chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial (lot # 011F21A) that had been refrigerated for more than 30 days (since 1Oct2021); gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial (lot # 011F21A) that had been refrigerated for more than 30 days (since 1Oct2021)) and PRODUCT STORAGE ERROR (gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial (lot # 011F21A) that had been refrigerated for more than 30 days (since 1Oct2021)) and PRODUCT STORAGE ERROR (gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial (lot # 011F21A) that had been refrigerated for more than 30 days (since 1Oct2021)) and PRODUCT STORAGE ERROR (gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial) 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 provided.   This case was linked to MOD-2021-375089 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow-up information received on 05-NOV-2021 contains no new information.
adult patient received/ pediatric dose of Havrix.; adult patient received/ pediatric dose of Havrix.; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 57-year-old male patient who received HAV (Havrix pediatric) (batch number ZJ3G3, expiry date 12th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th July 2021, the patient received the 1st dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On 14th July 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: It was reported that an adult patient received a pediatric dose instead of adult dose of Havrix, which led to adult use of a child product and underdose. Nurse wanted to know if the patient should  start over with adult dose schedule or complete the schedule with pediatric dose. The reporter consented to follow up.
fever to 38.3; This is a spontaneous report from a contactable physician. A 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) intramuscular on left arm single dose for COVID-19 immunization on 09Jan2021, 06:30 PM, at 69-year-old. Medical history included: hypertension. No known allergies. The patient did not have COVID prior vaccination. Concomitant medications in two weeks included: amlodipine, benazepril. The patient did not have other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on left arm for COVID-19 immunization on 19Dec2020, 06:30 PM, at 69-year-old. On 10Jan2021, 07:00 PM, the patient had fever to 38.3 which lasted about two hours. Treatment received as: acetaminophen 500 mg. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the event was resolved on 10Jan2021, 09:00 PM.
HEADACHE; TIREDNESS; FEELS BAD/TERRIBLE; This spontaneous report received from a patient via other company  concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 15-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On 16-AUG-2021, the patient experienced feels bad/terrible. On an unspecified date, the patient experienced headache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient recovered from feels bad/terrible, headache, and tiredness. This report was non-serious.
Took only one dose of Vivotif as the consumer forgot to refrigerate remaining doses; Spontaneous report received on 24FEB2020.  A pharmacist reported that a 27-year-old consumer who "took only one dose of Vivotif as the consumer forgot to refrigerate remaining doses" (PT: Intentional dose omission). The consumer was receiving Vivotif for immunization. The consumer took the first dose of Vivotif on 20FEB2020. Then, the consumer forgot to refrigerate the remaining doses thus, the consumer did not take any more doses. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the event was unknown.  Company Comment: A consumer took only one dose of Vivotif as the consumer forgot to refrigerate remaining doses (Intentional dose omission). Vivotif must be stored in the refrigerator at the recommended temperature and should be taken every other day. Considering the nature of event, the causality of intentional dose omission is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took only one dose of Vivotif as the consumer forgot to refrigerate remaining doses (Intentional dose omission). Vivotif must be stored in the refrigerator at the recommended temperature and should be taken every other day. Considering the nature of event, the causality of intentional dose omission is assessed as not applicable to Vivotif.
1/14, 2200 - chills 1/14, 2300 - onset of fever 1/15, 0100 - tremors, chills, fever, onset of headache 1/15, 0300 - peak fever @ 100.7 F (baseline is 96.5) 1/15, 1000 - fever resolved 1/15, 1200 - chills resolved 1/15, 2000 - headache resolved
Large swelling and hot redness at injection site. Swelling is spreading despite ice and tylenol and ibuprofen intake. Low grade fever spikes.
Late 10/6 11 pm - midnight developed fatigue that was severe & chills. Still present today 10/7/20 1130 am
Many women have experienced breast issues; This spontaneous case was reported by a consumer and describes the occurrence of BREAST DISCOMFORT (Many women have experienced breast issues) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST DISCOMFORT (Many women have experienced breast issues). At the time of the report, BREAST DISCOMFORT (Many women have experienced breast issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   It was reported that these women had to do mammograms.  Treatment information was not provided.
