chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm for two days; This is a spontaneous report received from a non-contactable consumer (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in Jan2021 (lot number and expiry date unknown), at single dose; then received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm, in Jan2021 (lot number and expiry date unknown), at single dose, for covid-19 immunization, at the hospital. There were no medical history and concomitant medication. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive other vaccines in four weeks. The patient experienced sore arm for two days in Jan2021. Treatment included two doses of Advil. The patient recovered from the event in Jan2021.  No follow-up attempts are possible; Information about lot and batch number could not be obtained. No further information is expected.
Myalgia, Fever, chills, pain and swelling in injection arm Narrative:
Vaccinated 8/27/13 - evening. 5PM - all evening - very painful, stiff, starting from injection site to elbow. No swelling - just pain.
Headache and sore arm  started during the night and after getting the vaccine. Next day, experienced extreme fatigue, nausea, and loss of appetite lasting all day. Had chills on following  night.  Began to slowly feel better  on 1/16/21
pt had a positive COVID test on 1/21/22 when seen at hospital; 1/25/22 transferred to hospital for worsening respiratory failure and altered mental status secondary to COVID pneumonia; required BiPAP; little improvement from medical management; pt made comfort care and expired in the hospital
This spontaneous report was received from a patient's wife refers to an approximately 74 years old male patient. The patient's pertinent medical history and drug reactions / allergies were reported as none. The patient's concomitant medications included metoprolol, sertraline, atorvastatin and finasteride. On an unknown date in November 2008, the patient was vaccinated with ZOSTAVAX (lot number, expiry date and strength were not reported) 1 injection for shingles prevention. Other suspect therapies included sterile diluent (STERILE DILUENT) one injection (dose, lot number, expiry date, indications are not provided). On an unknown date in 2009, the patients kidney was removed due to cancer. On an unknown date in February 2011, the patient experienced shingles on his right side. On an unknown date in 2012, the patient had an open heart surgery (cardiac operation). On an unknown date in May 2017, the patient experienced shingles again on his left side however the rash was more mild. It was reported that the patient was still experiencing residual pain at the time of this report. Lab diagnostics/studies were not performed. Treatment was given for the adverse events. The patient sought for medical attention by visiting physician. There was no product quality complaint associated with this report. The outcome of the events, nephrectomy, cardiac operation and neoplasm malignant was unknown. The outcome of the event herpes zoster (onset: Unk-FEB-2011) was recovered. The outcome of the events, herpes zoster (Onset: Unk-MAY-2017) and pain was not recovered. The causality assessment was not provided. Upon internal review, the events nephrectomy, cardiac operation and neoplasm malignant was determined to be medically significant.
Patient was vaccinated in her home (COVID J&J) on 3/8. Vaccinator obtained consent and confirmed throughout the process that patient as at baseline since patient was nonverbal and bedbound.   Later that same day she experienced an emergency and was take to the hospital and subsequently admitted to ICU. She died on 3/10, family present, on comfort care.   Per HPI, "Patient is a 85 y.o. female with advanced dementia (non verbal, wheelchair bound at baseline), chronic aspiration, recurrent UTIs, voiding dysfunction currently self-straight cathing, has suspicious bladder and gallbladder masses (being worked up), has right sided hydronephrosis, BIBEMS for acute hypoxemia, difficult to bag en route, ED had difficulty intubating and so performed cricothroidotomy.  Patient had brief PEA arrest due to hypoxia.  ED provider noted "excessive pulmonary edema in airway, unfavorable anatomy, and airway swelling." Suspected insult stemming from J&J COVID vaccination reaction.
3 YO was administered Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2023, the patient received Kinrix .5 ml and Kinrix Pre-Filled Syringe Device. On 11th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 11-JAN-2023 Reporter comment: Medical Assistant reported a 3 year patient was inadvertently administered a Kinrix dose. The medical Assistant called to inquire how to proceed. The reporter consented to follow up. Additional Supportive Information: The patient received Kinrix below the recommended age limit, which led to inappropriate age at vaccine administration.
