chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red, swollen circle around the injection site the size of a softball.  Was told to use cool compresses and Benadryl.  Reaction began right away and lasted about 5 days.  On left upper thigh.
14-year-old received the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14-year-old received the Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14-year-old received the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14-year-old received the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       As per source document a 14-year-old who was supposed to received a Pfizer vaccine, but instead received Moderna. They wanted to know if they can receive the 2nd dose of another vaccine. Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.
This spontaneous report as received from a medical assistant refers to an unspecified number of unspecified patients, whose ages and genders were not reported. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M021124, expiry date 02-FEB-2018; dose and route were not reported) for prophylaxis. The doses of the vaccine were exposed to a temperature excursion of 32.3 degrees Fahrenheit for a time frame of 67 hours, 8 minutes (date unspecified). A digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA008195.
sensitive stomach. She reports that this can happen not only with the Pfizer vaccine; significant hearing loss; ringing in the ears; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 12Apr2021 (Lot number was not reported) as single dose (at age of 60-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. On unknown date in Apr2021 patient experienced significant hearing loss, ringing in the ears, also reported as ear ringing like crazy and lost significant hearing. On unknown date she experienced sensitive stomach (she reported that this can happen not only with the pfizer vaccine). Patient stated that after receiving the first dose of Pfizer COVID-19 Vaccine, 10 hours later she developed a ringing in the ears (also reported as her ears started buzzing like ringing like crazy) to which she has seen her health care professional (HCP) and an ear specialist and has under gone hearing tests and states "has significant hearing loss" to which she is on steroids to help, she would like to know if Pfizer had any documented cases on this and what she needed to do about this. She has been going to an ear specialist and he said that she lost significant hearing in that ear where she heard the noise. For treatment, they are doing an injection into her ear. She is still having to go for injections but it does not sound like anything. She researched the internet and there is a whole group of people who experienced this with the Pfizer and Moderna and the other vaccine. Patient added that a doctor did not want to give an opinion or say anything. They did not know if this was permanent or will go away. Patient stated that a lot of people are out there, there are a lot of people with the same problem.  She does not know which vaccines they got. She is halfway vaccinated because she is afraid to take the second one. She read comments of people who took the second, and people say it was worse. They discussed with doctors that it should go away eventually. Some say it went away in 9 weeks, some still had the hearing problem and it is uncomfortable. Patient added that it is all day ringing in the air, in her left ear. She went to the emergency room because it was so unbearable, and they did not know what to do. Patient did not take any medications like she did not have any issues, no blood pressure or nothing. Patient said that she cannot take steroids by mouth because she has a sensitive stomach. She reports that this can happen not only with the Pfizer vaccine, it happened with people taking Moderna, Astra Zeneca and Johnson and Johnson reported that. It is all over the internet. A bunch of people are having this problem. Therapeutic measures were taken as a result of significant hearing loss and ringing in the ears. Outcome of the events was unknown. Patient skipped the second dose because she does not want to make it worse.  Information on the lot/batch number has been requested.
T100, 3 inch diameter red raised area with lighter central portion noted on Rt upper arm where she received SQ injection.  Mother states tenderness to touch but moves extremity without difficulty.  Parent has been using cool compresses to site.  Recommended warm compresses and to continue using Ibuprofen.  Mother to call physician if no improvement by 7/3/10.
This spontaneous case reported by a physician, describes the occurrence of illness (generally sick early afternoon), lip swelling (swollen bottom lip where she previously had fillers) and face swelling (left-side of the face swollen where she previously had fillers) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037521A and 028L20A) for COVID-19 immunization. No medical history reported. On Jan 20, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 11, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 11, 2021, patient experienced illness  (generally sick early afternoon). On Nov 12, 2021, the patient experienced lip swelling (swollen bottom lip where she previously had fillers) and face swelling (left-side of the face swollen where she previously had fillers). At the time of the report, illness (generally sick early afternoon), lip swelling (swollen bottom lip where she previously had fillers) and face swelling (left-side of the face swollen where she previously had fillers) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-385961 (patient link).
I felt dizzy and threw up Severe nausea Fever Chills  Body aches Dizziness Emotional- sadness Hallucinations  Extreme tiredness
Dizzy, severe headache, cough, 100.8 temp, very tired, lethargic, nausea, shooting pains up right arm, stiff neck, noise bothering him.
Patient booked and arrived at vaccine pod, for 2nd dose Moderna COVID-19 vaccine. Patient was checked in through clerical checkpoint and 2nd dose of the vaccine was administered by RN. 1st dose was administered on 3/18/21 at health department and 2nd dose was administered only 12 days later on 3/30/21. No adverse reaction has been reported by patient thus far.
