chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Balance issues; Fatigue; Double vision/2nd vaccine in May, it got worse for a few days then came back to the same as before/he neuro - ophthalmic doctor put a prism on his glasses so he can drive; This spontaneous case was reported by a physician and describes the occurrence of DIPLOPIA (Double vision/2nd vaccine in May, it got worse for a few days then came back to the same as before/he neuro - ophthalmic doctor put a prism on his glasses so he can drive), BALANCE DISORDER (Balance issues ) and FATIGUE (Fatigue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tetanus and Yellow fever. Concurrent medical conditions included Hypertension and Melanoma. Concomitant products included METOPROLOL, CLOPIDOGREL BISULFATE (PLAVIX), HYDROCHLOROTHIAZIDE and AMLODIPINE for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced DIPLOPIA (Double vision/2nd vaccine in May, it got worse for a few days then came back to the same as before/he neuro - ophthalmic doctor put a prism on his glasses so he can drive). On an unknown date, the patient experienced BALANCE DISORDER (Balance issues ) and FATIGUE (Fatigue). At the time of the report, DIPLOPIA (Double vision/2nd vaccine in May, it got worse for a few days then came back to the same as before/he neuro - ophthalmic doctor put a prism on his glasses so he can drive) had not resolved and BALANCE DISORDER (Balance issues ) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    The chronic conditions of the patient were reported as Heart and Prostate and was reported not specifically.  It was reported that patient developed diplopia on 09-MAY-2021 and went to emergency. On 12-MAY-2021patient consulted doctor. The first observation of the reaction event Diplopia was mentioned as 9 eso with half BUOS on 13-MAY-2021 and 20 eso with 3 BUOS on 03-JUN-2021 as stated by the reporter. The reporter stated that the events were continuing from first dose. The treatment for the event was mentioned as Fresnel prism in spectacles. The reporter also stated that third degree  base up had reduced but the horizontal (esotropia)had remained.     This case was linked to MOD-2021-132975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: The Follow-up document wasreceived contains significant information. The primary reporter details were added. The relevant patient medical history was added. The concomitant products were added. The event outcome for diplopia was updated from unknown to not recovered/not resolved.
This case was reported by a healthcare professional and described the occurrence of injection site inflammation in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included MMR vaccine (non-gsk); non-GSK manufacturer; unknown given on an unspecified date; varicella virus vaccine; manufacturer unspecified; unknown given on an unspecified date. On either 28 March 2011, 29 March 2011, 2 April 2011, 8 April 2011 or 13 April 2011 the subject received unspecified dose of KINRIX (unknown route, unknown arm). Less than one month after vaccination with KINRIX, the subject experienced injection site inflammation, swelling injection site and injection site soreness. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 7 children experienced the same side effects after receiving KINRIX vaccine. The vaccine was administered on 28 March, 29 March, 2 April, 8 April, and 13 April 2011. This is case 6 of 7; see case IDs A0924034A, A0924036A-A0924039A, A0924041A for details of the other reports.
Altered sense of taste to foods some worse than others  .  Taste of some foods so bad causing gagging and unable to swallow the food.   This lasted for 4 weeks and slowly improved over time .  Sense of smell not affected..  lost weight as not able to eat much
Burning in kidney area initially, then developed dry heaves, difficulty swallowing and a metallic taste in her mouth.
Approximately 10 minutes after injecting the 2nd dose of COVID19(Pfizer-bioNTech) the patient made me aware of numbness/tingling in her feet. She explained it like her feet falling asleep. Approximately 5 minutes later she said the sensation was radiating up her right leg. She said the symptoms subsided in her leg after approximately 10 minutes. She had no trouble standing or walking. At approximately 3:15pm she proceed to her shift. I was leaving the building at approximately 3:35pm and verified with her that the symptoms did not proceed any further and at this point of time she did not feel she needed emergency medical intervention
Usual sore arm and not feeling great, but thing I?m concerned about is left eyelid became sore soon after and later at night I noticed it was red and puffy. Not sure what to do.
pt recvd vax @ 20 to 30 yrs old & was vaxed w/2 doses of MMR vax & lab eval revealed neg titers; No further details were provided; nurse reported 8 pts;
PATIENT REPORTED DEVELOPMENT OF RASH AT SITE OF INJECTION AND EXTENDING 2-3 INCHES DOWN BACK OF ARM. RASH IS RED AND WARM TO THE TOUCH.
