chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of systemic allergic reaction in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 14 March 2014, the subject received an unspecified dose of BOOSTRIX (she was injected in the back of the arm and not in the muscle). On 14 March 2014, less than one day after vaccination with BOOSTRIX, the subject lost her eyesight for a minute and started to slur. Right after receiving the vaccine she had a systemic allergic reaction. She experienced tremendous hearing loss, had optical nerve damage and could barely see, and swelling. Her head was so swollen and her eyes were puffy. This case was assessed as medically serious by GSK. The subject went to the Emergency Room. They thought she had a stroke so she had an MRI and CT scan done (results not provided). The subject was treated with prednisolone. At the time of reporting, the events were improved. Agency has also gotten involved due to what happened. The subject said she is mostly fine now. The subject was not sure whether she was allergic to the vaccine or whether it was from a bad batch. She could not clarify this statement further other than she did not know and it could be either one. The patient did not wish to answer any questions from this report but agreed to receiving follow-up.
Patient presented for COVID vaccination today, first dose. Prior to receiving dose, she mentioned to RN that she has a history of vasovagal syncope following her shingles vaccine. She routinely has flu vaccines without any adverse reaction.  RN requested I standby and observe while patient receives vaccine. Within minutes of receiving vaccine, patient endorses prodromal symptoms lightheadedness, hot flashes, then lost consciousness while seated in the chair. After approximately 1 minute, the patient did regain consciousness. She was given orange juice and crackers and felt well enough to ambulate to a chair in the observation area. Vital signs were WNL and she was monitored closely in the observing area. She continued to complain of "queasiness" often stating that she just feels that she would like to go lay down and nap in her car. Rechecked her blood pressure which dropped to 94/64, patient states she usually runs low but systolic within the low 100's. She was taken to a private hallway where she laid down on a stretcher. Blood sugar checked reading 121. She was given more water but she was uninterested in any more food, as she questions if the orange juice and the crackers were the cause of the queasiness. Blood pressure was rechecked and she was again WNL. Given her persistent fatigue and "queasiness", team lead contacted ED charge nurse to discuss case. The recommendation was to have the patient further evaluated. Discussed with team lead, and it was agreed upon that this was best course of action given her persistent symptoms. EMS was called. Per EMS report, patient's blood pressure did rise which patient attributed to excitement/anxiety surrounding the situation. Patient ultimately declined EMS transfer to ED. Her husband arrived to drive her home. Discussed the importance of monitoring symptoms for the next 48 hours. If she has any worsening "queasiness", weakness, fatigue, nausea/vominting, throat swelling, wheezing, dyspnea then she is to call 911 immediately. Patient verbalizes understanding and is agreeable to emergency services should any of these problems occur.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-MAR-2016, the patient was vaccinated with an improperly stored dose of VAQTA "25U/0.5ml-SD LLok wCap Ped" which had a lot number L02259 and expiration date on 06-APR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an  unspecified date, the VAQTA vaccine had had two temperature excursions: one of 96 hours and other one of 360 hours. The lowest recorded temperature was 33 F (0.555555556 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Patient started to become short of breath. 911 was called, Pt was evaluated. Pt  CAOX4 and refused transport incident #21-0011110
I was suppose to give the patient a Hep A and I accidently gave her a Tdap.  I called mom and she states that patient is fine and not having any interactions from it. I called to let her know that patient was given the wrong  vaccine at her appointment.
This spontaneous report was received from a registered nurse refers to a unspecified number of patients of unknown age and gender. On 27-AUG-2015, an unspecified number of patients who were all older than 12 years of age were vaccinated each with (Oka-Merck) PROQUAD (dose, route, lot# unspecified). No adverse event was reported. No product quality complaint was reported. Additional information has been requested.
sick all day; fatigue; headache; joint pain; muscle pain; temperature; nausea; under an electric blanket with chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (sick all day), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included WARFARIN SODIUM (JANTOVEN) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced MALAISE (sick all day), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), PYREXIA (temperature), NAUSEA (nausea) and CHILLS (under an electric blanket with chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (sick all day), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), PYREXIA (temperature), NAUSEA (nausea) and CHILLS (under an electric blanket with chills) outcome was unknown.            The action taken with the drug was Not applicable.
