chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unable to get a good night's sleep due to the discomfort; discomfort; significant pain; Initial information received on 04-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 66 years old male patient who was unable to get a good night's sleep due to the discomfort and significant pain after receiving vaccine Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Back pain on 30-SEP-2023.  Concomitant medications included paracetamol (Tylenol).  On 02-Oct-2023, the patient received a dose of suspect Influenza Quadrival A-B High Dose HV Vaccine formulation, strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a unable to get a good night's sleep due to the discomfort (sleep disorder), discomfort and significant pain (back pain) (unknown latency) following the administration of Influenza Quadrival A-B High Dose HV Vaccine .  Reportedly, He also mentioned that he had tweaked his back over the weekend before getting the flu shot. He says that he asked the pharmacist which OTC would be good for his back pain and not interfere with the effectiveness of the Flu shot. The pharmacist directed him towards Tylenol. Caller wants to know if he can take more Tylenol or if he would be able to take. Caller injured his back on 30sep2023. He received FLUZONE HIGH-DOSE QUADRIVALENT on 02oct2023. He did not want to take the 6-day course of Medrol that he has used before in similar situations, and the Tylenol recommended by his pharmacist is not effective, so he has been experiencing significant pain since receiving the vaccine. He states that he has been unable to "get a good night's sleep" due to the discomfort.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events unable to get a good night's sleep due to the discomfort, discomfort, significant pain.  At time of reporting, the outcome was Unknown for the event unable to get a good night's sleep due to the discomfort, discomfort and significant pain.
This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received 2.5mL dose for their booster dose/2.5mL dose administered as booster doses for 2 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2.5 milliliter. On 03-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 2.5mL dose for their booster dose/2.5mL dose administered as booster doses for 2 patients). On 03-Dec-2021, ACCIDENTAL OVERDOSE (Received 2.5mL dose for their booster dose/2.5mL dose administered as booster doses for 2 patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patients received 2.5mL dose for their respective booster doses. Concomitant and treatment medications were not reported.
20 minutes after injection she started having burning and numbness to the base of her skull which later extended to her face including her nose and below her eye. No facial drooping. She also became flushed and felt that she was about to develop hives.  Approximately 6 hours later she developed a headache as well. She did not take Benadryl until approximately 6 hours later, after which her symptoms started to resolve.
1. Red spots with burning sense started on lower neck within two weeks after 1st dose of vaccine. No treatment took. 2. Burning sense increased with pain and bumps observed on )2/05/2021 on upper neck and back side of both ears. 3. Family doctor consulted and prescribed 1 week course - 3 times a day - of 1 GM ValACYclovir Tab with 4% Lidocaine patches (Once a Day).
Severe chills and shaking of arms hands, legs feet and torso. Some nausea no vomiting.  Weak and extreme fatigue, unable to stand without dizziness.  Lasted until 11pm.  Fatigue all next day.  Soreness at site two days, pain along arm and forearm one day.
The vaccine expired in the freezer on 06-Apr-2022 and administered on 17-May-2022; Administer  expired vaccine to a 100 patients/information on only 4 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer  expired vaccine to a 100 patients/information on only 4 patients) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 06-Apr-2022 and administered on 17-May-2022) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 prophylaxis.     Patient did not had any allergies. It is unknown whether the patient had tested or diagnosed for COVID- 19. Patient did not had Acute and Chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: pfizer (Pfizer primary series.) and Pfizer (Pfizer primary series.). Past adverse reactions to the above products included No adverse event with Pfizer and pfizer.    On 17-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer  expired vaccine to a 100 patients/information on only 4 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 06-Apr-2022 and administered on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer  expired vaccine to a 100 patients/information on only 4 patients) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 06-Apr-2022 and administered on 17-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  Patient received second booster dose. The vial was initially stored in the refrigerator on 28-Apr-2022 and 04-Apr-2022. Patient did not receive any other vaccines  within 1 month prior to Moderna COVID-19 vaccine   No treatment drug details was reported.
A-fib; heart pounding; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced A-fib and heart pounding. The events were considered non-serious by the reporting consumer. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 12-DEC-2017 and 11-APR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N004815 and expiration date 07-OCT-2018; lot# N024295 and expiration date 24-MAR-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Erythema, edema, warmth, fluid filled vesicles at injection site. Clear fluid in vesicles saw PCP- offered antibiotic - never took. Blisters resolved.
