chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lump at injection site on left deltoid; This spontaneous report was received from a physician via a company representative and refers to a 41 years old female patient. There was no information about the patient's medical history, concurrent conditions and concomitant therapy provided. On 24-JUN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection in prefilled syringe (intramuscularly in the left deltoid, exact dose was not reported, lot # R030453, expiration date not provided but upon internal review established as 23-JUL-2021) for prophylaxis.       On 06-AUG-2020, the patient experienced lump at injection site on left deltoid. No treatment was given for the event. The outcome of the event and causality were not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R030453; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Rapid heart rate; Two days of night sweats; Aching all over her body; Arm was sore; Hgh temperate / fever; Felt tired; Chills; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Rapid heart rate), NIGHT SWEATS (Two days of night sweats), MYALGIA (Aching all over her body), VACCINATION SITE PAIN (Arm was sore) and PYREXIA (Hgh temperate / fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-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 25-Jan-2021, the patient experienced HEART RATE INCREASED (Rapid heart rate), NIGHT SWEATS (Two days of night sweats), MYALGIA (Aching all over her body), VACCINATION SITE PAIN (Arm was sore), PYREXIA (Hgh temperate / fever), FATIGUE (Felt tired) and CHILLS (Chills). At the time of the report, HEART RATE INCREASED (Rapid heart rate), NIGHT SWEATS (Two days of night sweats), MYALGIA (Aching all over her body), VACCINATION SITE PAIN (Arm was sore), PYREXIA (Hgh temperate / fever), FATIGUE (Felt tired) and CHILLS (Chills) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 101.5 101.5 F. On 25-Jan-2021, Heart rate: 115.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
Patient given Flu IZ preservative free and Zoster IZ, both in left upper arm. Arm became very swollen with ecchymosis extending to upper part of forearm. Not hot to touch, but firm and tender. Pt taking NSAIDs and NORCO.
Left arm injection site became swollen, red, painful within 24 hours seen 48 hours later - given PO abx, Benadryl.
miss second shingles shot; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   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 as follows: The case was self-reported. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter was asking if he/she needs to start over the series, for missing the 2nd shot.
3 hours after she received a adult Hepatitis B shot she broke out in hives, was dizzy and had tachycardia (however patient did not take her pulse). The usual screening quesitons had been answered including the one about yeast. She indicated that she felt fine and had no allergies. After getting the shot she eat at a restaurant and had catfish, oysters and potatoes. She took 25 mg of Benadryl and it went away. Today, which is the day after, she is fine.
I had a fast heartbeat that lasted just a few seconds and then went away on its own. This was my 3rd shot Pfizer, the so called booster shot. I had the same brief reaction after the second dose so I was somewhat expecting it, so I remained calm and did not alert anyone and the fast heartbeat quickly went away but I want to signal it to you. After my heart rate went back to normal, I felt well and I have been doing great ever since, all day long.
I was 2 weeks pregnant for the first shot and 5 weeks pregnant for the second. I didn't realize I was pregnant at the time but we are trying, so I knew it was a possibility. I found out at the first ultrasound a few weeks later that the baby had died at 8 weeks 4 days. The due date was January 20. This is my first and only miscarriage. I had an uncomplicated pregnancy in 2019 with my son who is now 20 months.
Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (1st booster dose, Unknown manufacturer), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious), outcome "recovered", described as "Diarrhea".  Additional Information: It was reported that her second booster dose, AE occurred 3 days after the vaccination. No underlying conditions. AE was mild to moderate, it lasted for 1 day. Event took place after use of product.  The information on the batch/lot number for BNT162b2,  BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
The patient was taken to the emergency room by her father with a police escort at 5am on April 20th.  The two week old infant awoke her parents when she was gasping for air.  Her parents attempted to clear her throught and improve her breathing.  She became red in color and was taken to the hospital.  On the way to the hospital she became apneic.  She was given some oxygen in the ER and her saturation was 98%.  She had two episodes in the ER where her saturation dropped down to the 70 to low-80 range and she was dusky/mottled.  She was not responsive to IV attempts and listless per the ER report. She was admitted to the hospital for observation.  She was discharged home that evening.   **Admitting Diagnosis: Not Breathing, Choking, Desaturation. **Final Diagnosis: Choking episode associated with desaturation, Mild gastroesophageal reflux (?) No treatment was offered. Follow up on 6/30/05: She continued to have breathing problems for approximately 4 weeks post event. She was not sleeping well and had chronic sinus congestion. Over the past two/three weeks, she has improved her breathing.
Information has been received from a pharmacist regarding an 80 year old female with no pertinent medical history and no drug allergies. On 25-SEP-2012, the female was vaccinated with ZOSTAVAX subcutaneous 0.65 milliliters (site not reported) (lot number: H011050, expiration date 05-SEP-2013 as reported) to prevent shingles. Concomitant medications included: pantoprazole, atorvastatin, losartan (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), alendronate (manufacturer unknown), calcium and vitamin D. On 26-SEP-2012, the female developed an injection-site reaction of redness and swelling. The patient sought medical attention described as visited pharmacy. No treatment was given. At the time of this report, thee vent was not recovered. Additional information is not expected.
