chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; fatigue; headache; received dose on 17Oct2022, 04Oct2022 was considered the expiration date as it was put into a refrigerator on 03Sep2022; received dose on 17Oct2022, 04Oct2022 was considered the expiration date as it was put into a refrigerator on 03Sep2022; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever), FATIGUE (fatigue), HEADACHE (headache), EXPIRED PRODUCT ADMINISTERED (received dose on 17Oct2022, 04Oct2022 was considered the expiration date as it was put into a refrigerator on 03Sep2022) and PRODUCT STORAGE ERROR (received dose on 17Oct2022, 04Oct2022 was considered the expiration date as it was put into a refrigerator on 03Sep2022) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose on 17Oct2022, 04Oct2022 was considered the expiration date as it was put into a refrigerator on 03Sep2022). On an unknown date, the patient experienced PYREXIA (Fever), FATIGUE (fatigue), HEADACHE (headache) and PRODUCT STORAGE ERROR (received dose on 17Oct2022, 04Oct2022 was considered the expiration date as it was put into a refrigerator on 03Sep2022). At the time of the report, PYREXIA (Fever), FATIGUE (fatigue), HEADACHE (headache), EXPIRED PRODUCT ADMINISTERED (received dose on 17Oct2022, 04Oct2022 was considered the expiration date as it was put into a refrigerator on 03Sep2022) and PRODUCT STORAGE ERROR (received dose on 17Oct2022, 04Oct2022 was considered the expiration date as it was put into a refrigerator on 03Sep2022) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient had fever, fatigue, headache which interrupted a planned trip. Patient had no adverse effects. Treatment medications were not reported.
Case number PHEH2013US023169, is an initial spontaneous report received from a consumer on 05 Nov 2013. This report refers to a male patient of unspecified age. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1308601, expiry date: Mar 2014) on 29 Sep 2013. Five minutes after vaccination, he experienced chills, loss of vision, profuse sweating, and loss of consciousness. His eyes rolled, vitals dropped (values not reported) and he turned grey. On the same day, the events subsided. The seriousness and causality were not reported. No additional information was available.
Typical symptoms starting 3-12-21 at ~9pm of mildly elevated temperatures (~99.8 degrees F), body aches, headache. These continued for ~24 hours and I felt well from ~9pm on 3-13-21 until mid-afternoon on 3-14-21 started having mild intermittent upper abdominal pains. These continued until ~7pm that day when I started experiencing abdominal distention, cyclical abdominal cramping, nausea and frequent and deep belching. Around 9pm 3-14-21 experienced several episodes of small volume but urgent episodes of diarrhea but with sensation of needing to go more but couldn't.  Abdominal distention, cyclical abdominal cramping, nausea, and belching all increased throughout the evening/night until  around 2am had a episode of large vomiting. Continued to feel need to have diarrhea but no actual stools occurred throughout the night.  Continued through night to have belching, distention, cyclical abdominal cramping. 3-15-21 experienced significant fatigue, some continued abdominal cramping, abdominal distention increased again (after going down some after episode of vomiting), fever intermittently (up to ~101), nausea to point of not being able to eat anything, significant body aches and headache.  Weight dropped ~ 7lbs between am of 3-14 and 3-16. The evening of 3-15 I started to feel better, was able to keep down Tylenol, most symptoms improved, able to sleep that night. Have felt well other than fatigued and some mild uneasiness in stomach since waking up on 3-16.  Myself and husband are both physicians and we are concerned I experienced symptoms of partial small bowel obstruction evening of 3-14. I was going to seek ER evaluation evening of 3-15 but started feeling better
Pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 23-Jul-2020 and the estimated date of delivery was 01-May-2021. On 02-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy.  On 02-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. She had one previous pregnancy on 29 Sep 2017 and had vaginal wall hematoma during delivery requiring blood transfusion and the pregnancy was live and full term birth.    Company Comment  This is a case of product exposure during pregnancy with no associated adverse events for this 37-year-old female. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy
At 7:00PM the pt experienced s cough, then severe chills, nausea and headache lasting 12 hours. Her eyes were red, no white visible for 36 hours. Went to bed and took store brand Excedrin.
Received a second dose of moderna on 5/13/2021 after receiving a first dose moderna on 4/22/2021.  Second dose of moderna was given at day twenty-one rather than on day twenty-eight, ultimately, seven days early.  The administrator informed management, who discussed the incident.
Information has been received from a health professional concerning a baby who was vaccinated with an oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Subsequently the patient vomited.  It was reported that the nurse then repeated the dosage.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Received flu vaccine on 10/18/2003. Developed severe joint pains in ankles, knees, hips, wrists, elbos and shoulders on 10/19/2003.  Seen by physican and treated with Vioxx 12.5 mg qd.  Reported to the on 11/13/2003.  Contacted clinic and requested vaccine and site information.  Clinic has not returned request for information.
