chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received expired Moderna Covid-19 vaccine for her second dose; First dose was Pfizer and second dose was Moderna; First dose was Pfizer and second dose was Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine for her second dose), INTERCHANGE OF VACCINE PRODUCTS (First dose was Pfizer and second dose was Moderna), COVID-19 IMMUNISATION (First dose was Pfizer and second dose was Moderna) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 05-Jul-2021, Prevnar vaccine on 27-Mar-2023 and Hepatitis A Vaccine on 27-Mar-2023. Past adverse reactions to the above products included No adverse event with Hepatitis A Vaccine, PFIZER BIONTECH COVID-19 VACCINE and Prevnar vaccine. Concurrent medical conditions included Psychiatric disorder NOS. Concomitant products included CLOZAPINE for Psychiatric disorder NOS.    On 05-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine for her second dose), INTERCHANGE OF VACCINE PRODUCTS (First dose was Pfizer and second dose was Moderna) and COVID-19 IMMUNISATION (First dose was Pfizer and second dose was Moderna). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine for her second dose), INTERCHANGE OF VACCINE PRODUCTS (First dose was Pfizer and second dose was Moderna), COVID-19 IMMUNISATION (First dose was Pfizer and second dose was Moderna) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine for her second dose), INTERCHANGE OF VACCINE PRODUCTS (First dose was Pfizer and second dose was Moderna) and COVID-19 IMMUNISATION (First dose was Pfizer and second dose was Moderna).    It was more than 35 days between first and second primary series doses of Covid-19 Monovalent vaccine Pfizer and Moderna. Patient reported no other adverse reactions. No treatment information was provided.
4/4/16-dad called, states site of injection red with "wart-like" area.  Resolved.  4/11/16-Seen in office for sore throat, stomach ache.  Rapid Strep and culture negative, not treated.  4/14/16-Twin + strep, patient with peristent sore throat/stomach ache, fever.  Not seen, treated with Amoxicillin.  4/20/16-seen due to light headed, dizzy, headache.  Labs ordered.  4/22/16.  Seen due to +ASO, treated with Amoxicillin.  Saw neurologist (around 5/4) started on Tenex for tics.  Continued with no energy, pale, weak.  Encouraged to increase salt/fluids.  On Zofran and Antivert.  Saw Cardiologist 5/11/16, Per mom, cardiologist did not find cause of symtpoms.  5/16/16-seen in office for sore neck, dx'd with wry neck.
administration of Arexvy to patient that was stored at 30.308F x 20 hours; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 70-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3AK2K, expiry date 09-DEC-2024) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: administration of Arexvy to patient that was stored at 30.308F x 20 hours).The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 06-SEP-2023 The reporter reported that administration of Arexvy to patient that was stored at 30.308F x 20 hours, which led to incorrect storage of drug. The date of administration was unknown. The reporter did not get permission for safety follow-up at time of call.
Sunday morning (2 days after 1st shot) I started smelling cigarette smoke. This has continued for three days.
12:15pm- patient became flushed, "heart pounding", c/o headache.  BP 214/120  Pule 160 BPM  O2- 99%  12:20pm- Pt reported anxiety increasing. BP 211/85. Pule 148 O2- 99-100% 12:25pm- Headache continues, "heart pounding"  EMS called at 12:15pm and patient brought to Emergency Department.
Nausea and Vomiting and Dizziness with chills through out night, no fever reported.
shingles; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 69, Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 22Feb2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date. The patient wanted to know whether being on pregabalin (LYRICA) and gabapentin would diminish the effect of the Pfizer COVID vaccine. She has read online that taking acetaminophen (TYLENOL) will diminish the effect of the vaccine. The patient reported that she received the 1st dose of the Pfizer COVID vaccine last night (22Feb2021) and has been prescribed pregabalin today (23Feb2021) for the case of the shingles. The patient wanted to know where else she can refer to for additional information on drug interactions. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Initial report received from vaccine adverse event reporting system (VAERS 396173) on 25 Oct 2010: This patient was vaccinated with MENVEO (batch number unknown) and TDAP (batch number unknown) on an unspecified date. On an unspecified date, the patient fainted. Outcome of event was not reported.
