chrisvoncsefalvay/vaers-outcomes huggingface dataset:
light headache; The initial was missing the following minimum criteria: no adverse effect upon receipt of follow-up information on 19Feb2021 this case now contains all required information to be considered valid.   This is spontaneous report from a contactable consumer.  A 72-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201) on 12Feb2021 at 15:30  at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included Severe Peanut Allergy. The patient previous took Demerol and codeine and experienced dizziness. Concomitant medications included levothyroxine sodium, Colesevelam hydrochloride (WELCHOL), omeprazole and vitamin D3, all ongoing. On 13Feb2021 the patient experienced light headache. No treatment received for the event. The patient recovered from the event on an unspecified date.   No follow-up attempts possible. No further information expected.
RESIDENT DEVELOPED GENERALIZED BODY RASH.MD ORDERED HYDROXYZINE 10 MG VIA GTUBE AND  HYDROCORTISONE CREAM 1% FOR 3 DAYS
Severe myalgias on left side administered including neck, shoulders thoracic back. Site of injection ok. Developed lymphadenopathy. Required large doses anti inflammatory.
Swollen lymphnode approx 1 inch in diameter with swelling around the node approximately 2 inches in diameter.  Pain. Was directed by my PCP,s walk-in clinic to report.
PATIENT STATES FACE FEELS TIGHT AND FLUSHED. ALSO STATED THROAT FEELS  TINGLY. AFTER 5 MINTUES ALMOST ALL SYMPTOMS ARE GONE. BP 156/82 SAT 97%
Pain extending from fintertip to shoulder and neck, increasing in severity the following day (to the point of limited use of the arm).  Stayed on Aleve for treatment.  Wednesday morning, 10/07/09, increased pain, swelling of arm from neck to elbow with red splotches coming up around injection site.  Made a Dr appointment but went in early due to tightness in my neck with the feeling of something in my throat and tongue became numb and tingling.  Was treated with fast acting steroid injection (throat began to feel better within 15 minutes), 3 days of prednisone and several days of xyzal antihistamine.  I don't know if it would have progressed to something life threatening or not.  It is interesting that I had this strong of a reaction while taking Claritin daily for my other allergies.
Baby had perfect Apgar scores and was resting peacefully from birth to time of immunization. She was given her Hep B vaccine and we decided to try to rest. Approximately 1 hour later, patient woke up, was beat red screaming arching her back and vomiting. She has dealt with so much pain from reflux that we thought she was having seizures (EEG came back clear). At 17 mos old now, we finally have a diagnosis of long-term, incurable Mast Cell Activation Syndrome. She cannot eat any foods whatsoever and doesn't tolerate formula well. She vomits into her mouth hundreds of times a day and swallows back down.
patient said they had difficulty breathing the night of the third. felt like they had to think about breathing to make sure they were. Felt like their body was not doing it on their own. then on 11/4/21 they said they lost hearing in their left ear.. They said it buzzes when a sound is heard, like a "broken speaker". the lack of hearing is still going on. its obviously 4 days after so it is unknown whether is is permanent or not
July 3, 2009- I woke up at 6:30 a.m. to use the bathroom. When I turned around my wife saw that my right eye had become enlarged and drooped. I then decided to take a shower and afterwards I was feeling weakness in my right leg and left arm. At that moment I needed assistance to be dressed. My wife then took me into the emergency room at the Hospital. While being screened by the nurse, my tongue became numb and weak and started to slur. The attending emergency doctor requested for a CT scan which showed no signs of abnormality. And since it was a holiday, he advised that we see our family doctor first thing Monday morning for an MRI. And so I was released and the doctor indicated on the discharge paper as having a "probable stroke". At home the weakness, slurring, numbness and difficulty swallowing worsened. So we went back to the same emergency hospital at 7:30 p.m. At the time the attending physician requested for lab work to be done to see if I had Lyme disease, West Nile virus, and H1N1. He did mention about having symptoms of Guillian Barre. While waiting for the test results the symptoms worsened. In addition, my chest was feeling heavy. The doctor decided to have me transported to the Intensive Care Unit at Hospital. It was July 4th by the time we reached city. As soon as we arrived I advised the medical staff that my breathing was heavier and that I might not be able to breathe much longer. So they decided to put me on a ventilator. During my hospitalization in the ICU, they determined that I had Guillian Barre. IVIG was administered, EMG was conducted, Anti toxin E was also administered. July 21, 2009- Released from the ICU and transferred to the Skilled Nursing Facility at Medical Center. This unit is known for the care and maintenance of the ventilator which I was still attached to. I was then released on January 1st to Acute Rehab at Medical Center. January 1 2020-The start of acute rehab with physical, occupational, and speech therapy which extended out till my discharge on March 16, 2010. I am presently going to outpatient.
