chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen forehead; Swollen scalp; Swollen eyelid; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swollen forehead), SKIN SWELLING (Swollen scalp) and SWELLING OF EYELID (Swollen eyelid) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE MODERNA (Lot #: 016C21A Arm of injection: Left) on 27-Apr-2021.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Swollen forehead), SKIN SWELLING (Swollen scalp) and SWELLING OF EYELID (Swollen eyelid). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, SWELLING FACE (Swollen forehead), SKIN SWELLING (Swollen scalp) and SWELLING OF EYELID (Swollen eyelid) outcome was unknown.            The patient  experienced swollen forehead four different times. The  swelling moved from forehead up to the scalp of her hair then came down to the top of her eye lid and then her inner eye lid. She did not remember the 1st time she had the symptoms, but it was very mild, the 2nd time was in mid-May, the third time was 6 weeks ago, and the fourth time was 2 weeks ago.  Patient's healthcare provider thought it was shingles and she was on antiviral.  She confirmed that she had no previous use of face fillers. She did not provide her healthcare provider's information.
approx 1 hrs p/immun pt became very fussy cried cont 4 hrs & mom described as pain cry unusual for this pt & even cried in sleep; by early evening lt thigh became very swollen & red (twice the nl size); mom had APAP @ time of inject;
Information has been received from a physician concerning a 36 month old caucasian male who on 12/6/99 was vaccinated with varicella virus vaccine live (dose not reported). There was no illness at the time of vaccination. On 12/13/01, the pt presented with a vesicular rash. The pt was seen by a physician on 12/15/01 with 50 lesions in his diaper area, 20 more on the rest of his body and he was afebrile. The pt was dx'd with chicken pox. The pt had another visit on 12/18/01. The pt had about 100 lesions and some areas were scabbed. The pt was treated with alamine (-) camphor (+) pramoxine hydrochloride (Aveeno). The pt subsequently recovered. No further information is available.
Information has been received from a physician concerning a 63 year old female who on 17-APR-2009 was vaccinated with ZOSTAVAX (Merck) (lot#663673/1710X, route and site of administration not reported). The patient experienced rash on the inside of her left arm after the vaccination was given. The physician informed that the rash did not look like a shingles like rash and there were no vesicles present. The patient called the physician's office on 27-APR-2009 for unspecified medical attention, and reported that she had a rash in her rib cage area now. At the time of reporting the patient was not recovered. Additional information has been requested.
Headache, muscle aches, feverish and chills. Given epinephrine and Benadryl. ER work-up was negative.
Patient received ?rst in series covid vaccine at approximately 915... she breastfed her 12 month-old infant shortly thereafter without problem. around 1215 baby was getting fussy and breastfed for about 5 minutes before baby broke out in hives. EMS was called and epinephrine/diphenhydramine administered for course cough/wheezing, presumably anaphylaxis. Other foods consumed by baby on same day included banana, kids ?g newton bar, dried apples, meat from frozen meal, and two piece of cereal (new to baby). ER course required 4 hours of monitoring but no other medical interventions.
Approx. 2 hours following vaccination, experienced severe swelling of her tongue and tingling and numbness of her lips. She also experienced numbness in her face bilaterally. She took 25mg of Benadryl and within 30 minutes the numbness had improved and the swelling of her tongue had improved. She did not experience difficulty breathing or swelling of her throat. Approximately 7 hrs following vaccination, symptoms were much improved and by morning all symptoms had resolved. However, on 1-23-21, mild numbness has once again developed in her lower lip.  She does admit to frequent numbness related to her MS but not usually located in facial area.
This case was reported by a consumer and described the occurrence of muscle pain in a female patient who received SHINGRIX. On 6th February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain and adverse reaction. On an unknown date, the outcome of the muscle pain was not recovered/not resolved and the outcome of the adverse reaction was recovered/resolved. It was unknown if the reporter considered the muscle pain and adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that most of the side effects (unspecified) went away within 3 days, but she was still experiencing muscle pain in her arm around the injection site. The patient wanted to know if this was normal. The patient hesitated getting the 2nd dose of SHINGRIX.
