chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 9:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 10:51 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) 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 37.90   Concomitant products were not provided.  On 02-Mar-2021, Excursion time was 09,10,11 AM, 12 ,2,3 PM, temperature was 27,29,32,33,35,36, total doses given for the day was 177, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 30-Mar-2021, Excursion time was 09 AM, temperature was 33  total doses given for the day was 173, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 3 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021  On 02-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 00, 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 AM: 33, 1PM: 36, 2 PM: 35, 3 PM: 36, 4 PM: 37 and 5 PM: 37.  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 Fisher brand 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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Started menstruating day after each vaccine with cramps; Started menstruating day after each vaccine with cramps; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient also 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 19Aug2021 at 16:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On an unknown date in 2021, day after first vaccine and on 20Aug2021 at 04:00, day after second vaccine, the patient started menstruating with cramps. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started menstruating day after each vaccine with cramps was resolved on an unknown date in 2021.
Pt had DTP/OPV on 31AUG90 & the 1st wk of SEP90 devel apnea & convuls; pt was brought to hosp; mild weakness rt upper ext;
Expired vaccine (Td) given to patient. Td (TENIVAC) has expiration date 10/3/15.
Initial unsolicited report received form a Consumer on 23 January 2015. An 11-years-old patient, whose gender, medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (batch number U5101FA and expiry date 30-JUN-2015) in the left deltoid and also received an intramuscular dose of ADACEL (batch number C4666AA and expiry date 15-JAN-2015) in the left deltoid on 15-JAN-2015. On 15-JAN-2015 i.e. 15 minutes post vaccination the patient was tired, irritable, went into a sleep like state for 3 min and awoke with head heaviness, tightness in chest, increased irritability and became inconsolable and paranoid. The patient also had periods of being her normal self and paranoia which took 2 hours to resolve. Laboratory investigations were not reported and the physician prescribed MOTRIN to the patient. Illness at time of vaccination was denied. The patient had allergy to tree nuts. The patient's birth defects and medical conditions were not reported. Other vaccination within 4 weeks of FLUZONE QIV and ADACEL vaccinations was not reported. At the time of this report the patient was recovered. Documents held by sender: none. Addendum on 30 Mar 2015: Upon second medical examination of case at time of internal review a significant correction was performed to create an additional event record for 'went into a sleep like state for 3 min and awoke,' to delete event 'became inconsolable', modify event to 'chest tightness' and modify listed ness of event 'irritability' from listed to unlisted.
Per husband started that day c/o GI upset N/V and belching(gas) called ambulance at home could not breathe but pt belched and felt better did not go to hospital. For two week thereafter c/o off and on fever, muscle aches, GI upset, not eating well. Lost 5-6lbs total weight, third week no symptoms feeling better, fourth week (last 2 days) c/0 off and on fever, muscle aches and eye red with exudate.  Has never seen a doctor at this point per husband. Referred patient to a doctor NOW since only fever and muscle aches are noted on VIS given to patient at time of visit.  No mention of OTC meds by husband. he was "all over the place with symptoms" and I had to struggle to get him on a time line. ASAP physician with evaluation and possible blood work was my suggestion to patient since I am not a physician and we have NO physician on site. Told husband I would be reported a VAERS to the CDC and that he needed to go to the doctor with his wife now.
dizzy; flu like symptoms; headache; Fever; pain in arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), PYREXIA (Fever) and PAIN IN EXTREMITY (pain in arm) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced DIZZINESS (dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), PYREXIA (Fever) and PAIN IN EXTREMITY (pain in arm). At the time of the report, DIZZINESS (dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), PYREXIA (Fever) and PAIN IN EXTREMITY (pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD21-089861, US-MODERNATX, INC.-MOD-2021-127829, US-MODERNATX, INC.-MOD-2021-127871 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-089861:Same reporter, different patient US-MODERNATX, INC.-MOD-2021-127871:Husband case US-MODERNATX, INC.-MOD-2021-127829:Husband case
Patient was administered varicella subque tech. to (L) upper arm. Approximately 15-20 minutes post vaccination it was observed that arm at vaccine site was red, raised and warm. The reddened area was approx 6 cm in diameter. Pt denied itching or pain. Ice pack applied to site and pt given BENADRYL 25 mg. IM injection to (R) gluteal. Pt released from office after an approx 20 minute observation. Rx for TAC steroid cream to affected area. F/U scheduled for 1/18/12.
left bell's palsy treatment with prednisone and acyclovir residual left face paralysis and left frontalis, obicularis oculi weakness
About 30 minutes after receiving COVID-19 vaccine by Janssen, patient reported having an itchy throat and some feeling swollenness in her throat. Pharmacist asked if she could breathe and she confirmed she can. Pharmacist asked if she would like to be administered IM injection or oral version of diphenhydramine and patient requested IM version. Pharmacist administered diphenhydramine 25mg intramuscularly and monitored for response where patient reported feeling better and less swelling and itchiness. Patient requested an additional dose due to incomplete resolution of symptoms and about 2-3 minutes later, pharmacist administered an additional dose of diphenhydramine 25mg intramuscularly. Pt was monitored for about 40 minutes until her spouse came to pick her up. Patient was advised to contact her provider and potentially request and epinephrine pen for on-hand use. Pharmacist found a pharmacy, CVS, that carried the epinephrine pen and informed patient where that was so she could inform her provider where to call in the script. Patient left premises reporting feeling like she could breathe fine and no swelling upon leaving the store. The store also provided patient with a box of diphenhydramine (Benadryl) oral tablets to take with her as well as a bottle of water. Her spouse took her so she would not need to drive after feeling potentially drowsy upon injection of diphenhydramine.