numbness of upper lip; Swelling of upper lip; Vaccination site redness; Imjection site swelling. worse and more swollen but with now fever; Fever up to 38.3 degree Celsius; Chills; Arm soreness all day; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever up to 38.3 degree Celsius), CHILLS (Chills), PAIN IN EXTREMITY (Arm soreness all day), HYPOAESTHESIA ORAL (numbness of upper lip) and LIP SWELLING (Swelling of upper lip) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included ALPRAZOLAM and Thyroid medication for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (Fever up to 38.3 degree Celsius), CHILLS (Chills) and PAIN IN EXTREMITY (Arm soreness all day). On 06-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (numbness of upper lip), LIP SWELLING (Swelling of upper lip), VACCINATION SITE ERYTHEMA (Vaccination site redness) and VACCINATION SITE SWELLING (Imjection site swelling. worse and more swollen but with now fever). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever up to 38.3 degree Celsius), CHILLS (Chills), PAIN IN EXTREMITY (Arm soreness all day), HYPOAESTHESIA ORAL (numbness of upper lip), LIP SWELLING (Swelling of upper lip), VACCINATION SITE ERYTHEMA (Vaccination site redness) and VACCINATION SITE SWELLING (Imjection site swelling. worse and more swollen but with now fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient has taken Tylenol two in the night and two in the morning
I tested positive for COVID on January 24th.  I never had a fever throuhgout my illness; however I did have mild cold symptoms, and lost all sense of taste and smell.  My taste and smell just started to return a few weeks ago.   I received the Pfizer vaccine on Friday, March 12th.  On Monday, March 15th, I lost all smell and taste.  When I completed a virtual care visit, I was advised that since I had COVID within the past 12 weeks, I was not eligible to be retested for COVID.  However, I was informed that loss of taste and smell were not side effects of the vaccine and that I needed to go home and quarantine for 2 weeks.    I requested a second opinion, and was instructed from my second opinion to get retested (although this was against routine CDC guidelines).  My retest was negative for COVID.  I have been advised that my loss of taste and smell should be reported to the CDC as a side effect of the vaccine.  I still do not have taste or smell as of March 20.
At first I felt fine, I was very hydrated and ready to get the shot.  I sat down in a waiting area for about 2 minutes  and still felt good-then within seconds I started having trouble breathing an felt nauseous. I couldn?t speak to well and then I started sweating and started to feel like I was going to loose consciousness. The pharmacy staff was with me by this time and they layed me on the floor.  At this point passed out for a minute and don?t remember much but when I opened my eyes the paramedic team was with me. They sat me up and took my vitals.  I started to feel better and was able to explain what happened.  My blood pressure and sugar  were good so I asked if I could just go home, monitor symptoms and follow up with my doctor. This is what I ended up doing .  I have an appointment with my doctor but and I have have also called my cardiologist to understand what happened better.   I do not intend to get a second dose as this was a very scary event for me.
Patient felt "tired" after vaccination. 10/18 2300 pt. woke screaming, next day was unable to walk, treated for constipation but symptoms not resolving. 10/21 transferred to our facility and diagnosed with acute disseminating encephalomyelitis. 10/28/09 Hospital records received (includes discharge note) DOS 10/18/09, 10/19/09, 10/19/09 to 10/21/09 and 10/21 to 10/26/09. Assessment: Demyelinating disease CNS. Gait disorder ataxic.  Prior mild upper respiratory infection. Inconsolable screaming.  Diagnosed with constipation at ED on 10/18/09. Admitted on 10/19/09 for Go-lytely 'cleanout' and discharged. Patient now presents with titubation unable to stand or walk, legs stiffen. Loses balance if he sits, stands, or attempts to walk.
4 hours post vaccine, patient experienced swelling in the right side of face, neck, shoulder and arm.  Is ongoing, had night sweats throughout day and night with chills and low grade temp.    Had virtual MD appt today.  States she was ordered to take Benadryl at night and Claritin during the day (2-4 times usual dosage of both medicines).  Also ordered to take Acetaminophen as prescribed for fever/HA.  States she was given verbal orders for premeds to 2nd vaccine:  Claritin 1 hour prior to 2nd dose, increase monitor time to 30 minutes post vaccine
Information has been received from a licensed vocational nurse via a company representative concerning a female patient of unknown age. The patient had no pertinent medical history or drug reactions/allergies. On an unknown date the patient was vaccinated with the second dose of GARDASIL (strength, dose, frequency, lot number and expiration date were unspecified). The patient immediately fainted after vaccination. Treatment was not given for the faint. On an unknown date, the patient recovered from faint. At the time of reporting, the causality between faint and GARDASIL was not provided. Additional information has been requested.
