chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started having a sore arm the evening of 12/29/2021 - continued until am of 12/31/2021; and then I was fine until I had a vertigo episode on January 1 at 07:00 am. I didn't have cold symptoms but took a Mucinex - and the dizziness continued. Meclizine - my husband went and got it - one tablet and that helped. I was pretty fine the rest of the day. Woke up shortly after midnight - 12:30 am January 2 and I went to look at the clock and everything was spinning - severe episode of Vertigo -took more Meclizine and I propped my head up and went back to sleep eventually and went to Dr the next day - Urgent Care. I continued to take Meclizine every 12 hours; Dr Prescribed Flonaze - Dr saw some clear fluid in both of my ears but nothing that should be causing vertigo. She wanted me to follow up with other my Dr on Monday. January 4th. She checked (my family history has brain tumors) but nothing seemed to indicate that I would not need MRI; but was diagnosed with Vertigo that day. She recommended for me to see a physical therapist to move the crystals to see if they could move them if that was causing it and had two appts that week. But neither times were they able to recreate the Vertigo. At that time I was feeling better and I stopped taking Meclizine and I've been fine ever since. Got second dose of the vaccine - two days ago -didn't feel well - felt under the weather but no vertigo.
Looks like a little blue vein in the mark; "covid arm", warm, red, itchy, swollen; "covid arm", warm, red, itchy, swollen; "covid arm", warm, red, itchy, swollen; "covid arm", warm, red, itchy, swollen; hardness.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DISCOLOURATION (Looks like a little blue vein in the mark), VACCINATION SITE WARMTH ("covid arm", warm, red, itchy, swollen), VACCINATION SITE ERYTHEMA ("covid arm", warm, red, itchy, swollen), VACCINATION SITE PRURITUS ("covid arm", warm, red, itchy, swollen) and VACCINATION SITE SWELLING ("covid arm", warm, red, itchy, swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE and POTASSIUM for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Looks like a little blue vein in the mark), VACCINATION SITE WARMTH ("covid arm", warm, red, itchy, swollen), VACCINATION SITE ERYTHEMA ("covid arm", warm, red, itchy, swollen), VACCINATION SITE PRURITUS ("covid arm", warm, red, itchy, swollen), VACCINATION SITE SWELLING ("covid arm", warm, red, itchy, swollen) and VACCINATION SITE INDURATION (hardness.). At the time of the report, VACCINATION SITE DISCOLOURATION (Looks like a little blue vein in the mark), VACCINATION SITE WARMTH ("covid arm", warm, red, itchy, swollen), VACCINATION SITE ERYTHEMA ("covid arm", warm, red, itchy, swollen), VACCINATION SITE PRURITUS ("covid arm", warm, red, itchy, swollen), VACCINATION SITE SWELLING ("covid arm", warm, red, itchy, swollen) and VACCINATION SITE INDURATION (hardness.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       treatment med: hydrocortisone ointment, claritine, cold compress   Reporter did not allow further contact
According to pt's daughter-in-law, pt felt weak, exhausted, mentally confused and lost weight.
discomfort to touch, no fever, swelling;swollen lt upper arm(tricep area), sl warm, pink;
Had left drooping of my lips, also had tingling numbness on the left of my face. And my left eye was very watery; Called Dr. she told me  to go to the ER to make sure I wasn't having a stroke; Given a CT scan, results were normal; ER gave me prednisone, and NEURONTIN for the pain. My Dr. diagnosed me with Belles Palsy. Currently under Dr.'s care.
Tachycardia (HR 130s) despite extensive workup; This is a spontaneous report from a contactable physician. An adult non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), unknown dose number, via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunisation. Medical history was not reported. There were no known allergies. Concomitant medications included metoprolol (Manufacturer unknown), paracetamol (TYLENOL) and lorazepam (ATIVAN). The patient did not received any other vaccine within four weeks of the BNT162B2 vaccine. The patient experienced tachycardia (HR 130s) despite extensive workup on an unspecified date. The tachycardia self-resolved the following day. The tachycardia resulted in an emergency room/department or urgent care visit.  Treatment included Metoprolol, 3L IV fluids, Tylenol and Ativan. The outcome of event tachycardia was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, a possible contributory role of the suspect product \BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported event tachycardia cannot be completely excluded. This case will be re-assessed should additional information becomes available. The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concerns identified as part of this review, as well as any appropriate actions in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient's reservation said it was his first dose.  After administration, we learned that it was his second dose and his first dose was the one vaccine vaccine, which is not the same as the dose he received today(vaccine).
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 09-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot number L040415, expiration date 13-APR-2017 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
scattered isolated vesiculopustular erythematous lesions on neck, extremities, abdomen, back, various stages of healing . Symptoms started 3 days after receiving varicella vaccine.
