chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got her vaccine, the arm swelled up the top part of it, 3/4 of her arm swelled up and it was a huge red spot at the injection site that was big and hard.  It was severely itching, the kind that you cannot stop itching.  The pain up to her shoulders, upper to her neck to the point that she could not use her right arm for 2 days as it hurt so bad.  She could not use it to eat and so she had to do functions with the left arm instead.  She also felt very lethargic and felt like she was not with it, which continued for about a week.  The swelling went down after a week but part of the arm was still swollen, still hard, still red and still itching really bad.  Then she swelling and redness went from her arms to itching really bad.  It finally all stopped after about 2-3 weeks.  She did not go to her doctor and treated it on her own.     With the first vaccine, about 2 hours after the vaccine she started running a low grade fever which she had for 2 days.  She got redness and swelling at the shot site, probably got the size of 2-3" wide but red in the middle of it with a hardness in the area.  She just felt really really bad for those 2 days.   She called her doctor and he told her to wait a while until the newest version came out.   She is now afraid to get another shot as she has had reactions and the medical issues that she has.
Excessive and deep Coughing to the point of passing out. This was not happening before the vaccine booster but I believe it triggered my asthma more.  Dizziness Weakness Chills
Arm pain; unbelievable joint pain in hips; not able to walk; chills; could not lie down; chattering teeth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (unbelievable joint pain in hips), MOBILITY DECREASED (not able to walk), CHILLS (chills), ARTHRALGIA (could not lie down) and CHILLS (chattering teeth) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol.    On 22-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 ARTHRALGIA (unbelievable joint pain in hips), MOBILITY DECREASED (not able to walk), CHILLS (chills), ARTHRALGIA (could not lie down) and CHILLS (chattering teeth). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). On 27-Mar-2021, ARTHRALGIA (unbelievable joint pain in hips) and PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, MOBILITY DECREASED (not able to walk), CHILLS (chills), ARTHRALGIA (could not lie down) and CHILLS (chattering teeth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient has taken Percocet, Tylenol. concomitant medication include ezetimibe 10mg/day, telmasartan 80/mg/day, Hydrochrolizade 5mg/day   This case was linked to MOD-2021-121653 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: VAERS
shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In February 2019, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient received 1st dose of Shingrix last year and developed shingles 11 weeks ago, at the time of reporting. The reporter did not state dose 1 was related to shingles The patient did not receive 2nd dose of Shingrix and was asking for information on timing of dose 2 due to active shingles. The reporter did not provide any other details and did not consent to follow-up.
This spontaneous report as received from a medical assistant regarding a patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 05-APR-2016, the patient was vaccinated with second dose of ROTARIX suspension (dosing details, route, lot# and expiry were not reported) rather than ROTATEQ (dosing details, route, lot# and expiry were not reported) due to misdocumentation. No adverse reaction reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
This spontaneous report as received from an other unspecified source refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored PNEMOVAX23 (lot # J006921, expiration date: 09-AUG-2014, dose and route not reported). This is one of several reports from the same source (linked MARRS#: 1310USA014883, 1310USA014888, 1310USA014891. 1310USA000056, 1311USA000071, 1310USA015417, 1310USA014897, 1311YSA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064. 1311USA000020, 1311USA000021, 1311USA000040, 1310USA015096, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739. Additional information has been requested.
Patient called at 5:10pm on 5/16/21 stated she has shortness of breath.  I asked for details of what she felt and when it started and she stated about 30 -40 minutes after receiving the vaccine feeling  very tired.  I discussed that fatigue/tiredness were normal with the vaccine but shortness of breath was not ands asked if she has shortness of breath or fatigue and she stated "well both"  I advised her fatigue is normal and SOB is not,  and if she is experiencing shortness of breath to consider it an emergency and seek emergency care (911) and I would also report her adverse event.
Pt today presents with c/o musculoskeletal pains x 5 days. Injury: none, but had her final GARDASIL injection on 7/17;  Location: L arm;  Symptoms: pain and aching radiating to L neck; Exacerbating factors: movement;  Relieving factors: rest; Has a cleaning business and it is painful;  Has taken very little OTC medication
Client fully vaccinated with Moderna vaccine for Covid  in May and June, 2021.  Client became symptomatic on 8/10 (nasal congestion, cough, headache, loss of taste and smell).  Client tested PCR positive for Covid on 8/21.   Client had been in  on vacation when symptoms started and did not get tested until she came home.  Client's husband also was vaccinated and tested positive with symptoms starting on 8/16.  Reported as breakthrough Covid case in fully vaccinated person.
This spontaneous report as received from a licensed practical nurse via company representative refers to a 16 year old non-pregnant female patient. The patient's medical history including fainting after receiving unspecified vaccination shots. There was no concomitant medications reported. On 02-JUL-2015, the patient was vaccinated with third dose of the GARDASIL 9 0.5 ml, intramuscularly, (site, a lot# and expiry date were not reported). On the same day, after receiving GARDASIL 9 she fainted. There was no treatment given for the adverse event. On 03-JUL-2015, the patient recovered from the adverse event. The patient sought medical attention in the doctor's office. The relatedness between GARDASIL 9 and the event was not reported. Additional information is not expected as the reporter did not wish the further contact.