Patient received the vaccine at the pharmacy n October and developed uveitis in November . His dr. thinks it could be a side effects to the shingrix vaccine he received , however they are not sure on it . Pt did not report this to us until recently
Patient stating she was dizzy and hot during 15 minute monitoring period post vaccine. Patient provided with water and wet wash cloth. Noticed red splotches on patient's neck and she proceeded to say she felt like there was a lump in throat. Notified  APRN. Patient was examined with EKG performed. EKG normal, heart rate elevated. Patient then given Benadryl 25mg IM. Monitored. EKG was normal, heart rate normal and SpO2 good after Benadryl. Patient refused steroid injection or transport to ED for monitoring. Patient was released to her father once stabilized and feeling okay. Spoke with patient this morning 12/3/21, patient feeling well. Stated she did take Benadryl po last night when hives started to return.  Spoke with patient this morning 12/3/21 at 11:30am., hives, chest pain and throat tightness returned and patient went to Emergency Department. Currently being assessed.
Approx 3 hours after injection starting clearing throat action where it seemed to be a constant clearing of throat with irritation.  Medicine taken and within 3 minutes started to note some relief - it continued on thru afternoon but no increase of symptoms.  Started with chills and headache approximately around 3 PM - home at 4 PM, to bed - forcing fluids - ASA and Motrin.  Better in AM - only c/o headache.
Brief heart pain that he has never complained about before (and it was clear he had not heard about the potential myocarditis side effects). It was, however, very brief and the pain has not returned.
Erythema, heat and swelling at injection site. Patient presented at pharmacy at 7PM on 1/29/14, recommended diphendydramine and cold compresses to reduce swelling. Advised patient to see physician in swelling spread.
Rage for about 30 minutes. This happens about 2 days following flu vaccines as well
This spontaneous report as received from a pharmacist refers to a two unspecified patients of unknown age and unknown gender. No pertinent medical history, drug reactions or allergies were reported. On 10-OCT-2014, the two unspecified patients were vaccinated with expired PNEUMOVAX23 (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were known. Concomitant therapies were not reported. The outcome of the events was unknown. Additional information has been requested.
Pt has osteoarthritis in L wrist. Had surgery and regained 90% range of motion for years. About 2 weeks after dose 1 of Shingrix (in L deltoid) , his L wrist swelled some and remained swollen. After 2nd dose of Shingrix (in L deltoid), L wrist swelled much more, and now has about 10% range of motion. It has persisted for 3 weeks, and was seen by his physician. His Rheumatoid Factor is now 162.7 (range of 1-13.0), and he was referred to a rheumatologist.
Light warm erythema lateral (L) deltoid 10cm lateral upper arm (1/2 of humerus circumference) with medial humerus not involved and 11cm vertical erythema for reference humerus is 18cm in length. Improving with no corticosteroids.
The refrigerator that houses the vaccines experienced a temperature excursion. The FLUARIX and INFANRIX vaccines were considered to be out of range and therefore invalid.
Significant red, raised, and indurated area, approximately 1" x 1.75", pruritic, oval-shaped traveling downward arm with beginning upstream site of injection. Noticed upon child's complaint shortly after she arose. Recovery not established as of 5/31/07 at 6:15pm since significant itching, redness, and discomfort still exists, but it is likely. Treatment with cool packs at home.
Extreme fatigue. Presented 24 hours later, duration was 6 days. Also some discomfort and swelling at the site of the injection.
08/20/2021 he went to Pharmacy and received  a Pfizer(FC3181) vaccine by mistake
positive for COVID on 9/20 cough, congestion, runny nose, body aches negative  for COVID on 9/27
Developed febrile rxn 4-6 hrs p/ the immun. Assoc irritability. Symptoms persisted x 36 hrs-48 hrs. Concurrently DX: otitis media p/ 24 hrs of fever.
fatigue; fever of 101 degrees F; hurting all over; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PYREXIA (fever of 101 degrees F) and PAIN (hurting all over) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (hurting all over). On 07-Mar-2021, the patient experienced FATIGUE (fatigue) and PYREXIA (fever of 101 degrees F). On 07-Mar-2021, FATIGUE (fatigue), PYREXIA (fever of 101 degrees F) and PAIN (hurting all over) had resolved. Not Provided          No concomitant medication is provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-060651 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060651:dose 2(husband case)
Pt given FLUZONE HD on 9/7/16-pt fine at time of shot, but later that day had sore throat and left side of tongue swelling up to cause difficulty swallowing and eating. Pt states no fever or other symptoms. Symptoms lessen with gargle of hydrogen peroxide.
vertigo started minutes after injection. duration x5 days. describes "spinning" sensation with associated nausea.