Pt recv vax on 3/8/99; on 3/10/99 pt exp rt arm tender, red, swollen
red, round 2x2 inch lasted for one week; lumpy arm; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (lumpy arm) and ERYTHEMA (red, round 2x2 inch lasted for one week) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced NODULE (lumpy arm). On an unknown date, the patient experienced ERYTHEMA (red, round 2x2 inch lasted for one week). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NODULE (lumpy arm) and ERYTHEMA (red, round 2x2 inch lasted for one week) outcome was unknown. Not Provided          The patient took the second dose of the mRNA-1273, hence action taken with the vaccine in response to the events was not applicable.   No concomitant medication was reported.   This case was linked to MOD-2021-051536 (Linked Report).; Sender's Comments:  MOD-2021-051536:Companion case
Starting 2 to 3 days after administration the patient experienced Swelling, Redness, Soreness and Hot to the touch at the injection site.
My eyes were really heavy and tired. I developed a runny nose and a cough. I also had extreme fatigue and a headache for 1 or 2. I developed a fever of around 100 degrees. I also had 1 day of diarrhea and loss of appetite. I tested myself on September 10, using a home COVID-19 test kit and it was positive. I contacted my doctor the next day who recommended isolation and prescribed PAXLOVID. My symptoms did not improve much from the medication. It took about 2 weeks for the symptoms to go away. I had a lingering cough for about 2 days after the 2 weeks. I have currently completely recovered from all my symptoms.
About 25 hours after receiving the vaccination, I felt rather intoxicated, though I do not drink alcohol or use any sort of illegal drugs. I also felt a little nauseous as well as extremely tired. I slept for several hours in the middle of the day. I felt better a few hours after waking up. I did not report these symptoms to my physician.
Patient called today with complaints of fever since the day of the injection, muscle soreness and local skin irritation.  Patient also states she has flulike symptoms.
02/22/2010 8:04 AM Pt left message at Physicians office that she had a Tdap on Wednesday in the office and noticed a "red patch the size of a deck of cards & and swollen area at the injection site" that continues through this morning.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional (reported as staff). This case involves a 49 years old patient of unknown age who experienced chest pain, throat tightness and muscle spasms, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. On 17-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6260BA expiry date: 30-Jun-2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious chest pain 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious throat tightness 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious muscle spasms 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data.) Final diagnosis was muscle spasms, throat tightness and chest pain. It was not reported if the patient received a corrective treatment. The patient outcome is reported as recovered / resolved on an unknown date for chest pain, as Recovered / Resolved on an unknown date for throat tightness and as Recovered / Resolved on an unknown date for muscle spasms. List of documents held by sender: none.
Arm red, swollen, and sore for a week; stayed red for a long time. O.K. now.
Patient was given her TDaP and Menveo vaccine in the left arm and then received her HPV in her right arm. Vaccine was given and patient proceeded to slump to the left and go limp. Patient then proceeded to shake her arm and hands. Mother started talking to patient and we laid her back on the exam table. Patient became alert and responded to mother. Patient knew where she was and stated that she was dizzy and warm. Patient was also sweating. Mother continued to speak to patient. Provider called into the room to help access patient a well. Ice pack was applied to forehead. Patient was allowed to lay flat for a number of minutes and when she felt ready was allowed to sit up. Patient was given apple juice and some graham cracker due to not eating much prior to appointment. Patient stated that she was feeling much better. Patient was allowed to stand and was stable.  She then transferred to bench in room so vitals could be obtained. Vitals were done and charted in chart. Patient was allowed to then leave the office alert and oriented. Mother was advised to monitor patient and to call the office with any further questions or concerns. Mother verbalized understanding.
This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received BNT162B2 (Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 09:30 (Lot Number: EN6198) as SINGLE DOSE for COVID-19 immunization.  Medical history included hypertension from an unknown date and unknown if ongoing High Blood Pressure.  Concomitant medication included hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN) taken for an unspecified indication, start and stop date were not reported.  The patient experienced starting off as a possible upset stomach but rapidly progressing into intense to possible severe abdominal pain and upset stomach but rapidly progressing on 26Feb2021 13:30 with outcome of recovered.  About four hours after initial injection, abdominal issue began to develop. Starting off as a possible upset stomach but rapidly progressing into intense to possible severe abdominal pain. At first I tried Pepto Bismol to no avail. Then I tried Mylanta. Again, to no avail. Went to bed that night hoping I could fall asleep and finally did. It was gone the next morning. I could have had to have called in sick. Was treatment received for the adverse event with Antacids Pepto Bismol and Mylanta. Therapeutic measures were taken as a result of starting off as a possible upset stomach but rapidly progressing into intense to possible severe abdominal pain and upset stomach but rapidly progressing. The outcome of the events was resolved on an unspecified date.