Patient received 1st dose of Moderna Covid 19 at age 17. Moderna vaccination only indicated for 18 years of age and older
pt had flu shot 910AM went to another agency & got pneumonia shot @ 1110AM; sx started about 310PM the same day h/a, nausea, fever, chills & sore arm @ inject site; pt is to see MD today;
Patient came to pharmacy on 3/16/22 and made an appointment for a booster dose of the J&J vaccine. Upon looking over the patients information, we noticed that the patient was not 18 when he got his first vaccine on 11/05/2021. Patient did not disclose the information on where he got the vaccine. J&J is not indicated for anyone younger than 18. He came into the pharmacy on 3/16/22 looking to get the booster but since he is now 18, I gave him the vaccine as if this was his first dose since now he is eligible.
Narrative:  Pt was a 59 YO male with PMH of DM2, HTN, tobacco use, HLD, fatigue, and hemorrhoids. Per records, patient presented to Medical Center with cardiac arrest and subsequently passed. No evidence that vaccine contributed to the patient's death.
pt stated that she had common side effects first night after vax but woke up in the middle of the night  with a hot and red rash covering her entire face which subsided within 3 hours.  Rash has not returned nor does she have any other symptoms.
groin pain; she was dragging her legs because of the pain/tenderness; she was dragging her legs because of the pain/tenderness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GROIN PAIN (non-serious) with onset 20Mar2021, outcome "recovered" (20Mar2021), described as "groin pain"; PAIN IN EXTREMITY (non-serious), TENDERNESS (non-serious) all with onset 20Mar2021, outcome "recovered" (20Mar2021) and all described as "she was dragging her legs because of the pain/tenderness". Therapeutic measures were taken as a result of groin pain, pain in extremity, tenderness.  Additional information: The patient received her first dose on 20Mar2021 - she reports that immediately after getting the vaccine she experienced groin pain and by the time she got home and went to bed she was dragging her legs because of the pain/tenderness. The symptoms resolved the following day after taking pain relieving medication. She wants to know if this is reported side effect. Referred her to HCP for further discussion. Spoke from attached document FACT SHEET FOR HCPs ADMINISTERING VACCINE; FULL EUA PI (v1.0) (LAB-1457-7.0 Revised: 06 April 2021) section 6.1 Clinical Trials Experience. Response: Referred her to speak with husband's HCP for further guidance and treatment recommendations. Informed caller that Pfizer does not have information on concomitant use of medications with the covid vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia, Diarrhea, SORENESS,FATIGUE,HEADACHE Narrative:
Patient reports pain and muscle spasm  from shoulder to hand. Patient think a nerve have been pinched.
Pt had a allergic reaction to the MMR lot # H018949. Just when I injected the MMR vaccine it started to swell up. I then told dr to inform her. Dr then informed me to give pt a cold patch to put on right leg. Pt then waited 15 mins. but it was still the same.
Numbness down the right arm into hands/right side of face has numbness/also down to right leg; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 07Sep2021 at 14:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis, type 1 diabetes and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient received other unspecified medicines within two weeks prior to the COVID-19 vaccine. On 07Sep2021 at 14:45, the patient experienced numbness down the right arm into hands, right side to face has numbness and also down to right leg. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event numbness down the right arm into hands/right side of face has numbness/also down to right leg was not recovered at the time of this report.
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), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number unknown), for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number unknown), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I took the booster I got very very ill". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
red area about 1 cm,raised about .5cm at or near the  varicella injection site. shot was given on 7/8 and the spot did not appear until 7/14. we saw the patient on7/18. mom states the lesion or spot was the same on 7/14 as 7/18. denies the child having a fever during that time. looked kind of like a mosquito bite.
