chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications information was not reported. No treatment medications were provided. The vaccine was stored in the freezer and one to two vials were taken out and placed in the fridge each day as needed.
This case was reported by a healthcare professional and described the occurrence of extra dose administered in a 30-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline), Influenza vaccine. Previous and/or concurrent vaccination included ENGERIX B; GlaxoSmithKline; injection; unknown given on 15 November 2010; FLULAVAL; GlaxoSmithKline; unknown; unknown given in October 2010. There were no concurrent medications. On an unspecified date the subject previously received a dose of Influenza vaccine (unknown). At an unspecified time after vaccination with Influenza vaccine, the subject experienced a sore muscle. At the time of reporting the outcome of the muscle soreness was unspecified. On 15 November 2010 the subject received 2nd dose of FLULAVAL (.5 ml, injection, right arm) and experienced extra dose administered. The subject inadvertently received a second dose of FLULAVAL one month after receiving the first dose. The FLULAVAL lot number was reported as "AF1A521AA" and ENGERIX B lot number was reported as "AHBB942CB".
Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On an unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L024253 with expiration date 01-JUL-2017, lot # L024256 with expiration date 01-JUL-2017, lot # L001328 with expiration date 13-JAN-2017, lot # L016123 with expiration date 06-MAY-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion and data logger was involved. No adverse effect was reported. This is one of two reports from the same reporter. Follow up information has been received from the physician on 24-OCT_2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for the patient identifiers, lot number and expiration date and dates of vaccination. The correspondence details were reviewed with the physician, if information becomes available. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient (of unknown age and gender) was vaccinated with an improperly stored dose of VARIVAX with lot number L001328 (expiration date 13-JAN-2017). No adverse experienced were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Sore arm; itchy rash covering left upper arm; severe headache and body aches; slight fever (99.8); chills; loss of appetite day after shot.  This is 2 days after shot and no fever or chills but the other symptoms are still going on.
Moderna COVID-19 Vaccine EUA 13:00: Proximal left arm tightness around injection sight and tenderness with raising arm above 90 degrees 18:00 Fatigue 22:00 Intermittent chills and diaphoresis 23:30 Temperature 100.0 degrees F
hives; itchy; tired; achy; This is a spontaneous report from a contactable consumer. This consumer reported for a 88-year-old female patient (wife) in response to Non-HCP letter sent via follow-up letter. A 88-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9267; Expiration Date: May2021) via an unspecified route of administration on 10Feb2021 (at the age of 88-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included warfarin sodium (COUMADIN), acetylsalicylic acid (ASPIRIN LOW), lisinopril (LISINOPRIL) and apixaban (ELIQUIS) taken for an unspecified indication. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3248; Expiration Date: Apr2021) via an unspecified route of administration on 20Jan2021 (at the age of 88-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of first dose vaccination. It was reported that, patient was tired plus achy the first 48hours on an unspecified date in Feb2021. Then became itchy on the third day she had red raised spots (Hives) on upper back on 12Feb2021. Treated with Benadryl and Calamine lotion. It did not help saw doctor after four days of hives prescribed seven days of prednisone. That helped, but as soon as regiment ended the hives spread over trunk of body. Doctor prescribed two weeks on prednisone. Her last dose will be 10Mar2021. She feel much better. Therapeutic measures were taken as a result of AEs. The outcome of events was resolving.  No follow-up attempts are possible. No further information is expected.
First dose: sinus congestion, headache, lethargy, mild fever Second dose: Muscle/joint pain, dizziness, mild fever, headache, excessive sweating while sleeping, fatigue/lethargy
Information has been received from a nurse concerning a 13 year old female who on 05-DEC-2007 was vaccinated intramuscularly (site not reported) with the 1st 0.5ml dose of Gardasil (lot# 659437/1266U). On 19-DEC-2007, post vaccination the patient was not able to move her head, hands and legs and was taken to the emergency room and then hospitalized. At the time of this report the patient had not recovered. The patient not being able to move her head, hands and legs was considered to be immediately life-threatening and disabling by the nurse. Additional information has been requested.  1/18/08 Reviewed hospital medical records which reveal patient experienced HA, lethargy, muscle weakness, difficult to arouse, altered speech, difficulty walking.  Admitted 12/18-12/19/2007.  Discussed w/Neuro.  Vax record included w/hospital records.  Admitted for observation & improved to baseline by d/c.  Psychogenic source considered. FINAL DX: muscle weakness.
