chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was a drive thru shot facility. They gave me a shot in my left arm and asked me to pull around to park.  I parked my vehicle and didn?t feel well so I switched seats with my girl friend. As soon as I got into the passenger seat I was out. She said My eyes rolled back in my head and I started shaking and eyes at this point she said where going up down and side to side . She ran for help and after about 1-2 minutes I  woke up. I thought I passed out so I instantly put my feet on the dash of my car and the pharmacist gave me water and chocolate milk.  He then checked my heart rate it seemed good  and after 20 minutes he let us go home.
After receiving the HBV vaccine on 4/25/08 he noticed having a headache that afternoon. That night he hardly slept and was real restless.  Saturday morning he felt like he had water in his ear, jaw was numb.  Then he noticed the left side of his face also got numb and his left eye would not blink.  He went to the hospital Saturday evening and was diagnoses with Bells Palsey.
This spontaneous report as received from a Registered Pharmacist refers to a 55 year old female patient with no known pertinent medical history or drug reactions/allergies. On 25-AUG-2013, the patient was vaccinated with ZOSTAVAX (Lot # J003360; exp. date: 21-JUN-2014) 0.65 ml, subcutaneous. Concomitant therapies included influenza virus vaccine (manufacturer unknown). On 27-AUG-2013, the patient developed tenderness, redness and warmth at the site were ZOSTAVAX was injected. The patient also reported "pain in her lymph nodes". The patient sought medical attention, she went to see the pharmacist. No laboratory tests were performed. As treatment for the events, the patient was instructed to use ibuprofen (manufacturer unknown) and apply a cold compress to the injection site. The pharmacist reported that no rash and no fever was present. At the time of the report, the outcome of the events was not recovered. Additional information has been requested.
Menstrual cycle irregularity - increased frequency and prolonged menses. Pt received COVID-19 #2 on  6/6/21,. Pt had menstrual period on 6/8/21 for 10 days, then again on 6/29/21 for 14 days, then again on 7/22/21 that lasted 1 month until 8/20/21. OCPs started to help regulate her period.
Flu like symptoms; Reactions from flu vaccines; Tiredness; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (Reactions from flu vaccines) and FATIGUE (Tiredness) in an elderly male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Crohn's disease (moderate to severe adult).   On an unknown date, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) UNK (CF) and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (Reactions from flu vaccines) and FATIGUE (Tiredness). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (Reactions from flu vaccines) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medication was reported. The primary reporter did not have the lot number information, because the packaging was discarded. It was reported that the patient had an adalimumab (solution for injection in pre-filled pen). It was unknown if the patient was enrolled in a COVID-19 vaccine trial. The reporter causality for the events of tired, reactions from flu vaccines and flu like symptoms was not provided with adalimumab (Humira). The reporter causality for the events of tired and flu like symptoms was not provided and probable with event of reactions from flu vaccines with influenza vaccine. No treatment information was reported.
Information had been received on 24-JUL-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 21-SEP-2012 at a medical center, as recommended for routine adult health maintenance and for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 28-JUL-2016, the patient was treated by a physician at a medical center (different from the one where the patient was inoculated with ZOSTAVAX on or about 21-SEP-2012) for a painful and blistering vesicular outbreak, which was diagnosed as Herpes Zoster, or shingles.   The patient has been prescribed "valcyclovir" for management of his painful symptoms.  As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
04/11/2003: Localized rash left thigh with induration, red triangular area 19 x 13 x 23 cm with splotchy red inferior perimeter at site.  Warm to touch.  Patient active with weight bearing. Benadryl 12.5 x 4 since before injection and had DTAP put on thigh (1st time had put separate from other shots), no fever but induration redness heat started 2nd day, today better than yesterday, tender but active able to bear weight.
I had full body spasms every few seconds for most of the time from 4 am on the15th to 9 pm on the 16th.  They gradually reduced in intensity. They were very intense the first day, making my body jump head to toe.  The second day the intensity was reduced and they seemed to be originating from the stomach area. Still, some of them were strong enough to move my body head to toe.  I did take a prescribed medication, Tizanidine around 9 PM on the 14th, and I think there may have been an interaction with it.  I've never had issue with it other than this event.  The spasms seemed to be directly linked with my recovery from the vaccine, stopping around the time I started to feel better. Tylenol did seem to reduce the intensity, especially the first day.  Other than the spasms, I  had aches and chills start at the same time as the spasms, and a mild fever briefly in the afternoon of the 15th.
pt diagnosed positive for COVID 7 days prior to entering hospital; c/o increasing weakness for 3 days, decreased po intake, fever; O2 sats 90-92% on RA; placed on O2 2L via NC; tested positive again for COVID, also diagnosed with UTI; given dexamethasone, remdesivir, antibiotics. Lovenox, DNR; O2 sats dropped off and on requiring up to 6L O2 via NC; pt's condition worsened and she died peacefully in the hosp
Redness, swelling and bruising at site for 3 weeks and still hard not....did see doc.
