chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 17-AUG-2016, the patient was inadvertently vaccinated with an expired dose of VARIVAX (lot # K010442 and expiration date 22-JUL-2016, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
About 2 months receiving 4th dose of Moderna I experienced a breakthrough case of COVID-19. Began as mild cold like symptoms. Symptoms began to worsen and become more Flu like. Fever was never above 99.7.  Saw PCP when I returned home and he prescribed prednisone and inhaler.
lightheadedness; fatigue (sleeps a lot, he is too tired and does not have energy); This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness) and FATIGUE (fatigue (sleeps a lot, he is too tired and does not have energy)) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013S20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced FATIGUE (fatigue (sleeps a lot, he is too tired and does not have energy)). On an unknown date, the patient experienced DIZZINESS (lightheadedness). At the time of the report, DIZZINESS (lightheadedness) and FATIGUE (fatigue (sleeps a lot, he is too tired and does not have energy)) outcome was unknown.        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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: NNI FU - No new information was provided
patient was administered MENACTRA after the expiration date with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient who was administered MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] after the expiration date with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 04-Oct-2022, the patient received a 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, formulation was unknown, lot ABXB34AA and expiry date: 31-Jul-2022) via intramuscular route in the right deltoid for Immunization.  On 04-Oct-2022 the patient developed a non-serious event of patient was administered menactra after the expiration date with no reported adverse event (expired product administered)(Latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken : not applicable.  Outcome: Unknown  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.
My adverse event started on 02/17/2023 in the morning. I had dry cough and I wasn't feeling well. The next few days I had fatigue and productive cough, loss of voce,  and fever. On 02/19/2023 I went to an urgent care and the doctor prescribe me a Z-pack and Dextromethorphan  which really didn't help. I was tested for COVID-19 and Flu which both were negative.  My doctor through I had an upper respiratory issue.  On 02/21/2023 I went to   an Urgent Care again where they prescribe me  with Levaquin and Dextromethorphan which it helped greatly. They did Chest -X-ray which showed I had Pneumonia.  End of October to November I experienced sudden hearing loss.  On 02/15/2023  I went to an ENT and was diagnosed with hearing loss. He prescribed me with Prednisone which helped. On 02/17/2023 I went back to the ENT and they said the medication was helping to improve with the hearing loss. I had an MRI done on 12/19/2022  and the doctor told me it was normal. As of today 02/28/2023 I haven't recovered fully yet but, I feel way better than before.
t106 fever (@ home) 101.4 in office 2 days p/vax miserable but alert; WBC 5,600-no disability; 27JAN95 got new fever 29JAN fever gone-now a rash papular the eccymotic; looks like vasculitis;
Red, diffuse, papular non pruritic rash beginning at site of MMR injection, eventually covering all of skin from head to toes. This began evening of vaccination.
Fatigue on the same day of the vaccine and the next day. Left arm soreness for about 2-3 days after the vaccine.
PT described feeling a tightness in his chest and slight shortness of breath the night after he recieved the Intranasal influenza immunization.  This is the first time the patient recieved this vaccination.  No life threatening sypmtoms occured.
woke up at 2:00 amon Thursday, 4/15/2021 following injection with very bad chills, fever 101.8, headache - continued until the following day, Friday, 4/16/2021, late afternoon-early evening.  No appetite the entire time and really not until Sunday, 4/18/2021.  Not a whole lot of energy.
Flubok was given to pregnant women with no reported adverse event; Initial information received on 27-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 27 years old female patient who was pregnant  and who got the Flubok vaccine, with no reported adverse event. (INFLUENZA QUADRIVALENT RECOMBINANT VACCINE).  The gestation period at onset was not reported. The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancies.  On 27-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE 0.5ml lot UJ893AA at expiry date of 09-JUN-2023 via intramuscular route in the right arm for Immunization.  On 27-OCT-2022 the patient developed a non-serious flubok was given to pregnant women with no reported adverse event (exposure during pregnancy) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Flubok was given to pregnant women with no reported adverse event).  At time of reporting, the outcome was Unknown for the event flubok was given to pregnant women with no reported adverse event.
Headache, Myalgia, Arthralgia, Fever,  fatigue, congestion, injection site pain/arm pain
Swelling x 4 inch area tight skin, itching, Benadryl given for symptoms.
About 12 days after vaccination, severe hives and rashes appeared all over body. Extreme discomfort and itchiness all over body. Hives and rashes tend to appear on upper thighs, groin, stomach, around armpits, chest, back, wrists/hands, feet, knees.
