chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccines given after the BUD; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines given after the BUD) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines given after the BUD) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines given after the BUD) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccines given after the BUD).    Concomitant product use was not provided by the reporter.   Vaccine was given after the BUD. Moderna vaccines was stored in the freezer of storage unit which was a dorm style refrigerator with a separate freezer compartment. Individual vial of the vaccine was thawed out the day of use and disposed of if not completely used. No treatment information was provided.
Fever as high as 101.4; Chills; Whole body aches; Whole body soreness; Weakness; Fatigue Took Tylenol Extra Strength every four hours; Increased water intake; Stayed in bed Lasted for approximately 48 hours
Left leg swollen. Total thigh extending from knee and groin. Erythema, induration, extended out to posterior. ? at 48 hours from administration. He is recovering.
PATIENT CALLED THE OFFICE THIS MORNING AROUND 10AM STATING SHE STARTED TO FEEL SICK ON THE EVENING OF 9/10/11  AND THOUGHT THIS WAS A REACTION TOWARDS THE FLU SHOT. SHE SPOKE WITH THE NURSE PRACTITIONER AND TOLD THE PT TO TALK TO ME, THE MEDICAL ASSISTANT TO GET ALL DETAILS, AND ALL SYMPTOMS SO WE CAN REPORT THIS TO VAERS.  SHE VOMIT FOR 2 STRAIGHT DAYS, SOME SWEATS, WEAKNESS, FEVER, BUT NO OTHER SYMPTOMS. TODAY SHE ONLY FEELS SOME WEAKNESS AND HAS NOT VOMIT ANYTHING ELSE.  WE WILL CALL PT TOMORROW TO SEE HOW SHE IS DOING.
My face has been twitching since I got the vaccine. It feels like I have muscle spasms in the arm I got the shot in and in my back. The arm that I got the shot in still hurts a day after. .
3NOV93 145PM almost non-stop crying since inject; mom reassured-reinforce instructions for APAP & cold & warm packs to shot site; mom called MD who said same; 345PM pt sleeping;
arm, part of chest and back were burning; could not sleep well; armpit was sore and swollen; armpit was sore and swollen; aches; arm trembled violently six times; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (arm trembled violently six times), CHEST PAIN (arm, part of chest and back were burning), INSOMNIA (could not sleep well), PERIPHERAL SWELLING (armpit was sore and swollen) and AXILLARY PAIN (armpit was sore and swollen) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced TREMOR (arm trembled violently six times). On 23-Mar-2021, the patient experienced CHEST PAIN (arm, part of chest and back were burning), INSOMNIA (could not sleep well), PERIPHERAL SWELLING (armpit was sore and swollen), AXILLARY PAIN (armpit was sore and swollen) and MYALGIA (aches). On 22-Mar-2021, TREMOR (arm trembled violently six times) had resolved. At the time of the report, CHEST PAIN (arm, part of chest and back were burning), INSOMNIA (could not sleep well), PERIPHERAL SWELLING (armpit was sore and swollen), AXILLARY PAIN (armpit was sore and swollen) and MYALGIA (aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications were not provided by reporter.   This case was linked to MOD-2021-057906 (Patient Link).
This spontaneous report as received through email from a physician via company representative refers to a 14 year old female patient. The patient's concurrent condition included depression. The patient historical drug included unspecified Attention deficit disorder treatment. The patient was not pregnant. On 04-FEB-2014, the patient was vaccinated with GARDASIL (Lot number unspecified) dose 1, intramuscular injection in the office. Other suspect therapies included AFLURIA (dose unspecified) intramuscular injection administered on 04-FEB-2014 at the same time with GARDASIL. Concomitant therapies included PROZAC and ADDERALL Tablets. On 04-FEB-2014, following the administration the patient became dizzy, clammy and experienced fluttering eyelids. Additional symptoms included intermittent crying, tears and quivering. She was kept at rest in the office and was able to sit up after about a half hour had passed. However the patient continued to experience some dizziness and was short of breath. Labs diagnostics unspecified. The patient sought medical attention and was treated by other physician. There was no significant disability or incapacity to the patient. No hospitalization needed for the events. The events were not life threatening. No product quality complaint involved. No additional information was available. The outcome of events was unknown. The reporters causality assessment for the events with the therapy of GARDASIL and AFLURIA was not reported. Additional information has been requested.
