chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Jynneos vaccine administered intradermally; Jynneos vaccine administered at dose 0.1 ml; Jynneos had a temperature excursion; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-002046 is a spontaneous case report initially received on 23-Aug-2022 from a nurse via Communication (reference number: USBAV22-1123) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On 18-Aug-2022, Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00003) had a temperature excursion (explicitly coded as 'product storage error').  On the same date, the patient was vaccinated with the affected Jynneos vaccine (batch number: FDP00003), at dose reported as 0.1 mL, administered intradermally (explicitly coded as 'underdose', 'inappropriate route of vaccination' and 'product administration error'), for monkeypox prophylaxis.   At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received from on 24-Aug-2022 included the local case ID.  The case is linked to cases US-BN-2022-002030, US-BN-2022-002045, US-BN-2022-002028, US-BN-2022-002047, US-BN-2022-002048 and US-BN-2022-002049, concerning the same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated with the Jynneos vaccine, at dose reported as 0.1 mL, administered intradermally for monkeypox prophylaxis, and Jynneos vaccine had a temperature excursion prior the vaccination, which is considered as underdose, inappropriate route of vaccination, product storage error and product administration error. No associated adverse events have been reported with the reported medication error. The events of underdose, incorrect route of product administration, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose, inappropriate route of vaccination, product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the Jynneos vaccine, at dose reported as 0.1 mL, administered intradermally for monkeypox prophylaxis, and Jynneos vaccine had a temperature excursion prior the vaccination, which is considered as underdose, inappropriate route of vaccination, product storage error and product administration error. No associated adverse events have been reported with the reported medication error. The events of underdose, incorrect route of product administration, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose, inappropriate route of vaccination, product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Woke approx. 2 AM 6-2-07 nauseous, stomach ache-Cold sweats 7 AM-Treatment OTC Claritin 10 mg once daily x 7 days Vistaril 25 mg 1-2 QID PRN
Patient received the COVID-19 Pfizer vaccine at 10:22 am on 2/28/2021. Patient began to experience throat swelling and an itch from the chest to her neck. Vitals were taken: BP 138/72, HR 125, SPO2 98%. Patient was given an epi pen into her right thigh at 10:50 AM. Epi pen lot number 0FM501, EXP 05/22. Patient was also given a Kenalog injection into the right glute at 11:06 AM. Kenalog lot number AP200265C, EXP 9/22.
On 12/21/2022, approximately 04:00AM, I had a runny nose. I got up about 08:00AM, and I had a sore throat. I did a home COVID-19 test and it was positive. I called the doctor's office about 09:00AM and they had a nurse practitioner call me back. I was starting to get a headache and she suggested PAXLOVID. I had my first dose by noon the next day. By 12/23/2022, I was in pretty good shape. I did get a rebound case around 12/28/2022. I called the doctor's office back and the nurse practitioner this time said nothing I could do. By 12/31/2022, I was coughing really hard. Things started to improve at the first of January. I tested negative on 01/07/2023.
My left arm was sore for about 2 weeks; I had difficulty lifting, headaches, feverish, no appetite, weak and feeling sweaty. As of present still experiencing low grade headaches and no energy and appetite has changed.
upper respiratory infection; Fatigue; Headache; Ringing of the ears/Ringing in ears; Nausea; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142, expiry date: unknown), via an unspecified route of administration on 04Jan2021 10:25 at single dose (left upper arm) for COVID-19 immunization. Medical history included asthma (diagnosed at 8 years old), covid from 2020 (she had Covid last year twice). There were no concomitant medications. The patient experienced nausea, headache, and ringing of the ears/ringing in ears on 04Jan2021; and fatigue on 05Jan2021. This went on for 2.5 days. By day 3 post vaccine (06Jan2021) got upper respiratory infection. Stated she is pre disposed because she is asthmatic. She states she took Zofran to treat the nausea, 8 mg, and that she took 1000mg Tylenol for the headache. States she received the vaccine at her employer, (healthcare center name). States the symptoms resolved after about 3 days, exact dates unknown. She wanted to know if the second vaccination is the exact same as the first. She wanted to know if Pfizer manufactures the Shingrix vaccine. Therapeutic measures were taken as a result of nausea, headache. The outcome of the event upper respiratory infection was unknown, while for other events was recovered on an unspecified date in Jan2021.
