chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient administered vaccine outside of recommended range; This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.      On 28-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot # T006792 (lot # T006792 was verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date not provided but upon internal validation established as 24-AUG-2021) (dose and route of administration were not reported) for prophylaxis.         The vaccine was exposure to a temperature excursion of -9°C to 8°C (-8.5°C) during a time frame of 1 hour and 19 minutes called by a data logger. The vaccine was also exposure to previous excursion of -14°C to-10°C (-11.9°C) for 55 minutes.
Feeling flu symptoms the next day. Then noticed Saturday, all the hair on my upper right arm fell out. Gradually thinnig to normal mid forearm.  My psoriasis on my elbow improved but not disappeared.
bruise on both breasts, right underm, tummy and wrist; Itchiness on bruises; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise on both breasts, right underm, tummy and wrist) and PRURITUS (Itchiness on bruises) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031LZ0A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced CONTUSION (bruise on both breasts, right underm, tummy and wrist) and PRURITUS (Itchiness on bruises). At the time of the report, CONTUSION (bruise on both breasts, right underm, tummy and wrist) and PRURITUS (Itchiness on bruises) outcome was unknown.            no concomitant product was reported.  no treatment product was reported
Erythema, induration and swelling of left arm developed within 24 hours of vaccination in left arm with DTAP and IPV. Clear blisters also developed around injection site. Symptoms and signs resolving with oral Benadryl and Ibuprofen.
Staff gave patient Moderna booster 0.25mL instead of Moderna 3rd dose vaccine. Patient contacted by provider and will be returning on 12/10/2021 for Moderna third dose 0.50mL.
Increased crepitus in right wrist, which became symptoms of bilateral carpal tunnel within one week or so (09/11-09/20), paresthesia in right arm, right forearm, and left elbow. was seen by urgent care provider on 09/20. Between 09/20 and 09/22, symptoms progressed more in left hand and left forearm; was seen by PCP Dr. on 09/22 in the am. Within 24 hours, symptoms were worse bilaterally, with paresthesia in all extremities and neck pain. Was seen by PCP again on 09/24 afternoon, who made an emergency neurology referral and said to present to ER over weekend if any worsening symptoms. Seen by neurologist Dr. @ Clinic same day for an after hours, emergent appointment. Dr. noted "multiple neurologic symptoms, with paresthesia in upper extremities and lower extremities, myalgias after possible viral infection (negative COVID test 1 week prior)," wrist pain mostly in 3, 4, 5 digit, medial aspect of forearm, moserate left paraspinal tenderness, right trapezius and phomboid tenderness, increased vibration sensation in feet compared to hands bilateral, sensations were decreased in bilateral LE, decreased light touch, vibration, temperature sense, and prorioception. gait and station wide based when examined in small exam room. Romberg;s test positive.
01/26/2021 ED  FOR CHEST PAIN sinus congestion, cough, SOB
09/29/2003, Mon even.  Felt chills, headache, sweats, no temperature.  09/30 & 10/01, felt ill, same as above.  10/21, had swollen glands, rash stomach, trunk, back, face, arms and legs. Temperature 99-99.8. Fatigue raised, pink rash. 10/02: Clinic: Rule out strep-Neg, West Nile virus test done, not back for 10 days. 10/04: Saw physician who says shes not contoglous.  Off work till 10/14. Fatigue, rash fading, still has on arms, legs, trunk.
Two hours after injection, head ache started and felt very woozy. Nausea started in the afternoon. Around 10:00p body aches, chills, sore joints, feverish. At 2:30a cough and sore throat developed. Condition improved over next 24 hours. 2/16/21 was very fatigued, headache and nausea persisted, and body aches still present. Injection site was also swollen and hot to the touch. Symptoms continued to improve and were mild to nonexistent by 2/18/21.
Facility administered 1 patient expired dose of the Moderna Vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Facility administered 1 patient expired dose of the Moderna Vaccine) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. No Medical History information was reported.On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Facility administered 1 patient expired dose of the Moderna Vaccine). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Facility administered 1 patient expired dose of the Moderna Vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No Concomitant product use was reported. No treatment information was provided.
