chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received via pediatric medical records from a physician concerning a newborn patient with passive smoke risk who's mother was vaccinated IM on 04-Dec-2008 with a 0.5ml first dose of GARDASIL while pregnant (WAES#0812USA1628). It was reported that on 13-JUL-2009, at the age of 3 days, the baby underwent an ultrasound test in order to investigate a scrotal mass. The ultrasound revealed moderate right sided hydrocele. The baby's testicles appeared to be normal with the right testicle measuring 1cm and the left testicle 9mm. Arterial flow was noted in both testicles. The epididmyides appear normal. On 13-JUL-2009 the following test results were obtained: blood lymphocyte count 25.0%, blood segmented neutrophil count 65.0%; blood band neutrophil count 4%, slight anisocyte observation, slight poikilocyte observation, slight polychromatic erythrocyte observation, slight macrocyte observation. Also performed on this day were congenital hypothyroidism, hemoglobinopathy, galactosemai, biotinidase deficiency, congenital adrenal hyperplasia, cystic fibrosis, amino acid profile, fatty acid profile and organic acid profile. All reported as normal. The baby was seen for multiple well visits where the genitalia was reported as normal. At the time of this event, the patient recovered from Hydrocele. No further information is available. All available medical records will be provided upon request.
Temp to 101.9 (R) after vaccines Temp 100.4 next day. Seen in office for URI Sx 4-5-2018.
Raised red welts, rash all over body except face. Not a solid rash, but sporadic over her body, not itchy. Started 1/22/14 got worse on 1/25-1/26. Still currently has the rash and was instructed to see doctor. Pt reports using Childrens BENADRYL and hydrocortisone cream.
heart inflammation; Troponin extremely high; This is a spontaneous report from a non-contactable consumer (patient). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date (at the age of 15-year-old), dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced heart inflammation. The lab level of Troponin was extremely high. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
After the first shot, I was lightheaded and dizzy; After the first shot, I was lightheaded and dizzy; muscle spasms in my chest, back, left calf and neck for over 24 hours/The chest and leg spasms were so painful; The pain was not constant and was sporadic; The evening of the 27th I was awakened out of my sleep; This is a spontaneous report from a contactable other hcp for herself. A 57-years-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration (at the age of 57-years-old), administered in Arm Left on 06Mar2021 09:00 (Batch/Lot Number: EN6202) as SINGLE DOSE, dose 2 via an unspecified route of administration (at the age of 57-years-old), administered in Arm Left on 27Mar2021 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included telmisartan. The patient was reported to have allergy to lisinopril. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with covid-19 prior or post to the vaccination. Patient reported that after the first shot, she was lightheaded and dizzy for about an hour after. After the second shot, she experienced muscle spasms in her chest, back, left calf and neck for over 24 hours. The pain was not constant and was sporadic. The chest and leg spasms were so painful on 28Mar2021 02:00. And the evening of the 27th she was awakened out of my sleep. Treatment was not received for any event. Events were considered non-serious as reported. Outcome of all events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received her injection of Moderna #1 dose at 9:06 AM. While being monitored by 9:18 she began to complain of her arm itching and burning at the injection site. There was a rash at the injection site of the deltoid that was lacey, red, slightly raised that covered the whole deltoid. At around 9:25 AM she began to c/o feeling very hot and "not feeling well". At that time, she was laid on the floor and BP 118/68 Pulse 64 and had to remove mask to feel that able to breathe better. Color was from slight pale to pinker. About at 9:29 AM she began to c/o being cold. Cold pack that had been applied to back of neck removed and covered with her jacket. By 9:31 she began to shake and was shivering to the point her teeth were chattering and she was pale/gray in color and began to c/o "my bones are hurting, and I am so cold". Skin dry but cold to touch and face pale gray in color. 9:33 am she was becoming extremely anxious and c/o being cold and bones hurting and unable to get pulse or BP by now and she was grabbing chest and unable to lie still, EMS called. Epi pen administered at 9:33 am and monitored. EMS arrived and resumed care at 9:35 am. She was continuing to c/o being cold and bones hurting, color pale. Seemed less anxious. At 9:43 am she left with EMS. After dismissal from the ER and before going home, came to clinic. Had notable swelling of the whole deltoid area, but is not read at this time and reports still feeling cool and having pain in legs.  Patient reports today 1/11/21 that all weekend had a headache that would come and go. It started as a warm pressure from neck up to top of head. She reports feeling "irritated, on edge, sensitivity to noises, loss recognition of all days before Saturday after 11". Also has had c/o muscle aches, sore arm and at times being unable to lift arm due to discomfort.