I did not have any symptoms after getting the vaccine. I started having body aches and fever on August. I contacted for a telehealth visit and then they scheduled an appointment for a drive thru Covid test on 08/05/2021. I got the Covid test on 08/05/2021 and it came back positive on 08/07/2021. That lasted for about a week.
No additional adverse effects reported; on 08/19/2020 a patient was administered a dose of PNEUMOVAX 23 (lot R010724 expiration 06/13/2020); This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 19-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R010724, expiration date: 13-JUN-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. No additional adverse effects were reported.
Information has been received from a registered nurse (RN) concerning a 6-year-old white female with no pre-existing allergies, birth defects, or medical conditions who on 08-JUL-2002 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. On 04-JUL-2007 the patient's mother called and stated that all of the patient's siblings had chickenpox, and now the patient has a few lesions. The patient was afebrile. No medical attention was sought. No laboratory or diagnostic tests were performed. On 09-Jul-2007 the patient recovered. This is one of several reports from the same reporter. The RN also reported that four of the patient's siblings developed chicken pox following varicella virus vaccine live (Oka/Merck) administration (WAES numbers: 0706USA04088, 0707USA01591, 0707USA01593, 0707USA01594). Additional information has been requested.
Abnormal vaginal bleeding, Iron deficiency anemia due to chronic blood loss. Loss of memory and concentration, affect my vision and energy.
Painful arm; This is a spontaneous report from contactable nurse (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 28Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported to have received the Pfizer Covid vaccine yesterday (28Dec2020). The patient experienced painful arm even on the second day. The outcome of event was not recovered.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
Rash; Felt hard; Felt warm; Itched like a mosquito bite; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Felt hard), FEELING HOT (Felt warm), PRURITUS (Itched like a mosquito bite) and RASH (Rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced RASH (Rash). On an unknown date, the patient experienced INDURATION (Felt hard), FEELING HOT (Felt warm) and PRURITUS (Itched like a mosquito bite). The patient was treated with HYDROCORTISONE at a dose of 1 dosage form. On 24-Jan-2021, RASH (Rash) had resolved. At the time of the report, INDURATION (Felt hard), FEELING HOT (Felt warm) and PRURITUS (Itched like a mosquito bite) had resolved.            .   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: No specific follow-up information recorded.
Friday night at about 10ish I suddenly got a terrible migraine, shaking uncontrollably, and my body have stiff. I tried going to bed at 11pm, but couldn't fall asleep. I got up sometime around 2am and I still had all of these along with extreme nausea. Check my temperature, it was 101.4 F. Got more blankets and tried to get some sleep, but took a while due to the migraine.   At 7:30am, the shaking was gone and the migraine was not as bad, but I still had a temperature of 99.1 F and nausea. After calling my boss and mother, I went back to sleep. Stayed in bed until about 1:45pm Saturday. By then, the migraine was manageable and nausea was not as bad, though still had a temperature of 99.9 F. Took a shower and took 2 pills of  ibuprofen.
pt recvd vax 12OCT93 & 2NOV93 pt devel numbness & tingling of the tongue & rt side of the mouth; progressed to right facial numbness & difficulty closing the rt eyes; MD dx Bell's Palsy on 7NOV93;
No adverse event patient was given and infant dose (Dtap) instead of a (Tdap) given to our 11 yr olds.
Body rash, itching and dry heaves the day following vaccine administration (9/4/14). Reported here by pt on (9/12/14).
First dose 1/27/2021, patient likely conceived 2/4/2021, received second dose 2/13/2021, positive home pregnancy test 2/14/2021, pregnancy first detected by ultrasound 3/9/2021 estimated 5 weeks gestation, second ultrasound 3/22/2021, fetal growth delayed but cardiac activity noted with HR only 78 bpm, third ultrasound 3/30/2021, confirmed no additional fetal growth, fetal pole measured 5w6d and diagnosed missed miscarriage. D&C on 3/31/2021, chromosomal testing still pending
ON 4/15/13 STARTED WITH FEVER TO 102.8.  ON 4/17/13, FEVER RESOLVED BUT PATIENT BECAME "UNCOORDINATED", GOING FROM PREVIOUSLY ABLE TO RUN AROUND TO FALLING AFTER 2 STEPS AND HAVING TO BE CARRIED AROUND. BY THE TIME OF THE OFFICE VISIT, HE HAD REGAINED MUCH OF HIS EQUILIBRIUM AND WAS ALMOST BACK TO NORMAL.  DAD WAS ADVISED TO F/U IN 1-2 DAYS IF THERE WAS NOT FULL RECOVERY.  NO F/U WAS NEEDED.
presented with arm tightness and very mild swelling in the left arm. developed prominent left shoulder veins. Found to have:1. Acute appearing partially occlusive deep vein thrombus involving the left supraclavicular subclavian vein. 2. Acute focal superficial venous thrombus involving the left cephalic vein at the antecubital fossa.
