chrisvoncsefalvay/vaers-outcomes huggingface dataset:
So tired; Body is a little achy; 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 male patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "So tired"; PAIN (non-serious), outcome "not recovered", described as "Body is a little achy".  Additional information: Report was not related to a study or programme. Batch/lot number, expiry date and NDC number of vaccine for covid was not provided. Other products were not provided. Patient history was not provided. Investigation assessment was not provided. Patient first dose of the vaccine for Covid last Wednesday. It has been about a week and he is still experiencing side effects. He was looking online and it seems like after the first shot it should be pretty much back to normal after a couple days but he is not feeling that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Syncope  Information has been received from a nurse concerning 5-10 female patients who were vaccinated with a dose of HPV rll 6 11 16 18 VLP vaccine (yeast) (lot number, injection site and route not reported). Subsequently the patients fainted. Some fainted after the first dose, other after the second and third dose of vaccine. Several times the patient had left the office but fainted in the elevator. Subsequently, the patients all recovered from the events. Attempts are being made to obtain additional identifying information to distinguish the individual patience mentioned in this reports. Additional information will be provided if available. This is in follow-up to report (s) previously submitted on 8/14/2008. Follow-up information was received from the registered nurse which reported that she did not have specific patient information but stated that most of the faining occuured in girls who received more than one immunization (unspecified vaccine) at the time of the GARDASIL administration. No further information is available.
Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; Vaccine administered after 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 temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree Fahrenheit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). In November 2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that 10 vials of 15 doses each were stored in a freezer of which the temperature range was at all times from 24.3 degree Fahrenheit to 24.7 degree Fahrenheit. The reporter stated that they always had the freezer between the 24.3 degree Fahrenheit to 24.7 degree Fahrenheit temperature range. The storage condition at the time of excursion was reported as Frozen storage. The maximum temperature reached was reported as Maximum of 24.7 degree Fahrenheit. Excursion duration was reported as from 09-Nov-2021 to current date (vials have not been removed from freezer). It was reported that the vials are stored in the freezer. The vials had never been thawed. The proposed desired Use by Date was unknown. 10 vials of 15 doses were impacted. It was reported that 2 vials were used and the doses were administered on 23-Nov-2021 and 27-Nov-2021. It was stated that two vial's were used to administer HCP's office employees. It was also reported that all doses were injected intramuscular in deltoid muscle. It was reported that 19 patients were involved of which 3 were males and 16 were females.   It was reported that 2 second doses were given (both given to female patients) and 17 boosters were given.   Administration date was reported 23-Nov-2021 and 27-Nov-2021. Reporter stated that while the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt, they have not had any adverse events.   This case was linked to MOD-2022-474599, MOD-2022-479993 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: I-narrative updated
Dizziness, nausea, pinching pain in left thigh, and then I collapsed. I had to go to the hospital and all tests looked normal. Ultrasound for blood clot did not show any clotting. That was two days ago. Today my vision is blurred, body aches and chest pain on the right side (Injection side.)
Abdominal muscle spasm and spasticity in right leg - same leg as vaccination given.
patient was given his second dose at a two week interval instead of the 4 week interval. no other symptoms reported.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 1:32 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 1:32 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 54.09 years Concomitant products were not provided.  On 28-APR-2021, Excursion time was reported at 9:00 A.M  with  temperature as 33  degrees Fahrenheit, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-APR-2021, vial was moved to clinic on  28-APR-2021. 30 vials were sent to clinic. Vaccine BUD date was 19-MAY-2021.  Vial was stored on cooler 1, on 28-APR-2021, Excursion duration At 9 AM: 33, 10 AM: 36, 11 AM: 40, 12 AM: 41, PM: 41, 2 PM : 39, 3 PM: 41, 4 PM: 40.  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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Day after vaccines "sick as a dog" w/ a little nausea, fever/chills/aches/pallor/profuse diaphoresis, arm swelling, itching at injection site, malaise. No treatment sought.
