chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt diagnosed with cellulitis and treated with steroid dose pack and doxycycline. Day 9 after shot and patient complains of redness, swelling and warm to the touch in the area of shingrix.
Swelling, pain and redness at immunization site. Approximately 2 inches x 3 inches red welt.
Paresthesias of tongue for 45 minutes which began few minutes after vaccination. Resolved without treatment. Vertigo developed approximately 18 hours after vaccination. Resolved within 48 hours.
Fever, chills, sore throat, headache, and nerve pain from 10PM the day of the second vaccine until the following morning. By 8AM all symptoms were gone.  No reaction from the first vaccine.
This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received the 3rd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# FF2888 and expiry date: unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient previously took the first and second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection), on unspecified dates, for COVID-19 immunisation. Reportedly, patient got the booster shot and had a reaction to it, which the patient hasn't had before. The patient just wanted to know if it is one of the known reactions to the vaccination. On an unspecified date, patient experienced breaking out in hives and running a fever. When the patient got the first two because this is the third booster, patient never broke out in hives and just trying to find out if this is a side effect. The patient just woke up and had hives. The patient really wanted to know if it was normal. The patient received treatment for running a fever (pyrexia) with ibuprofen (stated as 200 mg each). The patient took two of them (400 mg total). Reporter seriousness for breaking out in hives and fever: unspecified; with outcome of unknown.
pt recv vax 13JUL95 & 18OCT96 lab eval was negative for varicella zoster antibody;
Employee had an allergic reaction after receiving the covid vaccine 2nd dose. She had rashes and redness all over the body
Patient advised he woke up and had hives all over and itching. By Wednesday the hives had gone down, but the itching was still present. Went to Doctor on 12/16/2015 and was told he had a reaction to the vaccine and was given a steroid shot.
Patient received Shingrix  vaccine on  7/25/19. The site became itchy and red the next day. Redness spread down arm . Site is not tender; however, it is red with heat to it. Pt states the site itches from time to time.
This case was reported by a consumer and described the occurrence of mass in a female patient who received BEXSERO for prophylaxis. On 28th June 2018 21:00, the patient received the 1st dose of BEXSERO. In June 2018, less than a day after receiving BEXSERO, the patient experienced mass and induration. On an unknown date, the outcome of the mass and induration were unknown. It was unknown if the reporter considered the mass and induration to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient noticed knot kinda hard right shoulder on the edge. It made shoulder, the top of her arm to look abnormal. The patient got vaccines for Hepatitis and meningitis.
Breakout in hives on thighs, back, groin, and back of arms.
After the second vaccine in Agoust, my period delyed 3 weeks. The next one delyed 10 day, the third one was more or less regular and now I'm Waiting my period since 1 january, and I've done the third vaccine booster yesterday. Befor Covid19 vaccine my period was regular, just 2 or 3 days delayed.
Fever, Chills, Bodyaches, Nausea, Vomitting, and local site reaction (redness, tenderness)
At 9/26/11 office visit, mom reports woke with rash the day following immunization. Dr. described as fine maculopapular rash all over body. BENADRYL recommended. (Mom denied any SOB, wheezing or swelling of face or lips).
Child would not walk or change positions due to severe pain in his leg. He will not allow it to be touched or have clothing on it, and has been crying and lethargic for 27 hours so far. Obviously still in serious pain. Still has not walked at 27 hours. He's had three doses of Tylenol, which hasn't seemed to reduce pain.
Urticarial rash onset 24 hrs after vaccines admin. Mild nasal congestion - no airway problems. No joint pn., no vomit or diarrhea. No tongue or lip swelling.