It started with body ache, fever, chills and dizziness.  Patient went to ER where she was given Toradol y Relafen.  Se continued to feel dizzies  and headaches started for a whole week.  Then she began to have involuntary movements of the left hand and her mouth twisted to the left.  Eventually the symptoms subsided but  she started to feel numbness of the fingers and tingling on the neck .  She went back to the ER and was given Pepcid, antibiotics and a COVID-19 test (PCR) which result was negative (04/18/2021).  The symptoms persisted so she visited an ER again where a CT was performed and results were normal.  Her primary physician gave a referral to the an ER of a healthcare facility where a contrast CT was performed and was given Vistaril and Morphine.  In this last ER visits she started to tremble.  The results of this last test and lab results were normal.   She finally was referred to a neurologist who gave klonopin and is pending further tests.
Took the first dose and did not had 2nd dose in 28-day window period and its now past 60 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Took the first dose and did not had 2nd dose in 28-day window period and its now past 60 days) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Took the first dose and did not had 2nd dose in 28-day window period and its now past 60 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Took the first dose and did not had 2nd dose in 28-day window period and its now past 60 days) had resolved.        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.   Concomitant product use was not provided. Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: FU received  - No adverse event occured
1st shot migraine head ache for week, dizzy ness, fell down steps, hard to breath, pain in chest, call and ask health clinic if should get second shot they said ok to. blood pressure up by 10-15 pts 2nd shot- 3 hours dizzy, head ache,   8 hours later, gaunt start in right foot,  hot and freezing every 15 minutes rotation in for day, stabbing stomach pains, 3 black outs for up to 4 hours each, 2 day burning eyes, and gaunt start in  other foot left foot, and gaunt move up to ankle on right foot.  blood pressure now 20-25 pts higher. notified heath clinic again.
This spontaneous report as received from a pharmacist (a daughter of the patient) via a company representative refers to a 81-year-old female patient. The patient's medical history included unspecified dementia. The patient' concurrent conditions and concomitant therapies were not reported. It was reported that, the patient did not think that she had any allergies. On an unknown date in February 2015, the patient received unspecified form of PREVNAR (dose, route of administration, lot number and expiry date were not reported) with unspecified results. On an unknown date in March 2016, during the morning hours, the patient was vaccinated with a dose of PNEUMOVAX 23 in the left arm (lot number, expiry date and route of administration were not reported). On an unknown date in March 2016, reported as on the same day in the afternoon or evening, the patient developed a sunburn-like rash and edema in the whole lower part of her left arm. The pharmacist's mother sought medical attention at an unspecified urgent care clinic on that same day, and the recommended treatment was wrapping of the arm to protect it. The representative states that the pharmacist didn't specify whether or not her mother had ever received PNEUMOVAX 23 before the dose that was administered on an unspecified date in March 2016. The outcome of the adverse events was reported as recovered (unknown date). Relatedness between the events and the vaccination with PNEUMOVAX 23 was not reported. Additional information has been requested.
My left arm was hurting, body aches and a headache was hurting for about 48hrs and all subsided with taking tylenol and ibprophen.
tingling in fingers; cold numb sensation in fingers; cold numb sensation in fingers; malaise; chest discomfort; severe sciatica like pain; received first dose on 10Mar2021 and second dose on 27Apr2021; This is a spontaneous report from a contactable consumer or other health care professional (Patient).   A 40-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: ER8732, Expiration date: Unknown), via an unspecified route of administration, in Left Arm on 27Apr2021 (at the age of 40-years-old) as DOSE 2, SINGLE for Covid-19 immunisation at School or Student Health Clinic. The patient medical history included seasonal allergy from an unknown date and unknown if ongoing. The patient received concomitant medications within 2 weeks included ibuprofen (ADVIL [IBUPROFEN]), ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN & MINERAL) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot/Batch: EN6199, Expiration date: Unknown), via an unspecified route of administration in Left Arm on 10Mar2021 (at the age of 40-years-old) as dose 1, single for Covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date Approx 6-7 weeks after second vaccine: tingling in fingers, cold numb sensation in fingers, malaise, chest discomfort, followed by severe sciatica like pain for 2-3 days in right leg. I do not typically develop sciatica like pain (last experienced during pregnancy over 5 years ago), The patient received first dose on 10Mar2021 and second dose on 27Apr2021. Therapeutic measures were taken as a result of tingling in fingers, cold numb sensation in fingers, cold numb sensation in fingers, malaise, chest discomfort, severe sciatica like pain. The treatment received for the events which included Ibuprofen and gabapentin to help with pain. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events was recovered on unspecified date of 2021.   Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
3-4 days later developed a rash around flu shot site, about lemon sized. He applied topical hydrocortisone cream - it gradually improved. The 1.5 wk after flu shot, rash broke out on both legs. He tool OTC allergy pills (? BENADRYL). On 11/21/11 was seen at office with extensive crop of petechial palpable lesions both legs - thighs, knees, calves, front & back.