chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report had been received from a physician via medical representative. The report concerns a male patient. The patient's medical history and concomitant medications were not reported. The patient received treatment with nasal FLUMIST QUADRIVALENT on 24-Oct-2013. The patient had Bell's palsy. From 25-Oct-2013 he started feeling funny, but did not report to his mother till 26-Oct-2013. Patient was taken to the emergency room (ER) and had MRI of his brain with negative result. He was tested positive for varicella and negative for Herpes Simplex virus. At the ER they also suspected for Lyme's disease and the patient was given VALTREX and doxycycline. The doxycycline was discontinued after 6 days as they found that the patient did not have Lyme's disease. The patient was recovered from the events. The report was considered to be non-serious by reporter. Summary of follow-up information received by AstraZeneca/MedImmune 09-Dec-2013 from physician: patient's gender and birth date was reported, new non-serious event of varicella was reported, the patient recovered from the events, start date of the suspected product added, laboratory tests were performed and narrative updated.
Patient reports he developed alopecia areata after receiving first dose of Anthrax vaccine.  He presents to our immunization clinic for post-deployment Anthrax vaccine #4.  He is concerned his alopecia areata is due to the Anthrax series.
supraclavicular lymph nodes that have popped up; severe neck pain; shoulder and clavicle pain; This is a spontaneous report from a contactable other health care professional. This health care professional reported for a consumer (patient). A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included breast cancer from 19Oct2020 (Diagnosis: breast cancer; Ibrance 75 mg) and ongoing. Concomitant medication was not reported. The patient experienced supraclavicular lymph nodes that had popped up, severe neck pain, shoulder and clavicle pain. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache; Skin was warm to touch; Chills; Difficulty sleeping; This is a spontaneous report from a contactable consumer. A 37-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via intramuscular route of administration on 14Apr2021 at 11:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis and colectomy. It was unknown if the patient had allergies to medications, food or other products. The patient received unspecified antibiotics within two weeks of vaccination. Prior to the 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 vaccination. On 14Apr2021 at 16:00, the patient experienced headache, skin was warm to touch, chills and had difficulty sleeping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events headache, skin was warm to touch, chills and difficulty sleeping were resolved the day following vaccination, on 15Apr2021 by 08:00.  No follow-up attempts are needed. No further information is expected.
This case was reported by a physician via call center representative and described the occurrence of pericarditis in a 60-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 10 days after receiving SHINGRIX, the patient experienced pericarditis (serious criteria GSK medically significant) and lung infection (serious criteria GSK medically significant). On an unknown date, the outcome of the pericarditis and lung infection were unknown. It was unknown if the reporter considered the pericarditis and lung infection to be related to SHINGRIX. Additional details were reported as follow: The case was reported by the patient's friend. The age at vaccination was not reported. At the time of reporting, the patient was 60 years old. The patient was in excellent physical condition with regular workout regimens and very healthy diets. The patient received SHINGRIX several months before the time of reporting. It was reported that, after initial infection of the pericardium the patient's lungs were also involved. The event was treated at hospital. The patient's friend was not hostile to vaccines and the patient spent several years advocating for evidence-based medicine. The patient's friend considered the coincidence, had just learned of the reporter's expertise and interest in this particular area of vaccine research, his thought the reporter might be interested in pursuing this further. The patient's friend was happy to grant the access to his chart and the patient's friend had similarly willing to share his information. The patient's friend had given the consent to contact him either by email or by the phone call. The patient's friend also experienced similar events (refer case US2018GSK215669). Follow up information received on 30th November 2018: The physician granted the access by the pericarditis patients to their files.
large rash on both sides of neck that wraps from front to back; sore arm; rash; injection site hard; injection site warm; This case was reported by a consumer and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (very mild case about 6 years ago located on one side of body around the bottom of bra line).   On 22nd July 2019, the patient received the 1st dose of Shingrix. On 22nd July 2019, immediately after receiving Shingrix, the patient experienced pain in arm, injection site rash, injection site induration and injection site warmth. On 25th July 2019, the patient experienced widespread rash. On an unknown date, the outcome of the pain in arm, injection site rash, injection site induration, injection site warmth and widespread rash were unknown.   It was unknown if the reporter considered the pain in arm, injection site rash, injection site induration, injection site warmth and widespread rash to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine at 4 pm, since then had expected sore arm, but the injection site continued to be rash-like, hard, warm, and about a golf ball size radius.  In the morning of the date of reporting, over 48 hours after her injection, the patient woke up with a large rash on both sides of her neck that wrapped from front to back.  The patient asked to advise if she should see her physician or avoid the 2nd dose of the vaccine. The patient was provided Shingrix package insert and as per the IAC (Immunization Action Coalition) was recommended to apply a cold compress to the injection site if localized reaction occured, such as soreness, redness, itching, or swelling at the injection site.  The patient was also asked to consider taking an analgesic (pain reliever) or antipruritic (anti-itch) medication and was informed that these were general recommendations from IAC and had not been evaluated with Shingrix. For the large rash on both sides of the neck the patient was asked to refer her doctor. The patient had scheduled an appointment with her physician.
must have needed a booster shot / I have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient itself. The age group was not reported but was captured as adult as per vaccine indication. The age at vaccination was not reported. The patient received Shingles vaccine and experienced shingles. The patient guessed if he/she must had needed a booster shot. The follow-up would not possible as no contact details were available.
