chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other AE's; temperature excursion on RECOMBIV AX that was administered.; This spontaneous report was received from the medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-APR-2021, the patient was vaccinated with improperly stored Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 1 time dose (lot numbers reported as T004378 and T022566; expiration dates established upon internal validation as 07-MAR-2022 and 03-NOV-2022, respectively) (exact dose, route of administration and anatomical location were not provided), for prophylaxis. Administered dose of vaccine experienced temperature excursion of 48.2 degrees Fahrenheit for 2 hours. There was no adverse event reported. Data logger was not involved. There were no previous excursions reported.  This is one of three reports received from the same reporter.
Fever - 38.6C for 48 hours, headache, chills, swollen glands on side shot was administered, red welt at site of shot
pt recvd vax; fever to 101 approx 6hrs p/ vax; given w/ hypoirritability for subsequent 24-48 hrs;
PAD (peripheral artery disease) -Procedures:  left common femoral and superficial femoral artery endarterectomy with bovine pericardial patch angioplasty, left superficial femoral artery drug-coated balloon angioplasty as well as self-expanding nitinol stent angioplasty. Recovery in hospital and discharged home. Hospital admission within 6 weeks of receiving the COVID vaccine.
Information has been received from a physician concerning a 4 year old caucasian male who on 2/12/98 received the 1st vaccination of MMR II. On 11/17/00, the pt received the 2nd MMR II in the right thigh. He also received DTAP + IPOL. On 11/17/00, later in the evening, the pt's parents called the physician to report the pt had changes in his voice, swelling of lips, edema, and hives. The pt's respiratory status was stable. The pt did not have wheezing or stridor. The pt was given hydroxyzine HC1 (Atarax) but "spit it out". The pt was then given Benadryl and his symptoms resolved. On 12/4/00, the pt's mother called the physician concerned about "lisp". The pt's mother was worried that the pt's speech change could be due to the vaccines. The pt was referred to speech therapy and the evaluation is pending. In further follow-up, the pt's physician did not feel that the lisp was related to the child's vaccinations. She indicated the child has been referred to speech therapy and that as far as she knows, the lisp is still present. The physician also reported that the child has "recovered completely" from his other symptoms. Additional information has been requested. The changes in voice, lisp, swelling of lips, edema and hives were considered to be "Other Medical Events". The changes in the pt's voice and lisp were considered to be disabling. Follow-up info corrected the date of vaccination and date of onset. Also, previous vaccination date was changed.
Information has been received from a pharmacist concerning an adult female employee with no medical history or allergies who on 11-MAY-2006 in the evening was vaccinated intradermally in the left forearm with a 0.5 mL dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 649674/0239R). There was no concomitant medication. On 11-MAY-2006 she developed a 4x5 cm raised red area with discoloration, itching, pain and mild cellulitis at the injection site for two weeks. The patient completely recovered after approximately three weeks on 29-MAY-2006 without treatment. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Felt as if i had a mild flu. Muscle aches, headache, fatigue.  lasted until the next morning.
fatigue, injection site reaction Narrative:  Patient states fatigue + arm pain that lasted less than 24 hours
This spontaneous report as received from a registered nurse refers to a 49 years old female patient with Chronic obstructive pulmonary disease (COPD), emphysema and drug allergy to sulfas. The patient's medical history included pneumonia. The patient was intramuscularly vaccinated with a dose of 0.5 ml PNEUMOVAX23 (lot number reported as 19478A, expiry date: 20-OCT-2013) on 31-OCT-2012. No other co-suspects were reported. Concomitant medications included albuterol sulfate and fexofenadine hydrochloride, ALLEGRA. On 31-OCT-2012 the patient could not lift her arm after receiving PNEUMOVAX23. The patient called the physician, who advised that she take BENADRYL (unspecified strength and amount) and alternate hot and cold compresses on the affected arm. There were no laboratory diagnostics studies performed. The outcome of could not lift her arm after receiving PNEUMOVAX23 was reported as recovering/resolving. This is one of several reports from the same source. Additional information has been requested.