12/06/2021: admitted with cough, fever for 5 days with all over body aches and pain now SOB. Sx gradually worsening since that time. ER found to have COVID positive. Pt has been vaccinated with 2 doses of Pfizer (2/12/21 and 3/5/21). 12/07/2021-12/15/2021: treated with dexamethasone 6 mg x 10 doses (last dose 12/15), Remdesivir (last dose on 12/10), and supp oxygen. Patient is also on azithromycin and Rocephin for possible pneumonia. 12/15/2021: Patient's oxygen continued to drop to low 70s while on high flow with NRB. Start BIPAP. 12/18/2021: start cefepime, micafungin, and Zyvox for secondary infection. Pt has UTI and yeast in urine culture.  12/21/2021-12/23/21: Patient's RR was not sustainable and had to be intubated. Patient was sedated. Transition to comfort care.  12/23/2021: Patient was extubated and deceased.
Painful swollen stiff (L) arm. Elbow to shoulder. Temp 101.3. BP elevated 142/82. Earlier in day during physical 118/78. Slight headache and abd. nausea within 4 hours. Prednisone was prescribed.
This spontaneous report was received from a healthcare student refers to a patient of unknown age. On an unknown date in 2012 the patient was vaccinated with first dose of GARDASIL (dose, route and frequency were not reported0. On 11-MAR-2014, the patient was in the office to receive the second dose of GARDASIL. No adverse effect reported. No further information was provided. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Self-Reporting. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 05Apr2021 at 13:45 (Batch/Lot Number: ER8733) (at the age of 36-years-old) as dose 1, single for COVID-19 immunisation. The vaccine facility type was public health clinic/veteran's administration facility. The patient is not pregnant at time of vaccination. Medical history included endometriosis. The patient's known allergies included: Nickel skin contact, oral fruit allergy, any fruit you can eat the skin of swollen, itchy tongue, throat; environmental allergies itchy face, nose, eyes; allergic to all trees, grass, weeds except cocklebur. Concomitant medications included VITAMIN D taken in two weeks for an unspecified indication, start and stop date were not reported. The patient previously took BACTRIM and experienced allergy severe fever, sore throat, full body rash. The patient reported that she began feeling itchy on her back, sides, chest, outer upper arms, face, nose, ears. The attending nurse noticed that her eyes were swelling, she was very flush over her entire body, and her ears had hives on them. This began 15-20 minutes after receiving the vaccine. The event start date was on 05Apr2021 at 02:15 PM. They did not tell her vitals but remarked after treatment that they were coming back into normal range. They administered a shot of Benadryl and a shot of steroids and the reaction cleared. They seemed a bit alarmed and strongly advised that she should not receive the second dose. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment which included Benadryl and steroid shots. The patient had no COVID prior to vaccination. The patient was not tested for COVID post vaccination. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
S: Patient 41Y F unit assistant came to Covid vaccine clinic for vaccination on 12/27/2020. Received injection at 1436. Employee was instructed to sit in clinic for observation. At 1445, employee reported nausea, lightheaded, a "floating' sensation and sore throat. The floating sensation was also described as a "oozing sensation". States that she ate noodle soup for lunch at approximately 1pm. Took Tylenol at 2pm prior to arriving to clinic for vaccine. She denies chest discomfort, palpitation, shortness of breath, wheezing, or blurry vision. History of craniotomy in 2017 and pulmonary embolism in 2016. No history of HTN or GI conditions.    O: VS at 1445: BP 126/75, HR 75, temp 98.3, O2 sat 96% room air, RR 18, pain 0/10. Reports symptoms onset.  At 1455: BP 123/76, HR 72, temp 98.3, O2 97% room air, RR 18, pain 0/10. Nausea resolved. Continue to have mild sore throat, lightheaded, and "floating sensation."  At 1510: BP: 132/80, HR 69, temp 98.3, O2 96%, RR 18, pain 0/10. Sore throat improved. Denies lightheaded, floating sensation.  AAO4, follow commands, lung sounds clear, heart sounds normal. No angioedema. No acute respiratory distress.    A: Adverse reaction to Covid-19 vaccine   P: Employee was closely monitored in clinic for additional 30 minutes. Employee was provided fluids. Employee states that her symptoms has gradually resolved. Employee was advised to monitor her symptoms. If symptoms worsen or persist, she needs to notify her manager and go to urgent care/ED for further evaluation. She stated understanding. Employee returned to work, left clinic in stable condition. No acute distress.
