chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold sore; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 14Apr2021 at 14:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis, hypertension and hyperlipidemia. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and golimumab (SIMPONI); all medications for an unknown indication from an unknown date and unknown if ongoing. On 17Apr2021 at 09:00, the patient experienced cold sore. The event did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with ABREVA. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cold sore was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
8 hours after receiving the Meningitis vaccination my daughter began having a severe headache. It began with the right side of her face and quickly spread to her neck and shoulders. Within an hour she said her entire right side of her body was achy and hurting. She was in so much pain she could not tolerate light or sound and was nauseous. She began spiking a low grade fever within the hour. We gave her 3 ibuprofen which did nothing for the pain or symptoms. 1 1/2-2 hours later we gave her 2 large doses of CBD oil. She could do nothing but cry and rock in pain for 3 hours straight. Finally after the 3rd hour her pain began to subside enough she could lay down and fall asleep. She continued to have a low grade fever throughout the night but it did not get any worse. She feels very achy and has a "stiff" neck and slight headache this morning.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unknown date, the patient was inadvertently administered a dose of PROQUAD, lot # R024015, expiration date 19-FEB-2020 for prophylaxis (dose and route of administration were not reported) that had been improperly stored (product storage error ). The lot of PROQUAD  was reconstituted with properly stored DILUENT MRK (lot # and expiration date were not reported). The administered dose of the vaccine experienced a temperature excursion 20.1 F for 4 hours and 10 minutes, as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported. The outcome of the event product storage error was not provided.
On 4-3-14 reported to Employee Health - dx with cellulitis. C/O 1 week after injection developed pain and lump formed. Saw primary care MD. Treated with antibiotics and still swelling. So referred to surgeon. Redness gone but still lump and itching. Seeing surgeon again on 4/15/14.
diagnosed with blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (diagnosed with blood clots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (diagnosed with blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (diagnosed with blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was mentioned by reporter  No treatment medication information was mentioned by reporter  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up received on 10-Aug-2021 and included no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous prospective pregnancy report was received from a female patient of unknown age, reporting on herself. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On 16-FEB-2016, the patient was vaccinated with a dose of MMR II. Other suspect therapies included (Merck) VARIVAX vaccinated on 19-FEB-2016. Patient reported that two weeks after receiving the MMR II and then (Merck) VARIVAX, i.e. approximately on 01-MAR-2016, she found out that she was 4 weeks pregnant in an unspecified way. LMP and EDD were calculated as 01-FEB-2016 and 07-NOV-2016, respectively. Patient also complained that she developed itching and rash on her upper left arm with redness and hardness at the injection site. But, it was unspecified whether the injection site was MMR II or (Merck) VARIVAX. The patient required medical attention and visited an unknown office. Outcome of the injection site reactions were unknown. Causality assessment was not provided. Additional information has been requested.
On my fourth vaccine I had  a very red reaction at the site, my arm was very sore and I felt bad enough the next day that I did not go to work. I did not seek medical care.  On 28SEP2022 I contrtacted the COVID-19 virus and was sick for five days my Doctor prescribed Paxlovid for me on about day two.
Pt claimed he was dizzy then in a matter of seconds he was staring off into space with his eyes open, not responding to his name.  he immediately was drenched with sweat.  pharmacist called 911.  by the time ems answered he had came back and asked us not to ask the ambulance to come.  pt stated he hadn't had anything to eat or drink and is anxious about receiving shots.
Slightly red, slightly flaky 5mmx5mm red patches x2 to eyes and border of upper lip; slight burning sensation.
Child had low grade fever intermittently for 7 days after immunizations. On 11-30 pm had fever 103 all night despite antipyretic treatment. At 950am 12-1-2011 had 3 minute seizure, generalized, tonic clonic in this office. Recovered over next 1-2 hrs.
A week after the vaccine i woke up to a very sore arm, and sore  armpit.  The upper arm was red, and itchy.  It has lasted since then though is a little better today.
