chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer reporting for himself. A 76-year-old male patient received first dose of PREVNAR 13, intramuscular on arm left on 14Sep2016 at 11:45 at single dose for pneumonia prevention. Medical history included seasonal affective disorder, ongoing borderline type 2 diabetes, glaucoma, ongoing cholesterol abnormal, pollen and grass allergies and sinus. He had pneumonia several times in the past and the worst he had was in 1978: "he was taken out of action for 2 weeks, it felt like somebody was sitting on his chest. He has had what is loosely termed "walking pneumonia" about 6 times, but has not had in 20 years". Concomitant medication included simvastatin for more than 10 years and ongoing for Cholesterol control at 40 mg, 1x/day (at night), fluoxetine from 1997 and ongoing for seasonal affective disorder at 20 mg, 1x/day (in the morning), metformin from 2015 and ongoing for borderline type 2 diabetes at 500 mg, 2x/day, timolol maleate began probably 5 years ago and ongoing for glaucoma pressure at 2 Gtt (1 drop each eye) 2x/day ophthalmic, dorzolamide 2% ophthalmic solution, from 2015 and ongoing for glaucoma pressure supplementation at 1 Gtt (one drop in right eye) 2x/day ophthalmic and LUTEIN for his eyes and a multivitamin. In 2015 he received a pneumonia shot (not PREVNAR 13) because of his age and history. In Sep2016 the patient experienced injection site soreness (within a day or two of receiving the vaccine), entire arm was sore and limitation when he moved his arm. On an unknown date he had fatigue/tired feeling, headache and decreased appetite. He had alerted his doctor about these side effects after about a month, and his doctor said it was just a reaction to the shot. The patient's upper left arm was still sore, but it has gotten better very slowly. More than 2 months later, his muscle soreness where the injection occurred and the left arm limitation when he moved his arm still affected him and his daily living. It has been about a 25% improvement. The outcome of injection site soreness and arm limitation was recovering. Fatigue, headache and decreased appetite recovered on an unknown date. Entire arm was sore recovered with sequelae.
pt rcvd vax; pt exp pain & soreness in shoulder 1 wk; low grade fever & malaise 2-3 days after inject; pt had mild flu;
This spontaneous report as received from a registered nurse refers to a 3 month old patient of unknown gender. The patient was planned to receive ROTATEQ on 30-APR-2016. On 30-APR-2016, patient came to office but vaccination was deferred as patient had fever. Nurse stated that, on 04-MAY-2016 the patient returned to office and received first dose of ROTATEQ (lot # L029618) at a dose of 2.0 ml, once orally which was beyond age guideline for first dose. No adverse effects have been reported. Additional information has been requested.
dizziness; problems with breathing; low blood pressure; slow blood circulation; Icy hands; hands are shaking; fever 101.3F; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: ER8735), dose 2 via an unspecified route of administration, administered in Arm Left on 23Apr2021 08:45 as dose 2, single for covid-19 immunisation. Medical history included allergy to eggs from an unknown date and unknown if ongoing and patient was completed healthy. There were no concomitant medications. The patient previously received first dose of bnt162b2, via an unspecified route of administration, administered in Arm Left on 02Apr2021 09:00 AM as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. On 23Apr2021 08:45 patient experienced 30 minutes later after vaccination: dizziness, problems with breathing, low blood pressure, slow blood circulation- icy hands, hands are shaking 30 minutes. 12 hours later fever 101.3F. Patient received treatment put patient on wheelchair, hold head down, brought on fresh air, give something warm in the hands. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included blood pressure measurement: low on 23Apr2021, body temperature: 101.3 fahrenheit on 23Apr2021, Nasal Swab: negative on 17Oct2020, Nasal Swab: negative on 02Feb2021. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Seborrheic dermatitis occurred after the second dose about two weeks after injection that is mostly concentrated on the legs that look like mosquito bites. Hydrocortisone cream does not work, coconut oil did not work either. Seborrheic dermatitis on my face is slowly improving as well.