9/7 - extremely sore arm at injection site, muscle pain. 9/8 - w/muscle pain fever - 101 degree, shivering normal activity impossible slept all day - extreme exhaustion, headache upset stomach - nausea, vomiting diarrhea. 9/9 - still exhausted, headache. Note: reaction to 1st dose limited to sore muscle at vaccination site.
experienced very severe and uncomfortable migraine; mild headache; Fever; This is a spontaneous report from a contactable consumer (patient sister). A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. The patient had finished their 2 doses of the PFIZER-BIONTECH COVID-19 VACCINE but had experienced very severe and uncomfortable migraine from Tuesday up until today (2 days from having the vaccine) (as reported). The patient also experienced some mild headache and fever but had resolved immediately. Caller would like to know if this was a common side effect among younger participants (16-year-old) since she read that it should have been resolved normally after 2 days (referring to the severe migraine). Caller would like to know if his brother can take anti-migraine medications alongside tylenol. It was informed that Pfizer was also unable to make recommendations for individual patients who received an invalid vaccine dose; clinical judgment made by the health care provider such as that of physician and any qualify HCP based on medical history and clinical status should dictate the appropriate actions to be taken. Referred to HCP for proper diagnosis and clinical recommendations. Outcome of the events headache, fever was recovered; migraine was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After the first dose she was experiencing pain on her arms; This is a spontaneous report from a Pfizer Sponsored Program . A contactable consumer (patient) reported a female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Mar2021 after receiving BNT162B2 the patient experienced pain on her arms. The outcome of pain on her arms was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Vaccine was administered subcutaneously; Local site reaction, singular hive which is raised but not painful and slightly warm; Malaise; Fatigue; This is a spontaneous case initially received from other health professional via agency (case ID: SEQ19-04956) on 17-Oct-2019, concerning an unspecific age male patient.   The patient's medical history was not reported and concomitant medication included Myrbetriq (mirabegron) for unknown indication.    On 16-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: deltoid, batch number: 261197, expiration date: 15-Jun-2020, route of administration: subcutaneous] (explicitly coded as Inappropriate route of vaccination') for prevention of seasonal influenza.  On the same day, after vaccination, the patient developed local site reaction, singular hive which was raised but not painful and slightly warm. Also, the patient reported symptoms of malaise and fatigue.  On 17-Oct-2019, the patient visited nurse. The patient had been instructed to apply an ice pack on the injection site. The patient had also taken Zirtek as treatment. The patient had gone to work and seemed fine.  At the time of initial reporting, the outcome of the events was not reported.  The reporter assessed the case as non serious and did not provided causality criteria.  Non-significant follow-up reported by other non-health professional from agency [reference number: SEQ19-07093] on 12-Dec-2019: Additional reference number added. No changes in narrative.  Company comment: The patient was administered Flucelvax QIV, subcutaneously instead of intramuscular route. Reportedly, on the same day, after vaccination, the patient developed vaccination site urticaria, fatigue and malaise. Chronology is plausible. More information regarding patent's medical history is needed. Based on provided information, causal role of the suspect product is assessed as possibly related for all three events. Incorrect route of product administration is assessed as not related per company's conventions.
Positive COVID-19 screen upon admission to hospital.  No respiratory symptoms.  Previous COVID-19 infection in December 2020, as well as completion of vaccination series
He stopped talking. Banged his head against the wall. Acted like his was "checked-out". Spacey look in his eyes. Hard blinking with his eyes as if he was in pain. He would ball up his fists, squeeze his eyes real hard and shake. Irritable. Bad smelling and watery diarrhea. Hand flapping.
I experienced peripheral neuropathy about 3 weeks after my first vaccine. The neuropathy discomfort was in an area where I previously had shingles. I experienced sharp pain, aching and nerve pain for approximately three months before I went to my PC physician. My physician prescribed Gabapentin. The medication alleviated the pain but I still have numbness in the general area. I just received my second dose of the shingles vaccine and am hoping I won?t experience the painful neuropathy discomfort.
Patient received first dose of Moderna COVID-19 vaccine on 1/4 and second dose on 2/1. Pt called the vaccine line the day after his second dose and reported symptoms of fatigue, body aches, low grade fever, dizziness, and elevated heart rate. He was subsequently advised to visit the ED due to his dizziness and tachycardia. Patient had treated himself with acetaminophen 2 hours prior to arrival to the ED and was given ibuprofen 600 mg in the ED. HR and temperature improved in the ED and was advised to use ibuprofen and acetaminophen for further treatment.
