chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse Event; Medical assistant reports Vaxneuvance given oral not IM.  No side effects reported.  No further AE.  No PQC.; This spontaneous report was received from an other health professional refers to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE), oral ((lot #, expiration date, exact dose, and anatomical location were not reported) for prophylaxis (incorrect route of product administration). No adverse event reported (no adverse event).
Pulmonary embolism; Shortness of breath; A spontaneous report was received from a physician, concerning a 67 years old female patient, who received Moderna's COVID-19 vaccine and experienced shortness of breath and pulmonary embolism.  The patient's medical history was not provided. Concomitant product details were not provided by the reporter.  On 15-Feb-2021, prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis. On 15-Mar-2021, after the recovery from the events, the patient received her second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On 18-Feb-2021, after first dose of vaccine, the patient experienced shortness of breath and required 2 days hospitalization for pulmonary embolism. Treatment using Enoxaparin was reported. The shortness of breath was gone once being discharged  from the hospital. Rivaroxaban was prescribed as the discharge medication.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events shortness of breath was considered resolved and of event pulmonary embolism was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Continuous muscle spasms in lower extremities, loss of proprioception. These have continued for 90 days without easing up.
Called physician-symptoms-runny nose, sore throat and hoarseness.  No treatment, recovered.
23JAN95 pt recvd vax & 2/in 1-2 hrs max temp 103, febrile x 1 1/2 days, h/a off & on x 1-2 days; lt arm where vax recvd swollen & painful x 1 day w/sharp  pain; radiating thru arm & occasionally to head;
Shortly after receiving the covid vaccine first shot. I began to develop symptoms that I have never previously felt and have sent me to the hospital in the time since. I have developed serious pins and needles sensation in my left foot, and hands. My left foot and leg constantly feel stiff. My left foot constantly feels as though it is buzzing or vibrating. I have received 3 blood test, imaging test, spent thousands of dollars trying to figure out what is wrong with me. The only thing in my life that changed was the covid vaccine. I can no longer work out due to pain in my leg. I am extremly heat intolerant. This vaccine has ruined my life.
Patient at had stated that she was not feeling well, and asked for us to grab her water. Came back with water and was able to drink some water, but then fainted and started to have convulsions (all this while she stayed seated). After she back after convulsions, she was not 100% aware, and then did faint and had convulsions again. This second incident did not last as long. She came back again, and although was still feeling faint, her color was coming back but still was not feeling back to normal. Vomiting did occur after the 2nd incident while she was aware. 911 and EMTs were called after first incident of convulsions and they arrived after the patient had vomited. This occurred between 9:30am and 9:50am. Patient was taken to the hospital.
Tenderness, warm to touch, red, itchy and then rash on 3rd day after vaccine. Applied ice. Lasted about 6 hrs.
Was Shingrix originally a single dose; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in April 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The patient was the reporter. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
SYRINGE WAS CRACKED AND AS I GAVE SHOT FLUID CAME OUT THROUGH THE BOTTOM OF SYRINGE ON MY HAND. PT STATED DID NOT FEEL THE FLUID GO IN. PROVIDER NOTIFIED AND OK TO REPEAT PER HER.
received flu at another clinic,  No reactions. Mother had forgotten she already gotten a flu vaccine elsewhere.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a adult male patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was unknown. It was unknown if the reporter considered the chills to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that the patient experienced chills. No details were provided by healthcare professional.
Immediately upon receiving injection I had tingling/numbness in my left arm that went all the way to my hand. I had weakness in my left hand.  25 minutes after injection my numbness significantly intensified and I had contracture of the left hand. I also experienced tingling of the lips, tongue and face.  Within a couple minutes my right hand also began to experience contractures. At this same time my heart started racing and i had difficulty breathing (likely hyperventilation due to stress).  Once I arrived at the emergency room a ecg was completed. The contractures went away, but re-emerged multiple times. My ionized calcium was found to be low (1.11 mmol/L), but no other notable lab abnormalities.  This persisted for a few hours and finally went away.
submassive pulmonary embolism 12/23,  required heparin therapy, ICU care, acute hypoxemic respiratory failure
Patient was asked before administration if he had received any Covid vaccine before and pt denied ever receiving any covid vaccine. So a dose of the Janssen vaccine was administered during a mass vaccination event but it was later discovered during documentation that patient had previously received a dose from a different clinic in March.
