chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slightly more tired than normal; the area of the area of the arm where administered was sore to touch/arm was extremely sore and couldn't lift above shoulder level; muscles were fatigued; muscles were fatigued and tightening considerably in shoulders and back, way beyond normal soreness; muscles were fatigued and tightening considerably in shoulders and back, way beyond normal soreness; muscles were fatigued and tightening considerably in shoulders and back, way beyond normal soreness; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 24Feb2021 at 14:45 (at the age of 47-year-old), dose 1, single for COVID-19 immunisation. The patient had no medical history and there were no concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 24Feb2021, the day of vaccination, the patient's area of the arm where vaccine administered was sore to touch. On 25Feb2021, next day, the arm was extremely sore and could not lift above shoulder level and she needed to rest and was slightly more tired than normal. On 26Feb2021, the patient resumed activities, and arm could raise to normal. From an unspecified date in Feb2021 (by the weekend and even the entire following week), the patient's muscles were fatigued and tightening considerably in shoulders and back, way beyond normal soreness. The patient received chiropractic care for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
AFTER 2ND VACCINE I DEVELOPED CHEST PAIN, REQUIRING CARDIAC CATHETERIZATION REVEALING 99% BLOCKAGE IN LAD,   2 STENTS PLACED
PT RECEIVED PRIME DOSE OF COVID 19 VACCINE 02-26-2021 MANUFACTURER  MODERNA LOT NUMBER 015M20A. COVID-19 VACCINE BOOSTER ADMINISTERED 03-24-2021 PFIZER MANUFACTURER. .
Pt experienced angioedema involving entire right upper extremity following 3rd dose of Anthrax.
Gardasil shots - 1st shot (11/12/07) Painful at shot location and had a dull headache November through January.  2nd Shot (1/23/08)Pain at immunization site for a couple of weeks.  Developed cold and sinus issues by the next day.  Migraine type headache (very painful) began on 01/30/08. She began having major fatigue,dizziness, muscle pain, major sensitivity to light and sound, nausea and vomiting. We had several tests ran and trips to the emergency room.  She had CT scans, MRI of head and neck, and lumbar puncture.  She was out of school for 3 months unable to concentrate, short term memory loss, continuous pain (head and body).  Improved enough after doctors, medications, massage therapists to return to school for the last month and a half.  3rd shot (06/03/08)with 3 other shots.  She developed a cold sinus and her headache came back within a week to a worse level that before.  Her headache has never went away since January 30th.  She has muscle pain and spasms, short term memory loss, lethargic, dizziness, major sensitivity to light and sounds, nausea and vomiting.  She has no energy and basically has had no life for the last 11 months of her life.  12/19/2008 MR received from PCP. Seen 11/12/07 for 1st HPV and Flu vax.  Returned 11/27/07 with c/o chills, low grade fever, tight neck muscles. Dx:  Nausea, Vomiting. 2nd HPV 1/23/08. Returned  1/30/08 with c/o fatigue. Dx:  sinusitis/pharyngitis. Returned 2/5/08 with c/o h/a, neck soreness, productive cough and light sensitivity. Dx:  H/A. F/U visit 6/3/08 for hospital stay for h/a and 3rd HPV, to f/u with neurologist. OV 8/8/08 with c/o muscle spasms on back with shooting pain down left. DX:  Muscle spasm ? Polymyositis. Tx with Flexeril. OV 8/22/08 with c/o worsening H/A, nausea, and photo/phono phobia. DX: Tension H/a.  To see neurologist. 1/12/09 MR received for 2 ER visits and one outpt visit. Pt presented to ER on 2/26/08 with c/o 3 1/2 week hx of constant frontal h/A with intermittent emesis.  No releif with previously prescibed meds.  (+) photophobia.  PE WNL. To f/u with Neuro. Dx:  Migraine. Returned 3/10/08 with c/o H/A, worse at night disturbing sleep.  PE WNL. LP done to assess pressure-16. DX:  H/A. D/C to f/u with Neuro. Neuro visit 3/20/08 for persistant H/A (7 weeks) with photo and phonophobia. Pt reports depressed mood without energy and anxiety 2' to this condition and missing school as well. Dx: H/A.  Recommended psych eval.  1/29/09 MR received from neurologist dated 9/2/08 to 1/6/09 with DX: Chronic daily H/A, muscle spasms/fibromyalgia, functional L hemiparesis. Pt reports onset of H/A with photo/phonophobia after 1st HPV vax 11/12/2007.  Following Worsening of sx following subsequent vax, now with chronic daily H/A with minimal response from multiple medications, accupucture and chiropractic. PEs show no papilledema. PE 1/6/09 (+) for give-way weakness.
Patient reports pruritus and pale. She has been fussy and states it is tender to palpation. Doctor prescribed clindamycin if redness spreads.
04/09/2021 Patient became very week and unable to balance or walk, was dehydrated. Called 911 who transported to Hospital ER, was kept for 6 hours, did chest X-Ray and administered IV fluids, was discharged to home in much better condition.
