chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed headaches; swelling of thyroid gland; tenderness; pain on swallowing; elevated TSH; low T3,T4 levels; low T3,T4 levels; subacute thyroiditis; This is a spontaneous report from a contactable physician (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELO142), via intramuscular route of administration on 23Dec2020 (age at vaccination: 55-years) at a single dose in the left arm for COVID-19 immunization. Medical history included Diabetes mellitus (DM) and Hypertension (HTN). Concomitant medications were not specified. The patient previously took codeine and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 27Dec2020, the patient developed headaches, swelling of thyroid gland,  tenderness, pain on swallowing, elevated TSH, low T3,T4 levels. Patient thought to have subacute thyroiditis. The events resulted to physician office visit. The patient did not receive any treatment for the reported events. The patient underwent nasal swab test on an unspecified date and showed negative result. The outcome of the events was recovered on an unspecified date.
Headache, nausea, diarrhea, chills, fever, weakness, and pain at injection site
No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant therapies were not reported.  On 11-NOV-2021, it was administered therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot number T033814 had been verified to be a valid number; expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that no had previous temperature excursion. No addittional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
A LOT OF THE LIQUID CAME OUT THE SIDE OF THE SYRINGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced a lot of the liquid came out the side of the syringe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a lot of the liquid came out the side of the syringe was not reported. This report was non-serious.
Headache; Feeling bad all days; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), on 09Apr2021 at 16:00 as dose 2, single (Lot number: ER8737) intramuscular, in right arm for covid-19 immunization. The patient's relevant medical history included: "Type 2 Diabetes", start date: 2005 (ongoing), notes: Pertinent Details: Only take medication. The patient took concomitant medications. Vaccination history included: BNT162b2 (Pfizer/BioNTech Covid-19 Vaccine Details:, Dose: 1st, Date: 19Mar2021, Time: 10:30, Anatomical Site of injection: Right arm, Route of administration: Intramuscular, Batch/Lot Number: ER2613), administration date: 19Mar2021, for COVID-19 immunization, reaction(s): "The vaccines only left me with arm pain". The following information was reported: HEADACHE (non-serious), outcome "unknown"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling bad all days". Relevant laboratory tests and procedures are available in the appropriate section. Sender's Comments: Linked Report(s) : PFIZER INC-PV202200038868 same patient, different dose/AE.; PFIZER INC-PV202200026969 same patient, different dose/AE.;
Hours after received the H1N1 vaccine the client became very tired with an exhausted feeling. She developed body aches, especially in her back, neck and shoulders at 6:00pm. This was now 7 1/2 hours after receiving the vaccine. At 8:00 pm she went to bed, but felt nauseated and with chills during the night. She started having watery stools diarrhea on 3/01/10 at 1030 am.
pain all over body esp L arm, fever, chills, after 1st dose only had sore arm
Flushed cheeks, red ears. BP 147/111 (pulse 77), BP 141/83 (pulse 66).
Apnea, bradycardia, desaturations starting 9/30/17 0030. Infant required stimulation, oxygen and tube feeds. Infant was monitored, feeds advanced. Weekly labs were drawn on 10/2/17.
Pt asked for TDAP, MMR, and Varicella and was inadvertently given Menveo, MMR, and Varicella.
Narrative:  70 yo patient with PMH: CVA, T2DM, neuropathy secondary to T2DM, HTN, depression, morbid obesity, insomnia, GERD, HLP, and hearing loss was admitted for acute hypoxic respiratory failure following COVID19 positive test on 8/2/2021. Patient received both doses of Pfizer vaccine on 1/14/2021 and 2/4/2021. Patient did not use O2 at home but was started on 3L NC. His respiratory status worsened over the course of his hospitalization. e soon required non invassive positive pressure ventilation. On August 12 he was intubated due to worsening respiratory failure. Sedation was achieved with versed, propofol, and fentanyl. He received courses of remdesivir, dexamethasone, and barcitinib. There was concern for superimposed infections during his stay and he received broad spectrum antibiotics including ceftriaxone, cefepime, meropenem, and vancomycin. At times he required vasopressor support for hypotension. He also experienced sinus bradycardia as well as atrial fibrillation. A transthoracic echocardiogram was reassuring. His stay was complicated by pneumothorax and his wife declined chest tube placement. In the week prior to his death the patient had bloody airway secretions that required pRBC transfusion. He also had an episode of asystole where atropine was given. The palliative care team and the ICU team had multiple discussions with the patient's wife and son over the following days. Both agreed that the patient would not want further invasive procedures performed. The patient's wife, son, and brother visited on Aug 28 and the decision was made to withdraw care. Sedation was weaned and the patient was extubated. Time of death was 10:24am 8/28/2021.