Spontaneous Urticaria, dermatographia, extreme itching; vaccinne was administered 11/13/21; symptoms started 11/23/21
Sudden onset of pneumonia and Afib; Sudden onset of pneumonia and Afib; fever; chills; cough; chest pain on breathing; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265) via an unspecified route of administration, administered into the left arm on 12Feb2021 (at the age of 72-years-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included rosuvastatin (ROSUVASTATIN) and timolol (TIMOLOL). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246) administered into the left arm on 22Jan2021 08:00 (at the age of 72-years-old) for COVID-19 immunisation. On 29Mar2021 01:00, patient had sudden onset of pneumonia and afib (atrial fibrillation), fever, chills, cough and chest pain on breathing. The patient was brought to the emergency room and was then hospitalized for 4 days due to the events reported. It was also reported that the patient was treated with antibiotics and heart medications. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 29Mar2021 and negative on 02Apr2021. Outcome of events was unknown.  Follow up attempts needed. Further information is expected.
A third Dose of the vaccine was administered to the patient after already completing the series several months ago.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was Cardinal refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Severe migraine onset around 2:45 PM. Patient was screaming and crying. He said he couldn't see. His face and lips were swelling. He vomited 3 times. His behavior changed and he became erratic and confused. Left side of his body was in pain down due his thigh.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 01Mar2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: EVAMIST, start date: 01Sep2014, stop date: 26Oct2022. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin"; Tetracycline, reaction(s): "Known allergies: Tetracycline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient received PAXLOVID for treatment of COVID-19 from 16Oct2022 to 21Oct2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Extreme pain in left arm around 7-8 pm the same day of the injection (7/9/20). This was not just soreness; it hurt as badly as a broken bone and took my breath. It lasted for 4-5 hours until I finally was able to go to sleep. At the same time as the intense pain, I lost all use of my left arm which is the arm in which the injection had been given. My left arm would not move at all when I tried to lift it. I finally had to put my hand in my pocket to keep my arm out of the way. I could feel my arm but it just would not respond - no movement, not able to even wiggle my fingers. The next day (7/10/20), the pain was gone and I just had normal soreness but I was still not able to use my left arm. As the day went on, I gained back some use of the arm and was able to move my fingers and raise my arm about 3 inches. It took until 7/15/20 (6 days) to gain full use of my left arm.
This is a spontaneous report from a contactable consumer (patient's mother). A female patient of unknown age, race/ethnicity received on 03Apr2018 a single dose of TRUMENBA and single dose of GARDASIL, both for immunization. Medical history and concomitant medications were not reported. Patient had vaccinations on 03Apr2018 and she is having very severe side effects: chills, backache, she "feels like the needle is still in her arm", her back and feet are hurting and are preventing her to walk too fast, and her body is numb from the shoulders down (Apr2018). Outcome was not reported.
Erythema, swelling, heat and tenderness at injection site. Area 3cm in size. Noticed the evening or morning after vaccination seen by physician two days after vaccinations.
tired; pain in my left arm pit; I felt around its very swollen; It feels like swollen lymp node but its large; having issues lifting my arm due to the pain; spiked a temp of 103.5; didnt feel well in the evening; This is a spontaneous report from a contactable Nurse (patient). 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021 12:30 (Batch/Lot Number: Ew0186) as 2ND DOSE, SINGLE for covid-19 immunisation. Patient received the first dose on 29Apr2021. Medical history included asthma and migraine. Concomitant medication included butalbital, caffeine, paracetamol (FIORICET) taken for an unspecified indication, start and stop date were not reported.  After the first dose, I had a terrible migraine. I Took medication it didn't work. After the second dose, from 20May2021 21:00, I didn't feel well in the evening, was tired the following day. During the evening I spiked a temp of 103.5, took Tylenol. I feel a little better but still not well. I took a shower and had pain in my left arm pit. I felt around it's very swollen. It feels like swollen lymp node but it's large. I'm having issues lifting my arm due to the pain. Patient also felt tired on 20May2021. Outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
I experienced a breakthrough case of COVID-19 with minor symptoms such as runny nose and a cough almost like a sinus congestion, I decided to test for COVID-19 and tested positive, my symptoms cleared a couple days later.