Refrigeration excursions identified/undergone several temperature excursions; No adverse event; Vaccines have undergone several temperature excursions and may have been administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022 at 6:33 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 22-Sep-2022 at 6:33 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients).    No concomitant medication was provided.  Patient took first, second and third dose through intramuscularly at deltoid region. Dose 4 vaccine administered at deltoid region.   Date vial was moved from freezer to refrigerator on 7-Sep-2022.   The vial had undergone temperature excursions.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.   Reportedly, the nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter.
Just began overnight last night ~ 1 week after vaccination. Injection site is sore, worse to the touch and itches.
Per patient, she fell and hit her head on a coffee table earlier today, she is unclear how she fell. Patient denied LOC, chest pain, and dizziness prior to event. Patient also c/o difficulty breathing this morning, which was new for her. Prior to today she felt like her usual self. She sleeps with 1 pillow and denies any orthopnea or LE edema.   For collateral information, daughter was contacted. Daughter states that patient was disoriented this morning. Pt is able to answer questions appropriately but daughter feels she is still not at her baseline. Patient lives with daughter, but does not leave the house. Pt did have a sick contact on Christmas Eve (daughter's boyfriend tested COVID positive 12/28) and patient's grandson is visiting from out of state (no symptoms).   Patient and daughter deny fevers, CP, cough, appetite changes, n/v/d. Patient's daughter states that patient was SOB at home.  Pt is COVID vaccinated x2 and also received influenza vaccine this year.
Administer expired vaccine to patient after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that it was unknown when the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non-significant information.
SEIZURES; DID NOT SLEEP WELL; IRRITABILITY; ANGER; CRYING; BAD RASH ON HIS BOTTOM; This spontaneous report received from a consumer concerned a 32 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included quadriplegia, deafness, and seizures. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 on left arm for prophylactic vaccination. Concomitant medications included unspecified seizures medications. On 06-Apr-2021, after receiving the vaccine the patient did not sleep well, since then extra seizures. The patient has had an inaudible seizure for several years. On 21-APR-2021, the patient slept through the night, irritability. The patient was totally different, angry, crying a lot, had rash, one on his bottom and bad one there. The patient took seizures medicine three times a day. The patient did not have any further information.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the did not sleep well, seizures, irritability, anger, crying and bad rash on his bottom was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : - Covid-19 vaccine ad26.cov2.s-SEIZURES- This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. 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: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Unknown adverse reaction. Pfizer vaccine mixed using the wrong diluent. Bacteriostatic 0.9% Sodium Chloride for Injection was used rather than NON-bacteriostatic as recommended per manufacturer.
Headache , slight fever 99, severe tremors, severe fatigue, chills, confusion, and weakness
Sat the patient down for their vaccine, after administration patient stood to wait while mother and sister received their vaccines. While waiting patient was leaning on wall when she passed out and slid down, that's when I ran over to catch the patient and help her into a chair. Gave her water, orange juice and a granola bar. After patient felt better I checked her blood pressure and it was within normal limits.
arm was hurting; This is a spontaneous report from a contactable consumer via Medical information team. A 76-year-old female consumer (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number and expiration date: Not reported) via an unspecified route of administration as a single dose for COVID-19 immunization on an unknown date. The patient past medical history included Alzheimer's. Concomitant medications were not reported. The patient reported that on an unknown date, she woke up in morning and her arm was hurting, so she felt her arm and the band aid felt wet. She wants to know if this could be fluid from the vaccine that leaked out. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache, Myalgia, Fever, SkinRash, NauseaVomiting, Palpitations, Fatigue. "Teary eyes". "Rapid heart beat". Narrative:  Intermittent moderate fever x1 week, moderate headache x3 weeks, mild muscle pain x3 weeks, mild fatigue x5 days, moderate nausea x1 week, moderate red warm rash gradually improved over 3 weeks, mild "teary eyes", mild rapid heartbeat. Resulted and unable to work 1/16/2021 and 1/22/2021.