Information has been received from a nurse practitioner, concerning a 74 year old female patient.  The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 11-SEP-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23, subcutaneous in an arm (strength, dose, exact anatomical location, lot number and expiration date were not provided) for prevention of pneumococcal disease (prophylaxis). Two hours after vaccination, the patient's arm, where the vaccination was applied, became swollen from shoulder to elbow, the patient called doctor's office and visited doctor on 12-SEP-2017. It was unknown if the patient received treatment for the adverse event or if laboratory studies were performed. At the time of the report, the patient was not recovered from the vaccination site swelling and the causal relationship between the adverse event and PNEUMOVAX 23 was not assessed.
RN called to the lobby to assess patient. Patient experiencing dizziness after receiving covid and flu vaccine. Patient received covid injection in left deltoid which was pfizer and the booster. A few minutes after the injection, patient got very dizzy which was a room spinning sensation. Per patient, this does occur after injections and blood draws due to the needle. Patient was given apple juice. Patient also complained of a mild headache. Vitals: blood pressure 112/72, heart rate 79 and oxygenation 100%. Patient received vaccine at 1535. At 1600, patient complained of left arm/hand tingling/tight sensation. When asked to squeeze fingers with both hands, left side was weaker and pointer finger did not move to grip writers finger. Denies any chest pain, shortness of breath, throat swelling, and redness at injection site. RN consulted with DO who stated patient should be evaluated in the ER. RN brought patient to the ER and informed staff of symptoms.
pt recvd vax 3FEB95 & reported that on 4FEB95 felt nauseated & weak, lt deltoid was swollen as big as a baseball et red;
Patient's wife brought in Rx for PERCOCET and Cephalexin. She said sx red, warm, very swollen and painful. She said Rx for cephalexin was "just in case".
RED SPOTS ON HEAD AND TRUNK. NOTICED TODAY (6/3/19)   LOW GRADE FEVER FOR ONE DAY. . DIARRHEA FOR ABOUT ONE WEEK.
Monday January 13, patient broke out with just 4 spots of chicken pox. As of today January 17 they are still there but are starting to blister up. No treatment at this time.
Ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history.  Concomitant products included METHOTREXATE for an unknown indication.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 PAIN (Ache). At the time of the report, PAIN (Ache) outcome was unknown.            On 2021, Patient received first dose COVID-19 vaccine by an unknown manufacturer.
death; Neurologic symptoms; exposure via transplant; Initial information received on 11-May-2022 regarding an unsolicited valid serious case received from a other health professional.   This case involves Adult and unknown gender patient who experienced death, neurologic symptoms and exposure via transplant from an individual who received blood transfusion from the vaccinated individual who received vaccine yellow fever vaccine [YF-VAX].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received organ from an individual who received blood transfusion from the vaccinated individual (exposure via transplant) who received who received a dose of suspect yellow fever vaccine unknown formulation and strength lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, post organ transplant, the patient developed neurologic symptoms and YF virus was found in CSF or brain tissue (unknown latency).  On an unknown date, Patient died (death) (unknown latency. This event was assessed as medically significant and was leading to death.  Action taken: Not applicable for all.  It was not reported if the patient received a corrective treatment for any of the event.  At time of reporting, the outcome was Unknown for the event neurologic symptoms, was Fatal for the event death and was Unknown for the event exposure via transplant. The cause of death was reported as unknown.; Sender's Comments: Sanofi company comment dated 18-May-2022: This case involves an adult patient who died of an unknown cause. An unspecified time prior, the patient had received organ from an individual who received blood transfusion from a vaccinated individual who received vaccine yellow fever vaccine [YF-VAX]. There is limited information in the case. Further information regarding medical history, concurrent condition of patient, previous vaccination, concomitant medications and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: unknown cause of death
Bloody Nose. He thought he had a runny nose all night, but when he woke up the next morning, discovered blood.
10/1 5PM c/o febrile episode w/chills;10/2 8AM hives-neck, chest, rt face;10/2 6PM shooting pain rt arm, ROM WNL;
Patient woke up at 4am on Feb. 14th 2021 with extreme headache, nausea, dizziness, and blurry vision. patients wife called 911 and patient was taken to  Hospital ER for emergency evaluation. CT scan revealed a brain bleed. patient was rushed to Hospital Neuro ICU for immediate care. patient was at  Hospital from Sunday Feb. 14th - Tuesday Feb. 16th. patient blood pressure (which is usually well controlled) had spiked up to dangerous level and caused a rupture to an AVM in the tegmentum region of his brain. hospital treated patient and got his blood pressure regulated. Patient discharged on Tuesday Feb. 16th 2021 with the expectation of making a full recovery after several weeks of rest.