The evening of the vaccine, patient developed a 102 fever and vomited, was pale and lethargic.  On 06/18/2016, she developed hives and as of today 06/19/2016, she just has hives around the injection site.
sudden and quick pain in my chest; pain in her arm; Joint pain; Tiredness; pain comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (sudden and quick pain in my chest), PAIN IN EXTREMITY (pain in her arm), ARTHRALGIA (Joint pain), FATIGUE (Tiredness) and PAIN (pain comes and goes) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.    Co-suspect product included non-company product IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started IBUPROFEN (ADVIL [IBUPROFEN]) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (sudden and quick pain in my chest), PAIN IN EXTREMITY (pain in her arm), ARTHRALGIA (Joint pain), FATIGUE (Tiredness) and PAIN (pain comes and goes). At the time of the report, CHEST PAIN (sudden and quick pain in my chest), PAIN IN EXTREMITY (pain in her arm), ARTHRALGIA (Joint pain), FATIGUE (Tiredness) and PAIN (pain comes and goes) 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 medications were reported.
I experienced a breakthrough case of COVID-19 with tiredness, sore throat and coughing.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Right thigh red and swollen. Cefzil 25 mg 1 tsp bid x 10d.
vaccine that underwent a temperature excursion was administered; No additional adverse effect reported; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # T007231, expiration date was reported as 26-FEB-2022 but upon internal validation established as 27-FEB-2022; lot # T003384, expiration date was reported as 27-JAN-2022 but upon internal validation established as 28-JAN-2022; lot # S023656, expiration date was reported as 29-JUL-2021 but upon internal validation established as 30-JUL-2021; lot # S039313, expiration date was reported as 03-DEC-2021 but upon internal validation established as 04-DEC-2021) underwent a temperature excursion.  On 11-JUN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose and route of administration were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 47.2 Fahrenheit (F) (above 46 F) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004367: US-009507513-2106USA004368: US-009507513-2106USA004370: US-009507513-2106USA004372: US-009507513-2106USA004384: US-009507513-2106USA004374: US-009507513-2106USA004375: US-009507513-2106USA004376: US-009507513-2106USA004377: US-009507513-2106USA004356: US-009507513-2106USA004365:
Approximately 5 minutes after administration of vaccine client c/o stomach pain and urge to have a BM. In the rest room client experienced syncopal episode, regained full consciousness after ~ 30 seconds to a minute. BP supine 90/55 P 52  and sitting 91/54 P 62, skin warm and dry.  Approximately 15 minutes after client continued to c/o stomach pain and urge to have BM and vomit, however did not. Client taken to Emergency Dept. for further evaluation. When falling client hit chin on toilet seat and sustained superficial laceration to chin. No c/o SOB, no hive, no swelling.
Patient developed diarrhea and broke out in a rash 16 days after the  vaccinations. erythematous macular rash primarily centrally at the time of visit. NO vesicles, petechiae or purpura. No fevers. the rash just starting to show at the ankle but sparing of the palms and soles.
This spontaneous report was received from a licensed practical nurse, referring to an 18 year old, male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 25-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # L004014 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Client tested positive with symptoms for Covid on 4/27/2020.  Developed pulmonary sequelae after having Covid: asthma.  Sees pulmonologist regularly.  Takes a daily inhaler for asthma and also has a rescue inhaler.  At routine visit to pulmonologist on 10/11/2021, client was tested with PCR and result was + for Covid.  No symptoms (no change in asthma symptoms).  Client was vaccinated with Moderna vaccines in February 2021.  Reported as breakthrough Covid case.