chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pharmacist however cut her finger from the broken syringe/the barrel of the syringe collapsed and broke while the needle was still in the patient's arm; pharmacist however cut her finger from the broken syringe; the pharmacist pushed on the plunger of the syringe to inject the vaccine, the barrel of the syringe collapsed and broke; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2020SA305671.  This case involved adult female patient for whom pharmacist however cut her finger from the broken syringe (Occupational exposure to product ), the pharmacist pushed on the plunger of the syringe to inject the vaccine, the barrel of the syringe collapsed (Needle issue) and broke and pharmacist however cut her finger from the broken syringe/the barrel of the syringe collapsed and broke while the needle was still in the patient's arm (Injury associated with device) was reported for the patient, while administered INFLUENZA VACCINE TRIVALENT [FLUZONE HIGH DOSE].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient started using FLUZONE HIGH DOSE IM US PRE-FILLED SYRINGE dosage unknown (with an unknown batch number and expiration date) for prophylactic vaccination.  On an unknown date, the pharmacist however cut her finger from the broken syringe (Occupational exposure to product ), the pharmacist pushed on the plunger of the syringe to inject the vaccine, the barrel of the syringe collapsed (Needle issue) and broke and pharmacist however cut her finger from the broken syringe/the barrel of the syringe collapsed and broke while the needle was still in the patient's arm (Injury associated with device) was reported for the patient, unknown latency following the administration of INFLUENZA VACCINE TRIVALENT [FLUZONE HIGH DOSE].  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for Injury associated with device and not applicable for rest events.  There will be no information available on the batch number for this case.
patients who have received vaccines that were previously exposed to temperatures below 32 degrees F; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to cases 2019SA193105, 2019SA193107, 2019SA193106, 2019SA193110, 2019SA193111, 2019SA193112, 2019SA193113, 2019SA192698, 2019SA192699 and 2019SA192700 (Same reporter).  This case involves a 1 years old male patient who received 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UI969AAB, expiry date: 04-Apr-2020 via intramuscular route in unknown administration site) on 28-Jun-2019, which was previously exposed to temperatures below 32 degrees F.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  It was unknown whether the patient had any adverse event.  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.  List of documents held by sender: none.
Patient received Dose 1 of COVID-19 12Y+ Pfizer-BioNtech on 6/14/2021, Dose 2 of COVID-19 12Y+ Pfizer-BioNtech on 12/8/2021, and Booster dose on 12/30/2021. Per CDC guidelines if the second dose is administered beyond 6 weeks (42 days) there is no need to restart the series. Booster dose should have been given 6 months after 2nd dose. Booster dose given too soon.
Near syncopal episode post immunization. Pt reported dizziness, visibly became pale. Was assisted to a laying position for about 5 minutes, given juice also. Pt became sweaty. Resolved about 5 minutes later without fully fainting.
This spontaneous report as received from a vaccine coordinator refers to a 4-year-old male patient. The patient's medical history was not reported. On 10-JAN-2018, the patient was vaccinated with improperly stored PROQUAD therapy type RHA, lot # N023001, expiration date 19-FEB-2019 or lot # N019249, expiration date 20-DEC-2018 for prophylaxis (dose, route and site of administration were not reported). The vaccine underwent a temperature excursion of 20 degrees Fahrenheit for 1 hour and 42 minutes. Other temperature excursions were: 6 degrees Fahrenheit for 48 minutes, 18 degrees Fahrenheit for 1 hour and 5 minutes and 8 degrees Fahrenheit for 1 minute. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA013248: US-009507513-1802USA005174: US-009507513-1802USA005176: US-009507513-1802USA005177: US-009507513-1802USA005178: US-009507513-1802USA005179.
1st shot 01/19/21 large red itchy rash encircling the shot site.  2nd shot 2/16/21 moderate, red itchy rash encircling the shot site, body aches, low energy, runny nose.  1st booster 12/17/21 same symptoms as 2nd shot.  2nd booster 05/20/22 no rash, no symptoms. 6/13/22 positive test result for Covid.
I did not have an adverse reaction to the vaccine. I started feeling symptoms on 10/07/2022 of runny nose and congestion. I tested positive with a home test for COVID-19 10/08/2022. I contacted my doctor on 10/10/22 and was prescribed PAXLOVID. I tested again for COVID-19 on 10/18/2022 and it was negative. As of today, I feel about 80% better. I continue to cough and have a little congestion.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 77-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 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The pharmacist reported about the administration of expired Moderna vaccine that was given as booster shot to patient. The vaccines was stored in freezer, which was taken out one to two vials and place in fridge each day as needed.  No treatment was given on the patient.
pt recvd vax & 11 days p/vax pt exp cerebellar ataxia; addtl info has been requested;01NOV95-ADD'L INFO RECVD-REPTR FELT ATAXIA DUE TO INBORN METABOLIC ERROR, NOT TO VAX.
