chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got large mouth sores that were oozing; I got large mouth sores that were oozing; my sense of smell and taste went bad - I could taste and smell but everything tasted and smelled really bad; my sense of smell and taste went bad - I could taste and smell but everything tasted and smelled really bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The reporter is the patient. A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Feb2021 08:30 (Lot number: EM9810) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing); "drug allergy" (unspecified if ongoing); "Lichen Planus" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; OMEPRAZOLE; PROGESTERONE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: E9265, Location of injection: Arm Right), administration date: 04Feb2021, when the patient was 65 years old, for Covid-19 immunization.  The following information was reported: STOMATITIS (non-serious), WOUND SECRETION (non-serious) all with onset 12Mar2021, outcome "recovered with sequelae" and all described as "I got large mouth sores that were oozing"; PAROSMIA (non-serious), TASTE DISORDER (non-serious) all with onset 12Mar2021, outcome "recovered with sequelae" and all described as "my sense of smell and taste went bad - I could taste and smell but everything tasted and smelled really bad". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of stomatitis, wound secretion, parosmia, taste disorder.  Additional information: there is no hospitalization prolongation. The patient received booster dose on 17Nov2021 at 15:45 (Batch/lot number: 330268D, age at the time of vaccination: 66-year-old) administered in arm left for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Vitamin D within 2 weeks of vaccination. 2 weeks after second dose, patient got large mouth sores that were oozing.  6 weeks after second dose, sense of smell and taste went bad, could taste and smell but everything tasted and smelled bad. She was tested both times for COVID and both tests were negative, so she assume it had to do with the vaccine. She have had Lichen Planus and I heard that could make her susceptible to these side effects. It was now 7 months later, and still have problems with taste and smell. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
7 minutes after receiving injection patient developed left jaw pain, pain behind eyes, dizziness, nausea and 2 episodes of vomiting. Given antiemetic medication and ibuprofen for symptomatic treatments. Monitored in the ED for several hours without new or worsening symptoms.  Of note, patient was seen for left jaw pain, pain behind eyes and dizziness on Dec 26 in the ED as well. States these symptoms were thought to be improving until dose of vaccine, symptoms returned. New symptom is N/V after dose of vaccine.
The caller confirmed no side effects were experienced; The caller confirmed the dose given to her mother and father was 0.5 ml dose of RECOMBIVAX; This spontaneous report was received from the patient's daughter and refers to her mother of unknown age. The patient's concurrent conditions pertinent medical history, drugs reactions or allergies, and concomitant therapies were not reported.  In approximately August 2022 (reported as "a month ago"), her mother was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml dose, lot  number T032918 with expiration date 12-NOV-2022 (route of administration and anatomical location were not provided) for prophylaxis (Incorrect dose administered). The caller confirmed no side effects were experienced.; Sender's Comments:  US-009507513-2210USA003238:MSD
Shortly  after receiving the shot,I  obtained a floater in my left eye,my I  can see 2  things, a floater and a halo when looking  to the left,looking down, I  only  see the floater,when looking  to the left, I  see both
Patient fainted/ seized about 10 minutes after receiving vaccination.  Patient admitted to not eating anything prior to coming in for vaccine.  Patient was sat up on the floor and given crackers and water and a cold rag.
Pt. received both a ZOSTAVAX vaccine subcutaneously and a FLUVIRIN vaccine IM; both in right arm. Within about 1/2 hour pt. felt dizzy and area of ZOSTAVAX became very red, hot and swollen, and rash appeared over most of body. Swelling of arm resolved, rash resolving. ER Dr. put her on prednisone and hydroxyzine.
pt went to husband's MD; pt says arm became red-feverish; 23NOV93 it was OK; no swelling or redness;
Starting the night of and all days until today, has c/o leg pain, stomach pain, headache; and a nosebleed today only.
