chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 20 year old female with depression, anxiety disorder and migraine and no drug reactions/allergies who on 22-JUN-2007 was vaccinated with a first dose of GARDASIL (lot# 653735/0688F) 0.5mL IM. Concomitant therapy included LYRICA, PROCAC, DEPAKOTE, BUSPAR, trazodone HCl and nabumetone. On 27-AUG-2007 the patient was vaccinated with a second dose of GARDASIL (lot# 655503/0012U) 0.5mL IM and is "2 months pregnant". Medical attention was sought. A urine beta-human chorionic gonadotropin test was positive for pregnancy. The date of the last menstrual period was approximately 06-JUL-2007 and the estimated date of delivery is approximately 11-APR-2007. No other information was available at this time. Follow-up information was received from the L.P.N. The L.P.N. reported that the patient delivered a baby girl "just yesterday, last night" (08-MAY-2008). A C-section was performed since the baby was breech. The baby was 7 pounds 4 ounces and 19 inches long. The baby was healthy with no congenital anomalies. The patient's due date was 06-MAY-2008 so the baby was born at 40 weeks and two days gestation. Upon internal review breech presentation was considered to be an other medical event. Additional information is not expected.
Flu shot 10-1-12 AM and that evening developed pruritic rash upper arms & wrists along with malaise & chills. No fever. No previous reaction to flu shot. Tx: ZYRTEC 10 mg. daily per Dr.
After the patient got Covid -19 vaccine , Janssen , he was resting on the post-vaccine chair. About 5 minutes later, the patient has fallen. He woke up a few seconds later, reported he felt warm. His blood pressure was 122/88. He drank a bottle of water and slowly he got back to his normal condition. He stated he has not been getting vaccination for a while since he was child.
arm/rt shoulder where vax given pain in joint, diff carrying, painful to move x 1wk w/no improvement;
Rash on neck; gall bladder attack; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration at the left arm on 18Dec2020 10:30 at a single dose for  COVID-19 immunization in the hospital, and morphine sulfate (manufacturer unknown), via an unspecified route of administration from an unspecified date at unspecified dose and frequency for an unspecified indication. Medical history included S/P rouxen-y gastric bypass, sleep apnea, cholelithiasis, HSV-2, obesity, and Hashimoto hypothyroid disease. The patient was not pregnant at the time of vaccination. Concomitant medications included ursodiol, valacyclovir, levothyroxine sodium (LEVOTH) and vitamins. The patient previously took morphine and experienced allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced Rash on neck, morphine reaction and May or may not be related - gall bladder attack on 18Dec2020 14:30. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was administered with NS bolus, diphenhydramine (BENADRYL) and also morphine in response to the events. Since the vaccination, the patient had been tested for COVID-19 via Nasal Swab/COVID-19 rapid ABBT which was negative on 18Dec2020. The action taken in response to the events for morphine sulfate was unknown. The outcome of the events was recovered with sequel. The patient assessed the events as non-serious.   Pfizer is a marketing authorization holder of morphine sulfate in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of morphine sulfate has submitted the same report to the regulatory authorities.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sore arm; This is a spontaneous report from a contactable consumer. A 12-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on 14May2021 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. It was unknown if the patient had any medical history. It was unknown, if the patient had any known allergies. It was unknown, if the patient was taking any concomitant medications. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. On 14May2021, the patient experienced sore arm. It was unknown whether any therapeutic measures were taken for the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event sore arm was resolved on unknown date in May2021.   No follow-up attempts are needed; information about lot/ batch number cannot be obtained.
Severe chills (uncontrollable shaking for 4 hours) even being bundled up in sweats and thick socks and under thick blankets.  Aches (acute skin sensitivity and soreness) all over the body for 15 hours.  Fever (100.4 F) at 1am which put a stop to the chills and started the sweats and hot flashes. Patient took Tylenol at 6:30am which stopped the fever.   Throbbing Headache with the fever.  Dizziness and light headedness after fever and headache ended.
Immediate metallic taste in mouth that lasted about 72 hours.  This happened with both doses.
Client was 17 years old when he received Moderna  (1st dose) vaccine. Client and parent notified and deny any adverse events. Client and parent educated that off label use for vaccine would be that he can and should receive 2nd dose. Parent in agreement.
This case was reported by a healthcare professional and described the occurrence of swollen gland in a 43-year-old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  Previous and/or concurrent vaccination included hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix); GlaxoSmithKline; unknown; unknown given on an unspecified date.  On 14 December 2007, the subject received 2nd dose of Twinrix (.5 ml, unknown, left arm).  On 15 December 2007, 1 day after vaccination with Twinrix, the subject experienced left swollen glands, swelling under tongue on left side, sore throat and left side of face numb.  The healthcare professional considered the events were disabling.  The subject was treated with diphenhydramine hydrochloride (Benadryl) after contacting the health department.  At the time of reporting the events were unresolved.
Pt states she woke up friday morning with fever, chills, fatigue, vomiting & diarrhea. Had previous contact @ 1wk ago with COVID (+) person Test negative 2x for COVID & 1x for flu. Has virtual appt with Dr. on Thursday.
