chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed mild to moderate COVID; Developed mild to moderate COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (age reported as 50 with no units provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "Developed mild to moderate COVID". The event "developed mild to moderate covid" and "developed mild to moderate covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: mild to moderate covid. Therapeutic measures were taken as a result of covid-19. The reporter provided the following information: Family of 5 who were all vaccinated with Comirnaty ranging in ages of 50 (received primary series and booster) with other family members receiving primary series (ages 50, 20, 17, 13) all developed mild to moderate COVID. No family member was hospitalized.  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-202200131953 Same reporter/RA, Different patient/AE;US-PFIZER INC-202200204042 Same reporter/RA, Different patient/AE;US-PFIZER INC-202200204043 Same reporter/RA, Different patient/AE;US-PFIZER INC-202200204041 Same reporter/RA, Different patient/AE
Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.     Concomitant product use was not provided by the reporter.  On an unknown date, the patient received booster dose of mRNA-1273 (Moderna COVID-19 Vaccine).  It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of pain was not provided.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Breakthrough case admission after 3 vaccines Moderna 4/22/21 Lot# 002C21A;  Moderna 05/20/21 Lot# 002C21A;  Moderna 11/13/21 Lot# 091D21A
Myalgia, chills, headache starting 1/6/2021 at 6 am Local pain and swelling starting 2 hours post vaccine
This spontaneous case, initially received on 15-Oct-2018 from pharmacist, concerning a 74-year-old, elderly, male patient. The patient had no relevant medical history and concomitant medications. On an unspecified date, vaccines suffered two temperature excursions. In the first case, the maximum temperature was 48.4 Fahrenheit and was out of range for 3 hours. In the second case, the maximum temperature was 46.4 Fahrenheit (which was 8-degree Celsius) for 3 hours. On 13-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250783, expiry date: 30-Apr-2019] which underwent temperature excursion. The patient did not experience any adverse events after the vaccination. The reporter assessed the case as non-serious. This case: 201804513 was cross-linked to the case: 201804514 reported by the same reporter. Non-significant follow-up received from reporter on 17-Nov-2018: The reporter confirmed that the patient did not experience any adverse event. No changes were made in the narrative.
Soreness in upper shoulders and neck and left arm. Debilatating pain persistent in left arm and shoulder after three days of first symptoms date. Treated with over the counter pain relievers.
swollen rt arm (upper & lower) to wrist;no redness or pain in arm;pt states arm burned:phone call to clinic nurse 450PM advised applying ice to arm;APAP given @ 5PM;pt stated felt tired & didn't feel well-no specific complaints;face flushed
Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose; Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose; This is spontaneous report from two contactable nurses, two contactable physicians, one contactable pharmacist. These reporters reported similar events for four patients. This is a 2nd of 4 reports. An unknown age and gender patient received 1st dose of BNT162B2 (LOT# unknown) at single dose for immunization. Medial history and concomitant drug were not reported. It was reported that patient experienced flu-like symptoms from the overdose. Eight healthcare workers in a long-term care (LTC) facility received the entire vial contents (0.45 mL), without dilution, for their first dose of the Pfizer-BioNTech vaccine. Four of the eight workers were hospitalized as a precaution after experiencing flu-like symptoms from the overdose. Outcome of the event was unknown.  Information on the Lot/batch number has been requested.; Sender's Comments: The association between the events "received entire vial contents without dilution" and flu-like symptoms with BNT162b2 can not be fully excluded.  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.,Linked Report(s) : US-PFIZER INC-2021032445 same reporter/SD/AE, different patient
The first day, hours later,  I experienced muscle soreness, nausea, headache and fever. 2nd day, continued headache, nausea, muscle soreness and fever albeit controlled with tylenol and mild chest discomfort. 3rd day, the chest discomfort became more concerning. My legs  buckled out from underneath me in weakness.  At this point I sought treatment at the local emergency room. Upon arrival the intake nurse noticed I had left side facial droop. I spent the day and evening in the ER. I followed up with my PCP who strongky advised I absolutely do not take any additional doses.