Redness with about 2-3 inches diameter welts on arm around injection site day after injection; redness with welts covered about 6 inches diameter second day after injection.  Second day after injection fever of 102.0, severe headache in top and back of head, and blood pressure of 168/88.  Fever lasted for approximately 36 hours, began about 48 hours after injection.
This spontaneous report was received from a pharmacist refers to a multiple unspecified patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (lot # L044530 and expiry date 09-FEB-2017. No adverse effects reported. Additional information has been requested.
pt recvd vax 4AUG92 & had fever 102, vomiting x 1, rash similar to hives @ inject site; MD dx starts of cellulitis;
pt recv vax & 80 days later became pregnant;eval revealed dec AFP levels & an ultrasound revealed alobar holoprosencephaly;pregnancy was terminated @ 20wk;
SLEEP APNEA ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE HYPOXIA
Administered doses that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   On 3rd November 2022, the patient received Havrix. On 3rd November 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: The reporter was a clinic manager. The reporter reported that the patient received Havrix vaccine which was expired on 09th August 2022. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used. This case was 1 of 6 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022162501:Same reporter US-GSK-US2022162505:Same reporter US-GSK-US2022162509:Same reporter US-GSK-US2022162508:Same reporter US-GSK-US2022162506:Same reporter US-GSK-US2022162506:Same reporter
UTI; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EP7534, Expiry Date: Unknown) via an unspecified route of administration, administered in left arm  on 23Mar2021 15:00 (at the age of 60-year-old) as dose 1, single for COVID-19 immunization and Cefalexin (CEPHALEXINE, Capsule, Lot number: unknown, Expiry Date: Unknown) 500mg four times day via orally for 5days indicated for UTI (Urinary tract infection) from 08Apr2021 unknown if ongoing. Medical history included Paraplegic from an unspecified date in 2011 and unknown if ongoing ("diagnosed after a motorcycle accident, he was a T10 complete, and because of that nothing works right below the sternum"). Concomitant medications were there. The patient had not received any other vaccine within 4 weeks or on the same day as getting the COVID-19 vaccine. It was reported that on 08Apr2021 patient experienced UTI ("an Internal Infection"). Reporter stated UTI started several days ago and was diagnosed yesterday. Reporter seriousness for UTI was unspecified. Patient was scheduled for his second COVID-19 shot on 13Apr2021.Reporter wanted to know was it safe to get the second shot with an active UTI infection and while taking antibiotics. Patient also stated he was old, and his eyesight was not so good now. He said that this medication was dispensed in an orange pharmacy bottle, there was some writing that was too small for him to read, it was a standard sized red capsule. Therapeutic measures were taken as a result of the events which included on 08Apr2021 Antibiotic therapy (Cephalexin," started taking it yesterday about noon"). Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Moderna COVID-19 Vaccine EUA.  Initial reaction of redness at the injection site with swelling and tenderness.  This lasted about 5 days, lessening every day.   Some fatigue and headache for about 24 -36 hours.  Ten days after the vaccine, nausea, headache, all over body aches, chills but no fever.  I feel like I have the flu but I have not left my house in more than a week and have not been around any other people.  These symptoms have now been present for about 36 hours and are very similar to my first positive COVID experience.