A report was received from a healthcare professional on 25Nov02, concerning a 57 year old female vaccinee who experienced a blister at the injection site 8 days after receiving a Fluvirin injection in the right deltoid on 12Nov02. On 20Nov02 the vaccinee reported a blister at the injection site which scabbed over and had resolved at the time of reporting. The reporter has assessed the relationship of the vaccine to the event as probable.
loss of sense of taste; This is a spontaneous report from a Pfizer sponsored program  support from a contactable pharmacist reported for a female patient. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer Covid 19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route on 21Apr2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 21Apr2021, after an hour of getting the first dose of vaccine patient experienced loss of sense of taste. Due date to get second shot was 12May2021. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
my temperature and it's at 99.3 F/a little fever; weak; I didn't have appetite; This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9264) via an unspecified route of administration on the left arm on 08Feb2021 at a single dose for COVID-19 immunization and apixaban (ELIQUIS) via an unspecified route of administration from an unspecified date and ongoing at an unspecified dose and frequency for an unspecified indication. Medical history included afib and heart rate (abnormal). Concomitant medication included propranolol hydrochloride (MANOPROLOL) for afib. The patient previously received first dose of BNT162B2 on 18Jan2021 for COVID-19 immunization (lot: EL1283 on the left arm) and experienced a little bit of soreness at the injection site. The patient took his temperature and it was at 99.3 F. Patient asked, "Is that within range? Can I take Tylenol?" The patient stated that when he first got his shot of the Pfizer Covid Vaccine at the (Hospital name) in (City name) he didn't have any problems or didn't experience any side effects. Then after receiving his 2nd shot on 08Feb2021, he mentioned that he started having trouble. On 10Feb2021, he started to experience some side effects and stated, "I was as weak as I could be, I didn't have appetite and I had a little fever. I just feel super weak but not like if you have corona. Now, I can sleep under oxygen and it doesn't bother me anymore and when I get up I don't need oxygen anymore and I can breathe freely." Wanted to know how long will his symptoms last. He was as weak as a rag, has a little fever that comes and goes, does not go over 101, stated he was taking Eliquis does not know if that was important or not, slept with oxygen but has not had any trouble breathing. Wondering if this was standard. The action taken for apixaban was unknown. Outcome of the event 'didn't have appetite' was unknown and not recovered for the other events.
One week after my fourth total Pfizer COVID shot (second booster), I caught COVID at a large, packed music event. I was fatigued for two days and my throat hurt, but no other symptoms. On the third or fourth day, I swapped symptoms entirely to congestion and a sharp pain on the left side of my nose, near my eye. Approximately where my glasses nose piece rested, but the pain was present without my glasses on. I was no longer fatigued and my throat was no linger sore, bit the co getting was enough that I had trouble breathing even when taking OTC medication such as Dayquil or Nyquil. I made a telehealth appointment on 11/07/2022 and was seen by a doctor who I had not seen before or since. I had tested myself with an at-home rapid test on 11/02/2022 and I knew it was positive for COVID, and I told the doctor all of this. She told me to stop taking the medications I had been taking, and instead take Afrin for a maximum of 3 days to relieve the symptoms, and Mucinex instead of Dayquil/Nyquil as the active ingredient phenylephrine was no linger relieving symptoms. She also told me to use a nasal rinse. I did so, and this alleviated the syptoms enough. I continued taking Mucinex and using the saline nasal rinse through 11/14/2022 to be able to breathe through the nights. I am no longer needing to take medicine or perform a saline rinse every day/night to breathe, but I am still congested as of 12/08/2022. I need to blow my nose multiple times a day, and the snot that is expelled is thick and a darker color than normal. Occasionally there is blood in the snot as well, likely from blowing too aggressively. I have an appointment with my primary doctor on 12/30/2022 where I plan to bring this up if I am still congested. If i get worse I will of course make a new telehealth appointment.
Patient states she received 2nd dose Pfizer Covid 19 vaccine lot #EL3302 on 1/11/2021. Patient reports 7/10 body aches, fever 38.2, nausea and dizziness that prevented patient from standing without being steadied by someone else. Patient reports dizziness and nausea lasted two days. Body aches improved after one day. Fever present only on the second day. Patient had to miss work on 1/12/21 & 1/13/21 due to symptoms. Patient was tested for Covid and reports Covid swab was negative. Patient denies any side effects following the 1st Pfizer vaccine. Patient denies any ongoing symptoms or concerns today. VAERS. D/c from EHS.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender who on an unknown date in 2012 ("few days ago") was vaccinated with ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient came back to the clinic to receive an antiviral medication (date unspecified). The pharmacist did not know the reason for the antiviral medication. The reporter did not think that it was related to the ZOSTAVAX vaccination. The outcome of the event was unknown. Additional information has been requested.
