chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.   This case is linked to cases 2023SA054981(CLUSTER) and 2023SA057733(CLUSTER).   This case involves an adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Developed acute arthritis of great toe within a day of the secondh Moderna COVID 19 vaccine. Prior episode after a night of heavy drinking in 2021
Narrative: Yesterday, he received his second dose of COVID-19 vaccine. About 5 hours after receiving the vaccine, he noted onset of myalgias, headache and nausea. He has felt warm, had chills and slight sweating. He is tired and has no appetite. He reports coughing a few times yesterday, but has not coughed today. He has not had measured fever, vomiting, diarrhea, runny nose, sore throat, dyspnea or abdominal pain. No change in his senses of taste or smell.
pt states that on 2/27/2021 she started getting nervous and dizzy.  She fell on 2/27/2021 and 2/28/2021.  On 2/28/2021 she started coughing and having trouble breathing so she went to Urgent Care.  She was tested for flu and covid and then told she needed an EKG so was told to go to the ER.  She did not go to the ER but went to a Cardiologist Dr. next morning on 3/1/2021.  They took chest XRAY,  EKG, Blood Work, and covid test.  Dr. changed her prescription  Carvedilol 6.25 mg x 2 daily and Furosemide 20mg once a day.  Pt is expecting them to call her today w/ test results and will FU w/ regular Cardiologist.
12/31/2020- chest pain 1/1/2021- Tingling in face. Benadryl then eased.  1/2/2021- Tingling on lips. Chills. Benadryl then ceased 1/3/2021- Chills 1/4/2021- Tingling on lips. Puritis to lips and face. Benadryl then ceased  1/6/2021- Feeling that something was in the back of the throat. 1/9/2021- Feeling of something in throat. Throat tingling. Benadryl then ceased.  1/10/2021- Sensation of the tongue being burnt. Benadryl then ceased.  Feelings of burnt tongue/sensation in the back of the throat lasted until approx 1/18/2021 with periods of this occurring presently.
Patient reported increased shortness of breath on exertion since receiving COVID vaccine on 3/9/21.
After my 2nd dose I got a period. After my 3rd dose I got another period.
legs cramps; stomachaches; has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat; sore arm; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the left arm, on 09Jan2021, at single dose, for COVID Prevention/COVID-19 immunization. Medical history included heart palpitations. Concomitant medication included unspecified medication for heart palpitations. The patient did not receive any other vaccines on the same day as BNT162B2. On 09Jan2021 (the same day as the patient received the vaccine), she developed sore arm which went on about for three days. The patient reported she put rubbing alcohol on it and that helped. On 12Jan2021 (day three after the vaccine), the patient experienced leg cramps and stomachache which went on about for 24 hours. The patient reported that she has a history of heart palpitations, but when she got the vaccine, on 12Jan2021 (day three after the vaccine), she felt her heart started rushing more, she had rapid heartbeat, but then she got it under control. She reported she has some pills for that, so she took an extra dose of her pills and that helped out with the palpitation. The patient recovered from the event sore arm on 12Jan2021; from leg cramps and stomachaches on 13Jan2021; and from "has a history of heart palpitations/she felt her heart started rushing more, she had rapid heartbeat" on an unspecified date.
The patient inadvertently received the pediatric dose of Pfizer vaccine instead of the adult. Patient will be given the adult dose in 21 days. Call was made to Pfizer  who stated that they follow CDC guidelines. In this instance the patient will be considered fully vaccinated following his 2nd dose which will be of the adult dose.
