chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Missed/late menstrual cycle started in May 2021. Hair loss, hair thinning started in April 2021. Hot flashes started in April 2021
Information has been received from a nurse concerning a 21 year old female who on 10-JAN-2008 was vaccinated intramuscularly "in the left arm" with 0.5 mL of her first dose of Gardasil (lot # not reported). There was no concomitant medication. On 19-JAN-2008 the patient experienced hives "on her entire left arm". She took BENADRYL and the symptoms subsided in two days. On 08-FEB-2008 the patient experienced itching "at the injection site" The patient phoned the office to report both episodes. At the time of this report he outcome of the itching was unknown. Additional information has been requested.
Tingling in injection arm, fingers; tingling in face; tongue swelling 30 minutes- 1 hour after vaccine.  Visited immediate care; received IV of Benadryl, Pepcid & Steroid.
Headache; Significant increase in pain; This is a spontaneous report received from a contactable consumer, patient. A 54-years-old male patient received 1st dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6955) to arm left on 17Mar2021 at 12:30 as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, spinal stenosis, spinal osteophytosis, chronic pain, hypertension and obesity. Relevant past drug use included Penicillin, Tetracycline and unspecified Sulpha drugs for an unknown indication from an unknown date and experienced drug allergy. Concomitant medications included Ibuprofen (MANUFACTURER UNKNOWN) and Acetaminophen (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 17Mar2021 at 19:00, patient experienced significant increase in pain and headache. The patient stated that, he experienced a significant increase in pain in existing injuries and a headache within 7 hours of the dose and that's continued for 3 days. Pain levels were gradually decreasing at the time of the report. The patient reported that he did not receive any treatment for the events and did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. It was also reported that the patient was not diagnosed with COVID-19 prior to vaccination and since vaccination, patient was not tested for COVID-19. The clinical outcome of the events significant increase in pain and headache were resolving at the time of report. No follow-up attempts are needed. No further information is expected.
FEVER, FATIGUE, SHORTNESS OF BREATH, ACUTE CYANOSIS WITH RESPIRATORY FAILURE REQUIRING INTUBATION (SUCCESSFULLY EXTUBATED 2/17)
Pt with numbness, tingling in right arm and leg within an hour of the vaccine administration.
Patient experienced peripheral artery disease; asthenia; This spontaneous case was reported by a physician and describes the occurrence of ARTERIAL DISORDER (Patient experienced peripheral artery disease) and ASTHENIA (asthenia) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTERIAL DISORDER (Patient experienced peripheral artery disease) and ASTHENIA (asthenia). At the time of the report, ARTERIAL DISORDER (Patient experienced peripheral artery disease) and ASTHENIA (asthenia) outcome was unknown.        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.   No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-229920 (Patient Link).
Patient was given a varicella with and an  MMRV vaccine, instead of an MMR and varicella, at the same time.  There have been no reported adverse symptoms.
This is a spontaneous report from a contactable pharmacist via a sales representative. A 67-year-old female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced cellulitis left arm deltoid muscle on an unspecified date with outcome of unknown. Sender's Comments: Based on the information currently available, it cannot be fully excluded that the vaccination with PREVNAR 13 might have played a contributory role in triggering the occurrence of cellulitis left arm deltoid muscle. More information such as medical history, concomitant medication and vaccination site are needed for meaningfully medical assessment. 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.
Staff person received flu vaccine and approx. 2 1/2 hrs later c/o fatigue pain in neck in upper chest and felt SOB appeared anxious. P130-140, R 20 then fewlminutes later c/o numbness and tingling in fingertips skin normal color and temp. Observation only in ER. Tx with Benadryl po IV and 25 mg po Q 6 x 48 hours at home.