Within a week after vaccination, my eyes started swelling up and became very crusty. They eventually swelled shut and it was irritating and painful. I was having trouble with my vision. I had big red lumps on both of my eyes. I went to a walk in clinic and they suggested that I see a eye doctor. Three or four days later, I had to go to the doctor and get eyelids lanced at an eye doctor. That did help and I also had to take some medications and antibiotic cream. I got my second dose and had swelling and pain in both eyes. I also had flu like symptoms. My second dose was on 5/6/2021, lot 004C21A.
Patient appeared to have syncope about 5 minutes after receiving the Moderna vaccine.   Patient became responsive about 10 seconds later.  About 5 minutes later patient had another syncope episode and became responsive about 10 seconds later.  Patient's mother and 911 were called.   Paramedics arrived and took patient's vitals.    All tests performed were normal.  Patient's mother arrived and took patient from the pharmacy.   Patient stated that he had not eaten since the day before.
injection site has a discoloration (yellow/green); had trouble sleeping; fatigued; received Flu shot at the same time and in the same arm as Shingrix; This case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2021-2022 season (intramuscular). In September 2021, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced difficulty sleeping, fatigue and product administration error. On an unknown date, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved and the outcome of the difficulty sleeping and fatigue were recovered/resolved and the outcome of the product administration error was unknown.   It was unknown if the reporter considered the injection site discoloration, difficulty sleeping and fatigue to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient had received the first dose of Shingrix vaccine a few weeks ago (end of September 2021) could not remember exact date, in the left arm. The patient also received the Flu shot at the same time injection site a few inches lower than Shingrix injection site, which led to product administration error. The patient stated that same night he had trouble sleeping and was fatigued the next day. The reporter stated that several weeks after vaccination, he noticed the injection site had a 2x4 inch rectangle of discoloration (yellow/green) near Shingrix injection site. The reporter consented to follow up. This case was linked with US2021210528, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021210528:same reporter
Pharmacy was contacted by an aunt, who is also a healthcare provider. This contact was requested by the family. Per nurse practitionar who is the aunt of the deceased), patient passed away on Monday, 4/19/2021. He was found unresponsive on a jogging trail, where he had been jogging, by a third party person. They had called an ambulance and could not revive him. Family requested a VAERS report due to the proximity in time to his 2nd Pfizer vaccination. He had received his vaccination at 9:56am on 4/14/21 (lot ER8730) and per father the only side effect he indicated was a sore arm. Autopsy pending per family.
Arm redness and swelling along with tenderness from superior deltoid to superior elbow. Complete recovery with cool compresses and Tylenol.
Muscle joint pain; Muscle joint pain; Headache; Fatigue; Nausea; Diarrhea; Fever of 99.00; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 15:30 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, supraventricular tachycardia (SVT) and COVID-19 on 30Sep2020. The patient has no known allergies to food, medications or other products. Concomitant medications included acyclovir (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 08:30, 17 hours after vaccination, the patient experienced fever of 99.00 (unspecified units). On 08Apr2021 at 10:00, the patient experienced muscle joint pain, headache, fatigue, nausea and diarrhea. On 08Apr2021 the patient underwent body temperature measurement and the result was 99:00 (units unspecified). The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events muscle joint pain, headache, fatigue, nausea, diarrhea and fever of 99.00 was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Bell's palsy; Cough; Whole face is numb; Lymph node in the back of the ear; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EM9810) as 2nd dose, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: EL9265) on 02Feb2021 for Covid-19 immunization. The patient stated that she got her first Pfizer Covid vaccine on 02Feb2021 and the second one on 05Mar2021. A week and a half later, she got Bell's palsy (Mar2021-pending clarification). She wanted to know if there have been other reports of it. The patient further reported that she got the second dosage on 05Mar2021, a week and a half later she got the cough, her whole face is numb, like she has dopey eyes. The patient added that it was hard for her to talk, as she still wants to cough and it was really impossible to talk, it hurt a lot. The patient further stated that she got lymph node in the back of the ear (pending clarification) and went to the hospital on 22Mar2021. She added that she has all the medical records. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
General feeling of illness, loss of appetite, mild nausea, extreme fatigue, red eyes with blurry vision which lasted 2- 1/2 days, rested in bed, sleeping much of the time, increased fluid intake
Had first Pfizer vaccine on 8/8/21.  First 24 hour had expected sore arm, body aches and fatigue. Next 24 hour and for 4 weeks asthma was flared up. Have had other symptoms, such as sores in mouth, but may be due to another virus?
