chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My arm is hurting; Swollen hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EW0175) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm is hurting"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swollen hand". Therapeutic measures were taken as a result of pain in extremity, peripheral swelling. No follow-up attempts are possible. No further information is expected.
Patient was hospitalized with a stroke 2 days after receiving the first dose of the Moderna vaccine.
Patient presented with nausea and vomiting. Also, c/o itchy throat, like something was stuck in her throat
3 x 4" Redness, swelling, (fever 101), warm to the touch at injection sites. Went to hospital ER 5-4-07 Dx: Cellulitis both legs. Rx of Augmentin 600mg - given.
Booster; Received both pfizer's COVID booster and flu vaccine yesterday; Received both pfizer's COVID booster and flu vaccine yesterday; Left side lymph nodes are swollen; pain in armpit; discomfort in neck; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 14:05 (Lot number: fj8762, Expiration Date: Jun2022) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 01Dec2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Time: 14:25PM, Anatomical Site of injection: Arm, Batch/Lot number: Lot #EL3247), administration date: 23Feb2021, for Covid-19 Immunization; Bnt162b2 (2nd dose, Time: 14:10 PM, Anatomical Site of injection: Arm, Batch/Lot number: Lot #EL3247), administration date: 16Mar2021, for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 01Dec2021, outcome "unknown" and all described as "Received both pfizer's COVID booster and flu vaccine yesterday"; IMMUNISATION (non-serious) with onset 01Dec2021 14:05, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset Dec2021, outcome "unknown", described as "Left side lymph nodes are swollen"; AXILLARY PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "pain in armpit"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset Dec2021, outcome "unknown", described as "discomfort in neck"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "chills". Therapeutic measures were taken as a result of lymphadenopathy, axillary pain, musculoskeletal discomfort.  No follow-up attempts are possible. No further information is expected.
Found in bed having a seizure & Vomiting EMT called Versed Administered, taken to ED. Dx Complete Febrile Seizure Todd's paralysis
Influenza vaccine (inactivated injectable) given in left triceps muscle resulting in 0% extention of left wrist (radial nerve palsy) within 24 hours on injection on 10/22/2010.
Red 8x12 cm lesion approx 6cm distal to injection site firm, red, warm nontender no itching - Also smaller satellite lesions.
rebound Covid; rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results.  Clinical information: Forwarded as an Adverse Event by the team on 14Jul2022. Reporter provided verification of contact address on 14Jul2022 you need to update your records on rebound Covid after taking your antiviral medication. In my small circle she know 7 people that have gotten Covid again. "If I do my husband has it again and I am still testing positive. I never would have taken it if I knew that percentage of peoples that get it again. It should only be given to very high risk people".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200023743 same drug /event, different patient.;
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 17-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L020189, expiration date: 03-JUN-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
This case was reported by a healthcare professional via sales representative and described the occurrence of febrile seizure in a 2-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). On an unspecified date the subject received the 1st dose of PEDIARIX (unknown). Less than one day after vaccination with PEDIARIX, the subject experienced febrile seizure and fever of 101 degrees Fahrenheit. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the febrile seizure and fever were unspecified.
Pt recv vax on 8/17/98; on same day pt exp fever (104.5), decreased appetite, febrile seizure, red throat/ears; tx=antibiotic injection; dx=strep throat
Did not receive 2nd dose. It has been 2 months since they received their 1st dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose. It has been 2 months since they received their 1st dose.) 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 PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose. It has been 2 months since they received their 1st dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose. It has been 2 months since they received their 1st dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.  It had been 2 months since he received his 1st dose. He was in a nursing home (rehab) and the facility would not give them a 2nd dose.
immed p/inject given-lump @ inject site (3-4 cm across) not red, not painful, but significantly swollen; observed pt for 30 mins w/no systemic sx's appearing; swelling had gone down alot p/30 mins; not painful; briefly checked by MD;
She had facial fillers injected (restylane Defyne brand) 9/29/21, and approximately 5 weeks prior to today (4/20/21) developed swelling in the treated area along the jawline.  I evaluated her today, and initiated treatemtn of a suspected granulomatous like reaction
Raised red area about 2 to 3 inches around. Headach. Nausea,  Aches, tiredness, weakness. For 2 days now.
