chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; achy; extremely tired; loose bowels; head ache; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and hypothyroidism (reported as thyroid hypo). The patient did not had allergy to any medications, food, or other products. The patient received unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 05:00, the patient experienced chills, achy, extremely tired, loose bowels, and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for reported events. The clinical outcome of the events chills, achy, extremely tired, loose bowels and headache were recovered with sequelae on an unknown date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Vomited x 2 9:00 am 5 minutes after receiving. 10 am 1 hour later after receiving.
Sudden loss of extensor strength in legs and left arm lasting for 15 minutes. Returned in right arm with a burning sensation in right face (CN V2 distribution) and lasted for 10 minutes.
Patient came to the pharmacy on 2/20/21 at 9:40am and reported swelling and itch at the injection site on her left arm staarted on 2/19 a week after her Moderna dose 1. The swelling is 2/3 of her upper arm and hot to the touch.  Informed patient it could be an injection site reaction and advised patient to take benadryl 25 mg and if the swelling and itchiness become worsen within a few hours or days, go to urgent care. Also advised patient to report to V-safe. Patient said she is feeling  fine except the swelling that is a bit bothersome.
17 patients, were inadvertently administered vaccines, deemed to be nonviable from excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a child patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date-17-MAY-2022 Reporters comment- The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371. Registered nurse manager called in to inquire about the time interval for repeat dose and if it was safe. The reporter was unable to provide any vaccine or patient details. The reporter consented to follow up. Additional supportive information: The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371, which led to incorrect storage of drug. This was one of 17 linked cases reported by the same reporter.
This is in follow-up to report(s) previously submitted on 3/7/2005. Information has been received from a consumer concerning her newborn niece (one day old) who on 03/08/2004 was vaccinated with an adult formulation of hepatitis B virus vaccine rHBsAG (yeast) (10mcg/ml).  Concomitant therapy that day included "another hepatitis vaccine" (manufacturer unknown).  On 03/09/2004 the patient had a "rash on her stomach around her navel. " The patient sought unspecified medical attention.   Additional information has been requested. This is an amended report. The patient's age of one day old has been added. This report is corrected, as amended.
09/02/22 presents to  ED for "fall". PMHx of "CAD, hyperlipidemia, hypertension, type 2 diabetes"
12/22/20, 13:36: 6 minutes after receiving the 1st Pfizer vaccine injection, there was stiffness felt behind my ears and in the back of my neck. 10 minutes after the injection, there was a fullness noted along my throat and upper pallet. The symptoms only slightly lessened after 30 minutes. I have a hx of Rheumatoid Arthritis, completing prednisone doses 4 days ago and currently taking Celebrex and IBU daily. The Benadryl liquid dose (25mg) taken at 14:15 completely resolved my reaction symptoms by 15:15.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022).    No concomitant product use was reported.  Patient received half dose.  Vial did not undergone any temperature excursions.  No treatment information was provided
pt recv 2 doses of vax 29DEC95 & 9FEB96 & MAY96 lab eval revealed negative seroconversion;
Pfizer Vaccine administered to individual under 12 years old; vaccine is only authorized for 12+.  No adverse event/outcomes noted.  Parents of children misrepresented their age when making the children appointments to get the vaccine.  Registration noticed the children were under 12 years old when they were looking at second dose scheduling and noticed duplicate accounts with same info but different ages.
Patient has history of anaphylaxis with wheat, mango, mosquito, and leak. She was told to wait post vaccination for 30 minutes. After vaccination I checked on the patient around 20 minutes mark and she said she said she felt itchiness on the injection site and itching in her chin/mouth area. I recommend and administered benadryl 25mg and observed for another 30 minutes. Patient said she felt better so I sent her home.
12-26-2020 uncomfortable heart palpitations, tired and disruption of sleep x 2 days.
This non serious case was received on 08 May 2009 from a health care professional.  A 12 year old female patient received a second dose of ADACEL (lot number C3068AA) intramuscularly in the left deltoid and MENACTRA (lot number U2869AA) intramuscularly in the right deltoid on 07 May 2009.  On 08 May 2009 the patient developed a fever, headache, and dizziness.  The recovery status was not reported.  Follow up information received on 26 May 2009 from a health care professional who reported that the patient recovered.  No further information was provided.  List of Documents held by Sender:  none.
