chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a non contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration on left arm on 25Mar2021 at 14:30 (at the age of 46- year-old) as a single dose, for COVID-19 immunisation. Past medical history included Novocain allergy. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 15:15 the patient experienced difficulty breathing, red and slightly swollen face, irregular pulse, dizziness. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. No therapeutic measure was taken in response to the event. The clinical outcome of the event difficulty breathing, red and slightly swollen face, irregular pulse, dizziness was resolving at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
15 minutes after second vaccine patient complained of tongue swelling, throat closing, and difficulty breathing. She was then given epi times 1 and benadryl. Symptoms then improved. 20 minutes later symptoms returned and she was given another dose of epi. EMS then took patient to local hospital.
"I woke up at 4:52 am to pain under my arm and noticed my lymph nodes were swollen. I feel them even when I move my arm. There's pain under my arm where the swelling is and at the corners of my armpit in the front and back".
This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 02-JUL-2015, the patients were vaccinated with improperly stored oral, ROTATEQ lot # K011947, expiration date 07-JUN-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had a lot of dental work and the provider cut the gum a lot; Patient had a lot of dental work and the provider cut the gum a lot; Patient was sick for 2 weeks; Patient had every possible side effect; This spontaneous case was reported by a patient and describes the occurrence of TOOTH DISORDER (Patient had a lot of dental work and the provider cut the gum a lot), GINGIVAL INJURY (Patient had a lot of dental work and the provider cut the gum a lot), ILLNESS (Patient was sick for 2 weeks) and IMMUNISATION REACTION (Patient had every possible side effect) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient experienced TOOTH DISORDER (Patient had a lot of dental work and the provider cut the gum a lot) and GINGIVAL INJURY (Patient had a lot of dental work and the provider cut the gum a lot). On an unknown date, the patient experienced ILLNESS (Patient was sick for 2 weeks) and IMMUNISATION REACTION (Patient had every possible side effect). At the time of the report, TOOTH DISORDER (Patient had a lot of dental work and the provider cut the gum a lot) and GINGIVAL INJURY (Patient had a lot of dental work and the provider cut the gum a lot) outcome was unknown and ILLNESS (Patient was sick for 2 weeks) and IMMUNISATION REACTION (Patient had every possible side effect) had resolved.            No concomitant medications were reported.  Patient reported that she was due for her 2nd booster the next day. She also reported that she had a lot of dental work on the day of this report and the provider had cut the gum a lot.  No treatment medications were reported.
Rash at injection site: red, raised, warm, mildly itchy, about the size of my hand. I noticed it 3 hours ago, but it may have been there for longer. I have been feeling very mild swelling  in my throat and slight tenderness in right-side lymph nodes for about 36 hours, but didn?t think anything of it until I saw the rash.
administered a .5ml booster dose,not aware that she had been administered 2nd dose in February; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (administered a .5ml booster dose,not aware that she had been administered 2nd dose in February) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (administered a .5ml booster dose,not aware that she had been administered 2nd dose in February). At the time of the report, ACCIDENTAL OVERDOSE (administered a .5ml booster dose,not aware that she had been administered 2nd dose in February) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient 2nd dose had been administered in February. No Concomitant Drug details were reported.  No Treatment information was provided.
Headache, Myalgia & Fever Per supervisor report: "received 2nd shot 4/22/2021; headache, muscle ache, fever"
A report was received from a health care professional on 11/18/03, concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 11/14/03. On 11/14/03, the vaccinee inadvertently received 0.5ml Fluvirin. The vaccinee did not exhibit any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/13/04: A follow up report was received from a health care professional indicating that no adverse events had occurred at the time of reporting. Follow up pending.
he was in a lot of pain in her arm and believed the doctor hit her bone after the administration of MMR II.; daughter was administered MMR II via intramuscularly via subcutaneously; Doctor informed her that new research states that it is better to give MMR II via intramuscularly; This spontaneous report was received from a pharmacist referring to her daughter a 25 year old female patient. Information regarding the patient's pertinent medical history, concomitant therapies, drug reactions, or allergies was not reported.     On 21-APR-2021 and 02-JUN-2021, the patient was vaccinated with the first and second dose, respectively, of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live rHA (recombinant human albumin) 0.5 milliliters (ml) on her arm, intramuscularly instead of subcutaneously (lot number S020161 and expiration date: 30-JUN-2021) for prophylaxis even though paperwork said the vaccine was administered subcutaneously On 02-JUN-2021 the patient experienced a lot of pain in her arm (vaccination site pain) and believed the doctor hit her bone after the administration of the above mentioned vaccine (incorrect route of product administration). The patient self-medicated with (paracetamol) TYLENOL and recovered from the event. The patient contacted the physician and the physician informed her that new research stated that it is better to give  Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R) II vaccine via intramuscularly instead o subcutaneously but wouldn't provide the patient with information (off label use).  The causal relationship between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and the vaccination site pain was not reported.
administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.  It was reported that the dose administered after 30-day Use By Date or after manufacturer date of expiry. Original expiration was 2Mar2021 but the expiration was changed to 2Oct2021 Nurse reported that she wrote expired on the box but the doses were accidentally administered . Date the vial was initially stored in the refrigerator was 30Sep2021.   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345457, MOD-2021-345460, MOD-2021-345565, MOD-2021-345619, MOD-2021-345620, MOD-2021-345666, MOD-2021-345833, MOD-2021-345910, MOD-2021-345931 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up received includes Reporter details, lot no and Expiration Date Updated .
p/vax pt probable seizure; T104 in ER; recv ceftriaxone sent home
About a week after the first dose of the Moderna vaccine, I started getting headaches. After two weeks my right leg started cramping. I didn't think it was anything to worry about at the time. After the third week, I started to get worsening headaches that were like a sinus infection, runny nose, and a sore throat. Thought it could be allergies. When my second dose was due, I was told to wait until symptoms improve before getting the 2 nd vaccination. I continued to get leg cramping that radiated up into my back of my right leg. Since then the cramping in my leg has come and gone and I continue to have headaches. I wake in the middle of the night with cramps and numbness in my right lower extremity that comes and goes and I cannot sleep well due to the pain. I get occasional shortness of breath and it feels like I can't catch my breath every once an a while. Plan to go to see a physician today.
Received her first dose Pfizer vaccine (LOT#: EW0173 EXP: 8/2021) at 1009 on 5/02/21. PHN was alerted by EMT who was told by patient that vaccinator made her anxious about the vaccine. Patient stated that vaccinator told her she was bleeding more than usual and that there was a small bump on her arm. EMT contacted patient at 1015. Patient reported swelling and hematoma at injection site. At 1025 patient reported feeling anxious and was crying. PHN assessed patient and reassured her the swelling in her arm was going down. PHN educated patient on worsening signs and symptoms at injection site and treatment of swelling. Patient verbalized understanding. PHN asked EMT to take vital signs. EMT took patients vital signs at 1033. BP: 140/111, pulse: 72, RR: 20. EMT reassessed patient at 1040. Patient stated that she was feeling a lot better and less anxious. EMT retook patients vital signs at 1042. BP: 142/108, pulse: 66, RR: 20. Patient had completed her observation time. Patient left at 1045 by herself, unassisted with a steady gait.
After 48 hours of Fatigue ,  body aches and head aches,  Everything subsided but i still have a headache in the back on my head (behind right ear for 2 weeks now.
vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023; No Adverse Event; Patients administered doses after the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients administered doses after the BUD), PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-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 23-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients administered doses after the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients administered doses after the BUD), PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients administered doses after the BUD) and PRODUCT STORAGE ERROR (vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023).    No concomitant medication was provided.  It was reported that the 6 patients had received the vaccine beyond BUD and no reported symptoms were provided.   Treatment medication was not provided by the reporter.  The case belongs to the sixth patient out of 6 patients who had received the vaccine as described by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2023-713876 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2023: Live significant follow up was received. Batch/lot number was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713876:(Master Case pt 1 of 6)
Approximately 4-5 mins after flu vaccine was given she began to fell drozy, light headed then began vomiting. BP 130/100, HR 100, No difficultly breathing or rash noted. EMS called and sent to ED.
Both doses mensural cycles lasted longer. 1st dose was on period and lasted 5 extra days. 2nd it started 4 days earlier and but lasted for 9 days. Each cycle was 9 days and normally its about 4 days, I thought it was a UTI and cramping and blood in my urine. Went to Urgent care on 9Jun2021 cultures came back fine and x-ray for normal.
This spontaneous report as received from a health care worker refers to a 30 year old female patient (who was also a office staff). The patient's pertinent medical history was none and was allergic to CECLOR. On 28-JAN-2015, the patient was vaccinated with RECOMBIVAX HB (dose, frequency and route were not reported) (lot # K006530 and expiry date: February 2016). Concomitant medications were none. On 29-JAN-2015, patient experienced tingling and numbness in the arm in which RECOMBIVAX HB was received. The patient did not sought medical attention and no treatment was provided for the events. The outcome of tingling and numbness in the arm was reported as recovering/resolving. The causality of tingling and numbness in the arm was not reported. No product quality complaint (PQC) was reported for RECOMBIVAX HB. Additional information has been requested.
pt says she had headache and body chills that lasted until he next day but then a few weeks later she started feeling achy in the lower half of her body.  This progressively has got worse each day to where it has almost becoming debilitating.  Every day the pain comes early afternoon and gradually get worse throughout the evening.  She takes Advil for the pain.  She went to her PCP on 4/29/21.  She had extensive blood work with normal results.  Patient says the pain in her body and especially her legs continue to get worse every day.
Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, route not provided, lot number # reported as M0025058, expiration date 11-JUL-2017). No adverse effects were reported. There was no product quality issue (PQC) involved. PROQUAD, M0025058, exp. 07/11/2017. Temperature: 14F. Time frame: 2 hours, 15 minutes. Was back in range? Yes. Was previous temperature excursion? No. Was call because of a data logger? No. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a physician and described the occurrence of injection site joint effusion in an adult subject of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (unknown details). At an unspecified time after vaccination with BOOSTRIX, the subject experienced injection site joint effusion. The physician stated that the joint effusion was "near" the injection site. The physician also documented that the subject did not experienced fever. The lot number was reported as AC528103AA; however, based on lot number characterization, this lot number is incorrect and the correct lot number will be verified. At the time of reporting the outcome of the event was unspecified. This physician reported three cases of adverse events with BOOSTRIX. See cases A1010985A and A1010984A for details on the other cases. Follow up received from Vaccine Safety on 8 March 2013. The lot number reported as AC528103AA from the reporter; however, based on a safety lot number review, the lot number was updated to AC52B103AA.
Vomiting, fever, muscle aches. 5 days later still sick taking Zofran now.  Not acting himself at all, crying frequently, sleeping all the time,  heightened sensory issues smells, sounds making him feel sick. He's really out of it. He's not acting like himself at all since the day after the covid vaccine. Younger son had one too and he's fine just a headache for a day.
Patient received 2 vax in 1 arm. Next day had red, swollen rash at (L) upper arm. He didn't seek med attention. Told RPh 12/9. Had PPV13 1 yr prior.
Patient should have received Fluzone Quad due to being 64, but received FluzoneHD.  Patient will be 65 in less than 2 months. Spoke with patient and no reaction.
2 episodes of SVT, lasting <5 minutes, able to use vagal maneuver to exit; did not seek care at health facility. Occurred 9/21/23 around 10:30 am, and 2nd episode happened around 6:30 pm on 9/22/23.
This spontaneous report has been received from a licensed practical nurse referring to multiple unspecified patients. On unknown dates the patients were vaccinated with doses of PROQUAD (Merck) lot # L030586 (expiration date 10-FEB-2017), lot # L024125 (expiration dare 30-DEC-2016), which were improperly stored at -14.7 C for 1 hour and 30 minutes. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Red, patchy, itchy rash on base of both palms. Started within 24 hours of dose, became apparent on third day, and has persisted from date of dose to present (August 5, 2022). No other symptoms. Patient on claritin for seasonal allergies but has no effect on rash and itchiness. Persistent, wakes up itching palms.  If not resolved before second dose on August 18, 2022, clinic visit will be scheduled.
No symptoms reported. No additional AE information; improperly stored VARIVAX was administrated to a patient; This spontaneous report has been received from a medical assistant referring to a 12 months old male patient. Information about the patient's past drug and medical history, as well as concurrent conditions and allergies were not provided.  On 30-DEC-2019, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, subcutaneously, lot number S024366, expiration date on 06-AUG-2021 (concentration, dose number, and anatomical location were not reported), for prophylaxis, that had been improperly stored in a temperature of 6 Fahrenheit degrees to 14 Fahrenheit degrees (14.1 Fahrenheit degrees) for 30 minutes, and 15 Fahrenheit degrees to 46 Fahrenheit degrees (26.6 Fahrenheit degrees) for 4 hours and 18 minutes; varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with sterile diluent (lot number and expiration date were not reported). No symptoms and no additional adverse events were reported. There was not previous temperature excursion and the temperature was recorded by a data logger.  The outcome of the event was unknown.
86 Y/o female nursing home resident sstarted with intractable nausea, vomiting and abd pain x 2 days, she tested + for COVID however denies respiratory symptoms. She has recieved pfizer covid vaccine per report PMHX Dementia 2) Anxiety 3)Depression 4) hyperlipidemia 5) HTN           8/5/2021tested positive 8/8/2021 discharged
A large, square shaped rash appeared on same arm as injection. Central point of rash was approximately 5-6" below injection site. Slightly warm to the touch, and raised along the edges of the rash. Not itchy or painful.  Loratadine tablet, 10mg, (Generic form of Claratin ) taken around 2pm. Rash swelling and redness reduced within a few hours.  Currently close to 12 hours after initially noticing rash, still red and raised.
Information has been received from a nurse concerning her daughter, a 14 year old female who on 28-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast), lot number was not provided. On 29-JUL-2008, the patient woke up with swelling on her entire face and a "raccoon and mask of pimples around her eyes". Then, on 31-JUL-2008, the patient got her period for the first time in her life. The nurse reported that the patient had been told since she is very athletic and a gymnast, so, she would not get her period for a really long time. The patient sought unspecified medical attention. The swelling and mask disappeared within 24 hours. No further information is available as the reporter did not provide physician's name.
they got the main vaccine over a year ago and then In the hospital got a lot of transfusion; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (they got the main vaccine over a year ago and then In the hospital got a lot of transfusion) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Unknown. On an unknown date, the patient experienced IMMUNISATION REACTION (they got the main vaccine over a year ago and then In the hospital got a lot of transfusion). At the time of the report, IMMUNISATION REACTION (they got the main vaccine over a year ago and then In the hospital got a lot of transfusion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Patient was having concern about blood transfusion and Moderna vaccine.
persistent muscle pain bilaterally in arms between elbows and wrist beginning days after 2nd injection and persisting almost three weeks later