chrisvoncsefalvay/vaers-outcomes huggingface dataset:
information is a verbal report from spouse, onset of illness 32 days after vaccination, treated by primary care MD, thought he had a virus, became blind by 11/21/07, continued deterioration to death. Autospy preformed: found patient had a demylinating process as cause of death.  05/27/08 Autopsy report reviewed which states COD as presumed acute pneumonia (autopsy limited to examination of brain).  Report also states clinical hx of acute respiratory failure, febrile illness & staph aureus & e.coli dx on bronchoalveolar lavage 1/14/08.  Other contributing conditions included: acute aggressive multifocal demyelinating disease w/white matter lesions multiple areas of the brain including previous biopsy sites & cervical spinal cord; cerebral atrophy & edema.  9/26/08 Reviewed hospital medical records of 1/3-/-19/2008. FINAL DX: multiple CNS lesions w/gadolinium-enhancing CNS lesions; myalgia; hypoxic respiratory failure; dysphagia; poor oral intake; nutrition; possible pneumonia; prophylaxis. Records reveal patient experienced re-admission for brain biopsy which revealed acute demyelinating process.  Failed high dose steroids & plasma exchange.  Tx w/mitoxantrone treatment & second course of high dose steroids in ICU.  Mental & respiratory status deteriorated, significant muscle spasms & pain.  Mechanical ventilation.  Brain lesions continued to grow & new lesions appeared.  Developed decerebrate posturing.  Comfort care only decided & transferred to hospital closer to family home.  5/23/08 Reviewed initial eye clinic records of 11/29-11/30/2007 FINAL DX: probable retrobulbar ischemic ACON. Records reveal patient experienced HA x 3 days & blurred vision x 1 day.  Patient had viral infection w/fever approx 10 days prior & still has sore eyes & stiff neck.  Referred to neuro-ophthal.  6/6/08 Reviewed neuro-optho medical records for 11/30-12/2/2007. FINAL DX: bilateral optic neuritis Records reveal patient seen in clinic 11/30 emergently & admitted to hospital same day.  Had used Cialis & noted difficulty reading next AM w/HA.  Then developed blurry vision, decreased vision & pain over 3 days.  Exam revealed visual acuity hand motion in right eye & 4/200 left eye, IOP WNL, no ptosis, slit lamp WNL, fundus w/1(+) edema of right optic nerve & trace edema left optic nerve.  Admitted for stat MRI & IV steroids.  No improvement & D/C to home on continued tapering steroids.    7/4/08 Reviewed hospital medical records of 11/30-12/02/2007 which were previously included in clinic records. FINAL DX: bilateral optic neuritis
CURRENTLY PREGNANT , GESTATION APPROXIMATELY 27 WEEKS . NO NOTED PROBLEMS POST VACCINES . CURRENTLY IN CLINIC FOR ONE HOUR GLUCOSE TOLERANCE TEST.
Information has been received from a physician concerning a 32 year old male who in approximately, October 2004, was vaccinated with 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Three weeks after receiving the vaccination, the patient had rapid weight gain and swelling and was diagnosed with nephrotic syndrome. The patient sought medical attention and was hospitalized for a week. Subsequently he recovered. Additional information has been requested.
Information has been received from a certified medical assistant concerning an adult female who was "recently" vaccinated intramuscularly with 0.5 mL dose of Pneumovax 23 (lot # 651319/1007P). Subsequently the patient developed injection site pain, redness and swelling. The patient sought medical attention and was treated with OTC Advil. Subsequently, the patient recovered. Additional information has been requested.
Difficulty breathing, hoarseness to voice with sensation of throat closing, generalized urticarial rash.
Administered   meningococcal into  R deltoid,  Patient stated her r arm felt heavy.   Administered  Tdap into   L deltoid, immediately after withdrawing the needle, hers eyes rolled upwards and she lost consciousness. Laid her down as much as possible, ( we were in a mobile vaccine van) she aroused after about 10 seconds.   Her arms did stiffen while she was arousing. She was alert to person, place and time. She said," I don't feel good, I think I am going to throw up. "  Gave her an emesis bag and she did vomit approx 120 ml of semi solid emesis. Her face was pale and clammy.   BP was 92/60, heart rate was 100 and regular.  Watched her for approx 20 minutes.         she wanted to go home and mother was ok with her going home.  advised the mother to take her home and let her lie down, give her some cool and sweet to drink and watch her for a couple of hours. instructed the mother to call 911 if any issues arise on the drive home. patient was still a little weak and was escorted to car by staff.