A 2 month old female pt had routine vaccines, including Prevnar, and developed a fever, 8 days, post vax, of 101.9F; perforated tympanic membrane and otitis media which grew pneumococcus.
About 7 weeks after the second shot I started experiencing muscle spasms, tremors, and muscle jerks.  A buzzing sensation all over my body.  I can't sleep because of it.
Patient received flu shot on 10/13/2020. When pt was walking to car she fainted, Pt woke up soon after. 911 was called. Patient called member information. Did not remember passing out. She was sent home and going to be monitored by parents
Gave MMR - within minutes - pt was very dizzy, nauseated - some disorientation. No difficulty breathing - BP stable. No itching.
This spontaneous report as received from a pharmacist refers to a 66 years old female patient with no pertinent medical history. The patient's drug reactions/allergies included: trimethoprim, sulfamethoxazole, simvastatin, lovastatin, penicillin and codeine. The patient was vaccinated with ZOSTAVAX in upper left arm in 2011 "about a year ago". Lot# and administration route were unspecified. Concomitant medication included: doxepin. In 2011 on the day that ZOSTAVAX was administered, the patient experienced pain at the injection site and it persisted for an unspecified amount of time. In 2012 at the reporting time, the patient had a dime size lump on her upper left arm at the injection site. The outcome of patient was reported as not recovered/not resolved. The patient sought unspecified medical attention. Additional information has been requested.
Patient reported to the pharmacy on 3/17/19 that a day after receiving her first SHINGRIX dose, she had a fever of 100.7, chills, muscle soreness and redness in her arm. The fever subsided 24 hours later. She still complained of a sore arm and redness at the injection site.
Client received immunizations and PPD on July 21, 2008, returned to health department on July 24, 2008 for PPD reading.  During visit, client stated her right arm began hurting Tuesday evening.  Right arm evaluated, noted two injection sites, one IM and one SQ, to be red and swollen.  States pain started Tuesday evening along with a headache.  Client took Advil Wednesday AM.  Headache has resolved and her arm is "better today" but had been "hard to move due to the pain."  Areas slightly warm to touch during today's visit. Diluent used for MMR and Varicella, lot # 5000X, expiration date:  May 2010.
Suspected vaccination failure; I had Shingles AFTER having the vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 GSK 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 age at vaccination was not reported. The patient had shingles after having the vaccine. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not reported.
Pt. was given Flu and HPV vaccine. Several minutes later pt C/O partial vision loss and nausea. Pt then had vomit x1, reports S/S resolved.
7cm x 3 1/2 NMO red minimally indurated not around.
Patient presented to clinic and recived a 2nd primary Pfizer shot. In records it showed she had a 1st primary Moderna shot on 1/20/2022. Upon further investigation via Immunization Registry, she recieved a 1st primary Moderna vaccination on 8/6/2021 at a different vaccination site. Several attempts have been made to contact this patient and she has not responded. Troubleshooting: error not reported, found in data mining. Have reviewed medication error with vaccinator and scribe; reviewed CDC guidelines referring to not mixing and matching primary shots, time between vaccinations.
Around 6pm on Monday night (the day of  my injection) I was feeling nauseous, I couldn't eat dinner, then around 8:30 i started vomiting this continued until around 1am (i vomited around 4 times).  I also had chills and body aches through the night.  Tuesday I felt exhausted and had horrible body aches.  Around 3pm the body aches were mostly gone but i still had no energy for the rest of the day.  Today, Wednesday, i'm a little achy and still lack energy but feel much better than yesterday.