Severe outbreak of shingles on right side of forehead and eye (lid and all of eye area). Also scalp.
intussusception; INTESTINAL OBSTRUCTION; Information has been downloaded (US-EMA-20110131-rtevhumanwt-190240506).  This spontaneous report was received from a health professional concerning a 3-month-old female patient. Medical history, concomitant medications and concurrent conditions were not provided.   On 12-MAR-1999, the patient was vaccinated with a dose of diphtheria toxoid, pertussis acellular 4-component vaccine, tetanus toxoid (ACEL-IMUNE) (dose, route, frequency and the expiration date were not reported) Lot# 457-790 for prophylaxis; Hib conj vaccine (CRM197) (dose, route, frequency, lot# and the expiration date were not reported) for prophylaxis and polio vaccine (unspecified)lot# N0957 (dose, route, frequency and the expiration date were not reported) for prophylaxis.  On 16-APR-1999, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot# reported as 0079J (dose, route, frequency and the expiration date were not reported) for prophylaxis and rotavirus vaccine (unspecified)lot# 4988086, 1 dose orally (frequency and the expiration date were not reported) for immunisation.   On 19-APR-1999, the patient experienced intestinal obstruction.  On an unknown date the patient experienced intussusception and due to these events, the patient was hospitalized.      At the time of reporting, the outcome of intestinal obstruction was reported as recovered. The outcome of intussusception was unknown.  The relatedness between the suspect therapies and adverse events were not provided.; Sender Comments:Fax-ref: F2057F1
Doctor ordered a pfizer 5-11yrs 0.2ml for the patient. I accidentally drew up a pfizer 12+yrs and administered to patient. The patient received a pfizer 12+ yrs 0.2ml. I reached out to patient's  father in regards to the mistake. Father stated patient is not showing any side effects/Symptoms. Patient has only complained of left sore arm.
My arm was very sore. I was a little tired the next day after vaccine. I did not receive any treatment, it went away after a day.
Fever 101 F and flulike symptoms on and off for 4 days and counting.
VACCINE ADMINISTERED TO INAPPROPRIATE AGE GROUP; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 16 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and expiry: 23-JUN-2021) .5 ml, administered on 31-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the subject experienced vaccine administered to inappropriate age group. On 31-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to inappropriate age group and off label use was not reported. This report was non-serious. This report was associated with product quality complaint: 90000181255.
first dose approximately 16 months ago; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose approximately 16 months ago, from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter stated that, the second dose was late due to the patient residing in different states throughout the year and not due to supply issue.  The reporter was calling from home and did not have patient details or lot number and expiration date details. The reporter consented to follow up. Healthcare professional gave permission for follow up, but declined to provide mailing address. This case is linked with US2022027781, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022027781:same reporter, different patient
This spontaneous report as received from a nurse practitioner refers to a 23 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with first dose of GARDASIL on 17-JUL-2012 (lot number and route were not reported). On 17-JUL-2012, the patient developed nausea, dizziness, lightheadedness and a cold sweat immediately after receiving GARDASIL. Treatments given for events included juice and cookies. The outcome of cold sweat, lightheadedness, dizziness and nausea was reported as recovered/resolved on 17-JUL-2012. The patient sought medical attention in the office. Additional information has been requested.
DIZZINESS, NAUSEA WITH VOMITING, HEADACHE, CHILLS
Developed pain and mild soft tissue. Swelling in axilla after infl. injection. No visible erythema. No palpable adenopathy. No evolving of cellulitis.
Severe nausea, confusion, muscle aches, low grade fever, severe headache with increased skin sensation, noise sensitivity, light sensitivity,  chills, excessive sweating, cheats pressure, head and eye pressure, cough (more severe at night), itching, memory loss, sensitivity to excessive stress that increases symptoms
Vaccine given beyond expiration date. Vaccine expired 3.07.2022. Spoke to Merck rep who states as per Merck in house stability data-the product has maintained potency and there is no need to re vaccinate, but ultimate decision should be made by provider
3 Hours later acting fussy - 1 a.m. 102 degrees, Tylenol given, red from head to toe - twitching won't let you touch her alot 100 degrees today at 3p.m. - still fussy.
