chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced racing heart rate (120 bpm resting), mild chest pressure, moderate fever (102 F), chills, nausea, headache, injection site soreness, and left arm lymph node soreness.  Rested, and most symptoms subsided over night.  Heart rate still slightly elevated (100 bpm resting) with occasional chest pressure.
Hearing loss; Tinnitus/constant ringing in the ears; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via unspecified route of administration in left arm on 03May2021 (lot number: EW0153) at single dose for COVID-19 immunization. The relevant medical history included ongoing high blood pressure (had for 6-7 years), ongoing thyroid problems from 2012, acute asthma from unspecified date, she is overweight from unspecified date. Concomitant medications included unspecified medications. She was on 7-8 different medications. They were maintenance and blood pressure medications. She was on blood pressure medication because she was overweight. She was trying to get off of it. She was not on anything for diabetes or cancer. The patient previously received the first dose of BNT162B2 (Lot Number: ER8732) on 12Apr2021 at the age of 44 years old for Covid-19 immunization and experienced tinnitus. The patient had received both doses of the Pfizer Covid 19 vaccine. She reported after receiving the first dose of the vaccine on 03May2021 (as reported) she had severe tinnitus and hearing loss and constant ring in the. She stated that at first she had a few episodes and didn't know what it was. It got a little better and then she got the second dose and it has gotten worse after that. She thought she was now at a plateau. She clarified that she received the first dose on 12Apr2021. The tinnitus started the next day and had worsened since the second dose. The hearing loss started after the second dose. She received the second dose on 03May2021. The hearing loss started in May2021, a week or two after getting the second dose. She added that she saw her doctor and he mentioned that he saw lots of patients that their blood pressure and hearing were affected. Her doctor didn't know what to do. The doctor was still documenting what his patients were telling him. She saw the doctor on Friday. He did a full blood work panel including a CBC, metabolic panel, thyroid panel. She had a full blood work panel since she had had issues. She wanted to make sure there was nothing in her blood that was alarming other than the hearing loss and tinnitus. They called this morning and said everything was normal and to report it and she could go to a specialist if she wanted to. The patient who had received both doses of the Pfizer BioNTech COVID-19 vaccine and stated that she would like to report an adverse event. She did not have the precise dates of vaccination but mentioned that she received the first dose of the Pfizer BioNTech COVID-19 vaccine on 03May2021 (as reported). She mentioned having developed severe tinnitus, hearing loss and constant ringing in the ears since receiving the Pfizer BioNTech COVID19 vaccine and would like to report it. She did not have a request. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Pt reports redness that progressed over a 4 day period that covered the deltoid to the tricep/bicep region. The day after the shot pt had about a baseball sized knot at injection site. He states there was no pain but there was heat/fever among the red area. All symptoms subsided by 1-9-18.
Patient called clinic COVID Hotline and reports: she had her second covid shot on 4/29/21. States about 5 hours after the shot she had bilateral leg pain and numbness in her toes. It has still not improved as of today. Is able to walk but feels like she has to move slower. Denies redness/streaking, swelling, hot to the touch or SOB. Has not taken anything for the pain as due to health hx she isn't suppose to take OTC pain meds. Has tried heat, ice and warm baths with no improvement. Information forwarded to PCP, who recommended completing report.