I got the 1st Pfizer vaccine on 1/6/21, I had mild itching and fleeting chills after the shot. I took some Benadryl when I got home, and I was ok. I got the 2nd vaccine on 1/27/20 at 8 am. At around 8:10 I started getting itchy. The itching escalated, and I notified one of the nurses at the vaccination clinic. At around 8:32 they administer Claritin and called the rapid response team because I started having tightness in my chest (similar to my asthma reaction). The Physician who responded to the rapid response recommended that I be transferred to the ER for observation. I was taken to the ER and was given IV fluids with Solu-Medrol, Pepcid, and Benadryl. I had some improvement, but still experienced some mild itching, which is still ongoing (as of today 1/31/21 @ 01:47). I?ve had a headache and fatigue the past 2 days, the headache has resolved, but still feeling fatigued. I was prescribed prednisone and I am to take Benadryl as needed. I have been compliant with all my prescribed meds. I had a follow up with my PCP on 1/28/21 @ 8:10, she recommended that I continue taking the medications prescribed in the ER, and to follow up with the office for further assistance or go back to the ER if I have tightness in my chest. She also recommended taking Tylenol for the headache. As of this morning (1/31/21 02:05), I have not had tightness in my chest. I've been using my prescribed Inhalers (both the flovent and albuterol).
This spontaneous case reported by a consumer, describes the occurrence of anosmia (loss of smell and taste), nasal congestion (congested), ageusia (loss of taste and smell) and myalgia  (soreness of the arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 045A21A) for COVID-19 vaccination. No medical history reported. On Mar 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 23, 2021, patient had myalgia (soreness of the arm). On Apr 6, 2021, patient experienced anosmia (loss of smell and taste), nasal congestion (congested) and ageusia (loss of taste and smell). At the time of the report, anosmia (loss of smell and taste), nasal congestion (congested), ageusia (loss of taste and smell) and myalgia (soreness of the arm) outcome: unknown. Diagnostic results: On Apr 6, 2021, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant medications were not provided. In November 2017, also reported as "the date between 08-NOV-2017 to 14-NOV-2017", the patient received one separate dose of improperly stored PNEUMOVAX 23 Lot # N010105, expiry date on 15-NOV-2018, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature at or above 32°F (Farenheit) to 35°F during 15 minutes. No previous temperature excursions were reported and the call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA013951: US-009507513-1711USA013953: US-009507513-1711USA013954: US-009507513-1711USA013955: US-009507513-1711USA013958: US-009507513-1711USA013959: US-009507513-1711USA013960: US-009507513-1711USA013963: US-009507513-1711USA013964: US-009507513-1711USA013965: US-009507513-1711USA013967:
w/in 5 mins p/vax pt collapsed & was unresponsive for approx 60 sec; during that 60 sec pt became rigid w/tremors;  neck hyperextended & eyes rolled back;
Client with history of short term memory loss. Came in for 1st dose of Pfizer, accompanied by father. Father unaware of client previously vaccinated with Modern vaccine. Client did not disclose/could not remember if previously vaccinated. Client received 1st dose of Pfizer. While in observation area, client could not remember is 1st or 2nd dose vaccine. Upon further investigating, records reviewed indicated client had received 2 previous doses of Moderna. NP on site consulted client due to receiving 3 vaccines in total. Client left clinic after 15min observation in no acute distress or reaction noted.
reporter states when verifying the childs name w/foster mom wrong name was given;pt given dose OPV that was not necessary;
Woke up thrashing in bed with feet on fire and itching, sat up and throat, tongue, lips itchy with tongue and throat swelling.  Took epinephrine breathing treatment, 100 mg of Benadryl,  40 mg prednisone, Duo neb breathing treatment.   Another epinephrine breathing treatment.  Symptoms lessened after taking medication.  I have this medication d/t allergies and asthma. If symptoms had not improved I was prepared to go to ER to call an ambulance. SpO2 85% before breathing treatment and 89-90% after treatments.  Medication started immediately  upon waking and symptoms began improving within the first 20-30 minutes. Reported symptoms to work and did not go to work until 11 am and worked only till 1-2 pm.  Also reported event to MD and was told not to take  the next dose d/t reaction.
This spontaneous report as received from registered nurse refers to a patient of unknown age and gender.  Patient's concurrent conditions and relevant medical history was unknown. On 26-SEP-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot number, dose and route unspecified) that was exposed to temperatures outside of the proper storage range. Concomitant medications were unknown. No adverse event was reported. The outcome of the events was unknown. The causality of the events with (Oka/Merck) VARIVAX was not reported. Product quality issue was not involved. Additional information has been requested.
