chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Radiating pain from injection site (L Shoulder), to L cheek, jaw muscles sore and neck muscles sore.  Pain spread to gums and teeth on L side from 1 hr post injection to 18 hours post injection.
extended menstrual cycles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM. Vaccination history included: Bnt162b2 (Dose1, single), for COVID-19 immunization. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 06Dec2021, outcome "recovering", described as "extended menstrual cycles". The event "extended menstrual cycles" was evaluated at the physician office visit. Therapeutic measures were taken as a result of oligomenorrhoea with Progesterone.  Additional information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
First sign of a symptom, was that night - at 07:00 or 08:00 - I was very hot, mild headache; and then during the night I had muscle aches, headache, extreme fatigue, and nausea (I vomited once) and I spiked a fever - the highest my temperature got was 103.7. All of these symptoms lasted for three days. I took Tylenol and ibuprofen - whenever one of these would wear off my fever would spike back up. I had all these symptoms on the 2nd, 3rd, 4th (fever finally broke into the morning of the 5th). On the day of the 5th, I started feeling better - but wasn't 100%  myself until after the 8th. I went back to work on the 8th but I was still very weak, shaky and fatigue that morning.  I took an OTC cold medication and I took Zofran as well - (one Zofran on one of the days). I was out of work for that entire week with that exception of the day that I received the vaccine on the 1st. I did not get a rash. I was in contact with my occupational health to report on the app.
My first period, post covid vaccine wasn?t anything like my periods have been since I started my period when I was 16. My periods have stayed consistent every month for years. The first day was always fairly light, second day I would say medium heavy, I never wore anything large than a regular tampon. Then each day I would bleed less, and less. My period would last 5 days. My first period after the covid vaccine and every one since then has been completely different. The first day is fairly light, the second, third, and sometimes fourth day I use a super tampon and a thick pad. I have to change both at least every hour or I bleed through. When I say bleed through, I mean LOTS AND LOTS of blood, enough to saturate my pants. I have also noticed some decent size blood clots. I usually get kind of light headed and very drained.
Patient describes rapid heartbeat and severe exhaustion starting a few hours after receiving the vaccine.  Symptoms lasted until Sunday evening, gradually dissipating over the course of the couple of days.  Patient had an appointment with MD on the following Monday and mentioned it to her but symptoms had resolved by then and she states that md wasn't overly concerned
Myalgia, Arthralgia, Fever, UrticariaPruritus, Lethargy,chills , soreness at injection site Narrative:  Other Relevant History:
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). On 08-JAN-2018, the the patient was re-vaccinated with a dose of VAQTA dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001550: US-009507513-1806USA001551: US-009507513-1806USA001552: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001555: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1806USA001561: US-009507513-1806USA001547: US-009507513-1806USA001548: US-009507513-1806USA001549: US-009507513-1710USA003103:
Narrative:  Patient did not receive the COVID-19 vaccine from our facility. He received his first dose on 12/26/20 and second dose on 1/23/21. On 4/18/2021 he tested positive for COVID-19.
Fully vaccinated with COVID breakthrough ASYMPTOMATIC infection with inpatient hospital stay.    Boosted on 11/12/21.
About a week after first shot, I started experiencing burning waves in my right leg below the knee.  The wave would start on the top of the calf and flow down to bottom of calf.  The burning feels like I?ve stepped too close to a camp fire so it is more surface burning than deep.  It waves periodically through the day and can occurs 2-3 times/ hour.
This literature report concerns a series of 10 fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults and 1 elderly. This case (9 of 10) concerns a 61-year-old male patient, who had a medical history of hypertension, diabetes, peripheral vascular disease and end stage renal disease. The patient died of cardiac / respiratory arrest and gram-negative sepsis, 13 days after H1N1 vaccination (type: monovalent, inactivated, split-virus or subunit vaccine; manufacture: unknown). Reporters comments: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant underlying illness (including illness that might be indication for vaccination) was present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths await review of final autopsy results or death certificates by CDC (Centers for Disease Control).
At 11:30pm I started shaking uncontrollably which lasted for nearly an hour (my husband thought I was having a panic attack, but I told him no it wasn?t stress) - (the only time I had a panic attack was as a teenager from a roller coaster and just once).   In addition to the shaking, I ran a fever of 102 F, and my heart began racing - my husband is an RN and he checked my blood pressure which was normal and my heart rate which was 122 ( normal for me is about 72). Until about 6am my heart continued to race, and even with Advil and Tylenol my fever didn?t stop until  the next morning.    The next two days I felt pretty beat up, had a headache, and have been very tired.
Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient got the first Shingrix dose a few months ago and had experienced a sore arm. The case has been linked with the case US2020AMR199588 reported by same reporter.
On 12/10/21, 2 days after vaccine, around 2:00 pm the patient's mother noticed drooping of the right side of the patient's face and that he could not close his right eye.  He was taken to the ER around 05:00 pm.  He was dx with Bell's Palsy.  He took a course of Acyclovir and Prednisone.  At the time of this report, 1/4/22, the patient's symptoms have largely improved.  He continues to have some right sided facial weakness.
Covid test post vaccination: covid test date=16May2022, covid test result=Positive; covid_test_post_vaccination: covid_test_date=16May2022, covid_test_result=Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 31-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 22Mar2021 as dose 2, single (Lot number: EL3247) and on 07Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 16May2022, outcome "unknown", described as "Covid test post vaccination: covid test date=16May2022, covid test result=Positive"; VACCINATION FAILURE (medically significant) with onset 16May2022, outcome "unknown", described as "covid_test_post_vaccination: covid_test_date=16May2022, covid_test_result=Positive". The patient underwent the following laboratory tests and procedures: Body temperature: (16May2022) 102, notes: High; SARS-CoV-2 test: (16May2022) Positive, notes: COVID test post vaccination COVID  test type post vaccination=Nasal Swab,. It was unknown if therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events vaccination failure and Covid 19  cannot be completely excluded.
At 1305, 49-year old female received her first flu vaccine and was directed to the fifteen minute observation area to sit. Approximately ten minutes after the flu shot, patient reported feeling "whoozy". Patient's legs were elevated and vital signs were taken. BP 210/112 (RA) 192/98 (LA), HR 88, Respiration 16. Patient was negative on the Cincinnati Stroke Scale. Patient was also negative for the following: chest pain, dyspnea, urticarial, dizziness. Patient's skin pink, dry, warm, normal. Pupils PERRLA. Patient's vitals were re-assessed at 1317. BP 174/80 (LA) 170/84 (RA). At 1324, patient's BP 162/82 (LA) 166/84 (RA). Patient's primary care MD was contacted with the patient's consent, and patient was able to make an appointment for the afternoon.
Similar reactions to first dose, but accelerated and more intense. About 2 minutes after injection, burning at site lasting about three minutes. About 10 minutes after injection, numbness of left hand lasting about one hour. About 12 hours after injection, soreness of left arm lasting about 24 hours, and chills. About 24 hours after injection, noted body temperature about two degrees above usual (thermometer runs low). Lowered one degree the next day.
Approximately 15-20 minutes post-injection I started to feel lightheaded, dizzy, shaky and increased heart rate. This was swiftly followed by a feeling of tightness in my throat, shortness of breath, and coughing. In addition I had a moderate to severe headache. The hospitals rapid response team was called and I was brought to the emergency department on-site. I was given a racemic epinephrine and albuterol neb treatment which resolved upper airway stridor and cough. I received PO Benadryl, Pepcid, and Prednisone. A EKG was completed. I was observed in the emergency department for about 2 hours until discharge. I was discharged with prescriptions for an Epi-Pen, Prednisone, and Pepcid. The diagnosis on my after visit summary was: Allergic Reaction. I was unable to finish my scheduled shift as an RN.
The pt developed itchiness, rubor and an erythematous lesion at the site of the injection. Treated with 250mg Solu-Medrol injection (IM).
Booster; blood clots in both lungs; blood clots in both lungs and legs; face redness; Face swelling; dizziness; short of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "Booster"; PULMONARY THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "blood clots in both lungs"; THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "blood clots in both lungs and legs"; ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "face redness"; SWELLING FACE (non-serious) with onset 2021, outcome "unknown", described as "Face swelling"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "short of breath". The events "blood clots in both lungs", "blood clots in both lungs and legs", "face redness", "face swelling", "dizziness" and "short of breath" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) negative x 2. Therapeutic measures were taken as a result of pulmonary thrombosis, thrombosis. Clinical course: With booster, the patient had some side effects immediately. Fortunately, the patient went to ER. The patient had no preexisting condition nor genetic cause for this and believed in the vaccine but would not want to die from it. Now the patient was on blood thinners for the rest of life as a precaution.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Vaccine expired 10/31/22 and was given 11/01/2022, the patient has not had any complications post vaccine.
