chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives that did not itch appearing  8hrs after injection. resolved with zyrtec for about 3-4 hrs but returned and 1 pepcid OTC was given and then resolved; This is a spontaneous report from a contactable other health care professional. A 16-year-old (Age group- Adolescent (12-17 Years) non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EW0183), intramuscular, administered in right arm on 19Jun2021 at 08:30 (Age at vaccination: 16-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included seasonal allergy from an unknown date and unknown if ongoing, urticaria (Known allergies- had hives 5 yrs ago for about a month for unknown cause but none since) from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) 5mg daily, acetaminophen (ACETAMINOPHEN) and ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported in two weeks. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EW0173) as dose 1, single intramuscular, administered in right arm on 29May2021 at 12:45 AM for COVID-19 immunization. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination. Facility type vaccine at hospital and facility name. On 19Jun2021 at 16:00, the patient experienced hives that did not itch appearing 8hrs after injection. Resolved with zyrtec for about 3-4 hrs but returned and 1 pepcid otc was given and then resolved. It was reported that, adverse event treatment- Patient mother (I am her mother) and a family practice PA so treated patient with cetirizine and the pepcid as above. Post vaccination patient not tested for COVID. The outcome of the event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
I had a case of COVID; I had a case of COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had a case of COVID". The event "i had a case of covid" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The doctor recommended Paxlovid for treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146282 same patient, different drug/event;
Swelling inside upper & lower lips; teeth cutting inside lips; some foggy thinking first few days; sore arm with swelling at the injection site (right arm), stiff neck - mostly on right side; after 2-weeks started with dry mouth and numbness on inside upper and lower lips.
Patient got his flu shot on 10/13/2021 and as of 11/22/2021, he was still experienced pain in his arm
Patient states the evening after the shot was given he experienced left arm swelling, blood red color down to his wrist, aching and pain in his arm. He did not seek medical attention but said he considered it. He used ice packs for 5 days.
This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age. On 02-MAY-2014, the patient was vaccinated with both the VARIVAX (lot# J009992; exp: 12-AUG-2015) (dose and route of administration not provided) and MMR II (lot#J008533; exp: 12-JUL-2015) (dose and route of administration not provided) that were improperly stored. The reporter stated that VARIVAX was exposed to 10F for 9 hours and MMR II was exposed to 71F for 9 hours. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Patient only received the MenCYW-135 liquid conjugate component. Vaccine was never reconstituted.
Missed menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 20May2021 at 09:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jun2021 at 00:00, the patient had missed menstrual cycle. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event missed menstrual cycle was unknown at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the right arm on 10Jun2021 at 09:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation.
Pt became lightheaded at recovery table near syncope . brought to cot to lie down, elevated feet. ice pack to back of neck. no LOC, No SOB, no N/V. Pt stated she is menstruating.  Rt arm vac site benign. VS 108/58, HR 80 Reg, strong, resps 12 reg, non labored, SPO2 98%.   Gave water for hydration, provided reassurance. After lying down flat for 15 min, pt stated "I feel better, I OK". Ok'd to exit with family.
Headaches, tired, rupture vessel in brain. This letter is in regards to the shot my son received on Aug 2,2005 called Menactra. Pt was hospitalized on Nov 11, 2005 due to what the doctors believed to be an AVM. I honestly believe that his injury was caused by the shot Menactra. Pt was in very good health and never complained of headaches before he received this shot. He had surgery on his brain 4 days after he was rushed to emergency and spent 76 days at a hospital. He is now back in school, but goes to therapy 4 times a week to help him with the weakness of his right leg and right arm. 60 day Follow-up Information 12-JUL-2006: At this time patient is going through physical therapy. He has weakness in his right leg and right arm. Follow-up: Still has weakness in right arm, hand and right leg. Pt is now 13 yr old and still wears an ankle brace(R) for proper motion.
Low grade fever, chills, body aches, headache, nausea - symptoms started 12 hours after injection, fever, chills, nausea and body aches lasted roughly 18 hours, headache lasted closer to 36 hours
Ringing in my ears, noticed after second shot 5/20/21.  This has gotten better but some days the ring is very loud. The ringing is in both ears and constant. Sounds around me take me attention away from it, but if it is quiet the ringing is very present. No treatment provided.
Swelling and redness at vaccination sites of both arms. Left arm reaction 10 cm x 12 cm, right arm reaction 8 cm x 5 1/2 cm.
Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On an unspecified date in or about 2007, the patient was vaccinated with ZOSTAVAX (dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the healthcare professional. On an unknown date, the patient experienced shingles and on an unspecified date in 2016, the patient was treated for shingles at doctor's office. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient had not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
This spontaneous report as received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ oral liquid (orally, lot # M019690, expiration date 02-NOV-2017 and lot # M019708, expiration date 25-OCT-2017) for prophylaxis (strength and dose were unknown).  On unknown dates, the following temperature excursions were registered : between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 20 minutes and between 46°F and 77°F for 10 minutes. There were no previous temperature excursions. Digital Data Logger was involved. No adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008578: US-009507513-1701USA008577: US-009507513-1701USA002579: US-009507513-1701USA008575: US-009507513-1701USA008579:
Information has been received from a physician concerning a female who was vaccinated with all three doses of GARDASIL (lot numbers unspecified).  The patient had all negative Pap tests prior to vaccination.  After vaccination, the patient's Pap test came back as positive for high risk papillomavirus.  No other information is provided.  The patient sought unspecified medical treatment in the office.  Additional information has been requested.
Had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had a sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Had a sore arm). At the time of the report, PAIN IN EXTREMITY (Had a sore arm) outcome was unknown. Not Provided          Treatment details included ice.  No concomitant medications were provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Under my arm my lymph nodes are inflamed; Under my arm my lymph nodes are tender; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Under my arm my lymph nodes are inflamed) and LYMPH NODE PAIN (Under my arm my lymph nodes are tender) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for an unknown indication.     The patient's past medical history included No adverse event.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced LYMPHADENOPATHY (Under my arm my lymph nodes are inflamed) and LYMPH NODE PAIN (Under my arm my lymph nodes are tender). The patient was treated with CHLORHEXIDINE GLUCONATE, THIOMERSAL (SOAK) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Under my arm my lymph nodes are inflamed) and LYMPH NODE PAIN (Under my arm my lymph nodes are tender) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Warm compress and Tylenol were recommended by the HCP.
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Severe, Systemic: Hypertension-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Child received nasal spray vaccine in the afternoon at a school clinic. Her parent picked her up to take her home. When they arrived home they noticed child had a rash across nose, cheeks, and onto her neck. Parent gave the child Benadryl.
About 4 days after receiving DTaP #5 and MMR #2, patient complained of bilateral knee pain, body shaking with heaving. Symptoms. Evaluated by doctor about 3 days later and found to have neck stiffness with position change, lower extremitiy areflexia, ataxia, shaking at rest when sitting. Diagnosed with GBS. Rx IVGG  Nurse follow up on 06/17/04 states: "Pain."   As Per annual follow up report: have not seen Pt or spoken to family since 08/04 as family has moved. (called mother 05/14/05 stated pt doing well) Recommend contacting family for follow up at new address.
after the first injection fever headache and inflammation very painful in both shoulder impossible to sleep on them lasting 4 days .THEN after the second dose same symptoms. Then a week after the second dose i got again the same symptoms for at least 4 days.I was listening to NPR one day and a woman complained about the same symptoms an inflammation in her all body with knee pain.I felt some inflammation also in all my body .
PATIENT PHONED ON 3/12/19 STATING THAT HER ARM WAS RED, HOT AND SWOLLEN FROM THE ELBOW UP ON THE ARM THAT RECEIVED THE SHINGRIX INJECTION. IT WAS ADVISED THAT SHE CONTACT HER DOCTOR. UPON FOLLOWING UP ON HER ON 3/15, THE REDNESS AND SWELLING HAD GONE DOWN AND THE SITE WAS ITCHING.
Fever; A spontaneous report (United States) was received from a consumer, who was also a female patient, who received Moderna's COVID-19 Vaccine and experienced the event: patient has fever of 100.7 after taking COVID vaccine.  The patient's medical history included COVID. No concomitant medications were reported.  On 23 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273.   On 24 Dec 2020, the patient experienced the event, patient has fever of 100.7 after taking COVID vaccine. No treatment information was reported.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event, patient has fever of 100.7 after taking COVID vaccine, was unknown.; Reporter's Comments: This case concerns a female patient with medical history of COVID-19, who received their first of two planned doses of mRNA-1273 (Lot unknown),  and who experienced the non-serious listed event of fever.  Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event was considered possibly related to the vaccine.
