chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was expired on 13May2022, stored in refrigerator on  7Jun2022 and administered on 7Jun2022; No adverse event; administer a expired vaccine to more than 40 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer a expired vaccine to more than 40 patients), PRODUCT STORAGE ERROR (Vial was expired on 13May2022, stored in refrigerator on  7Jun2022 and administered on 7Jun2022) and NO ADVERSE EVENT (No adverse event) in a 25-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 022C21A and 040B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Apr-2021 at 9:09 AM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 13-May-2021 at 8:08 AM, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 07-Jun-2022 at 10:52 AM, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 10:52 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer a expired vaccine to more than 40 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13May2022, stored in refrigerator on  7Jun2022 and administered on 7Jun2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer a expired vaccine to more than 40 patients), PRODUCT STORAGE ERROR (Vial was expired on 13May2022, stored in refrigerator on  7Jun2022 and administered on 7Jun2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administer a expired vaccine to more than 40 patients) and PRODUCT STORAGE ERROR (Vial was expired on 13May2022, stored in refrigerator on  7Jun2022 and administered on 7Jun2022).    Concomitant medications were not reported. They thought that Moderna had an extension like Pfizer, and they though it would expired on the 13Jul2022 but it was expired on the 13May2022, they realize this on the 8Jun2022. The total Number vials reported as 5 vials. The vial did not undergo any temperature excursions. Treatment medications were not reported.
pain and discomfort is a 3.5 out of 10; electric shock going down his arms and legs; numbness and tingling in left arm and leg/"little back numbness and tingling in right arm and leg"; numbness and tingling in left arm and leg/ "little back numbness and tingling in right arm and leg"; could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness and tingling in left arm and leg/"little back numbness and tingling in right arm and leg"), PARAESTHESIA (numbness and tingling in left arm and leg/ "little back numbness and tingling in right arm and leg"), INSOMNIA (could not sleep), DISCOMFORT (pain and discomfort is a 3.5 out of 10) and ELECTRIC SHOCK SENSATION (electric shock going down his arms and legs) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 020B21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 10-Mar-2021, the patient experienced HYPOAESTHESIA (numbness and tingling in left arm and leg/"little back numbness and tingling in right arm and leg"), PARAESTHESIA (numbness and tingling in left arm and leg/ "little back numbness and tingling in right arm and leg") and INSOMNIA (could not sleep). On an unknown date, the patient experienced DISCOMFORT (pain and discomfort is a 3.5 out of 10) and ELECTRIC SHOCK SENSATION (electric shock going down his arms and legs). At the time of the report, HYPOAESTHESIA (numbness and tingling in left arm and leg/"little back numbness and tingling in right arm and leg"), PARAESTHESIA (numbness and tingling in left arm and leg/ "little back numbness and tingling in right arm and leg"), INSOMNIA (could not sleep), DISCOMFORT (pain and discomfort is a 3.5 out of 10) and ELECTRIC SHOCK SENSATION (electric shock going down his arms and legs) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-220937 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up significant. Event information updated.
Patient complained of a "knot" where the injection site occurred.  The knot had subsided by the next day.  Patient also complained of lethargy on 9/22/10.
Patient called on 10/11/13 stating she received both PNEUMOVAX and FLUVIRIN day before. She said her arm was swollen, and warm. Told patient she should take BENADRYL and visit local urgent care center. Awaiting future information.
Urticaria, facial flushing, wheezing, coughing. Prednisolone and BENADRYL 6 mL also given. Gave 0.2 mL of 1/1000 Epinephrine injection.
This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and concurrent conditions were reported. The nurse reproted that on an unkonwn date, unkown number of patients were inadvertently administered GARDASIL (confirmed not GARDASIL 9) (unspecified dose and route) lot # K007828, expiry date 02-MAR-2017. On an unspecified date the vaccine had been improperly stored. No adverse effects were reported. There was no product quality complaints (PQC) involved. The outcome of the event was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Fever, chills, body ache; headache including irregular pulsing pain on right side of head
Suspected vaccination failure; Had them once even though I had the vaccine for them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. Even though the patient received Shingles vaccine, he/she had shingles once. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Patient received one dose of Moderna and one dose of Johnson and Johnson's Janssen vaccine. Patient did not report any adverse reactions/side effects.