Client called on 1/22/21 at 11:05 am concerned about black-blue and yellow area to right arm at the injection site of Covid-19 vaccine.  Client stated it is now turning yellow.
first dose 2 years ago, did not take second, sheltering during pandemic; This case was reported by a consumer via call center representative and described the occurrence of social problem in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago of reporting date, at a local pharmacy).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: The reporter received a first dose of the Shingrix vaccine but did not take a second dose because he and his wife were sheltering during the worst part of the Covid pandemic. The reporter asked should they start the two-dose vaccine series from the beginning again or should they go ahead and take the second dose now. Additional Supportive Information: This case has been linked to US2022AMR066362, reported for patient's wife.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR066362:Same reporter
Nearly passed out very shortly after receiving the vaccine, before leaving the doctor's office dizziness and weakness.
Patient is a 73 yo woman with h/o afib, PE, severe AS who presented with slurred speech, left sided weakness/incoordination found to have acute stroke   CVA: slurred speech and left sided weakness/incoordination.   --CTA with right MCA occclusion.  Underwent thrombectomy 2/10 --unclear why she developed this while on eliquis but does have h/o PE and afib and family history of DVT as well --check antiphospholipid ab for if positive, would consider transition to warfarin --consider malignancy but just had CT c/a/p last week in preparation for possible TAVR and there was no evidence of malignancy there. --aspirin for now per neurology.  --TEE ordered for 2/11.   --consider change to xarelto or coumadin as stroke occurred on eliquis --neurology following --PT/OT/speech following but deficits seem resolved   Atrial fibrillation: long standing --hold eliquis for now as risk of bleeding higher than clotting after acute stroke.  Defer to neurology for when to resume anticoagulation --continue aspirin for now --continue metoprolol   Hyperlipidemia: normally on crestor, here on lipitor --lipid panel in a.m.   Severe aortic stenosis: last echo with AVA 0.45 --being considered for TAVR vs surgical AVR --stop IVF; is at risk for volume overload --daily weights, accurate I/Os
This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a licensed practical nurse concerning an 18 year old female with a history of dysmenorrhea who on 25-JUN-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN) (manufacturer unknown). On 25-JUN-2007 the patient experienced swelling, redness, and burning in both hands. The patient was advised to take diphenhydramine hydrochloride (BENADRYL) for the swelling, redness, and burning of the hands. There were no laboratory or diagnostic testing performed. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Fever left lymphadenopathy, pain under left armpit in lymph nodes Narrative:
Patient reported sharp chest pain approximately 30 minutes post vaccination.  Patient was transferred to recumbent chair for monitoring, attached to EKG, vital signs and 50 mg diphenhydramine administered IM to left deltoid.  Transfer of care to rescue squad for transfer to local ER.
Hot flash; Dizziness; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 15Apr2021 at 13:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. It was unknown, if the patient was pregnant at the time of this report. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included vitamins (unspecified) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 18:15, 2 days after vaccination, the patient experienced hot flash, dizziness and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hot flash, dizziness and diarrhea was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt was receiving Gardasil, Hep A and Then  Menactra. Right after administering the Menactra she said I feel funny and passed out. She was out for about 10 seconds. Then vomited 1x. Said she felt really tired.
Patient found to have asymptomatic intracranial sinus vein thrombosis in the transverse/sigmoid sinus on the left side
Initial unsolicited report received from a consumer (patient herself) on 27-Oct-2017. This case involves a 72-year-old female patient, who was vaccinated with 0.5ml dose of FLUZONE HD frequency: once(batch number, expiry date and dose in serise were not reported) in left arm via intermuscular route on 22-Oct-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, (reported as that night) following the vaccination, the patient's developed a red lump towards her elbow that it was about 4 inches around it was hot and painful to the touch. Laboratory data was not reported. The patient received corrective treatment with Steroid Cream. Outcome of the events were reported as not recovered. List of documents held by sender: none.
Within a few hours of vaccine administration, my menstrual cycle ceased to exist. At the time of the vaccine around noon I was on a heavy flow of day 2 on my period. I was changing tampons at my usual rate of every 4 hours. By 8pm the same day of administration, my period ceased to exist. I no longer needed to use tampons or pads at all. My menstrual cycles are consistently at LEAST 5 days long, not 2. Will follow up with my regular ob/gyn.
Consulting MD reported 3 deaths which occurred in a particular family over a 5 yr period following 1st DTP vax; autopsy dx SIDS in all 3 infants; 1 of 3 pts vaxed 54 days of age was found dead in bed in early AM 11 days p/vax in 1979;
Dizziness- at 12:59 am on 04/11/21 Fever of 102.7 at 12:50am on 4/11/21 Fast heart beat when getting up at about 12am on 4/11/21 Headache at 5pm on 4/10/21
PFIZER COVID-19 VACCINE EUA: Fully vaccinated patient presented on 110421 with a 1 day history of congestion and following a direct exposure on 102921.
