chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site rash; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had injection site rash.
Cough, runny nose, fever, cold sweats while sleeping, restlessness, full body aches. Symptoms set in 12 hours after receiving first dose and continued for 4 days. Second dose had the same symptoms but only 2 days.
patient states sore arm deep inside with limited range of motion ( hurts to be raised) 30 days after vaccine given.  Immediately after vaccine he had inflammation at injection site which resolved in a few days but pain stayed.
This spontaneous report was received from a nurse and refers to a currently 12-year-old male patient. The patient had no medical history, concurrent conditions, concomitant therapies and drug reactions or allergies. On 08-SEP-2009, the patient was vaccinated with the first dose of VARIVAX subcutaneously (dose, lot # and expiration date not provided) reconstituted with sterile diluent (lot #, expiration date not provided). On 27-SEP-2011, the patient was vaccinated with a second dose of VARIVAX subcutaneously (dose, lot # and expiration date not provided) (lot#, expiration date not provided). On 19-SEP-2018, the patient's varicella level was invalid. The patient sought medical attention. No laboratory tests were performed. The patient did not receive treatment for the event. The patient did not recover at the time of the report. The causality assessment between the event and VARIVAX was not reported.
Pain, Redness, and swelling right upper thigh. Mom states childs complaint started 10/13/06 after going to school am. Seen at 10:00am at out office. Site on right upper thigh redness and swelling was the size of a quarter and mom states Hot to the touch. Advised per Dr to use cold compress at site.
stopped her period/ Missed menstrual period; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Dec2021 (Lot number: FK5618) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 24Dec2021, outcome "not recovered", described as "stopped her period/ Missed menstrual period".  Additional Information: Reporter daughter got the first dose on 08Dec2021 and second dose on 29Dec2021. Wants to report a reaction- it stopped her period completely. Patient got her first period in Sep2021- patient was very regular and gets it every 28 days. Patient had periods in October and November. The next period should have started on 24Dec2021 however patient still has not started to this day. Patient states, this was very concerning to me. Patient was going to take her to the doctor but know they aren't going to give me any answers? Do you have any information? Patient has read articles reporting girls getting heavier periods. Reporter reports that her daughter has not had a menstrual period since her first dose. Reporter was concerned that her daughter has not gotten her menstrual period since Nov2021. Family Medical History Relevant to AE(s): not provided. No other vaccines were given within 4 weeks. Emergency Room? No. Physician Office? No. Additional Vaccines had not Administered on Same Date of the Pfizer Suspect.  No follow-up attempts are possible. No further information is expected.
Patient complained of extreme pain on date of shot and pain in his arm throughout the day and evening. Cuddling helped a little. On Sat., he awoke at 4:30 a.m. screaming in pain. I gave him 3 children's tylenol at 5 a.m. and put an ice pack wrapped in a cloth on his arm, over his pj top. He complained about pain all day Sat. and said it hurt to move his arm. Patient screamed in pain if anyone even accidentally touched his left shoulder. I gave him children's tylenol around 2 p.m. Sun. morning, Patient's entire upper arm was red and extremely swollen. I'd say the swollen and red patch was a good 6" long and 2-3" wide. Patient complained of pain Sun., but didn't say anything Mon. Swelling is nearly gone now. My husband is an RN and diagnosed this as an allergic reaction to the vaccine. We plan to call and report the reaction to the doctor on 10/2/07.
Patient had received the Dtap #5 on his (L) arm on 4/26/12. On 4/28/12 Mom had called an office stating that the patient has upper arm swelling & redness which has now spread to the elbow. Patient came into the office with (L) upper arm swelling, which was hot, swollen & pink - treatment MOTRIN & cool compresses.
Bright red, itchy, 2-3 inch spot by injection site 8 days after injection.  Slowly fading away.
Pain, swelling and redness 14 hours, post vax, followed by chills, fever and bad malaise on the next day. Symptoms started to resolve on the 3rd day.
Patient presented to emergency department on 10/20/2021 complaining of nausea, vomiting, and generalized pain for past 5 days. She fell down stairs, which led her to calling ambulance. She was admitted for further management. Patient found to be COVID-19 positive on 10/22/2021. Patient was discharged home on 10/24/2021.