Information has been received from a physician concerning a female patient who " A few years ago" was vaccinated with a dose of VARIVAX (Merck) (Lot# not reported), SQ. The physician stated that a female patient had experienced chicken pox after receiving a dose of VARIVAX (Merck) years before (duration of time unspecified). It was reported that the therapy was discontinued "A few years ago". At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Began a fever of 103 on 4/10/03 with chills, headache which persisted on 4/11/03 and still 4/12/03.  Was seen in ER on 4/12/03 for cellulitis of vaccine site and given IV fluids.  Sent home on Keflex po.
Headache; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VOMITING (Vomiting) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (Headache) and VOMITING (Vomiting). At the time of the report, HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No concomitant medications were reported No treatment drugs were reported
Pt experienced syncope for 1-2 mins. Had pt laid down on the floor. called 911
I've been puking, feeling of puking; sweating cold; dizzy; no energy at all; still needing to take naps; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (sweating cold), DIZZINESS (dizzy), ASTHENIA (no energy at all), SOMNOLENCE (still needing to take naps) and NAUSEA (I've been puking, feeling of puking) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination.     The patient's past medical history included Epilepsy. Concomitant products included LORAZEPAM (ATIVAN), CARBAMAZEPINE (TEGRETOL) and CLOBAZAM for Epilepsy.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced COLD SWEAT (sweating cold), DIZZINESS (dizzy), ASTHENIA (no energy at all) and SOMNOLENCE (still needing to take naps). On 17-Jun-2021 at 10:00 AM, the patient experienced NAUSEA (I've been puking, feeling of puking). On 20-Jun-2021, COLD SWEAT (sweating cold) had resolved. At the time of the report, DIZZINESS (dizzy), ASTHENIA (no energy at all), SOMNOLENCE (still needing to take naps) and NAUSEA (I've been puking, feeling of puking) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was unknown
Induration for 2 weeks on left leg. + erythematous pustule on left thigh for one day, 2 weeks after vaccines.
ADVERSE REACTION TO THE COVID SHOT TO JANSSEN VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced adverse reaction to the covid shot to janssen vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction to the covid shot to janssen vaccine was not reported. This report was non-serious.
7 mins after administered heart rate jumped to 127, began shaking uncontrollably and became dizzy and confused. 12 mins after administered heart was up to 159. Slight face swelling. Symptoms continued for an hour. Benadryl helped. Stomach pain started an hour after the vaccine and Benadryl. After going home, took Pepcid which helped with stomach pain and allergy symptoms. 3 hours after vaccine, have headache (shooting head pains).
Pt c/o nausea 13 mins after receiving vaccine. She denied any other complaints and noted that she has no past medical history. She was evaluated and assessed by NP and paramedic. BP - 133/78, HR - 78, resp - 14, O2 sat 100%. Pt monitored for another 10 minutes.
Booster; Stated she had trouble to walk/hard to stand up and walk on; States that she had her booster dose yesterday and apart from feeling a sore arm,; she woke up in the middle of the night with a mayor pain in her feet and ankles/Woke up to ankle and foot throbbing and stabbing with pain; she woke up in the middle of the night with a mayor pain in her feet and ankles/Woke up to ankle and foot throbbing and stabbing with pain; throbbing and shooting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 2), for COVID-19 Immunization; Bnt162b2 (DOSE: 1), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; GAIT DISTURBANCE (non-serious) with onset 09Dec2021, outcome "unknown", described as "Stated she had trouble to walk/hard to stand up and walk on"; PAIN IN EXTREMITY (non-serious) with onset 09Dec2021, outcome "unknown", described as "States that she had her booster dose yesterday and apart from feeling a sore arm,"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 09Dec2021, outcome "unknown" and all described as "she woke up in the middle of the night with a mayor pain in her feet and ankles/Woke up to ankle and foot throbbing and stabbing with pain"; PAIN (non-serious) with onset 09Dec2021, outcome "unknown", described as "throbbing and shooting". Therapeutic measures were taken as a result of gait disturbance, pain in extremity, pain in extremity, arthralgia, pain. The lot number for bnt162b2 was not provided and will be requested during follow up.