Fever up to 101.4 Nausea Fatigue Night sweats  Chills Body aches
Information has been received from a medical assistant, referring a patient of unknown age and gender. Information on medical history, concomitant medications and drug allergies was not provided.   On an unknown date, the patient was vaccinated with a dose of improperly stored PROQUAD (lot# M039448, expiration date 20-MAR-2018) for prophylaxis (dose and route of administration were not reported). The temperature of storage for PROQUAD was above -10 Celsius and below 8 Celsius for 1 hour and 2 minutes (2 excursions). A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA011638: US-009507513-1706USA000480: US-009507513-1706USA000482: US-009507513-1703USA002284: US-009507513-1706USA000487: US-009507513-1706USA000488: US-009507513-1706USA000489: US-009507513-1706USA000490: US-009507513-1706USA000491: US-009507513-1706USA000492:
administered with only the AS01B adjuvant of Shingrix.; administered with only the AS01B adjuvant of Shingrix.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 7C483, expiry date 14th November 2022) for prophylaxis.   On 24th September 2021, the patient received Shingrix. On 24th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional information was provided as follows: The nurse practitioner reported that a female patient was administered with only the AS01B adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is 1 of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021206993:same reporter US-GLAXOSMITHKLINE-US2021206991:same reporter US-GLAXOSMITHKLINE-US2021206990:same reporter
Swelling of lower lip on the left side/ upper left lip swelled; Overnight "I" was awoken by a torturous rash; Urticaria; Itch; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 09Apr2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 12Mar2021 at 19:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation and the patient was fine on the first shot. On 09Apr2021, after the second vaccination, the patient was awoken overnight by a torturous rash, which appeared to be urticaria and included swelling of her lower lip on the left side. After looking online, the patient took Benadryl, which helped the itch and took subsequent courses of Benadryl throughout the day. The next night, the patient's upper left lip was swelled. For the next 10 days, the rash would come back upon her rising, though it was not nearly as severe as the initial one. There was no itch for 2 days, then the last night (on 20Apr2021), the rash came back at what the patient could say was 70 percent of the original rash. The patient took Benadryl, but it took far longer to take effect than it previously had. The patient had no additional lip swelling after the first two events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling of lower lip on the left side/ upper left lip swelled was resolved on an unknown date in Apr2021. The clinical outcome of the events overnight "I" was awoken by a torturous rash, urticaria and itch was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Many years after vaccine with no history of chicken pox illness,  pt developed classic appearing shingles at great toe. Confirmed by another physician, responded Acyclir.
Patient received Pfizer vaccine as her 3rd booster dose instead of Moderna, which was the original series that she completed.
Approximately 30 minutes after receiving my 3rd vaccination (booster dose), I began to experience strong pain in my two upper rear molars on the left side of my mouth. Inflammation of my gums was slightly noticeable. A few days later, I developed mouth ulcers across the roof of my mouth for no reason.  The ulcers lasted about 10 days and were very painful. Salt rinses were done daily to keep them from becoming infected. The tooth pain has continued daily since my booster. I am currently taking Advil's and Tylenol daily to manage the discomfort. The pain varies and the gums do not seem infected. Teeth are not loose. I am seeking medical attention from my dentist this week.  Within an hour of my 3rd vaccination (booster dose) I experienced the same strong, sharp chest pain as I noticed in my 2nd dose. It only lasted about an hour at the time, but since that event I have experienced the chest pain several times a week with no warning or discernible reason. I will be reaching out to a doctor for assistance this week. I am no longer with this facility for health care.