Pt received 1st dose of Pfizer vaccine. Per safety officer to this writer: Pt sitting in post observation and c/o chest tightness without difficulty breathing. Pt denies other symptoms. HR and oxygen  sat WNL. Pt states symptoms resolved on own after 10 min. Pt instructed to seek medical care if symptom persist. Pt exited facility in company of Pt.
Swollen skin underneath Eyes; Skin sensitive to the touch underneath her eyes; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (Swollen skin underneath Eyes), SENSITIVE SKIN (Skin sensitive to the touch underneath her eyes) and VOMITING (Vomiting) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced SKIN SWELLING (Swollen skin underneath Eyes), SENSITIVE SKIN (Skin sensitive to the touch underneath her eyes) and VOMITING (Vomiting). At the time of the report, SKIN SWELLING (Swollen skin underneath Eyes), SENSITIVE SKIN (Skin sensitive to the touch underneath her eyes) and VOMITING (Vomiting) outcome was unknown. Not Provided          No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender who in July 2014 about 2 or 3 weeks ago was vaccinated with a dose of ROTATEQ (lot # and expiration date unknown), it was unknown how many in series of ROTATEQ that the patient received. On an unknown date, the patient had developed vomiting and diarrhea since receiving ROTATEQ. The outcome of vomiting and diarrhea was unknown. This is one of three reports from the same reporter source.  Additional information has been requested.
Child had pain and swelling in left arm the evening after the flu vaccine was admin. Temp. max 100.8, arm pain and swelling continued and parents took child to local ER on 10/25/19 diagnosed with local reaction to flu vaccine.  Seen in our office 10/26/19 given 5 days of prednisone tablet 20 mg 3 tables once a day for 5 days for arm still warm to touch and itching.  Told to stop prednisone sooner if symptoms were relieved before 5 days.
Swollen injection arm, extremely tired fever, chills, headache, sinus pressure, runny nose sore throat and got a prescription for PAXLOVID and still remained extremely tired.
p/vax pt exp flu sx including a clear mucous in nostrils & a constant sneezing fit;attempted to treat sx w/ pseudoephedrine HCL, chlorpheniramine maleate, APAP (Theraflu) w/no success;
Pt developed with redness, swollen and itch around the area where she got flu shot. Pt C/O numbing of the whole arm. She applied anti-itch cream and feels a bit better today, but it is still warm to touch. I referred her to see MD. She agreed to see MD today after work.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 26-SEP-2014 the patient was vaccinated with a dose of GARDASIL (lot number, expiration date, dose, route were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received Td and MMR 9/02/03. Within 2 hours after injections in left arm, complained of aching, redness, fever, hardness at Td site of deltoid. Also complained of achy throat same day of injections. Began Benadryl 50 mg (1 dose), Tylenol (3 doses) and complained of shoulder pain - 11 x 6cm hot, hardened, red raised area left deltoid. Recovering with Tylenol and cool packs to area.
On day of vaccine, fussed for 7/8 hours refusing to breast feed. Developed stools black, were watery mucus x 3 days. Occult +. Not himself for the next 6 days with fever 5 days after with temp 101.7 next 24 hours. Gradually improved.  9/11/07 Received partial medical records from receiving hospital which indicates patient admitted 8/31/07.  No D/C summary available.  Patient experienced fever, intermittent abdominal pain & distention & 1 bloody BM x 1 week.  Ped surgery consult obtained.  IS felt unlikely; felt probable AGE.  9/18/07 Reviewed vax record which confirms RO dose & lot # as reported.  Visit note of 8/24/07 reveals patient in good health on day of vax. 9/18/07 Reviewed ER medical records which reveal patient experienced fever, irritability, rash & mucousy stools x 1 week.  Seen in ER on 8/30/07.  Patient's sibling broke out w/chickenpox on 8/24.  Seen at pcp office same day & sent to ER due to w/heme (+) stool, firm & tender abdomen.  LP in ER was unsuccessful.  Transferred to higher level of care. FINAL ER Dx: acute febrile illness, questionable etiology; heme (+) stools, r/o IS; bilateral foot rash.