DRIZZY, UNABLE TO WALK, UNABLE TO EAT, DARK CIRCLES UNDER EYES, PAIN THROUGH OUT BODY.
severe vomiting, starting about 20 min. after vax, fell asleep 3 times during day, MD prescribed APAP suppositories 31oct96 afternoon. vomiting continued throughout the night. saw MD again 1nov96 am then full recovery
Strong headache for 36 hours, nausea and slight chills. I did NOT get better with Advil 200mg or with UBRELVY (ubrogepant) 100mg (migraine medicine)
Patient said 2 days after receiving vaccine her arm was still sore at site of injection and she also began to have flu like symptoms. She returned to the pharmacy to see if arm soreness/flu symptoms were normal after the vaccine. She was recommended over the counter cold medicine.  Patient reports as of 1/7/19 her arm is still sore and hurts when she moves it. There is no redness, swelling, or warmth at injection site but sometimes she feels her arm pulsating at injection site.  she went to urgent care and was told to apply warm compresses and monitor for any change.
After a long hospital stay and diagnosis of COVID19, patient died on 12/05/2021
Pain and weakness, limited range of motion in left arm, persisting over a week after immunization.
No additional AE; HCP called to report the patient was given a dose of VAQTA  and VAXNEUVANCE after the doses were stored improperly. case with the supported outcome. No additional AE/PQC      ?    Names of vaccines involved (including lot/exp) VAQTA; This spontaneous report was received from a health care professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-MAY-2023, the patient was vaccinated with improperly storage hepatitis a vaccine, inactivated (VAQTA) 0.5ml/ series, valid lot #X003791, expiration date: 01-JUN-2024 (frequency, strength, and route of administration were not provided); and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5ml/ series, valid lot #W027275, expiration date: 09-JUL-2024 (frequency, strength, and route of administration were not provided). Both administered for prophylaxis. It was reported a temperature excursion occurred (on 02-MAY-2023) with temperature reported as 34 Fahrenheit (F) for 7 hours. At the reporting time, the outcome of the event was unknown.
The patient was vaccinated inadvertently by staff who did not realize that the Moderna vaccine was not approved for those under 18.  He did not have any adverse effects at the time of vaccination or afterward. I spoke with him on the phone about an hour after the vaccination to explain the situation and he expressed understanding, and was advised to report if any adverse effects should occur.
Pt was seen by healthcare provider on 4/8/10 with c/o redness, swelling, bruising of (R) shoulder + (R) arm above elbow. Per husband report pt  will be receiving follow-up treatment. Pt was noted to have unsteady gait + required assistance with ambulation. Pt noted to have new abrasion on nose. Clerical staff reports pt stated that she felt. Pt reports nx of balance problems and unsteady gait.
Information was received 14-JUL-2017 via a phone call from a female office manager who reported that an unspecified number of patients were vaccinated with improperly stored vaccines that underwent temperature excursion every day since May 2017. She also reported that the vaccines may also have had temperature excursions prior to May 2017. She was not able to provide the lot numbers and expiration dates or the details of the temperature excursions. The phone call was due to the use of a data logger. The vaccines involved in the temperature excursion are: GARDASIL 9, VAQTA, ROTATEQ and RECOMBIVAX HB. Follow-up information was received 24-JUL-2017 via a phone call from a physician who provided additional information about the administered vaccines that had undergone temperature excursions. For GARDASIL 9 lot numbers are: N003703 expiration 29-OCT-2019, M024261 expiration 31-JUL-2018, M018810 expiration 28-MAY-2018, L043214 expiration 30-AUG-2017. For VAQTA lot numbers are: N005746 expiration 26-MAY-2018, M047658 expiration 28-OCT-2017. For ROTATEQ lot numbers are: N003401 expiration 13-OCT-2018, M031553 expiration 19-MAR-2018, L046320 expiration 29-SEP-2017. For RECOMBIVAX HB lot numbers are N006321 expiration 08-NOV-2019, M037248 expiration 21-FEB-2019. These vaccines were stored at 32 to 35 degrees Fahrenheit for 25 hours and 47 to 77 degrees Fahrenheit for 55 hours. There had not been a previous temperature excursion and the phone call was a result of the data logger. No adverse effects were reported. No further information was provided. Additional information was requested.