(note I had half the dose in each arm because my first shot had caused reactions of rash, lightheadness and swelling tongue). This time I am having more effects. Immediately I had blurred vision in my right eye and facial muscle tightening.  Upon arriving home I  became severely fatigued and and still am 24 hours later.  As of 16 hours later I developed severe pain in the right arm only, body aches, loss of taste and various facial tightening sensations and swelling tongue (I took Zyrtec for the latter and that helps). NO anaphylaxis.  THese may go away in the next day or so but that is as yet unknown.
a little bit of swelling on her bottom lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (a little bit of swelling on her bottom lip) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 016M20A and 088B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (She states that she's a highly allergic person.). Concomitant products included FAMOTIDINE, MONTELUKAST SODIUM (SINGULAIR) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY NIGHTTIME) for Allergy.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (a little bit of swelling on her bottom lip). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10-20mg , qd; DEXAMETHASONE (oral) at an unspecified dose and frequency and FAMOTIDINE (oral) at a dose of 40 mg. At the time of the report, LIP SWELLING (a little bit of swelling on her bottom lip) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-302461 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Non significant follow-up received on 3 sep 2021 include no new information. On 09-Sep-2021: Non significant follow up received on o9 SEP 2021 contains no new information
I glad I got the shot had a mild case/ Suspected Vaccination Failure; had a mild case; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient reported that if it was a mild, the patient glad to had the shot. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
I can not move my arm pain traveling up and down arm into back area.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 30Mar2021 at 16:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder not otherwise specified (thyroid problem) started on an unknown date. Concomitant medications included loratadine (CLARITIN) and levothyroxine (MANUFACTURER UNKNOWN)  both for an unknown indication from an unknown dates. The patient previously received aspirin on an unknown date and experienced drug allergy. 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 03Apr2021 at 08:00 the patient was not able to move her arm, pain traveling up and down arm into back area. The patient consulted the doctor for which he said this was normal but the patient was not sure about it. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event can not move her arm pain traveling up and down arm into back area was not recovered at the time of this report.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Vaccination appointment was at 1:30 pm on Monday, April 5. I received the shot at around 2:00pm in my left arm. It hurt going in, but quickly dissipated as I moved my arm. I felt fine for the rest of the day. I felt normal the following morning (April 6), but started to feel tired in the early afternoon. I took a nap around 3:00-4:30pm, and woke up feeling slightly hungry. I went to bed around 11:00pm. I woke up the next day (April 7) with a headache. I called in sick to work and stayed in bed as my headache grew worse and nausea began to appear. I threw up for the first time at 11:00am, then again around 11:30am. I emptied my bowels in between these bouts of vomiting, and my stomach was very obviously empty after the second bout. I took a nap from 12:00-2:00pm, after which I threw up at 2:30pm and then again at 3:00pm and again at 3:30pm. I took another nap from 4:00-5:00pm, then threw up again around 5:30pm. I threw up a seventh time around 6:00pm and saw  a couple flecks of blood in my vomit. Each bout was sudden in onset and violent but quick. I think I burst some of the blood vessels in my throat, because it was sore. I called a friend to take me to the ER, and threw up once or twice more while waiting. On the way to the ER, I threw up for the last time. The ER gave me Toradol, Zofran, and two bags of IV fluids. This improved all my symptoms. The next morning, April 8, I felt much better until 12:00pm, when I laid down for a nap and couldn't get out of bed until 4:30. My headache had returned so I took Advil, then ate some rice. I felt better from 6:00pm onwards.
Extra dose given, prior additional booster given on 5/3/23 (same vaccine)
HYPOTENSION 3/11/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Started out with a sever headache early in the morning on October 18,2019 by approximately 1030am my right side of my  face became numb, along with my tongue which affected my speech.  I then developed facial drooping . I went to the ER thought I was having a stroke.
Patient called on 4/15/2019 reporting redness at the injection site, swelling, tenderness, warmth, and a ring around the site. The patient was advised to go to the doctor.
Vaccine was administered at 9 months of age. Baby fussy.  Fever after all vaccines that were due that day.
Nausea.  No vomiting.  Had pt lie down with elevated legs.  Pt felt better immediately, and was completely fine 15 minutes later.  observed total of 30 minutes after symptoms of nausea, with guardian and pt's school counselor also carefully monitoring pt.