Today is Tuesday, January 18th, 2022. For the last 9 months, ever since my first COVID shot, my left arm has been stinging. Nearly each day, I am grabbing my left arm, at the injection site, in pain. The only treatments that I do are that I self-massage the injection site, multiple times each day. I stretch my arm out each day as well. Since I have gotten my booster shot, the pain has gotten worse.
Two days after receiving Covid Vaccine (my second booster dose), while taking a morning shower, I noticed a swelling in my armpit. During the past few days, I have noticed the swelling of my arm muscle and the armpit swelling has not resolved (nor increased). I feel that my left pectoral muscle and shoulder also are a little bit swollen, also the left side of my face. It seems to be mild lymphedema.  I have had a little weight gain (around 1.5 pounds) during the past week.
FEVER, VOMITTING, SHAKES, HA, MALAISE.  INJECTION SITE IS CLEAR.
Patient was driving from our clinic up into another state. While he was driving, he began to experience shortness of breath, malaise, lightheadedness, tachycardia, weakness, vision changes, and drowsiness. Patient pulled his car over to the side of the road and called 911. Patient was transported to Hospital ER, where he was stabilized. He was then transferred to another Medical Center, where he was hospitalized for 2 days. Patient states that he was found to have cardiac arrhythmias while inpatient.
Within 6 hours of admin all over body aches, chills, malaise. Fetus was 13w6d at time of mother?s administration, fetal death estimated early 14 w.  Mother induced to abort at 15w by cytotec induction; Hospitalization followed to monitor bleeding.
Urinary Tract Infection; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced urinary tract infection (non-serious) on an unspecified date. It was reported that Caller will take the 2nd dose on 19Feb2021. As per the caller he has been diagnosed with Urinary Tract Infection (UTI) and advised to take medication today or tomorrow. Caller would like to know if she can take the medication before the 2nd dose. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Day 2 after vaccine administered: Severe tinnitus/ringing/humming in Right ear/hearing interference along with high pitched tinnitus in both ears/back of head. Dizziness/vertigo - Moderate to severe. Exhaustion/fatigue, muscle weakness. Continued tinnitus in Right ear through mid-August 2018. Exhaustion/fatigue, muscle weakness continued through September 2018. High-pitched tinnitus in both ears/back of head continues. Right ear tinnitus continues intermittently. Visited primary doctor 2x, referred to ENT and for MRI (6.6.2018). Prescribed medication/meclizine for dizziness (no improvement with medication and tests were inconclusive/did not show anything). Tinnitus and headaches continued. Visited Occupational Therapist (7.27.18 and 8.3.18). Cranial sacral work was preformed, after which (approx. early to mid-August) right-ear tinnitus reduced (continue intermittently) and headaches ceased. Some high pitched double-ear/back of head tinnitus continues and right-ear tinnitus continues intermittently. Reluctant to get 2018 flu vaccine due to my experience with the adverse reaction from the 2017 flu vaccine. A doctor at a clinic I recently visited recommended that I report the adverse reaction.
About the 13th of February I had a sore throat. I noticed that I had a fever too. The next day my sore throat got really bad, and I started having pain in my chest and ribs. I equated that with pneumonia because I had it before in the past. When I went to the doctor it was confirmed that I had pneumonia and also covid. I was prescribed some medication for the pneumonia for 10 days. I am just now starting to feel better, but I am still very weak. I feel like I have a sinus infection. I had a really bad headache that was more like a head cold. I was sick but not deathly sick. I was on my back in bed for a week because it was too exhausting to get up and move around.
Fever: 100.9, severe headache, chills, nausea, vomiting, muscle and joint pain, severely swollen lymph nodes.
Chest and arm rash, itchy skin, and sl SOB about 30 min after vaccine admin. No improvement and worsening SOB, w/o resp distress, 30 min after BENADRYL 25 mg at 12:25 pm. Epi 0.3 mg via Epi pen at 12:55 and transferred to ED. NKA.