3/31/21 - Wednesday evening started experiencing flu-like symptoms, aches, fever, diarrhea, headache, swollen under left armpit. 4//02/21 - Friday morning woke up and couldn't hear in left ear, right ear 50%.  Light headed, dizzy, unable to concentrate and slow in processing thoughts.   4/06/21 - Went to Urgent Care.  Dr. examined ear and did not see any fluids or signs of ear infection. Current 4/23/21 - Still unable to hear out of left ear.
Body aches, chest pain, feeling hot, malaise. Diagnosed with pericarditis in ER.
Based upon internal review done on 07 July 2014, a significant correction was done to update the listedness of the case from unlisted to listed. This study case was received from the investigator in a trial on 30 June 2014. A male subject, date of birth and medical history not reported, experienced a slightly elevated troponin lab result, considered mild in severity, days after he received an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) on 06 February 2011. On 24 June 2014, 40 months post vaccination the Troponin I result was reported as 0.12 ng/mL. On 24 June 2014, electrocardiogram (ECG) was reported as normal. A redraw was performed on 30 June 2014 and the investigator will report the results once available. The subject did not require any medical treatment. The patient's outcome was reported as still present, not recovered. According to the investigator, the event of elevated troponin was considered other important medical event and remote possibility related to the trial product. Upon internal review done on 07 July 2014, the listedness of the events elevated troponin and potential myopericarditis was changed from unlisted to listed. Documents held by sender: None.
Headache ARM PAIN, BODY ACHES, CHILLS, FEVER, NAUSEA Narrative:
Itchiness all over my body about 10 or 11 days after the booster. Whenever I rub it slightly itch my skin anywhere on my body, it?ll become red and welt up. Sometimes I?ll get a rash there too. Much like dermatographia.  I went to a dermatologist after 4 days of having this condition. He thinks it?s likely to be an adverse reaction to the booster. He prescribed my prednisone.  I had no side effects from the first two vaccine shots.   Also of note, I had swollen lymph nodes under my armpits for about a week or so after the booster.
Pt developed Immune Thrombocytopenia (ITP) after his 1st dose of COVID vaccination, requiring hospitalization and treatment.
Bursitis; This spontaneous case was received on 27-Oct-2020 from other non-health professional (consumer) via Health Authority (reference number: SEQW20-04322) and concerned a 73-year-old, male patient.   The patient's past medical history included two hip replacements, two heart attacks, clot bladder removal, heart failure and cardiac arrest. The patient's concurrent conditions included diabetes and prostate cancer. The patient concomitant medications included Eliquis (apixaban), Pravacol (pravastatin sodium), Jardiance (empagliflozin), atorvastatin, Aldactone (spironolactone), Aspirin (acetylsalicylic acid) and metformin, all used for an unreported indication.  On 25-Sep-2020, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5ml, anatomical location: right arm and route of administration: not reported) for influenza prophylaxis. The batch number was not reported.  On 29-Sep-2020, in the morning, four days after receiving Fluad Quadrivalent, the patient started feeling pain in his lower back and pain moved to right hip. He visited his surgeon and X-ray revealed that everything was fine. The doctor diagnosed him with bursitis. The patient never had bursitis before. He was treated with cortisone and for about three to four weeks he got better and was fully recovered.  On an unspecified day in Oct-2020, the patient recovered from bursitis.   The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: A 73-year-old, male patient was administered Fluad Quadrivalent in right arm. Four days after receiving Fluad Quadrivalent, the patient started feeling pain in his lower back and pain moved to right hip. The doctor diagnosed him with bursitis. The patient's past medical history included two hip replacements, which confounds causality. However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related. (defaults to "related" in the safety database for reporting purposes); Sender's Comments: A 73-year-old, male patient was administered Fluad Quadrivalent in right arm. Four days after receiving Fluad Quadrivalent, the patient started feeling pain in his lower back and pain moved to right hip. The doctor diagnosed him with bursitis. The patient's past medical history included two hip replacements, which confounds causality. However, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related. (defaults to "related" in the safety database for reporting purposes)
had diarrhea twice; vomiting all afternoon; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Feb2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "had diarrhea twice"; VOMITING (non-serious), outcome "unknown", described as "vomiting all afternoon".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (side effect) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (side effect). At the time of the report, ADVERSE REACTION (side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
temperature excursion; This spontaneous report was received from a customer (reported as type "other") and referred to a patient of unspecified age and gender. Information of the patient's  pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On 11-JUL-2023, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid (2 milliliter (ml), lot# 1968385, expiration date upon internal review was established as 22-MAY-2024, strength was not reported) orally for prophylaxis (product storage error).  It was stated that the vaccine had the following temperature excursions: 34.9 degree Fahrenheit (F) with a time frame of 6 hours and 34 minutes (on 20-JUN-2023); 51.4 F with a time frame of 7 hours and 33 minutes (on 03-JUL-2023); 51.1 F with a time frame of 24 hours (on 04-JUL-2023); and 50.7 F with a time frame of 9 hours and 27 minutes (on 05-JUL-2023).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA009885: US-009507513-2307USA009292:Original Case # (no patient identifiers)
Severe rash and swelling on right arm, measuring 21 cm by 20 cm at widest points.
