chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anaphylactic reaction; sore arm; This is a spontaneous report from a contactable consumer. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 13Jun2021 (Lot Number: EW0217) at age of 61 years old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma and arthritis and she take medication for both. She took inhaler for her arthritis. The patient took a flu shot every year but she did not take it this year. She is worried about the Flu vaccine now. She never had any bad reaction to the flu vaccine but only this one. After the first shot when the patient initially got the shot there was just normal reaction like sore arm and all that but nothing traumatic. Twelve hours later she experienced anaphylactic reaction and all those things described is what happened to her consumer thought she was dead. The patient had the anaphylactic reaction which sent her to the hospital for five days. The patient took the second shot of the Pfizer and she had the anaphylactic reaction to it really severely. She had exactly all the symptoms like fainting she had the fainting she fainted she passed out actually and she had a tongue swell. She had mental confusion. She had really bad breathing and she had impaired voice and her eyes rolled back in her head and she had a feeling of doom. The consumer had call the EMS and she was totally unaware what was going on for about two hours. Then she was in ambulance and then she came to and she was in hospital for five days and what they did they just said that her oxygen count was low and that was major come to the hospital at that time and then just right under three months she had the very same thing happened to her again. She was in the bathroom and she just passed out dead on the floor and she had all the symptoms you know the fast heart rate, tongue swelling, the eyes falling back into the head, mental confusion not aware what was going around did not know consumer was there didn't know EMS was there, breathing bad, feeling sub doom eyes falling back in her head, and impaired voice. She went to the hospital this time they said that she had a bacterial infection, and then they just gave her some antibiotics and send her home. She almost died twice from the shot. The first time they didn't gave her anything for treatment. The outcome was unknown.   Follow-Up (04Oct2021) attempts are completed. No further information is expected.
First of all I decided to get the booster because I had an antibodies test and barley had any, only 7 months later after my 2nd shot. After receiving the booster, I started to have pain in my right breast, same side as injected arm.   I looked it up and said this is a side affect due to swollen lymph nodes.  After a week the pain got worse and I discovered  that I had a red and purple ball under the breast, which was starting to spread to the nipple area.  When I touched this area, I literally screamed in pain.  I went to see my doctor.  I was diagnosed with cellulitis.  Most commonly, it occurs in areas that may have been damaged or are inflamed.  Seeing that my lymph nodes were inflamed, this makes sense.  If this does not get better in a few days than I have to see him again.   Cellulitis can be a serious condition, however, remains to be seen what my outcome will be.
OBSTRUCTIVE SLEEP APNEA ACUTE ST ELEVATION MI, ANTERIOR WALL ACUTE ST ELEVATION MI, UNSPECIFIED HYPOTENSION 9/7/2022 -- RECURRENCE OF SAME SYMPTOMS
This spontaneous report was received from a Nurse refers to an unspecified number of patients of an unknown age and gender. On an unknown date, an unspecified number of an unspecified patients were vaccinated with improperly stored VAQTA lot # K018531 (expiry date: 28-APR-2017) (dosage not reported). Temperature excursion reported was 56 F for 6 hours. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a health professional concerning a 7 year old male who on 31-JAN-2008 was vaccinated with a second subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot# 658964/1466U). On 03-FEB-2008, the patient developed itching, silver dollar sized redness and raised-like rash. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Patient received vaccine - Afluria at approximately 1200 PM.  At 1330, member presented to mass vaccination site with complaints of Hives.  Patient was assessed - and confirmed HIVES.  Patient states back in 2007 he also had a reaction to the influenza vaccine - he states then it was worse with immediate anaphylaxis.
This spontaneous report was received from a nurse, refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-AUG-2016, the patient was vaccinated with improperly stored VAQTA, 25/0.5 injection, lot # L043209, expiry date 17-SEP-2017, 0.5 ml/once, intramuscularly. Temperature/time frame were 1.7C for 4 hours 10 minutes (on 26-AUG-2016), 1.7C for 2 hours 48 minutes (on 29-AUG-2016), 1.3C for 7 hours (on 30-AUG-2016) and 1.2C for 10 hours 14 minutes (on 31-AUG-2016), because of data logger. Prior excursion was 1.3C for 45 hours 18 minutes (on 07-JUL-2016). No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Really bad hand pain/ Someone hitting hands with hammer; felt an excruciating amount of pain; very bad pain in her hands and joints; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Really bad hand pain/ Someone hitting hands with hammer), PAIN (felt an excruciating amount of pain) and ARTHRALGIA (very bad pain in her hands and joints) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced PAIN IN EXTREMITY (Really bad hand pain/ Someone hitting hands with hammer), PAIN (felt an excruciating amount of pain) and ARTHRALGIA (very bad pain in her hands and joints). On 15-May-2021, PAIN IN EXTREMITY (Really bad hand pain/ Someone hitting hands with hammer), PAIN (felt an excruciating amount of pain) and ARTHRALGIA (very bad pain in her hands and joints) had resolved.            No concomitant products were reported. Treatment information provided included Ibuprofen. But the patient is not sure that she had taken it. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-049572.