This case was reported by a nurse via call center representative and described the occurrence of tingling of extremity in a female patient who received ENGERIX B adult (batch number 45SJ2, expiry date 17th February 2017). On 18th May 2015, the patient received ENGERIX B adult (intramuscular). On 18th May 2015, less than a day after receiving ENGERIX B adult, the patient experienced tingling of extremity, influenza-like symptoms, nasal discharge discoloration and fever. On an unknown date, the outcome of the tingling of extremity, influenza-like symptoms, nasal discharge discoloration and fever were recovered/resolved. The reporter considered the tingling of extremity, influenza-like symptoms and fever to be probably related to ENGERIX B adult. The reporter considered the nasal discharge discoloration to be unrelated to ENGERIX B adult. Additional information provided: The patient experienced the events within 24 hours of receiving the vaccine.
Arm a little sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (had old one).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had first of new Shingles vaccine in last week from reporting date and stated that his/her arm was just a little sore on the next day. The patient could get 2nd dose in a couple months. The patient reported that it was expensive even with his/her insurance and worth it. The follow-up would not possible as no contact details were available.
Headache, Sedation, Myalgia, Arthralgia, none Narrative:
Pt recvd rubella vax 3 days post partum on 17FEB91 & 24FEB91 pt devel fever of 101-102 & severe h/a, joint pain, red induration of 2 1/2in in diameter @ vax site; pt devel pruritic rash on trunk, legs, & face; Seen by MD 01MAR91;
Suspected vaccination failure/my mother got the shingle vaccine and ended up getting the shingles; ended up getting the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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: 5-Aug-2022 Reporter's comment: This case received from the patient's children via interactive digital media. The patient got the shingle vaccine and ended up getting the shingles, the physician made money and kick backs for administrating these drugs. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR119929, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022AMR119929:Same case/Same reporter
fever 104 ax & pale episodes x 3 days; fever 1st 12 hrs;
high pitch scream, excessive sleepiness, difficulty with breastfeeding due to issues with latching on and continuously falling asleep while feeding; balance and coordination issues, extended bedwetting, ADHD behaviors, insomnia behaviors, muscle weakness, burning sensation on outer part of ears
Incomplete ID vaccine administration.  During ID administration, medication leaked out so pt did not receive the full dose.  Pt revaccinated subcutaneously. Pt stable and released from the vaccination site.
My son was standing at school and suddenly became very dizzy, vision became blurry, and he fell backwards. His complexion was very pale and he broke out into a sweat, with beads of perspiration on his face. He did not register any fever. He remained lethargic and I brought him home from school to monitor him the rest of the day. So far, the symptoms have not recurred.
Patient reported "feeling warm" "feeling funny in stomach" after receiving both varicella and MMR in separate limbs while, sitting in a chair. Patient stated feeling "somewhat better, not 100%". He began exit to check out Nurse suggest he wait longer in another room / while walking to other room to rest, patient gait became unsteady. And was escorted to a chair 911 was called. While waiting for EMT B/P 90/60 skin cool Pulse 66. Patient still talking answering questions had a bowl rice three hours before. Before that meal was right before EMT arrived. Patient signed their paper to refuse to leave with EMT.
Patient fainted while sitting in a chair in our waiting area. He slowly fell forward, lightly hit his head of the blood pressure machine, and went to the ground. He was out for only 5-10 seconds and able to speak with me right after waking up. We called 911, he stated he felt light headed until the EMT's arrived and they did an EKG and blood pressure/heart rate reading and decided to take him to the hospital just to be safe.
Less than 24hr pt ate egg & lips swell, throat got tight BENADRYL helped. Pt now gets this reaction after eating eggs. Never had an egg allergy before Tdap.
A non-serious spontaneous report of a pregnant "women" receiving FLUMIST was received from a registered nurse concerning a 33-year-old female. The patient's medical history and obstetrical history were not provided. Early Oct-2009, the patient received FLUMIST. One week after vaccination she realized she missed her period and was pregnant. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 76-year-old female patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. On 8th November 2018, the patient received the 2nd dose of SHINGRIX. On 8th November 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling, injection site induration, injection site erythema and injection site hemorrhage. On an unknown date, the outcome of the injection site swelling, injection site induration, injection site erythema and injection site hemorrhage were unknown. It was unknown if the reporter considered the injection site swelling, injection site induration, injection site erythema and injection site hemorrhage to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient developed a hardened red swollen area with minimal bleeding at the injection site. No further information reported regarding the event. The reporter did not give consent to follow-up.