This spontaneous report as received from an unknown reporter from an immunization program refers to a patient of unknown age or gender. On an unknown date the patient was vaccinated with GARDASIL (dose and route not reported, lot # J003727, expired date 07-NOV-2014). It was reported that GARDASIL was improperly stored vaccine. Additional information is not expected.
Swelling in the axillary region that extends into the front left pec and the back to the scapula and down to the middle ribs. No redness. Swelling is minimally tender to touch. Feels like fluid.
Pt presented 2 days after Tdap with cellulitis right upper extremity, Pt states she first noticed symptoms developing afternoon of injection. Vital signs stable.
I started getting symptoms on Thursday 07/21. I woke up with a sore throat and a little bit of a headache. And then I felt off throughout the day, by dinner time I felt the chills so I just went to bed. I woke up the next morning with a sore throat. And i took 4 test only one was positive. I called my doctor and told him my symptoms and he gave me Paxlovid. So I isolated for 5 days and i have been testing and it was negative.
Information has been received from a licensed visiting nurse concerning a 55 year old female who on 26-JAN-2007 was vaccinated with a dose (0.5 ml) of varicella virus vaccine live (lot # 654083/0917F) (Oka/Merck). There was no concomitant medication. On Approximately 30-JAN-2007, "about four days after receiving injection" the patient experienced redness and swelling. On 16-FEB-2007 the patient experienced broke out with 50 or less lesions after receiving varicella virus vaccine live. the patient's redness and swelling and lesions persisted. unspecified medical attention was sought. there was no product quality complaint. Follow-up information received from the registered nurse indicating that the patient's age is actually 55 years old. No further information available.
Pain in left shoulder and limited range of motion of shoulder and left arm. Still a problem as of 02/27/2016.
Cluster of papules at injection site. Isolated papules on upper chest, 1 on back of neck. Afebrile and asymptomatic.
pt recvd vax;5 hrs later,severe chills;v;diarrhea & some constriction of her throat,lasted x 6 hrs;next day was weak;has recvd vax x last 5 yrs & has had no rxn before;pt states felt great before shot given;
Localised reaction, redness, burning, pain starting from site of injection then radiating all over the arm and other visceral parts. No energy for 2 days. Now after 3 days patient feeling better.
Severe left arm swelling from shoulders into arm and hand. Started Medrol Dose pack  today 08/06/2021.
Information has been received from a registered nurse concerning a 42 year old female pt with asthma who on 10/29/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. In March 2002, the pt's titer results were very low. Unspecified medical attention was sought. Additional info has been requested.
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 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 11:37 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 11:18 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced 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). 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.     Concomitant products were not provided.  On 27-FEB-2021, Excursion time was 09 AM,11AM,12PM,1PM,2PM,3PM,4PM and 5PM. temperature was 22,33,35,35,35,35,34,34, and 35 respectively. total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-FEB-2021, vial was moved to clinic on 27-FEB-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-MAR-2021.  On 27-FEB-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34 and 4 PM: 34 and 5PM: 35.  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  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.
Bell?s palsy the morning after the vaccination administration with left facial droop, left lip swelling
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 31-year-old female patient received BNT162b2 (BNT162B2), on 21Aug2021 as dose 3 (booster), single (Lot number: EW0185) at the age of 30 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Known Allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM [ESCITALOPRAM OXALATE], start date: 10Oct2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Negative antigen test; (14Nov2022) Positive, notes: Positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 02Nov2022 to 06Nov2022.; Sender's Comments: Based on the known the information available the Causal relation between the events DRUG INEFFECTIVE, COVID-19 and suspect drug cannot be excluded completely
This non-serious spontaneous case, was initially received on 14-Sep-2017, from other Health Professional and concerns a female patient of unspecified age. The patient's concomitant medications included FLONASE for unknown indication. On an unspecified date in Sep-2017, the vaccine stored FLUCELVAX QIV in a new fridge that reached 29-degree F and later it was displaced to the fridge after it reached 63.96-degree F for less than 24 hours in the previous one. On 14-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). It was reported that four administrations took place after second excursion, recommended the vaccines be discarded. It was reported that, no adverse event was experienced by the patient. The outcome of the events was not reported. The reporter assessed the report as non-serious. Follow up report received on 20-Sep-2017: It was reported that, no adverse event was experienced by the patient. The narrative was amended accordingly. Non-significant case correction received on 14-Sep-2017: Batch number was added in the screen. The narrative was amended accordingly.