I have lumps above, on and below my lips since my second Covid vaccination; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced i have lumps above, on and below my lips since my second COVID vaccination on an unspecified date. Patient reported that, this was not letting her write more than a few words. The patient had lumps above, on and below her lips since second COVID vaccination. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt stated she felt weak and had a headache. Pt has HX of anxiety with needles and shots. EMS monitored pt condition. She improved in ambulance in cool temp and said felt much better
Soreness in site of injection. Soreness spread over next several days through connective muscle tissue traveled through back shoulder muscles and front pectoral muscles and upward thru neck muscles. Soreness diminished as it traveled outward and dissipated completely after 5 - 7 days
pt recvd vax & was crying x 2 days; all night very listless; fever;
6pm 12/16 non-pruritic red bumps on cheek and jaw; 12/16 confluent non-pruritic rash on chin, cheek, jaw, face ballooned, and skin hot with rash spreading to arms. Arthus type reaction rt arm. PMD 12/20 dx as reaction to PPV and tx with prednisone to which rash and edema is responding. No respiratory distress-able to run/walk 2+ miles per day. "Just looks bad" according to pt.
Developed moderate localized leg (thigh) swelling and redness in area of shots on left leg and thigh. 13 x 8 cm size.
He was so weak, went to get out of bed, had to get fire department, no way of moving, limp as a noodle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old male patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) at the age of 80 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Secondary progressive multiple sclerosis" (ongoing), notes: concurrent condition ; "increase in falls" (ongoing), notes: concurrent condition ; "lost weight" (ongoing), notes: concurrent condition ; "doesn't straighten up" (ongoing), notes: concurrent condition ; "Alzheimer's" (ongoing), notes: concurrent condition ; "Severe spasms worse" (ongoing), notes: concurrent condition ; "MS progression" (ongoing), notes: concurrent condition . Concomitant medication(s) included: OCRELIZUMAB; BACLOFEN; TIZANIDINE; LISINOPRIL; FUROSEMIDE; PREGABALIN; MEMANTINE. The following information was reported: ASTHENIA (non-serious) with onset 12Apr2021, outcome "recovered" (12Apr2021), described as "He was so weak, went to get out of bed, had to get fire department, no way of moving, limp as a noodle".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2/5 my head behind my left ear hurt, I looked fatigued to others,  in the evening my tongue seemed swollen, On 2/6, my taste was off and left eye started running, my lips felt swollen.  On 2/7 I woke up to not being able to close my left eye and lift my left lips.  Immediately contacted my PPC who did an exam and determined it was Bell's Palsy.  Was started on Predisone and antiviral medication immediately
little gassy; I experienced severe abdominal cramping; A little soreness in arm; dose 2 administration date 24Mar2021/dose 1 administration date 08Mar2021; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received second 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 47-years-old), as a single dose for COVID-19 immunisation. The patient did not report any medical history. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient previously 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 08Mar2021 at 13:30 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient received dose 2 administration date 24Mar2021/dose 1 administration date 08Mar2021 (Inappropriate schedule of vaccine administered); the patient experienced a little soreness in arm but last night after shot approximately 10 hours after, the patient reported "I experienced severe abdominal cramping",  on 24Mar2021. It lasted for several hours approximately 3 and then patient felt asleep. Woke up next day morning without cramps but a little gassy on 25Mar2021. The clinical outcome of the little soreness in arm and severe abdominal cramping and little gassy were unknown at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Description as reported updated from "Inappropriate schedule of vaccine administered" to "dose 2 administration date 24Mar2021/dose 1 administration date 08Mar2021", Medication error checked in product details, Lead sentence updated as "non-contactable consumer", Final sentence updated.
Fever onset, general discomfort on first two days. Third day, woke up with high grade fever and was stiff and shaking (possible seizure) and lethargic. Fourth day woke up with a rash that resembled measles and a high grade fever. All fevers came down with medication.