I had the shots and I got shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 82-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the shots and got shingles for the very first time. The reporter stated that it does not prevent shingles. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Member complained of fatigue, numbness and burning, extending down left arm from site of injection and spiked a fever of 102F approximately, 7 hours, post vax. Member received Tylenol. Then the next morning, he had a temperature of 98.9F. Exam revealed normal Neuro-Exam of left arm (distally Neurovascularly intact). No local reaction in area of shot and no focal signs of infection.
LEG WEAKNESS, CHILLS, SHORTNESS OF BREATH Narrative:  Patient reported after taking his second dose of Moderna vaccine on 2/25/2021 he developed extreme leg weakness, shortness of breath, fever, chills and elevated blood pressure. States the fever and chills lasted for 5 days and the chills were so bad he "shook all over". Patient states the leg weakness and SOB are not completely resolved yet. He completed a chest xray this week and the results are: streaky opacities at the lung bases, likely atelectasis and/or scarring. Patient to complete PFT soon. States his BP has been running 167/88 until 3/15. However patient reports he doesn't take his metoprolol all the time. Legs are still weak 3/15, but began using an exercise machine yesterday for his legs and "feels that may help". Patient also reports he had purchased a "so clean" device to keep his cpap machine clean. He received a letter from the Clinic stating those devices have been linked to asthma and lung problems so he stopped it.
NO adverse event; Expired vaccine that was administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients) and NO ADVERSE EVENT (NO adverse event) in a 74-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (NO adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients) and NO ADVERSE EVENT (NO adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (NO adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine that was administered to patients).    Concomitant medications were not reported.  Patient age was reported as 74 years and 1 months.  NDCID number was reported Reportedly, the number of patients at facility that received this Moderna vaccine between 08Apr2022 and 15Dec2022.  Treatment medications were not reported
2nd dose of covid vaccine on 4/21/21, last week of June I started having extreme pain in my left calf. On july 2nd ultrasound showed i had 4 DVTs in my left leg.
Starting within 2 days after shot, have developed tinnitus in left ear. It still remains. Never had this before.
pt recvd vax; exp inject site reaction consisting of swelling, erythema,tenderness & warm to touch;
After running a half marathon one month prior, and within days of Gardasil dose #1 (Lot #0057AA) administered on 7/19/2011, patient could not finish her daily 3 mile run due to extreme lack of ability to catch breath, fatigue, and dizziness. Needed to be rescued. # months after the vaccination, because she was still struggling to walk up a flight of stairs by mid October (approx 3 months after Gardasil dose) she had no stamina and landed in the emergency room with severe head-ache, spiked fever and racing heart rate that could not be managed. Still severe symptoms when returned home for winter break. Primary Physician referred patient for a Pulmonary Stress test early January 2012. Heart rate did not return to rest and she was admitted to the Cardiac unit. In hospital 5 days. Diagnosed with POTS and put on a beta blocker. Could not return to college for spring semester. Ongoing and new and debilitating symptoms keep appearing, with no answers.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (pain in the arm), asthenia (weak) and fatigue (tired and exhausted) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006B21A) for COVID-19 immunization. No medical history reported. On Mar 23, 2021, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 23, 2021, patient experienced pain in extremity (pain in the arm), asthenia (weak) and fatigue (tired and exhausted). At the time of the report, pain in extremity (pain in the arm), asthenia (weak) and fatigue (tired and exhausted) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
HEART POUNDING; ELEVATED HEART RATE; This spontaneous report received from a patient concerned a 69 year old of unspecified sex. The patient's height, and weight were not reported.  The patient's past medical history included unexplained lips swellings, and premature ventricular contraction, and concurrent conditions included allergic to several antibiotics, and other pre-existing medical conditions included patient was on small dose of beta blocker that was tapered off over a month period.  The patient experienced drug allergy when treated with rosuvastatin calcium, and atorvastatin calcium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 17-MAR-2021, Laboratory data included: Heart rate (NR: not provided) 85-95 BPM. On 17-MAR-2021 20, the subject experienced heart pounding. On 17-MAR-2021 20, the subject experienced elevated heart rate. On 18-MAR-2021, Laboratory data included: Heart rate (NR: not provided) 70 BPM, 60-65 BPM. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart pounding, and elevated heart rate on 18-MAR-2021 05. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Patient received vaccine on 05/15/13 and traveled by car to MD. Reported sore arm and leg cramping on 05/17/13 at approx 6:45 pm.
Localized macular rash that developed around the Hep A at the site. Generalization to legs and cheeks, no issues breathing.
Patient injected with Gardisil Vaccine, on L deltoid at 01:15 PM shortly after patient verbalized "I'm not feeling well" skin color on face was pale, patient was slightly coherent, perspire and vomiting. This nurse helped patient to sit back in chair and cold wet cloth applied on back of neck. Patient had vomited all milk that had consumed per mom. Requested mother to give her a well balanced meal before next appointment, with plenty of fluids. Instructed mother to verbalized the nursing staff to lay patient down for following injections. Mother verbalized understanding. Mother stated" all of her sisters do the same thing when getting vaccination".