Severe hot flashes, hives on arm, trouble breathing on exertion,  headache, dizziness, leg cramps, heavy and painful menstrual cycle
Fever, Body ache, Headache, chills, and Sinus Congestion began within a month of the vaccine.
Feeling like having heart "palpitations." @13:46         B.P.192/131            100%           Puls: 86 @13:51         B.P.200/109             100%          Pulse: 80 @13:58          B.P. 178/97              100%           Pulse: 85 Stated takes blood pressure medications " going home to take medication now."
24 hours of fever, chills,headache, nausea, muscle pain and fatigue. 48 hours later neck began to swell. Ultrasound of the neck done 8/4/21 showed a "mixed cystic and solid hypoechoic heterogeneous nodule" measuring L 6.9 cm x W 2.8 cm x H 2.6 cm.  The mass was seen by MD most recently 12/2/2021 and appears to be enlarging.
Patient received vaccination (0.2 mL) in right deltoid without incident Patient jumped down from exam table ~ 1 ? 2 minutes after vaccination received     Immediately fell to the floor, eyes closed, unsure if loss of consciousness or not     Opened eyes < 10 seconds from incident and responded appropriately Patient observed for 30 minutes in office, received juice/crackers, and was at neurologic baseline upon release from the office
Swollen anxillary lymphnodes tapering off ..and nearly resolved after 4 weeks
Headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm, on 11Feb2021 at 16:00 (lot number: EH9809; expiry date: unknown) at a single dose for COVID-19 immunisation. Medical history included dermatitis contact and known allergies: adhesive. Concomitant medications included levothyroxine; ergocalciferol (VITAMIN D); zinc; calcium; and ascorbic acid (VITAMIN C). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. Facility type vaccine: Other. The patient did not receive other vaccines within four weeks prior to COVID vaccination. On 12Feb2021 at 09:00, the patient experienced headache which lasted for 2 days. On the 3rd day (unspecified date in Feb2021), nausea set in. The events were not treated. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
sneezing rt as dose given, vaginal itching lt eye swollen, vital signs stable, no hives;given DPH also had upset stomach & very sleepy;
Fatigue; Chills; Fever; Body aches; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 31Mar2021 at 08:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder. Concomitant medications included lithium (MANUFACTURER UNKNOWN) and risperidone (MANUFACTURER UNKNOWN). The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 the patient experienced fatigue, chills, fever, body aches and loss of appetite. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fatigue, chills, fever, body aches and loss of appetite was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Pt experienced swelling, erythema, warmth about 5-8 cm around injection site. No discomfort or undue pain, able to walk.
rash-fine follicular diffuse mild erythema & sand paper like feel pt c/o itching;tx DPH PRN;
Severe chills, body aches, stiff neck, fatigue, fever; began around 8:00 AM on 3/12/21 and lasted until around 10:00 PM. Symptoms generally resolved by the time woke up the next day. Also had a reaction around the injection site - redness, itching, swelling. That symptoms persisted until 3/16/21, with some improvement each day.
