chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; Slightly feeling Nausea; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 47 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 29Mar2021 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; NAUSEA (non-serious), outcome "unknown", described as "Slightly feeling Nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt states after getting  vax on 2/6/2021 he got and itchy feeling around injection site.  On 2/7/2021 the pt noticed a 3x3 red, swollen area around injection site and hot to the touch.  Pt also had a tender spot under his right eye.  Pt states he does not have a temp.  Pt has not contacted his PCP yet but will if his symptoms do not subside.
The patient presented to the emergency department on 10/10/21 for altered mental status.  History was primarily obtained from the son and EMS. Last time the son was in contact with his mother was at 2:30 yesterday, she was doing well.  This morning he went over to check on her found her stuck between the toilet and the wall. Noticed that she was slurring her speech not moving her left side, EMS was called.  Upon arrival EMS noted her to be hypoxic not moving her left side activated her as a stroke.
he noticed a tremor in both hands; This non-serious case was reported by a consumer via call center representative and described the occurrence of tremor in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In DEC-2022, the patient received the 1st dose of Shingrix (intramuscular). In JAN-2023, less than 2 months after receiving Shingrix, the patient experienced tremor (Verbatim: he noticed a tremor in both hands). The outcome of the tremor was not resolved.   It was unknown if the reporter considered the tremor to be related to Shingrix.     It was unknown if the company considered the tremor to be related to Shingrix.   Additional Information: GSK receipt date: 11-MAY-2023. The patient was self-reported this case. The patient had his first Shingrix dose in DEC 2022.  In January he noticed a tremor in both hands. The tremor comes and goes.  The patient noticed it at rest and while holding a golf club.  The tremor stops when he thinks about it.  On 10-MAR-2023 he received his second dose of Shingrix.  Till the time of reporting patient has not seen his HCP but plans to. Nothing else was reported. The reporter did consented to follow up.
At about 6:30 patient began feeling a scratchy throat which slowly progressed to a tightening in her throat. She went to a walk in clinic and her blood pressure was quite elevated. BENADRYL was administered and symptoms subsided. When she presented at the pharmacy her concern was to identify any possible ingredients in the vaccine which might preclude any subsequent vaccinations with like ingredients.
Patient came out of the immunization room (~12:29pm), and sat down in the waiting room, as he was told to do for 15 minutes following his vaccine.  At 12:30pm, the patient hit his head on the wall in the waiting room, slumped down in his chair, and began seizing for approximately 30 seconds. He, then, woke up, sat up in the chair and did not know what happened.  The last thing he remembered was getting his shot.  The medics arrived and finished the discussion with the patient.  He remained in the waiting  room for a bit, and felt better in about 30 minutes.
(L) shoulder pain with limited range of motion. Treatment: cortisone injection in bursa of shoulder.
PATIENT STARTED SHAKING 5 MINUTES AFTER BOTH VACCINES WERE GIVEN. PATIENT WAS GIVEN WATER AND RESTED IN VACCINE CHAIR AND WAS FINE
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's weight was 135 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, and expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211038507, 20211038614, 20211038664, 20211040433, 20211038442, 20211038411, 20211034734, 20211002617 and 20211038269.
headache, sore and tired, low grade fever and rash developed on day2 inside of arms, shoulders, neck and chest and stomach
Pt had vomiting, bloody diarrhea. Seen in ER. Seemed to be in pain - bright red blood in diaper, mass palpable in abdomen. Ultrasound suspicious for intussusception. Contrast enema diagnosed/reduced intussusception. Pt had enema within approx 5 hours of start of symptoms. Hospitalized overnight. Hgb stable.  10/14/09 ICD-9 Codes received: 560.0 Intussusception.
All over body rash, progressed over the course of about 3 days, slight tightness of throat for about 4 hours on day 1 of the rash. Resolved without intervention, symptoms managed by benadryl and one steroid pill
First effects I had was a sore arm and a rash all down my left arm. Then about 2 weeks later I started having uterine bleeding. My period wasn't due till November 26th but I started bleeding on November 12th. I kept bleeding until December 5th. I started having issues with being able to get up and move around. I was having trouble breathing if I tried doing anything so I would stay in bed all day. I had terrible brain fog where I would forget how to say things and unable to think. Recently I developed insomnia to where I would wake up at 1am and be awake for 6 or 7 hours then sleep all day. My sleep cycle is reversed. I have had an extreme amounts of fatigue and not having any energy at all. I am starting to get extreme depression. I went to ER for the bleeding. PCP doesn't know how to help me because we just did consultations over the phone. I was referred to a post covid clinic but cant get in until February 7, 2021. I haven't had any test did yet.