pt recv vax 24JUL98 1230PM & pt devel bradycardia & pale complexion & weakness;pt was laid down & oxygen was given;pt regained & asked what happen;
I received  BOTH Moderna from where I work 12/23/20 and again 1/19/21  had no issues.  on 10/31/21 I  had my BOOSTER of Moderna  pharmacy     (my thyroid levels/lab had been good for over 2 years no changes) within 4 days of my BOOSTER  my hair was shedding and I knew something was wrong with my thyroid, I was correct I was no HYPERTHYROID so my PCP reduced my Synthroid from 112mcg to 100mcg and rechecked yesterday  now I have very Hypothyroid TSH  level 10.29  my PCP has moved me back to 112mcg.    I can tell you I have never had numbers this crazy in 20 years and I have had Hypothyroidism since 1992 so I would know.   I don't regret getting the first 2 vaccines but I think I'm not happy I got the booster  hard to know,  Knock on wood I have not had COVID 19 "yet" but messing with my Thyroid levels is no fun
Sore Arm after first dose of the Covid Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 14:00 (Lot number: EN6202, Expiration Date: 30Jun2021) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies" (ongoing), notes: Verbatim: Allergic to mold, mildew, dust, pollen, some trees, dander, lactose intolerant.; "Bronchitis chronic" (ongoing), notes: Verbatim: Chronic bronchitis; "Bowel intussusception" (ongoing), notes: Verbatim: Bowel Intussusception, Was causing bowel blockages, every 2 days or so.; "Nonpolyposis colon cancer" (ongoing). Concomitant medication(s) included: LINZESS taken for intestinal obstruction; EPIPEN taken for anaphylactic reaction. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "recovered" (13Mar2021), described as "Sore Arm after first dose of the Covid Vaccine".  Additional information: Concomitant Products Linzess used for Bowel Blockages. After the first dose of the vaccine she mentions she had a sore arm. States she expected that. Says it lasted for a day then it was gone. States her doctor recommended the Covid Vaccine because the caller has anaphylactic allergies. States she uses Epi-Pens as needed and gets chronic bronchitis from any sinus or allergy. Reporter states her doctor's told her that since her allergies started in her 40's they will likely just get worse as she gets older. Denies any other medical conditions or medications relevant to events. Denies any labs, testing, or treatments relevant to events. States she wants to have further testing done to see if she had a virus; or if she is immune to the virus. Wonders if that is why her lymph nodes are swollen, because they are fighting hard? Mentions again that she can't lift her arm and has weakness and fatigue. Vaccination facility type was hospital. Vaccine was not administered at military facility. No prior vaccinations (within 4 weeks). No AE(s) following prior vaccinations. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None reported. The patient not visited emergency room due to events.  No follow-up attempts are possible. No further information is expected.
ON THE 7TH DAY AFTER THE VACCINE, RED, RAISED RASHES DEVELOPED ON CHEST AND ABDOMEN, AND CONTINUED TO SPREAD ON SIDES OF THE BODY , WAIST  AND BUTTOCKS. ON THE 8TH DAY IT CONTINUES TO SPREAD MORE ON GROINS, THIGHS, UPPER BACK AND BILATERAL  ARMPIT. BENADRYL TAKEN AND HYDROCORTISONE CREAM APPLIED WITH LITTLE EFFECT, WILL  START METHYLPREDNISOLONE  TOMORROW
no adverse effects reported; vaccinated with improperly stored Proquad; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 14-JAN-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot # R010468 expiration date: 10-APR-2020, (dose, frequency and route of administration were not reported) for prophylaxis. The suspect vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # N035970, expiration date 30-APR-2020). No adverse effects was reported. The vaccine was stored in 16.5 Fahrenheit degrees for 1 hour and 44 minutes. There was no previous temperature excursion.. Digital data logger was involved. This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA002106: US-009507513-1904USA003436: US-009507513-1904USA003434:
Began to feel unusual couple hours after the injection of vaccine moderna, didn't sleep well, next morning felt worse...more fatigue, muscles started to hurt and a headache... was dizzy... pharmacist said I could take Tylenol didn't have any but I felt so bad driving home I couldn't stop... hurt so bad difficult to walk but finally got upstairs to bed and for the next five or six hours couldn't move with extreme and severe pain... joint aches muscle aches headaches nauseous sharp shooting pains up the side of my head sharp shooting pains in my shoulders extreme chills and a temperature of 101... realized I had 1 hydrocodone with Tylenol from a broken ankle years before...took half and 30 minutes later the symptoms begin to subside took the other half and by the next day I was mostly recovered but still had minor symptoms... continue to recover but four days after the vaccine I had a minor setback with body aches joint aches headache nauseous took only Tylenol and it abated after 36 hours or so
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with GARDASIL 0.5 ml (dose strength not provided), intramuscular, and received the first dose on 28-NOV-2006, the second dose on 05-FEB-2007 and the third dose on 22-JAn-2008. On 31-AUG-2011 the patient was vaccinated with a fourth dose of GARDASIL, lot number 668819/0477AA. On 08-JUL-2013 was administered a fifth dose of GARDASIL, Lot number H021861. The last two doses were administered in the nurse's office, the previous three in another practice. No adverse experiences were reported. Additional information has been requested.