Round circle directly under injection site occurring 2 hours after injection and still visible 2 weeks later. Looks like a burn and peeling  11 days post injection.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 36 year old female of unknown race and ethnicity. The patient's weight was 75.9 kilograms, and height was not reported. The patient's concurrent conditions included: primary pulmonary hypertension. The patient received selexipag (tablet, oral, batch number: 031542202 expiry: 31-AUG-2022) 1600 mcg orally 2 times daily, therapy dates were not reported for primary pulmonary hypertension.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported , batch number: Unknown and expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included tadalafil.  On 18-NOV-2021, the patient diagnosed with covid-19 infection and suspected clinical vaccination failure. Patient stated that  she was fully vaccinated and symptoms have been fairly mild.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of selexipag was not changed. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20211161711-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS  20211161711-UPTRAVI- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
unconscious; I was almost dying; become extremely stiff; become extremely red; rigid; shaking; I was extremely pale; This is a spontaneous report from a contactable consumer reported for himself. A 19-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 12Sep2021 11:15 AM (Batch/Lot number was not reported) (at the age of 19-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included covid-19 from an unknown date, the patient got covid prior vaccination. There were no Known allergies. There were no concomitant medications. There were no other medications in two weeks. There was no other vaccine in four weeks. The patient stated as soon as he got the shot on 12Sep2021 11:15 AM he immediately became unconscious. Not even the slow beginning to faint. His mother said as soon as he pushed the plunger his eyes rolled back and he fell forward out of his chair. After about a minute, according to his mom and the (Name) pharmacist, he started to become extremely stiff and started to become extremely red and rigid, and started shaking according to the pharmacist and his mother. He felt like he was almost dying. He had problems with needles as a kid. But this was nothing to do with anxiety or feeling anxious. He felt completely calm going into the shot. After he woke up he was extremely pale. And had to sit for a prolonged time until he could walk. The patient did not get covid tested post vaccination. There was no treatment received for the events. The outcome of the events was resolving.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Pt came to Pharmacy for flu shot. Stated he got hives several days after last Flu shot and needed hospitalization. Wanted to try again this year at advice of his doctor and daughter. Today reported hives again.
tested positive to COVID-19 Virus; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient received the first dose on 14Mar2021. After the first dose, the patient was tested positive to COVID-19 virus on unspecified date in Mar2021. The patient was scheduled for second dose on 03Apr2021. The patient wanted to know if he could have the second dose after he tested positive to COVID-19 virus. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Eleven hours after 2nd dose shingles vaccine I started to experience headache,  hot/cold, fever, aches, a little nausea, fever.  About 18 hours I was better but continued to feel fatigued for another day.  I took Ibuprofen.  And sore arm.
ACUTE NON ST ELEVATION MI 5/1/2023 ACUTE NON ST ELEVATION MI
Fever peaked 101, severe body/joint aches, headache, no appetite.  Symptoms were really bad on Friday night thru to Sunday morning but still had bodayaches, headache, no appetite on Sunday. Fever down to 100.0
1ST dose Moderna Vaccine- Acute Hypertension with no other symptoms ( No headache, No chest pain, No tinnitus, No cardiac issues). Elevated BP could have been from the begining, however, since  no other symptoms,  it wasn't discovered until 24 hrs later.   BP  160-190  mmHg    HR  70-78 bpm  remained in 180 for at least 4 hrs. 162 mg  (2 tab) Baby aspirin, rest and hydration.  On call MD contacted  through clinic.  Advised  to administer 20 mg  Lisinopril (Husband's med) if BP over 190 mmHg. Contact in  AM for possible prescription if hypertension remains overnight.  at 2300: BP 160/64 HR 76  with NO meds administered .  slightly sore right arm at injection site.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 37-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. It was reported that the patients have been administered doses while the temperature excursion assessment was ongoing and reported that no adverse reactions were reported by any patients.
During a chemo section she suffered heart attack symptoms, this one week after being vaccinated with the 2nd dose of Pfizer. It is important to note that in my chemo sections I had never presented any problem. Later, they gave me the treatment of the Anastrozole medication by mouth, since they suspended the chemo by veins, due to what happen before. Then I got shingles and a lot of fatigue. I thought it was due to the new medicine, but it was not in accordance with the side effects of the same. I have experienced numbness in my left foot and leg, and in the knee of my right leg, along with swelling. Also in my hands, a lot of pain in my bones, especially the lower part of the back. Currently I find it difficult to walk and close my hands, without pain, even being able to open a bottle of water and go up or down steps.
first dose in oct 2020 / never got my second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient wanted to know that did he/she start over. The patient had only few minutes and was hoping for a quick answer regarding 2nd dose and would need to try again call when he/she had more time. The follow up would not be possible as no contact details were available.
chills; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and ARTHRALGIA (joint pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced CHILLS (chills) and ARTHRALGIA (joint pain). At the time of the report, CHILLS (chills) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided .
Severe chills began 12 hours after vaccination. Also body aches, fatigue. Body aches and fatigue continued the next day.
Patient lost vaccine card. Was given a 4th dose of Pfizer vaccine accidently. Learned of our error 2/22/22. No symptoms or problems noted.