Td given 5/15/07. Painful (R) deltoid at site of injection. Today very indurated and wheal large (7 cm) ventrally and 5 cm transversally. Very tender and warm Heat Motrin recommended
About a week after receiving my vaccine, I went to the doctor for hip pain. He noticed in my x-rays that I had severe osteoarthritis. After that, everything went downhill even further more. I started limping more and went to see to my ortho doctors. My restless leg syndrome flared up; I went from walking normally and freely to now having to use a walker for assistance for the last 3 or 4 months to get around due to severe pains I'll have shooting up my leg. I have an appointment with my ortho and neurologist soon for updates soon.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: PATIENT SAID NAUSEA, DIZZY, AND LIGHT-HEADED.  CALLED 911 WITH HER CONSENT.  EMS CAME AND TALKED WITH HER.  I WENT BACK TO PHARMACY.  I TRIED TO FOLLOW UP WITH HER, BUT SHE DID NOT RESPOND YET TO MY MESSAGE.
FATIGUE; NAUS. HEADACHE; PROFUSE SWEATING. ON AND OFF FOR 4 DAYS (UPSET STOMACH RECENTLY STOPING)
PATIENT HAD A NORMAL HGBA1C OF 5.6 ON 3/3/2021 (PRIOR TO RECEIVING ANY VACCINE). HE WAS ADMITTED ON 5/3/2021 FOR DKA AND NEW ONSET DIABETES MELLITUS WITH A HGBA1C OF >14 AND SERUM GLUCOSE OF 561.
initially first day to day 3 had sore arm, some hardness and swelling at site, all of that went away totally.  1/2/21 my left arm was fine, 1/3/21 at 2pm I had an itch and found to have significant hardness and red warm area at injection site about 1 3/4" in diameter. I circled it and then 1/4/21 at 6am noticed the redness and swelling and hardness had increased by an inch.  I contacted my doctor who diagnosed cellulitis and ordered oral antibiotics for 10 days
She got sick again; Lymph nodes under her arms swelled up; This is a spontaneous report from a contactable consumer patient (sister). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization and experienced very sick. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported that she got sick again, and all her lymph nodes under her arms swelled up. The reporter considered the events as non-serious. The outcome of events was unknown.  The lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.
Patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.  None of the patients have reported side effects, so far.
- local reaction: ice pack et. ibuprofen 800 mg. - 12/18/06 itchy rash all over body: was RX prednisone x 7 days
Employee reports approximately 6 hours after vaccine, she felt "light uncomfortable pain" to "entire lower back.  She reports next day, 3/20/10 in the morning she felt a "paralyzing sensation" to lower back with "intolerable pain" She rates pain a "5" on 0 to 5 pain scale.  She states she took Advil and Motrin to alleviate the pain.  The same symptoms on 3/20/10 continued on 3/21/10 with continued Advil and Motrin.  On 3/22/10 she felt improved enough to go to work but still felt pain to lower back.  Today, 3/25/10 she reports continued pain to lower back which she rates as a "2" on 0 to 5 pain scale and is felt at low back and to right side of lower back.  She states it has improved from the initial pain to entire lower back.
Patient c/o numbness directly below the injection side.  Redness noted to area.  VS-BP 180/103, P 71, R16.  Patient anxious due to having an allergic reaction (difficulty breathing) after taking a flu shot approximately 7 years ago.  Patient monitored for 30 minutes in the observation area.  Patient denies any SOB or difficulty breathing.  Released at 3:10.  BP 171/97.  Numbness to area subsided.
PATIENT STATED THAT AFTER RECEIVING THE FIRST DOSE SHE DEVELOPED OPEN WOUNDS ON HER HEAD
left hand index finger, red swollen, inflamed and painful, unable to curl finger down due to inflammation; left hand index finger, red swollen, inflamed and painful, unable to curl finger down due to inflammation; unable to curl finger down due to inflammation; left hand index finger, red swollen, inflamed and painful, unable to curl finger down due to inflammation; This is a spontaneous report from a contactable consumer. This consumer reported for 58-year-old male patient (Husband) that: A 58-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported), via unspecified route administration on 10Aug2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced left hand index finger, red swollen, inflamed and painful and unable to curl finger down due to inflammation. It was reported that reporter was a Pfizer employee calling on behalf or her 58 years old husband who received the first dose of the Pfizer Covid vaccine on 10Aug2021. He was reporting left hand index finger, red swollen, inflamed and painful, unable to curl finger down due to inflammation. Although swelling was reported as side effect of the Pfizer Covid vaccine. Specifics of where you are reporting the swelling is not listed. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. The outcome of events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Patient received an influenza vaccine on 11/8/2013. Pt had no reported signs or symptoms of an adverse reaction to the vaccine. Staff was informed on 11/10/13 that pt passed away in her sleep.