Severe muscle and joint pain over entire body. Lasted just about 36 hours. Followed by minor muscle pain 12 hours.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil. subsequently, following vaccination, the patient loss consciousness. The patient regained consciousness after a few minutes. Unspecified medical attention was sought. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Information has been received from a physician and a medical assistant concerning a 15 year old female with no past medical history, who on 29-DEC-2006, at 11:15 AM was vaccinated in the right arm with the first dose of GARDASIL (0.5 ml).  There were no illnesses at time of vaccination.  Subsequently, following vaccination, on 29-DEC-2006 at 11:20 AM the patient felt week and dizzy, then stated that she felt sick to her stomach.  The patient suddenly fell forward into her mother's arms, and passed out.  The patient was passed out for less then a minute.  The patient was given something to eat and drink and was kept in the office for 30 minutes.  After the 30 minutes, the patient stated that she was fine.  No further information is expected.
3 Areas of site reactions on left arm and shoulder - warm, red rashes measuring 3 to 4" in diameter each swollen and painful lymph nodes in left side of neck
p/vax pt began to flush; loud crying w/a wheezy breathing; became lethargic & limp; required oxygen therapy & epinephrine & benadryl;
A few weeks after my injection I started developing a heaviness in my Left temporal forehead and cheek area. Developed a twitching in my left eye. And it seems to be along the branch of a facial nerve in my left side. I don't have muscle weakness or dropping just heaviness and change in sensation on the left side of my face down to my left cheek area. I saw my doctor and I have been under a great deal of stress lately and she put me on a low mg dose of Celexa. I have an MRI scheduled to rule out any other problems other than stress. 2.5 weeks prior to vaccine I had Botox on my forehead. And I've had it before without any complications.
Approximately 8 hours after vaccination, patient began to experience hallucinations while going to bed. Sensed that she was sinking into her bed infinitely. Limbs were heavy/sore, felt she couldn't move. She is a marathon runner and her lower extremities were painful like she'd just run a race. After some hours was able to prop herself up. Was experiencing paranoia, like that the government was monitoring her. When she was able to get out of bed, had some minor visual hallucinations like thinking she spilled a bottle of medication that she had not. Felt she could "see" sounds as colors and shapes. No auditory hallucinations. Drifted in and out of sleep all night with strange dreams, and though the sheets were dry the next morning, there was a foul odor. Temp was normal in the AM when she first checked it. Had more mild paranoia about work throughout the next morning and felt back to normal by 4:30 PM (about 24 hours after vaccination), just a mild sore arm at that point. She used psilocybin once approx 20 years ago as a teen and states this felt similar. Has mild depression, well controlled, no other mental health issues, no other history of hallucination save with the remote psilocybin use, no current or recent illicit drug use.
a couple hours after getting the vaccine the patient had swelling between the neck and right clavicle. The swelling grew to the size of an egg. No shortness of breath was experienced. The patient applied ice and took benadryl to manage the swelling. Ice would reduce the swelling a little but then it would return. By 9/30 the swelling is now the size of a pea and the patient has an ultrasound pending. peak swelling occured between 9/16-9/20.
Pt. received vaccine on 2/3/2021. Coded at home on 2/17/2021.
nurse who was very ill each time she took the injection; 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 MALAISE (nurse who was very ill each time she took the injection) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (nurse who was very ill each time she took the injection). At the time of the report, MALAISE (nurse who was very ill each time she took the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.     patient doesn't know whether it was the Moderna or other covid-19 shot.
Lightheaded and very thirsty even though I had drunk several glasses of water lasted over 24 hours Pain in arm but went away after about 4 hours
pt received 1st moderna dose and fainted about 5 mins after receiving the dose.  He recovered without incident, drove away after the drive through event.  Nothing significant to report.
Patient received a completed series of Pfizer and then received a dose of Janssen. 1st dose of Pfizer on 1/11/21, 2nd dose of Pfizer on 2/1/21, 3rd dose of Janssen on 3/30/21.
VOMITTING; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 24-MAR-2021, the subject experienced vomiting. On 24-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and vomiting. This report was non-serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 at 14:30 as dose 1, single (Lot number: ER8734), in left arm and on 22Apr2021 at 14:30 as dose 2, single (Lot number: EW0170) at the age of 29 years, in left leg for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Dec2021 at 14:30 as dose 3 (booster), single (Lot number: 060H21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known Allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After 3 days of testing negative; Positive, notes: began testing positive again; Positive, notes: Treatment of COVID-19. Therapeutic measures were not taken as a result of drug ineffective, covid-19.