Patient received her first dose of the Moderna COVID-19 Vaccination on Saturday January 16th 2021 at approximately 12pm. She completed all necessary screening forms and was deemed to be at low risk for serious allergic reactions. She tolerated the vaccination well, and no complications or immediate adverse events occurred. She was observed for a full 15 mins per CDPHE/CDC guidelines and left the Clinic in stable condition after her observation period was complete. On the morning of Tuesday, January 19th, 2021, the patient was found unconscious and unresponsive by her husband. She was transferred by Ambulance to Hospital shortly thereafter. She was diagnosed with a brain bleed that was determined to be inoperable. She was transferred to other Hospital for higher level care. She was seen by neurosurgery and diagnosed with a ruptured aneurysm. She was treated in the ICU for 24 hours, at which point her team determined that the severity of her brain bleed would not respond to treatment. Supportive cares were withdrawn on Wednesday Jan 20th, and she passed away shortly thereafter.
Left arm after 2 days with TDAP and VARIVAX. Noted to have swelling, hardness and itching. Deltoid area with ill defined bordered swelling, redness and induration centered around. TDAP site. Not tender with pressure. No fluctuant, no pointing. Type 4 hypersensitivity to TDAP. Treatment - Triamcinolone, ice and Zyrtec.
This spontaneous report was received from a nurse refers to unspecified amount of patients of unknown age and gender. Medical history was not reported. On an unknown date these unspecified amount of patients were vaccinated with M-M-R II (lot #, dose and route were not reported), that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported.   Follow up has been received from nurse who stated that the lots numbers involved in the case for M-M-R II was: J016235, expiration date: 19-DEC-2015.  Follow up information was received from the nurse. After temperature excursion vaccines were verified as stable. On 21-AUG-2014 at 16;19, multiple patients were vaccinated with M-M-R II (lot number J016235, expiration date: 19-DEC-2015, dose and route were ot reported. No adverse reactions were observed or reported. This is one of several reports received from the same reporter. Additional information is not expected.
No additional AE reported; Patient was administered Improperly Stored, Separate VAQTA; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-FEB-2023, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, pre-filled syringe, lot #W036135, expiration date: 13-MAY-2024 (dose, dose number, and route of administration were not provided), administered for prophylaxis (product storage error). The vaccine was stored in a temperature of 48.3 degrees Fahrenheit for 1 hour and 30 minutes. The most recent temperature excursion occurred on 15-FEB-2023. There was no previous temperature excursion. No additional adverse event (AE) was reported.
This spontaneous report as received from a 67 year old female patient reporting on herself. The patient reported that, if she takes aspirin (manufacturer unknown) for an extended amount of time, she did not feel well. No other pertinent medical history was reported. On 06-MAR-2014, the patient was vaccinated with ZOSTAVAX one shot (route, lot number and expiration date not reported) for shingles prevention. The patient stated that she received the shot at an unusual place on her arm which was behind arm and up high on the underside of the arm in front of the armpit. Concomitant therapies included SYNTHROID and omeprazole. The patient reported that the evening on the same day she received the shot she had developed an injection-site reaction which was a red spot on her arm. She also reported that the spot began as about the size of a dime and then enlarged and got redder until it was about a 4 inch oval which extended all the way down the arm and was strawberry red. At the time of the report the patient still had an injection-site spot on her arm which is about 2 inches in diameter and is still red but faded. The patient also stated that, about a week ago, in approximately 01-APR-2014, she began to experience itching and rash which has been spreading on her body and which is currently on her stomach, legs and wrist. The patient had been taking cortisone (unspecified) for her itching and rash. The patient reported that the cortisone provides only temporary relief. No lab diagnostic studies were performed. The patient sought the physician for medical attention. The outcome of the injection site reaction which was a red spot on her arm and the itching and rash which had been spreading on her body and which were currently on her stomach, legs and wrist were reported as not recovered/not resolved. Additional information has been requested.