THROAT SWELL UP; low energy; Infection; Lingering Nasal congestion; Earache; Sore lymph nodes; Severe headaches; Rashes; Moderna Dose 1 on 15-Mar-2021 and Dose 2 on 14-Jun-2021; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (THROAT SWELL UP), ASTHENIA (low energy), INFECTION (Infection), NASAL CONGESTION (Lingering Nasal congestion) and EAR PAIN (Earache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 14-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 on 15-Mar-2021 and Dose 2 on 14-Jun-2021). On an unknown date, the patient experienced PHARYNGEAL SWELLING (THROAT SWELL UP), ASTHENIA (low energy), INFECTION (Infection), NASAL CONGESTION (Lingering Nasal congestion), EAR PAIN (Earache), LYMPH NODE PAIN (Sore lymph nodes), HEADACHE (Severe headaches) and RASH (Rashes). At the time of the report, PHARYNGEAL SWELLING (THROAT SWELL UP), ASTHENIA (low energy), INFECTION (Infection), NASAL CONGESTION (Lingering Nasal congestion), EAR PAIN (Earache), LYMPH NODE PAIN (Sore lymph nodes), HEADACHE (Severe headaches), RASH (Rashes) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 on 15-Mar-2021 and Dose 2 on 14-Jun-2021) outcome was unknown. Not Provided          No concomitant medication was provided by the reporter  On unknown date(s), the patient experienced Humira pen Misfired/malfunction in tip.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The reporter's causality for the events of earaches, infections, lingering nasal congestion, rashes, severe headaches, sore lymph nodes, throat swell up and low energy with Moderna COVID-19 vaccine was reasonable possibility.   No treatment medication was provided by the reporter.
I tested at home, I had sore throat and congestion. I was positive for COVID-19 and so was my husband was positive as well. I called my PCP and the said treat the symptoms with ZYRTEC, TYLENOL and tea and honey. It was not recommended that I get PAXLOVID due to the side effects on the liver and kidneys. My symptoms lasted through about the that Sunday. They were lessoning each day, I tested on Tuesday, and I was still positive without any symptoms.
9/24 tired, weak. 9/23 evening diaphoretic next 3 nights. Also c/o feeling dizzy at times and hoarseness.
1st Vaccine Swollen Lymph nodes after, sore arm, tested positive for COVID with PCR. 2nd Vaccine Chills, fever, Fatigue, injection site red and swollen
PT has red rash around injection site on L arm. Pt described rash as itchy and hot. PT complaining that the rash started to get sore to the touch.
On May 20 started feeling tired. May 21 arm was "really sore" & noticed "streak" of red moving towards armpit. May 22 streak moved down bicep. Went to ER on 22 May - given 2 IV antibiotics. Diagnosed by ER doctor - vaccine induced rash.
I got the tetnius shot, i woke up in the middle of the night and my throat was closing swelling shut. it was hard to breath and hard to swallow. outcome was i survived but have lingering fear/ptsd from the fear of losing my life. while typing this and calling doctors i was crying.
Patient erupted in hives covering extremities and thorax. Reaction occurred within 5-10 minutes. Patient reported no other symptoms associated with reaction and denied any itchiness or respiratory issues.
12 hrs after DTaP shot pt's body temperature dropped 95.6 (he held a normal temp before the shot).
I get pain behind and above my eyes. My eye balls are tender to the touch at this time. If left untreated (Ibuprofen or other OTC NSAID seems to work) the pain turns into a rather severe headache. Currently treatable with Ibuprofen, but symptoms have not gone away and I have to take Ibuprofen a couple of times a day in order to function pain free. Have been to primary care and ophthalmologist but have no real diagnosis as of yet. Supposed to get MRI, but I feel that would be a waste of money given my suspicion that this is a side affect from Flumist H1N1 vaccine. Took presciption Zpack from primary care dr for supposed sinus infection, but no help with symptoms.
Pt fainted (syncopal episode), fell into arm of vaccine administrator and eyes rolled up. After child was lifted up, she fell back on exam table and eyes rolled up again. Then child "came around" and asked "Where am I?" appeared weak, unstable on legs, BP decreased 108/90 to 90/50.
No additional adverse event; administered earlier than minimal interval of 4 weeks after 1st dose; This spontaneous report was received from a nurse, referring to a 28-year-old female patient. The patient's pertinent medical history, concurrent condition and concomitant medication were not provided.  On 29-MAR-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml; strength and route were not provided) for prophylaxis. On 04-APR-2023, the patient vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml; strength and route were unknown), which was administered earlier than minimal interval of 4 weeks after the first dose. (Inappropriate schedule of product administration). The Lot# was reported as 0121342 with expiration date 14-DEC-2024, but unsure it was for the first dose or second dose or both. No additional adverse events or product quality complaints (PQC).