I had trouble all day.  In the morning, my shoulder where the shot was administered, I couldn't lift my 19 month old out of her crib. Checked my heart rate, and it was at 130 with O2 at 97%.  Shoulder then got better throughout the day, but then my knees felt like they were 87 years old.  I had a major headache all day and felt like I was having an asthma attack all day as my chest was tight.  After I went to a doctor visit (heart rate at 115 and O2 at 96%), I came home, sat on the couch and picked up my youngest daughter and my heart started racing.  I felt cold and was wanting to sleep. I put my daughter down and checked heart rate - 150 and O2 at 96%. I felt like I was working out, but was not moving at the time. This lasted for 20 or so minutes and had to call ambulance.  On the way to hospital, heart rate flucuated from 120 to 95. Again, not doing anything except sitting in the ambulance.  At the moment, my heart rate has been at a steady 100-110. Before, my resting heart rate was 60.
I had bleeding between my cycle, so basically 2 cycles a month. I also had a breast lump. These symptoms also continued after the booster dose 3.
About 1-2 weeks after first COVID Vaccine, he started to experience breast and axillary tenderness + swelling which are still present.
onset 8/4 with BA and chills, tested 8/5. Fluctuated between extreme shaking and sweats, only lo grade fever. Was admitted to HCF 8/5, discharged 8/7. Received antibody infusion and steroids. Case was diagosed with x2pneumonia as well as covid. Continued his isolation at home through 8/15. Unknown exposure. Case has a history of stroke and diabetes. Has followed up with PCP recently, currently experiencing painful swelling in lower legs.
Dr. suggested during a routine visit that I have a repeat of the pneumonia vaccine, which I agreed to.  Since I was planning a trip on 6/17/07, I asked if there would be any reactions and he said no. The RN administered the injection, never giving me any written information regarding the injection. That evening my face became very flushed and I began feeling very tired and a lot of malaise.  I called and talked to an RN, who said she would check with the doctor and call me back, but she never did.  The next day I was still pretty sick and my arm ached so bad I could hardly move it.  Also, I developed a huge red lump at the injection site.  The third day I felt about the same, but I now had red welts appearing on my arm and shoulder.  My temp for the 2 day period after the injection was about 99.  I then called a second time and the RN advised me that I should have been given the insert, which she insisted on reading to me before she would transfer me to the doctor.  Dr. then talked to me. He never really identified himself and his name does not appear on my medical records.  He advised me to take Benadryl and apply heat to the affected areas.  He said if I became worse to go into the ER, because they were too busy to fit me into their closing schedule.  The next day I improved without further incident. On 6/28/07 I requested my medical records and discovered that no mention of the reaction or any of my phone calls had been made, which I do not understand.  Would you kindly advise me how to have my medical records corrected?  I do not know if it is relevant or not, but I would like to state that in June I initiated a formal complaint against a local hospital where I had volunteered. Thank you very much for your help.
Arm start hurting; temp 103.8; stabbing to the bone pain; hurts all over body; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (stabbing to the bone pain), PAIN (hurts all over body), PAIN IN EXTREMITY (Arm start hurting) and BODY TEMPERATURE INCREASED (temp 103.8) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was sick for 40 days.) in November 2020.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced BONE PAIN (stabbing to the bone pain) and PAIN (hurts all over body). On 18-Feb-2021, the patient experienced BODY TEMPERATURE INCREASED (temp 103.8). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm start hurting). At the time of the report, BONE PAIN (stabbing to the bone pain), PAIN (hurts all over body), PAIN IN EXTREMITY (Arm start hurting) and BODY TEMPERATURE INCREASED (temp 103.8) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment includes Ibuprofen.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020. On 19th February 2018, the patient received SHINGRIX (intramuscular). .5 ml. On 21st February 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, rash and swelling arm. On an unknown date, the outcome of the pain in arm, rash and swelling arm were not recovered/not resolved. The reporter considered the pain in arm and swelling arm to be possibly related to SHINGRIX. The reporter considered the rash to be probably related to SHINGRIX. Additional information was provided as follows: The patient received SHINGRIX on the left arm. Concomitant medication was unknown. The patient experienced rash, swelling and pain in his left arm. The pharmacist reported that the events had started on Monday when she gave him a SHINGRIX injection and they had continued. The healthcare professional's call was transferred to Medical Information System for discussion on events. Only documented information was asked.
