chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she believes her dermatologist is treating other patients who have urticaria after getting Covid-19 Vaccines; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (she believes her dermatologist is treating other patients who have urticaria after getting Covid-19 Vaccines) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (she believes her dermatologist is treating other patients who have urticaria after getting Covid-19 Vaccines). At the time of the report, URTICARIA (she believes her dermatologist is treating other patients who have urticaria after getting Covid-19 Vaccines) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment details were reported.
First 24 hours, I had the typical fever, chills, nausea, fatigue, headache, blurry vision. By day four, I developed a moderate rash on my abdomen, which I still have. It has not spread beyond my abdomen.   I am pregnant and due August 19.
Information has been received from a health professional concerning a 12 year old female with no allergies who on 27-JUN-2007 was vaccinated SC on right arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657404/0592U). Concomitant therapy included a first IM dose on right arm of Menactra (Lot # U2343AA). There was no illness at the time of vaccination. It was reported that the patient developed redness and rash at injection site. No medical attention was sought. At the time of report the patient had recovered. Additional information has been requested. This is one of several reports received from the same source.
Patient felt light headed, dizzy and nauseous within 5 minutes after receiving the vaccine.  She felt as though she may pass out if she got up.   She was closely monitored and felt better within the next 5-10 minutes.  After she felt better she was monitored for another 30 minutes before leaving the store.  She said she felt back to normal and left the store on her own without assistance.
swollen lymphnodes under left arm. Still experiencing pain to the sight that was very swollen. swelling lasted over 2 weeks
WITHIN 5 MINUTES OF VACCINE PATIENT FELT FAINT, LIKE HIS HEAD WAS SPINNING.  BP WAS 80/40. PULSE WAS 42.  BLOOD SUGAR WAS 125.  VERY PALE, LIPS WERE PALE/BLUISH IN COLOR.  HAD A DECREASED LEVEL OF CONSCIOUSNESS.    SPO2 WAS 88%, OXYGEN WAS PLACED ON HIM. HE WAS TRANSPORTED TO HOSPITAL VIA EMS
expired dose of Daptacel inadvertently given to patient, no AE; Initial information received on 31-Mar-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 17 months old female patient who inadvertently received a 0.5 ml dose of an expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (cycle series 4, lot C5367AA, expiry date: 30-Mar-2020) on 31-Mar-2020, via an intramuscular route in the left thigh  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  It was an actual medication error due to expired vaccine used.  At the time of reporting, the patient did not experienced any adverse 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 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.
Narrative:  A 63yo Homeless male with PMH of OA, Chronic Pain, Chronic Back Pain, Opioid Dependence, Hepatitis, Knee Pain Per Nurse's documentation he received Pfizer's Covid - 19 vaccine per policy and protocol without complication First dose on March 9, 2021 and second dose on March 30, 2021 No ADR reported The system shows this patient passed away on April 22, 2021
Discoid eczema outbreak started 1 week post shot and has continued (currently at 3 weeks post first shot). No other changes were made regarding clothing, lifestyle, diet, travel, etc. mainly has appeared on legs, hands, and wrists.
Received vaccine 9/4/19 knot noted 10/17/19. Not erythematous or tender. Ultrasound order. Reason for report is that patient developed soft tissue was in January 1 month after Pediarix vaccine and  it developed into abscess that had to be drained 2 month after the vaccine.
patient got progressively worse at home with shortness of breath PCP had tested her Wed day before and returned today positive patient was going to get an infusion today but got worse and arrived at the ED patient was admitted with COVID patient is a known diabetic BNP was 13,822 and first troponin was 0.340  Patient expired on 8/10/2021 at 07:09
Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Mild, Systemic: Weakness-Mild, Additional Details: Patient received vaccine and immediately after complained of dizziness, weakness, feeling nauseated and sweatiness. Pharmacist on duty gave patient water and some candy and some sugar, in case of low blood sugar. Patient diabetic. Patient waited 15-20 minutes; stated he felt better and went home. We asked that he call the pharmacy later this evening if he had any other issues regarding the vaccination today.