sick; not feeling well; I had a feeling of "intoxication", which included sporadic slurred speech and heaviness in legs and feet.; I had a feeling of "intoxication", which included sporadic slurred speech and heaviness in legs and feet.; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration on 24Mar2021 at 12:45 PM (at the age of 54-year old), as 2nd dose, single, in right arm for COVID-19 immunisation and received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248), via an unspecified route of administration on 03MAR2021 at 16:45 (at the age of 54-years old) as 1st dose, single in right arm for COVID-19 immunisation at Workplace clinic. The patient's medical history included uterine cancer and bipolar 2. Concomitant medications received within 2 weeks of vaccination included oxycarbaxepine, alprazolam, quetiapine, lorazepam, D-amphetamine, vitamins D3 and biotin. Patient had no allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, approximately 7 hours following vaccination, the patient had a feeling of ''intoxication'', which included sporadic slurred speech and heaviness in legs and feet. Symptoms resolved within 24 hours. After first vaccination, patient had a feeling of ''euphoria'' SUPER HUMAN and was able to complete very difficult CrossFit moves in the gym, which she was never able to complete for the past 6 years. First vaccine event was not reported because it was a positive event and not an adverse event, but now patient wondered if there was a connection between her reactions to both vaccines, or possibly an interaction with her concomitant medications. There was no treatment received for the adverse events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Upon FU received on 06Apr2021, patient reported to be too sick and upon FU received on 09Apr2021, patient reported that he was still not feeling well, but still alive.  No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm was swollen a little bit), PYREXIA (fever), AGEUSIA (No sense of taste) and ANOSMIA (No sense of smell) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE SWELLING (arm was swollen a little bit) and PYREXIA (fever). On 16-Jan-2021, the patient experienced AGEUSIA (No sense of taste) and ANOSMIA (No sense of smell). On 15-Jan-2021, VACCINATION SITE SWELLING (arm was swollen a little bit) and PYREXIA (fever) had resolved. At the time of the report, AGEUSIA (No sense of taste) and ANOSMIA (No sense of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.
Swollen, red, very warm to touch, painful when sun shines on it and headaches.
no adverse effects; received an expired dose of PROQUAD; This spontaneous report was received from a nurse referring to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 05-APR-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) injection (0.5 ml, lot#: U029296, expiration date: 19-MAR-2023; strength, route of administration, and anatomical location were not reported) with sterile diluent for prophylaxis (expired product administered). No adverse effects were noted (no adverse event).
1915 c/o itchiness, VS HR 76 RR 14 B/P 106/68, no difficulty breathing, able to talk. Observed until 1955 and released with instructions to take BENDARYL 50-100mg as directed. OTC medication for age and weight, take by mouth, parents verbalize understanding and agree to comply, phone # given for follow-up, 2115 contacted parent via telephone. He indicated that patient reports feeling better; itching decreased, no rash or hives no difficulty breathing. Parent sts 2 tabs BENADRYL given to patient - total dose 50mg. Recommended to cont. to observe for further reaction, if symptoms persist in AM to contact primary physician, parent agreed.
Pneumovax given 8/23/2001. Complained of swelling, itching, painful left arm on 8/24/2001, 10 by 10cm erythematous raised area, warm tender. Diagnosis possible early celluitis. Given ice packs, QiD for 24 hours then warm compress, hydroxyzine 25mg TiD, TMC cream, Keflex 500mgTID for 7 days.
Sore arm; not body ache so much anything like that just it really tired/ Tiredness; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "not body ache so much anything like that just it really tired", "Sore arm"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "not body ache so much anything like that just it really tired", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "not body ache so much anything like that just it really tired/ Tiredness".  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352612 same patient, different dose/event;
sore arm; tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (tired) outcome was unknown. Not Provided          No concomitant medication were reported  No treatment medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow up received on 05-Nov-2021 contains no new information.
Narrative: Patient received Moderna Covid vaccine #1 on 1/15/21. On 2/1/21, he called his primary care clinic and per notes he was very anxious and had reports of thinking he had a liver stone, white stools and that he was not eating. Per nursing notes, he was unable to stay on the topic at hand and he was urged to go to the emergency room. No scanned records to indicate if he did so. The next note is on 2/16/21 in which the police called his primary care clinic to report that neighbors called them as they had not seen patient for several days. The police were able to gain access to his home and he was found deceased on the floor. Per notes they do not suspect foul play and no trauma was noted. Unclear if an autopsy was done or not. Time from vaccine to date of death is approx. 30 days.
As I woke the following day- I experienced a sore arm at shot site. I had a headache which I took Tylenol for. I also had body aches. Later in the day I felt more tired than usual and feel asleep on and off.
Adverse Event : shaking and shivers with complaints of mild breathing problems. was cognizant and responsive to questions. 911 was called and the EMT arrived at 12:10 PM and took over treatment. Patients wife commented that these symptoms have happened in the past with Xanax and when I asked what the treatment was she replied, " they sat in the emergency room and they observed him for 2 or 3 hours and then the adverse event dissipated." Once the EMT arrived they took him to the hospital.
