chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse and refers to multiple patients of unknown demographics. The patients' medical history, concomitant medications and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M034189, expiration date 23-MAY-2019 (route of administration and anatomical location were not reported), for prophylaxis. The doses were stored in temperature between 9 degrees Celsius (C) to 25 C (9.7 C) for 7 hours and 20 minutes which was recorded by a digital data logger. There was no previous temperature excursion reported. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA012463.
Day 1: No adverse reaction Day 2: Extreme Muscular Swelling; right leg muscle (noticed at approx. 9 am) - Patient was brought into the ER. They drew a circle on it to see if it went outside of the circle or she developed a fever and instructed to come back if she did.  Day 3: Muscular Swelling got worse; right leg muscle. She went into the doctor and was told that this was normal. The swelling got outside of the circle drawn.
Patient presented non emergent to Clinic for chest tightness. Stated pain hours before but that had subsided. VSS, no distress. Due to complaint, patient sent to ER  for further cardiac evaluation unavailable at Clinic location.
On approximately 8/24/95, the pt experienced an outbreak of lesions. She experienced four more outbreaks of lesions. The most recent outbreak occurred after another of the reporter's children was vaccinated. The pt was taken to the ER where she tested positive for strep. The pt was hospitalized. The physician was unaware of the pt's present experience. He indicated that he saw the pt during one of the occurrences of lesions. He indicated it was a spot and he was not at all sure if it was related to varicella. The lesions were pustular in nature. He did not believe this pt's past or present rashes were varicella, and did not believe the rashes were related to the vaccine. He stated the current rash looked like folliculitis. The pt was doing well and did not have any additional symptoms other than the rash.
1st day after the shot, I just had some fatigue.  2nd day after the shot, I had severe lower back pain and a stomach ache.  3rd day after the shot I back lower back pain and diarrhea.
Sore Arm; Chills; A spontaneous report was received from a consumer concerning a 78-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) sore arm, chills.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, chills was unknown.
pt recvd vax; 1dec94 late eve,pt unable to walk;t 99;c/o pain in legs when getting out of bed in am;MD & ortho-specialist consulted because no swelling in joint;advil in use but pt still uncomfortable;dx rubella side effect;
my kid has been violently ill and cannot even exercise vigorously anymore after he got this shot; my kid has been violently ill and cannot even exercise vigorously anymore after he got this shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), EXERCISE TOLERANCE DECREASED (non-serious), outcome "unknown" and all described as "my kid has been violently ill and cannot even exercise vigorously anymore after he got this shot".  Additional information: The associated LRN and the product mentioned is Pfizer-BioNTech COVID-19 vaccine. Please let us know if there are any questions. Open-ended question: While you were rating the ad, we noticed that your interest changed during different portions. Please press PLAY below to view a portion where your interest. Then please take a moment to tell us in the box below why your interest. Open-ended question: Your classic typical fear mongering acting as if the virus will come and take your kids out unless you mask them to death and shoot them up with a bunch of vaccines and it falsely States the fact that it is less harmful than the actual covid itself. I can tell you for the fact that my kid has been violently ill and cannot even exercise vigorously anymore after he got this shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a consumer with penicillin allergy and a history of cold sores who was vaccine ("about 2 weeks ago") with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine virus vaccine live (Oka/Merck) (prn) (manufacturer unknown), and "occasional ibuprofen." The patient mentioned that he would be traveling out of the country. About a day and a half later after the vaccinations, he developed a cold sore on his lip. Since the patient has a history of cold sores, he started acyclovir (manufacturer unknown). The cold sore resolved. No further information was available. There were no lab diagnostics studies performed. The outcome is reported as recovered. There was no product quality complaint. Additional information has been requested.
Information has been received from a nurse a the daughter of a female patient (demographics not provided) who on 06-SEP-2006 was vaccinated with the first dose of Gardasil (Lot # not provided). The mother reported to the nurse that on 06-SEP-2006 after receiving the vaccination her daughter developed an elevated temperature (actual measurement not provided), nausea and chest pain. The mother reported to the nurse that she gave her daughter Benadryl (dose not provided). It was reported that the nausea, elevated temperature and chest pain resolved "in about three days". Additional information has been requested.