On Monday 4/12/21, 5 days after taking the J&J vaccine, I had an extremely itchy and painful full body rash. It was big red bumps like mosquito bites all over my body including legs, back, arms, chest, stomach, etc..I could not sleep all night due to the pain and itch and had to constantly apply cortisone cream as well as ice to make the pain bearable. The rash went away almost completely the following morning but then returned again the following night. I have never had any prior allergies or skin conditions and worry that this may become a recurring event since it has now happened for 2 nights. I did hear that a rash at the injection site was a possible side effect from the covid vaccines but this was way worse as it was all over my entire body.
get Shingles, had received the vacillation/Suspected vaccination failure; get Shingles, had received the vacillation; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-SEP-2022 Reporter's Comment: This case was reported via interactive digital media. The reporter stated that his/her doctor told him/her that in all his years of practicing medicine he had only saw about 15 patients got the Shingles who had received the vaccination and that he had never saw a vaccinated person got them twice. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case had been linked with case US2022AMR140140, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR140140:Same reporter
Not Happy that pfizer is not as effective as Moderna I had Pfizer; This is a spontaneous report from a Pfizer sponsored program Pfizer.com - General Company Information. A contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. It was mentioned that, patient was not happy that pfizer was not as effective as Moderna patient had Pfizer. Get the ball going now on a booster and vaccines for all ages. Push the FDA. No time to waist. Very disappointed in Pfizer. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient reported to clinic the next day with redness, pain and swelling in injection site. She stated this had worsened overnight.
Presented to the emergency department on 11/6/21 for evaluation of abdominal pain as well as cough for 1 day prior to arrival.  Patient is fully vaccinated for COVID with moderna vaccine with last dose being April 1, 2021.  She was recently discharged from nursing home approximately 1 week ago and was negative for COVID at discharge.  In the emergency department, CT angiogram of the chest was done which did not show any pulmonary embolism but did show some small bilateral pleural effusions as well as chronic thoracic aortic aneurysm.  CBC did not show any leukocytosis but BNP was high at 1270 and troponin was mildly elevated at 0.055.  COVID was positive. She was found to be desaturating on room air into the 80s therefore she was placed on 2 L nasal cannula and saturating in the low 90s on exam.  She was given 1 L normal saline bolus, full-dose aspirin as well as Decadron in the emergency department. Patient was admitted for acute hypoxemic respiratory failure likely secondary to COVID as well as some CHF.  She was treated with Decadron, Rocephin, azithromycin as well as remdesivir.  Oxygen to maintain saturations.  She required 2-3L O2 via NC for first 48 hours to maintain saturation >90%. Afebrile, aleukocytosis; with initial BNP 2070 improved to 830, and mildly elevated trop 0.055. She received 1L NS bolus, and x5 days of Rocephin 1g, Azithromycin 500mg, Remdesivir and decadron 6mg.Received lasix 40mg IV/PO daily throughout stay, which improved her oxygen requirements and cleared fluid from lung. She was continued on lasix 40mg PO daily as outpatient.Pt was discharged saturating >94% on room air and was active and back to her baseline mentation (A&Ox2) on 11/11/21
The pharmacist, did not know how to administer a vaccine.  She used a BD 1mil Insulin Syringe U-100 instead of the "locking" one typically used.  She pulled my son's skin out, rather than stretching it out.  Upon attempted administration, the syringe bowed and broke, splashing the vaccine all over herself.  She jumped up and panicked and left my son sitting there.  Upon her return she told me they ran out of the syringes they usually used, she hated these that are used for insulin, this was the second time it happened, and she didn't know what to do.  She called Pfizer.  Pfizer advised her that she should have administered the vaccine again in the opposite arm. She told us that since 45 minutes had passed, that was too long, as the advice from Pfizer was immediately.  She advised to follow up with my doctor, who advised me to follow up with the CDC, who advised me they can't provide recommendations.
J&J vaccine expired on 9/21/2021 at midnight. Patient was vaccinated with expired J&J  11 hours past expiration date on 9/22/2021. J&J was contacted and patients were notified or attempted to be notified of the situation.
headache; felt tired; Chills; strong fever peaked around 103 measured; considerable sweating; This is a spontaneous report from a contactable consumer (Patient).  A 46-year-old male received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EK5730 and expiry date was not reported), via an unspecified route of administration in left arm, on 23Mar2021 at 15:30 (age at vaccination 46-years-old), as, DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included atorvastatin and losartan taken for an unspecified indication, start and stop date were not reported. No known allergies reported. The patient did not receive any other vaccine in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EJ1685 and expiry date were not reported), via an unspecified route of administration on left arm, on 03Mar2021 at 9:00 AM (age at vaccination: 46-years-old), as DOSE 1, SINGLE for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the covid vaccine. Patient did not had covid prior or post vaccination. The reported that, within few hours of injection, on 23Mar2021 17:30, the patient experienced headache, within 12 hours felt tired and started with Chills within 22 hours severe chills and after 28 hours had a strong fever peaked around 103 measured with a forehead digital thermometer and after 32 hours fever broke and considerable sweating, patient felt great 36 hours later. Patient responded I became aware of these adverse reactions on the 24th and filled out report on the 25th. The patient did not receive any treatment for the events and felt great 36 hours later. On an unspecified date the patient underwent lab tests and procedures which included body temperature which was found to be 103. Outcome of the events was recovered in Mar2021.   No follow-up attempts are possible. No further information is expected.