No signs or symptoms reported; a temperature excursion occurred/ROTATEQ was administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, allergies, and concomitant therapies were not reported  The reporter indicated that on 11-OCT-2021, a temperature excursion occurred, the temperature was 9.7°C for a time frame of 1 hour, and there was not previous temperature excursion. Then, on 22-OCT-2021 the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # T003011 with expiration date 26-NOV-2021, 1 time dose, for prophylaxis (strength and route were not reported) , which experienced the temperature excursion (product storage error). No signs and symptoms were reported (No adverse event).
8th day after vaccination I had a few itchy welts inside of wrist. 9th day I had more welts on other wrist. 10th day I had scattered welts on various places on my body.  They are raised red welts similar to mosquito bites, bit more itchy. Took antihistamine Allegra on day 10. Outcome is unknown at this time.
I observed a 20 minute and a two hour 'shivering' cycle  a day or two after injection. Presently, I have  observed several months later a symptom of internal shaking vibration.  I am hopeful it is only Thyroidism medication side effect or perhaps dietetic measures of too much sea salt.  My blood daily pressure readings are between no higher than 125.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 03-OCT-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not provided) that was stored in improper temperature. This is one of several reports from the same source. Additional information is not expected.
Within 36 hours of administration patient called complaining of site pain, reddness, swelling, headache, and fever (102'F)
I know so many people that get the shot and they're the first ones with the flu; Initial information received on 27-Nov-2022 regarding an unsolicited valid Social Media non-serious case via consumer/non-hcp.  This case involves an unknown age and unknown gender patient and the reporter stated that i know so many people that get the shot and they're the first ones with the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) route in unknown administration site for prophylactic vaccination. Information on batch number and expiry date was requested.  On an unknown date the patient had a non-serious event of  i know so many people that get the shot and they're the first ones with the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
Severe Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Severe Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Severe Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
The patient describes a erythematous rash on his left forehead associated with numbness and paresthesias over his left face approximately 25 h after vaccination, that resolved after several hours.  He experienced another episode of numbness/paresthesia the next day lasting for half an hour without a rash. No further symptoms afterwards.  Unknown whether this is due to the vaccine.
She developed freq. congested cough in April-May,  treated at home with oral fluids and Vicks.  The cough subsided and systemic rash late  June, that resembled scabies, and was treated for 2 courses for that, but no improvement. The rash progressed to rest of body and developed into blisters, and biopsy in July, 2021 confirmed bullous pemphigoid.
Information has been received from a consumer, referring to her 20 year old daughter. Information about medical history, concurrent condition and concomitant therapy was unknown. On an unknown date, the patient was vaccinated with GARDASIL (dose, strength, route, frequency, lot# and expiration date unknown) for prophylaxis. On an unknown date, the patient experienced nerve damage, back pain (also reported as so much pain) since she received with GARDASIL. The outcome of the events was reported as not recovered. The causality assessment was not provided by the reporter.
