chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022/ Vial stored in fridge post puncture; received doses from a vial first punctured the day before the date of administration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration) and PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022/ Vial stored in fridge post puncture) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022/ Vial stored in fridge post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration) and PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022/ Vial stored in fridge post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Date the vial was initially stored in the refrigerator was reported as 14-Jul-2022. Date and time of vial was first punctured was reported as 14-Jul-2022, time unknown estimation at 10:30 AM. Date and time of administration of vaccine was reported as 15-Jul-2022 first administration 09:30 last administration 11:30. Vial did not undergo temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree celciu  to 25 degree celcius is equal to 46 degree celcius to 77 degree F) was between 10 minutes and 35 minutes.  No treatment medications were reported.
Patient received first dose of pfizer dose on 2.25.2021 at health care facility  Patient accidentally recieved second dose on 3.16 of Moderna Vaccine
arm was swollen and red for 13 days; arm was swollen and red for 13 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PERIPHERAL SWELLING (arm was swollen and red for 13 days) and ERYTHEMA (arm was swollen and red for 13 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021c21a, 037k20a and 023l20a) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to topical drugs (rash to oilment) and Allergy to antibiotic (doxycycline). Concomitant products included LISINOPRIL and VITAMINS NOS for an unknown indication.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen and red for 13 days) and ERYTHEMA (arm was swollen and red for 13 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Nov-2021, PERIPHERAL SWELLING (arm was swollen and red for 13 days) and ERYTHEMA (arm was swollen and red for 13 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. First dose was received on 05-Dec-2020 or 06-Dec-2020. Following vaccination the same day of vaccination 8 to 12 hours after receiving the booster dose patient experienced the adverse events. Adverse events did not cause patient to seek medical care. It was reported that patient did not experienced a similar event in the past, when she had the polio vaccine or small pox vaccine might be.   This case was linked to MOD-2022-669121, MOD-2022-669123 (Patient Link).
This health care professional reported the same event for 2 patients. This is the second of two reports. This is a spontaneous report from a contactable health care professional (HCP). A 17-month-old female patient received PREVNAR (lot number N47827, expiration date Nov2017), via an unspecified route of administration, in the left thigh, on 31Oct2016, as single dose for immunization. The patient's medical history was reported as none. Concomitant medication included FLU SHOT, as single dose for immunization. The patient previously received pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein), as first dose, lot number M27767, expiration date Apr2017, on 16Dec2015 in the right arm for immunization. On 01Nov2016, the patient experienced 5x5 raised hot mark on thigh. The outcome of 5x5 raised hot mark on thigh was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016512345 Same reporter, same drug, same event, different patient.
The day of the vaccine had no problems, the next day 2/26/21 she started feeling bad in the evening with dizziness, light headed, no strength, weak.  No reaction around the vaccine site.  She has just felt horrible and no energy or strength to do anything, and felt like she was going to pass out if she tried to do anything.  Today she is still having the same symptoms, not nearly as bad but still no strength.  Still has no problems with the vaccine site, no pain around vaccine site.  She did take Tylenol once.  She has not notified her doctor of this issue.   Trying to drink water and eating little off and on.
FEELING TIRED; CHILLS; HEADACHE; MUSCLE PAIN; This spontaneous report received from a patient concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) , dose was not reported, administered on 06-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced muscle pain. On 07-APR-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 07-APR-2021, was recovering from headache, and had not recovered from muscle pain, and feeling tired. This report was non-serious.
25 y/o with no past medical history that presents with dizziness post vaccination. Patient states that this is the first dose in the two-dose series. Patient states that normally gets faint with blood draws. Patient states that vaccination was received to the left arm. Patient was placed in wheelchair and taken to the partitioned area with the NP and Paramedics. Patient vitals within normal limits (116/55 BP, 64 HR, 97% RA, 12 Resp). Patient placed in Trendelenburg position and monitored. Patient continued with normal vitals. Within 10 mins of observing patient, patient states that ?feels better?. Patient vitals upon discharge within normal limits (122/70 BP, 94 HR, 98% RA, 12 Resp). Patient able to ambulate without difficulty. Patient discharged in stable condition.
Decided to get second vaccine 1/11/21 even though she was still getting hives from 1st dose. Developed swelling on inner canthus L eye. Saw Dr. 1/14/21 and famotidine was ordered. This reduced hives. In 1/16/21 developed swelling of R inner canthus. Took Benadryl and famotidine hs on 1/17/21. Took famotidine 1/18/21 before work, but developed hives under arms and tongue began to swell that evening. Took another dose of famotidine. Tongue improved within 40 minutes but L side of face began to swell. Took Benadryl 50mg. Facial swelling improved but did not go away. Called Dr. this am and was ordered a Medrol dose pack. If this is not effective then she will be referred to Dr., allergist.
