chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW1053), in left arm, on 01May2021 as dose 2, single (Lot number: EW0167), in right arm and on 31Oct2021 as dose 3 (booster), single (Lot number: 330268D) at the age of 39 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "history of subarachnoid hemorrhage" (unspecified if ongoing); "chronic Epstein Barr" (unspecified if ongoing); "overweight" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: After 4 days testing negative (August 9th-12th); (unspecified date) Positive, notes: COVID 19 Treatment; (19Aug2022) Positive, notes: received a positive test result on 19Aug. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not receive other medications in two weeks. Anti viral details: brand: Paxlovid for Treatment of COVID-19; Treatment start date 29Jul2022; treatment end date= 03Aug2022. Known allergies: Penicillin, Ceclor. Other medical history: history of subarachnoid hemorrhage; chronic Epstein Barr and overweight (not severe).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reported increased osteoarthritis pain, headaches, and lightheadedness that she has experienced since her second dose of the Pfizer COVID-19 vaccination in late April.
Patient was immediately nauseated after the vaccines, then became dizzy.  Within 15min  developed double vision and blurry vision.  Dizziness and blurry vision never resolved (more than 12 hours later at this point).
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Mild, Additional Details: shortly after receiving vaccination, the patient became unconscious, fell out of his chair and to the floor, and began to seize. Body shaking lasted around 15-20 seconds. Patient then immediately became alert and concscious. Stated after this episode that he has a history of fainting and having seizures after he receives vaccinations. Patient vomited ~15-20 minutes after this episode.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 10Apr2021 as dose 2, single (Lot number: ER8732), in left arm and on 03Sep2021 as dose 3 (booster), single (Lot number: EW0179), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Mar2023) Positive, notes: Started Paxlovid 02Mar2023- same day I tested positive-; (07Mar2023) Negative, notes: Tested negative 07Mar2023, 08Mar2023, 09Mar2023; (08Mar2023) Negative, notes: Tested negative 07Mar2023, 08Mar2023, 09Mar2023; (09Mar2023) Negative, notes: Tested negative 07Mar2023, 08Mar2023, 09Mar2023; (15Mar2023) Positive, notes: Tested positive 15Mar2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received other medication in 2 weeks was reported as yes. The patient received Anti viral COVID-19 Treatment with Paxlovid from 02Mar2023 to 07Mar2023.
Woke up at night to go to bathroom, then quickly started feeling like I was about to pass out, very weak, had to sit down on the floor to try and wait it out, had trouble seeing, was able to get up finally and find way back to bedroom by touch. With lights on vision was patchy. Was given water & a granola bar and was able to recover within 5 min.  Slept fine after that
sharp pains near gall bladder; Sore arm; cold like symptoms; congestion; Body ache; chills; nausea; joint hurt; fatigue; Fever; Sharp pains in right lower side of head towards the bottom of scalp; This spontaneous case was reported by a patient and describes the occurrence of BILIARY COLIC (sharp pains near gall bladder), PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (cold like symptoms), NASAL CONGESTION (congestion) and MYALGIA (Body ache) in a 68-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.     The patient's past medical history included Gallbladder infection (sepsis).    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced BILIARY COLIC (sharp pains near gall bladder), PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (cold like symptoms), NASAL CONGESTION (congestion), MYALGIA (Body ache), CHILLS (chills), NAUSEA (nausea), ARTHRALGIA (joint hurt), FATIGUE (fatigue), PYREXIA (Fever) and HEADACHE (Sharp pains in right lower side of head towards the bottom of scalp). On 30-Jan-2021, PYREXIA (Fever) had resolved. On 01-Feb-2021, BILIARY COLIC (sharp pains near gall bladder), PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (cold like symptoms), NASAL CONGESTION (congestion), MYALGIA (Body ache), CHILLS (chills), NAUSEA (nausea), ARTHRALGIA (joint hurt), FATIGUE (fatigue) and HEADACHE (Sharp pains in right lower side of head towards the bottom of scalp) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient was treated with Tylenol (acetaminophen) for sharp pains.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Additional information received captured reporter details.