Very sore arm at site of vaccine beginning at about 6 pm after vaccine administration. The next morning the patient reports having had joint and muscle pain and discomfort all over body. Patient reports that she took extra strength acetaminophen and iced the vaccine administration area. Her symptoms lasted 2 to 3 days.
difficulty in breathing; Itching, hives; nauseated; headache; achiness in her muscles; A spontaneous report was received from a healthcare provider (HCP) concerning a female patient of unknown age  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling nauseated/Nausea, difficulty in breathing/Dyspnea, itching and hives/ Rash pruritic, headache/Headache and achiness in her muscles/Myalgia.  The patient's medical history was not provided. No concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   An hour after receiving the vaccine the patient experienced feeling nauseated, difficulty in breathing, itching, hives, headache and achiness in her muscles. The patient was rushed to the emergency room (ER) and treated with epinephrine, steroids, benadry, & pepsin.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome for the events, feeling nauseated, difficulty in breathing, itching, hives, headache and achiness in her muscles was unknown.; Reporter'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.
headache; sore eyes; sore arms; nausea; fever; found food disgusting; woke up very nervous; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), EYE PAIN (sore eyes), MYALGIA (sore arms), NAUSEA (nausea) and PYREXIA (fever) in a 40-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.     No medical history was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 HEADACHE (headache), EYE PAIN (sore eyes), MYALGIA (sore arms), NAUSEA (nausea), PYREXIA (fever), TASTE DISORDER (found food disgusting) and NERVOUSNESS (woke up very nervous). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), EYE PAIN (sore eyes), MYALGIA (sore arms), NAUSEA (nausea), PYREXIA (fever), TASTE DISORDER (found food disgusting) and NERVOUSNESS (woke up very nervous) outcome was unknown.            Patient reported that, on unknown date, her blood pressure was monitored which came with abnormal results. Patient also reported that she had abnormal heartbeat sometimes.  Concomitant products were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Significant follow up Appended - Reporter's first name updated and lab data was added
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. Initial information was processed along with additional information received on 02-JUN-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in MAY-2021, approximately one month after receiving the vaccine, the patient was tested positive for covid-19. The patient thought that the patient had a fairly mild case of the vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:  The suspected product quality complaint has been confirmed to be not voided (meets product quality complaint criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: COVID-19 VACCINE Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
patient received 0.2ml of diluted adult covid 19 pfizer vaccine instead of the pediatric vaccine. patient didnt not have any reaction to the medication
Patient was one of five patients who received the MENVEO vaccine from a box where a vial of diluent was found to be "left over." After making inquiries, it is impossible to tell which of the five may have received an incomplete vaccine (the MENVEO powder mixed with an incorrect diluent).  After contacting the manufacturer of the vaccine to find out proper recommendations, the parents were called and asked to bring in the child for a repeat vaccination as soon as possible. There was no harmful effect from this event other than the child having to receive another shot.
pt recvd vax; pain at inject site, feeling weakness, weakness of lower limbs;
01/16/22 presents to ED for "fatigue, N/V/D, and near syncope". PMHx of "CAD, DM, ESRD s/p kidney transplant on prograf, cellcept, and prednisone"
We did not discard the extra volume in the vial during our initial clinics. I came to realize this was not authorized under the EUA after the fact and ceased the practice after the first four clinics on 3/10, 3/11, 3/12 and 3/13/21. When we reported the extra doses, we were advised by KDHE to cease pooling doses and report to VAERS, citing EUA guidelines. We gave 21 extras doses on 3/11/21 but no adverse reactions have been reported related to this issue.
Pt reported lips tingling, tight throat, Benadryl 25mg tab administered, no difficulty swallowing, VS stable. No symptom improvement at 20 minutes and expressed a feeling of having a golf ball stuck in his throat, denied SOB, itchiness, no noted hives, denied chest pain/tightness, dizziness, vision changes or anxiety. Benadryl 25 mg tab administered, no noted or voiced difficulty with swallowing.  VS stable.  Pt observed another 30 minutes and symptoms began to resolve. Full resolutions of symptoms at 3 hours,  pt discharged home @ 13:20.  Emergency situations reviewed with instructions to call 911 if reoccurrence of symptoms.