Incorrect vaccine was administered to patient. Patient is only 14 years old and received the Moderna vaccine 1st dose.
Received flu shot at 0630, 10/12/04.At 1300, felt flushed in face like he had a fever. Felt worse all afternoon. At 1830, chills began and he shook hard and it continued until 0200 10/13/04 when his fever broke. Later the same day he began getting small bumps/raised rash the size of a finger tip on his arms, back and right leg. This morning, 10/14/04, all that remained was a soft ball sized patch of flat red rash on his buttock.  After showering this morning, the rash was gone. All of the rashes itched.
Myalgia began on 1/9/2021 mid day.  Sunday 1/10/2021 at noon fever to 100.7.  Symptoms since have resolved with no interventions.
Fever, aching, red, itchy, swollen and hard left upper arm. Went to CMC ER Sat. 9/25/10 approximately 09:30AM. Dx- cellulitis and abcess formation. Abx - Doxycycline 100mg tab 2x daily (x7 days).
Reaction noted on 5/2 lt arm with 14 1/2 x 18 1/2 cm erythema around lt deltoid with 3cm induration.
Has been doing very well with mental state very well controlled for over 5 years.  He did fine with first and second shot; however after the third he has developed mania and confusion.
Approximately 2 hours after my #3 Covid booster, I began having numbness around my upper lip on L side. Within 15 minutes area became swollen and swelling continued spreading to my upper lip and to the right side of my mouth. Lasted until approx noon the following day. No trouble swallowing or breathing.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Hydronephrosis" (unspecified if ongoing); "Known allergies: grass allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin"; Known allergies: levaquin, reaction(s): "known allergies: Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included nirmatrelvir; ritonavir (PAXLOVID) from 18Aug2023 to 22Aug2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
tested as routine follow up due to known exposure from positive roommate- tested positive on binax rapid antigen test  asymptomatic on day of pos test, developed cough 1 day following. has had 2 doses of Moderna plus booster listed above
After one day soreness at injection site. On day two severe muscle pain, aches. Started to get better subsequently but has we?re going to increase in severity.  Today is extremely sore.
BAD MIGRAINE; FELT LOTS OF PAIN; LUMP IN ARM; This spontaneous report received from a patient concerned a female of unspecified age. 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: 207A21A, expiry: 07-AUG-2022) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced bad migraine, felt lots of pain, and lump in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt lots of pain, and lump in arm, and had not recovered from bad migraine. This report was non-serious.
13 days after Covid booster ( third vaccine, half dose) I began getting hives all over my trunk, ears, neck, and severe itching all over body. Went to urgent care clinic, diagnosed with allergic reaction, given IM steroid and then a 14 days course of high dose steroids which I completed.  Saw my dermatologist, Dr. , who was able to see the hives.  on Dec. 1 I was able to see Allergist, Dr. , who stated I had acute Urticaria and Angioedema ( due to my hands swelling). She prescribed antihistamines which helped with severe itching. Allergist stated his reaction was likely due to Covid booster vaccine.
- Fever - Aches - Chills - Headache - Tired - Sore Arm - Nauseas
about 5hrs p/vax an episode of apnea, hypotonic-unresponsive state, also febrile;APAP given 3hrs prior to episode; EMT arrived to home-T103, found breathing dec, pt had t102 in ER exam nl
Facial numbness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA7484), via an unspecified route of administration, administered in arm left on 23Jul2021 at 18:45 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing hyperthyroidism (over 20 years). Concomitant medication included levothyroxine sodium (SYNTHROID) taken for hyperthyroidism from an unspecified start date and ongoing. The patient experienced facial numbness on 23Jul2021 (reported as 20-30 mins after). The clinical course was as follows: The patient experienced the facial numbness with no other symptoms 20-30 mins after she received the dose. Stated numbness lasted 4 hours; she took 2 diphenhydramine (BENADRYL) and facial numbness (including across cheekbone and nose) started improving an hour after she took BENADRYL dose. The patient explained she is scheduled for her second shot on Friday, 13Aug2021. After the first dose, she experienced numbness in her face. She wanted to know if this is a normal side effect, she hasn't seen it listed anywhere. The first shot was given on 23Jul2021 at around 6:45pm in the left upper arm. The facial numbness was noticed about a half hour later, after getting the shot. She took a couple Benadryl and about 4 hours later after waking from a nap, it improved. By the next morning it was gone. She hasn't received a lot of vaccines, just childhood vaccine and one as an adult that she doesn't remember what it was, but she had no reaction. She doesn't normally get vaccines. Therapeutic measures were taken as a result of facial numbness. The outcome of the event was recovered on 24Jul2021.  No follow-up attempts are needed. No further information is expected.