A wave of something came over me almost right away, where I just felt a little off - I was still able to drive home, and felt pretty much ok for the rest of that day.  By the next morning, I had horrible muscle aches, a headache, extreme fatigue, chest tightness, and a mental fog that at times had me slightly disoriented and almost dizzy.  These symptoms lasted that entire second day, even with the administration of Tylenol.  I started to feel somewhat better by night fall, but by the following day I was back to normal.
Injection site became swollen; Injection site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site became swollen) and VACCINATION SITE ERYTHEMA (Injection site red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Injection site became swollen) and VACCINATION SITE ERYTHEMA (Injection site red). At the time of the report, VACCINATION SITE SWELLING (Injection site became swollen) and VACCINATION SITE ERYTHEMA (Injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Headache, fever, muscle aches, tiredness.  Resolved over course of 3-4 days.
STOMACH PAINS; CHILLS WITH FREEZING SHIVERS; PAIN WHERE VACCINE WAS INJECTED; ENTIRE STOMACH FEELS BLOATED AND GASSY; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included low testosterone, alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. Concomitant medications included testosterone for low testosterone.  On JUN-2021, the subject experienced entire stomach feels bloated and gassy. On 23-JUN-2021, the subject experienced pain where vaccine was injected. On 25-JUN-2021, the subject experienced stomach pains. On 25-JUN-2021, the subject experienced chills with freezing shivers. Laboratory data (dates unspecified) included: Colonoscopy (NR: not provided) colon twisted. Treatment medications (dates unspecified) included: simeticone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills with freezing shivers, and had not recovered from stomach pains, pain where vaccine was injected, and entire stomach feels bloated and gassy. This report was non-serious.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: pt felt numb on left side of cheeck, then radiate as tingling sensation on tongue and lip. blood pressure was going up.
mom reported that pt recv vax 28OCT98 & w/in 24hr devel T102 w/high pitched screaming that lasted for several hr evening of vax & the next day;rt leg swollen, very red & hot to touch;also fever;reporter felt poss rxn to vax;
pt stated that she woke up with left arm throbbing, has chills, was extremely thirsty, very fatigued, has cough and nausea with no appetite.  Pt states she is not sure if she has a temp but took 500 mg Tylenol at 3:00AM.  Pt will contact PCP for medical advice.
Pregnant 27 yo called 11-25-2009 to report following: started experiencing numbness and tingling in left cheek and in wrist 4-5 hours after immunization (similar to feeling of having a filling). Tingling and numbness are intermittent with varying duration. Report filed 11-30-09 with complaint still present.
Chills; Body aches; Menstrual period for 2 1/2 months straight; Pretty sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Menstrual period for 2 1/2 months straight), PAIN IN EXTREMITY (Pretty sore right arm), CHILLS (Chills) and MYALGIA (Body aches) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced MENSTRUATION IRREGULAR (Menstrual period for 2 1/2 months straight) and PAIN IN EXTREMITY (Pretty sore right arm). On an unknown date, the patient experienced CHILLS (Chills) and MYALGIA (Body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. On 18-May-2021, PAIN IN EXTREMITY (Pretty sore right arm) had resolved. At the time of the report, MENSTRUATION IRREGULAR (Menstrual period for 2 1/2 months straight) had not resolved and CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported.  Patient's menstrual period started before the first dose of the vaccine. Patient reported that she never had COVID before and wanted to stress that she firmly believes that the extended menstrual period was associated with the Moderna vaccine.   This case was linked to MOD-2021-262879 (Patient Link).
Pt vaccinated with DTP/OPV developed fever 40.2 lasted for about 2 days; unconsolable crying on & off x 1 day.