right sided numbness/tingling, inability to control hand/foot movements.  Right sided lip tingling. Nausea and sensation I might be  passing out.  Always right sided,; occurred intermittently like episodes or attacks.  Symptoms have continued for 8 weeks.  In the last 3-4 days the symptoms have been less frequent and les intense but are ongoing.  Saw internist who requested brain MRI and autoimmune labs - all of which were within normal limits..  Saw neurologist who interpreted the MRI as normal .
pt recv vax; LOC, probable sz between 12 & 12:30pm on 16jun95;tingling & jerking in rt hand & the LOC; eyes rolled back;dad witnessed rxn & states, lasted approx 5-10 mins;
Extremely sore arm "muscle pain" at injection site. Tender to touch. No redness or swelling.
Patient fell and hit head after walking from the observation area to the elevator. No bumps, bruises, or scrapes. Vitals stable. BP 109/61, pulse 60, 98% O2 sat. AO x 4.
Reports having itching in area on 11/22/02. Saw vesicles around area on 11/25/02 and reported. Client states redness and swelling began on 12/2/02; 4cm X 11 1/2cm (3 1/2" X 4 1/2"), left mid upper arm. Client reports she has used ice and Eucerin Cream when area started itching and began using ice soaks when area started hurting on 11/28/02. Above symptoms gone after 48 hours. At ER, was given Keflex 500mg TID, Naproxen and Allegra and to follow-up with PMD in 4 days, (12/05/02).
Patient described a swollen tongue and senation in back of throat sensation. Onsite EMS was called vitals BP 128/60. Patient recovered and went home.
Swelling, rash, soreness at injection site starting at 5pm 06/20/18. Fever of 102F starting at 3:00am 06/21/18, uncontrolled shaking 3:00-5:00am. Fever decreased and resolved by 9:00am. Soreness, swelling, rash continued until 06/24/18.
no additional AE/PQC reported; administration of improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 23-SEP-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA) (PROQUAD) lot # T015598, expiration date 02-NOV-2021 for prophylaxis (exact dose, strength, dose #, route of administration and anatomical location were not provided).   The temperature excursion was as follows: 20.5 degrees Fahrenheit (F) for 1 hour and 54 minutes. There was following previous excursion: from 6 degrees Fahrenheit to 14 degrees Fahrenheit (12.3 F) for 23 hours. The digital data logger was involved. No additional adverse events were reported.
numb arm, fever, chills, light headed, couldn't walk, couldn't breathe, heavy legs, hurt to move feet, blood clots in stomachs and lungs
The day following my vaccination I developed a large itchy red rash at the injection site which extended halfway down to my elbow.
Supsected vaccination failure; Bells Palsy; internal shingles; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, bell's palsy and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, bell's palsy and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got internal shingles along with Bell's palsy. This case was considered as suspected vaccination failure since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
undiluted 0.3ml vial was given to patient, the patient did not have any adverse affects reported
No additional AE/PQCs reported; administration of improperly stored PROQUAD.; This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 29-OCT-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status rHA (lot number T015598 was confirmed to be valid, expiration date: 02-NOV-2021) (dose, route of administration, vaccination site were not specified) for prophylaxis. The vaccine underwent a temperature excursion between 20.5 degrees Fahrenheit (F) for 1 hour 54 minutes. There was a previous temperature excursion between 6F to 14F (12.3F) for 23 hours. Digital data logger was involved. No additional adverse effect was reported.
Received flu vaccine 2 weeks ago in early a.m. (see time). Within 12 hours had developed fever, chills and aches. Has persisted until today when she began to feel improvement. Has sought no medical attention. Declines offer for referral to Occ Med. Four days ago began to have cough with sneezing but has since resolved.