This spontaneous report was received from a registered pharmacist concerning a patient of unknown age and gender. On 12-SEP-2012, the patient was vaccinated with expired ZOSTAVAX of lot number 670616/0617AA. Expiry date was provided as 26-JUL-2012. No concomitant medications were reported. The patient was not experiencing any known symptoms. Additional information has been requested.
07/11/22 presents to Emergency room for "abdominal pain". PMHx of "cholecystectomy several years ago, recent covid infection"
pt devel pain & edema immed p/vax;next day area became red & warm;redness spread to rest of arm;wk later area is still warm, red & tender;tx w/DPH & cold compresses;
Information has been received from a physician concerning a patient who was vaccinated on 17-Jul-1996 with a dose of varicella virus vaccine live. The patient was recently exposed to a wild-type virus and developed a breakthrough case of chickenpox. There were not many lesions present but the lesions were larger than usual. The physician reported that the patient's case of chicken pox was mild. The patient also developed a cellulitis of the left arm which consisted of a zone of redness 3 cm across. The patient was treated with amoxicillin (+) clavulanate potassium (Augmentin) po and had since recovered. According to the reporter, the location where the varicella virus vaccine live was administered was not indicated in the patient's chart. Unspecified medical attention was sought. Additional information has been requested.
client had just received 1st dose of vaccine @ 1042am, was in observation area@ 1055am. Client disclosed to Observation lead that she was about to "pass out." Nurse assisted client to the floor, NP assessed client as well. EMT on site monitored clients vitals: at 10:55am HR 61 02sat 98%, 10:58am HR 52 o2sat 98%, 11:00am HR 60 O2sat 98% BP 140/83,  @ 11:05 HR 58 O2sat 99% BP 125/73. Client alert and oriented during incident, talking to NP the whole time. client approx 28weeks pregnant. Last vitals taken at 11:29am  HR 63 O2sat 99%. Client was advised to by NP to report to her OB/GYN. Client left site with boyfriend at her side.
On 1/18/2021, I developed a bright right itchy rash at the injection site. The rash had paler raised skin in the center with an uneven border.  I took two separate doses of benadryl, a zyrtec the next morning, and a benadryl the next night again. I also began to apply cortisone cream. The visible rash gradually lessened and was no longer visible on 1/21/2021, but some itchiness lingered and then also remitted after about 24 hours later.
incorrect product storage; no adverse event; This spontaneous report has been received from an unspecified reporter referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T026954 with expiration date of 13-APR-2022 (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. The vaccine was exposed to a temperature of 47.35°F during a time frame of 10 minutes. No previous temperature excursions 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; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T026954; expirationdate: 13-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
A red rash the size of my fist or slightly bigger. It did not itch. The red patch went away after a week.
First dose of COVID vaccine  given was ma was manufactured by Moderna.  Second dose given on 3/12/2021 was manufactured by Pfizer.  Patient nd her son were informed that n error was made in the type/manufacturer of the vaccine she received.  Possible expected reactions of the vaccine she received were described and the son and patient were asked to call if any other  serious adverse reactions occurred.  To this date there has been no contact.
Information has been received from a physician concerning a female patient who on 20-OCT-2006 was vaccinated with the first dose of GARDASIL. Subsequently the patient developed severe arm pain at the injection site. At the time of this report, the outcome of the event was unknown. No further details were provided. Additional information has been requested. 01/05/07: This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a physician and a nurse concerning a female patient who on 20-OCT-2006 was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced severe arm pain at the injection site. There was no redness and no swelling. The nurse reported that the pre-filled syringe "popped" when attempting to use it, causing the patient pain. The nurse then used another syringe which "worked fine". At the time of this report, the patient had not yet received her second vaccination. Additional information has been requested.
Palpitations, increased blood pressure,  wheezing ,SOB within 5 minutes symptoms increase as time went on-tachycardia -epi pen administer after 15-20 mins after injection
1.  About 4-5 minutes after getting vaccinated my left eye had new floaters and what looked like strands of hair.  They cleared after 35 minutes except for a few floaters. 2.  About 1.5 days later for 24 hours I had a headache and took advil.  Injection site was tender 24 hours after injection for a couple of days.
had the shot and he got the worst case/ Suspected vaccination failure; got the worst case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's brother. The age at vaccination was not reported. The reporter stated that, the Shingles shot did not work as the patient got Shingle shot and got worst case of shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
An hour after felt flush; An hour after felt flush and nauseated; Weird taste; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 30Apr2021 at 12:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccination within 4 weeks of COVID-19 vaccine. The patient did not receive other medications within 2 weeks of COVID-19 vaccine. The patient had no known allergies. On 30Apr2021 at 13:15, 30 minutes after the vaccine, the patient had weird taste in mouth which was more noticeable when drinking water. On 30Apr2021 at 13:45, an hour after the vaccine, the patient felt flushed and nauseated. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events weird taste in mouth, felt flush and nauseated were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient reported on 8/11/22 that he was having normal side effects (muscle aches, fever, fatigue, HA) but had eye pain in addition.  He described the pain as a muscle ache that was sharp when he moved his eyes and dull at rest.  He rated the pain at a 2-3 (out of a 10 point scale).  Patient took one Aleve  in the morning which did not help the eye pain but relived the other symptoms.  Patient sought medical care and was told to monitor the situation.