This spontaneous report was received from a registered nurse concerning a currently 4-year-old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, and drug reactions/allergies was reported. Concomitant therapies included sterile diluent (DILUENT MRK). On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot number N014630 and expiration date 11-AUG-2019 or lot number N014371 and expiration date 09-MAY-2019 or and lot number reported as N012699 and expiration date 09-JUN-2019) for prophylaxis (dose and route of administration were not reported). The specific lot number of VARIVAX administered to the patient was unknown by the reporter. The vaccine had been improperly stored prior to the administration at a temperature of -14 °C to -10 °C for 2 hours and 55 minutes, however, the vaccine did not have a previous temperature excursion and the call was made due to a data logger. The reporter also stated that the sterile diluent (DILUENT MRK) (lot number and expiration date were not reported) used to reconstitute the VARIVAX, did not undergo a temperature excursion. No adverse effects were reported and no further information was provided. This is one of several reports received from the same reporter. Lot number N012699 is an invalid lot number varicella virus vaccine live (oka/merck).
Chief Complaint: Slurred Speech (LKN yesterday at facility, , but c/o worsening and left facial droop. COVID + 10 days ago) and Fall (2 days ago, denies injury, on coumadin).  Diagnosed with Covid over 10 days ago.  Patient out of the window for any aggressive treatment.  Currently fairly stable with minimal use of oxygen. Hold off on steroids. Vitamins and other supplementation.
This is a spontaneous case initially received from the other non-health professional (consumer) on 13-Nov-2018, concerning a 69-year-old, elderly female patient. The patient's current conditions included thyroid, reflux, high blood pressure which was under control and allergy to thiomersal (reported as medical history). The patient's concomitant medication included Propranolol, lisinopril, diazepam, Levothyroxine, omeprazole, Vitamin D and baclofen for unknown indications. On 19-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252656 and expiry date: 31-May-2019). On the same day after vaccination, the patient started vomiting profusely. The patient had to take a bag to her room as she could not even make it through the bathroom. The patient administered suppository of promethazine, which did not help much. On 20-Oct-2018, one day after the vaccination, the patient experience soreness and numbness (reported as sore and numb) in arm. The patient when had a look to it, she had a huge black mark (not black blue, but black). The patient developed a tiny mark (it was not even symmetrical, dark coloured pink). The outcome of the event vomiting was recovered on 21-Oct-2018. The outcome of the event sore and numb arm was not reported. The outcome of the event skin discoloration was not recovered. The reporter assessed the case as non-serious.
Administered second dose of IPV in error. Patient had no immediate reaction to double dose received. Observed in waiting room for 45 minutes at time of this report and no adverse reactions have been noted. Patient is alert & oriented, playing with siblings, no adverse symptoms have been noted.
PEOPLE KILLED BY VACCINE; This spontaneous report received from a consumer via a company representative via social media concerned a multiple patients of an unspecified race and ethnic origin. Initial information was processed along with the additional information received on 10-OCT-2022. The patient's weight, height, and medical histories were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 in total, dose, start therapy dates were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients died. Cause of death was not reported. As per reporter, "I know peoples who were killed by your covid vaccine". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This report was associated with product quality complaint: 90000254593. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria since this report states the reporter knows of people killed by vaccination. This reports patient death with no product quality issue reported therefore it does not require a quality investigation) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20221013757- covid-19 vaccine ad26.cov2.s- people killed by vaccine. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
significant joint pain in hips, shoulders, knee, spine ever since I got the first injection on 1/7/21.
"Pfizer-Bio-Tech COVID-19 Vaccine "  Individual received the Pfizer Covid-19 vaccine. She began to feel throat tingling, lip numbness, and flush at 11:15 am. Patient denied SOB of breath, dizzy, and was swallowing well. Her vitals were 146/98,99, 20, 72, 90/% at 11:17 am. She was given Benadryl 50 mg IM in right Deltoid at 11:18 am. B/P 122/96,20, 88 P, 99 RA. 11:25 am. Individual reported the numbness and tingling has decrease.  11:30 am 128/82 99% RA 86,20. Individual stated that she no longer has any symptoms. 11:45 pm vitals 124/74, 20, 71, 99% RA no noted distress, flush feeling, tingling or numbness. 11:58 am 110/70, 99, 71, 18 Individual was escort to car with no noted distress and sent home with Additional information for Item 18: with family. .
Pt noticed large bump 4-5 inches south of injection site that hasn't gone away in 2 weeks.
acute swelling at injection site (upper left arm), with rash and blisters. Raised rash that developed to blisters on chest and right arm. Pain, tingling,  burning and itching!!