Child came in day after receiving vaccines presenting with rash (hives) abdomen & back. Bump at injection site warm to touch.
Patient received pfizer COVID-19 vaccine instead of flu vaccine at an offsite COVID/flu clinic.
hurting so bad shoulder across shoulder to neck; hurting so bad shoulder across shoulder to neck; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported for herself that an 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0186) at the age of 80-years, via an unspecified route of administration, administered in left arm on 26Jun2021 at 10:10 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer stated that she was just calling to report her side effects from first Pfizer shot, she got her shot on Saturday and then on 28Jun2021 (Monday) it hurts so bad, 28Jun2021 (Monday) 29Jun2021 (Tuesday) and 30Jun2021 (today) she was hurting so bad her shoulder across her shoulder to her neck and she didn't know what could be to ease the pain, she would tell that she had tried heat, she have tried cold little wash cloth, she was taking paracetamol (TYLENOL) with codeine, she was taking the muscle relaxant (unspecified medication), rubbed it with this diclofenac sodium topical gel, she had rubbed it as per cream nothing does any good, patient wanted to know what she can do for. Consumer stated it was just severe pain from her shoulder. The adverse events occurred on 28Jun2021. Outcome of the events was not recovered/not resolved  Follow-up attempts are completed. No further information is expected.
Complete boby hives for 10 days It started approximately 5-6 days after vaccination
Patient was given her second dose of Moderna and in her 15 minute waiting period after the vaccination she started to faint. Her eyes started to roll but never lost consciousness. She was awake and alert but was not responding to me for about 30 seconds to a minute. I told her to take some deep breaths and once she started doing that she began to respond and said she was feeling better. This patient has a history of fainting after vaccinations (She said she fainted with her second dose of the HPV vaccine). She did not faint or have any kind of reaction to the first dose of Moderna. The paramedics came and took her oxygen level and blood pressure and all were good. She left feeling 100% better.
Muscle aches, fatigue, headache, nausea, sore glands in neck
Burning sensation in his leg; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation in his leg) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced BURNING SENSATION (Burning sensation in his leg). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Burning sensation in his leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided.
This spontaneous case, initially received on 24-Jul-2018 was reported by other health professional and concerns a male patient of unspecified age. The patient's current condition included mesothelioma (since an unspecified date). The patient's concomitant medications included KETRYDA for mesothelioma, ZOFRAN, COMPAZINE, oxycodone for unknown indications. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after vaccination the patient developed allergy to influenza vaccine. No further information was available. The outcome of the events was not reported. The reporter assessed this case as non-serious. Update 24-Aug-2018 (CRD): Significant case correction was performed with IRD 24-Jul-2018: As reported causality was corrected from not related to unassessable for the event Influenza vaccine/Allergy in the event tab. Also, the event of mesothelioma was removed from the case.
Headache; All joints hurting; Legs feel heavy; Arm was hot to touch and sore; Arm was hot to touch and sore; BNT162B2 was administered before 19 days of primary dose.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Sep2021 at 18:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estradiol (MANUFACTURER UNKNOWN) and unspecified medication (reported as well uterine) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Sep2021 at 11:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. On 21Sep2021 at 18:15, the patient experienced headache, all joints hurting, legs feel heavy, arm was hot to touch and sore. The events did not result in doctor or other healthcare professional office/clinic visit/emergency visit. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, all joints hurting, legs feel heavy, arm was hot to touch and sore was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This case was reported by a pharmacist and described the occurrence of injection site rash in a adult patient who received FLULAVAL quadrivalent (batch number 99LN2, expiry date May 2016). In 2015, the patient received FLULAVAL quadrivalent. On an unknown date, an unknown time after receiving FLULAVAL quadrivalent, the patient experienced injection site rash, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site rash, injection site warmth and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site rash, injection site warmth and injection site swelling to be related to FLULAVAL quadrivalent. Additional details were provided as follows: This case was reported by a pharmacy director. This case was 1 of the 2 cases reported for the employees of the pharmacy who experienced an adverse reaction after the vaccination. The two patients received the FLULAVAL QIV vaccine from different vials purchased at the same time. In 2015, the patient experienced large red rash, warm and puffy (swelling) surrounding the injection site of the FLULAVAL QIV vaccine. The reactions lasted for few days. The reporter was not aware of any other issues regarding either of the vials containing the vaccine. This case has been linked to case US2015GSK155182, reported by the same reporter.
Vomiting - began 4 hours after vaccine given. Lasting 5-6 hours. Vomiting every 4 hours, chills, "burning up feeling" fever. Headache.
Administered second dose of Pfizer 5-11 to a patient that turned 12 between doses.