received one dose of HPV vaccine before the recent pregnancy; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On an unknown date, the patient received one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, after the vaccination, the patient got pregnant (vaccine exposure before pregnancy). On an unknown date, the birth took place however no details were reported. The patient chose not to receive the inpatient another dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) during prenatal care at hospital.     This is one of two reports derived from the same literature article ( linked MARRS # 2105USA000217).   A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2105USA000217:
anaphylactic reactions; throat and lip swelling; throat and lip swelling; mild chest pain; This is a spontaneous report from a non-contactable pharmacist. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took terbinafine (MANUFACTURER UNKNOWN) and experienced allergy. The patient experienced anaphylactic reactions, throat and lip swelling, and mild chest pain on an unspecified date. The patient was observed for five hours. The clinical outcome of anaphylactic reactions, throat and lip swelling, and mild chest pain was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: There is a reasonable possibility that the events anaphylactic reactions, throat and lip swelling, and mild chest pain were related to BNT162b2 based on known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
The vaccinee received his 1st injection of Engerix-B on 3/26/02, without adverse experience. On 4/25/02, the vaccinee received his 2nd injection (20mcg rather than the recommended 10mcg) of Engerix-B. On 5/1/02, he experienced fever, achiness and flu-like symptoms. He was seen by a physician. Treatment was not specified.
Narrative: COVID infection after completion of COVID vaccine series: 12/30/2020 COVID vaccine dose #1 01/19/2021 COVID vaccine dose #2 07/16/2021 Pt presented to ED c/o high-grade fever and chills X1d and cough X3weeks that produces white/clear phlegm 07/16/2021 COVID positive per nasopharyngeal swab. Discharged home with meds for supportive care. 07/17/2021 Pt reported continuation of sx 07/18/2021 Pt reported onset of loss of sense of taste and decreased appetite 07/18/2021 Pt presented to ED c/o high-grade fever for multiple days which did not respond to APAP. RN discovered taking incorrectly. Pt discharged home. 07/19/2021 Pt reported low-grade fever and continuation of other sx 07/20/2021 Pt admitted to facility due to high-grade fever and low BG. Administered course of remdesivir, Rocephin, and dexamethasone. 07/24/2021 Pt discharged from facility. During telecare f/u pt O2sat is 88% so advised to go to ED to be assessed so can get O2. 07/25/2021 Pt reported onset of myalgia and constipation. Continuation of loss of appetite and cough. 07/28/2021 Pt reported continued constipation, cough, and fatigue. Onset of nausea (likely due to constipation).
Information has been received from a certified medical assistant concerning a 16 year old female who on 05-OCT-2006 was vaccinated with a first dose of HPV (lot # 653735/0688F). There was no concomitant medication. on 06-OCT-2006 the patient experienced sharp pain around the abdomen area and vaginal area and intense pain during urination. It was reported that the pain was on and off. It was reported that the patient was going to go to the physician's office to be evaluated. At the time of the report, the patient's outcome was unknown. Additional information has been requested. 01/05/2007 Initial and follow-up information has been received from a certified medical assistant concerning a 16 year old female who on 05-OCT-2006 was vaccinated with a first dose of GARASIL (lot #653735/0688F). There was no concomitant medication. On 06-OCT-2006 the patient experienced sharp pain around the abdomen area and vaginal area and intense pain during urination. It was reported that the pain was on and off. It was reported that the patient was going to go to the physician's office to be evaluated. At the time of the report, the patient's outcome was unknown. Additional information is not available.