CHIEF COMPLAINT:  TONGUE SWELLING (patient had her second COVID vaccine today, later developed tingling in her mouth and tongue/lip swelling and dry mouth. Denies difficulty swallowing)  Assessment/Plan:  DIAGNOSIS at time of disposition:  1. Allergic reaction, initial encounter   Symptoms:  Patient had second dose of COVID 19 vaccine today at 1230 p.m. She states at around 530 - 6 p.m. she started coughing and felt like that was a hair caught in the back of her throat, states throat is tingling and looked in the mirror and states her tongue is swollen. Feels that her heart rate is abnormal, but states it could relate to anxiety. COVID vaccine clearance needed if future booster needed. Informed patient to follow up with PCP if needed after ED visit. HISTORY OF PRESENT ILLNESS: The patient got her 2nd dose of COVID vaccine today at noon.  At 5 she started feeling a bit of a tickle and scratchiness of her throat and her mouth felt very dry.  She was concerned about allergic reaction.  No shortness of breath chest pain rash itching hives or any other concerns.  She has not taken any Benadryl.  The patient is in no distress.  Symptoms been going on for 3 hours.  This could be a very mild allergic reaction.  Therefore I am giving her 50 mg of oral Benadryl.  Given the symptoms been going on for 3 hours and I do not see any angioedema I am comfortable letting her go home at this point in time.  I do not think steroids would be beneficial.  She will return here if worsening and I instructed her to use Benadryl 50 mg every 4-6 hours if needed.  BLOOD PRESSURE SCREENING: Based on last blood pressure taken in the ED of 171/98, HTN (>/=140/90), recommend follow up with PCP within 1 month.
Pt received flu shot on left upper arm. He left with his girlfriend and her mother to go upfront to buy something in the store.  While in line, he fainted.  He woke up and felt a bad headache but never lost consciouness after that.
This is a spontaneous report from a contactable consumer reporting for himself. A 64-year-old male patient received PREVNAR 13 via an unspecified route of administration in upper right arm at 0.5ml single on 27Jun2016 at 10:30 for immunization at general physician's office. Medical history included sulfa drugs allergy ongoing since Mar2016 and he was overweight (not diagnosed by MD). The patient previously took DEMEROL; he had not been taking it since 1970. Concomitant medications were none. The patient experienced horrible welts/ridges described as raised areas from 3" to 6" wide on both sides of his upper, mid and lower back and chest on 27Jun2016 at 22:00 with outcome of recovering, itching on 27Jun2016 at 22:00 with outcome of recovered on 04Jul2016, allergic reaction to vaccination on 27Jun2016 with outcome of recovered on 27Jun2016 at 18:30, tiny pin point red dots/rash on 28Jun2016 at 08:00 with outcome of recovered, was slightly nauseous on 27Jun2016 at 11:45 with outcome of recovered, could hardly move arm on an unspecified date in 2016 with outcome of recovered, hard red knot at the injection site on an unspecified date in 2016 with outcome of recovered, rash in a lighter form spread to, chest, skin of both legs and tops of both feet on an unspecified date in 2016 with outcome of recovered, swelling, redness, pain at injection site on an unspecified date in 2016 with outcome of recovered. The events required doctor visit on 28Jun2016. Therapeutic measures included max dose of liquid BENADRYL per pharmacist's recommendation, and Cold compressed, the itchiness and welts resolved. The patient reported horrible 3-6 inch red and itching ridges or welts across upper, mid and lower back; also same rash spread to sides, chest, skin of both legs and tops of both feet. Rash included small red dots as well as red, itching 3-6 inch welts or ridges. He further stated he was sure that pneumococcal 13-val conj vac (dipht crm197 protein) contained no Demerol. Maybe, if it did, the vaccination would not have been the most extremely painful vaccination that at 64 years old, he had ever received. He could hardly move his arm for 24 hours and had a hard red knot at the injection site. The pain and discomfort paled in comparison to the 3-4 inch itching, red welts that covered his back, sided and chest for 8 days. Eventually, the rash in a lighter form spread to both sides and tops of both feet. It was horrible. Follow up (10Aug2016): New information reported from a contactable consumer included: information regarding Demerol; details on course of events. Follow-up (31Aug2016): New information from the same contactable consumer includes: clarification about past drug history, additional events, clinical course of events details. Follow-up (19Sep2016): New information reported from a contactable consumer included: outcome, treatment received.
COUGHING; FREEZING; FEVER; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included liver transplant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A2IA, expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JUN-2021 09:00, the subject experienced coughing. On 25-JUN-2021 09:00, the subject experienced freezing. On 25-JUN-2021 09:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 97.9. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from freezing, coughing, and fever. This report was non-serious.
approx 8 hrs p/vax became febrile-103 ax w/hallucinations; reaching for unk objects & c/o seeing bugs-lethargic; vomiting; last halluc. 16SEP93 @ 7AM; vomiting ceased 18SEP93; only meds given APAP'
Felt liquid dripping down her arm without any feeling of a needlestick; Felt liquid dripping down her arm without any feeling of a needlestick; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (Felt liquid dripping down her arm without any feeling of a needlestick) and UNDERDOSE (Felt liquid dripping down her arm without any feeling of a needlestick) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (Felt liquid dripping down her arm without any feeling of a needlestick) and UNDERDOSE (Felt liquid dripping down her arm without any feeling of a needlestick). On 23-Mar-2021, DEVICE CONNECTION ISSUE (Felt liquid dripping down her arm without any feeling of a needlestick) and UNDERDOSE (Felt liquid dripping down her arm without any feeling of a needlestick) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.  No treatment medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No new information was provided.
soreness in left breast; swelling of left breast; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 31Mar2021 at 09:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 28Apr2021 at 08:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any concomitant medications. The patient had no past drug history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced soreness in left breast and swelling of left breast. The clinical outcome of the event soreness in left breast and swelling of left breast was not recovered.   No follow-up attempts are needed. No further information is expected.