Severe abdominal pain, persistent vomiting in middle of night (3AM) until mid am after imm given late after noon (5:00 pm) imm given. Stopped vomiting at noon next day.
Caller is a respiratory therapist who reports that he tested positive for covid after receiving the first dose of the vaccine on 17Dec; Caller is a respiratory therapist who reports that he tested positive for covid after receiving the first dose of the vaccine on 17Dec; This is a spontaneous report from a contactable consumer (patient) reported that a 32-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration from on 17Dec2020 at single dose (once by injection in the right arm/bicep) for COVID-19 immunization (Healthcare worker). There were no medical history and concomitant medications reported. The patient/caller is a respiratory therapist who reported that he tested positive for covid after receiving the first dose of the vaccine on 17Dec2020. He called to ask if he can get the second dose. He also wanted to ask if people experienced side effects or what side effects people experience after the second dose. He tested positive for Covid-19 on 21Dec2020, after receiving the first dose of the vaccine. He said it had been 14 days since he tested positive for COVID and he is if he can get the second dose. He says he is actually on his way to get the second dose right now, and thought he should call. The outcome of the event was unknown.
Bilateral inguinal lymph nodes enlargement with tenderness to touch about 48 hours after vaccines administrations to bilateral thighs. No previous lymph nodes enlargement to groins or anywhere else ever assessed previously.
Site: Bruising at Injection Site-Mild, Additional Details: Patients daughter called to state that after her Mom was given the second vaccine booster, there was a bruise that formed and lasted for up to 2 weeks. no other side affect or issue thereafter.
Extreme chills, Fever (TMAX 102.2 F), body aches, fatigue, headache   Lasted 48 hours and started improving after. Still not 100% after 48 hours   Minor nose bleed after 48 hours
1. Started Saturday Sept 10th 2023 2. On average has diarreah 5 times a day now its about 3x a day. However there were a few days where he had diarreah up to 10 times per day but most of the time it was mucus or watery stool. 3. He also has  mucus and watery stool when he has passes gas . He can't control it, so he has accidents throughout the day.  This happens at least 5 times a day. He has never had an accident in the past since he's been potty trained. 6. He is in pain prior to having diarreah and  while he is having a bowel movemet. Sometimes it takes him at least 10 minutes to go and only a little bit comes out at a time ( it hurts when he pushes )  7. He is very bloated and passes a lot of gas prior to having a bowel movement
No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0  48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002932: US-009507513-2105USA002933: US-009507513-2105USA002934: US-009507513-2105USA002942: US-009507513-2105USA002941: US-009507513-2105USA002940: US-009507513-2105USA002939: US-009507513-2105USA002938: US-009507513-2105USA002937: US-009507513-2105USA002943: US-009507513-2105USA002935: US-009507513-2105USA002866:
Patient's caregiver called hospital call center on 11/29/21 for c/o of "hives all over pt's body" Mother denies treatment symptoms at home and no acute distress during call.  Mother was advised to take pt to ED for evaluation. Patient's mother will follow-up with pt's PCP in regards to symptoms instead. ER precautions were provided by RN during call.
feel a lot of pain in my limbs and my muscles; feel a lot of pain in my limbs and my muscles; bone pain; He got the duplicated first dose in Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Pfizer-BioNTech), administration date: Jun2021, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Dec2021, outcome "unknown", described as "He got the duplicated first dose in Dec2021"; MYALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "feel a lot of pain in my limbs and my muscles"; BONE PAIN (non-serious), outcome "unknown", described as "bone pain".  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-up (22Mar2022): This is a spontaneous follow-up report from a contactable consumer. Updated Information Included reporter mailing address updated. Historical vaccine administration date updated.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Chills, vertigo, malaise, dry cough, fatigue, muscle/joint pain, insomnia; ibuprofen as needed is helpful
BACK PAIN; SHOULDER PAIN; AWFUL ALLERGIC REACTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced back pain, shoulder pain, and awful allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from awful allergic reaction, shoulder pain, and back pain. This report was non-serious.
Vaccine given on 7/9/19 with patient compliant of immediate severe pain at time of injection at injection site that resolved on 7/12/19. Patient states within 5 minutes of injection noticed left under arm, collar bone and upper back pain that started to improve on 7/15/19. On 7/10/19 patient noticed red rash on face. She started taking Benadryl 25 mg on 7/14/19, 3 doses with no improvement. Patient came to the clinic on 7/15/19, diagnosis with adverse vaccine reaction, instructed to continue benadryl every 4 hours and prescribed valacylovir 1gm TID x 7days.
Patient says she felt very faint and weak about 2 hours after the vaccine was given, and the area around the vaccine became very swollen.
Severe allergic reaction. Facial swelling, rash and hives, difficulty breathing, flush
Pt died on 1/9/22.  She had respiratory failure  after surgery for type A aortic dissection and was unable to wean from ventilator. Pt and family chose comfort care with removal of life support.