Patient received the Prevnar 20 vaccine, about 5 minutes after the vaccine was administered, he started to feel dizzy, chills, sweating, and blurred vision. The patient was provided supportive care, he was seated (did not feel faint) in an upright position, applied cold compresses to back of neck and face, provided water at his request after ensuring his airway was open and no symptoms of allergic reaction were present. His blood pressure was monitored also. After 15 minutes, he said his vision was back to normal, he said he was feeling much better.  He was alert and coherent the entire time. He decided he wanted to leave after 15 minutes since he said he felt much better and stated he was fine.
pain in left lower leg that traveled up thigh, red red and sore.   went to ER  for suspected blot clot  ultrasound  dx with DVT and superficial VT  treatment with Eliques
Chills; Fever; 1st dose of the Moderna 23Apr2021 & second dose on 03May2021; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna 23Apr2021 & second dose on 03May2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna 23Apr2021 & second dose on 03May2021). On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 03-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna 23Apr2021 & second dose on 03May2021) had resolved. At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant product was provided. No treatment information was provided.
pt recv vax & 2 days later devel an inj site rxn w/redness & soreness @ the site of pnu immune 23 administration;pt given DPh;
TEMPERATURE 106 DEGREES- WENT TO ER. HAD TEMPERATURE 103 X 4 DAYS.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 30Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Nov2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Interchange of vaccine" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for 15 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Anti-viral Product for COVID-19 Treatment, Brand Paxlovid, treatment start date 01Jun2022, treatment stop date 05Jun2022. Patient tested positive for 15 days still have symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
3-4? red circle around injection site.   Appear day after injection and I still have it 3 days later.  It is firm, hot, sore and slightly itchy.   I?ve been taking benedryl but hasn?t had much effect. This did not occur with my first two vaccines but did with this booster.
Right arm has large dark red area approximately 3 1/2 inches, very hot, & sore.  Developed on      5-07-08
swollen & sore arm on lt side beginning on noc of vax 3 days later reported that joints started to hurt-stiffness & swelling in hands;arthralgia disseminated;poly arthralgia of body;
Brain fog; Dizziness; Headache; Fatigue; Nausea; Bodily muscle aches; Bodily muscle spasms; Erratic temperatures (hot and cold); This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 07Apr2021 at 13:45 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included tendonitis, milk allergy, allergy to wheat, tomatoes allergy, latex allergy, and sulfonamide allergy. The patient previously took erythromycin (MANUFACTURER UNKNOWN) on an unknown date and for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included buspirone (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA) and ibuprofen (MANUFACTURER UNKNOWN) for unspecified indication from an unknown date and unknown if ongoing.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 16:00, about 26 hours after the vaccine, the patient experienced brain fog, dizziness, headache, fatigue, nausea, bodily muscle aches and spasms and erratic temperatures (hot and cold). The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events brain fog, dizziness, headache, fatigue, nausea, bodily muscle aches and spasms and erratic temperatures (hot and cold) were resolved on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Information has been received from a licensed practical nurse on behalf of a mother who works for the physician's office concerning her 13 month old daughter who on 19MAY2003 was vaccinated with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). Concomitant therapy given on the same day 19MAY2003, included varicella virus vaccine live (MSD) and poliovirus vaccine inactivated. On 19MAY2003 the nurse reported that the child was administered MMR II in what appeared to be an intradermal method as opposed to subcutaneously. It was reported that the injection was given like a TB test and created a wheal. The wheal was still very large and swollen two days later on 05/21/2003. At the time of this report the patient had sought medical attention and the outcome was unknown. No additional information is expected.
There wasn't an adverse reaction.  Patient received a 0.5ml dose instead of an 0.25ml dose.
Information has been received from a physician concerning a 5 year old male who on 9/27/2000, when he was only 6 months old, was vaccinated once with a 0.5 ml subcutaneous dose of varicella virus vaccine live. It was reported that the patient came to the office with a heavy case of chickenpox that began on 6/23/2005. The patient had lesions all over his body, including his scalp. No treatment was given. It was reported that the patient was recovering at home. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Within 5 minutes post vaccine administration began to feel as if I was having an asthma attack. Went home and used rescue inhaler (VENTOLIN ?). Follow day had periorbital edema, headache generalized "not feeling well".
Information has been received from a registered nurse concerning a 66 year old female with allergy to "sulfa" and penicillin who on 14-OCT-2008 was vaccinated with PNEUMOVAX 23 vaccine, Lot # 657413/0380U, intramuscularly in right deltoid). It was reported by the registered nurse, that on 14-OCT-2008 the patient developed an adverse reaction. The patient's injection site arm because warm and red several hours after vaccination with PNEUMOVAX 23 vaccine. The reaction was at the injection site, but inner aspect of the injection site arm. Patient took BENADRYL for the symptoms. The patient sought medical attention, she called and returned to the office. At the time of the report the patient was recovering. Additional information has been requested.