Both legs swelled up from thighs through toes; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 11:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin. The patient had known allergies to tetracycline hydrochloride (TETRACYCLINE). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d nos (VITAMIN D), calcium (MANUFACTURER UNKNOWN), aciclovir (ACYCLOVIR) and multivitamin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021 at 14:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 18:30, approximately 24 hours after shot after a 5 hours car drive, the patient experienced both legs swelled up from thighs through toes and swelling lasted about 36 hours then started to return to normal. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with first lying down with legs above heart and that helped and also used ie on ankles which seemed to help. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event both legs swelled up from thighs through toes was recovered on 12Apr2021, after the duration of about 36 hours.   No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (received the 1st dose of the Moderna vaccine on 23July2021 got Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (received the 1st dose of the Moderna vaccine on 23July2021 got Covid-19). At the time of the report, COVID-19 (received the 1st dose of the Moderna vaccine on 23July2021 got Covid-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that, their doctor told they should wait 90 days after their symptoms gone, and pharmacist referred them to Moderna. They haven't received the 2nd dose yet. No concomitant medication was reported. The treatment information was unknown. This case was linked to MOD-2021-294322 (Patient Link).
Nausea; Back pain; This is a spontaneous report from a non-contactable consumer, the patient. A 34-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 07May2021 at 12:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medication within two weeks of vaccination.  The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 08Apr2021 at 00:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 08May2021, the patient experienced nausea and back pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea and back pain were resolving 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.
pt recvd vax & exp pain & tenderness in the elbow area of the injected arm which radiated down to hand; pt presented to MD for feeling of tiredness; PE as well as lab eval for CBC, biochemical profile, PSA, T4, TA3 & TSH were nl;
Covid + since receiving the first dose; Covid + since receiving the first dose; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included near end of life (patient was transitioned to hospice). The patient's concomitant medications were not reported. Per second (2nd) vaccination clinic on 12Jan2021, it was reported the one resident was transitioned to hospice (and is near end of life) and also reported was COVID positive (+) since receiving the first dose on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event COVID positive (+)  based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Patient received his second COVID 19 vaccine at 1533.  At 1550, he developed flushing on his ears and a feeling of warmth in his body.  His temperature was 37 degrees.  His BP was 110/62, HR 78 and respirations 24 and unlabored.  I reported his symptoms to Dr.  She assessed him and noted two hives on his neck and two on his chest.  He had no respiratory distress or wheezing.  At 1554, EpiPen 0.3 mg was administered into his left thigh.   At 1559, his BP was 112/58, HR 84 and respirations 22.  His SaO2 was 99% on room air.    At 1605, two hives remained, the flushing on his ears improved and the ER was notified.  At 1612, he was transferred to the ER via wheelchair.
This spontaneous report as received from a pharmacist refers to a 60 year old male patient. There were no patient's concurrent conditions, medical history nor concomitant therapies. On 15-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming unit (PFU) with lot number M026874 and expiration date of 19-JUL-2017 (dose, route of administration and anatomical location were unknown) for prophylaxis. On 04-MAR-2017 (reported as "3 days ago"), the patient developed a cold sore on an unspecified location. The patient was seen by an unspecified physician and that physician prescribed him an unspecified dose of acyclovir to treat the event. There were no laboratory diagnostics studies performed. At the time of reporting, the patient was not recovered from the event. The causality between ZOSTAVAX and oral herpes was not provided. Additional information has been requested.
I developed Trigeminal Nerve pain in my right lower jaw.  Dr. prescribed Carbamazepine 100mg and Gabapentin 100mg for pain.  The nerve problem lasted about a month and then went away.  I had a Covid-19 booster on 09/28/2021 and did not experience any side effects.
Patient was administered a vaccine that had expired (expiration date was not documented).  No detectable harm to pt.
Patient describes subjective tingling/swelling around lips and tongue.  No difficulties with breathing.  States this is similar to how she reacts when exposed to seafood.  Patient was transferred to Urgent Care.  She was given a single IV dose of diphenhydramine.  No further complications or evolution of symptoms; ultimately discharged in stable condition.
Information has been received from a patient who was placed on therapy with GARDASIL. Subsequently the patient experienced an unspecified adverse event. This patient also experienced an adverse event on lisinopril (WAES# 0907USA046021). Additional information has been requested.