Fever, chills, muscle pain, joint pain, tiredness, headache, injection site pain, injection site redness, nausea
Moderna COVID-19 Vaccine EUA itchy, red rash on chest, abdomen and left arm
8 days after vaccine #1, child had abrupt onset of substernal chest pain lasting several hours. This was eventually improved with ibuprofen and did not recur. Vitals at that home were normal as far as could be taken (HR 90-100, O2 sat 97). He was not previously warned about chest pain as potential side effect prior to experiencing this as we did not want to suggest symptoms to him. He was in tears, with a balled fist over his sternum, and was not distractible from his pain. Took him to doctor the next day, EKG was normal, we did not pursue further workup. He did c/o stomach pain intermittently on that day (Monday), and Tuesday he had a single episode of emesis at school, and then apparently completely recovered thereafter. He has not had recurrent chest pain since initial episode resolved with motrin.
Adult couple was administered a booster dose of 0.25ml from the Pediatric Moderna vial NDC 80777-0279-05; This spontaneous case was reported by a non-health professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Adult couple was administered a booster dose of 0.25ml from the Pediatric Moderna vial NDC 80777-0279-05) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Adult couple was administered a booster dose of 0.25ml from the Pediatric Moderna vial NDC 80777-0279-05). At the time of the report, INCORRECT DOSE ADMINISTERED (Adult couple was administered a booster dose of 0.25ml from the Pediatric Moderna vial NDC 80777-0279-05) outcome was unknown.            No concomitant medications were provided by the reporter.  Patient got booster dose.  No treatment information was provided.   This case was linked to MOD-2022-607602 (Patient Link).
Swollen deltoid and muscle soreness for 3 days following injection. Heavy fatigue on day 3. 6-7 days later, very noticeable swollen lymph nodes in left arm pit only. Tender to the touch and when adducting the arm.
Guillain Barre syndrome; Initial information received on 20-Feb-2020 regarding an unsolicited valid serious case received from other healthcare professional.  This case involves a 56 year old female patient who was diagnosed with Guillain-Barre syndrome (Guillain-Barre syndrome), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   On 28-Jan-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT6713MA, expiry date: 30-Jun-2020) via intramuscular route in the left arm for prophylactic vaccination.  On 19-Feb-2020, the patient was diagnosed with Guillain-Barre syndrome (Guillain-Barre syndrome), 22 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  Relevant lab tests were not reported.  Final diagnosis was Guillain-Barre syndrome.   The patient was treated with an intravenous (IV) infusion of normal saline for Guillain-Barre syndrome.  The outcome for Guillain-Barre syndrome was not reported.; Sender's Comments: This case involves a 56 year old female patient who was diagnosed with Guillain-Barre syndrome 22 days following the administration of FLUZONE QUADRIVALENT. Time to onset is compatible. There are multiple possible etiologies of Guillain Barre Syndrome and the causal relationship with the vaccine cannot be ascertained without ruling out the other causes of this event. Based upon the reported information, the role of the vaccine cannot be assessed.
This case was reported by a pharmacist and described the occurrence of local reaction at injection site (induration) in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL. At an unspecified time after vaccination with FLULAVAL, the subject experienced local reaction at injection site (induration (golf ball sized indurations to distal injection). It was swollen and hard at the injection site. At the time of reporting the outcome of the events was unspecified. Product complaint was also noted. It was reported that 6 subjects experienced adverse events following administration with FLULAVAL. The vaccines were given from two vials with the same lot number. The vaccines were administered by the staff of a nursing home. The director of nursing reported the adverse events to the pharmacist. It was noted that the facility would be shutting down on 16 October 2011. Linked cases include A0947071A, A0947173A, A0947175A, A0947176A and A0947177A. Follow-up information was received on 19 October 2011. It was reported that 0.5 ml of FLULAVAL was administered to the subject on 23 September 2011. The reported events began on 23 September 2011. The events were not considered to be serious and resolved on an unspecified date. No additional information is available. According to the product complaint investigation results reported by GSK quality assurance/ Biologicals on 31 October 2011, the product complaint was assessed to be unsubstantiated.