woke up with a slight headache; she felt her whole arm was sore; slight soreness at the injection site; felt some warmness right after the vaccine, like she felt kind of high; This is a spontaneous report from a contactable nurse (patient).  A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular at deltoid left on 23Dec2020 at single dose for COVID-19 immunization.  The patient medical history included ongoing high blood pressure.  Concomitant medication included hydrochlorothiazide/losartan (strength: 25mg/320mg, formulation: tablet), oral one dose form from an unknown date and ongoing, once a day for blood pressure high. The patient previously took flu vaccine for immunization and experienced soreness in her arm and generally felt tired throughout that week. The patient reported that on 23Dec2020 she felt some warmness right after the vaccine, like she felt kind of high (she doesn't know if it was just nerves with this being a new vaccine) and slight soreness at the injection site, on 23Dec2020 at 19:00 she felt her whole arm was sore and on 24Dec2020 she woke up with headache. The patient outcome of the events was unknown.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a first dose of GARDASIL (lot#: not reported) and subsequently the patient developed chest pain. On an unspecified date the patient was vaccinated with a second dose of GARDASIL (lot#: not reported) and subsequently the patient developed leg cramps. At the time of the report, the physician stated that the patient refused to get her third dose of GARDASIL because all events listed above. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No further information is available.
Patient came in 5 Mar 10 at 14:15 and received Anthrax for the first time and Typhoid. Dr states that night noticed rash on his right neck. States a few hours after vaccination he also experienced elevated heart rate.
pt recv vax & devel an inject site rxn characterized by a 10-40cm area of redness & pain;pt recovered;this is 1 of 11 pt from this facility to devel an inj site rxn p/flu vax w/lot#4978296;
It started about seven hours after the vaccine with chills so bad my hands were shaking, then fever, then dizziness .  About 15 hours after the vaccine I start vomiting bile.  I was so dizzy my husband had to help me walk to the bathroom.  I got scared and we talked about calling 911, but decided nothing was life threatening.  On the third day of this I broke out in a red rash from my neck to my thigh that lated for several days getting lighter each day.  Even with these 3 days of hell, I would take the vaccine again because I think it is vital to getting rid of the pandemic.
A 27-year-old female patient had inadvertently received a left deltoid, intramuscular injection of Daptacel, (product not recommended for use in this age group), lot number C2630AA, on 01 September 2006. This product was administered instead of Adacel.  The following day, the patient experienced muscle soreness. No testing or examination by a physician was required. The patient took nonsteroidal anti-inflammatory medications as needed. The patient recovered from the event within 96 hours.
2 days after the vaccines started with bloody diarrhea, decreased intake and fever. 4-5 episodes of bloody diarrhea and fever up to 101. Due to the symptoms and age was hospitalized. He required IVF, abdominal US (normal), XR(normal), stool studies( PCR positive for EAE coli PCR -aggregate and Rota PCR), blood culture (negative), and urine culture (negative). After the initial 4-5 episodes of bloody diarrhea it resolved. He started to tolerate foods better. While in the hospital he became quite neutropenic, down to 70. Trended labs there and then at her hospital f/u here repeated a CBC and CMP. ANC now 1133 which is back at normal. Has continued to be more sleepy than normal, no quite acting himself per Mom. Had an episode in the hospital of 30-40 seconds of robotic type movements which concerned Mom. No further episodes since then. Will follow up next week to see how he is doing, overall looked good on exam, gaining weight and eating.