she had trouble swallowing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, 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: DYSPHAGIA (non-serious), outcome "unknown", described as "she had trouble swallowing".  Additional information: The patient stated that she got her first Pfizer covid-19 vaccine and had a bad reaction to it. Patient mentioned that she had trouble swallowing and wants to know if it's okay to get the Pfizer new vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About an hour after the shot I felt like I was getting the Flu.  body aches, fever, fatigue, cold chills. I woke up the next day to go to my job and as I was standing at my closet to grab a shirt I felt like I was going to pass out. everything went black. The next thing I knew I was laying on the floor with a shirt in my hand but don't remember how I got on the floor or if I even fell.  I asked my Girlfriend if she had heard me fall, She said no. I walked into the bedroom and layed back down on the bed still feeling "out of it". after what felt like a few minutes, I began Heaving like I was going to throw up but I felt like it was a dream and was very slow to react until my girlfriend told me to run to the bathroom. the whole time I was coughing up a foam.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15May2022 at 11:30 as dose 4, (booster) single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Sulfa drugs, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (14Jun2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Unknown; (17May2022) positive, notes: day 1; (20May2022) negative, notes: day 4; (22May2022) negative, notes: day 6; (02Jun2022) positive; (14Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2weeks. Took Paxlovid day 1, 17May of  positive COVID test, day 4 and day 6 tested negative and felt 100 percentage better. On 31May2022 at 12:00 PM, event started. Tested again (for work) 02Jun2022 (10 days later) and was positive with 'allergy' symptoms returning. Continued to test positive until 14Jun2022. Never had more than mild covid symptoms. She did have nausea while taking Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
pt recvd flu vax 1991-1992;soon p/vax pt fainted & hit head (failed his bar exam several days following vax);no further details available
PE localize erythematous warm macule L deltoid tender to touch w slight induration  pcp discussed w mom that this can be a reaction to vacc or vacc components and NOT ALLERGY  to continue w RICE other conservative measures discussed analgesics around the clock x 2 days to help w pain/inflammation ibuprofen as directed advice  to rtc Mo if no changes pt and mom counseled
About 5 hours after receiving the vaccine, patient complained of pain/soreness at the injection site (left thigh), to the point where he had trouble standing. He also developed a mild fever of about 100.9 and was generally irritable and sleepy. We gave him Fever All for the fever and the fever seemed to dissipate over the span of about 24 hours after symptoms started, and the sleepiness and irritableness seemed to get better about 24 hours after the fever went away. However, patient had a very minor cough the morning before his vaccination, and that cough got much worse right after that initial 48 hours of adverse effects. At that point, he had a bad cough, sore throat, runny nose, tiredness, irritability, and a slight fever, which has lasted another 48 hours. His pediatrician believes this second round of symptoms is an unrelated cold.
Extreme fatigue (began about 11:00 pm 2/7/21 but still ongoing although lessened  Fever (began about 8:00 am 2/8/21 100.6 and with two extra strength Tylenol went to 99.6 broke in 24 hours Chills (before fever and during) All over body aches (continues but lessoned) Injection site sore (ongoing) Injection site red and itchy (2/10 at 10:00 am)