patient may have improperly stored GARDASIL 9 administered; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 11-MAY-2020, the patient may have been administered an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R030453 (expiration date: 23-JUL-2021) for prophylaxis (additional dosage regimen information was not reported).  It was mentioned that the vaccines were found out of the refrigerator on 13-MAY-2020. 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: 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; Sender's Comments:  US-009507513-2007USA008888:
Diarrhea; Low grade 100.3 fever; Severe headache; Myalgia; Arthralgia; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included HTN, hypothyroidism, mild asthma, chronic migraines and latex allergy. The patient was allergic to sulfur. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 20Mar2021 at 17:00, the patient experienced 24 hours severe headache started with myalgia and arthralgia. At 48 hours, all the conditions, headache, myalgia and arthralgia increased severely and diarrhea, low grade 100.3 fever started off/on for 2 days. On 21Mar2021, the body temperature was reported as 100.3 (Units unspecified). The fever broke on 4th day and by 5th day symptoms subsided leaving over heating off and on with major activity only. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events severe headache, myalgia, arthralgia, diarrhea, low grade fever was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Left deltoid edematous (entire upper arm), red, tender. Patient is afebrile (97F); given Tylenol and ice pack.
About one hour after receiving vaccine child beganto have hacking cough, fever, no appetite. ER visit 06/14/08.  06/17/08 child is better, eating well but still has cough.
I started feeling covid-like symptoms on the 12th and I felt really crappy all weekend. I went to a walk-in clinic to get tested for flu and covid and covid test came back positive.
Roughly 5-10 minutes after receiving the vaccine, patient fainted and began seizing for about 30 seconds. 911 was called, but patient came too and denied ambulance. Patient then vomited a couple minutes after. Patient reported he had not eaten anything and he was given orange juice and water. Patient waited another 30 minutes and reported feeling better. denied any further medical treatment.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was intramuscularly vaccinated with improperly stored of PNEUMOVAX 23 (dose, frequency and indication were not reported, lot # M024673 with expiration date: 17-NOV-2017). No adverse effects reported. The administered dose was stored in 52 F for 4 hours. There was no previous temperature excursion. The data logger was involved. Additional information has been requested.
Area around where the shot was injected has become swollen and itchy. It's an oval shaped area, roughly 2-3 inches in diameter. He hasn't had a similar reaction to shots before. It also didn't appear until about 9 days after the dose.
Information has been received from a health professional concerning a 13 year old female who was vaccinated with the second dose of Gardasil.  5 minutes following the administration of the second dose of Gardasil, the patient experienced a syncopal episode.  The patient sought unspecified medical attention.  Subsequently, the patient recovered from the syncopal episode.  The reporter felt that syncopal episode were not related to therapy with Gardasil.  No further information was available.  Additional information has been requested.2/10/2010. This is a follow-up to report (#) previously concerning a 13 year old feeale with a history of scoliosis wha on 26-Sep-2007 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 28-Dec-2007 the patient was vaccinated intramuscularly in the left arm with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). (659439/1267u). 5 minutes following of the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient experienced a syncopal episode. The patient sought unspecified medical attention. Subsquently, the patient recovered from the syncopal episode. The reporter felt that syncopal episode were not related to therapy with HPV rL1 6 11 16 1N VLP vaccine (yeast). No further information was available. Follow-up AE information 03-Jan-2008: Per the reporter the patient had a syncopal episode 5 to 10 minutes after the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) on 28-Dec-2007. The patient lost consciousness (undetermined time frame) with no reports at any injury. There was no other information to report. Follow up information was received from the doctor on 29-JAN-2008. The patient passed out. MD saw patient lying on the ground. Alert and oriented. P approx. 100. no X. clear to auscultation (CTA) null. The patient was assisted to chair. given water. She felt better and left before being checked again. Additional information has been requested.