Disseminated varicella diagnosed about 30 days after first MMR-V vaccine. Child presented with non-pruritic vesiculo-papular rash on sacrum which spread to left lower leg, trunk and left neck associated with low-grade fever. Lesion was unroofed and PCR positive for varicella. He was treated with parenteral acyclovir for 3 days and clinically improved. He was discharged home with oral valacyclovir to complete at 10 day course.
Tiredness began upon return home from shot location.  Severe bone pain in right hip, thigh, knee, both shoulders, chest pain when taking a deep breath and headache began approximately 15 hours after injection and continue at 3pm on Tuesday the 16th of February.  Just not the "happy camper, I usually am. :(
Confirmed no other AE occurred.; Caller reported an AE for PROQUAD. The caller said they have a patient who moved their arm during administration and less than the full dose was administered. Confirmed no other AE occurred. AE letter sent to prescriber. No other AE. No PQC.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 11-AUG-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot #w038812, expiration date: 04-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 11-AUG-2023, the patient moved their arm during administration and less than the full dose was administered. Confirmed no other AE occurred. AE letter sent to prescriber. No other AE. No PQC.  Patient was sitting on moms lap in bear hug position. Mom had her arm around patients arme. Nurse cleaned patients right arm and explaied each step that she would now be administering the vaccine. During the placement child flinched her arm enough that the needle had been removed. At this point not all the vaccine had been administered. She asked her manager, if this should be readministered. She adviced her to call Merck company for advice. Nurse spoke to Merck team and was told that vaccine would need to be done again. Administered second dose to right vastus lateralis with support of another clinical staff member who held leg in place. Seond vaccine was administered with no issues. Patient was not injured. She and mom were notified of all steps.
Hives all over my body. I?ve never had a hive prior to the booster
2 1/2 hours after shots patient had wheals with white dots on them went to emergency room and patient was given Benadryl and Prelone. Mom brought child to health unit on 6/18/07. Child still has solid bruises on legs and wheals still on the arms, legs and head.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On an unknown date, the patients were vaccinated with PNEUMOVAX23 (dose, lot number and route not provided). No co-suspect or concomitant therapies were reported. The medical assistant reported that multiple unspecified patients were administered PNEUMOVAX23 that was improperly stored (dates not specified). No adverse effects were reported. This case is linked to cases 1406USA008435, 1406USA008521, 1406USA008522, 1406USA008523 and 1406USA0085524 (same reporter link).
booster dose; pain in left arm that is radiating to his shoulder and neck; pain in left arm that is radiating to his shoulder and neck; sick; pain in left arm that is radiating to his shoulder and neck; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 15Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), reaction(s): "Covid 19 immunization"; Bnt162b2 (2nd dose), reaction(s): "Covid 19 immunization". The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "not recovered", described as "booster dose"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "pain in left arm that is radiating to his shoulder and neck"; ILLNESS (non-serious) with onset Dec2021, outcome "unknown", described as "sick".  Additional information: The reporter reported he had booster dose of covid vaccine on 15Dec2021. He experienced pain in left arm that radiated to his shoulder and neck. He declined to provide any contact details. He was sick from the vaccination and could not wait to mail something to the legal department for compensation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash on left lower extremity 7 days after administration of vaccines, then noticed four more on Bilateral leg. Seen in clinic as f/u rash on 8/12/2023
Patient said that he had some pain in his arm around injection site a few days but the pain traveled up to his shoulder and his been bothering him since the injection.  He has seen the specialist twice and the Dr. told him that there is fluid build up around the shoulder joint.  He received a cortisone injection in his shoulder but still having discomfort.