Initial information has been received from a health professional on 30-OCT-2007 concerning a 59 year old male with a history of heart problems who on 23-OCT-2007 was vaccinated with the first dose of Pneumovax 23 (lot number and batch number not reported). Concomitant therapy included aspirin. On 23-OCT-2007, six hours post vaccination, the patient experienced severe muscle pain with stiffness in the hip (site not reported) and was not able to weight bear. The patient received treatment with indomethacin and dihydrocodeine. The patient may have to cancel his forthcoming holiday due to the events. The patient has not yet recovered. Upon internal review on 01-NOV-2001 by company physician. This case has been upgraded from non-serious to serious due to significant disability/incapapcity as the patient was unable to weight bear due to muscle pain and stiffness in the hip. Other business partner numbers included: E2007-07545
Thirty minutes after receiving the vaccine, I noticed tingling on the left side of my lips with some numbness   & left side tongue  numbness shortly after that. Perhaps an hour after that, I had some numbness on the left side of my throat, a few heart palpitations, a slight headache, and crackling in both ears. Approximately 5 hours post vaccine, I felt slightly feverish. My temperature at that time was 99.1 (I usually run a low body temperature ,  in general)
On  the next day after vaccine, I woke up with chills. I ached all over,  I had a headache and fever later. Then nausea and dizziness along with weakness. On the next day it was the same, until about 12:30pm, the symptoms started lessening and was not as severe. Today, on 12/24/20, I still have nausea and I am really tired , and injection site is bright red and really sore ( about the size of a  dime).  Feels like I have fever around it.  Swelling on both hands.
Rash, generalized over entire skin surface. Multiple, raised, urticarial-type wheels.
hot flashes and chills, uncontrollably vomiting, ringing in ears, chest pain and pain on the middle of the back between shoulder blades, blurred vision. All symptoms lasted 12-24 hours
Erythema and swelling over 3.5" x 3.25" area started on KEFLEX for possible cellulitis.
Spot sore on injection. Later in PM, felt very sore. Upon exam saw reddened area felt hot. Put ice pack on. Reported in AM at work.
A hard swelling about 3 1/2 inches, uneven edges, at injection site, and it was itchy and the rest of the arm itself was puffy, and the Dr. called it COVID arm, advised to draw a line around it to make sure it did not spread and to put Benadryl cream on it cold compress on it and it lasted 12 days before it went completely away.
Pain/swelling, redness, malaise, low grade fever, headache lasted 7 days.
Large red swollen lump at inj site. Warm to touch. Lump is grapefruit sized.
This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Flu unspecified for prophylaxis. Previously administered products included ZOSTAVAX (dose received on an unknown date). On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza and sickness were recovered/resolved. It was unknown if the reporter considered the vaccination failure, influenza and sickness to be related to Flu vaccine. Additional information received as follows: This was reported previously to the doctor. The age at vaccination was not reported. The patient mentioned that she no longer received the flu vaccine because whenever she received the flu vaccine (unknown manufacturer) in the past, she would get sick or experienced the flu. This case was considered as a suspected vaccination failure case as the time to onset and the lab test confirmation for influenza were unknown. The patient did not wish to provide her physical address. This has been linked to the case US2018183633, reported by the same reporter for the same patient.
This spontaneous report as received from a physician refers to a 68 year old female patient. No demographics were provided for the patient involved. In August or September of 2012, the patient was vaccinated with ZOSTAVAX (dose, route and lot# unknown). No other co-suspects were reported. No concomitant medications were reported. "A week ago, on approximately 22-APR-2013 the patient experienced a mild case of shingles in the upper shoulder area. The patient had sought medical attention by doctor's visit. The outcome of a mild case of shingles on the upper shoulder area was reported as not recovered/not resolved. The reporter did not provide assessment of the relationship of the adverse event to the suspect therapy. Additional information has been requested.
Piercing sound in left ear began on March 28. Saw ENT on March 30; diagnosed with tinnitus. Follow-up visit with ENT scheduled for week of April 19. ENT indicated he may prescribe steroids if tinnitus has not resolved by then.
Complainiing of cough, HA, chest congestion, ears are "plugged," and scratchy throat, hurts to swallow. 1 day  PO medication Zithromax, steroid, decongestion, and  suportive care.
Had shingles vaccine shot on 9/5/10. Broke out in bad rash in 3 days on chest, face & underarms. Took month plus before subsiding. Have had small outbreaks on face, arms & hands recently that still continue.
Cramps, back pain, vaginal bleeding Narrative: Pt developed back pain, stomach cramps and vaginal bleeding after the vaccine. Pat went to non-facility ER 2 days after vaccination (records unavailable).
1st vaccine 1/31/21; 2nd vaccine 2/21/21; developed N/V/D, HA, chills onset 2/21/21 after vaccine; seen at ICC 2/26/21 for ongoing symptoms; sent to ED from ICC 2/26/21 for treatment of symptoms.
Patient's guardian stated that patient's birthdate , but when billing insurance we found that the birthday was actually, meaning the patient was 11 at time of vaccination. We called the guardian and they confirmed that they lied about the birthday.