Patient had swelling and redness over the right deltoid area 2 hours after the vaccine is administered.  Her arm was warm and she had low grade fever.
Varicella vaccine given SQ left thigh on 11/27/2004. Fever to 101.5 began 12/07/04. Also noted redness and swelling at inj site, non tender, no warmth. 12/08/04 developed 3 erythematous papular lesions on abdomen. Remainder of exam 12/08/04 was normal.
This case was reported by a physician and described the occurrence of celiac sprue in a 64-year-old female subject who was vaccinated with FLUARIX (trivalent or quadrivalent unspecified, GlaxoSmithKline). In September 2013, described as "last month," the subject received a dose of FLUARIX (unknown details). In 2013, within months of vaccination with FLUARIX, the subject experienced celiac sprue (described as "a celiac reaction"). This case was assessed as medically serious by GSK. At the time of reporting the event was resolved. Per the physician, the subject had "recovered from the reaction." Per the physician, the subject may have contacted GSK for information about such a reaction and may have been previously reported; however, attempts to locate such a case were unsuccessful. The physician did not have any further information about the reaction.
Within one day-swelling-half dollar size- around site of vaccine. Beginning 12/10/02-much gastrointesfinal discomfort and pelvic pain-resulting in trips to gynecologist and ER.
Broke out into a rash; This is a spontaneous report from a contactable physician (patient).   A 45-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 21Aug2021 between 10:00-11:00 AM (Lot Number: FC3180), at the age of 45 years old, as 1st single dose for COVID-19 immunisation. Medical history included allergy to many medications (unspecified). There were no concomitant medications. There were no prior vaccinations within 4 weeks from the 1st administration of BNT162b2. The patient reported that on 23Aug2021 she broke out into a rash. The patient was not sure if she was allergic to any of the ingredients in the vaccine. The patient had called her dermatologist and doctor but she did not visit any physician's office, nor went to ER. After a week, the rash went away. The patient got her 2nd dose of BNT162b2 on 11Sep2021 and rash re-appeared on 13Sep2021.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101199467 same reporter/patient, different dose/similar event
Client reported feeling tingling in neck and tightening of her back muscles and not feeling well. Skin pink, warm, dry. Pulse 63, SaO2 93% on room air. Provided Diphenhydramine HCI/antihistamine 12.5 mg chewable tablets, #4 for total of 50mg. Provided bottle of water and snack. Client felt better within 10-12 minutes. Pulse 66 and regular, SaO2 94% room air. Observed post vaccination for 30 minutes and released. Instructed to call 9_1_1 if she should develop further problems after leaving our facility. Follow up phone call on 11/17/2022, client reported she did not require further evaluation or medical intervention.
Systemic: Seizure-Severe, Additional Details: pt had seizure approximately 5 minutes after receiving vaccination,was sitting in waiting are,stood up,passed out,hit head,then seized.was short.called 911.pt apparently has history of seizures with vaccination.was cleared by ems. worker called pt at 6 pm and pt was fine..
Varicella vaccine breakthrough.  Had vaccine on 4-20-00 and 2-21-08.  Diagnosed with Varicella on 8-16-08.  Had 30 to 40 lesions.  No fever.
Pt received TDAP vaccine on 4/25/18 and returned to facility on 5/16/18 with complaints of: dizziness, altered gait, decreased sensation but all tests and examination showed no deficits.
a little bit of a low grade cold; sinus drip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "a little bit of a low grade cold"; SINUS DISORDER (non-serious), outcome "not recovered", described as "sinus drip". Additional information: Patient have not experienced a fever. Event sinus drip thing was going on. Reporter stated these symptoms have nothing to do with the COVID vaccine as they had received it 3 weeks ago and the symptoms were from a day or two ago when they were out in the wind. Patient was due for second dose on Wednesday, 31Mar2021. Reporter was querying if the events pose any problems in getting the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information currently available, the reported 'cold' and 'sinus drip' are likely intercurrent medical conditions and are unrelated to suspect product bnt162b2. Case will be reassessed if additional information is received.,Linked Report(s) : US-PFIZER INC-2021355750 Same reporter and drug; similar event; different patient.