Pt experienced left sided muscle tightness in jaw and was unable to open mouth one day post vax, until massaged. Subsequent to massage, the pt could open mouth but was unable to close mouth completely.
Right deltoid - red, warm moderate edema. Complained of discomfort and symptoms on 03/25 in the morning. In the evening of 03/28, no edema but complained of itching. Also itching on 03/29. 04/03 states has very crusted over area at site. States had headache from 3/25 - 3/27. Relieved with Tylenol.
Anthrax injection site 5.5cm circle larger reaction that on other 5 doses.
Initial report was received 18 November 2008 from a health care professional. A 23-year-old female patient with an unknown medical history, had received a first dose intramuscular right deltoid injection of FLUZONE SV 2008-2009, lot number U2749AA and a right deltoid injection (route not reported) of PNEUMOVAX (manufacturer and lot number not reported), on 10 November 2008 and approximately eight hours later, she developed a right deltoid abscess. The patient was hospitalized for two days (dates not reported) and she received corrective treatments with antibiotics (names and routes of administration not reported) and the abscess was drained. The reporter stated the patient's parent called them to report this event. At the time of the report, the patient had not recovered from the event and no further information was provided. Documents held by sender: None
Pt was not feeling well for the last few days after receiving his second dose of the Pfizer Covid vaccine; This is a spontaneous report from a contactable consumer. An adult male patient of an unknown age received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included COVID-19 (prior to vaccination patient was diagnosed with COVID-19). First dose of bnt162b2 (BNT162B2) was received on unknown date for covid-19 immunisation. Concomitant medications were not reported. It was unknown if since the vaccination patient had been tested for COVID-19. It was unknown if patient received treatments for the event. Patient was recovering from the event. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recvd vax 17NOV93 & 2 days later devel nausea, redness & swelling @ the inject site, & was tired;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021 at 11:37 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:37 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 51.08 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 37 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
DONOR STATED AFTER RECEIVING RABIES VACCINE ON 06/27/19 SHE HAD MILD SYMPTOMS DUE TO VACCINE THE DAY AFTER . SYPMTOMS INCLUDED NAUSEA W/ VOMITIMG AND DIZZINESS. DONOR DIDNOT SEEK MEDICAL ATTENTION , STATED SHE RECOVERED NATURALLY. DONOR ONLY ADVISED STAFF OF EVENT TODAY WHILE TALKING TO STAFF.
Redness, edema and pain at site of vaccines administration bilaterally arms. Pt mother states she was tx with ATB and BENADRYL.
Moderna COVID-19 Vaccine EUA: patient presented to emergency department (ED) lethargic, confused, and hypoxic two days after receiving vaccination reporting fatigue and malaise. Initial vital signs: blood pressure 120/64 mmHg, pulse 65 beats per minute, temperature 36.5 degrees Celsius, respiratory rate 15 breaths per minute, oxygen saturation 92% on oxygen 1 liter via nasal cannula. Patient reports cocaine use and non-compliance with medications for Parkinson's disease. Admitted to hospital for acute hypoxemic respiratory insufficiency- currently still hospitalized.
Shingles; I was very tired; Joint pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (manufacturer unknown), via an unspecified route of administration on 10Feb2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles at the same time on the second vaccine on 10Feb2020 (last week's Monday; so it has been 10 days). It was reported that patient was fine in the beginning. The patient became very tired. The patient goes out and does things but patient have to come back and rest because patient got tired and has joint pain. Patient was still very tired as of reporting time. Patient was asking if it was normal after so many days. Outcome of the event 'I was very tired' was not recovered while unknown for shingles and joint pain.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria 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-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  Information regarding Batch/Lot number has been requested.
About 45 minutes after vaccination (shot 1) pt developed large left knee effusion. No trauma, no history of similar, no history of joint disease. Large effusion appreciable on exam. transferred from  vaccination clinic to hospital via 911
Fussy after shots on 03/14/2002 with localized swelling and tenderness. Could not put him down at all, then developed temp for 3 days later.
Vial which was expired on 03-Oct-2021 was placed in refrigerator on 22-Sep-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial which was expired on 03-Oct-2021 was placed in refrigerator on 22-Sep-2021) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial which was expired on 03-Oct-2021 was placed in refrigerator on 22-Sep-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial which was expired on 03-Oct-2021 was placed in refrigerator on 22-Sep-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was not reported.  Vial did not undergo any temperature excursion.  It was reported that patient did not experience any adverse event.