No additional adverse events; patient did not receive full dose of VAQTA; inexperienced nurse who administered the dose and because of "user error"; This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 18-AUG-2022, the patient was vaccinated with a dose of Hepatitis A Vaccine, Inactivated (VAQTA) pre-filled syringe (dosage regimen and route of administration were not reported) lot number U031911, expiration date: 11-NOV-2022, administered as prophylaxis. The nurse reported that it was the inexperienced nurse who administered the dose and because of "user error" (Product administration error), part of the dose was sprayed on the floor and part in the vaccine; therefore, the patient did not receive the full dose of Hepatitis A Vaccine, Inactivated (VAQTA) (Underdose). No additional adverse events were reported (No adverse event).
Unmixed/undiluted pediatric Pfizer vaccine (0.2ml) was administered to the patient. No adverse event reported yet
No additional AE reported; Healthcare provider reports the administration of an expired dose of VAQTA to a patient on 27-JAN-2023.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. Patient's pertinent medical history, drug reactions and allergies and concomitant medication were unknown by reporter.  On 27-JAN-2023, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA), intramuscular injection, administered as prophylaxis, (dose, strength, route of administration, and anatomical location were not provided; lot number U021561 had been verified to be a valid number; expiration date was reported and established as 14-JAN-2023) (expired vaccine used).  No additional adverse event reported.
This non valid spontaneous report was received from a pharmacist and refers to an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history, drug reactions or allergies. Concomitant therapies included sterile diluent concomitant therapies were not reported. On 30-APR-2018, the patient was vaccinated with a properly stored expired dose of M-M-R II (lot number M004305 and expiration date of 25-JAN-2018) (dose, dose number, route and anatomical place of vaccination were not provided), for prophylaxis, which was reconstituted with sterile diluent which had a lot number of N013282 and expiration date of 23-AUG-2019. No adverse effects were reported.
Weakness, chills, fever, malaise. Reaction at site- 5 cc swelling
This spontaneous report has been received from a registered nurse and refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On 05-MAY-2017, the patient was vaccinated with the first dose of VARIVAX subcutaneously (strength, dose, frequency, lot number and expiration date were not reported) for prophylaxis, that were reconstituted with sterile diluent (DILUENT MRK) (lot number and expiration date were not reported). Subsequently, on 24-MAY-2017, the patient received the second dose of VARIVAX subcutaneously (strength, dose, and frequency were not reported; lot number reported as M004437 with an expiration date 04-NOV-2018) that was reconstituted with sterile diluent (DILUENT MRK) (lot number N007932 with an expiration date 06-MAY-2018). There were no adverse effects reported. Additional information has been requested.
Syncope with seizure like activity. Bradycardia and hypotension, HR 30-40 BMP
nasty infection in my nose; horrible cyst on my back; sick with fever for 5 days; sick with fever for 5 days; This is a spontaneous report from a contactable consumer (patient himself). A 60-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EP7533; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 14May2021 (at the age of 60-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had not any known allergies. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EP6955; Expiration date: unknown) via an intramuscular route of administration, administered in Arm Left on 07Apr2021 (at the age of 60-years-old) as DOSE 1, SINGLE for COVID-19 immunization and experienced horrible infection in thumb. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that, after the 2nd shot on 17May2021 patient got nasty infection in nose and as soon as that went away 5 days later got a horrible cyst on back and have been sick with fever for 5 days. The infections were outrageously fast after shots even shocked to the Doctor. The second was a cyst on back and while patient have had cysts before never anything like this one. AEs resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of AEs as patient was prescribed with sulfamethoxazole (Drain infection prescribed sulfamethoxazole). Since the vaccination, patient has not been tested for COVID-19. Relevant tests were reported as none. The outcome of all events was resolved on an unspecified date in 2021.  Follow up attempts are completed. No further information is expected.
This spontaneous report was received from a physician via company representative refers to a currently 59 years old female patient who on 10-JAN-2013 (Thursday) was vaccinated subcutaneously with a 0.65 ml once dose of ZOSTAVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. On 10-JAN-2013, the patient developed a "localized site reaction in the left arm" which was described as being "red" and "swollen". The patient called on the on-call doctor at the practice the same day and it was determined that there was "no fever, no body aches and no rash" reported. The reporter also mentioned that initially the patient's reaction was not painful until the patient went to an unspecified massage therapist which afterwards, the patient complained it "became painful" (onset date: approximately in January 2013) but was "not warm" to the touch. The patient was told to take BENADRYL and use a heating pad on the injection site and over the next few days, the symptoms improved. Patient's outcome was reported as recovering. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
pt recvd vax; hives, swelling, lost consciousness 8 hrs after inject; seen in er; 20jan94 no response to f/u request;