flu likesymptoms, body aches, chills , patient is no longer feeling those symptoms but last week started experiencing"insides shaking". Patient voiced still feeling like "insides shaking"  Date and time of vaccination: (list both if they received both shots):1/12/21 11:00, 2/2/21, 11:00 Brand and lot of vaccine:1 vaccine Pfizer lot# EL1283, 2nd vaccine: Pfizer lot #EN5318
No Adverse Event; Caller reported AE for improperly stored administered PROQUAD. No symptoms reported. Obtained consent to contact HCP. TE Filed (Case #02441023). AEs Filed (Cases #02441027, 02441050, 02441051, 02441052, 02441053). No additional AE/PQC.  Product Name:; This spontaneous report was received from a nurse refers to a 4-year-old patient of unknown gender.     The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-JUL-2023, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin), (PROQUAD) lot #W024551, expiration date: 31-JAN-2024, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis.         Administered dose of vaccine was exposed to the temperature excursion reported as 0.6 C/ -10 degrees Celsius up to 8 degrees Celsius for 6 hours and 15 minutes (product storage error). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).; Sender's Comments:  US-009507513-2308USA001106:
super tired.; This case was reported by a consumer and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of fatigue (received 1st dose on an unknown date, refer case US2021AMR183085).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced tiredness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingles shot and that left him/her super tired. The patient advised to take vaccine when you could take a couple days off. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183085:same patient, same reporter
antibody test was negative; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number; Unknown) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The reporter stated that a few weeks after receiving the second dose, he obtained an antibody test from his doctor to see if he had developed antibodies after the vaccine. He says his antibody test was negative but doesn't know which antibody test was used because the lab won't tell him. He is looking for any guidance on this subject and would like to know if he is immune. The outcome of the event was reported as unknown.   Information on the lot/batch number has been requested.
30 minutes, post vax, noted heat at site, face felt hot, co-worker noted face to be very red and slightly swollen. No SOB, wheezing or oral swelling. No rash. Return to clinic if redness of face, possible puffing around eyes or SOB. Has a slight headache. Rx'd Benadryl liquid and monitored. Stable on release to home with oral Benadryl and instructions.
Patient received 1st of COVID vaccine with Pfizer, relocated  and missed her 2nd shot appointment.  When returned to states, unable to find location to receive 2nd Pfizer vaccine and schedule self for a Janssen vaccine to complete series.  Records were not checked prior to receiving the Janssen vaccine.
when he urinated there was pure red/ bleeding in the urine; This is a spontaneous report from a contactable consumer (patient). An 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration in left arm on 20Mar2021 (between 9 and 10 in the morning) (at the age of 81-years-old) as dose 1, single for COVID-19 immunization. Medical history Crohn's colitis since an unknown date diagnosed around 20 years ago, or 25 years ago patient added that it all happened when he quit smoking, lung cancer non small cell, on an unknown date in Jun2018, diabetes. Concomitant medication included insulin LANTUS 10-16 units a night for brittle diabetic type 1, insulin aspart NOVOLOG (has been on since 1994 or 1995), MESALAMINE (has been on for 15 years, 4 pills a day. He takes it for Crohns), patient takes other medications, and just vitamins. Patient also had the other vaccine (unspecified) for shingles but that was a couple years ago. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not have any AEs. On an unknown date, the patient experienced bleeding in the urine. He mentioned that it first occurred 24 hours after his 1st dose. He mentioned that it looked like pure blood/ pure red. It lasted for an hour or hour and a half in the morning. Patient added it was not light red, it was dark red. It was about the same color when he cut his hand the last time. He mentioned that he was going in for more testing with his doctors. He was asking if there have been reports of this event associated with the vaccine. Patient confirmed that the pure red stopped after that, and then came back after the second vaccine. Patient had an MRI the other day and they said his urinary tract was normal, they found nothing. He does not know if it has anything to do with the Pfizer vaccine or not. He searched and can not find anything. The adverse event resulted in physician office visit. On an unknown date, the patient underwent lab tests and procedures which included CAT scan Normal and MRI Normal. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
I have a large rash where I go injected. I noticed early this morning. It is not painful or itchy, just hot to the touch.
On May 9th my father started to not feel well. On May 16th he was admitted to the hospital with sepsis. He had 2 MRIs which concluded he has an infection in the bone of one of his toes. He was sent home after 5 days in the hospital with a PIC line where he has to be on 2 antibiotics and a blood thinner for 6 weeks. If infection doesn't resolve he will have to have toe amputated. Prior to Covid vaccines my father was very active and healthy. He could do things without distress. He can now barely walk too far because he is so weak.
Mother called UCHD on morning of 10/8 and reported daughter had started running a fever during night: 101-102 F. Mom treating with TYLENOL and Ibuprofen which "has helped". Mom denies any local reaction at site of injection.
This spontaneous report as received from a physician refers to a multiple patients of unknown age and gender. On an unknown dates in 2015 multiple patients were vaccinated with a doses of oral, ROTATEQ (doses, routes and lot numbers were not reported). The doses of oral ROTATEQ were exposed to a temperature excursion of 24F for 720 continuous hours from unspecified consecutive days in January to February 2015. The physician noted that those vaccines were not exposed to temperatures below 24F. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.