chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lips, red rash at the edge of the lips, itchy, burning sensation for 12 days now. Using Chapsticks for 12 days now and Abreva for 2 days now.
Angiderma to head, lips, eyes, throat and hives on torso and extremities.
Extremely fatigued; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 7RK7K, expiry date 26th November 2021) for prophylaxis.   On 4th October 2019, the patient received Shingrix (intramuscular) .5 ml. On 5th October 2019, 1 days after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient got Shingrix on friday and started feeling extremely fatigued on Saturday.  The patient was still feeling the same way today. The reporter consented to follow up.  No further information was available.
11/11/21-Annual visit-He has been having some mild cough as well. His wife and son who live with him both have Covid. He has been around them about ten days and did a home test that was negative this past Sunday.
Narrative: Patient admitted to Palliative Care Unit for comfort measures for Parkinsons Disease and dysphagia. Expired 7/27/21.
Very sore arm Severe Chills Headache Fever Body Aches Light Headed Shortness of Breath
On 11/8 at 1pm, I was in the store speaking with an employee.  I lost ALL vision in right eye for approx 5-10 minutes.  When vision returned, I immediately drove to eye doctor who examined my eye, did eye scan/picture, and sent me to my PCP. It was their opinion that I had a small clot that caused visual loss.  CT was completed and is normal.  Carotid Doppler is also normal.  So far, no known cause.  This happened 9 days post vaccination. On 10/31, I developed a low fever, body aches & skin sensitivity.  I also had a momentary pinpoint flash in my right eye and for just a few seconds.  I didn?t have concern until complete loss on 11/8.
Body aches; Swollen lymph node in the underarm area, it was very tender; Lymph node slightly warm to the touch; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 08Apr2021 at 16:30 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was not allergic to any medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. It was unknown whether the patient received any other vaccines within four weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 18Mar2021 at 16:30 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. On 10Apr2021 at around 07:30, the patient woke up with body aches and a swollen lymph node in the underarm area. The lymph node was very tender, swollen, and slightly warm to the touch. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events body aches, swollen lymph node in the underarm area, lymph node was very tender and slightly warm to the touch was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Vaccines gave him a heighten sense of awareness, heighten sensitivity, a lot of energy and mental clarity; Effects were euphoric; Felt lessened energy on the morning of 04June2021.; Between the morning of 02June2021 and the evening of 03June2021, the patient did not sleep.; Sour Stomach; The patient also did not eat or drink much during that time frame.; The patient also did not eat or drink much during that time frame.; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Between the morning of 02June2021 and the evening of 03June2021, the patient did not sleep.), DYSPEPSIA (Sour Stomach), THERAPEUTIC RESPONSE UNEXPECTED (Vaccines gave him a heighten sense of awareness, heighten sensitivity, a lot of energy and mental clarity), EUPHORIC MOOD (Effects were euphoric) and DECREASED APPETITE (The patient also did not eat or drink much during that time frame.) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autistic disorder (Patient reports that he is autistic) and Autoimmune disorder NOS (Patient reports that he has had autoimmune issues his entire life.).   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced SLEEP DISORDER (Between the morning of 02June2021 and the evening of 03June2021, the patient did not sleep.), DYSPEPSIA (Sour Stomach), DECREASED APPETITE (The patient also did not eat or drink much during that time frame.) and THIRST DECREASED (The patient also did not eat or drink much during that time frame.). On 04-Jun-2021, the patient experienced ASTHENIA (Felt lessened energy on the morning of 04June2021.). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Vaccines gave him a heighten sense of awareness, heighten sensitivity, a lot of energy and mental clarity) and EUPHORIC MOOD (Effects were euphoric). On 03-Jun-2021, SLEEP DISORDER (Between the morning of 02June2021 and the evening of 03June2021, the patient did not sleep.), DYSPEPSIA (Sour Stomach), DECREASED APPETITE (The patient also did not eat or drink much during that time frame.) and THIRST DECREASED (The patient also did not eat or drink much during that time frame.) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Vaccines gave him a heighten sense of awareness, heighten sensitivity, a lot of energy and mental clarity), EUPHORIC MOOD (Effects were euphoric) and ASTHENIA (Felt lessened energy on the morning of 04June2021.) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-209325 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: FUP: new events added, medical history updated
Patient received Pfizer vaccine for 1st dose on 5/04. Patient was given Moderna vaccine for 2nd dose. Patient did not report any issues.