This is a spontaneous report from a contactable consumer or other non hcp (friend). A female (age 66, unit unknown) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date in Mar2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) for COVID-19 immunization. It was reported that patient received her dose 3 or 4 days ago and now reported chills and a fever of 101F on an unspecified date in Mar2021. Reporter asked if patient should seek medical intervention or what they could do. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on Mar2021. The outcome of event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Hives rash all over chest, stomach, and arms. Started about 3 hours after vaccine. They were big, red, hot blotchy spots.  Also developed a fever, along with extreme body aches and chills.  Hives lasted for about 2 hours. Fever was gone by this morning. Muscle aches and fatigue have continued into this morning.
feeling unwell; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the vaccine on 25Mar2021 and was due to get the second dose tomorrow, 15Apr2021. She would not be able to make tomorrow's appointment because she was feeling unwell (2021). She would like to reschedule her second dose to up to two weeks from now as advised to her. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient reports that she received her second vaccination for COVID 19 (Pfizer) and was feeling well initially but after 10-15 minutes stood up and got acutely dizzy. Denies any associated pain, nausea, palpitations, sob. Feels perfectly well at time of my evaluation: all symptoms resolved and patient is requesting to be discharged to go to work.
Patient received first dose of Modern vaccine on 1/24/21 and second dose on 2/25/21. He developed thrombocytopenia: 126 (3/9/21) and then 22 (4/15/21), which is suspected to be ITP secondary to COVID vaccine. Currently is admitted, receiving IVG and N-plate, and planned to have bone marrow biopsy.
This spontaneous report was received from a 74 year old female patient who was reporting on herself. No information regarding the patient's medical history was provided. The patient's concurrent conditions included high cholesterol. No drug reactions or allergies were reported. On an unknown date, about 5-6 years ago, the patient was vaccinated with a dose of ZOSTAVAX, injection, dose: 0.65 ml, (route, injection site, lot number and expiration date were not reported). Concomitant therapies included simvastatin (manufacturer unknown). The patient stated that 6 months after vaccination, she had developed shingles. According to the reporting female patient, the first time she developed shingles it was on her chest under her breast and she described it as being severe. Ever since then she had consistently had smaller outbreaks on different parts of her body. It was also reported that at the time of this report, the patient had a severe outbreak on her hands and face. The patient sought medical attention via office visit. No laboratory diagnostic tests were performed. The patient was given unspecified antiviral medications and unspecified cream for treatment of the event. The outcome of the event of shingles was reported as not recovered at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. No PQC involved. Additional information has been requested.
Exhaustion started 2 hours after injection, the next day I had a fever of 101.4, chills, my skin hurt, and no appetite. The fever broke over night. The following day I had hardly any appetite, brain fog, and exhaustion.
redness edema at site. headache. and general achiness flu like ache for about 48  hours
Information has been received from a registered nurse concerning a 57 year old female with a drug hypersensitivity to DEMEROL who on 19-OCT-2007 was vaccinated with a first dose of PNEUMOVAX 23 (lot# 657529/0993U) 0.5 mL IM in the right arm.  Concomitant therapy included influenza virus vaccine (unspecified) in the left arm.  On 20-OCT-2007 "24 hours post vaccination" the patient developed a fever of 101 degrees F, headache, achiness and redness and swelling at the injection site of the right arm.  The swelling at the injection site was the size of a baseball.  Medical attention was sought.  The patient was seen in the office on 22-OCT-2007.  The symptoms were subsiding and the patient was recovering.  The treatment for the patient included comfort measures ice compress as needed.  No other information was given.  No further information is expected.
weak; tired; cough; headache; This is a spontaneous report from a contactable consumer or other non hcp (patients grandmother) via medical information team. A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 14 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced weak, tired, had a cough, headache that went away. Reporter stated she read the side effects for the vaccine but did not see cough and headache. Reporter wanted to know if these are side effects to the vaccine. The outcome of the events was recovered on an unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I receive Moderna vaccine on my  bottom because i use to have reactions with others vaccine after  15 minutes Moderna vaccine Im staring  to feel dizziness, nausea headache sore throat stay in clinic for 3 hours later  nurse gave me Benadril 50 mg unable to drive my car. I saw a rash around injection site on next day and developed severe headaches VAS 8/10 for no reason also tachycardia for next days irregular palpitations. Pain for inflamation of  left shoulder and arm   constantly.