15 Minutes after injection lightheaded. Developed headache some nausea. No food intake this a.m. No hypertension taken today BP at 12:45 152/104, P 81, at 12:50 157/101 P 74, fell asleep 13:00p.m. Woke up 13:15 p.m. BP 145/105, P 87, RR 15. Right-sided pain of head. Employee encourage to go home and rest.
Pt c/o soreness and swelling in left arm from elbow to shoulder 4 hrs after vaccination. She went to Dr the next day and received treatment.
Patient became symptomatic with shortness of breath on 06/04/2021. She was admitted into the hospital on 06/06/2021. She was discharged on 06/08/2021.
mild injection site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "mild injection site pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Wake up at 4am  very nauseous, with body aches, hot/cold chills and head ache. I took phenergan for the nausea, but it didn?t help. I throw up a couple times from 4am to 5pm, but felt super nauseous the whole time. I started to feel a little less nauseous aroun the last time I threw up about 5pm.
01/15 fever of 102.7. 11/16 noticed red spots that looked like bites scattered all over. They itched ad turned into pustules over next few days. Lasted few day and gradually resolved. Had about 100 lesions.
Ten days after the vaccine. I passed out due to my pressure dropping to low. I woke up at 2pm feeling dizzy and fell hit the floor, and shoulder blade was separated.
Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 49 years old female patient who had shoulder pain, loss of mobility and palpable quarter sized bump under the skin, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 21-Nov-2018, the patient received a dose of 0.5 ml suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: 3JY3FF) (expiry date, dose in series and route was not reported) in the right deltoid. On an unknown date, following the vaccination the patient experienced shoulder pain, mobility decreased and rash. (Other relevant tests included no lab data.) Final diagnosis was shoulder pain, mobility decreased and rash. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown for all events. List of documents held by sender: none.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/29/2022 CHOLEDOCHOLITHIASIS  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 1/29/2022 CHOLEDOCHOLITHIASIS  ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/29/2022 CHOLEDOCHOLITHIASIS  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 1/29/2022 CHOLEDOCHOLITHIASIS  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 1/29/2022 ABDOMINAL PAIN         ACUTE HYPERCAPNIC RESPIRATORY FAILURE 1/29/2022 ABDOMINAL PAIN
Pt presented to hosp DOA just over 48 hrs post vax w/hx of some vomiting;
Dizziness (pretty bad).  Nausea satisfying 430am and persists
s/s measles/rubella: constant sx's fever, malaise, body aches L/A; URI sx's of cong/cough sore throat; rhinitis sx's of arthralgias, dark sx's of rash above waist.
Patient had vaccine 29 Aug 13, 4 days later she contacted (MD) to report a reaction. Patient reported being off balance for 2 days, lightheadedness, some congestion, and a feeling of being sunburned on her left side of her face. Patient reported all signs disappeared 2 days after the vaccination (31 Aug 13).