Pt presented at the ER with ecchymosis from shoulder to elbow with tenderness at injection site 17 days after immunization.
SINUS PRESSURE, ST, BODY ACHES, COUGH, NAUSEA.
Right arm/injection site. Swelling noted from deltoid to slightly above elbow. Nickel and quarter sized raised areas with erythema. Arm is sore from Shoulder to elbow.
Chills, warmth down throat, lots of mucous, cough, fever, lethargy.
Chest tightness/pain.  Abnormal EKG.  Pericarditis.
severe anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 6 patients. This is the first of 6 reports.    A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date at a single dose for vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced severe anaphylaxis, on an unspecified date. Outcome of the event was unknown.    No follow up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003208 different patient/same drug/event;US-PFIZER INC-2021003209 different patient/same drug/event;US-PFIZER INC-2021003210 different patient/same drug/event;US-PFIZER INC-2021003211 different patient/same drug/event;US-PFIZER INC-2021003212 different patient/same drug/event
Left arm started to feel hot & pain (scale of 5 out of 10) w/onset of sx @ 11:00 PM. Woke up 10/18/14 redness and increased in size to 3" X 2" in size & hot to touch. Tingling to finger tips.
PASSED OUT; CONVULSIONS; BLOOD PRESSURE CRASHED TO 78/50; IRREGULAR HEART ACTIVITY; LIGHT-HEADED; FELL OUT OF CHAIR; CAN'T SLEEP; LIVING IN FEAR; This spontaneous report received from a parent concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was waiting in the seating area with reporter's wife when he felt light-headed, passed out, and fell out of the chair. Reporter's wife helped him back to his chair wherein he again passed out for the second time and went into convulsions. During this time the nurses called 911 and he was transported by ambulance to the hospital where he was admitted to emergency room (ER). The doctor had ordered electrocardiogram (EKG) and head computed tomography (CT) of the patient which was normal. The blood pressure of the patient had crashed to 78/50 mmHg and even after two bags of intravenous (IV) fluid the blood pressure was not above 100/70 mmHg. After remaining in the ER for the remainder of the day the patients blood pressure (BP) leveled off (normal) and he was released that evening. The attending physician recommended that the patient not receive a follow up or booster vaccine in the future.  The patient continued to have irregular heart activity and was seeing an internal medicine doctor near his college. It was reported that the patient had been in the hospital twice in his life, the day he was born and the day he had received the johnson and johnson vaccine. The patient was living in fear and struggling with classes as he could not sleep due to heart irregularities and was placed on beta blockers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure crashed to 78/50, had not recovered from irregular heart activity, and can't sleep, and the outcome of light-headed, passed out, fell out of chair, convulsions and living in fear was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211000598-COVID-19 VACCINE AD26.COV2.S-Passed out, Convulsions, Blood pressure crashed to 78/50. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 16-Mar-2022; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 16-Mar-2022) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 16-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 16-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that date the vial was initially stored in the refrigerator was on 31-Jan-2022. No temperature excursion. No treatment medications were reported.   This case was linked to MOD-2022-525860 (Patient Link).
fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on 6th November 2020, refer case US2021103231).   On 6th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 6th May 2021, less than a day after receiving Shingrix, the patient experienced fever. Rechallenge with Shingrix was positive. In May 2021, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient experienced fever that lasted 24 hours then resolved.  The patient also had bloodwork which showed low lymphocytes and it was unknown whether the low lymphocytes had resolved by the time of reporting.  The reporter did not consent to follow-up. No further information was reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021103231:same reporter
Information has been received from a 60-year-old female (licensed visiting nurse) who on 08-OCT-2007 in the evening was vaccinated subcutaneous in the left arm with her first dose of Zostavax (Oka/Merck). On 09-OCT-2007 in the morning at the injection site the patient developed welts and had swelling and redness from her elbow to her shoulder that persisted for a week. "It was also warm to the touch". The patient sought unspecified medical attention. The patient took BENADRYL to help her reaction. On 14-OCT-2007 the patient recovered. A product quality complaint was not involved. No further information is available.