Developed a papular rash on the right ankle 30 days after the injection. The rash spread up the left calf and to the right calf. It was first unsuccessfully treated with a topical steroid (Betamethasone Valerate) and then oral steroids, which suppressed the rash for a few months but it returned. It was then treated with a another topical treatment (Clobetasol Propionate), which clears up the rash, but it periodically return every month or so.
Actually not bad. Doing this form thinking it helps your data. I had a sore arm at injection site, shoulder soreness and maybe a slight headache. It lasted from Friday late PM until early Sunday, declining in soreness during that time.  Otherwise did not notice much else. Hope this helps.
This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored PNEUMOVAX 23 (strength, dosing details, anatomical location, lot# and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
intense nausea that started the evening of the vacine and lasted for 3 to 5 days
Because pt was uncomfortable he did not use his CPAP machine. 45 hours after second dose was administered my husband was sitting up in bed eating breakfast, He tilted his head back to swallow his his escitalopram and baby aspirin, sipped his coffee chewed and swallowed. He then went speechless and began staring off to his left. He lost consciousness. His chin stretched out to the left and his head rolled back as did his eyes. Eyelids remained open. His head and upper body began to tremble and seemed stiff though his hands remained down by his side. Time slows when in such an emotional situation but I think the complete event lasted about 35 real seconds.  I wonder if his temperature being elevated a couple of degrees and with his absolute lymphocytes on the rise if his strong immune response revealed a family predisposition to dystonia?
I felt cold-like symptoms (stuffy nose, scratchy throat) on around 12/19/2022. My husband had tested positive for COVID-19 a few days prior, so I took a home antigen test. The first time I tested, the result was negative, and the second time, the result was positive. I had a telehealth visit on 12/20/2022 or 12/21/2022 and got a PAXLOVID prescription. I began taking it that day. I basically just felt like I had a cold. For a couple of days while taking the PAXLOVID, I had a metallic aftertaste in my mouth. The COVID-19 pretty quickly resolved itself, and by 12/26/2022, I felt fine again.
Hospitalization due to shortness of breath,  diagnosed with bilateral pulmonary embolism.  The PUI lives in a Senior Living facility and she was taken to the hospital for blood clots in her lungs. They did a Covid test and she was positive, but she had not had any symptoms and was vaccinated in February. The later had another Covid test done at the hospital, where where she was for 3 days and the test came back negative.
Patient received the vaccine at around 1:05pm, 10 minutes later the patient developed a dizzy, hot, clammy, tired feeling. Pt did not feel well and paramedics were called. After the paramedics evaluated the patient it was determined that they were going to take her to the emergency room.
His reaction started on his first dose, but increased after his second dose. At first he had a sore arm. Then he started getting pains in his shoulder blade and down his arms. And if he lifted his head wrong it would hurt also. He went to the doctor, After about 3 weeks he started getting tingling in his right arm and hand all the way up to his elbow. Has continued on and was given prednisone and cyclobenzaprine. After a week on the meds the pain went away. He still has numbness and tingling.
severe erythema, induration, tenderness surrounding vax site on rt thigh; area measures 7x11cm & devel w/in 24 hrs of administration;
COUGH; CONGESTION; BACK PAIN; FEVER; FATIGUE; NAUSEA; SEVERE HEADACHE; COLD SWEATS; MUSCLE CRAMPS; GENERALIZED PAIN; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy, and antibiotic allergy, and other pre-existing medical conditions included the patient had allergy to pain medication (except toradol and ibuprofen). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 20-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced cold sweats. On 09-APR-2021, the subject experienced muscle cramps. On 09-APR-2021, the subject experienced generalized pain. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced severe headache. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced congestion. On 10-APR-2021, the subject experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, muscle cramps, and fever on 13-APR-2021, was recovering from severe headache, and had not recovered from generalized pain, fatigue, back pain, cough, nausea, and congestion. This report was non-serious.