Initial report received from a healthcare professional via other company (GSK) on 08 January 2014. A 52-year-old male patient whose medical history, concomitant medication were reported as unknown had received a 0.5 ml dose of Influenza vaccine (lot number, dose number, route of administration were not reported) in the left arm on 16 October 2013 at around 15:00 hours. On 16 October 2013, same day after vaccination, the patient experienced sore arm. Laboratory investigation and corrective treatments were not reported. At the time of this report, the patient had not recovered. Causality as per reporter: Probable. Documents held by sender: none.
experiencing swelling; knee pain; This is a spontaneous report from a contactable Nurse. A patient of an unspecified age and gender received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 09Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that nurse calling on behalf of employee who just received the first dose of the Pfizer COVID 19 vaccine and was experiencing swelling and knee pain on 09Feb2021 and was asking this was a side effect of the vaccine. Caller stated she was a nurse on the floor and does not have time to answer questions. Stated she has called before and just keeps getting the run around and she was losing her patience. Stated she just wants to be transferred to someone who can answer her question then disconnects the call. The outcome of events was unknown.  No follow-up attempts are possible. Information on Batch number, Lot number cannot be obtained.
Sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient was feeling sick after receiving the 1st flu shot. The patient's doctor was trying to convince the patient for further doses but, the patient had made it clear that it won't happen. For the tolerance of 2nd flu shot, refer the case- US2020AMR227335.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR227335:2nd time
Redness, swelling at injection site. Also small fluid filled blister at site warm to touch, no pain, no fever, no infection.
7 days after the second Covid vaccine shot, painful burning feet woke me up in the middle of the night, it wouldn?t go away,, with pins and needles itching all day. Then again the following night (last night)  my feet burned all night.  In hindsight, I had had a very bad reaction after the second shot on 4/2 that started the night of the shot, when I woke up at 3 am feeling like my feet, legs and entire body  was burning, then Saturday I had a high fever all day, 103.8, chills, burning sensation on and off, chest pain, heart pain, which I treated first with Tylenol then Motrin. It was a horrible two nights, but by Sunday 4/4 I was fine. I have been fatigued all week but didn?t think much about it. Then Friday night into Saturday of exactly a week after the second shot, this has happened. The burning sensation on my feet is intolerable and I haven?t slept for two nights.
Within 12 hours of the shot, I've got a SEVERE headache; nausea; Shot site soreness.; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program  (patient reported for self). This is one of the two reports.  A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Oct2021 (age at vaccination not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had earlier received first dose of BNT162B2 (Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as dose 1, single for Covid-19 Immunization and experienced Severe Headache and Shot site soreness. The patient reported that, the patient just got 2nd vaccine, yesterday afternoon. Within 12 hours of the shot, patient got a severe headache, nausea and shot site soreness, within 12 hours of the shot, patient got a severe headache, nausea and shot site soreness on 03Oct2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt recvd vax & several hrs later devel several episodes of intermitant unresponsiveness w/pale to bluish color changes; also had period sof crying, irritability & swelling @ inject site; hospitalized overnoc-dx apnea; no further epiosdes; ;
The day after my vaccine,  February 4, 2021, my injection arm hurt in the morning.  At around 1:00 p.m. that afternoon, I began to notice swelling, accompanied by numbness, starting by my right nostril and migrating down toward the right side of my lip and around and under about 1/4 of my lower lip.  By 5:30 p.m. the swelling and numbness were completely gone.
Body ache; Temperature of 102°F; Chills; This spontaneous case was reported by a dental hygienist (subsequently medically confirmed) and describes the occurrence of PAIN (Body ache), PYREXIA (Temperature of 102°F) and CHILLS (Chills) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Previously had COVID-19).    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 PAIN (Body ache), PYREXIA (Temperature of 102°F) and CHILLS (Chills). At the time of the report, PAIN (Body ache), PYREXIA (Temperature of 102°F) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 °F (High) 102 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Fever and chills are consistent with the known safety profile of the vaccine.   This case was linked to MOD-2021-003029 (Patient Link).   Reporter did not allow further contact; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Fever and chills are consistent with the known safety profile of the vaccine.