Infant had high-pitched screaming all evening/night and was inconsolable. Fever spiked to 105.7 night of vaccine administration. Infant became lethargic, glassy-eyed, appeared to be starting a seizure with unblinking stare and tongue-rolling movements although no generalized seizure activity was noted. Spoke with on-call physician 3 times that night and was advised to continue routine Tylenol and cool baths and bring infant to office in AM.  The following morning, infant was seen in Dr office where blood work was done. Was told to return to office if fever did not improve. Fever then continued to be 102 or above for 10 days following. This resulted in two more office visits where blood work, nasal cultures, xrays, and catheterization for urine cultures were completed. All tests were inconclusive. At 10 days post vaccination, fever broke.  By this time, we were having trouble bottle-feeding. Infant appeared to be unable to latch properly, would become frustrated and scream for hours. Syringe fed infant for several weeks, because she was unable to latch enough to feed completely. Multiple phone calls to office resulted in advice to "just keep doing what you're doing." Infant stopped lifting her head and quit rolling over or sitting - things she had been doing well prior to vaccination. Noticed that her gaze was often directed downward, and she was slow to look towards the sound of your voice. Her facial expressions were now blank most of the time, and we could no longer get her to smile frequently. She also could no longer sit without being VERY supported, whereas prior to vaccine she was close to sitting on her own. Also, began to notice when infant was lifted, she would turn her feet inward (similar to decorticate posturing). She also started having sensory issues, in such as, she could no longer sleep during the day because every little noise and light would wake her up screaming, and she could no longer soother herself. She would scream and scream until she would vomit. I STARTED swaddling, covering the windows, and using white noise to help her sleep during the day. These issues were pointed out to physician multiple times, but nothing was every done. Was told "Sometimes, infants go through little regressions, we'll keep an eye on her." She has had delayed development and feeding issues ever since, and has currently been scored at 6 months behind her real age. She has global hypotonia and unrefined gross/fine motor skills. She did not sit or crawl until 10.5 months. She began pulling to stand around 11 months. At 16 months, she still does not stand alone, walk, talk, or feed herself. Only with much effort have we been able to keep her from the failure-to-thrive range. She gags, vomits, and has trouble swallowing her foods. We still grind most of her foods, especially meats. Standing, crawling, and cruising along the furniture are very slow and uncoordinated. At 15 months, we finally received referrals for therapy, Neurology, and Orthopedics. Ortho has prescribed braces for her legs. Therapy is providing physical therapy, occupational therapy, speech therapy, and developmental specialist. We have not yet seen Neurology to date.
she had swollen lymph nodes on left side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 (Lot number: EW0162) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Lyme Disease" (unspecified if ongoing); "Allergy: other cleaning products" (unspecified if ongoing), notes: allergy to Nickel and Ethylenediamine Dihydrochloride and other cleaning products. Concomitant medication(s) included: DOXYCYCLINE taken for lyme disease, hypersensitivity. Past drug history included: Nickel, reaction(s): "Allergy: Nickel", notes: allergy to Nickel and Ethylenediamine Dihydrochloride and other cleaning products.; Ethylenediamine dihydrochloride, reaction(s): "Allergy: Ethylenediamine Dihydrochloride", notes: allergy to Nickel and Ethylenediamine Dihydrochloride and other cleaning products. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 16Apr2021, outcome "recovered" (2021), described as "she had swollen lymph nodes on left side".  Additional information: Patient was taking this for what they thought was Chronic Lyme Disease but now they think it was from her allergy to Nickel and Ethylenediamine Dihydrochloride. Patient states it is in a lot of cleaning equipment and they are cleaning things better to be Covid safe. Patient received her 1st dose of the Pfizer vaccine in April. After the 1st dose she had swollen lymph nodes, for a couple weeks and went away. Patient clarifies that originally, her only reactions to the vaccines were swollen lymph nodes under her arm on the side that she had the injection on,  which she saw was common. Event started on the day of the vaccine and lasted for a week or two after the vaccine. Patient asks any links between the Pfizer vaccine and breast cancer and asks is there any antibody testing being done.   Follow-up attempts are completed. No further information is expected.
Throat closed up; This is a spontaneous report from a contactable consumer(patient friend).  A female patient of an unspecified age received bnt162b2 (Pfizer Covid 19 Vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced throat closed up on her at night and she was told not to get her second vaccine on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 23-MAY-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L04407 exp date 06-OCT-2018) (dose and route not reported). The temperature and time of excursion was 8.33 degrees C for 24 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
On 06/08/2014 notice itching and a red knot appearing on the arm (area of injection). The redness has disperse slightly down the arm. Patient start taking Zyrtec daily and has not experienced any other side effects.