Initial report received from a healthcare professional on 27 February 2014. A 53-years-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (batch number UH897AC, dose number was unknown) intramuscularly in the left deltoid on 24 January 2014. On 26 January 2014, after three days of vaccination the patient could not lift the left arm with a shooting pain from injection site to fingers. The patient's illness at the time of vaccination was unknown and the patient does not have any pre-existing diagnosed allergies and birth defects. Corrective treatment and laboratory details were not reported. The patient was recovered on an unspecified date. Documents held by sender: none
First Covid 19 vaccine administered March 2021.  Starting ~ April 2021 (unfortunately cannot remember exact date) noticed tingling in right pinky toe.  Shortly after noticed tingling in left pinky toe as well.  Over time tingling progressed to involve multiple toes and then hands (symptoms in both hands and feet noted by June 2021).  Severity of tingling waxed and waned throughout day.  By August 2021 also noticed pain in right calf (burning, intermittent), and intermittent, short-lived, shooting, shock-like pain in single digit on left foot (observed when walking down stairs).  Was evaluated at clinic on June 17, 2021 and had CBC/Diff, CMP, Cardiovascular risk assessment, Vit B6, Hemoglobin A1cL, LDL cholesterol, Lipoid panel with LDL/HDL Ratio, magnesium, phosphorus, TSH+Free T4, vitamin B12 and folate, Vitamin D levels checked - all WNL.  Also spoke with OB/GYN as gave birth vaginally- no differentials given at that time.  Referral to Neuro recommended.  Moved cross country, saw new PCP.  Had zinc, Vit B12, ESR, ANA, Intrinsic factor, Sjogren antibody panel, protein electrophoresis, UA, brain MRA, celiac disease panel, cervical radiographs, and lyme testing performed between August and December 2021 - all within normal limits.  Had telemedicine consult with Neurologist January 17, 2022.  Diagnosed with presumptive peripheral neuropathy.  Spinal tap and EMG recommended, but have not been performed yet as would require travel and I elected to wait until weaning my infant to travel due to Covid.  NO CAUSE OF PERIPHERAL NEUROPATHY HAS BEEN DETERMINED, SO I DO NOT YET KNOW IF RELATED TO VACCINE.  Did not report until now as I recently read that peripheral neuropathies have been reported post vaccination.  Currently, pain has resolved.  Tingling in fingers and toes persists, continues to wax and wane, but is overall much more mild than it was previously.  May be worse when dehydrated/after lying down.
Symptoms started about 8 days after receiving first vaccine.  The first symptom to present was Tinnitus started light then went to SEVERE. About 6 days after onset of tinnitus I started with cold sweats, chills, BAD vertigo, Nausea, headaches around my head (not just in one spot) and no appetite. In the following days symptoms have not subside .....going on 2 weeks now.
Chills; Achy; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and MYALGIA (Achy) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced CHILLS (Chills) and MYALGIA (Achy). On 01-May-2021, CHILLS (Chills) and MYALGIA (Achy) had resolved. Not Provided          No concomitant medication were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-066832 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066832:wife 1st dose case
Several Days after the first  Moderna vaccination an old fatty cyst site on my back flared up and became infected. The cyst had be drained,  treated with antibiotics and tested positive for staph infection two years earlier and was dormant prior to the covid shot. I am being treated with antibiotics by my dermatologist, have received the second Covid shot and the cyst site is still active.  I do have a history of getting staph infections. When I was in high school, I had severe mat burns from wrestling, accompanied by swelling of the lymph glands in my armpits and groins.  I have had a few recurrences of staph triggerd by events like insect bites and minor cuts.
Started feeling exhaustion, went to dinner at 6pm, threw up all of dinner, had chills, next day woke exhausted & with cold symptoms- sneezing, 99 degree fever, sore throat.