By early evening I was  in extreme pain trying to move my right arm.  The person who gave me the shot insisted 2x that it was exztremely important for me to raise my right arm every hour on the hour.  by 3:00 am I was crying and took Vicodan for the pain.  I suffered thru Friday expecting to be better and on Saturday am I called the doctor's office and got an emergency appointment.  I had also begun sever allergic symptoms with my face swelling (Glasses left dents in side of face) My ears were extremely red and hot to touch and the NP gave me a steroid shot for the allergies.  She yelled at me for taking leftover pain medicine and stated Oh my God you have frozen Shoulder.
Erythema and edema of arm that received injection. Bruising and pooling of blood in tricep region.
STARTED ON 2/11/2021 WITH HEADACHE ,FEVER ,CHILL,S BODYACHE, HEADACHE, LOSS OF APPETITE, NAUSEA, PAIN AND TIGHTNESS LEFT ARM AND LEFT AXILLA, LEFT CERVICAL PAIN, PHOTOPHOBIA. UNABLE TO GO TO WORK TODAY.
I had my booster recently and since then my blood pressure has been going up consistently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: Unknown, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: HYPERTENSION (non-serious), outcome "not recovered", described as "I had my booster recently and since then my blood pressure has been going up consistently". Relevant laboratory tests and procedures are available in the appropriate section.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Twisted my ankle; This spontaneous case was reported by a consumer and describes the occurrence of LIGAMENT SPRAIN (Twisted my ankle) in a patient of an unknown age and gender 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 LIGAMENT SPRAIN (Twisted my ankle). At the time of the report, LIGAMENT SPRAIN (Twisted my ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.  Patient queried about taking Advil (ibuprofen).
Information has been received from a nurse practitioner concerning a female patient with allergy to Ceclor, who on 31-MAR-2009 was vaccinated with the first dose of GARDASIL (Lot not reported). On 01-APR-2009 the patient developed itchy ears and jaw. At the time of reporting the outcome of the patient was unknown. Additional information has been requested.
Severe pain left elbow into shoulder Headache Fatigue Fever  Ibuprofen every four hours 2/6/21-2/7/21
Have been having dull headaches; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received bnt162b2 (lot number: EK5730 and Expiry Date: 31Mar2021), via an unspecified route of administration on 30Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer Covid vaccine on December 30th. Since that day she has been having dull headaches. It has been 9 days. The patient does not want to take Tylenol for dull headaches. The outcome of the event was not recovered.
No additional AE reported; received the 2nd dose 3 weeks after the 1st dose; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.      On approximately 15-FEB-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact dose, route, lot number and expiration date were not provided) for prophylaxis. On 08-MAR-2021, 3 weeks after the first dose, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact dose and route were not provided; lot number T008152; expiration date 21-JUN-2022) for prophylaxis(inappropriate schedule of vaccine administered). No additional adverse event (AE) reported.  This is one of two reports received from the same reporter(case # 2104USA001691). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008152; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001691:
Strong metallic or chemical taste and sensation in throat shortly after taking pills; sensation in throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Strong metallic or chemical taste and sensation in throat shortly after taking pills) and OROPHARYNGEAL DISCOMFORT (sensation in throat) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Migraine, Borderline hypertension and Anxiety. Concomitant products included LISINOPRIL, PROPRANOLOL, FREMANEZUMAB (AJOVY [FREMANEZUMAB]), MULTIVITAMINS [VITAMINS NOS], CALCIUM, ERGOCALCIFEROL (CALCIUM/VITAMIN D [CALCIUM;ERGOCALCIFEROL]) and FISH OIL for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On 11-May-2022, the patient experienced DYSGEUSIA (Strong metallic or chemical taste and sensation in throat shortly after taking pills) and OROPHARYNGEAL DISCOMFORT (sensation in throat). At the time of the report, DYSGEUSIA (Strong metallic or chemical taste and sensation in throat shortly after taking pills) and OROPHARYNGEAL DISCOMFORT (sensation in throat) was resolving.            Patient had allergic reaction to Pain killers. Patient had Strong metallic or chemical taste and sensation in throat shortly after taking pills. Pills had a strong odor when opening package. The patient was taking any other medications within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.