Information has been received from a physician's assistant concerning a 62 year old female patient who on Dec 16, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The reporter indicated that since receiving the vaccination, she has developed a low-grade fever and tachycardia. It is unknown if medical attention was sought. Additional information has been requested.
I noticed ringing in my ears in October, but it might have started before then, as it wasn't too bothersome. It appears to have gotten worse after my booster shot which I received on 11/19/2021. I received the Pfizer booser. It is now constant and fairly loud.
Experiencing sore arm; muscle pain; bruise at the injection site; This is a spontaneous report from a contactable consumer (patient) via a Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm, muscle pain and bruise at the injection site. The patient wanted to now if she could take ibuprofen as she knew that she cannot take Tylenol after her second dose of the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fast heart beat, palpitaions; Felt sick; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Fast heart beat, palpitaions) and ILLNESS (Felt sick) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PALPITATIONS (Fast heart beat, palpitaions) and ILLNESS (Felt sick). On 28-Jan-2021, PALPITATIONS (Fast heart beat, palpitaions) and ILLNESS (Felt sick) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: fast (High) fast heart beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
Had small seizures at night shortly after the second covid shot.  Began to have periodic tonic-clonic seizure in February 2021, after second covid shot.  One of the seizures resulted in hospitalization with skull fracture, rib fractures, and upper extremity injuries.  This patient is a veterinarian and had no health issues prior to beginning covid shot series.  She continues to have small seizures despite anti-seizure medication, and has undergone hand/wrist surgery to repair injuries sustained during a seizure.  She also has headaches as a result of the skull fracture sustained during a seizure.
Pt was given MENACTRA - Vaccine given 5/28/09 redness 5/29 then seen 5/31 in ER Hosp. for right arm swelling shoulder to hand - Numb/tingling hand -Vaccine site 3" redness - Dx cellulitis - RX KEFLEX - Symptoms improved over days 6/4 itchy dic - ed KEFLEX
Information has been received from a health professional concerning a 16 year old female who on 06-AUG-2007 was vaccinated intramuscularly with the first dose of GARDASIL. Concomitant therapy included doxycycline. On 06-AUG-2007 the patient fainted while leaving the office. The patient was brought back into the office and monitored for 30 minutes. Subsequently, the patient recovered from fainting while leaving the office. The patient has not received the second dose of GARDASIL and no further information is available. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to 24 unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (lot # reported as M020900 with an expiration date: 27-APR-2018, subcutaneously (dose and frequency were not reported). Administered doses of VARIVAX experienced temperature excursion of 6.2 degree Fahrenheit for 14 hours and 28 minutes, on 02-AUG-2016; 6.2 degree Fahrenheit for 13 hours and 45 minutes on 05-AUG-2016l 6.2 degree Fahrenheit for 14 hours and 10 minutes on 11-AUG-2016, 6.2 degree Fahrenheit for 13 hours and 59 minutes on 22-AUG-2016, 6.2 degree Fahrenheit for 61 hours and 50 minutes on 29-AUG-2016. There was no previous temperature excursion. Digital data; logger was not involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
3 months after receiving my 2nd dose of the Pfizer vaccine I contracted COVID-19 on the 13th of August. My daughter and her kids were around who caught COVID-19 and that's how I contracted COVID-19. After finding out she had COVID-19 I went to Walgreens and went to get a rapid test that came back positive. I made an appointment for the hospital for the same day where they gave me the another COVID-19 test and confirmed that I had COVID-19. Then they gave me the antibody infusion and prescribed me antibiotics. They also suggested some vitamins to take that can help with the process of getting over the COVID-19. I would say I have recovered I am just experiencing a little fatigue from catching the virus.
Pt exp adverse effect following vax  w/Hep B; No further details were provided;
Information has been received from a pharmacist concerning multiple patients of unknown ages and gender. The patients' pertinent medical history, drug reactions, allergies and concurrent conditions were not informed. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lots #, expiration dates, dosages and therapy routes were not provided), for prophylaxis. Concomitant therapies were not informed. The pharmacist was not aware of any adverse effect. The doses of PNEUMOVAX 23 were exposed to a temperature of 33F and were out of range for 10 days. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Additional information has been requested.
The day after the vaccine I had a terrible pain start in my thumb joints. I took naproxen for the pain and that helped a little bit. The doctor states that they wanted to watch it and had prescribed naproxen. The pain never went away but it did start to subside over 8 months. When I got my flu shot in mid November the pain started all over again. I still have some bursts of pain in my joint specifically the right hand. In 01/2022 I did see a rheumatologist. He diagnosed me with osteoarthritis. He recommended cortisone injections, but I declined.
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 08-JAN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "HPV 10-x1 sdv", lot # J009788 with expiration date of 17-MAR-2016 (strength, dose and route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the reported temperature excursion lasted 152 hours, where the lowest recorded temperature was 26 F (-3.333333333 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several reports received from the same source. Additional information has been requested.
