster starting with 2 spots on her back. On 01/17/02, the vesicles ran from her right shoulder blade, under her right arm, to her spine ("right dermatome"). She started that the vesicles were burning, tingling, and itchy. It was noted that there was no correlation with the injection site and the present site of herpes zoster. On 02/21/02, she had not recovered from the herpes zoster which she described as painful. Unspecified medical attention was sought. Additional information has been requested.
@ time of vax pt stated it hurt going in;later that evening lt arm was sore & still is sore;then area had a knot @ inj site swollen & red;had a temporal h/a;today still had h/a, area on arm red, warm to touch & painful when touched;
Adverse event started with runny nose and eventually included headache, sore throat, and cough. After 3 days, it extended into my lungs, and cough became worse. I sought medical attention and was prescribed Z-pack on Monday.
There was an excursion from the freezer; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported. On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not reported.Treatment medications was not reported.
Patient reported prior to vaccination hx of anaphylaxis to shellfish and macrobid.  She was a 30 minute post-vaccine nurse monitoring.   ~15 minutes after receiving vaccination, patient reported to the nurse dizziness, nausea.  Nurse placed patient on stretching and called for provider assistance.  SBP in 160s, DBP >100, HR 130s or higher, oxygen saturation on room air ~98%.    Epinephrine 0.3mg IM administered. Nurse placed Nasal cannula oxygen with oxygen saturation 100%.  Patient BP improved, HR improved to low 100s occasionally in 110s if patient talking to someone new such as Fire response.  Patient reported continued dizziness. BP prior to EMS arrival 146/91 left arm automatic cuff, Temp 98.3F, P 106, oxygen on nasal cannula 100%. Upon EMS arrival, patient transferred to ER.
Second dose not received in allowed time; Head pain; Neck Pain; Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck Pain), MALAISE (Not feeling well), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not received in allowed time) and HEADACHE (Head pain) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 021B21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE for Hypertension.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (Not feeling well). On 19-May-2021, the patient experienced NECK PAIN (Neck Pain) and HEADACHE (Head pain). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not received in allowed time). At the time of the report, NECK PAIN (Neck Pain), MALAISE (Not feeling well) and HEADACHE (Head pain) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not received in allowed time) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Blood pressure measurement: 112/78 (normal) 112/78. On an unknown date, Blood pressure measurement: 212/98 (High) 212/98.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications include ice pack.
Vomiting, chills, and severe headache for 2 days, headache 3 days.
symptoms were much worse after the first two doses; symptoms were much worse after the first two dose; 104 fever for 6 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (symptoms were much worse after the first two doses), CONDITION AGGRAVATED (symptoms were much worse after the first two dose) and PYREXIA (104 fever for 6 hours) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (symptoms were much worse after the first two doses), CONDITION AGGRAVATED (symptoms were much worse after the first two dose) and PYREXIA (104 fever for 6 hours). The patient was treated with IBUPROFEN for Adverse reaction, at a dose of 2 cycles. At the time of the report, VACCINATION COMPLICATION (symptoms were much worse after the first two doses), CONDITION AGGRAVATED (symptoms were much worse after the first two dose) and PYREXIA (104 fever for 6 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 fever (High) Had a 104 fever.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported.   This case was linked to MOD-2021-407184, MOD-2021-407170 (Patient Link).
She hasn't taken 2nd dose yet because of side effects; She had a very bad weakness; Felt sick for couple of weeks after 1st dose; She also had swollen lymph nodes, She still has them.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She hasn't taken 2nd dose yet because of side effects), ASTHENIA (She had a very bad weakness), ILLNESS (Felt sick for couple of weeks after 1st dose) and LYMPHADENOPATHY (She also had swollen lymph nodes, She still has them.) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Diabetes and Blood pressure high.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She hasn't taken 2nd dose yet because of side effects), ASTHENIA (She had a very bad weakness), ILLNESS (Felt sick for couple of weeks after 1st dose) and LYMPHADENOPATHY (She also had swollen lymph nodes, She still has them.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (She hasn't taken 2nd dose yet because of side effects) had resolved, ASTHENIA (She had a very bad weakness) and ILLNESS (Felt sick for couple of weeks after 1st dose) outcome was unknown and LYMPHADENOPATHY (She also had swollen lymph nodes, She still has them.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant includes diabetes and high blood pressure medications. Treatment information was not provided.