Having persistent allergic reactions; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The medical history and concomitant medications were not reported. On an unknown date the patient experienced persistent allergic reactions. It was reported that the patient received first dose 01Apr and having persistent allergic reactions. The outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch cannot be obtained.
Metallic taste in mouth starting approximately 5 minutes after vaccine and persisted at least 24 hours.
LOSS OF TASTE; This spontaneous report received from a pharmacist concerned a 30 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced loss of taste. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from loss of taste. This report was non-serious.
8/26, Generalized itching, hives, knots in face and neck, skin burning 8/27  Continued itching, headache, tinnitus 8/28 Syncope, weakness, headache, dizziness, loss of balance, tinnitus, joint pain As of today's date 9/1, continued tinnitus, joint pain, weakness, headache
Three months after my second Pfizer COVID19 vaccine, I started getting intense migraines (I've never had migraines previously). The migraines were accompanied by many side effects: pain, black spots in vision, nausea, distorted vision, stiff neck, whooshing in ears, increased heart rate. I had my eye specialist check my eye alignment (born with severe strabismus) and my alignment is normal. That doctor ordered a full check up by a internal medicine doctor including blood work, and ordered an MRI of my brain and ocular space. I established care with an internist who switched my oral birth control and did bloodwork. Bloodwork came back normal. MRI is scheduled for 8/6/2021.
Upper back pain; Leg pain, foot pain; Headache; This is a spontaneous report received from a contactable physician. A 53-year-old non pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN5318) intramuscularly on the left arm on 31Jan2021 (at the age of 53-year-old) at 12:00 PM, second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) intramuscularly on the left arm on 28Feb2021 at 12:00 PM (at the age of 53-year-old) as single dose for COVID-19 immunisation. Medical history included systemic lupus, migraine, seasonal allergies and allergy to bactrim. Concomitant medications included zolpidem (MANUFACTURER UNKNOWN), SINGULAIR and UBRELVY. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccine. After the first dose of vaccine, on 01Feb2021, the patient experienced headache, leg pain, foot pain and upper back pain. After the second dose of the vaccine, the events headache, leg pain, foot pain and upper back pain were worsened. The patient received TYLENOL as a therapeutic measure for the events headache, leg pain, foot pain and upper back pain. The clinical outcome of the events headache, leg pain, foot pain, upper back pain was not resolved and the patient was still complaining about her symptoms at the time of this report.   No follow-up attempts are needed. No further information is expected
Information has been received from a clinical medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with MMR II (lot# reported as K011188, expiry date 12-AUG-2015; dose and route were not reported), which were involved in a storage issue. This is one of several reports from the same reporter. Additional information has been requested.
pt recv vax 15APR96 & 8FEB97 pt devel 6 varicella lesions & a low grade fever;it was reported that cellulitis of the eye may have contributed to fever;
had a little muscle soreness; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on 24Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his vaccine on the 24th, four days ago. He only had a little muscle soreness and took Tylenol. He has another vaccine coming up next week. His next dose isn't until valentine's day. He asked if it was ok to get another vaccine between his doses. The outcome of the event was unknown.  No follow-up attempts are possible; information on batch number cannot be obtained.
Presents to ICC with fever, chills, and headache six days after receiving  2nd dose of covid vaccine.  Tested negative for covid on 2/12.  Diagnosed with Acute Viral Syndrome.
feeling pain on the left side of [their] arm where [they] got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "feeling pain on the left side of [their] arm where [they] got the shot".  Additional information: This 52-year-old caller stated he and his 51-year-old wife received the first dose of the Pfizer-BioNTech COVID-19 yesterday (unspecified date in 2021). He added they "are feeling pain on the left side of [their] arm where [they] got the shot". He asked if they could take Ibuprofen or Tylenol for the pain after vaccination. He said he is concern that if he takes "those medications, they could create some problem with the vaccine".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021292288 same reporter/product/event, different patient.
Pt experienced fever up to 100.1 degrees, unconsolable crying and vomiting. Pt was treated with TYLENOL for the fever.
Localized redness and papule with pruritus at site of vaccine only. No fever or other rash - papule developed 14 days after vaccine.