o I recently needed to travel to  perform a walkdown of the nuclear power facility. o I opted to drive, and had "layovers" i over 01-APR-2021 through 09-APR-2021 (yes, happy easter). o I kept public interaction to a minimum, but, having to eat, make a containment entry, and answer nature's call, some interactions were close quartered, and prolonged. o Upon my return  I started a (10) day quarantine, as directed by CDC guidance . o I had muscle aches, and general fatigue, but attributed that to long daily drives in holiday traffic throughout the trip
Information has been received from an office manager concerning a 17 year old female patient who on 23-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number not available). The office manager reported that after the patient was vaccinated with the three doses of RECOMBIVAX HB, all blood work (hepatitis B surface antibody) came back negative (less than 5), "not immune", requiring a fourth dose of RECOMBIVAX HB. The patient did not develop hepatitis B. No other adverse events were reported. At the time of the report the patient had not had follow up laboratories. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information received via medical records indicated that the patient was a female (weight 151, height 64 1/4) with no illness at the time of vaccination, who on 23-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (manufacturer unknown) (lot # AHBVB789AA). On 26-SEP-1992 the patient received a first dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown); on 23-NOV-1992 the patient received a second dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown) (lot # ENG1057A2) and on 01-OCT-1993 the patient received a third dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown) (lot # ENG1057A2). On 16-JUN-2010 the patient had an anti-HBs titer (less than 5); it was reported that the patient did not have immunity to hepatitis B virus. On 30-JUL-2010 the patient had another anti-HBs titer which came back reactive. This is one of several reports received from the same source. No further information is available.
Shot site was very hot. Arm sore down to elbow and fingers on hand tingling. Chills and sweats occuring intermittently. Body aches and pains. Nausea. Headache. Redness around site.
Information has been received from a consumer concerning their child (age and gender unknown) who, on an unspecified date, was vaccinated with a dose of Hib conj vaccine(OMPC). Subsequently, the patient experienced a cold. The patient did not seek medical attention. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Sore throat, fatigue, low fever on 5/22 I tested positive. I then started Paxlovid on the 23 or 24th. Then had a mild case.  I then had COVID-19 again and symptoms started Nov 19th which were sore throat, achiness. Tested negative on the 21st and positive on the 22nd. Started Paxlovid in the evening and ended it 11/27 am and I still have a sore throat and testing positive.
Used 1 1/2 needle  over 240 lbs noticed resistance.  Pulled Back & injected.  Felt some resistance Pt. reported some discomfort, said she had some shooting pain up to neck until 4 AM 9-22-2009 now has bad ache 9 22- 5 pm.
3 inch diameter redness and warm to the touch. Also itchy  and small lump in center
Turned VERY red and hot.  Knot, a lot of Swelling.  Spread to 6x5 inches, hurt, sore and lasted 5 weeks.
sore throat that lasted for 24-36 hour; Slept all day due to Fatigue; A spontaneous report was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore throat that lasted for 24-36 hour, just slept all day due to fatigue.  The patient's medical history was not provided. Concomitant medications reported were eliquis, Ambien, Atorvastatin for drug use for unknown indication.  On 3 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) sore throat that lasted for 24-36 hour, just slept all day due to fatigue.  Treatment details included as  no treatment taken.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore throat that lasted for 24-36 hour, just slept all day due to fatigue was unknown.
When attempting to withdraw and the suspension leaked; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate reconstitution technique (Verbatim: When attempting to withdraw and the suspension leaked). The outcome of the inappropriate reconstitution technique was unknown.   Additional Information: GSK Receipt Date: 31-MAR-2023 HCP (healthcare professional) stated that no air was injected into the Shingrix adjuvant suspension vial while attempted to withdraw but the suspension leaked only onto the countertop, not on her hands, which led to Inappropriate reconstitution technique. HCP stated that she believes that the needle was not securely fastened to the syringe.  The reporter consented to follow up.
A report was received from a health care professional on 11/10/03 concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 10/27/03. On 10/27/03, the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting, the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
AFTER  PATIENT WAS  ADMINISTTERD THE VACCINE. HE WAS WAITING IN THE LOBBY AND HIS  FATHER NOTIFIED THE PHARMACIST THAT HIS SON WAS COMPLAINING OF  INCREASE HEART RATE AND CHEST PAIN ON THE LEFT SIDE OF CHEST. PATIENT WAS TAKEN BACK TO THE IMMUNIZATION ROOM TO CHECK HIS VITALS. HIS BP WAS 121/76 WITH HEART RATE 0F 102.   THE DAD SO HE WAS TAKING HIM  TO THE HOSPITAL AND THE PHARMACSIT OPTED TO CALL EMS. THE PATIENT DID WANT  THAT.   HE SAID HE FELT BETTER , BUT BEFORE EMS ARRIVED HE STARTED EXPERIENCING CHEST PAIN AGAIN. ONCE EMS ARRIVED AND CHECKED HIS VITALS AGAIN. HE STATED " HE FELT BETTER AND HIS VITALS  WERE NORMAL . EMS LEFT AND THE PATIENT DID TOO.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't use my left arm) and VACCINATION SITE PAIN (My arm was sore at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't use my left arm) and VACCINATION SITE PAIN (My arm was sore at injection site). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't use my left arm) and VACCINATION SITE PAIN (My arm was sore at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-406205 (Patient Link).