Initial information received on 20-Aug-2018 in the regarding an unsolicited valid non-serious case received from a nurse. This case involves an 18 years old male patient who was vaccinated with a 0.5 ml second booster dose of MENACTRA (Lot number: U5916AA; expiry date: 27-Jun-2019) via intramuscular route in the left deltoid on 15 Aug 2018. The patient was also vaccinated with a booster dose of MENACTRA on 04-Jun-2018 at another healthcare professional. It was also reported that patient received his first dose of MENACTRA on 02-May-2011. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no concomitant medications. It was a case of actual medication error due to extra dose administered. There were no signs of adverse reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
low grade fever, fatigue, shaky , weak, nausea , fever 99. ,eyes swollen, Taking advil and apap every 4 hours, ears ringing
Tingling/numbness of lips, tongue and Area surrounding mouth 15 minutes after injection.  Swelling of right upper lip Confirmed in car mirror at 20 minutes.   Returned to employee clinic and was evaluated by MD, escorted to ER.  Was giving Benadryl and 2 hours later was given prednisone 40mg.  Was sent home with 3 day course of prednisone and was told to take Benadryl before bed and prn.
Two vaccines administered on same day.  Fever, muscle ache, headache and exhaustion began approx. 12 hours after administration and lasted approx. 12 hours.   Fever broke approx. 12 hours after symptoms began.
Fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FATIGUE (Fatigue) in a 66-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to event was not applicable.   This case was linked to MOD-2021-088825 (Patient Link).
patient received 2 vaccines in same arm and reported one was too high and had severe pain in shoulder went to dr and she stated that he did receive vaccine too high and to report incident
pt was given a shingrix shot 6/20/22 in her left arm.  Pt stated she had a sore arm 6/20, 6/21, and 6/22,  By 6/23 she developed a 3" band of itchy bumps around her arm.  When she came to the pharmacy, they appeared swollen welts
Shoulder pain; Can't move arm; A spontaneous report was received from a consumer concerning herself, a female patient of an unknown age who received Moderna's (mRNA-1273) COVID-19 Vaccine and experienced shoulder pain and inability to move her arm after receiving the vaccine.    The patient's medical history was not provided. No concomitant medications were provided.   On an unspecified date, prior to the onset of the symptoms, the patient received their dose of mRNA-1273 (Lot/Batch number unknown) for prophylaxis of COVID-19 infection.   The patient received the vaccine and now was having shoulder pain and can't move her arm. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events shoulder pain and inability to move her arm after receiving the vaccine was provided.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-JUN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 0.5 ml (lot # K011492, expiration date 22-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 24,34 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 176, 48 and R; 48, 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of fatigue in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 25th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue, nightmare, hallucination, pain in arm and abnormal dreams. On an unknown date, the outcome of the fatigue, nightmare, hallucination, pain in arm and abnormal dreams were recovered/resolved. It was unknown if the reporter considered the fatigue, nightmare, hallucination, pain in arm and abnormal dreams to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. The patient received the SHINGRIX vaccine at a local pharmacy (different location from reporter). The patient reported 5 days of symptoms and several nights of dreams and hallucinations. The patient experienced fatigue, sore arm, nightmares, and possible hallucinations.
Expired vaccine was administered in error with no reported adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 18 months old male patient who was administered expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine [Pentacel] in error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza Vaccine (Influenza Vaccine) for Immunisation; Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar) for Immunisation; and Hepatitis A Vaccine (Hepatitis A) for Immunisation.  On 09-Dec-2022, the patient received 0.25 ml total standard dose of expired suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) vaccine Suspension for injection in error with no reported adverse event (expired product administered) latency: same day (with an unknown batch number and dose number) (Expiry date: 12-May-2022) via intramuscular route in the left thigh for immunization.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I contracted COVID-19 on 05/16/2022 with symptoms of severe headache, dry cough, runny nose, myalgia, joint aches, and fatigue. The next day I developed severe congestion, the headache would not abate, and I had a fever of 102.7, profuse sweating. Wednesday I had diarrhea, and laryngitis develop. On 05/18/2022 I was prescribed Paxlovid and my symptoms began improving. The fever, cough, joint pain, myalgia, diarrhea, and headache have resolved. I am experiencing lingering symptoms of congestion, laryngitis, and fatigue.
Extensive left lower extremity/iliac DVT requiring surgical intervention. No history of thromboses. No family history of thromboses.
Eight days following vaccination, raised red rash on arm just below injection site appeared. Rash is about 2 inch by 2 inch.
Approximately 25 minutes post vaccine pt complained of headache, nausea,feeling faint, skin pale/dry. B/P 115/67, P60.