Flu like symptoms for 3 days after vaccination.  Vertigo for 1 week after vaccination. Pain at injection site for 3 days.
Client received Typhoid vaccine 0.5 ml in Left Deltoid on 06/19/2008. Phoned Health Department at 0930 06/20/2008 stated she "had mild hives on her head and both arms that were splochy and itching", also stated "sometimes I get hives for no reasaon, my skin is very sensitive". Advised client to seek medical attention if condition worsened and she could take OTC Benaydrl as ordered. (Pt. stated she had also recieved Tdap on 06/12/2008 at her private doctors office).
Employee called to report that she developed headache and body aches this morning rated 7/10. She is 26 week pregnant. Instructed her to notify her PCP or OBGyn.
EXTREME TIREDNESS, HEADACHE, SNIFFLES, ACHY, INABILITY TO CONCENTRATE, LASTED UNTIL PM ON 11/19/2009. 12/2/09 Medical records received. OB records from date 9/9/09 to 11/17/09. DX: pregnancy. LPM 7/1/09, EDC 4/7/10. Most recent OV 11/17/09 normal IUP. FHR(+), fetal movement(+). Received H1N1 vax.  12/3/09 medical records received for DOS range 9/24-11/17. OB/GYN notes. + FHR in 150's, + fetal movement. Nausea.Round ligament pain. Posterior placenta. Anatomic WNL Declined flu vax, but agreed to H1N1.
When I first noticed the symptoms, it was a running nose and I thought it was dust or allergies. Then I started to not feel like myself. I started to get a sore throat and I thought right away I should test myself and I took a test after supper. I tested myself and noticed, I was positive. I went to bed and when I got up my wife called urgent care.  They did a PCR test. Then we went home, by the time I got home I started to feel worse, my joints, arms, skin and a really bad headache started, I also started shaking and I felt very cold. My temp at home was 100.5. That day I just kind of sat around, I calmed down from the shakes after a while. I slept mostly and the headache was bad, and my eyes were hurting. My nose and throat did get better. Going to bed was rough because I was so cold and still a little shaky. As days went on it did get better and better. And today I feel a bit more normal. I still have a little headache and body aches.
After the first dose, developed floaters that resolved after 24hr. After the second dose, I developed severe jaw pain, teeth pain and back pain that resolved after 2-3 days.
Neck pain, head pain, face stiffness, tiredness, confusion, dry eyes, joint pain, pain in shoulder, swelling of glands, apathy.
1 inch red splotches on arms next day after injections leading to red splotches over entire body with very red cheeks on face, per Mother of child.  Private physician seen with no treatment done.
body rash 1 day after vaccination. Papular generalized pruritic non erythematous
Patient stated she was dizzy and nauseated after receiving the MMR. Patient thought she was going to vomit and had to lay her head down for a few minutes. Patient complained that she was abnormally hot and didn't feel well.
hep-B: 20-JAN-2004, 22-MAR-2004, 11-APR-2005, 18-OCT-2005; hep-B: 22-MAR-2004, 11-APR-2005; hep-B: 20-JAN-2004, 22-MAR-2004; This spontaneous report has been received from a licensed practical nurse, via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (MARRS # 2303USA000170), concerning an 8-week-month old, female patient. The patient's medical history, concurrent conditions and concomitant therapies prior to vaccinations were not reported.  On 20-JAN-2004, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis. On 22-MAR-2004, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis (inappropriate schedule of product administered). On 11-APR-2005, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis (inappropriate schedule of product administered). On 18-OCT-2005, the patient was vaccinated with the fourth dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis (extra dose administered).  This is one of several reports regarding the same patient.  All available medical records will be provided upon request.; Sender's Comments:  US-009507513-2303USA000170:Original Case 2303USA000170 US-009507513-2306USA000601:Split 2306USA000601 US-009507513-2306USA000600:Split 2306USA000600
Belching; Diarrhea; Fatigue; Chills; Nausea; Vomiting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERUCTATION (Belching), DIARRHOEA (Diarrhea), FATIGUE (Fatigue), CHILLS (Chills) and NAUSEA (Nausea) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, LOVASTATIN and VITAMIN 15.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ERUCTATION (Belching), DIARRHOEA (Diarrhea), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). On 27-Feb-2021, ERUCTATION (Belching), DIARRHOEA (Diarrhea), FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Urticaria , welting after scratching all over. Arms legs, palms, chest, abdomen, back, soles of feet.  Different spots at different times.  Taking Zyrtec day and Benadryl at night helps but this has been ongoing
AKI (acute kidney injury) Hyponatremia NSTEMI (non-ST elevated myocardial infarction) ABDOMINAL PAIN VOMITING DIARRHEA NAUSEA
Patient began to have tingling under her right eye and face, then she began to have a rapid pulse (156), she felt chest heaviness,   contact clinic.  Clinic suggested taking patient to the hospital to be evaluated.  Patient decline the ride to clinic but stated she would have her spouse take her to the hospital.