No adverse effect; Expired vaccine used; Information has been received from a company representative referring to a 15 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 05-AUG-2019, the patient received one dose of expired Hepatitis A Vaccine, Inactivated (VAQTA) Hepatitis A Vaccine, Inactivated (VAQTA) (lot # R013859, expiration date: 14-JUN-2019, strength, dose, frequency and route were unknown) inadvertently (expired vaccine used) for prophylaxis. No adverse effects were reported.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE PERICARDITIS, UNSPECIFIED
No additional AE; temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 12 months old patient of unknown gender. the patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.   On 10-MAR-2021, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route were not provided; lot number was T025945 and expiration date was 30-JUL-2022) 0.5 ml and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (strength and route were not provided; lot number was S039319 and expiration date was 04-DEC-2021) 0.5 ml involved in temperature excursions for prophylaxis (product storage error). No additional adverse event was reported (no adverse event).  The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion from -10 degree Celsius to 8 degree Celsius (-1.6 degree Celsius) for 1 hour 36 minutes 0 seconds. The administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (stored in freezer) experienced the temperature excursion from -50 degree Celsius to +8 degree Celsius (-1.6 degree Celsius) for 1 hour 36 minutes 0 seconds. There was no previous temperature excursion. The event of temperature excursion was detected by a data logger.
Severe convulsions/chills that lasted approximately four hours, followed by extreme exhaustion that lasted for a couple of days. Metallic taste in mouth and upset stomach lasted for about as long as the fatigue.
meuniere in my right ear; Migraine; fibromyalgia flare ups; sweating; restless sleep; severe back aches; nausea; All my conditions are exasperated; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 16Jul2021 at 11:30 (at the age of 65-years-old) as a dose number unknown, single for COVID-19 immunization. Medical history included allergies. Concomitant medication(s) included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced meuniere in her right ear, migraine, fibromyalgia flare ups, sweating, restless sleep, severe back aches, nausea and all her conditions were exasperated on 17Jul2021. The patient did not receive any treatment. The clinical outcome for the events was not recovered.  Information on the lot/batch number has been requested.
Recipient of vaccine complained of dizziness, tongue tingling, and shortness of breath and was taken to the emergency department.
This spontaneous report as received from a consumer (also reported as patient's father) refers to a 19 year old female patient. No concurrent conditions and medical history were reported. On an unknown date approximately in August 2015 the patient was vaccinated with GARDASIL (dose 3), intramuscularly (lot number and expiry date unknown) (dosing regimen and frequency unknown) or GARDASIL 9 (dose 3), intramuscularly (lot number and expiry date unknown) (dose regimen and frequency unknown). No concomitant medications were reported. On 18-AUG-2015 (also reported as 6 hours after receiving an injection) the patient experienced muscle pain in the stomach. It was reported that the patient did not seek medical attention. It was reported that this was the final injection of GARDASIL or GARDASIL 9. The action taken with the therapy with GARDASIL or GARDASIL 9 was unknown. The outcome of myalgia was unknown. The relatedness of the events to the therapy with GARDASIL or GARDASIL 9 was unknown. There was no product quality issue reported. Additional information has been requested.
Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------------- CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/13/2023 DM 2 W MICROALBUMINURIA HYPOXIA 4/13/2023 DM 2 W MICROALBUMINURIA CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/13/2023 DM 2 W MIXED HYPERLIPIDEMIA HYPOXIA 4/13/2023 DM 2 W MIXED HYPERLIPIDEMIA
red; sore; itchy arm at the injection site; headachy; nauseous; lethargic; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (sore), INJECTION SITE PRURITUS (itchy arm at the injection site), HEADACHE (headachy) and NAUSEA (nauseous) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (sore), INJECTION SITE PRURITUS (itchy arm at the injection site), HEADACHE (headachy), NAUSEA (nauseous) and LETHARGY (lethargic). At the time of the report, INJECTION SITE ERYTHEMA (red), INJECTION SITE PAIN (sore), INJECTION SITE PRURITUS (itchy arm at the injection site), HEADACHE (headachy), NAUSEA (nauseous) and LETHARGY (lethargic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On April 3, in the middle of the night, I experienced nausea, vomiting, and chills. In the morning I no longer felt vomiting or nausea. Symptoms now has changed to headache and continuing chills (but not as badly), and loss of smell and taste.  The loss of smell and taste is new and very unusual for me, and I haven't heard that that is a vaccine side effect, so I am reporting it.  I have not reported it to my primary care physician; the advice line told me that if I'm still experiencing symptoms on Monday (today is Saturday) to call my doctor.
really pretty much down; This is a spontaneous report from a contactable consumer (patient's spouse). A 37-year-old female patient received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at the age of 37 years old as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. During the first vaccine, the patient had been hospitalized. On an unspecified date, she was really pretty much down and in bed for about 3 days. Outcome of the event was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.