1/7/2021 I was extremely tired and could not raise left arm without assistance. I also, experience quit a bit of pain at the injection site. Arm pain decrease the next day and was able to raise arm without assistance. 1/8/2021 Tired and lightheaded. I felt like I would pass out if I did not sit down. Cannot stand on my feet longer than 30 minutes at a time.  Also experience shortness of breath.
Information has been received from a nurse practitioner concerning a 67 year old male with hypertension and sulfonamide allergy who on 25-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck) in his left arm at another facility. Concomitant therapy included lisinopril (manufacturer unknown), atenolol (manufacturer unknown) and aspirin. On 04-MAR-2011 the patient came to the nurse practitioner's office with a red, raised, cluster rash on his right hip, which was vesicular, macular and papular. The nurse practitioner reported that the patient reported that the rash was moderately painful, and itchy. The nurse practitioner reported that the patient was in no distress and the patient was afebrile. There was no treatment given to the event. There were no diagnostics studies performed. At the time of the report, the patient was recovering. Follow up information has been received from a nurse concerning the patient who on 13-MAR-2011 14:44, was experienced red raised vesicular rash 1"X2" on the right hip. At the time of the report, the patient had recovered. No further information was available.
STARTING 2 DAYS AFTER 2ND MODERNA DOSE PATIENT REPORTS HIS LEGS BECAME WEAK AND HE HAS NOT REGAINED ORIGINAL STRENGTH.
upon injection, immediate dizziness and slightly faint along with weird tingling and weakness feeling in hands and feet. Had mild headache and mild arm ache which went away after 2 days, no fever, site redness, no chills. It has now been 10 days and I still have tingling and weakness mainly in hands and feet but sometimes it spreads to calfs, thighs, and arms. It feels like the beginning stages of a charlie horse about 25% of the time and I am getting 1 to 2 charlie horses each day.
Abscess formation at site. N/V, lethargy. Tx: Antibiotics PO
Patient had swelling of arm around elbow, redness around swelling. No soreness or problem around injection site.
Receiving expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving expired vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received booster dose. No concomitant medications were reported. Date the vial was initially stored in the refrigerator on 02-Feb-2022 The vial did not undergone any temperature excursion. No treatment medications were reported.   This case was linked to MOD-2022-489211 (Patient Link).
Initial report was received on 15 October 2012 from a health care professional. A cluster of three unidentified patients had received in October 2012 FLUZONE HIGH-DOSE, lot number U525AA (route, site and exact date of administration not reported) and an unspecified amount of time later the same month experienced redness, swelling and pain at the injection site. The patient's were referred to a physician. One of the patient's was treated for infection and antibiotics. No further information was available at the time of the report. The patient's outcomes were unknown. Documents held by sender: none.
Very mild erythema localized to (L) upper arm/deltoid at site of injection given on 2/27/12. Patient noticed day after injection & a small node under (L) arm - which resolved at time of exam on 3-1-12.
expired dose of pentacel was administered with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1-month-old female patient for whom expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Sep-2023, the patient received an expired dose of 0.5 ml (frequency: once) suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) vaccine of standard strength Suspension for injection (lot: DTAP/IPV: U7311AA, HIB: UJ757AA, Expiry date: 09-Sep-2023) via intramuscular route in the right vastus lateralis for Immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  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 the 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.
Experienced numbness and tingling in left arm on day of vaccination (day 0).  On April 26th (day 3), developed flushing.  Wen to ED on May 3rd (day 8) for axillary lympadenopathy, arm swelling, cough, stridor and shortness of breath.  Was diagnosed with acute allergic reaction and placed on oral prednisone.  On May 5th, reported ED visit to employee health nurse.  Another doctor took her off the prednison and saw her the next day for exam, including EKG and cardiac enzymes.  EKG was normal, enzyme results pending.