AFTER APPOX 1 WEEK STARTED WITH EASY BRUISING, PROGRESSED TO EXCESSIVE BRUISING AND RED SPOTS ALL OVER BODY AFTER THE NEXT FEW DAYS BROUGHT TO LOCAL PEDIATRIC CENTER, LABS TEST WERE DONE AND TRANSFERRED TO MEDICAL CENTER, WHERE A DIAGNOSIS OF IDIOPATHIC THROMBOCYTOPENIC PURPURA WAS MADE, SHE WAS GIVEN AN IMMUNOGLOBULIN AND REPEATED BLOOD TEST TO MAKE SURE THE PLATLET COUNT WAS COMING UP. (FOLLOWED UP BY A YEAR OF BLOOD MONITORING) HER HOSPITAL STAY WAS 2 OR 3 DAYS. IT WAS ALSO DETERMINED THAT THE LIKELY CAUSE WAS VARICELLA VACCINE AND BECAUSE IT WAS GIVEN WITH THE FIRST MMR VACCINE BOTH WOULD BE CONTRAINDICATED FOR HER.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE. On 31-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  Caller stated that Vials were in refrigerated conditions, the vials suffered 2 temperature excursions, temperature went to 34.81°F for 30 minutes. They were moved from the freezer to the refrigerator on 30October2021, and they were applied on 31Oct2021. The first temperature excursion was on 31Oct2021 at 11AM, and the second one on 31Oct2021 at 2PM. After the first excursion, the pharmacist took actions to restore the temperature of the vials. The vial was administered to patients. She did not have information of how many patients were at the moment of the call, but she said that they were around 5. No further information was obtained about the patients. Caller used the online temperature excursion tool after it was provided in the call, and the tool stated that after that one excursion, the vials could be used, no action required. Vials were administered after one temperature excursion to patients without checking the tool before that.
Patient in for her 2 month vaccines. Brother and sister were in for the flu vaccine and inadvertently given to the 2 month old. Mom was notified right away called manufacturer for any adverse side effects to watch out for. Mom said patient will be ok. Called today to check on patient. Mom stated doing well.
Day off or day after patient experienced knot in center of injection site and redness. One week out patient presented to pharmacy with a 4 x 6 red raised itchy rash. Her MD recommended BENADRYL and ice. Patient experienced no SOB or chest pain.
No other AE/PQC reported.; MA calling to report expired dose of GARDASIL 9 was accidentally administered to a patient. Permission to contact HCP was unspecified. Vaccine was supported through expiry date however caller disconnected before information was provided. No other AE/; This spontaneous report was received from medical assistantand refers to a patient of unknown age and gender (initials were reported).  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #U007477, expiration date: 14-APR-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 21-APR-2023, Medical Assistant calling to report expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was accidentally administered to a patient. Permission to contact HCP was unspecified. Vaccine was supported through expiry date however caller disconnected before information was provided. No other AE/PQC reported.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with improperly stored dose of oral ROTATEQ (lot # L008059, expiry date 18-DEC-2016) (lot # K023532, expiry date 21-JUN-2017) (lot # L008053, expiry date 28-FEB-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that there was no previous temperature excursions. It was reported that Lot # L008059, expiry date 18-DEC-2016 was exposed to cumulative temp of 48 Fahrenheit (F) for 16 hours, Lot # K023532, expiry date 21-JUN-2017 was exposed to cumulative temp of 52.3 F for 72 hours and Lot # L008053, expiry date 28-FEB-2017 was exposed to temp of 41.8 F for 16.5 hours. It was reported that this report was reported due to a data logger. No adverse effects were reported. The action taken with the therapy with oral ROTATEQ was unknown. The outcome of the event was unknown. There was no product quality complaint reported. This case is linked to case number 1602USA008168 via same reporter link. Additional information has been requested.
Patient reported a nosebleed, starting the night of the vaccine and lasting for a day. Also reports fatigue, headache and exacerbation of tendonitis.
Patient complained about feeling dizzy about 10 minutes after receiving vaccine. Before that time, he and I had been talking, and he said he had felt fine. He was put in a reclining chair and continued to feel dizzy, experienced a mild headache, slightly scratchy throat and skin and nausea. For a minute or so, he stopped answering my questions. At that point, I was becoming concerned this could be an allergic reaction, versus vasovagal episode. His vital signs were done, essentially normal with exception of elevated BP.  he was given diphenhydramine 50 mg IM and stated about 5 minutes after that, that his symptoms were slightly better. 911 was called when he seemed to be getting worse, not lucid. . EMTs assessment was same as mine, allergic reaction versus vasovagal.  His EKG NSR, vitals remained  the same. BP still high, not dropping. EMS staff suggested he go to ED, which patient declined. He was feeling better about 1 hour later.
Evening after immunization patient experience pain starting at injection site, going up arm, along shoulder and neck to base of skull.  Pain was very severe.  She used ibuprofen , I suggested she also  use ice, and contact her provider as well.   she was going to call her provider immediately after our conversation.