Pt recvd 3 doses of Engerix-B vax 8DEC90, 17JAN91 & 12JUN91 & 17AUG91 titers were checked & a value of 4.9 was obtained; pt showed a borderline response;
Had an allergic reaction to the vaccine in the right arm.  Swelling around injection site, fever, redness, headaches (still ongoing), shortness of breath (still ongoing), lightheadedness  (ongoing), nausea (ongoing).  On medications for headaches.
Delayed-onset skin rash in the left arm following vaccination: large, red, swollen, square-shaped rash without itching or being hot to the touch. Have photo if needed
Information has been received from a registered nurse concerning an elementary school aged child who was vaccinated with a dose of varicella virus vaccine live. On approximately 23-FEB-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/12/2006.  Information has been received from a registered nurse concerning an elementary school-aged child who on 22-FEB-1999 was vaccinated with a dose of VARIVAX (Merck).  On 05-MAR-2006, the patient developed breakthrough chickenpox.  Unspecified medical attention was sought.  There was no product quality complaint involved.  No further information was available.  Additional information has been requested.
Felt like a bad head cold with stuffy nose, coughing and spitting up; was tired. I slept almost a whole day. I noticed as those symptoms relented that my sense of smell was defunct. Nyquil; Dayquil and Aspirin was treatment. I had the symptoms pretty heavy Tuesday and Wednesday. I have felt the last couple of days. But if I don't take the cold medicine, I start to feel it build back up. I try to stop taking it and then I realize that I still need it. Thursday, the 28th, I went to the doctor. I did the 15-minute COVID-19 test there and they said I was positive for COVID-19. I haven't gotten the results back yet for the longer test. I have been feeling better every day pretty much since Wednesday the 27th. The doctor referred me to the hospital for an Infusion, but after reading all the materials and because my symptoms are reducing and I starting to feel fine, I decided not to do it. I haven't gotten my sense of smell back yet. The cold medicine is knocking down the symptoms where it isn't physically bothering me.
18 hrs after vaccination i had severe shortness of breath Condition lasts for about 2 hrs 30 mints.
Dose 1: injection site pain (3/23/21)  Dose 2: Injection site pain starting at around 10 pm the night of, body aches over night, and low grade fever (100) by the next morning (~7 am).
Information has been received from a consumer, concerning her 19 years old daughter, who was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot #, site and route of administration not reported) in Jun 2008 (reported as "three weeks ago"). When the patient got the first injection she went home and immediately fell asleep for 15 hours. She was very worried about getting the shot before it happened. Additional information is not expected.
On unspecified dates, the pt received her 1st and 2nd doses of Lymerix. The pt reported that her arm hurt and felt heavy for 2 days, post vax. Within 24 to 48 hours, post vax of the 2nd vax, the pt developed a fever of 102 to 102. The most recent information received on 5/26/00, reports the outcome of the events as resolved.
Headache; Mild Nausea; High level of fatigue; No energy; intestinal discomfort/cramp; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy) and ABDOMINAL PAIN (intestinal discomfort/cramp) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history information was reported.     On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy), ABDOMINAL PAIN (intestinal discomfort/cramp) and PAIN IN EXTREMITY (sore arm). At the time of the report, HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy), ABDOMINAL PAIN (intestinal discomfort/cramp) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy) and ABDOMINAL PAIN (intestinal discomfort/cramp) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history information was reported.     On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy), ABDOMINAL PAIN (intestinal discomfort/cramp) and PAIN IN EXTREMITY (sore arm). At the time of the report, HEADACHE (Headache), NAUSEA (Mild Nausea), FATIGUE (High level of fatigue), ASTHENIA (No energy), ABDOMINAL PAIN (intestinal discomfort/cramp) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Headache, NauseaVomiting, injection site sore. Told to follow up with primary care physician if no improvement Narrative:
Developed HA, muscle aches, skin sensitivity 1/18/04. Rash 1/19/04.
About 10 minutes after shot, felt hot sensation go from ahoulders down rest if my body. My heart rate went to 140bpm. I alerted RN, gave me water, juice took about 20 minutes for HR to fo down to around 100. Did not go to ER. Went home, rested. HR returned to 80bpm around 3pm. Metoprolol taken two hours prior vaccine.