Breakthrough case admission after 4 vaccines Pfizer 4/10/21 Lot# Ew0158;  Pfizer 5/1/21 Lot# EW0176;  Pfizer 12/15/21 Lot# FH8027;  Pfizer 10/28/22 Lot# GJ6739
The shot was jammed into deltoideus. Pain came on shortly and continuous to date. Couple of weeks after shot my latissimus dorsi became so painful I was unable to get up or down for 33 days Latissimus Dorsi is still aches at times.
Developed severe pain in my teeth and generalized myalgia, had fever and chills, headache, and some mental fuzziness, nausea, but no vomiting. Also had pain at the vaccination site. Symptoms worsened on the 16th of April into the 17th of April and I was unable to go to work on April 17th. I spent most of that day in bed, but by the end of the day I was able to get up for a few hours. I kept taking ADVIL every 6-8 hours as needed (which was ongoing for Sunday, Monday, Tuesday, and Wednesday and Thursday 4/15-19).
Patient is experiencing muscle pain for over 2 weeks. She explained that it didn't hurt upon administration but was sore over the next several days. She says it does not hurt unless is lifts her arms to put on.
Covid Arm - large itchy, painful swelling around injection site, Started on seventh day is still growing larger - is about the size of a large pancake size. Hurts all the time sensitive to touch even clothing brushing against it hurts.
10/3/09 - Received FLUMIST @ noon.  Developed hives @ 4PM.  Benadryl given per mom.  10/4/09 - Only a few hives remained on patient's trunk.  10/5/09 - Resolved; no further hives.
Experienced heavy pain in opposite arm of injection; Hot flashes; Chills; Joint pain; Rash; Night sweats; This is a spontaneous report from a contactable consumer. A 32years female (nonpregnant) patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: ER8737) was administered on 06Apr2021 at 12:00pm (age at vaccination was 32) as dose 1, single for covid 19 immunization. The patient medical history and concurrent conditions was Depression, migraine. Patient did not take any other vaccine in four weeks. No covid prior vaccination and did not tested covid post vaccination. On 07Apr2021 11:00 patient Experienced heavy pain in opposite arm of injection, hot flashes, chills, joint pain, rash and night sweats. All occurred 1-11 days after injection. The patient didn't received any treatment. The outcome of all events was Recovered on an unknown date on 2021.  No follow-up attempts are needed. No further information is expected.
administered with the vaccine beyond to 30 day use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. These were a mix of 1st and 2nd doses. HCP not sure if there were booster or 3rd doses included. There were 2 lot numbers (053E21A,032F21A) from where the doses which was beyond the 30 day use were administered to patients.
Immediately after injecting vaccine the surrounding area swelled to about the size  of a golf ball. Since this was at a pharmacy with a clinic inside, I took the patient next door to have it looked at. The NP stated it just appeared to be tissue swelling and sometimes happens with different preservatives. Pt was  instructed to go about her day and come back if the swelling did not go down in about an hour. I called the patient later that day to check on her and she stated the swelling went down by the time she went home and she was feeling fine.
Acute allergic reaction/anaphylaxis. Rash within 10 min. of injection tried to get back in to see Dr, but was told he was busy. Left office. Arm began to swell. By early evening arm had nearly doubled in size and circulation in arm was being cut off. Could not swallow water and was ice cold. Went to ER where they diagnosed an acute vaccine allergic reaction and IV'd steroids and histamine blockers for several hours. Was on prednisone for 2 weeks. Arm swollen for those 2 weeks!!
Five minutes after receiving the shot, my cheeks were flushed. After ten minutes, I started to feel slightly dizzy.  An EMT checked on me and brought me some Gatorade. I stayed in my car for an additional 10 minutes or so, and then I drove home; about a 5 minute drive. Once home I sat on the couch waiting for the dizziness to go away. Currently an hour and 15 minutes post-vaccine and still dizzy.