2 days following inject pt devel OM & conjunctivitis w/fever; treated w/Augmentin; devel vomiting & dehydration 3 days p/vax; unexputed death autopsy showed brain edema;
Fever- 102.7, body aches (muscles and joints), headache, chills, dizziness
Pt recvd vax 28MAY92 @ 2PM & @ 530PM had fever of 103.4; MD recommended APAP & sponge bath via phone; 29MAY fever of 101; no other sx; 30MAY @ 5AM temp nl; found dead in crib @ 630AM; Autopsy being performed;
Information has been received from a consumer concerning her friend's daughter, a 7 week old female patient who in July 2008 "about 7 weeks ago", was vaccinated with 1 mL of RECOMBIVAX HB (lot # not reported).  On approximately 31-AUG-2008, "9 days ago, the patient experienced a high fever and was taken to the emergency room.  She had tests done which showed that her platelets were low and she was admitted to the hospital.  The patient's platelets continued to go down.  The lowest the platelets got were 5000.  The consumer reported that the doctors continued to do test and everything came back normal. The consumer also reported that in addition to having low platelets, the patient also experienced an enlarged liver and spleen as well as a bloated belly.  The patient was subsequently put on a feeding tube"  Therapy with RECOMBIVAX HB was discontinued.  At the time of the report the patient had not recovered from high fever, low platelets, enlarged liver, enlarged spleen and bloated belly.  Additional information has been requested.
Mild pain in arm at site of injection, felt tired and cold, mild headache. Symptoms began about 12 hours after injection. Lasted about 1 day with no other complications.
PAIN IN EAR; PAIN IN JAW; STRANGE FEELING IN BACK OF THROAT AS IF SOMETHING WAS STUCK BOTTOM OF THROAT; ITCHING; TINGLING IN LIPS; BLOTCHING FLANK (UPPER BACK, NECK AND FACE); DISCOLORATION; RASH ALL OVER ARM (ARM OF VACCINE); TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid, and concurrent conditions included asthma, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use and also had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. Concomitant medications included salbutamol for asthma. On 01-JUN-2021, the subject experienced strange feeling in back of throat as if something was stuck bottom of throat. On 01-JUN-2021, the subject experienced itching. On 01-JUN-2021, the subject experienced tingling in lips. On 01-JUN-2021, the subject experienced blotching flank (upper back, neck and face). On 01-JUN-2021, the subject experienced discoloration. On 01-JUN-2021, the subject experienced rash all over arm (arm of vaccine). On 01-JUN-2021, the subject experienced tiredness. On 01-JUN-2021, the subject experienced headache. On 02-JUN-2021, the subject experienced pain in ear. On 02-JUN-2021, the subject experienced pain in jaw. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from strange feeling in back of throat as if something was stuck bottom of throat on 02-JUN-2021, and itching, and blotching flank (upper back, neck and face) on 01-JUN-2021, was recovering from rash all over arm (arm of vaccine), tiredness, and headache, had not recovered from pain in ear, and pain in jaw, and the outcome of tingling in lips and discoloration was not reported. This report was non-serious.
Dizziness overheated Oxygen 99 Heartrate 73 BP 110/62
Patient received IIV in her left upper arm around 0830, on 8 Nov 2016. Does not recall anything different about vaccine administration technique. Around 1800 on 8 Nov 2016 (day of vaccine receipt), patient noted a burning pain in her left hand, primarily in palm and fingers. Pain is intense (7-8/10) and constant; It worsens when the affected hand is near heat like when washing hands with hot water or when hand is in contact with laptop; pain has not changed in character over the past 15 hours. There is no numbness and tingling or weakness of extremity. No changes in the appearance of her hand. No history of trauma. Patient went to ER last p.m. (8 Nov 2016) and did not mention receipt of IIV earlier in the day. She was instructed to take BENADRYL to help her sleep, but no additional instruction and no diagnosis. On 9 Nov 2016, patient evaluated. Per PCM: 22 yo F presents to clinic with pain/numbness in her L and R hand and fingers for the past 2 days. SXs started the night after she had a flu shot and she believes that it may be an adverse reaction. Heat is the only thing that triggers the SXs--primarily located in palm and distal finger tips of all fingers except for thumb. She has taken TYLENOL with no improvement in SXs. Denies fever, chills, recent hand/neck trauma, HX of carpal tunnel, HX of reactions to flu vaccinations, neck pain. Does admit to HX of tendonitis in hands/wrist/forearms. EXAM: Musculoskeletal System: Hands: Right hand: Normal. No nodules. Hand was not tender on palpation. No limitation of motion was seen. No