Information has been received from a registered nurse concerning unspecified number of patients of unknown age and gender. The patients' concurrent condition, concomitant medication and medical history were not provided. On 03-NOV-2016, the patients were administered improperly stored doses of M-M-R II (therapy type: RHA) (lot # L047134, expiration date 24-NOV-2017) (strength, dose, frequency and route were not reported), which was exposed to a temperature of 14.3 Celsius degree (C) for 10 hours and 42 minutes. It was reported that the vaccine was also exposed to the temperature excursions as following: 14.3 C for 164 minutes on 10-NOV-2016, 12.4 C for 270 minutes on 11-NOV-2016, 11.3 C for 134 minutes on 12-NOV-2016, 8.9 C for 20 minutes on 13-NOV-2016 and 8.7 C for 74 minutes on 17-NOV-2016. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever (<100dF), which lasted several months.  Cough, which lasted a couple months.  Head cold, too.  (Treatment was with three sequential and different courses of anti-biotics.)
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 38 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as right) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Sore all over with rash all over.  Did not see provider.  Reported it months later.
Within first few hrs after Hep B and VARIVAX was given started to have blurry vision. After vaccinations 2/20/13 had mild blurrienss, but attributed it to "tiredness". In Feb blurriness resolved in 2-3 weeks. After most recent immunizations symptoms worsened until she went to see eye doctor 3/26/13. Was told by eye doctor she was having "ocular paralysis" from Hep B vaccine. On 3/27/13 says blurriness is resolving.
Patient had appointment 9/30/2021, nurse was on leave at the time, MD administered TDaP to patient. Inadvertently administering a TdaP that was 6 days past expiration date of 9/24/2021. Patient had no adverse outcome. Repeat TDaP provided today, 3/23/2022.
sore arm; body aches; fever; chills; extreme headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (body aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (extreme headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (body aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (extreme headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (body aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (extreme headache) had not resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-072980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072980:
At this time there is no adverse reaction, the purpose of this report is to document a medication/vaccination error. Patient was administered her 1st dose of Pfizer on 3/27/21, she was scheduled to follow up for 2nd dose on 4/16/21 but missed her appt, patient attempted to reschedule for 2nd dose and was rescheduled incorrectly for 4/20/21. Patient was administered a dose of Moderna on 4/20/21. Patient was observed for 30 minutes and did not develop any adverse reaction, she was instructed to continue t monitor and seek emergency medical attention if need be. Patient verbalized understanding and states she was feeling well upon release.
Red rash/lesion around the injection site. Slightly itchy, but seemingly harmless. Beginning to fade after about 72 hours from the time that I noticed it.
My heart was racing uncontrollably & I had to go to emergency room, where I was told that I had a "mild heart attack". I then went to the doctor. Topic, a cardiologist who checked me out. I told her I thought the vaccine caused this problem because previously I had NO problems with my heart at all. Dr stated that it was possible.
This case was considered medically important (OMIC). Information regarding Haemophilus B conjugate vaccine was received from an attorney regarding a male pt who experienced mercury poisoning and neurodevelopmental injuries. The pt received a dose on an unspecified date. It is alleged that as a result of cumulative exposure to mercury in the thimerosal-containing vaccine (s), the child developed "severe" neurodevelopomental injuries (neurological symptom) of mercury poisoning. No additional info was available at the time of this report.
Redness, swelling of injection site, "welt-like" bump, hot to touch. Dx: cellulitis Tx: Augmentin x 10d
Pt. presented with dizziness and mid-back pain; Pt. is on Pantoprazole; Tylenol; Lipitor; Dexamechasone;  Inpatient
Several days after the second dose, my apple watch alerted me that my heart rate had sky rocketed to 120bpm for my resting pulse. Typically my heart rate is between 60-70bpm. It's now between 90-110bp; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN8730), via an unspecified route of administration in the left arm on 29Mar2021 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other medications in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the left arm on 08Mar2021 at 14:45 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. 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 30Mar2021 at 16:00, several days after the second dose the patient's apple watch alerted her that the heart rate had sky rocketed to 120 beats per minute for the resting pulse. Typically, her heart rate was between 60-70 beats per minute. It was now between 90-110 beats per minute when resting. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. On 30Mar2021 at 16:00, the patient underwent lab test and procedure which included heart rate and result was shown as 120bpm. On an unknown date, the patient underwent lab test and procedure which included heart rate and result was shown as 90-110 bpm. The clinical outcome of the event heart rate had sky rocketed to 120 beats per minute for her resting pulse, typically, her heart rate was between 60-70 beats per minute, it was now between 90-110 beats per minute was not resolved at the time of reporting.    No follow-up attempts are needed. No further information is expected
post herpetic neuralgia; Shingles; Information has been received from a lawyer regarding a case in litigation concerning a female of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On about 19-FEB-2016, the patient was inoculated with Zoster Vaccine Live (ZOSTAVAX) at the pharmacy (dose, frequency, lot number, expiration date and anatomical location were not provided), for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, after Zoster Vaccine Live (ZOSTAVAX) inoculation, the pt was treated on unspecified date for shingles and postherpetic neuralgia. As a direct and proximate result of patient's use of Zoster Vaccine Live (ZOSTAVAX), the patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physical care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the reporting time the patient had not recovered from the events. The reporter considered the events to be related.