Pt reports she had covid in November 2020 and is a ?long hauler.? She states when she came to clinic she had a headache due to ongoing neurological symptoms from her covid. Pt is waiting to see a neurologist. When pt sat down in observation she reported to Staff Representative she was feeling very warm nauseous, and her head was hurting her. Staff rep moved the pt near the open door to get some cool air.  VS : BP 130/80 HR 68 RR 16 O2Sat 98%  Pt reported feeling better after drinking water and getting fresh air. Pt was offered EMS evaluation. Pt declined. Pt signed refusal form. Left clinic at 10:45 AM. Pt was advised on ED precautions, was advised not to drive if she is not feeling well, and also advised to contact her PCP today to discuss further. Pt verbalized understanding and agrees to the POC.
Fever spiked to 103*F by 11:00 pm the day after injection. Controlled with ibuprofen (400 mg) and acetaminophen (1000 mg), reduced to 1000 mg acetaminophen as needed at intervals of 4 hours or more. Fever persisted varying between 99*F and 102.5*F for the next 48 hours accompanied by chills, night sweats, joint pain expecially in hands, fingers, and toes, mild episodes of nausea, flushing of the face. Extreme soreness and swelling of injection site to the point of waking pain at night. Swelling is roughly 10 cm along the length of the arm and 5 cm wide, mild to dark red. Now 4 days after injection most symptoms still persist, mitigated by acetaminophen doses.
chills, body aches, fever 102.5, headache, lightheaded, loss of appetite, intense sweating, vomiting,
Reactions appeared the morning following each dose and lasted 1-2 days.  After the first 3 doses, there was swelling and pain in joints, first knees, then hands and wrists, making it difficult to use those joints, but not severe enough to stop taking the vaccine.  The night after the 4th dose, I had vivid nightmares.
1/9/21 FIRST COVID VACCINE (PFIZER)  SECOND VACCINE 2/1/21 (PFIZER)  BOOSTER 11/2/21 MODERMA TWO DAYS AFTER THE BOOSTER I WAS LAYING IN BED THINKING I HAD HEARTBURN MY LEFT ARM WAS KINDA NUMB SO I TOOK A SHOWER ABOUT 8:30PM THINKING IT WOULD HELP GOT DRESSED AND MY LEFT ARM AND CHEST STILL HURT LEFT ARM WAS NUMB DROVE TO HOSPITAL TO GET CHECHED EKG WAS SHOWING HEART PROBLEMS THEY DID A CATH SURGERY AND FOUND NO BLOCKAGE I TOLD THEM A JUST GOT THE BOOSTER 2 DAYS BEFORE
Two hours post injection pt. started feeling fatigue and confusion. Symptoms persisted and worsened. Pt. went to hospital on 9/29/14 to seek treatment. Pt. BG was 11 at time of admission. Pt. received glucose tabs. Pt was discharged on 9/30/14. Pt. developed a fever of 102 degrees F on 9/27/14 - fever resolved on 10/1/14.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 21-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 ,L (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 504 hours, the lowest recorded temperature was 20 degree F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
NauseaVomiting chills Narrative:  off work two days  Other Relevant History:
Getting two shingle shot hurted like hell / pain for 4 days from it; This case was reported by a consumer and described the occurrence of general body pain in a 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 general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient reported that, he/she received shingle shot, hurt like hell and his/her body was in pain for 4 days from it. For tolerance to 2nd dose, refer case US2021AMR175900.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR175900:same patient, same reporter, same suspect
Extreme fatigue (starting day after shot) Nausea (starting immediately after shot) Ear ache (approximately 36 hours after shot) Chest pain/dizziness (5 days after shot) Trouble breathing (5 days after shot) Artery damage (discovered in ER) Fainting (1 day and 5 days after shot)  Treated at hospital ER - hospitalized for observation
elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; smell altered on and off; taste altered on and off; muscle pain; headache; all over pain first 36 hours preventing sleep; a little bleeding from bowel at 24 hrs and nose at 36 hrs; Burning like fire at injection site; Hair follicle pain; a little bleeding from bowel at 24 hrs and nose at 36 hrs; extreme armpit pain like torn muscles; no use of arm first two days; fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ER 8733) via an unspecified route of administration at left arm on 27Mar2021 15:15 at a single dose for Covid-19 immunization. Medical history of patient was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included multivitamin, calcium and fish oil (other medications the patient received within 2 weeks of vaccination). Patient stated as injected arm went numb within 15 minutes and stayed that way 48 hrs, extreme armpit pain like torn muscles began at 48hrs, bad stomach cramps first 24 hours, a little bleeding from bowel at 24 hrs and nose at 36 hrs, no use of arm first two days could not even put a robe on, fever that climbed to 101.7 until breaking first 48 hrs, smell and taste altered on and off. Burning like fire at injection site 12 hours later that came and went in waves for another 36 hrs. Hair follicle paint at 12 hrs when headache started, headache lasting 72 hours, all over pain first 36 hours preventing sleep, nausea began within first hour lasting about 40 hours, muscle pain first 48 hrs, fatigue begins at 36 hrs and continues, elevated resting heart rate since first night, dizziness and light headedness from 1st hour. The patient underwent lab tests and procedures which included body temperature was 101.7 and heart rate was elevated (elevated resting heart rate since first night) on 27Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. The outcome of event was recovering.