8/2 fussiness, lack of sleep and eating, screaming. 8/3 same as above, but getting worse, and temp. 8/4 same as above, temp. goes real high 103 and up. 8/5 same as above, had seizure, went to the hospital. The follow up states staph aureus osteomylitis, pyomyositis, anemia, and leukopenia.
Patient received a second dose of Moderna booster ( 0.25ml) on 11/5/2021 patient received Moderna booster on 10/25/2021 patient received first moderna on 2/12/2021 patient received second moderna on 3/12/2021
After the vaccination, within 5 minute the patient felt faint and started to lightly vomit. The stayed seated and over the next 25 minutes, periodically vomited small amounts and eventually started to feel better and in better spirits.
Immediately following vaccine, client reports arm was sore, red, and warm to touch. This was the same reaction client had to first flu vaccine one year previously. Symptoms did not go away after one day, and arm felt hotter, so client went to clinic on 30 Sep. Site was then red, hot, swollen, firm, raised, and about the size of her palm. Client was given 7-day course of antibiotics to take 4 times daily. No relief of symptoms by 1 Oct. Client also reporting pain in elbow and wrist joints on 1 Oct. Advised client to try NSAIDs for pain relief and Benadryl for allergy symptom relief.
ON 1/20/21 DEVELOPED EYE/MOUTH DROOPING, VOMITING, NAUEA, CHILLS AND BODY ACHES. HAS CALL OUT TO PCP
Pt developed a maculopapular, discreet rash on 12/04/2001. No fever or other symptoms.
Severe back ache that continues.  12 days after and my spine is still killing me.
It has been four weeks since getting flu shot.  Muscle pain continues and seems to be getting worse at the injection site on left arm.  Have been getting flu shots for 25 years and never had any king of adverse reaction at all.  Pain at injection site would always go away after a day or two. Not this time?  Something is just not right this time?  Have not been to a doctor yet.  But plan on going first of year if not better.  The flu shot I received was suppose to protect against 4 strains of the flu.
Information has been received from a physician concerning a 15 month old female patient with no pertinent medical history or no drug reaction or allergy who on 30-MAR-2010 was vaccinated SC with a dose of VARIVAX (Merck) (lot# 665209/1153Y). There was no concomitant medication. On 23-JUN-2010 the patient broke out in "shingles". The patient sought unspecified medical attention. Lab diagnostic studies included bacterial and viral culture, CBC and HIV test. But the results were not reported. It was reported that they had not improved, but had gotten worse. Follow up information was received from a medical assistant who reported that the patient was recovering. Follow-up information has been received from a physician. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if it was present, to identify if it was associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. On 30-MAR-2010, the 15 month old patient (also reported as 16 month old) was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot# 665209/1153Y) SC into her left thigh. On 23-JUN-2010, the patient experienced shingles, unilateral, left sided, dermatomes 5-7, number of lesions was over 100 vesicles. The rash did not occur at the site of injection. The patient was afebrile and there was no pain. Other systemic symptoms included fussiness. There was no history of chickenpox or shingles, no major medical condition and no concurrent condition. There was no recent exposure to chickenpox or herpes zoster. Varicella zoster virus antibody test showed vericella/herpes. On 30-JUN-2010, the specimen was sent to the laboratory, and the PCR result from the specimen showed HSV1 and HSV2 which identified the presence of VZV Merck vaccine strain. At the time of reporting, the patient was not recovered yet. Follow up information was received from a physician who reported that a lesion sample was collected on 30-JUN-2010. The sample same taken from a lesion and swab of unroofed vesicle. VZV DNA was amplified. The PCR result from the scab specimen identified the presence of VZV Merck vaccine strain. Follow up information has been received from a medical assistant concerning the 15 month old female patient with no pre-existing allergies, birth defects or medical conditions and no adverse event following prior vaccination who on 30-MAR-2010 at 13:15 was vaccinated with the first dose of VARIVAX (Merck) (lot number 665209/1153Y) subcutaneously at left thigh, the first dose of MMR II (MSD) (lot number 665213/0945Y) subcutaneously at right thigh, and the first dose of VAQTA (MSD) (lot number 667009/0095Z) intramuscularly at left thigh. There was no concomitant medication. On 25-JUN-2010 the patient developed Herpes Zoster. On an unspecified date the patient recovered. Additional information is not expected.