Noticed a lump in my left arm about 3-4 months after the vaccine 3-4 inches below where the vaccine was administered.  There's no pain associated with the lump, but it is noticeable, and I will be going to the doctor for an exam.
unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 11 patients. This is 9th of 11 reports.   A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on Dec2020 (reported as between 17Dec2020-30Dec2020 (lot number EH9899) and in Jan2021 (between range of 07Jan2021-20Jan2021) (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks.  All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need an investigation, because they are seeing high viral loads in these individuals and symptoms. The physician reports it is not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The outcome of the event was unknown.  The patent is not in a study or program.    Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected Vaccination failure.   It is reported that COVID infection developed in fully vaccinated employee, with second dose plus two weeks, plus well over two weeks. There is limited information provided in this report.  This case will be reassessed once additional information is available.  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.,Linked Report(s) : US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
Flu vaccine administered 10/22. Next day started pain, redness and has increased in size from plum size to now size of orange with increased warmth. OMNICEF started.
Info from mom pt went to church 11AUG91, didn't feel well started breaking out in hives; high fever 103, hands were swelling & had huge hives; recvd 2 shots @ ER; dx allerg react delayed hypersensitivity;
This is spontaneous report was received from a health care professional referring to a female patient of unknown age. The patient's medical history and concomitant medication were not reported. On 30-OCT-2018 the patient was vaccinated with PNEUMOVAX 23 (Lot number and expiration date unknown) in the arm (unspecified) for prophylaxis and  at the same day the patient was vaccinated with influenza virus vaccine (unspecified) reported as  in the other arm. On an unknown date, the patient experienced redness and swelling from the injection site to the elbow (injection site swelling and injection site erythema)  in the arm where PNEUMOVAX 23 was administered. It was unknown if any treatment was given for the events. At the time of the report, the patient had not recovered from the events.. The causality assessment between PNEUMOVAX 23 and the adverse events was not provided.
Pt recvd 1st dose of Hep B vax 13AUG91; Approx 1 wk later pt devel swelling & discomfort of rt ankle; MD felt pt had bony prominence of the ankle;
No adverse event; Patient received 0.25 mL dose instead of 0.5 mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 mL dose instead of 0.5 mL dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 mL dose instead of 0.5 mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 mL dose instead of 0.5 mL dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received 0.25 mL dose instead of 0.5 mL dose).    Concomitant product use was not provided by the reporter.  Lower than authorized dose of Moderna bivalent vaccine administered to patient.  The patient received 0.25 mL dose instead of 0.5 mL dose.  The patient have not reported any adverse reactions at this time.   Treatment information was not provided.  This case contains information for the 10th of 18 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-666277, US-MODERNATX, INC.-MOD-2022-666284, US-MODERNATX, INC.-MOD-2022-666280, US-MODERNATX, INC.-MOD-2022-666278, US-MODERNATX, INC.-MOD-2022-666063, US-MODERNATX, INC.-MOD-2022-666248, US-MODERNATX, INC.-MOD-2022-666249, US-MODERNATX, INC.-MOD-2022-666250, US-MODERNATX, INC.-MOD-2022-666295, US-MODERNATX, INC.-MOD-2022-666290, US-MODERNATX, INC.-MOD-2022-666282, US-MODERNATX, INC.-MOD-2022-666281 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666284:Patient 9 US-MODERNATX, INC.-MOD-2022-666277:Patient 7 US-MODERNATX, INC.-MOD-2022-666278:Patient 14 US-MODERNATX, INC.-MOD-2022-666280:Patient 16 US-MODERNATX, INC.-MOD-2022-666063:Patient 1 US-MODERNATX, INC.-MOD-2022-666248:Patient 2 US-MODERNATX, INC.-MOD-2022-666249:Patient 3 US-MODERNATX, INC.-MOD-2022-666250:Patient 4 US-MODERNATX, INC.-MOD-2022-666295:Patient 12 US-MODERNATX, INC.-MOD-2022-666290:Patient 11 US-MODERNATX, INC.-MOD-2022-666282:Patient 18 US-MODERNATX, INC.-MOD-2022-666281:Patient 17
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.  It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed a rash on his upper arm after receiving a dose of SHINGRIX. The reporting pharmacist did not have any additional details at the moment. The call transferred to MI (medical information) to determine if the patient should get the second dose or not.
Patient felt lightheaded and passed out after he stood up right after getting the shots. Parents helped laying him down on the floor till paramedics arrived. He was alert and oriented, breaing normally by the time paramedics arrived.