RED BLOTCHES ITCHING ON CHEST, BLOTCHES ON STOMACH ON THIGHS AND ALL OVER TOPS OF FEET AND BOTH LEGS; SEVERE CHILLS; This spontaneous report received from a patient concerned an 85 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart attacks, and concurrent conditions included penicillin allergy, and tetracycline allergy. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) once a total dose was not reported, administered on 23-MAR-2021 at  left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) Normal. On 23-MAR-2021, the subject experienced severe chills. On 27-MAR-2021, the subject experienced red blotches itching on chest, blotches on stomach on thighs and all over tops of feet and both legs. Treatment medications (dates unspecified) included: cortisone, and paraffin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills on 24-MAR-2021, and had not recovered from red blotches itching on chest, blotches on stomach on thighs and all over tops of feet and both legs. This report was non-serious. This case, from the same reporter is linked to 20210355358.
Initial unsolicited report received from a pharmacist (Director of Pharmacy)on 12 October 2016. This case is linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848 (same vaccine). This case involves a patient of unknown age and gender, who was vaccinated with a dose of FLUZONE (batch number: UI669AA, expiry date: 30-JUN-2017 and site of administration was not reported) via intramuscularly on 04 October 2016 (also reported as over the past month). Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. On unspecified date (also reported as over the past month), following vaccination, the patient bright red, hot for 24 hrs (Vaccination site inflammation), headache and nausea. It was reported that the patient required emergency room or doctor visit. Lab data was not reported. Corrective treatment was reported as no. The outcome of the events was reported as recovered. Duration of the event bright red, hot was reported as 24 hrs and for the event headache and nausea was reported as 30 hours. List of documents held by sender: none.
The vaccination was given, but the syringe disconnected from the needle. The vaccine dose ended up on the patients arm and car. Likely administered into patient arm was less than half of the dose. Clinical Lead RN spoke with PA on call on Location. PA suggested to administer another dose into patients other arm. Vaccinator then gave new shot in patients left arm.
My periods since the vaccine have been very heavy and very crampy. After vaccine on April 23, 2021, symptoms started in May and June 2-3 days prior to the arrival of my period consisting of very heavy cramps. Cramps then subsided after 1 day until the day of my period's arrival. On the day of period arrival, my period was very heavy (not usual at all for me) and the cramps had to be treated with 4 tablets of 200mg ibuprofen tablets which dulled the pain,but did not remove it prior to my period and during my period.
This case was reported by a consumer and described the occurrence of almost passed out in a 64-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of FLULAVAL (subcutaneous, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced almost passed out, redness, swelling and intramuscular formulation administered by other route. The subject reported that she was administered FLULAVAL and had a reaction because it was administered subcutaneously. The subject declined to provide additional information. At the time of reporting the outcome of the almost passed out, redness, and swelling were was unspecified.
Information has been received from a nurse concerning a male adult over 50 years old, who in October ("past week") received a first dose of 0.5 ml PNEUMOVAX vaccine (lot # 660718/0551X, route and injection site unknown). The day after the injection, the patient sought medical attention in the office with pain, redness and swelling at the injection site. No treatment was required for him. The patient recovered on an unspecified day. Additional information has been requested. This is one of 3 reports from a same source.
FACIAL TIC RIGHT BELOW THE RIGHT EYE; Injection site pain; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 50-years-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in arm right on 25Mar2021 at 11:00 (50-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient not had any allergies to medications, food, or other products. The vaccination facility type was reported as pharmacy or drug store. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL), levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination and had not tested for COVID-19, since the vaccination. On 25Mar2021 at 16:00, the patient experienced injection site pain. On 26Mar2021 at 07:30, experienced facial tic right below the right eye. The treatment was not received for the event. The events were reported as non-serious. The outcome for the event injection site pain was resolving while other event facial tic right below the right eye was reported as resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 patients received Bivalent Boosters with 38 have improve of symptoms & 50 percent or more.; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 have improve of symptoms & 50 percent or more.) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 have improve of symptoms & 50 percent or more.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 have improve of symptoms & 50 percent or more.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 have improve of symptoms & 50 percent or more.).    This case contains information of 33 patients out of 42 reported by reporter.  Concomitant Medication use information was not provided by reporter.  Vaccine was given to patients for long COVID between March 2023 and 1 August 2023.  42 patients received Bivalent Boosters with 38 having improvement of symptoms & 50 percent or more. Vaccine was given within current guidelines except seven were under 65.  Patients were treated with skin lesions, brain, SBP 220, Tachycardia greater than or equal to 150 and body aches.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master Case (Patient 1out of 42 patients)
Gave third dose of Pfizer 0.3ml to 13 year old client. Client waited 15 minutes post vaccination with no adverse effects.  Parent advised to call health department and/or primary care provider if any adverse effects noted upon leaving clinic.
Breakthrough case admission after 4 vaccines  Moderna 3/5/21 Lot# 0299219;  Moderna 4/2/21 Lot# 016B21A;  Moderna 11/9/21 Lot# 058F21A;  Moderna 7/22/22 Lot# 016B22A