The worst sinus infection of my life started 2 days after the vaccine.; I woke up Sunday 3am sick; but it was squeezing my brain and on the back of my head too; desperate; Now, 2 weeks later it started again.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 10:15 (Lot number: Ew0182) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot_number=EW0171,, administration_time=09:30 AM, dose_number=1,, vaccine_location=Left arm), administration date: 17Apr2021, when the patient was 35 years old, for COVID-19 Imunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: SINUSITIS (non-serious) with onset 11May2021 15:45, outcome "not recovered", described as "The worst sinus infection of my life started 2 days after the vaccine."; ILLNESS (non-serious) with onset 11May2021 15:45, outcome "not recovered", described as "I woke up Sunday 3am sick"; HEAD DISCOMFORT (non-serious) with onset 11May2021 15:45, outcome "not recovered", described as "but it was squeezing my brain and on the back of my head too"; FEELING OF DESPAIR (non-serious) with onset 11May2021 15:45, outcome "not recovered", described as "desperate"; DISEASE RECURRENCE (non-serious) with onset 11May2021 15:45, outcome "not recovered", described as "Now, 2 weeks later it started again.".  Additional Information: Facility where the most recent COVID-19 vaccine was administered:Pharmacy or Drug Store, The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient has not diagnosed with COVID-19 Prior to vaccination. The patient has not tested for COVID-19 since the vaccination. The worst sinus infection of her life started 2 days after the vaccine. She took it on Saturday she woke up Sunday 3 am sick. She was kinda okay too but on Tuesday she had the sinus infection symptoms but it was squeezing her brain and on the back of her head too. She had it for 5 days. Now, 2 weeks later it started again. She was desperate.   No follow-up attempts are possible. No further information is expected.
Low Fever; This is a spontaneous report from a contactable pharmacist, reporting for himself. A 33-year-old male patient received the second dose of the bnt162b2 (BNT162B2; Lot Number: El3248), via an unspecified route of administration in the left arm on 25Mar2021 at 14:00 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. There were no allergies. The patient previously received the first dose (Lot Number: EN6203) of the bnt162b2 on 02Mar2021 at 2:00PM at 33 years of age in the left arm for covid-19 immunization. No other vaccines were given 4 weeks prior to bnt162b2. On 26Mar2021 at 03:00, the patient experienced low fever, which was non-serious. No treatment was given. There was no covid prior to or post vaccination. The clinical outcome of the event was recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Hives over entire body about 14 hours after shot administered. Called the Stillwater emergency room and was told to take (2) Benedryl and watch for indications of breathing trouble or swollen eyes. Rash stayed about 48 hours but hives and itching ceased by morning.
getting sick; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at a single dose for immunization, influenza vaccine (FLU VACCINE VII), via an unspecified route of administration on an unspecified date at unknown dose for immunization. Medical history included ulcerative colitis. Concomitant medication included infliximab (REMICADE) for ulcerative colitis, vedolizumab (ENTYVIO) for ulcerative colitis. Being switched from vedolizumab for treatment of ulcerative colitis to infliximab for treatment of ulcerative colitis after taking vedolizumab for a couple of years. The reporter reported receiving a flu shot and pneumonia shot but still getting sick when going out while taking infliximab on an unspecified date. The outcome of event was unknown.   Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Dad describing swelling left nodule under skin, light thigh with redness, swelling and tenderness since injection 7/5/06 Hep A. Erythema induration and papules surrounding site. Site measures 2.5cm in diameter.
Thirteen hours after the injection there was a sudden onset of joint and muscle pain as well headache. The intensity was severe enough to prevent sleeping for over eight hours. This was accompanied by chills alternating with feeling hot without a measured fever. Six hours after the onset of pain two 500 mg acetaminophen were taken with some blunting of the pain though minimal improvement. After the initial eight hours the pain in in the joints and muscles subsided over about four hours. The headache that was akin to migraines in the past persisted for another six hours and was eventually relieved by two doses of ibuprofen 600 mg six hours apart.
PT DIAPHORETIC, HYPOTENSIVE BP 90/40 HR 60-70 O2SATS 99%  ROOMS AIR PT PLACED IN STRETCHER, VITALS AND LOC CONTINUOSLY MONITORED-AT 2:33PM PT STATED "FELT BETTER, PT NO LONGER DIAPHORETIC, VITALS BP 114/60 HR 70, O2 SATS 99% RA
Information has been received from a registered nurse referring to  unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # J012376 with expiration date 03-OCT-2015, K0110582 with expiration date 08-AUG-2016, L003775 with expiration date 04-FEB-2017, and L007225 with expiration date 03-MAR-2017; dose, route and dose number were not reported), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Initial case received on 01 April 2014 from a health care professional. A patient (date of birth, age and gender not reported), with no reported medical history and no reported concomitant medication, experienced severe flu like symptoms following the administration of IMOVAX rabies (lot number J1391, expiry date: 26 July 2015) in the context of a professional exposure on an unspecified date. Time to onset, site and route of administration were not reported. The outcome of the event was not reported. Further information will be requested from the reporter. Documents held by sender: none.