pt recvd vax; swelling, warm, tender at site; streaking & rash down arm; swelling persists 1 wk later;
Mom called on 6/9/04. Child had taken a nap 6/8 soon after getting immunizations and woke up with left upper arm very swollen and red and itchy. No other sx. Mom has been treating child with Motrin and cold compresses, advised topical Benadryl for relief of itchiness. Advised mom to contact MD if Sx do not get better within 1 week. 07/22/04 T.C. to mom. Sx lasted only 1 week. Child ok now.
several weeks p/vax both knees sore, lt knee became swollen, painful;cannot extend knee;also has pin in lt hip & lt foot;pt cannot bear weight on knee, uses crutches;circulation to lt foot may be impaired;foot cold;pulselessness;
Patient came back after a month stating the injection site arm is still painful and cannot lift it up as before. He states it has very limited movement.
Flue like symptoms, fever 101.8, chills, body ache, lethargy.  Symptoms resolved within 72 hours.
Nine days following varicella vaccine - developed a reddened, warm, tender, cellulitis over the injection site. Required treatment with OMNICEF (antibiotic).
deceased 02/22/2022;   admitted 2/4/2022 with 3 days of cough, shortness of breath and weakness.  Developed hypoxia and progression of diffuse b/l  infiltrates
Developed a lump on her neck around the lymph node of he clavicle and it became swllen, had an enlarged lymph node under her jaw; Heart burn sensations; Did not feel well; Slight sore throat; Nausea; Body aches; Chills; Experienced a headache; This spontaneous case was reported by a nurse and describes the occurrence of OROPHARYNGEAL PAIN (Slight sore throat), DYSPEPSIA (Heart burn sensations), MALAISE (Did not feel well), LYMPHADENOPATHY (Developed a lump on her neck around the lymph node of he clavicle and it became swllen, had an enlarged lymph node under her jaw) and NAUSEA (Nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Slight sore throat), MALAISE (Did not feel well), NAUSEA (Nausea), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Experienced a headache). On 21-Feb-2021, the patient experienced DYSPEPSIA (Heart burn sensations) and LYMPHADENOPATHY (Developed a lump on her neck around the lymph node of he clavicle and it became swllen, had an enlarged lymph node under her jaw). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Feb-2021, OROPHARYNGEAL PAIN (Slight sore throat), MALAISE (Did not feel well), NAUSEA (Nausea), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Experienced a headache) had resolved. At the time of the report, DYSPEPSIA (Heart burn sensations) and LYMPHADENOPATHY (Developed a lump on her neck around the lymph node of he clavicle and it became swllen, had an enlarged lymph node under her jaw) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information received on 14 May 2021 has no new information.
covid vaccine breakthrough  dose 1 Pfizer 4/15/21  EW0162 dose 2 Pfizer 5/6/21 EW0164
Woke up to a severe headache, ear ringing,  light sensitivity  Clammy. Lightheaded, fell to the floor. The next morning, continued ear ringing. Lightheadedness and feeling winded with activity.
Two days after having the vaccine I had an issue with heart palpitations. Now I had COVID-19 twice. After having COVID-19 the first time my heart was out of rhythm, and I was having palpations and issues. I had three ablations to correct my A-Fib issues and the last issue I had been resolved by those years prior. After having COVID-19 I had to have an ablation again and it did not work- this post COVID-19 Ablation was the first time that it did not work and get my heart back in rhythm. I then had COVID-19 a second time and this happened again where I had the palpitations and the issues with my heart. I had my most recently vaccine on 01/30/2023 and it was two days later that I was having heart issues and palpations. This was different than with COVID-19 the illness as it was a month to a month and a half before the issue began as to where with the shot, I reacted with a cardiac issue within two days. I am following up with my cardiologist and we do have a plan that if I have an emergency I do to the ER and he will see me the next day or ASAP.
2 days after vaccine, flu-like symptoms 3 days after vaccine, developed erythematous pruritic rash below injection site on left anterior arm.  treatment with Benadryl and ibuprofen
Headache, Fever, NauseaVomiting, Dx with COVID in September 2020 Narrative:
PATIENT STATES THE REACTION FELT LIKE A HEART ATTACK, WENT TO ER