Symptoms started October 1.  Sore throat, headache, body ache, flu like symptoms.  Symptoms lasted 5 days.  Tested positive for Covid October 4 2022.  Tested negative October 17.
Vaccine correctly administered. Patient reported side effects like fevers, chills the day after. No injection site reactions
No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 27-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA001345: US-009507513-2207USA004695: US-009507513-2207USA004688: US-009507513-2207USA004690: US-009507513-2207USA004691: US-009507513-2207USA004679: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
3/13: headache, fatigue, fever (Noon and continuing throughout the rest of the day; took Tylenol and Naproxen Sodium) 3/14: headache, fatigue, fever, nausea (upon waking in morning & continuing throughout the day) 3/15: headache, fatigue, low-grade fever, nausea (upon waking in morning & continuing throughout the day) 3/16: headache, fatigue, nausea (continued throughout the day) 3/17: headache, fatigue, stomach cramps (1:30 pm and continuing for remainder of afternoon and evening); nausea, vomiting, and diarrhea (3:00 and continuing for remainder of afternoon and evening) 3/18: headache, fatigue, stomach cramps, nausea, bloody diarrhea  (2:00 am on) I went to ER at Noon on 3/18.
4/30/2021: Received second Moderna vaccine dose. 5/11/2021: Broke out in itchy rash all over body.  Ithchy welts appear in response to rubbing or scratching. 5/13/2021: Telemedicine consult, with photographs of rash.  Diagnosed "Dermatographic urticaria". Telemedicine visit summary reports Procedure codes. 5/14/2021: Began taking daily Loratadine for treatment. 5/26/2021: Itchy rash issue resolved.  Note: Health tracker records indicate elevated resting heartrate for 16 days.  5/11 - 5/26.  Then resting heartrate returned to baseline.  Similar reaction after Dose 3. 12/04/2021: Received Moderna Dose 3 (Lot 018FZ1A). 12/13/2021: Again, itching and rash started.  Same dermatographic urticaria symptoms as after Dose 2. Took 10mg Loratadine daily. 12/28/2021: Itchy skin reaction ongoing.  Elevated resting heartrate indicated by health tracker. 02/03/2022: Skin reactivity finally stopped.  Health tracker resting heartrate returned to pre-Dose-3 levels.  4/8/2022: I had submitted reports through the text message vaccine follow up system, V-safe. A representative from V-Safe called me on 4/8/2022, and encouraged me to report my experience through VAERS.
Information has been received from a physician concerning a female pt who was vaccinated with a second dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The mother reported that the pt experienced a seizure (possibly anxiety attack/passed out) following the vaccination. It was noted that she did not received the vaccine at this practice because the pt was new to the practice. The doctor had not seen the pt as of yet and therefore does not have a chart. It was unknown if medical attention was sought. Further information has been requested. Upon internal review, seizures are considered to be an important medical event. It was noted that the pt's brother had a similar experience following the administration of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) . Other Medical Event (OMIC).
Reported Allergic Reaction to COVID-19 mRNA vaccine. High severity - laryngeal edema.
Exactly 24 hrs after a shot broke out in raah, feeling of extreme sensitive skin tingling, followed by the feeling of burning up for 20 to 30 mins, followed by shivering and chills. Its been a about 3 hrs of feeling this way but it just now starting to slow down, like a more normal  feeling is returning