A few rounds of diarrhea and then vomiting.  It felt like the morning I woke up when I had COVID in March 2020.  By late afternoon, the nausea began to settle.  A few sinus issues headache that day.
had 3 shots because they keep failing/ suspected vaccination failure; had shots, keep failing; had 3 shots; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had got 3 shots because they keep failing, which led to extra dose administered. The patient stated that there was no help here. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Dizziness, Myalgia, Palpitations, fatigue, chills, pulse =112; temp 99.4; cold hands; pain at injection site Narrative:
Symptoms lasted for about 12 hours from waking at 7:30am. Mild to moderate fever throughout day. Fever and fatigue all day, developed diarrhea mid-day, finally progressed to severe chills for about 30 minutes. Blood pressure reading during chills was 154/125. After chills subsided blood pressure was 70/50 with a pulse of 130 while sitting. Fever increased to 104 degrees then subsided. Went to sleep and then was mostly normal health the next day.
Shading of her hair after her second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HAIR COLOUR CHANGES (Shading of her hair after her second dose of vaccine) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced HAIR COLOUR CHANGES (Shading of her hair after her second dose of vaccine). At the time of the report, HAIR COLOUR CHANGES (Shading of her hair after her second dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No treatment information was reported.
slight pain; tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (slight pain) and TENDERNESS (tenderness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 PAIN (slight pain) and TENDERNESS (tenderness). At the time of the report, PAIN (slight pain) and TENDERNESS (tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
MODERNA COVID-19 VACCINE EUA 1. Lymph node swelling 2.Peripheral vascular disease 3. Diminished blood flow to hand 4. Referred to Specialists for further treatment
PT STATED THAT SHE HAD A RED MARK ON HER ARM SURROUNDING WHERE SHE GOT THE INJECT. IT CAME UP ABOUT A WEEK AFTER HER INJECTION. IT WAS RED, AND HOT TO THE TOUCH AND PT SAID IT WENT AWAY WITHIN 24 HOURS. PT PUT HYDROCORTISONE CREAM ON IT.
Received two doses of Pfizer vaccine and was accidentally given the MODERNA vaccine instead of the shingles vaccine today; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received two doses of Pfizer vaccine and was accidentally given the MODERNA vaccine instead of the shingles vaccine today) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Received two doses of Pfizer vaccine and was accidentally given the MODERNA vaccine instead of the shingles vaccine today). At the time of the report, WRONG PRODUCT ADMINISTERED (Received two doses of Pfizer vaccine and was accidentally given the MODERNA vaccine instead of the shingles vaccine today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Abdominal pain; Monster headache; Arm sore at injection site; Suicidal ideation; Felt unstable/sitting on the couch like a zombie; Morbid thinking; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (Suicidal ideation) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bipolar disorder, Vasculitis and Depression.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced SUICIDAL IDEATION (Suicidal ideation) (seriousness criterion medically significant), FEELING ABNORMAL (Felt unstable/sitting on the couch like a zombie) and MORBID THOUGHTS (Morbid thinking). On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain), HEADACHE (Monster headache) and VACCINATION SITE PAIN (Arm sore at injection site). On 30-Apr-2021, SUICIDAL IDEATION (Suicidal ideation), FEELING ABNORMAL (Felt unstable/sitting on the couch like a zombie) and MORBID THOUGHTS (Morbid thinking) had resolved. At the time of the report, ABDOMINAL PAIN (Abdominal pain), HEADACHE (Monster headache) and VACCINATION SITE PAIN (Arm sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment of these events included water and Anacin.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Unable to Sleep-Severe
Pfizer-BioNTech COVID-19 Vaccine EUA: patient seen for allergy clinic follow-up visit reporting throat tingling within four minutes of vaccination. Three hours later experienced sensation of throat closing and left upper lip swelling. Patient went to emergency department (ED) where epinephrine and and steroids were administered. The patient was observed for three hours and discharged to home with a prescription for predisone. The next day patient reports facial erythema described as flat and non-pruritic that spread to the neck. The following day patient reports feeling feverish with elevated blood pressure, severe chills, chest pain, and trouble breathing. The patient returned to the ED, received diphenhydramine and steroids, was monitored and discharged to home.  Patient received another prescription for prednisone from primary care provider. Patient reports intermittent low energy, chest pain, troubles breathing, and lip numbness since vaccination.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 03-NOV-2014, an unspecified number of patients were vaccinated with improperly stored ROTATEQ lot # K001716, expiration date: 24-NOV-2015, oral (dose was not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.