Toxic fatigue (body aches, fatigue, irritable, mood swings),  tension in the jaw (lock jaw), headaches, body ache, muscle soreness, extreme tenderness and pain on injection arm 8 hours following the appointment; extreme fatigue
MODERNA COVID-19 VACCINE EUA on 3/26 arm started itching in the morning, then by noon the vaccine injection site was red, hard and itchy. The rash extended 2-3 inches around the injection area. on 3/27, arm is still red and hard but half the size it was yesterday and appears to be going away.
BODY ACHES; ARM ACHE; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced arm ache. On APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, arm ache, and chills on APR-2021. This report was non-serious.
Extremely heavy vaginal bleeding during period, breakthrough bleeding between cycles.  I have never had breakthrough bleeding.  I have taken the same birth control for 18 years which is the hormone pill.  I have it the same time every day.  I have had my labs checked and an ultrasound.  They don't see anything abnormal.  I keep bleeding like this since January 2021.
Caregiver/Sister, stated that on Monday, 3/29/21, approx. 11am is when she and the aid noticed the rash.  On Wednesday, 3/31/21, caregiver called me at the pharmacy.  She explained the rash and added patient had a scheduled appointment at 10am with the primary care physician.  I explained to show PCP and to stop by the pharmacy after the appointment so I could gather information to report and to view.  They stopped by the pharmacy approximately 11:30am.  I confirmed that they noticed the rash on 3/29/21 and verified by our vaccination records that he was immunized on 3/16/21.  I reviewed information again from constent form to verify no known allergies or prior adverse reactions to vaccines.  I also took a picture of the rash.  PCP had told patient not to get the second dose of Moderna. PCP told the caregiver to give Benadryl.   The rash was raised and splotchy red and ran from about 2in from top of deltoid down towards the inner arm/elbow for approx. 5 inches.  It didn't feel feverish.  I explained to monitor the rash by marking the edges to see if it spreads and to make note of the color.  That if it progressively gets worse to follow up with PCP.
Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Patient  unable to keep any food down, feeling very weak. Drinking plenty of fluids calling PCP and seeking care if no improvement
they have administered ADACEL to a 15-month-old patient with no reported adverse event; Initial information was received on 01-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA270745(CLUSTER).  This case involves a 15 months old male patient who have administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Aug-2023, the patient received a 0.5 ml, once dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: 2CA55D1, expiry date: 21-May-2025, strength: standard) via intramuscular route in the right thigh for Immunization (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Extreme menstrual cramping and lower back pain, pain in left ovary only accompanied by light menstrual bleeding.
adult booster administered to 11 year old patient. no adverse effects have been reported by patient yet
pt recv vax; crying constantly 2-3 hr; to sleep & began crying again non stop; on f/u, pt well;
Right arm red, swollen and warm to touch 2 days after injection. Rocephin gm given and then warm soaks.
Strong heart palpitations at night before I go to sleep and when I wake up. They stop during the day and come back at night. I have been getting them almost every night since getting the booster shot. However, they have been getting milder.
Received the 2nd covid19 in May was extremely sick my lymph node on my neck swelled up so big anyways got the flu shot that I always get for the past 10 years with no issues ever and this year my lymph node swelled up too....same place as from the covid vaccine...doctors said might be in my best interest not to ever get it again....crazy!!!
My face was really red and started to get swollen and today I woke up and my face is swollen and my neck seems red; My face was really red and started to get swollen; This is a spontaneous report from a contactable consumer or other non hcp reported for herself (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), via an unspecified route of administration, administered in arm left on 29Sep2021 (Batch/Lot number was not reported; Expiry date: unknown, age at the time of vaccination: 58-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient reported regarding the lot number as it looks like 30/35BA (further not clarified). The patient medical history was not reported. Concomitant medications included vitamins (VITAMINS NOS) taken for an unspecified indication, start and stop date were not reported. On 29Sep2021, the patient received her Pfizer vaccination and she did not get any allergic reactions, she waited for 15 minutes after administering the shot, then she reported, yesterday last night (02Oct2021), the patient noticed that her face was really red and started to get swollen and today she woke up and her face is swollen and her neck seems red. The patient not received treatment for the events. Investigation Assessment was No. The outcome of the events was unknown at the time of report.  Information about lot/batch number not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
2MAR98 pt c/o T102;sz c/o stiffness, foaming mouth, eyes rolled back;cried then slept;gave APAP & motrin;
Patient received 3rd dose booster dose before the interval timing. Received at 2.5 months from last vaccine instead of 5 months.