Same side received the vaccine arm pit, groin lymph node are swelled, annoying and it's painful; multiple nodes in my arm pits; I have two lumps and stuffs; Same side received the vaccine arm pit, groin lymph node are swelled, annoying and it's painful; multiple nodes in my arm pits; I have two lumps and stuffs; It feels like you got something in between your legs when you are walking because it's swollen; Felt sick; Cold; it's like nausea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EN6207) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's family history included patient's brother has Lymphedema really bad, so his body, he had Lymphedema was really bad Lymphedema and patient's mother had Lymphedema in her leg where it's the stuff, so patient don't know if it's family history or patient have the side effects. The thing was patient's family had the problem with but patient don't know if that was why patient was getting this because patient don't know. On an unspecified date, when probed for the concern, consumer stated, So, patient was reporting, patient took the Pfizer vaccine on Sympatric spe (not clarified) and patient was reporting that patient had the side effects. patient had the swollen arm pit and on the same side on groin, the lymph node all swelled and on the same side as (received the vaccine) but it's pretty annoying. It's painful and then the groin was where your leg was swollen in bigger, it feels like you got something in between your legs when you are walking because it's swollen and your arms, in fact in it's multiple, so it's multiple nodes in my arm pits, so not just one it's two, patient had two lumps and stuffs, you wouldn't read the paper before you got shot and it's like nausea. Patient felt sick this morning like that patient woke up and had a cold and patient was seeing all that but this, want to know this stuff was a bigger issue on the symptoms. When probed to confirm the concern, consumer stated, "Well, I do. I want to know do I take this, what can it happen when I take the second shot in 21 days because I already got this". The outcome of events was unknown.                 No follow-up attempts are possible. No further information was expected.
Patient had localized reaction to (L) deltoid with redness/swelling 3-4 inches below the injection site. Recommended BENADRYL, ice to reaction, go to ER if more serious reaction occurs.
Approx 4 hrs p/1st DPT Pt became limp hypotensive & became quite pale; pt was admitted to the hospital & observed for 4 days;
110mm x 100mm reddened area to (L) thigh. Mother advised by FNP to give BENADRYL.
LOSS OF TASTE; LOSS OF SMELL; CHILLS; TIRED; CHEST CONGESTION; This spontaneous report received from a patient concerned a 41 year old of unspecified sex. 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, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced chest congestion. On 29-MAY-2021, the subject experienced chills. On 29-MAY-2021, the subject experienced tired. On 05-JUN-2021, the subject experienced loss of taste. On 05-JUN-2021, the subject experienced loss of smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tired, chills, and chest congestion, and had not recovered from loss of taste and loss of smell. This report was non-serious.
Symptoms started 8-29-07 with vomiting, decreased oral intake, lethargy, fussiness, intermittent green stools. Intussusception seen on gastrograffin BE and successful reduced.  9/11/07 Received hospital medical records which reveal patient experienced progressively bilious emesis blood tinged stools, decreased oral intake for approx 5 days & then becoming profoundly lethargic on day of admit 8/31-9/1/07.  Kept overnight for observation s/p enema reduction of IS.  Did well & d/c to home.  FINAL DX: Intussusception, enema reduced.  9/11/07 T/C to pcp to request vax record to include lot #s.  Unable to print.  Verbally confirmed on phone that vax dose & lot #s correct as reported on VAERS form.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15May2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31May2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 25May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications in 2 weeks. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2023) negative, notes: tested negative; (15Feb2023) Positive, notes: 04:00. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 02Feb2023 to 07Feb2023. Clinical course: It was reported that, all symptoms resolved and tested negative for COVID by day 5 of the Paxlovid treatment. However, one week after completed treatment, symptoms had returned and tested positive for COVID again.   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-202300071028 same patient/vaccine, diff dose/event;
hosp reported pt had poss rxn from flu shot, requesting lot# & MFR;reports that pt exp GBS type sx, weakness, was intubated & on ventilator;limited info recv;pt currently in hosp;
entire body joint pain; axillary lymph node pain; same enlarged supraclavical lymph node; This is a spontaneous report from a contactable healthcare professional. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 5730 and expiry date: unknown), intramuscular on 08Jan2021 11:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant. There were no concomitant medications. Patient received the 1st dose on 21Dec2020 13:30 on the left arm. After the initial dose enlarged supraclavical lymph node enlargement on same side as vaccine dose-24 hour later-lasted 17 days after 2nd dose, same enlarged supraclavical lymph node within 2 hours of administration on 08Jan2021, followed by axillary lymph node pain starting at 8 hours (19:30)  after dose, then groin lymph node pain and entire body joint pain at 12 hours (23:30) after 2nd dose, then ILI like symptoms for 36 hours. No treatment was given for the events. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Intermittent episodes of increased fussiness, drawing up of legs, decreased oral intake. Evaluated in the Emergency Department where an bedside ultrasound showed sign of intussusception. Subsequent ultrasound when not fussy did not show evidence of intussusception (thus it spontaneously resolved without intervention).
This case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a adult male patient who received ENGERIX B (batch number 4795H, expiry date 14th July 2020) for prophylaxis. Co-suspect products included ENGERIX B for prophylaxis and ENGERIX B for prophylaxis. On an unknown date, the patient received the 1st dose of ENGERIX B, the 2nd dose of ENGERIX B and the 3rd dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, ENGERIX B and ENGERIX B, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The healthcare professional reported that after 3 dose series of ENGERIX B, the patient had low titres. The reporter gave consent to follow up.