The quality related event is a dose administration error.  Review of the patient history reveals the person received four covid-19 vaccine doses previously on 03/04/21; 04/01/21; 11/19/21; and 06/09/2022.  The new booster dose today on 7/18/22 is dose number 5 which is an error.  The recipient reports no adverse response to the dose number 5.
evening p/vax pt noticed face was red & painful had a sore throat; gen body rash;pt seen 2MAR98 by NP;pt appeared acutely ill w/macular erythema gen over body;sl periorbital edema, pharynx, erythematous edematous;conjunctivae
I received the Flu Vaccine on 10/11/06 in the am at work. On the morning of 11/14/06 I awoke at 0530 and was very aware of hearing loss in my left ear. I went to my physician on 11/16/06 for an exam. She informed me I had fluid behind my ear drum. She ordered an antibiotic, Bactrim DS twice a day fro 7 days. And Musinex as needed. I did this with no relief or hearing return. Dr. then ordered a different antibiotic for 7 more days. Still no results. I was then sent to an E.N.T specialist was told I have sudden hearing loss due to a virus. My hearing loss was 45-50%. I was given an anti viral medication for 10 days and Prednisone 60mg for 10 days with instructions to call after a week if I did not notice an improvement. I did not. I then saw another E.N.T. specialist. He inseted a tube trough my ear drum and did 5 injections of steroids directly into the inner cannal, 4 days apart. I did not have any improvement. I also had an MRI on 11/27/06, to rule out tumors, this was "unremarkable".
I feel super faint and am about to faint, my stomach has stabbing pains like knifes, my heart starts beating super fast, and get extremely hot or really cold.
Fever. Redness and swelling spreading to 3/4 of arm. Arm sore/painful. Arm swelled twice its size. Itching.
pt recvd 2 doses of varicella vax & lab eval 6-7wks post vax revealed 11 neg titers & 6 equivocal titers;1 pt devel lesions & another pt devel lesions p/vax titer results unk
A non-serious spontaneous report of administered expired FLUMIST was received from a other health professional concerning a 37 month old male. Neither medical history nor concomitant medications were provided. The product expired on 12-Dec-2010. On 13-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
I am a pharmacist. I administered a Moderna Booster (0.25 ml) to a 16 year old patient. She expressed she wanted to do the Moderna booster, but had received Pfizer as her primary series. I know that Moderna is approved for ages 12-17, but I was not aware that it was not approved for booster shots. I contacted the patient's mother, on 7/17/22 to make her aware of the situation. She stated that her daughter had no symptoms and was doing fine.
elevated blood pressure 202/102; This is a spontaneous report from a non-contactable consumer (patient). A 70-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 26Feb2021 at 08:00 (at the age of 70-years-old) as dose 1 single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had no COVID prior vaccination. On 26Feb2021, in evening around 20:00, the patient had elevated blood pressure 202/102. The patient received treatment for adverse event. Patient was not tested for COVID post vaccination. The outcome of the adverse event was recovered on an unspecified date in 2021.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Broke out in hives two days after second shot.; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 14Aug2021 at 14:15 (at the age of 49-years-old)  as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GWO198) via an unspecified route of administration in the left arm on 24Jul2021 at 15:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 17Aug2021, two days after the second shot, the patient broke out in hives. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event broke out in hives two days after second shot was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected
October 3rd, I visited my daughter, that night I had fever of 101 fever, I had cough, I felt better, I then on October 10th   went to another trip out of state, I have fever, shortness of breath, fatigue, it continued until I got home on the 19th of October. I took six home tests for COVID-19 and all of them were negative. I went to my doctor, the doctor did a PCR COVID-19 test and it was negative. I still had fatigue back then, shortness of breath and a cough, they checked my chest CT was done and chest X-ray doctor said I had COVID. I had a lab test and it showed a high sensitivity CRP, high protein.
4 days after Hep A and Hep B vaccine developed yellowing of skin in (B) arms. (+) submandubular glands swollen.
Went to ER. Red and swollen at site of administration. Dr. at ER said infected. Primary care physician said received in Sept 2018.
3hr p/vax pt devel an inj site rxn characterized by 80mm by 90mm area of erythema, induration & pruritus;applied ice to the area & recovered p/5 days;this is 1 of 9 pt from this facility to devel an inj site rxn p/flu vax w/lot# 4978139;
10/20/14 Administered vaccine. Arm sore that evening. 10/21/14 a.m. Below site arm red, swollen and hot to touch. Pt. called MD on 10/21. Told to apply warm compresses and report if it gets worse. 10/22 Redness spread. Still sore. Saw MD. Ordered KEFLEX 50mg 2 BID x 10 days.