Afraid husband may found her on the floor; Hardly can walk; So weak; Dizziness; Diarrhea; Vomiting; Fever; Headache; A spontaneous report was received from a sixty-six-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, diarrhea, vomiting, fever, headache, hardly can walk, so weak, afraid husband may found her on the floor.  The consumer's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the consumer received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the consumer experienced the events dizziness, diarrhea, vomiting, fever, headache, hardly can walk, so weak, afraid husband may found her on the floor.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events was unknown.  The assessment for the events was not provided.; 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.
After first shot of Moderna, I had light headaches during the first 5 days. Then I start hearing noise in the right hear... when walking every steps is resonating in my ear. I can clearly hear a degradation of my hearing. Driving a car makes some noise in the hear.
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Medical Information (Reference number- 00599921) and transmitted to Sanofi on 13-May-2021.  This case involves a patient (unknown demographics, adult) who received an expired 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported and expiry date: 08-May-2021) via an intramuscular route in an unknown administration site for prophylactic vaccination on 10-May-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error case due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
Mild body aches for 4 hours; LARGE red rash with warmth, swelling, large hard bump at injection site, tenderness for 10 days and counting.
Hospitalized 2/21/2022 for dyspnea and productive cough treated for pneumonia.
Ipol and the other vaccine, Pentacel and both have polio in the vaccine and want to know the side effects of the injection on a 2 month old infant today with no adverse event; Initial information regarding an unsolicited valid non-serious case received from the other health professional via phone at a call center as a Agency on 07-Jan-2021. This case involved a 2-month old male patient for whom it was reported that the IPV (VERO) (Ipol) and the other vaccine, DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Pentacel) and both have polio in the vaccine and want to know the side effects of the injection on a 2 month old infant today with no adverse event (Wrong product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine and pneumococcal vaccine 13V.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect IPV (VERO) (lot number: R1F973M, expiry date: 03-Oct-2021) via an unknown route in an unknown administration site for prophylactic vaccination.  The case involved an actual medication error as wrong vaccine administered.  At the time of reporting, the patient did not report any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
Hard to wake up this morning; bad dizziness; unable to walk; This is a spontaneous report from a Pfizer sponsored program via medical information team. A contactable 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 21May2021, (75 years old at the time of vaccination) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23May2021, the patient experienced bad dizziness, unable to walk, hard to wake up this morning. It was reported that patient take several deep breaths to try and calm his dizziness. it was reported that patient received first dose 21May2021, experiencing bad dizziness and unable to walk. Asks "How long will this last?" and "Will it go away?". Indicates laying down currently. Declined further demographics. Potential duplicate AE. Reported that for a couple of days he was okay with no symptoms. Yesterday he didn't do anything. He stood up and sat right back down. His wife helped him but the dizziness got worse and worse. This morning he had a hard time waking up. States he did several deep breaths to try and calm his dizziness. Asks if this is regular? Is there anything he can do? Reported that patient thought he was being transferred to Medical Information. Declines to complete a report. he does not want to do anything else; he just wants information. States if symptoms persist he will go to his doctor. It was reported that reporter seriousness for Bad Dizziness, Unable to walk, Hard to wake up this morning was Unspecified. The outcome of all reported events was unknown.
head began to feel itchy 1hr p/vax;by the time arrived home itchy all over body & mom observed welts all over torso;instructed to give DPH & take to ER if breathing problem arises;next morning rash disappeared;
Narrative: Fully vaccinated, COVID positive on admission to ICU for neutropenic fever. Patient treated for septic pneumonia and COVID
The next morning after the vaccine I had a sore throat and nasal congestion.  1/2 Chest pains developed with prompted me to get a COVID test and on 1/2 I tested positive to COVID-19.
initial light sweat, which subsided. About 6 hours later, I noticed some aching soreness in right arm. This was the arm I received the pneumonia shot in. I was awoken about 12 midnight, with a hurting arm, I could not get back to sleep. I was also having shivers. I took 2 Advil. My rt. upper arm was to sore to move. I am a primary care giver and needed to move my patient to the bathroom in the night, which I accomplished by favoring my left arm. We were up and down most of the night, finally fell asleep about 5 AM slept till 11 am. Am listless, tired, the right arm is clearly enlarged on its upper portion near injection site as compared to the left. I failed to go to work this day. Left message for my doctor and talked with the pharmist.
This spontaneous report as received from a nurse refers to a 72 year old patient of unknown gender. No medical history provided. On 27-MAR-2013 the patient was vaccinated with ZOSTAVAX (dosing, frequency, indication; lot # H018510), exp 15-JAN-2014). The vaccine had been improperly stored at minus 5C since 14-FEB-2013. Unknown whether the patient had been using any concomitant medications. No adverse event was reported. Additional information has been requested.
cold like symptoms, 2-3 days; nasal congestion, runny nose, headache, feels warm