sore arm; aching; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 23Apr2021 (Lot Number: ER8736; Expiration Date: 31Jul2021) as first dose, single and then via an unspecified route of administration on 14May2021 (Lot Number: EW0168; Expiration Date: 31Aug2021) as second dose single for COVID-19 immunization. Medical history included ongoing asthma and certain allergies. The patient's concomitant medications was taking medications for asthma. The patient had first dose on 23Apr2021 and second dose on 14May2021 and experienced a sore arm and aching after both doses on an unspecified date in 2021. Stated was taking medications for asthma and certain allergies in between the COVID doses for her pre-existing conditions that started way before having the Pfizer vaccine. It was confirmed she had been taking these medications because of her pre-existing conditions for about 40 years. Stated tomorrow will be two weeks since she got her second shot. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Approximately 3 days after the vaccine, I began to have irregular heartbeats throughout the day.  After about 2 weeks the irregular heartbeats began to feel more like heavy fluttering and gradually as the weeks went on turned to light fluttering.  Today, 5 weeks after the vaccine, I felt no fluttering at all for the entire day, for the first time.
COMPLAINED OF UNWITNESS SYNCOPAL EPISODE WITHOUT INJURY, NAUSEA, AND VOMITING LIQUID EMESISX2.
Information has been received from an unspecified reporter via a company representative referring to an 11 years old male patient. The patient's medical histories, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dose, route, lot # and expiration date were unknown) for prophylaxis. On an unknown date the patient had edema measuring 4cm at the injection site of GARDASIL 9. Outcome of the event was unknown. Causality was not reported.
2-3 mins following vax inject, pt was standing & c/o heart racing; radial pulse checked by RN counted @ 104; BP 130/92; pt sat down in chair p/10 mins-15 mins RP 80; pt given coca-cola, rechecked pulse & AP 30 mins p/inject RP 64; BP 120/88
TESTED POSITIVE FOR COVID-19; This spontaneous report received from a consumer concerned a 24 year old male. 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: 204A21A and expiry: 21-SEP-2022) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JAN-2022, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
FIFTEEN MINUTES AFTER VACCINATION THE PATIENT FAINTED. SHE WAS PALE AND DIDN'T RESPOND FOR A FEW MINUTES. SHE WAS GIVEN A SOMETHING TO DRINK (A SUGAR BEVERAGE). 911 WAS CALLED.
diffuse diarrhea that began 1 day s/p Moderna Covid injection #2.  diarrhea has continued x 5 days .  accompanied by 24 hours of fever, chills/ body aches that resolved
Patient was accidently given a 3rd dose of varicella. Medical Assistant and provider failed to check Immunization record.
Serious anaphylaxis started at 630 PM the day after the Moderna dose was administered .  I ended up at the Medical Center  ICU for two days  before conditions abated and I could be discharged .
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 2:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 2:40 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.96 years.  Concomitant products were not provided.  On 29-Sep-2021, the vaccines were moved to fridge and on 27-Oct-2021, 02 vials were moved to clinic. Proposed beyond use date for these two vials was 29-Oct-2021.  On 05-Oct-2021, the vaccines were moved to fridge and on 27-Oct-2021, 04 vials were moved to clinic. Proposed beyond use date for these four vials was 04-Nov-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On the date of administration, at 09:00 A.M., the temperature recorded was 29 Fahrenheit and on the same day, at 10:00 A.M., the temperature recorded was 32 Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Patient noted being "shaky and weak" the morning after receiving the vaccine. She claims she "passed out" at the health center the morning after receiving the vaccine. Patient attributes this incident to the vaccine.