Patient came to the pharmacy this morning and asked if we had the covid-19 vaccine. We told him we had the 3 available vaccines and patient stated he wanted to get the Pfizer vaccine. Patient came back at 4pm for the vaccine. He filled out the consent form, and was reading the VIS dated 08/12/2021 that I gave him all while I  prepared the vaccine. He is a patient of ours and I have on file that he has no known allergies, but I asked him before administering the vaccine to reassured.  I also verified he never had a reaction to a previous vaccine. I also asked,  Patient you did not get any prior dose of the covid vaccine? He said no, I have not. He waited the 15 minutes, we talked about the 2nd dose timeframe and I gave him the card. Patient left. I opened SHOTS to report it and found out patient had both doses of Pfizer covid vaccine on April 7 and April 22, 2021. I called the patient twice and  left a voice message. He has not returned the call. I also contacted his PCP and let her know. I called SHOTS for guidance on how to report this erroneous dose but it is after hours already.
swollen face; face redness; Urticaria; Rash; Fatigue; Pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swollen face), ERYTHEMA (face redness), URTICARIA (Urticaria), RASH (Rash) and FATIGUE (Fatigue) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives (Itchy hives) and COVID-19 in November 2020.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (Fatigue) and PYREXIA (Pyrexia). On 03-Mar-2021, the patient experienced URTICARIA (Urticaria) and RASH (Rash). On an unknown date, the patient experienced SWELLING FACE (swollen face) and ERYTHEMA (face redness). At the time of the report, SWELLING FACE (swollen face), ERYTHEMA (face redness), URTICARIA (Urticaria), RASH (Rash), FATIGUE (Fatigue) and PYREXIA (Pyrexia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.   Concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Headache, upset stomach, shakes, chills and feverish feeling, overall fluish feeling, lightheaded, chest discomfort, pain and hot feeling at injection site.
Started with extreme soreness at the injection site and in my underarm.  As the day went by, I started to have body aches all over while I was at work.  By after 11 am body aches had gotten very bad, sort of felt like it feels when one has the flu, but without the nausea.  Sore all over and sensitive to touch.
The injection was given with a 5/8 needle which is not IM as I am a 165 lb adult.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EA6206), in left arm, on 30Mar2021 as dose 2, single (Lot number: ER8730), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: EW0180), in left arm and on 17May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BENZONATATE, start date: 18Sep2022, stop date: 27Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: treatment of COVID-19; (23Sep2022) Negative, notes: home test; (30Sep2022) Positive, notes: home test. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 18Sep2022 to 22Sep2022.
received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported. Date of refrigeration on 07May2021.
tinnitus; This is a spontaneous report from a contactable physician. A 77-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN, not available/provided to reporter at the time of report completion) via an unspecified route of administration on an unknown date (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date the patient experienced tinnitus. The clinical outcome of the event tinnitus was unknown at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained. No further information is expected.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 23-JUN-2016 the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # L003218, expiration date 30-APR-2016, strength and route were not reported). No adverse effects were reported. Additional information has been requested.
The day following the vaccine I experience headache, dizziness, elevated temperature, sweats, fatigue. These symptoms were better on day 2 follow the injection. However, on day 3, today, I still get sporadic pains in my head. They are uncomfortable and  concerning. What could be happening....They are bothersome hence I am reporting them to VARS.
Redness in the side of the arm, Itchy, generalized rash, lesions in all body. amygdalitis , dysfonia.
Lethargy; Fever; Joint pain / Her joint pain was in / knees and fingers; Her joint pain was in her lower back; Flu like symptoms; Soreness at the injection site; Tiredness; Sleepiness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number GM2Y4, expiry date 10th May 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 17th September 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 17th September 2020, immediately after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain. On 18th September 2020, the patient experienced lethargy, fever, joint pain, low back pain, influenza-like symptoms, tiredness and sleepiness. On an unknown date, the outcome of the injection site pain, lethargy and fever were unknown and the outcome of the joint pain and low back pain were not recovered/not resolved and the outcome of the influenza-like symptoms, tiredness and sleepiness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, lethargy, fever, joint pain, low back pain, influenza-like symptoms, tiredness and sleepiness to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix and flu vaccine on same day and right away experienced soreness at injection site. The next day after vaccination experienced lethargy, fever, joint pain in lower back, knees and fingers. The patient was using heating pads for soreness and saw primary care physician.. The flu like symptoms resolved but it took 3-4 days for tiredness and sleepiness to resolve. The reporter mentioned that, patient was inquiring about the relationship between getting shingrix and the side effects. The reporter consented to follow up.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot #, expiration date, dose and route not reported). The doses of vaccine were improperly stored at 8.5 degree Celsius for 1 hour. Data logger was involved. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.