Patient was vaccinated for 2nd dose of COVID vaccine 7 days after the 1st dose.
eyes, ears, and jaws had an infection.; eyes, ears, and jaws had an infection.; eyes, ears, and jaws had an infection.; broke out in hives on my face; eyes started to swell shut; This is a spontaneous report from a contactable Consumer or other non-HCP (Patient) communicated to Pfizer-sponsored program Pfizer.com-General Company Information. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 04Mar2021, as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date, as single for covid-19 immunisation. On 10Mar2021, the patient experienced broke out in hives on face exactly where a mask was located, and eyes started to swell shut. Initially, the patient did not think the hives were caused from the vaccine. The patient took an antihistamine which stopped this action. On an unspecified date in Jun2021, after three months, the patient had an infection of eyes, ears, and jaws for which the patient had to get an antibiotic. It was reported that the patient was fine now and just thought to inform about this delayed reaction and was thankful for the vaccine. The patient outcome of the events was resolved on an unspecified date in 2021.  Information on the lot/batch number has been requested.
pt recv vax 20MAR97 & on 31MAR97 broke out in a rash covering most of body;became cranky, dec appetite & coughing on 28MAR;no fever noted per mom;pt was not seen by MD;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were reported. On unknown dates, the patients were vaccinated with doses of VARIVAX (Merck), 0.5 ml, subcutaneous (lot number and expiration date were not provided) that were improperly stored. Concomitant therapy was not reported. No adverse experience was reported. Additional information has been requested.
My entire face was covered with hives. Within 2 hours of the vaccine I developed hives to the bilateral aspect of my face, forehead, cheeks and eyelids. My hives were itchy and red and I have never experienced this before. I did not consume any new food or use any new products. I took Benadryl for the itchiness. I had a telemedicine visit and I also had a Covid-19 test which was negative. I called health and also reported this adverse reaction. Moreover, I had no reaction to my second dose which was on 01-28-2021.
Per the observation nurse, the patient was sitting down in a chair, looking down on his phone, when he suddenly fell from his chair to the floor on his left-side. Patient was unresponsive for about 4-5 seconds with convulsion-like movements, while he was on the floor. He then regained consciousness, he independently stood up and assisted to sit in the chair. Patient was pale in color, cool and clammy to the touch at this time (while alert and oriented). Two doctors were at the patient's side to assess him. Vitals were taken. Patient was alert and oriented (answering all questions from the MD). Patient continued to be monitored and he was given water to rehydrate for an hour after the incident. He was sent home with his wife. Prior to leaving, the patient was alert and oriented. He stated he felt better.
Administered vaccine into patient left deltoid, patient began to bleed and not clot quickly. Patient was dripping blood from vaccine site for 2 minutes, EMS was called in to confirm patient was feeling well and not pass out. Patient began to bruise and swell at injection site. Patient was coherent entire time, able to walk and move and stay for monitoring for 30 minutes. Patient denied medical transport.
Bell's Palsy; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: ELD14D, via an unspecified route of administration, in left side of arm, on 04Jan2021 at single dose for COVID-19 immunization. Medical history included early breast cancer from 2017 and ongoing. Concomitant medication included tamoxifen citrate 20 mg tablet by mouth once daily from 2017 and ongoing for breast cancer (cancer pill, she has to be on it for 5 years). The patient received the vaccine as she is "with fire department, thought she needed to take it, she had early breast cancer, is around lots of people". On 09Jan2021 the patient was diagnosed with Bell's palsy, assessed as medically significant and in Jan2021 she experienced earache (she thought it was an earache, but it was more than that, but it made her ear hurt, and she has no infection), her mouth was drawled a little, further detailed as numbness and "the eye, it is messing with it, when she is trying to see out of it, she can see, but it's blurry like" and, "where the ear thing is", on the back of the lymph node was real sore and her face was kind of puffy, which is the reason she went to the doctor. The patient had to go to her doctor, he told her she had a reaction to the shot, he called it Bell's Palsy, and said to let Pfizer know. Her doctor gave her something to take for mouth drawled/numbness, which is supposed to help, and she has to go back in a week. The event Bell's palsy outcome was unknown at the time of the report.
Pt seen in our office on 9/5/03 due to reaction on right deltoid from Td that was given 9/3/03. 12.5cm x 11cm red area on right arm with some swelling. Given Keflex 500 mg caps on 9/5/03.
Fever, crying, swelling, red mark. Later on constipation, eczema, and autism.