very tired; Menstrual cycle hasn't been the same since receiving the vaccine. It's always been normal up until then.; Sore all over; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 39-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318 ) via an unspecified route of administration in the left arm on 02Mar2021(at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, 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. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6189) via an unspecified route of administration in the left arm on 09Feb2021(at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 05Mar2021, the patient became very tired and sore all over. It was also reported that menstrual cycle hasn't been the same since receiving the vaccine. It's always been normal up until then. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very tired, sore all over and menstrual cycle hasn't been the same since receiving the vaccine was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
45 minutes after administered shot, felt warm evidence of hives and hard time breathing. ER admin a Benadryl shot. 20 minutes recovered and went home.
pt recv vax 20JUN97 & JUN97 pt exp rash (gen/trunk) & fever 101;
Post vaccination the patient developed thrombocytopenia, the platelet count decreased to 26,000. The patient had spontaneous recovery in 1 week.
received the first dose of the vaccine and then 5 days later was diagnosed with Covid; This is a spontaneous report from a contactable pharmacist. A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received the first dose of the vaccine and then 5 days later was diagnosed with COVID. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient stated sweating, dry mouth, shaky swollen eye on side as vaccination, lump in neck on same side, and rash local to injection site.
Patient was given a monovalent Pfizer vaccine instead of the bivalent vaccine for her booster.
The site of injection was very inflammed and there was swelling at the Prevnar site (right thigh).
Chills, fever of 102,  nausea and vomiting 8 times (unable to keep any liquid down until medicine prescribed by PCP), Virtual visit with doctor  headache, swollen glands,  swollen and very painful left arm at site of injection (still painful).
I participated in CDC surveys after receiving Covid vaccines. I never mentioned tinnitus in those surveys but I now recognize that the condition appeared after receiving the vaccines. My first shot was in January 2021 and by July 2021 I was researching tinnitus and discussing it with family. At the time, I didn?t realize it could be related. The condition persists today.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 at 13:00 as dose 1, single (Lot number: FN5318), in left arm, on 17Feb2021 at 13:00 as dose 2, single (Lot number: EN6200), in left arm, on 27Sep2021 at 13:00 as dose 3 (booster), single (Lot number: 301558A), in left arm and on 06Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Anti-viral details: product=covid 19 treatment, brand= pfizer, treatment start date= 22Jul2022, treatment stop date= 26Jul2022, indication= treatment of covid-19, known allergies: none.  The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported LOE events and the suspect drug BNT162B2 cannot be excluded.
Patient awoke after nap covered in hives.  No other symptoms.  Hives continued through the following 4 days.
Information has been received from a registered nurse concerning a 32 year old female who on 11/15/2001 was vaccinated IM in the left arm with a first dose of varicella vaccine. Subsequently, on 11/29/2001, the pt presented to the physician's office with a non-tender vesicular rash at the injection site (left arm) which was diagnosed as a varicella vaccine reaction. It was reported that the pt's L posterior arm had raised 5cm erythema with 6 small raised nodules with vesicles and was hot, warm, itchy and non-tender. The pt received no treatment and subsequently recovered. Additional info is not expected.
Information has been received from a 48 year old male consumer with no remarkable past medical history and no known allergies who on 06/11/2001 was vaccinated with hep A vaccine at a county health department. There was no concomitant medication. Three to four days after the vaccination, on approximately 06/14/2001, the pt started to lose his hair. The pt felt that his hair loss was due to hep A virus vaccine since "he never lost his hair prior to the vaccine." Unspecified medical attention was sought. Additional info has been requested.