Patient received Vaccination at 1645 on bus and proceeded outside to wait under pavilion for observation. Patient was seated in chair next to spouse when patient had syncopal episode and and fell out of chair, hitting back of his head. Patient was observed unresponsive for approximately a minute and then had seizure for approximately fifteen seconds before entering postictal stage. Within two minutes patient was a and o times four. An abrasion was noted to the back right side of patient?s head and his front left tooth was chipped during the event though patient did not fall forward onto face. EMS was contacted at 1650 and patient was kept alert and talking while vitals were taken waiting for EMS. Manual blood pressure observed at 122/72 with a palpated pulse of 64. Patient was observed to be diaphoretic and reported feeling dizzy with a headache. C spine was established as a precaution due to nature of event and fall though patient denied nausea, had full PMS, and PERL was present. Patient denies allergies and any medical history. EMS arrived and patient care and report was handed off to Fire Department with no other changes observed.
Information has been received from a physician, via a company representative, concerning a female patient over the age of 65 years (unspecified). In approximately March 2013 (a couple of weeks ago), the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose was not reported) for the prevention of shingles. In March 2013, the patient developed a rash around the injection site after receiving ZOSTAVAX. At the time of the report, the patient's outcome of rash around the injection site was unknown. Additional information is not expected.
Pt had syncopal event with subsequent tonic clonic movement. Lasted 20 sec with spontaneous resolution. Pt observed over 45 min and discharged after normal neurologic exam/vitals.
Headache, then next day around 8:00 PM injection site red, warm, itching, painful, whole left arm hurting, nauseated, ringing in ears, dizzy, diarrhea.
Runny Nose; cough; Sore Throat; body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHINORRHOEA (Runny Nose), COUGH (cough), OROPHARYNGEAL PAIN (Sore Throat) and PAIN (body aches) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced RHINORRHOEA (Runny Nose), COUGH (cough), OROPHARYNGEAL PAIN (Sore Throat) and PAIN (body aches). At the time of the report, RHINORRHOEA (Runny Nose), COUGH (cough), OROPHARYNGEAL PAIN (Sore Throat) and PAIN (body aches) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient reported taking coricidin for treatment, after which symptoms got better.
On day 6 after vaccination (4/29/03) developed pain in L Axillary area. Also with moderate to severe tape burn from adhesive. Cleared with non-use of tegaderm and corisone ointment. Day 9 c/o burning pain at site and tenderness and swelling in axilla. Temp 98.6. 1.75 inches or erythema at site. Seen by county medical director who recommends ice and 2400mg/day of ibuprofen Day 11-redness streaking from site to L axilla. Burning pain intense. Significant nodes L.axilla. Seen by medical director and prescribed Lortab 7.5 mg hydrocorton and ice. Day 12-burning pain at site not controlled by narcotics. Tenderness and pain in axilla pain scale 8-9 without meds, 1-2 with meds. Redness at site and axilla subsided, temp 98.2 Day 15-17 slight tenderness in L axilla, swelling almost gone, burning subsiding.
In addition to all 8 "general side effects" listed (each experienced, serially over 36 to 48 hours), 48 hours following injection sense of smell was acutely increased to a previously never experienced  level. Increase sense of smell diminished over next 5 days, returning to normal.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:23 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:23 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 26.55.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188 condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
received a double dose of liquid portion/not reconstituted with lyophilized portion; received a double dose of liquid portion/not reconstituted with lyophilized portion.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA4398, expiry date 30th August 2022) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMXA4398, expiry date unknown) for prophylaxis.   On 7th July 2021, the patient received the 1st dose of Menveo and the 2nd dose of Menveo. On 7th July 2021, unknown after receiving Menveo and Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details provided were as follows: The medical assistant reported that, the patient received double dose of liquid portion of Menveo not reconstituted with lyophilized portion which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The reporter denied to follow-up.
Patient got a large hot red itchy spot about the size of a softball around the injection site. She had to use calamine and hydrocortisone to reduce itching. After 48 hours it has not reduced in size.
Information has been received from a 67 year old female consumer with high blood pressure, type 2 diabetic, high cholesterol and thyroid disorder and drug reactions or allergies to penicillin who in February 2009, was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (dose, route and lot number not reported) L. Concomitant therapy included metformin, DIOVAN, levothyroxine Na, simvastatin (manufacturer unspecified) and AMITRIPTYLIN. The patient reported that 2 weeks ago, on approximately 13-AUG-2010, was diagnosed with shingles. An urine analysis and a spine x-ray were performed on an unspecified date (results not reported). At the time of the report the patient was recovering. Patient sought unspecified medical attention. No further information is available.
pt recv vax 13FEB98 & approx 15FEB98 pt devel a chickenpox like rash;