Redness (splotchy red areas on left arm) some pain and feeling hot per patient. Recommended Benadryl 25 1-2 PO q 4-6 x 24hr. Benadryl 25 mg 1-2 PO q4-6h pm for 24 hours + follow-up w/pharmacy or doctor if not improving
Next day started with itching under right breast.  Saw red rash that grew in size for entire area under breast.  Rash on right jawline, Following days smaller itching rash under left breast, rash on left jawline, rash by hairline forehead, 2 raised spots on right arm, injection area red,swollen and warm and about 2 inch circle.  Then right side waist had large horizontal rash  that eventually grew vertically.  Saw Dr and thought raised bumps on face that leaked might be poison ivy but wasn't sure about rash on waist.  As of today still itching although rash looks to be improving due to medical intervention.
Initial report received on 28 September 2009 from a health care professional. A 72 year old male patient with an allergy to salicylates and a history of diabetes, hypertension, and hyperlipidemia felt feverish in the evening after he received FLUZONE (lot number U3184AA) intramuscularly in the right deltoid on 22 September 2009. The following day, the patient awoke with a swollen eye and lip. Treatment included BENADRYL. The patient placed a phone call to the physician. No further details were provided. Concomitant therapy included propanolol, simvastatin, verapamil. The patient subsequently recovered. List of Documents held by Sender: none.
Rash in left arm, where received vaccine; rash that expand to elbow and fingers/ gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash in left arm, where received vaccine) and RASH (rash that expand to elbow and fingers/ gotten worse) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Apr-2022, the patient received fourth 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, the patient experienced VACCINATION SITE RASH (Rash in left arm, where received vaccine) and RASH (rash that expand to elbow and fingers/ gotten worse). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Rash in left arm, where received vaccine) and RASH (rash that expand to elbow and fingers/ gotten worse) had not resolved.            No concomitant medication information provided.  Patient  received all previous doses from Moderna. Patient developed a rash in the left arm arm, where he received the vaccine and now it was progressing and had expanded to his elbow and was now expanding to his fingers.  The symptoms had not subsisted and had gotten worse.
I woke up with extreme dizziness, nystagmus, disorientation, inability to stand, which got worse over the course of the next hour. My husband called an  ambulance and I was taken to the hospital for a CT scan, which was negative. Dizziness and headache persisted for the next 3-4 days. I had never experienced these symptoms before.
TB skin test and Td administered to LA according to protocol, 10 minutes later. client developed sx of dizziness, urticaria, of LA and burning and itching eyes. Vitals WNL. Lied client on Tx bed with knees up. Sx persisted. Administered Benadryl IM to LA, 1ml. Sx persisted with eyes, Itching at LA subsided. Called 911 when no relief was evident.
6 months after receiving Gardasil 9 vaccine my daughter stopped having periods. Two years later the problem has not been resolved.
The day after the second dose of the vaccine, I experienced breakthrough bleeding as if it was my period. It lasted 3 days and then abruptly stopped.   I am currently breastfeeding so I have yet to get my period back since giving birth.
received the 2nd dose 11 days after the first dose; A spontaneous report was received from a physician concerning a 76-year-old, female patient who received the 2nd dose 11 days after the first dose.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     Patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 6FEB2021.  On 17FEB2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.    Physician called to report that patient received the 2nd vaccine 11 days after receiving the first dose of the Moderna vaccine.Treatment information was not provided/unknown.    The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event, received the 2nd dose 11 days after the first dose was considered recovered/resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown  with no associated AEs.
Received vaccine on 10/26/2023 and discovered on 11/8/2023 that patient received a Pfizer COVID-19 vaccine for 6m-4yr that was diluted with expired normal saline.
frozen havrix was administered to a patient. Havrix was below 32°F (below freezing )for several minutes; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old male patient who received HAV (Havrix) (batch number J34DR, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The office manager reported that a frozen Havrix was administered to a patient, which led to incorrect storage of drug. Havrix was below 32 degree Fahrenheit (below freezing) for several minutes. The reporter enquired about revaccination. The reporter consented to follow up.
The night of vaccine had lots of alert energy The morning after, horrible head ache that lasted 2.5 days and then has recurred in the morning for 3 days so far. Chills, stomach pain with nausea, and extreme fatigue for the day after vaccine Fatigue and head ache 2 days after  Took Tylenol and later Advil