manic episode; scratched arms repeatedly (self harm)/scratching chest repeatedly; scratches on arms (self harm)/scratches to chest; felt like skin was crawling; This is a spontaneous report from a contactable consumer or other non-HCP. (patient's mother reported). A 13-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Left Arm on 08Jun2021 12:30 as single dose (at the age of 13-years-old) for covid-19 immunization (reported as, prevent infection of Covid 19). Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0169, Expiration date:31Aug2021) administered in Left Arm on 13May2021. Patient stated that it was a shot or needle to her left arm. Medical history included anxiety from 2015 and ongoing, depression from 2018 and ongoing. The patient's concomitant medications includes unspecified medications for Anxiety. No further details provided. History of all previous immunization with the Pfizer vaccine considered as suspect(or patient age at first and subsequent immunizations if dates of birth or immunizations are not available):None. Additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) If applicable, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. On 08Jun2021 20:30 the patient experienced scratched arms repeatedly (self harm)/scratching chest repeatedly and scratches on arms (self harm)/scratches to chest. On 08Jun2021 15:30 the patient experienced felt like skin was crawling. Reporter stated that her child received the second dose of Pfizer vaccine on Tuesday and had self harm that afternoon. Does not know if it is correlated or not. Stated that she felt like her skin was crawling and had to do something about it. Stated that she had self harm where she scratched her arms and chest repeatedly. Stated that she had to go to behavioral health center. Reporter stated that the patient was anxious before the vaccine and it built up and led to harming herself. Does not know if the vaccine caused it or not. Reported stated that patient was fine now. Stated that it was all a manic episode within hours of the vaccine. On an unspecified date, the patient experienced manic episode. Patient visited Physician Office for AE self harm. Reporter did not provide the Physician details. Stated that the scratches are still there and there is a potential for scaring. Treatment were None. Relevant Tests: None. The outcome of event scratched arms repeatedly (self harm)/scratching chest repeatedly had recovered with sequelae on 08Jun2021 and the outcome of event scratches on arms (self harm)/scratches to chest had not recovered. The outcome of event manic episode was unknown while the outcome of event felt like skin was crawling had recovered on 08Jun2021.   Information on Lot/Batch number is available; Further information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The medical assistant reported that, on an unknown dates, an unspecified number of patients were administered improperly stored doses of VARIVAX (Merck) (lot #, expiration dates, doses and routes of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I HAD AN UTERINE ABLATION 12 YEARS AGO, I HAVE NOT HAD A PERIOD FOR 12 YEARS. ON  11/28/21 - I STARTED HEAVY BLEEDING, IT HAS BEEN GOING ON FOR 3 DAYS NOW. MY MENSTRUAL CYCLE HAS BEEN NOTHING SINCE I HAD THE ABLATION DONE.   LIKE I SAID, IT IS HEAVY BLEEDING THAT IS DEFINTLY NOT NORMAL FOR ME.   I GOT THE VACCINE ON FRIDAY (11/26/21 IN THE AFTERNOON) AND THE BLEEDING STARTED ON 11/28/21, IN THE MORNING. I AM CURRENTLY WAITING TO SEE IF THE SITUATION RESOLVES ITSELF, IF NOT, I WILL BE CALLING MY DOCTOR AND/OR GOING TO THE HOSPITAL
Initially fever to 103 and headache, then developed a Stye on left eye and pain around entire left orbit lasting severe days, and has subsequently had significant brain fog, misplacing items, forgetfulness, which had never experienced before and in absence of any mood problem and is still ongoing a month later
c/o not feeling good p/vax;also feeling faint & dizzy & numbness rt deltoid muscle;pt to hosp 11OCT97 paramedic on 13OCT97 pt states OK  was not given anything was told by ER;pt just nervousness & hyperventilating;
It started on 11/26/22 I've been sick since then. I started to get pain two weeks ago. My fingers on my left hand started to get numb, It feels like the numbness has gotten worst. I had a phone consultation yesterday 12/15/2022 and doctor advised chronic medication treatment but they both disagreed on that treatment, and I will wait it out. I've never been sick like this.
Consumer stated he was diagnosed shingles in his eye. He received the vaccine in 25-FEB-2012. He was wanting treatment, I provided the Sr number and also the medical team number. The consumer has no drug reactions/Allergies.
Elevated bp hours after vaccine along with sore arm. Next morning, muscle/joint aches, inability to ambulated, severe headache, brain fog, chills, shaking/trembling,pain all over.  Evening of 1-2-2021, itching all over and hives on trunk.
Pfizer COVID vaccine incorrectly diluted with 0.9% normal saline in multi dose vial with preservative. Correct diluent should be 0.9% normal saline in single-dose vial without preservative. When Pfizer was called at store level, they were not able to give any information on anything other than the single-use vials that were studied. Hospital called the morning of 08/03/21 and spoke to the medical team at Pfizer who gave the same information. Was able to say that the reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials that were used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline. No adverse events reported by patient.
Initial misuse report received from a health care professional on 07 January 2014. A patient of unspecified demographics had received FLUZONE ID at inappropriate age. The patient did not experience any adverse event. Documents held by sender: none