Uveitis possibly related to zoster vaccine. Prolonged course with treatment involving acyclovir, glaucoma drops, and topical steroids over the last 12 months. Now under control.
This spontaneous report was received from a nurse and refers to a 22 year old non-pregnant female patient with no drug reactions or allergies, who was also a nurse in the same office. The patient had no pertinent medical history. On 23-MAR-2016, the patient inadvertently splashed (Oka/Merck) VARIVAX in her eye (lot # reported as L045678, expiration date: 09-MAY-2017). There was no concomitant medication. On 23-MAR-2016, the patient experienced burning in the eye that came in contact with the (Oka/Merck) VARIVAX. The patient flushed her eye with water for 3 minutes and the burning improved. No lab diagnostic studies were performed. The outcome of the event of burning in the eye was reported as recovering. The relatedness between the event of burning in the eye and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Pt. and sibling both given immunizations. Tray with immunizations labeled correctly, but given to wrong patient.
1st vaccine. Headache, low-grade fever, vertigo for 2 days   2nd vaccine   Beginning day following vaccination severe hives all over body, itching skin entire body
This spontaneous report was received from a pharmacist concerning a 66 year old male patient. No concurrent conditions or medical history were reported. On 24-JAN-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot No. H009826 Expiration date: 11-FEB-2014) (dose, dose number and route were not reported). There was no concomitant medication reported. On the same date of administration, the patient experienced injection site pain for several days, painful enough that he couldn't sleep for that period of time. The pharmacist stated that the patient did not report any redness or any other adverse effects. The patient did not seek medical attention. No treatment was given for the adverse events. Also, she stated that the patient came to her pharmacy only for his vaccinations. The outcome of injection site pain was reported as recovered on an unknown date. Additional information has been requested.
Pt recv vax on 11/6/98; on 11/7/98 pt exp irritable & tired, knot on vax site (6 in diameter), red & warm x 2 day; tx=Benadryl & Tylenol
Per his mother , the patient experienced vomiting, chills, hallucinations, left sided numbness of the face and body and difficulty breathing. The patient was taken by ambulance the the emergency department.
FEVER, CHILLS, HEADACHE, MUSCLE ACHES, DENTAL IMPLANT HURTS, EYES HURT
Fever, chills, congestion, full body tenderness and aches, drowsiness, headache  Increased heart rate all day (while sleeping and sitting on couch).
mom reported pt cried for 4 hrs had colic prev but different from that called PMD; MD recommended double up on APAP;
Breakthrough case admission after 4 vaccines pfizer 1/25/21 Lot# El9261;  Pfizer 2/15/21 Lot# EM9810;  Pfizer 8/18/21 Lot# FA7485; ; Pfizer 6/13/22 Lot# FP4554
Got vaccine on Friday morning. Saturday I began having what felt like a pinched nerve in my back.  On Monday I developed a shingles rash and was diagnosed with shingles. I have nothing that would make me high risk at such a young age
A 6 month old was given PENTACEL and PEDIARIX in error. Should have gotten a PEDIARIX and HIB due to the PENTACEL shortage. Called the state immunization program to make sure this would not harm the infant. PCP and mother were informed. An epidemiologist from the state lab called back and said she would have a nurse from the immunization program to call back too. No recommendations given yet.
Malaise onset 36-48 h after immunizations; chills and possible fever 42-54 h after initial immunization; documented afebrile Day 3 after immunization with concomittant onset of mild headache lasting <24 hours.  All symptoms resolved by day 4 after immunization.  No antipyretics or other OTCs taken during this illness.
Child initially felt extreme fatigue and dizziness. This was followed by difficulty walking and numbness in arms and becoming non responsive to questions. By the time we reached ER she could not walk on her own and was in pain. Felt increasing better over the following 2 hrs.
Patient states that the day after vaccination she had fever and her right arm was red and itchy. Couldn't go to work for two days. Did not seek medical attention and took TYLENOL and cold compress. On 10/7/2016 a phone call was placed and she stated that she felt better, only the itching remained and a little bit of redness on the right arm.
Left arm swollen and red. Shoulder edge to 2/3 lower lateral (L) upperarm. No nodes