This spontaneous report was received from a nurse regarding unspecified number of patients of unknown age and unknown gender. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot # L035504 and expiry: 16-DEC-2016) (route, dose and strength were not reported), which was improperly stored at -12.7 degree centigrade for 9 hours and 58 minutes. No adverse effects were reported. There was no prior temperature excursions and data logger was involved. It was reported that the MMR II (Lot: L011528 expiry: 03-APR-2017, Lot: L000458 expiry: 06-JAN-2017, Lot: K005174 expiry: 10-APR-2016) appears on the product list as temperature stability questions were asked, however, no doses of improperly stored were administered to patients. This is one of the several cases form same reporter. Additional information has been requested.
Next day nausea; severe back pain./Back pain lasted two days; Within 2 hours experienced dizziness; severe headache./After a week still have a headache.; Slight arm soreness; Severe exhaustion and slept 12-15 hours the first three days after shot.; Severe exhaustion and slept 12-15 hours the first three days after shot.; This is a spontaneous report from a contactable consumer. a 68-year-old female patient (consumer) received first dose BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration (anatomical location: arm left) on 03Feb 2021 at 12:15 pm at single dose for COVID-19 immunisation. Patient Medical history included low thyroid. The patient's concomitant medication included levothyroxine. It was reported that no other vaccine was given within Four weeks prior to the vaccination. On 03Feb 2021 at 02:15 PM (same day of vaccination) Within 2 hours patient experienced dizziness and severe headache. Slight arm soreness. Next day nausea and severe back pain. Back pain lasted two days. Severe exhaustion and slept 12-15 hours the first three days after shot. After a week still have a headache. The patient prescribed treatment with Ibuprofen, tylenol and meloxicam. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event headache was not recovered and other events was Recovering. Information on Lot/Batch number has been requested
First conjunctivitis then 2 days later high fever of 104 and 1 week after can't even move joints in every part of body to the point he couldn't get out of bed. Sed rate level was elevated and the week after that he has 3 seizures within 24 hours. Now he is diagnosed with epilepsy and is on heavy meds for it.
Had Pfizer vaccine on 4/7/21 and 4/28/21.  Symptom onset 7/19/21 with cough, chills , muscle aches and nasal congestion.  Tested positive for Covid-19 on 7/20/2021.
Rash on back and partially on chest; This is a spontaneous report from a contactable consumer (Patient). A 68-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 23Jan2021 14:00 at single dose at Left arm for covid-19 immunisation .  Medical history included type 1 diabetes mellitus.  Concomitant medication included insulin.  The patient experienced rash on back and partially on chest on 23Jan2021. This has persisted since vaccination date (23Jan2021) until 06Feb2021. Therapeutic measures were taken as a result of rash on back and partially on chest included Benadryl and Calamine. The outcome of event was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.    Information on lot/batch number has been requested.
Patient received her Dose number 2 of the Moderna Covid-19 vaccine 21 days after Dose number 2.
Per mother, approximately 24 hours after vaccine administration, patient developed a 104.2 fever with body aches and stomach ache. This morning, his temp was 99.9 without TYLENOL or MOTRIN.
I had a pneumovax vaccine the day before. I had to go to the ER. Shortness of breath-severe agitation, shaking
1/5/08 Legs gave way and she fell several times right together. Legs hurt and didn't have any strength in them. 1/8/08 Diagnosed with Guillain-Barre Syndrome (Admitted to hospital and stayed 5 days. Received intravenous immunoglobulin(s). 2/26/08-records received for DOS 1/8-1/13/08- DC DX: Guillain-Barre syndrome. One week prior became extremely weak and started to fall serveral times per day. On exam found to have areflexic partial lower extremity paraparesis. Ataxic. Treated with 5 days gamma globulin.  02/05/2010 Follow up: She still has pain and tingling in her legs and they are still weak.
Patient was supposed to receive Johnson and Johnson (Janssen) COVID vaccination (LOT 1855194). The pharmacist that was supposed to administer the vaccination (not myself) gave the patient a Moderna vaccination. In contact with patient, the patient had mild flu like symptoms, fatigue, and a sore  arm for a day or so.