Injection site pain and swelling; Injection site pain and swelling; mild headache and sensitivity to light; mild headache and sensitivity to light; muscle pain around shoulders and neck; muscle pain around shoulders and neck; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6201)), via an unspecified route of administration, administered in arm left on 08Feb2021 14:00 (at the age of 69-years-old) at single dose for COVID-19 immunization, the patient was not pregnant at the time of vaccination. The patient medical history included bronchitis chronic, uterine cancer from an unknown date and unknown if ongoing. The patient previously received codeine and experienced drug hypersensitivity within 2 weeks. The patient concomitant medications were not reported. The patient did not receive any other vaccines and was not tested for covid test prior to the COVID vaccine. On 08Feb2021 18:30 (04 hours and 30 minutes after the vaccination), the patient experienced injection site pain and injection site swelling, mild headache and sensitivity to light (headache), (photophobia), muscle pain around shoulders and neck (arthralgia), (neck pain). The patient did not received treatment for the adverse event. Seriousness of the event was reported as non-serious. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected
No adverse events from the vaccines.  Months later, I was infected with COVID during the variant outbreaks.
COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4265658-00 (Agency).  A 57 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 10Jun2021 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg,1 in 2 wk). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "COVID-19". The action taken for adalimumab was unknown.  Clinical Course: In Jan2020, the patient experienced contracted covid. In Jan2021, the patient experienced contacted covid. Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. The reporter's causality for the event(s) of contracted covid onset in Jan2020 and contracted covid onset. in Jan2021 with Humira (Adalimubab) was a reasonable possibility. Causality 1) COVID-19 (10084268) (COVID-19) Action(s) taken with drug : Unknown Causality as per reporter (Drug/Vaccine) : Reasonable possibility Dechallenge : N/A 2) COVID-19 (10084268) (COVID-19) Action(s) taken with drug : Unknown Causality as per reporter (Drug/Vaccine): Reasonable possibility Dechallenge : N/A Seq.No. : 2 Drug : Pfizer biontech covid-19 vaccine (Tozinameran)(Tozinameran),Unknown Route of Admin : 1) Intra-muscular Therapy Dates/Duration : 1) 10Jun2021 -10Jun2021 Causality 1) COVID-19 (10084268) (COVID-19) Action(s) taken with drug : Unknown Causality as per reporter (Drug/Vaccine) : Possible Dechallenge : N/A 2) COVID-19 (10084268) (COVID-19 (10084268)) [v.24.1] Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) : Possible Dechallenge : N/A  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Due to  the limited information in the case report ,  a possible causal relationship between the event and suspect drug BNT162B2 cannot be excluded.
7 days (4 Jan 21) after receiving the Covid-19 vaccine the injection site became red, swollen and hot to the touch. My skin feels like it is burning. I went to employee health the next day ( 5 Jan 21). The physician looked at it, tried to find pictures of reactions on the internet and then drew an ink pen line around the redness. Left an approximate 1/8th inch border. Told me to come back if it went past the lines. Within 12 hours it has swollen past the lines. My entire arm feels like it?s burning.
Pt reported "flushing and crawling" feeling on body. Redness observed on bilateral lower extremities, no tenderness or pain reported. Pt was alert and oriented; Liquid benadryl given per standing order. Pt denies other symptoms but reports feeling "anxious or nervous." Oxygen saturation was 96%. Pt  states a similar episode happened when she received her 1st dose and reported it subsided after taking benadryl at home. States she never reported the 1st effects to anyone.
Was in bed for two weeks; Three degree above normal temperature; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Was in bed for two weeks), PYREXIA (Three degree above normal temperature), CHILLS (Chills) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE (ANTACID [CALCIUM CARBONATE]) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced BEDRIDDEN (Was in bed for two weeks), PYREXIA (Three degree above normal temperature), CHILLS (Chills) and FATIGUE (Fatigue). On 13-Mar-2021, PYREXIA (Three degree above normal temperature) had resolved. On 24-Mar-2021, BEDRIDDEN (Was in bed for two weeks), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were provided.   This case was linked to MOD-2021-408535 (Patient Link).
The patient reported violently shaking around 8pm the day he received his flu vaccine. He did not lose consciousness and did not seek medical attention. He was very tired and had no appetite for 3 days after receiving the vaccine.
Arm swollen size of his fist, red and hot to touch. Advised BENADRYL, HC cream, cold compress mom called and spoke with RN and she sent Dr a pic from phone.
Patient started noticing left arm swelling and pain about 2-3 weeks after the vaccine. She then presented to the hospital 4/16/21 and was found to have a deep vein thrombosis in her left brachial vein as well as a thrombosis in her right internal jugular vein. She is currently being further worked up and will be admitted to the hospital for anticoagulation.
Red circle where the shot was placed. Swollen lymph node under arm pit and arm pain.