Menstrual bleeding x6 mos beginning 8/6/07. RLQ abdominal pain, with daily vomiting. Started OCP's, Feb 2008 x4 months period regulated, but pain continues w/ periods. Weakness and joint pains began 12/07. Have improved but still get them.
Patient is experiencing severe pain in left arm (where injection was administered). She states it is hard to move her arm and very painful. It has been 2 weeks since the patient received the SHINGRIX vaccine.
Initial report received from healthcare professional on 03 JULY 2013. A 50-year-old male patient (born on 17 DECEMBER 1962), had received an intramuscular dose of ADACEL (lot number: C4365AA, dose number not reported) in left deltoid on 28 JUNE 2013. The patient had no pre-existing physician diagnosed drug allergies, as per the reporter, the patient had no illness at time of vaccination. On an unspecified date after 1 to 2 days of vaccination, the patient had developed blisters and redness at injection site. Laboratory tests and corrective treatments were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender were none
1st dose given on 15Apr2021; no 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose given on 15Apr2021; no 2nd dose yet) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose given on 15Apr2021; no 2nd dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose given on 15Apr2021; no 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.
Patient developed a red area was slightly warm with mild firmness at vaccination site. The symptoms were improving without treatment at time of evaluation.
sx 4 hr of screaming, rash, vomiting; tx APAP, cool towels;
Systemic: Flushed / Sweating-Severe, Additional Details: Pt had excessive sweating, was not able to hold herself up in her chair. HR and RR were normal. Pt was already non verbal and unable to communicate any issue. 911 came, she was evaluated in ER and discharged with no issues. We called her daughter to follow up the next day.
feeling very tired after the 3rd dose, Exhaustion; Patient originally received Moderna's COVID vaccine; Patient originally received Moderna's COVID vaccine/ vaccine in the same arm and at the same time as her annual flu shot; This is a spontaneous report from a contactable consumer (patient). This report was received via a sales representative. A female patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FMB020) via an unspecified route of administration, administered in Arm Left on 22Oct2021 at 15:00 as dose 3 (booster), single for COVID-19 immunisation; influenza vaccine (FLU), via an unspecified route of administration from unknown date in 2021 to unknown date in 2021 as dose number unknown, single for an unspecified indication. The patient medical history and concomitant medications were reported as none. Historical vaccine included moderna vaccine (MODERNA COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as dose 1, single and moderna vaccine (MODERNA COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as dose 2, single for an unspecified indication and was completely ill and unable to function for days after receiving those two doses. Prior vaccinations reported as none. On 23Oct2021 Patient experienced feeling very tired after the 3rd dose. The action taken in response to the event for influenza vaccine was not applicable. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. Relevant tests reported as none. Outcome of the event feeling very tired was recovered on unknown date in 2021 and other events was unknown.  Follow-up attempts are completed. No further information is expected.
a week later my left arm was swollen, about 2.5 Inches bigger than my other arm; My arm was hot to the touch and the swollen area was 5.5 inches long by 4.5 inches wide.; itchy following the dose; sore following the dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy following the dose), PAIN (sore following the dose), PERIPHERAL SWELLING (a week later my left arm was swollen, about 2.5 Inches bigger than my other arm) and FEELING HOT (My arm was hot to the touch and the swollen area was 5.5 inches long by 4.5 inches wide.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included ZOLPIDEM, COLCHICINE, ASCORBIC ACID, ROSA CANINA (VITAMIN C [ASCORBIC ACID;ROSA CANINA]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and CALCIUM (CALCIUM supplement) for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PRURITUS (itchy following the dose) and PAIN (sore following the dose). On an unknown date, the patient experienced PERIPHERAL SWELLING (a week later my left arm was swollen, about 2.5 Inches bigger than my other arm) and FEELING HOT (My arm was hot to the touch and the swollen area was 5.5 inches long by 4.5 inches wide.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy following the dose), PAIN (sore following the dose), PERIPHERAL SWELLING (a week later my left arm was swollen, about 2.5 Inches bigger than my other arm) and FEELING HOT (My arm was hot to the touch and the swollen area was 5.5 inches long by 4.5 inches wide.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient complained of dizziness, difficulty breathing, tingling in throat and chest tightness. EMS was called. After several minutes of deep breathing, she stated the breathing was much easier, but the other symptoms remained till EMS arrived on the scene.
A report  has been received from a Health Professional concerning a 3 year old, male patient. Patient relevant history, concurrent diseases and concomitant drugs were not reported. The patient received nasal FLUMIST Quadrivalent on 24-SEP-2014. Patient was tested positive for influenza A on 05-DEC-2014. At the time of reporting, the event of influenza was improving. The reporter assessed the event to be non-serious.