About 5 to 10 minutes after vaccine patient stated hands shaking, heart racing . Called 911 due to complaints of heart racing and not subsiding. EMT came and transported patient to local hospital
CHILLS; POUNDING HEADACHE; FEVER; VOMITING; DIARRHEA; FULL BODY ACHE; COUGHING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609) dose was not reported, administered on 26-MAR-2021 10:30 on Right Arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced vomiting. On 27-MAR-2021, the subject experienced diarrhea. On 27-MAR-2021, the subject experienced full body ache. On 27-MAR-2021, the subject experienced coughing. On 27-MAR-2021, the subject experienced pounding headache. On 27-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, chills, pounding headache, and fever on 29-MAR-2021, was recovering from full body ache, and coughing, and had not recovered from vomiting. This report was non-serious.
After administering vaccine, patient was advised to wait in office for any sudden symptoms. After 5 minutes, patient stated that she was feeling lightheaded. Doctor was notified, and patient was taken into a room for her to lay down. I followed up with the patient after another 5 minutes and she stated that she was feeling a tingling radiating from her left hand to her forearm, she was also feeling hot and looked flushed from her cheeks, and complained of feeling itchy at vaccine site. Left arm did not look swollen, no tenderness, or any form of rash at site. Patient was monitored for 20 minutes in which orthostatic blood pressure and pulse was checked during a period of 15 minutes.
Pericarditis: presented to the ED on 5.26.2021 with chest pain x2 days. Has generally felt unwell since his 2nd COVID vaccination on 5.13.2021.
About 2 hours after receiving flu vaccine felt cold shivering - coughing- sneezing - Temp 100. Coughed for approximately 3 days.
tongue swollen up; the discoloration in the mouth was black and blue; lesions in the side of the tongue; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE, ORAL MUCOSAL DISCOLOURATION, and ORAL DISORDER in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065FCIA, 031M20A, and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Urinary tract infection. Concomitant products included NITROFURANTOIN for Urinary tract infection, ELIQUIS, CORTISONE, LISINOPRIL, HYDROCHLOROTHIAZIDE, ZETIA, ZYRETIC, BYSTOLIC, LIPITOR, CYMBALTA, NEURONTIN, BESEROL, and ASPIRIN for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced SWOLLEN TONGUE, ORAL MUCOSAL DISCOLOURATION, and ORAL DISORDER. At the time of the report, SWOLLEN TONGUE, ORAL MUCOSAL DISCOLOURATION, and ORAL DISORDER had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient took two antihistaminic for treatment of the events.
Narrative: Patient vaccinated with Moderna at outside facility on 1/7/2021 and 2/4/21 on schedule. He was admitted 8/5 with confirmed COVID-19 and started on treatment with remdesivir and dexamethasone. ID has been consulted to assist with management as patient remains in the MICU on HHFNC
Vaccine was given on my left arm. Exactly 7 days after the vaccine, I had a swelling on my left arm and it spread all over the hand by 9th day of vaccine. Went to urgent care and the doctor gave a treated itas cellulitis and administered antibiotics. Started a 7 day course of anti biotics. Daily 2 doses. The swelling reduced. After the anti biotic course started seeing rash all over hands and legs and it also on different parts of the body. I was not exposed to any unusual situations and was just statying at home. So 2 weeks after the vaccine, rash and hives appeared all over the body. Lots of itchiness. Went to primary care. Doctor prescribed steroids to control the hives and adviced to visit an immunologist and also to suspected this affect related to vaccine.
Significant arm pain at injection site that progressed to armpit and felt as though underarm was swollen. This pain hurt when touching, pressing or  lifting arm and breast tenderness. Blood pressure extremely high the week following vaccine which was first noticed on 3/14, as high as 140/90.  Prior to vaccine blood pressure was controlled with diet.  I saw Dr. on 3/20 because blood pressure readings were inconsistent.  Doctor checked me and wanted to monitor pressure readings for a while.  Did not prescribe medication because the blood pressure readings were inconsistent.  Scheduled an appointment me to return in a month. However, on  3/21 I started experiencing heart palpitations and 3/22  heart palpitations, shortness of breath and tightness in chest and throat. I went to the ENT who determined the I had acid reflux and advised that I should return to primary care Dr. to make sure that everything was okay with my heart.  I saw doctor again and the following test (acceptable) were conducted.
Developed hives approximately 24 hours after receiving the vaccine. Treated with non-sedating anti-histamines.