Fatigue, Pain at site of injection, abnormally heavy off-cycle menstruation, lower abdominal cramping, rhinorrhea, weight loss.
A report has been received from a Pharmacist concerning a 10 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on 10-Jan-2015. It was reported that the expired FLUMIST quadrivalent administered to two patients which started on 10-Jan-2015. The outcome of the event of expired FLUMIST quadrivalent administered to two patients is unknown. The report was considered to be non-serious.
Mom describes a period of extreme irritability lasting from 430PM to 830PM; was unable to comfort pt; also vomiting (1 episode); no other s&s x/fever 102 which was brought down w/APAP;
LT with redness, warmth, hard after vaccines given 6/29/11. No warmth at site since 6/29/11 pm. Probable inflammatory process - vs - infection. Txwith: Ibuprofen & BENADRYL, outlined red area to monitor.
FLU LIKE SYMPTOMS; LOTS OF BACK PAIN; SICKNESS; PAIN IN BOTH ARMS; FEVER 102F; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a 7 decade old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: unknown) dose was not reported, 1 total, dose 1 was administered to right arm on 21-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 64 years old. No concomitant medications were reported. On an unspecified date following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced flu like symptoms and fever 102F which lasted for about 5 days (Dose number in series 1). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The patient recovered from flu like symptoms and fever 102F. The patient received non-company suspect covid-19 vaccine (Bivalent booster) (Unspecified manufacturer) (Dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: Unknown), dose and start therapy date were not reported, dose 2 was administered for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). On an unspecified date following vaccination with covid-19 vaccine (Unspecified manufacturer), the patient experienced sickness, lots of back pain and pain in both arms (Dose number in series 2). The outcome of lots of back pain, pain in both arms, revaccination with different covid-19 vaccine and sickness was not reported. The action taken with covid-19 vaccine ad26.cov2.s, and covid-19 vaccine (Unspecified manufacturer) was not applicable. This report was non-serious.
Patient says she started to get hives over entire body about 30 minutes after receiving the vaccine.   She went to an allergist physician who tested her for any allergies to any component of the Moderna vaccine, and determined she was not allergic, it was an adverse reaction.   Patient came in today with her mom (a nurse) and got her second Moderna dose.    She waited 30 minutes in the pharmacy after the receiving the vaccine and did not experience any adverse effects.
Dizziness, Headache, Myalgia, Arthralgia, NauseaVomiting, Arm soreness, Narrative:
1st dose on 9/2020 and 2nd dose on 10/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number J5255, expiry date 13th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2020).   In October 2021, the patient received the 2nd dose of Shingrix. In October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix, later than the recommended schedule, which led to lengthening of vaccination schedule. Pharmacist enquired if the patient needed to restart the Shingrix. Pharmacist declined follow up from safety. The reporter did not consent to follow up.
Approx 12 hrs after shot, got severe headache and chills.  Headache continued next day with fatigue and feeling poorly.  Thursday, March 21st, my chest filled up with congestion so badly I would feel like I was choking when I coughed. I ran a fever and  had a bad sore throat.  It seemed to be getting progressively worse until I took an amoxicillin pill around 1 AM on March 22nd. On the morning of March 22, I asked Dr.'s office to prescribe an antibiotic and was told to come in.  I did, but they refused to prescribe. By Friday, I lost my voice and could only whisper.  After about 5 days, I also had upper respiratory symptoms.  I continued to have chest congestion and a cough for about a month. I rarely get sick and usually recover quickly.  When I was seen at Urgent Care on March 21 and at doctor's office on March 22nd, I was told that getting an illness after the shingles vaccine is common.
Client received just NS instead of Pfizer COVID vaccine. Client was notified and recommended to return for a correct dose. Client returned on 04/24/2021 and received a correctly mixed dose of Pfizer vaccine. Lot number ER8735, intramuscular, in right deltoid.