pain was elicited by motion. No weakness. Left Hand: Normal. No nodules. Hand was not tender on palpation. No limitation of motion was seen. No pain was elicited by motion. No weakness. Wrist: Right Wrist: Tenderness on palpation. Phalen's maneuver showed numbness/tingling in the median nerve distribution. Normal. No swelling. No nodules. No misalignment. Motion was normal. Wrist showed normal stability. Left Wrist: Tenderness on palpation 1st extension tendons bilat. Phalen's maneuver showed numbness/tingling in the median nerve distribution numbness in palm and distal fingertips bilat except thumb. Normal. No swelling. No nodules. No misalignment. Motion was normal. Wrist showed normal stability. Neurological: Oriented to time, place and person. Sensation: Sensory exam abnormalities were noted - Decreased sensation to light touch in left C5-6 distro vs right. Motor (Strength): Strength of the upper extremities was normal. No weakness of the right wrist was observed. No weakness of the left wrist was observed. Balance: Normal. Gait and Stance: Normal. Skin: Showed no ecchymosis. Temperature was normal. No skin lesions. Nails normal. ASSESSMENT/PLAN: Hyperesthesia: Vitals WNL. Neurovascularly intact in bilateral UE. Pain and numbness do not follow a specific nerve pattern--more of stocking and glove. Basic labs ordered. Will begin trial with gabapentin--titrate up to 900 mg daily--advised of possible SE. F/U in 1 month if not improved-consider NCV at that time. RX: Gabapentin 300 mg, MOBIC 15 mg. On 21 Nov 2016, patient's pain significantly improved, but not completely resolved.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Tachycardia-Mild, Additional Details: EVENT OCCURED WITHIN 5 MINUTES OF ADMINISTRATION.  DURATION OF LOSS OF CONCIOUSNESS LESS THAN 10-15 SECONDS.  PULSE PRESENT AT WRIST IMMEDIATELY FOLLOWING REGAIN OF CONCIOUSNESS. PER PATIENT AND CAREGIVER, PATIENT HAS HISTORY OF SYNCOPE WITH IMMUNIZATION/BLOOD DRAWS.  PATIENT ABLE TO WALK OUT OF BUILDING FOLLOWING 30 MINUTES OF OBSERVATION INCLUDING ELEVATION OF FEET, EVALUATION OF BP/PULSE (104/60 MMHG/87 BPM), AND INGESTION OF WATER AND CRACKERS.
This case was reported by a other health professional via sales rep and described the occurrence of injection site reaction in a adolescent patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a bad site reaction (unspecified). The reporter did not have the information about patient, vaccination, lot number and expiration date.
Red, swelling, pain and warmth to injection site. 2.5x3 inches size.
Red and feverish. Black and blue spot where needle went in. Swollen. None yet.
This spontaneous report was received from a nurse practitioner via company representative refers to a 23 year old female patient. On an unknown date, the patient was vaccinated with a dose of 0.5 ml GARDASIL, (lot number, expiry date was not reported and route was subcutaneous). Concomitant medications were not reported. On an unknown date in MAR-2013, the patient had a pap test which showed HPV positive (human papilloma virus). The patient has GARDASIL at the age of 14. The patient was at high risk. The nurse stated that they scheduling an endoscopy and looking into genotype tests. It was not clear if the patient had received the three vaccine dosages at the proper schedule. The outcome of the HPV positive was reported as not recovered. The patient did not seek medical attention. Additional information has been requested.
A report has been received from a Health Professional concerning a 9 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 04-Dec-2012. The patient experienced received expired FLUMIST which started on 04-Dec-2012. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious.
I got the vaccine on 4/1/2021.  For the first 3 days had sore arm from the vaccine with no noticable skin change around vaccine area.  Then around day 5 or 6 noticed pain and itchyness from the vaccine area with an egg sized big bump.  Skin was red for the big bump.  This lasted around 2-3 days and the bump went away, the skin became red and itchy.  When the skin was scratched, flat bumps would come up.  Today 4/14/2021, I noticed next to the egg sized red skin vaccine area, a patch of small red bumps like rash showed up.  The area is still very itchy.
Rash at the injection site; Vaccination site swollen; Warm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE OEDEMA (Vaccination site swollen) and VACCINATION SITE WARMTH (Warm injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE OEDEMA (Vaccination site swollen) and VACCINATION SITE WARMTH (Warm injection site). At the time of the report, VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE OEDEMA (Vaccination site swollen) and VACCINATION SITE WARMTH (Warm injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant information  provided. No Treatment information  provided