This case was reported by a healthcare professional (nurse and subject's grandmother) and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent medical conditions included tubes in ears for infection. The subject had no adverse events following previous vaccinations. Concurrent vaccination included KINRIX; GlaxoSmithKline; unknown; unknown given on 27 June 2013. Concurrent medications included FLONASE. On 21 October 2013 at 13:00 the subject received 2nd dose of KINRIX (intramuscular, right thigh) and experienced extra dose administered and vaccine administered at inappropriate site. Per the nurse, the "office administered KINRIX again by mistake not knowing that the patient had already received the vaccine previously." The preferred site of administration for KINRIX is the deltoid of the upper arm. "Later in the evening" on 21 October 2013, 6 hours after vaccination with KINRIX, the subject experienced extensive swelling of vaccinated limb and injection site irritation. Per the nurse "the injection site had swelled up, it was really ugly and got really irritated." The swollen area was about 2.5 inches by 2 inches (63.5 millimeters by 50.8 millimeters). On 2 November 2013, 12 days after vaccination with KINRIX, the subject experienced whining and feels aged. Per the nurse, the subject began "complaining and whining that she was feeling old." On 16 November 2013, the subject experienced bone pain. The nurse stated that the subject complained that her "bones were hurting, specifically her hands and feet." The nurse documented that the subject had not experienced a fever. At the time of reporting the outcome of the events of extensive swelling of vaccinated limb and injection site irritation were resolved on 24 October 2013. At the time of reporting, the outcome of the events of feels aged and bone pain were unresolved. At the time of reporting, the outcome of the event of whining was unknown. The healthcare professional considered the events of extensive swelling of vaccinated limb, injection site irritation, whining, feels aged, and bone pain were possibly related to vaccination with KINRIX. Follow up received from nurse (subject's guardian) on 28 January 2014. This case was assessed as medically serious by GSK. Per the nurse, the extensive swelling of vaccinated limb, injection site irritation, whining, feels aged, and bone pain were unresolved; however, the nurse also reported that the "leg site resolved within 3 days." The nurse also reported that the subject "still has complaints of pain in joints and limbs off and on". The nurse also reported that, within months of vaccination with KINRIX, the subject "has recently" complained of her heart hurts at different times and had rapid heart rate at that time." Per the nurse, there was no congenital anomaly or birth defect. The nurse reported that the events could have been related to erroneous administration and noted the following "RT computer program placement in patient history." The meaning of that statement was unclear.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 18-OCT-2017, the patient was vaccinated with improperly stored doses of ROTATEQ lot # N005619, expiration date 29-OCT-2018, orally, for prophylaxis (strength, dose and frequency were not reported) and RECOMBIVAX HB lot # N020613, expiration date 05-MAY-2020, for prophylaxis (strength, dose, route and frequency were not reported). The temperature/Time frame was 34.8°F for 8 hours 23 minutes and 34.8°F for 8 hours 15 minutes The previous temperature excursion was 47.6°F for 5 minutes There was a data logger involved. No adverse effects reported. This is one of several cases from the same source; Sender's Comments: US-009507513-1710USA010653: US-009507513-1710USA010654: US-009507513-1710USA010655: US-009507513-1710USA010656:
Very sore at the shot site, swelling of the shoulder where shot was given.  Fever of 102.3. Headache. He was taken to ER to be checked out.  He was given Ibuprofen and Benadryl and an Ice pack.
Pt reports L shoulder pain and L jaw pain that started 48 hours after COVID-19 Moderna booster injection. Patient received COVID-19 vaccine at another clinic. I evaluated patient on 02/13/2022 for L shoulder and L jaw pain.
Patient states she has bumpy rash on arms, legs, stomach, and back.  She states it is not itchy
Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium
Fever lasted 7 days at a point being high of 104.2 . Chills, Vomiting, hard time breathing felt like she was stuffed up. Itchy red eyes, fatigue, abdominal pain and of Loss of appetite.
HA, abdominal pain, diarrhea, acute depression and psychosis starting day 8 after vaccine
Aches  and pain that resemble the flu, sore arm (can hardly raise above my head), chills
After flu shot - pain down to fingertips for 2 days after injection.  Noticed difficulty lifting arm higher than shoulder.  Per MD - tendonitis - 6 days Methyl prednisone per patient.
Patient got the shot on Friday 10/24/03 and Saturday he had a fever 101 and sick to stomach and on Sunday he passed out on the toilet and stopped breathing for 3-5 minutes.
Swelling 4.5 inches in length, Oval shaped 2.75 inches at widest part, about 2/16th's raised from surface of rest of arm, red radiating from center of injection in an uneven shape taking up 2/3ds of swelling, warm to touch.
Swollen arm; Itchy arm; red arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy arm) and ERYTHEMA (red arm) 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.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy arm) and ERYTHEMA (red arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy arm) and ERYTHEMA (red arm) outcome was unknown. Not Provided          No relevant concomitant medication was reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-069974 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069974:second case
She developed flu like symptoms the day after receiving the vaccine, including, fever, chills, nausea, vomiting, fatigue, myalgias, rash, which have persisted for 6 days.