The first vaccination was fine, no reaction whatsoever. - The second vaccination was OK for remainder of that day and night and LIKE DYING all the next day and nigh (spent day and evening in bed). - The third day I woke up with large, fairly severe shingles type rashes in both of my arm pits (the upper arm half of my arm pits). - Since then to now (1/13/2021) this rash has continued on and off ever since and is still with me. It varies in severity from barely there to about 20% of the original attack with a VERY slow decline toward nothing.
Confirmed Breakthrough  1st Dose  2/2/2021 -- EL9265 2nd Dose 2/23/2021 - EN6200
Contracted shingles around July 12, 2021.  Symptoms are mostly gone as of Aug. 18, 2021
Heated Red Patch that continued to expand. Arm Soreness that lasted more than a week. Extreme Fatigue that continued past a week.
Injection was administered in the left arm.  Pain began in shoulder and upper right arm.  Small itchy bumps appeared on feet in the afternoon of 8/18.  They have continued to appear in various spots on my body.  Individual spots with water blisters.  Severe itching.  Most of the original bumps have developed brown scabs.  Bumps have continued to appear daily since then.  Last one found today.  Very large blister on the bottom of my right foot.  Other bumps have appeared up and down the left leg, my hips and stomach.  Yesterday 2 appeared, 1 on each arm at the elbow.  Two recent bumps have very large water blisters.
felt numbness going down his arm immediately after the injection; whole left arm fell asleep and numb; unable to sleep on his left side/shoulder for 3 nights; energy was gone; fatigued after getting the vaccine and so had to go for nap; pain in his left shoulder, and still feels that sometimes the sensation is still there; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (felt numbness going down his arm immediately after the injection), HYPOAESTHESIA (whole left arm fell asleep and numb), MUSCULOSKELETAL DISCOMFORT (unable to sleep on his left side/shoulder for 3 nights), ASTHENIA (energy was gone) and FATIGUE (fatigued after getting the vaccine and so had to go for nap) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced HYPOAESTHESIA (felt numbness going down his arm immediately after the injection), HYPOAESTHESIA (whole left arm fell asleep and numb), MUSCULOSKELETAL DISCOMFORT (unable to sleep on his left side/shoulder for 3 nights), ASTHENIA (energy was gone), FATIGUE (fatigued after getting the vaccine and so had to go for nap) and ARTHRALGIA (pain in his left shoulder, and still feels that sometimes the sensation is still there). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (felt numbness going down his arm immediately after the injection), HYPOAESTHESIA (whole left arm fell asleep and numb), MUSCULOSKELETAL DISCOMFORT (unable to sleep on his left side/shoulder for 3 nights), ASTHENIA (energy was gone), FATIGUE (fatigued after getting the vaccine and so had to go for nap) and ARTHRALGIA (pain in his left shoulder, and still feels that sometimes the sensation is still there) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter.
Hives to upper body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives to upper body) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced URTICARIA (Hives to upper body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of Pills and HYDROCORTISONE at an unspecified dose and frequency. On 10-Mar-2021, URTICARIA (Hives to upper body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
-Started period right after getting second dose -Have not had period since then  (period is > 1 week late and patient is not pregnant)
Cracked and dry lips that will not healDry; Cracked and dry lips that will not healDry; Swollen tongue; dry tongue; Weakened muscle; Burning and affecting glands; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, in the arm on 13Mar2021 12:45 (at the age of 69-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included minor COPD. The patient's concomitant medications were not reported. The patient had no known allergies. No other vaccine was given in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced cracked and dry lips that will not heal, dry and swollen tongue, weakened muscle, burning and affecting glands. The patient underwent lab tests and procedures which included CATSCAN and sars-cov-2 test: negative in Jun2021. Therapeutic measures were taken as a result of the events. The outcome of all events was not recovered.   Information on lot/batch number has been requested.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored (exposed to -8 centigrade for 78 hours and previous excursion of 2 centigrade for 24 hours) VARIVAX (lot number reported as M024701, expiration date: 18-MAY-2018, route and dose were unknown). No adverse effects were reported. Additional information has been requested.
RIGHT arm pain preventing pain-free active range of motion in addition to chills, sweats, and body aches. patient was provided acetaminophen for symptom management, placed on light duty in setting of pending inspection (can not hold a salute due to pain).