12/27/20 - Presented to urgent care with Nausea, swelling on face and hands, SOB.  Was given dose of SoluMedrol 125mg and sent to the emergency room.  12/27/20 Presents feeling sick, body aches, chills, nausea, rash and vomiting.  SOB better.   Given Zofran and IV fluids in ER.  D/C home with prednisone and Zofran.   D/C dx:  Acute allergic reaction, Nausea and vomiting
(LOT#: FF8839) received 2nd dose of Pfizer on 9/25/21. Patient alerted nurse  at 0915 while getting vaccinated that he felt lightheaded. Patient was given a juice and nutrigrain bar. Patient stated that the same thing happened to him when he got the first dose but it was sudden and symptoms subsided within 10 seconds. EMT  took patient pulse. HR: 53. PHN  recommended that patient stay for an extra 30 minutes for observation. Patient agreed to stay. Patient was also given an ice pack to help cool down. Patient was diaphoretic. EMT  took patients vital signs at 0923. BP: 132/82, HR: 79, 02: 98%. Patient stated that he did not eat breakfast and that he came straight from work. EMT  assessed patient. Patient stated that his dizziness was at a 3/10 and his symptoms were getting better. EMT reassessed and retook patients vital signs. BP: 132/86, HR: 86, O2: 100%. Patient stated that ate yesterday at 5:00pm and has no water since. Patient was given another nutrigrain bar. Patient finished both nutrigrain bars and water provided to him. At 0930 patient stated that his dizziness is at a 0/10 now and was not nauseous. EMT observed that patients skin was warm and dry. At 0933 EMT  reassessed and retook patients vital signs. BP: 142/78. HR: 66. Patient stated he was feeling a lot better. EMT  reassessed and retook patients vital signs at 0940. BP: 142/78, HR: 83, O2: 99%. Patient stated that his symptoms were completely gone 0/10 on lightheaded/dizziness. EMT reassessed and retook patients vital signs. BP: 144/84, HR: 64, O2: 100%. Patient stated he did not feel any other symptoms 0/10 lightheaded/dizziness. At 0948 PHN educated patient about high blood pressure and to make an appointment with PCP. Patient verbalized understanding and agreed to making appt with PCP regarding blood pressure. PHN  educated patient on side effects of COVID vaccine and when to call EMS. Patient verbalized understanding of education.
Pt called 10/18 both migraine - body stiffness since flu shot given on 10/14
pt recvd vax; pt's daughter reported, pt adm to hosp 1 wk later w/ dx of GBS;
VARIVAX was stored improperly. Unknown if MERCK STERILE DILUENT that was used to reconstitute VARIVAX was properly stored; No adverse effects reported; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R024144 with a expiration date on 23-AUG-2020, subcutaneous for prophylaxis (dose was not reported) that was reconstitute with a sterile diluent(MERCK STERILE DILUENT) that was unknown if it was properly stored. The administered dose of the vaccine experienced a temperature excursion of -13 degrees Celsius for 5 minutes. There was no adverse effect reported.  This call was because of a data logger.   No product quality complaint was involved.
8JAN95 pt recvd vax & 21FEB85 cerebral hemmorrhage sudden onset; adm to hosp
WITHIN 5 MIN OF RECEIVING VACCINE- BEGAN TIGHT COUGH"TICKLE" COUGH, THROAT ITCY, PROGRESSED TO FACIAL REDDNESS, HIVES TO FACE, THROAT, NECK, CHEST- PROGRESSING TO SCALP.  EMS IN ATTENDANCE AT OBSERVATION AREA- ADMINISTERED 25MG BENADRYL.  CLIENT SELF ADMINISTERED PERSONAL ALBUTEROL INHALER- 2 PUFFS.  VITALS MONITERED- WNL.  AMBULANCE TRANSPORT NOTIFIED AND TRANSPORTED.
Itchy rash which lasted a month. Started at my neck and went down my back and around my ribs.
runny nose, headache that increased in intendsity over 2 days, Body aches by 3rd day of symptoms with c/o malaise
Should have been a half dose because the patient is not immunocompromised/full dose booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Should have been a half dose because the patient is not immunocompromised/full dose booster) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     It was reported that patient has never been diagnosed/tested positive for Covid-19. The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Tuberculosis (when he was 3 to 4 years of age.). Concurrent medical conditions included Seasonal allergy.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (Should have been a half dose because the patient is not immunocompromised/full dose booster). At the time of the report, ACCIDENTAL OVERDOSE (Should have been a half dose because the patient is not immunocompromised/full dose booster) outcome was unknown.            The patient was on unknown concomitant for cholesterol. No treatment medication were provided. The patient was wondering if he should refrain from getting the 2nd booster dose and also asked whether second booster shot affect those patients who received full booster dose.   This case was linked to MOD-2022-533792 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow up contains no new Information.