Rash on back on right Trouble breathing, could not dress without laying down.   Could not make it up the stairs.  Very active and this is very unusual for me. Hardest part passed in about an hour
The patient was seen in clinic for a COVID booster vaccine. Patient stated she received J&J on 04-11-2022 at local facility. She stated that 35 minutes after she received her vaccine she started to have itching and tightness to her throat. Per her Allergist, she was recommended to receive Pfizer or Moderna as her booster and to take an extra dose of Zyrtec prior to vaccination. Patient reported taking extra dose of Zyrtec prior to vaccination. Per Allergist, patient was recommended to come to a Public Health Center for Pfizer vaccination. The patient's history was reviewed with providers and was OK to give vaccine. The patient received Pfizer on left arm at 12:54 pm and was instructed to wait for one hour to be monitored. At 1:21 pm, patient noted having mild itchiness to her throat, but was not c/o SOB. She was still awake, alert, able to speak, and answer questions. At 1:26 pm, patient was coughing and clearing her throat. She stated she felt her throat a little tight with a little more itchiness. MD was notified at 1:29 of the patient's symptoms. At 1:32 pm, MD assessed patient and instructed Benadryl 50 mg to be administered. Benadryl 50 mg was given at 1:38 pm to right arm. Patient was monitored and at 2:00 pm, patient was stating that she has feeling less itchiness to her throat. At 2:15 pm, the patient continue to state she was feeling better. By 2:31 pm, she no longer felt any more symptoms. MD was notified and patient was assessed again before being discharged. Patient was advised to call husband to pick her up. She left the clinic at 2:45 pm, with her husband she was awake, alert, and orient. Was instructed if she had any more symptoms to go to ER. Patient and husband verbalized understanding. VS Time                      BP                           P                             O2 sat 1:32 pm               151/85                  78                           100% 1:40 pm               123/95                  62                           100% 1:54 pm               125/82                  64                           99% 2:19 pm               125/81                  65                           99%
Headache, nausea, fever, chills, aches, swelling and redness at injection sight
Soreness around the injection site within 1-2 hours. Runny nose with clear mucus  within 4-5 hours. Muscle aches by end of day (more than 8 hours). Discomfort was a 3 ?? (where 10 is worst), and treated with acetaminophen. Whole body aches and pains increased to a 7 ?? the next morning. No fever or chills, just a little cold. Treated with acetaminophen every 4 hours and sleep.  Improving with sleep and acetaminophen to a 2 ?? at 4pm.
This patient is a 33-year-old female that presents by EMS where she received her first Pfizer vaccine.  She states because of her listed allergies she was told she had to wait 30 minutes.  She was sitting there waiting and began to feel jittery and fuzzy and walked up to the desk and told them that she was apparently little sweaty and ultimately these symptoms seemed to fade however she had a second phase where she had a sensation that her tongue was larger than usual and was twitchy feeling.  She never had trouble breathing or swallowing nor did she have any rash or itching.  She began to develop numb tingling her hands and feet EMS was called.  EMS gave her 0.15 of epinephrine IM and Pepcid 20 IV but no Benadryl given her prior allergy to Benadryl which makes her vomit and have diarrhea.  She states she can take loratadine and Zyrtec.  She states she was well prior to this vaccine.  She tells me that her heart was racing during this episode.  But she had no chest pain again no shortness of breath.  She was getting the vaccine so she would not have to wear a mask when she went out of town. It is not mandated  She denies any URI symptoms cough abdominal pain melena hematochezia constipation dysuria hematuria fever chills nausea vomiting or diarrhea.  No vaginal bleeding or discharge.  She relates that the epinephrine and Pepcid seem to help with a jittery feeling and sensation of her tongue being enlarged