Had first Shinglex vaccine on 12/7/20. Had sore arm, fatigue, mild flu-like symptoms, otherwise no adverse reaction. Had second Shinglex vaccine on 3/13/21.  Had sore arm for five days. On Day 3 (3/15/21)  had non-painful, non-itchy hives on my chest and forehead. Hives dissipated on Day 4.  Have also had fatigue and chills from Day 2 (3/14) until  Day 5 (3/19) -- today.
Pfizer vaccine was administered outside of the clinic - reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------------------- EPILEPSY, INTRACTABLE 6/30/2021 ATHEROSCLEROSIS OF AORTA  ACUTE DVT OF RIGHT FEMORAL VEIN 9/12/2021 ATHEROSCLEROSIS OF AORTA  ACUTE RESPIRATORY FAILURE 7/7/2021 ATHEROSCLEROSIS OF AORTA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/30/2021 ATHEROSCLEROSIS OF AORTA  EPILEPSY, INTRACTABLE 6/30/2021 RIGHT FEMORAL NECK UNSPECIFIED TYPE FX, INIT  ACUTE DVT OF RIGHT FEMORAL VEIN 9/12/2021 RIGHT FEMORAL NECK UNSPECIFIED TYPE FX, INIT  ACUTE RESPIRATORY FAILURE 7/7/2021 RIGHT FEMORAL NECK UNSPECIFIED TYPE FX, INIT  ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/30/2021 RIGHT FEMORAL NECK UNSPECIFIED TYPE FX, INIT  EPILEPSY, INTRACTABLE 6/30/2021 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, W OTHER BEHAVIORAL DISTURBANCE  ACUTE DVT OF RIGHT FEMORAL VEIN 9/12/2021 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, W OTHER BEHAVIORAL DISTURBANCE  ACUTE RESPIRATORY FAILURE 7/7/2021 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, W OTHER BEHAVIORAL DISTURBANCE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/30/2021 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, W OTHER BEHAVIORAL DISTURBANCE
Patient was given shingles #2 approx 1 wk ago.  No rxn to 1st immunization.  With this 2nd immunization, patient noted increased fatigue, tiredness, low-grade fever, and chills.  Patient slept for about 1 to 2 days and was very fatigued.  Patient notes 48 hrs after injxn, noted square patch like hive on R upper arm but below the injxn site.  Also notes lump/swelling in R dorsal hand and hurt to stretch her fingers out.  Patient did note some redness over this area.  Swelling spread thru hand.  Now right hand appears bruised swollen and hurts to make a fist.  Notes mild pain over wrist.   Tx: supportive care.  Pt went to hand specialist
Pfizer COVID vaccine 5-11 yr old for pediatric administered to patient undiluted. Patient reported drowsiness.
Some soreness in arm; heat around injection; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration in left arm on 08Mar2021 at 07:45 as single dose for COVID-19 immunisation. Medical history included pre-COPD (chronic obstructive pulmonary disease), allergy to penicillin, dairy and seasonal pollen. Concomitant medication included allopurinol, tiotropium bromide (SPIRIVA), rosuvastatin. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive any other medications in two weeks of vaccination. On 08Mar2021 at 11:00 patient experienced some soreness in arm and heat around injection site. No treatment received for adverse events. Patient was not diagnosed with COVID, prior vaccination. Patient had not been tested for COVID, post vaccination. The outcome of event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a consumer concerned a 50 year old male. 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 not reported, batch number: 205A21A and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210952662.
Client seen at ED on 5/11/09 for c/o scratchy throat feeling as if was swollen.Had received vaccinations that am for HepA/B and meningococcal. Was seen at Urgent Care and given EpiPen. Diagnosis at ED:Allergic reaction/dyspnea. Rx-Prednisone and Sudafed plus.Patient was discharged from ED.
Initial report received on 16 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a nine-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3923AA received on 05 December 2011, lot number C4143AA received on 13 February 2012 and lot number C4204AA received on 17 April 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms and paroxysmal cough without a whoop on 16 July 2012, approximately three months after the last dose. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 30 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 01 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 09 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 24 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.