This spontaneous report as received from a pharmacist refers to a 70 year old non-pregnant female patient. The patient's concurrent conditions included high blood pressure and high cholesterol. The patient did not have any known allergies or reactions. There was no information about patient's historical conditions. Concomitant medications included unspecified medications for blood pressure and high cholesterol. On 25-MAR-2017, the patient was vaccinated with ZOSTAVAX, subcutaneously, for prophylaxis (dose, lot number and expiration date were not reported). Approximately later on the same date (reported as shortly after receipt of the vaccine), she developed an injection site reaction. On an unspecified date, the patient visited her physician who prescribed her both oral steroids (unspecified) as well as a steroidal cream (unspecified) and within 10 days, the reaction was resolved. On 13-SEP-2017, the patient went to the pharmacy and it was noted that the injection site reaction has resurfaced in the same place. She went again to the physician on the same day, which again prescribed her stronger oral steroids (unspecified) as well as a steroidal cream (unspecified), but did not provide her with a diagnosis. No laboratory tests were performed. The outcome of the event was not recovered. No product quality complaint was involved. The causal relationship between the event and therapy with ZOSTAVAX were not reported.
I got flu shot 9/7/2021. Then the next day I saw the bruise on my arm and my arm hurts. I can't sleep on it. When I came to work today I told my manager who told me to go to employee health. Large reddened area, warm to touch. Pain 9/10 when moving arm.
Follow-up information received from the healthcare provider upgraded the case to serious. It also provided additional concomitant vaccines, test results, medical history, diagnosis and patient demographics. This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 2-year-old female patient who experienced low titer levels, recurrent pneumonia and chronic cough. At 12 months of age, the patient received the fourth dose on 18-May-2007. The patient also received the first dose of PROQUAD (Merck & Co Inc) and the first dose of VAQTA (Merck Sharp & Dome) on 18-May-2007. Concomitant therapy included VAQTA and PROQUAD. The patient experienced recurrent pneumonia on Jun-2008, 14-Jun-2008 and 21-Jan-2009. On 09-Apr-2009, the patient experienced low antibody titer levels. The patient also experienced chronic cough on an unspecified date. The patient recovered from the recurrent pneumonia. The outcome of low antibody titers and cough is unknown. No additional information was available at the time of this report. No additional information was available at the time of this report. See related case (s): US-WYE-H09094309 (adverse event, expedited); US-WYE-H09220109 (adverse event, non-expedited); and US-WYE-H09220309 (adverse event, non-expedited).
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding an 11 years old, male patient with no pertinent medical history reported. On 24-SEP-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 26-NOV-2012 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). On 29-MAR-2013 the patient received the third dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
3/20/2021  The patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  difficulty breathing and tingling around face and mouth   Assessment : Time of assessment .    Actions taken:  VS taken, BP- 129/62, P- 80, O2- 100% at 521 pm , recheck at 0531pm, BP- 109/61, P- 77, O2- 100%, 545pm, BP - 105/69, P- 72, O2- 100%.       Medications administered: Famotidine (Pepcid) 10 mg by mouth. Time: np. Administered by NP.Benadryl 25mg 1 tab PO x1 by NP, and given water.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/20/2021  5:09 PM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER2613   NDC: 59267-1000-1
Significant spike in OCD and anxiety - no triggers present  Depressive episode  - was not currently in depressive episode, no triggers present  Please note: this occurred after each of the 4 vaccine shots, but was far more pronounced with the two booster shots (Pfizer).
While administering FLUVIRIN, I felt the tip of needle swipe left index finger as I was inspecting the bevel. I examined my finger. It revealed no blemish and I administered vaccine. I noticed a finger stick after removing gloves.
Had sore arm for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received Shingles vaccine on an unknown date and had sore arm for 3 days but then it was ok. No further information were provided.
My husband tested positive for COVID-19 on December 13, 2022. I woke up on Monday, December 26, 2022, with a slight sore throat and a larger amount of postnasal drip than usual. I thought it was a cold, but, as a precaution, I took a COVID-19 test. The result was positive. I received a prescription for PAXLOVID and started taking it on December 27, 2022. Since then, the sore throat is completely gone. I still have a considerable amount of postnasal drip, but that is typical for me. I was taking BENADRYL as needed to keep it under control. I still have five doses of PAXLOVID left. I haven't had a fever at all. I've had slight diarrhea, but I'm not sure if it's due to the virus or the medication.