Developed rash 10-11-06 with no known fever. 10/12/06 telephone call- no hives-doing fine, recovered (used interpreter).
This spontaneous report as received from a pharmacist refers to a 63 year old female patient with no pertinent medical history. Drug reactions/allergies included macrolides, ketolides and ethanol. On 22-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J014812, Expiry: 20-FEB-2015, (0.65ml, dose number, strength and frequency unspecified) subcutaneous. No concomitant medication was reported. On 23-MAY-2014 the patient developed an injection site reaction that consisted of a large, round, red welt. There was no rash. The patient did not seek medical attention. No lab diagnostics studies were performed. The outcome of the event was reported as recovered 10 days after onset of symptoms (on 02-JUN-2014). Additional information has been requested.
This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a physician, via a company representative, concerning an 18 year old female patient, who on 26-JUN-2007, at 12:30 pm while sitting in a chair, was vaccinated IM, with the first dose of Gardasil (Lot #653736/0014U). On 26-JUN-2007, "shortly after vaccination" at 12:30 pm, when the patient attempted to stand up, she fainted or "blacked out," and fell to the floor in a sitting position. The physician added that this was possibly a "vaso-vagal spell." The patient "regained consciousness immediately," and complained of pain in her left "distal forearm and elbow, not at the injection site." She stated that before she fainted her "entire body felt tingly." The physician confirmed that the patient had recovered on the same day, and "is fine now." The patient sought unspecified medical attention. Additional information is not expected.
felt a little tired this morning; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 04Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated she felt a little tired this morning (on 05Jan2021). It was unknown if treatment was received. It was unknown if patient was diagnosed with COVID-19 prior to vaccination, and unknown if patient had been tested for COVID-19 since the vaccination. Outcome of event was unknown.
Bivalent Covid vaccine administered to patient 3 weeks after 'beyond use date' and therefor dose is not valid. Patient did not have any adverse reactions after vaccine administration.
Information has been received from a health professional concerning a 15 year old female who on 12-APR-2007 was vaccinated with Gardasil. Concomitant therapy included Depo-Provera Injection for birth control. On 13-APR-2007 after receiving her first dose of the vaccine, the patient experienced soreness in her breasts and weakness. It was reported that the patient received unspecified medical attention. No further information is available. Additional information has been requested.
While giving Covid Vaccinations, this patient under the age of 18 was given the Moderna vaccine.  Patient was monitored for 15 minutes as required after the vaccine and had no problems.  Patient was checked on today (7/2/21), and has had no problems.
Patient reported her "skin is on fire", she said it "feels like a really bad sunburn".  She reported a headache, vomiting, chills, redness on the back of her neck and bilateral legs as well as small red/ itchy bumps on her back and neck.
woke up this AM 8AM w/rash over body (not on back & not on face); red sl raised rash which itches;
Jab #1 was in Aug and Jab #2 in Oct 2021. Before Jab #1, our son was having 1 seizure every 6 weeks. After Jab 2, he's having 3 seizures in 1 month! Nothing else has changed. Diet, routine, behavior, exercise, meds - all the same. Jab#2 was the only new addition.
11:25 complained of itchy throat.  Given Benadryl 25mg po at 11:30 am.  No SOB, nausea, or other discomfort. 11:50 symptoms of itchy throat were resolved. Left clinic at 11:55 with family member
This spontaneous report was received from a registered nurse and refers to a 16-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
PAIN TO LEFT ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered in right arm on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced pain to left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain to left arm. This report was non-serious.
Initial unsolicited report received from a Consumer on 10-Nov-2015. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of ADACEL (batch number, expiry date and site of administration was not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, patient experienced reaction to ADACEL. Laboratory investigations and corrective treatments were not reported. On unspecified date, outcome of the event was not reported. Documents held by sender: none.
I received my period 2 weeks earlier. I am extremely regular. The period has lasted over 10 days a heavy clotting and severe cramping. Tissue and clots are heavy and extremely painful.