1 week of severe swelling, erythema, induration and tenderness about 1inch in diameter, persisting for 1 week
That same night I was very itchy all over my legs.  My legs felt bumpy but it was dark so I just went to sleep. 08/13/2021 the next morning I was still itchy and AFTER I scratched my legs I broke out in hives all over where I scratched.  After that my legs were normal again and no more hives. I have very sensitive skin so I assumed I would have some type of skin reaction as a symptom. Not horrible.  08/15/2021 I have started to feel quick flashes of pain in my middle chest area and even my stomach area. Today is 08/20/2021 and I still get the flashes of pain. Its a 3 on a scale of 1 to 10. I felt shortness of breath one time and my heart beat really fast at the same exact time I had shortness of breath. Im nervous to take my second dose now.  I havent noticed other symptoms at all so far.
It was reported that a 48 year old male received Fluzone SV '98-'99 USP vaccine on 11/6/98. Reportedly, on 11/9/98, in the morning, the pt had left side of face paralysis, which lasted 4 to 5 hours. Experienced difficulty sleeping at night. Continued to experience hot and cold episodes and ringing in ears. On 3/17/99, pt stated still experiencing the ringing of ears and difficulty sleeping. From additional information received via phone, on 3/31/99, it was reported that from his conversation with pt on 3/29/99, the pt stated the paralysis has decreased but is still experiencing ringing in ears and difficulty sleeping. From additional correspondence, received on 4/15/99, it was reported, "Reviewed, no additional information at this time."
diffuse hives for about 4 months (end of January to end of May 2021)
Date of Admission  11/18/2021   Date of Discharge  11/23/2021   Reason for Hospitalization   pt states she can't catch her breath. Hx of COPD, on baseline 3L  Hospital Course      a 70yo woman with PMHx of COPD on 3L baseline, chronic pain, rheumatoid arthritis, tobacco use, who was admitted for further management of COVID-19 pneumonia. CT PE was negative for PE. Pt was treated with dexamethasone, remdesivir, baricitinib. She showed improvement and was able to ambulate with her baseline 3-4L NC without desaturating or becoming too short of breath. She was discharged home with family on 11/23 with 5 more days of dexamethasone to complete a 10d course.
Extremely fatigued and sick to my stomach I had diarrhea for few days but the problem is that I keep feeling worse instead of better and its already been 6 days; Its getting worse; Almost immediately after I had the vaccine my whole body turned red and very hot; Almost immediately after I had the vaccine my whole body turned red and very hot/I did not have the fever but I thought feel like very internally hot; I broke out in rash on my chest; I felt very light headed like I was going to pass out; Nauseous; I have been experiencing extreme fatigue; Feeling very sick to my stomach; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 45-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included hyperthyroidism from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for hyperthyroidism, start and stop date were not reported, diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Consumer stated, On 09Mar2021 Almost immediately after I had the vaccine my whole body turned red and very hot, I did not have the fever but I thought feel like very internally hot, I broke out in rash on my chest and I felt very light headed like I was going to pass out and also nauseous so they gave me Benadryl and steroids and Pepcid and I stayed for a while and I felt a little better went home and then I got up to next day and all reaction they came and since then I have been experiencing extreme fatigue and feeling very sick to my stomach,I have been getting very hot again not a fever it is very hot internally and it has been going on for 6 days. Consumer also stated, Extremely fatigued and sick to my stomach I had diarrhea for few days but the problem was that I keep feeling worse instead of better and its already been 6 days. consumer stated, its getting worse. Patient received treatment for the events as Benadryl every 6 hours and steroids and Pepcid. Consumer stated well I went to emergency room yesterday. The patient underwent lab tests and procedures which included blood test: unknown result on unknown date. The outcome of the events diarrhoea, condition aggravated was reported as unknown and while other events was not recovered.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Havrix: expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 15th June 2022, the patient received Havrix. On 15th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comment: The reporter was medical assistant. The reporter stated that, The patient was administered with expired dose of Havrix. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022095705:Same reporter US-GLAXOSMITHKLINE-US2022095706:Same reporter
Local reaction, left arm pain, pt felt achy. Vaccine given on 1/7/10-symptoms started on 1/13/10. Amoxicillin 875 mg BID x 10 days.