I have no idea if this event is related to the vaccine but I was contacted by the folks that follow up on text reporting and told to report this incident on this website. I developed a case of hives on the evening of Sunday, November 14th after returning from a 4-day elk hunting trip. I had no exposure to anything that I can attribute the hives to and we are still working to get them under control and, if possible, root out the cause. I have never had this happen without a clear cause (bee/wasp stings).
Dose given 16 minutes after 6 hour window; A spontaneous report was received from a health care provider concerning a patient of unknown age and gender who received Modern's COVID-19 vaccine (mRNA-1273) and experienced a used punctured vial 16 minutes after the allowed 6 hour window to administer a dose/expired product used.  The patient's medical history was not provided. No relevant concomitant medication was reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 014M20A) intramuscularly for prophylaxis of COVID-19 infection.  The reporter stated that a punctured vial was used 16 minutes after the allowed 6-hour window to administer the dose.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event dose given 16 minutes after 6 hour window/ expired product used was recovered.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 014M20A)  with no associated AEs reported.
Extreme chills, 101.5 fever, headache, body and joint aches, diarrhea
Breakthrough COVID case after 2 PFE vaccinations; Breakthrough COVID case after 2 PFE vaccinations; This is a spontaneous report from a contactable Consumer or other non-HCP reported for a patient. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date in Feb2021 as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported), as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced breakthrough covid case after 2 PFE vaccinations. Event took place after use of product. It was reported that the second dose was given around mid Feb2021. The patient outcome of the event was unknown at the time of this report.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I did not eat anything prior to or following vaccination and I experienced urticarial following administration of vaccination.
Baseball size reaction at injection site, then small red rash down the left arm. The small red bumps were also on torso and legs
Day1, vaccine time 9:30am, 4:30 pm , Herpies flare up around gums, feeling very tired. Day2-3 soarness  left shoulder and neck, mild soarness on past hernia surgery sight and past skin cancer surgery site, Day 4 to present muscles and joints achey, feeling lethargic. No fever, but achy ness is similar to how I would feel with the flu.. 7 days feeling crummy
Patient received second Pfizer dose on day 17 instead of day 21. Per CDC guidelines, dose still valid although not given at optimal time. Patient received first dose at CVS pharmacy. Patient's caregiver notified.  Pharmacist, pediatrician and caregiver will continue to monitor.  No adverse reactions seen yet. Will continue to monitor patient.
PRODUCT ADMINISTRATION ERROR; OFF LABEL USE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On an unspecified date, the subject experienced product administration error, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administration error and off label use was not reported. This report was non-serious.
Per patient, on 2/10/22 woke up around 6:30am and got dressed and headed into the bathroom to relieve himself, stated when he got in the bathroom he felt weak and decided to sit on the toilet to urinate instead of standing to urinate because he legs felt weak.  Then after he was finished urinating he was too weak and couldn't feel his legs to walk so he got down on the floor and started to crawl out of the bathroom for help but was only able to crawl about 5 - 6 feet before he could not use his arms as well.  He then used the phone to call emergency and the paramedics took him to ER. Patient tated he was in the hospital for about 4 hours 7:30 AM to 12:30 PM.  Said at the hospital the doctor gave him and IV and some tylenol and after a little while he was able to walk again,  Stated the doctor checked his motor function before he left and he was fine.  Stated the ER doctor told him it was probably a rare reaction from the Covid shot.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    Patient was over 18 years of age. No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 26 Jun 2023, 2 doses were administered at administration site 2. No treatment medication reported.   This case was for the 33rd patient out of 47 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received contains Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case (Patient 01)
The day following the vaccine, I began to feel pain underneath my arm pit.  The next morning when I woke up, the lymph nodes underneath my arm were swollen and painful.
patient received a Fluzone HD on 24-Sep-2019 and on Last week, no AE; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 68 years old male patient who received two doses of 0.5 ml of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ232AB, Exp. Date 10-Apr-2020) via intramuscular route in the left arm on 24-Sep-2019 and on last week.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to extra dose administered.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient experienced "crazy hallucinations" and didn't remember certain events throughout the evening. She had broken out in hives. Also had swelling of the throat.