From initial information received on 4/13/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a female patient (age not reported) received her third dose of IMOVAX RABIES, lot number W1419, route and site of administration not reported, on 4/5/04. Reportedly, the vaccine administered was for post-exposure. An unspecified time later, the patient experienced swelling of the arm, nausea, vomiting, and a temperature of 104 degrees F. The reporter believes that the patient was treated in the emergency room. The patient recovered from these events. She denies any reactions after receiving her first or second dose of the vaccine.
myalgias,h/a,nausea,dizzy,shakes,near syncope episode,blurred vision,hands numb,t100.3;tx motrin,IV naCl,heparin lock
Herpes zoster diagnosis in one-dose varicella vaccine recipient. Symptoms: unilateral rash (pain unknown. Treatment given: acyclovir).
Developed swelling and fever at injection site, large knot golf ball size present at injection site, tender to touch.  By 02/04/13, know was the size of palm of hand.  Treated with Keflex and symptoms resolved.
Headache, Myalgia, eyes burning, feet tingling Narrative:  Per nursing report: "C/o feeling tired this morning, headache, eyes burning and lower extremity aching and feet tingling. Afebrile. States took 2nd dose of Moderna vaccine last Friday on 1-29-21 [sic] with no c/o problems. " Note that system shows 2nd dose was on Friday 1/22/21.  Other Relevant History:
On March 2nd woke up with right  calf pain.  Thought I had a charley horse in the middle of the night and thought this was the soarness you get afterward. Because I had been on Crestor for approximately 5 weeks I thought that the crestor may be causing muscle pain.  After 2 days of calf pain which was subsiding by then I visited Dr. who ordered a right ultrasound and I had 2 blood clots in the right leg (one in calf and one behind the knee). Due to the fact that I did not meet any standards for getting blood clots I was put on blood thinners (Eliquis) and told to see a hematologist.
+ covid hospital admission; + covid hospital admission; Dose Number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  An elderly male patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Lot number: FF2589) as dose 3 (booster), single, administration date 05Feb2021 (Lot number: EL3247) as dose 1, single and administration date 25Feb2021 (Lot number: EL3247) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 09Nov2021, outcome "unknown", described as "Dose Number: 3"; VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 06Jan2022, outcome "not recovered" and all described as "+ covid hospital admission". The patient was hospitalized for immunisation, vaccination failure, covid-19 (start date: 06Jan2022). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: Covid test type post vaccination: Unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported covid-19 and suspected vaccine BNT162B2 cannot be completely excluded.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The next day following the injection, she developed a fever. The reporter stated that her temperature was between 101 -102 degree F.
Tongue tingling, tightness in face, right side of face droopy, smile crooked, jaw and chin sore.
Woke up next morning: pain and swelling where injection was given.  Numbness in arm.  Mild to moderate swelling in under arm. Lymph nodes in axillary area very swollen and painful  Fevers 99-100.7 degrees.  Pain, numbness and swelling in left axilla radiates to hand and into left breast.  Advil 800mg every 6-8 hours.  Trying Z-pack 2 per mouth for 5 days.
Patient rec'd Pfizer #1 on 1/22/21 (L deltoid) @ 3:30 p.m.  1/22 @ 4 p.m. - Hives & itching started after obs, "feeling unwell" so patient returned to obs for additional 15 min. Cleared to RTW. After eating, @6 p.m. patient noted difficulty swallowing in evening & change in voice so she thought she had throat swelling. Took Benadryl 25 mg PO and Tylenol rapid release for HA. Hives resolved that evening and patient went to sleep.  Over the weekend, had flu like symptoms, nausea, fatigue, HA. Took Benadryl 12.5 mg PO on 1/23 and continued Tylenol through weekend.  1/26 - 1/27: Signs and symptoms resolved
About 10 minutes after vaccination the patient experienced lightheadedness and tingling along the right side of her body (the side which was injected) from face to foot. After another 20 minutes the patient said she was starting to feel better but definitely still tingly. Recommended she see doctor to evaluate.