eat an abnormally large dinner; single episode of vomiting; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERPHAGIA (eat an abnormally large dinner) and VOMITING (single episode of vomiting) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 HYPERPHAGIA (eat an abnormally large dinner) and VOMITING (single episode of vomiting). At the time of the report, HYPERPHAGIA (eat an abnormally large dinner) and VOMITING (single episode of vomiting) 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 considered VOMITING (single episode of vomiting) to be not related. No further causality assessment was provided for HYPERPHAGIA (eat an abnormally large dinner).    No concomitant medications were reported.   It was reported that in the evening after vaccination, the patient had a single episode of vomiting. He had no other symptoms after that, and he was not fussy and he was afebrile. The patient did eat an abnormally large dinner and the vomiting occurred immediately aft receiving warm milk prior to bedtime. The patient's pediatrician was informed, who felt that the vomiting was unlikely related to vaccine.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-608437 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-608437:(Same reporter)
Information has been received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II; (lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several  reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Nausea, vomiting, dizziness, chills, body aches, hives on right leg
"Pfizer-BioNTech COVID-19 Vaccine EUA" My left arm/shoulder had pain shortly after the vaccination.  Tha pain has been there since day one (1).  I have not been able to raise my arm above my shoulder level without pain. It has been difficult to perform a number of daily activities.
sore arm; horrible headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (Lot number: EL9267) as dose 1, single and administration date 06Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Acne" (unspecified if ongoing), notes: Verbatim: Acne; "Acid reflux (esophageal)" (unspecified if ongoing), notes: Verbatim: Acid reflux (esophageal); "Birth Control" (unspecified if ongoing). Concomitant medication(s) included: TRI-SPRINTEC taken for contraception; CALCIUM; PEPCID [FAMOTIDINE]; SPIRONOLACTONE taken for acne. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "horrible headache". Therapeutic measures were taken as a result of headache with 3 Aleve and a Tyleno.  Additional information: With the first dose the caller had a sore arm, but she got that with all of them, and then she had a horrible headache. Earlier that day the caller went on a run before that but she doesn't know if that had anything to do with it. The caller tried to knock it back with 3 Aleve and a Tylenol but it was a hard night.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
both legs became hot and shaky; both legs became hot and shaky; Elevated blood pressure for 3 days following vaccine; This is a spontaneous report from a contactable other HCP.  A 36-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1283), intramuscular on arm left from 16Jan2021 10:30 to 16Jan2021 10:30 at SINGLE DOSE for covid-19 immunisation.  Medical history included birth control implant. Concomitant medication included etonogestrel (NEXPLANON) for birth control implant. The patient previously took zithromax and experienced Known allergies: Zithromax. On 16Jan2021 10:30, within 2 minutes of vaccine, both legs became hot and shaky. Elevated blood pressure for 3 days following vaccine. Will continue to track bp (blood pressure). The patient underwent lab tests and procedures which Nasal Swab: unknown results (pending results) on 19Jan2021. Outcome of the events was recovering.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 96 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Next day after flu shot pt got a hematoma in his arm muscle the size of an orange. Pt went to urgent care Sunday 9/13/13/ and Dr. (PCP) on Mon 9/16/13. Pt had 2 previous hematomas this year and his COUMADIN contributed to it. After few days swelling subsided. Still black and blue sore and swollen 10 days later.
Client rec'd her vaccination on 04/09/2021. Approximately 2 weeks later, family states client started to not "feel well." Patient had leg pains and fatigue, as per family. On Saturday, May 8th, client drove her self to the ER, due to worsening symptoms of cough, leg pain, and shortness of breath. Client was evaluated in the ER and evaluation showed clots in bi-lateral lungs and lower legs. Surgery was performed to remove clots in lungs. Client was admitted. On 5/9/2021 client was intubated, and had an ECMO procedure. Client i remains in the hospital.
This case was reported by a healthcare professional and described the occurrence of erythema of arm at injection site in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 November 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route, unknown arm). In November 2011, less than one week after vaccination with FLULAVAL, the subject experienced erythema of arm at injection site, arm swelled at injection site, arm pain at injection site and arm warm at site of injection. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported events for this female, another female and herself with FLULAVAL. See cases A0953236A and A0953274A for details regarding the other cases.