11/1/00, awakened from 2 1/2 hour nap in PM, covered with hives. Was given 1 tsp of Benadryl and clothing removed. Hives were gone at 17:30. On 11/2/00, slight hives, more in PM, temperature 101F. Took to MD and Benadryl was repeated. Dx'd with ear infection. Rx'd Ceftin. Later, covered with hives again and 1 hours, post Benadryl, hives were gone. MD said might last for 2 or 3 days.
fever, headache, muscle aches, diarrhea, nausea, breast on injection site painful, sore throat, right ear ache, malaise
after the vaccine, I started to feel Body aches, chills, nausea, gum pain, I felt fine prior to the vaccine, I went to an Express Care they did a Covid 19 test, result was negative, I had a video visit with my doctor because I developed cough, chest tightness and shortness of breath, they did a 2nd Covid 19 test result was negative, The cough become persistent and the cough caused pain in my chest and back, The Doctor prescribed guaifenesin with codeine, albuterol and something for my gums. the cough and pain in chest was worsen and the Doctor gave me the zpack, I was out of work for 10 days. they said I had an acute URI
Information has been received from a physician concerning a 7 week old male who on 01/24/00 was vaccinated with one dose of Hepatitis B vaccine recombinant. On 01/25/00, the patient presented to the physician and was diagnosed with erythema multiforme secondary to Hepatitis B vaccination. The child was not started on oral steroids and his mother was non-compliant with oral Benadryl. He was treated with cornstarch and oatmeal baths. The rash cleared totally without running a classical lengthy course. No further information is available.
I received my 2nd dose of Moderna on 08/26/21 at 10:40 am. By 7:00 pm on 08/26/21  I had intense body aches, fever, headache, racing heart rate, back spasms, chills, and  pain on injection site in my right arm. On 08/27/21 (I had to call into work)  I had a fever, chills, headache, and body aches and nausea. On 08/28/21 I had a headache, and body aches. On 08/29/21 I had a mild headache, and no other symptoms.
This case was reported by a other health professional via call center representative and described the occurrence of pruritus in a 80-year-old female patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. On 15th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th October 2018, 2 days after receiving SHINGRIX, the patient experienced pruritus, facial swelling, red face and rash. On an unknown date, the outcome of the pruritus, facial swelling, red face and rash were not recovered/not resolved. It was unknown if the reporter considered the pruritus, facial swelling, red face and rash to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a medical assistant (MA). The patient received SHINGRIX in the left deltoid. The healthcare professional (HCP) reported that the patient developed itching and a rash (unknown location) and her face was swollen and red.
This case was reported by a pharmacist and described the occurrence of arm pain in a 62-year-old female who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Concurrent medications included Ibandronate sodium (Boniva). On 7 November 2006 the subject received a dose of Fluarix at 0.5ml, intramuscularly in the left arm. The vaccination was given about three inches below her shoulder joint, just above her bicep. The subject described to the pharmacist that she felt as though the administration of Fluarix was "deeper than any other" vaccination for influenza that she has received in the past. Initially, in November 2006, the subject experienced only mild pain at the injection site, which improved. However, in December 2006, the patient reported that the pain in her left upper arm, in the proximity to  the injection site of Fluarix, began to worsen. The pain was described as severe and radiating down her entire arm and sharp on movement. The pain worsens over time. The subject reported that at times she feels a "pins and needles" sensation in her left arm radiating down her arm and into her hand. The pain reportedly keeps the subject up at night. The subject has not received any treatment for the events. At the time of reporting the events were unresolved and the relationship of the events to Fluarix was not known.
Someone's teeth were hurting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TOOTHACHE (Someone's teeth were hurting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced TOOTHACHE (Someone's teeth were hurting). At the time of the report, TOOTHACHE (Someone's teeth were hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Swelling of lips and eyes. Within 2 hrs Conjanitiva red. Chills followed by sweats. 4-5 hrs. after vaccine fine the next day.
Started to get hives all over my body about 2.5 weeks after the second shot and they have been lasting for more than 2 weeks now
For post vaccine check, patient stated he developed dizziness after PCV 20 vaccine. BP at 1744, 149/100, HR 87. At 1748 BP 170/106, HR 90. Notified provider in clinic Dr. and he stated recheck in 15 minutes. 1810 BP on left arm 171/100. On right arm 176/103 at 1807. Patient stated he continues to feel dizziness and has not improved. Dr. stated he will see patient tomorrow for appointment at clinic and to take BP medications as prescribed for today. Patient voiced understanding. Follow up appointment scheduled. ER precautions given to patient and voiced understanding. Dr. stated patient can be discharged.