Employee states she developed itching and hives approximatley 20 minutes after receiving Influenza vaccine. Developed on hands, neck, face and was seen in the emergency room at hospital where employed.
pt recv vax 9AUG96 @ 1815 returned to ER 2100;rash started @ 1900 on chest & abd;no resp distress or throat swelling;DPH, EPi, Pred given;10AUG 1300 returned w/persistent allerg rxn med given;pt had rash & itching from head to toe;
Pt states that she broke out with hives all over body and it feels like her throat was swelling, pt took Benadryl for symptoms.
Initial and follow-up information has been received from a pharmacist and a pharmacy technician (also reported as a registered pharmacist) concerning a male patient of unknown age. No information regarding medical history or concurrent conditions was provided. On 11-APR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot# M000386; dose, route of administration and expiry date were not reported). There were no concomitant therapies reported. Within a day of vaccination, on approximately 12-APR-2016, the patient experienced rash, swollen and sore arm at the injection site. The patient recovered from these events on an unspecified date in April 2016. The relatedness between PNEUMOVAX 23 and the events was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Received vaccine past its 30-days Exp date vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received its 30-days Exp date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2022 at 3:52 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient received booster dose. Patient received lot number past its 30 day expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on about 20 Dec 2021. This vaccine was administered up until its manufacturing expiry date of 04 APR 2022.  Treatment medications were not reported.
Event:  In the morning, I got up to exercise and eat breakfast.  I was feeling dizzy.  I fainted and lost control of my bladder and bowels.  I woke up laying on my back on my kitchen floor.  I was unconscious for 1 - 3 minutes.   I stood up, ate cereal with milk, cleaned the kitchen floor and then took a shower.  I called two family members to come to my home. Treatment:  I contacted my doctor's office and the advice nurse spoke with me.  I took benadryl  (2 tablets) and increased my fluid intake.  I was unable to work the day after the vaccine. Outcomes:  I needed benadryl twice a day for 3 days and ibueprofen twice a day for 3 days.  Lymph nodes under left arm pit were swollen and painful.
Pt reports redness and swelling. It ran base of neck on right down to right elbow. TYLENOL/BENADRYL
Presented to UC with episodic lightheadedness that occurred today and yesterday but today with visual loss of intermittent nature. EKG shows normal sinus rhythm with only T wave inversion in V1 and V2.  She denies any chest tightness, chest pressure, jaw pain, arm pain and lacks cardiovascular risk factors.  Blood sugar was 88.  Discussed that her symptoms are intermittent in nature and that they have completely resolved. The next day patient presented to ED for evaluation of vision changes. Patient placed on observation status. On physical examination she does have a decreased sensation from left to right on my exam. We were able to obtain an MRI and a it showed a cytotoxic lesion in the corpus callosum this could be consistent with multiple sclerosis and may have been brought on or exacerbated by recent vaccination. Spoke with neurology regarding these findings, they recommend starting Solu-Medrol. Discharged in medically stable condition, follow-up for PCP and neurology.
MY ARM HURT IMMEDIATELY. AFTER WAITING THE 15 REQUIRED MINUTES, I LEFT AND STARTED TO FEEL ACHY ALL OVER. I HAVE BEEN RUNNING A FEVER ON AND OFF UP TO 102*. THE FIBROMYALGIA HAS WORSENED AS WELL AS NERVE PAIN IN BACK CAUSED BY SURGICAL REMOVAL OF TUMORS ON MY SPINE, MORE MIGRAINES. BLURRED VISION. BONE PAIN. EXTREME FATIGUE. EXCESSIVE THIRST. LOSS OF APPETITE.  WORSENED GERD. DIARRHEA. SKIN RASHES AND BLISTERING WITH YELLOW "PUSS" IT THE BUBBLES ON MY FACE. MORE INTENSE GEOGRAPHIC TONGUE. ALL IN ALL, I FEEL AWFUL AND IT'S BEEN THIS WAY FOR A WEEK, PRETTY MUCH THE SAME AS GETTING OVER THE "FLU" BUT NOT GETTING BETTER.
low grade temp; body aches; soreness in  arm; got a really bad headache; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th December 2022 14:30, the patient received the 1st dose of Shingles vaccine. On 13th December 2022, 1 days after receiving Shingles vaccine, the patient experienced slight temperature and general body pain. In December 2022, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the headache, slight temperature and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, headache, slight temperature and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that patient had 1st shingles vaccine yesterday at 2:30pm. The patient experienced soreness my arm which was expected but about 13th DEC 2022 at 12 noon today, got a really bad headache and now this evening low grade temperature and body aches. The reporter wanted to know was this normal. Additional supportive information: The follow-up could not be possible as no contact details were available. Note: For headache event onset date was reported as 13th Dec 2022 12:00 pm, however partial date was captured to calculate precise time to onset in field.
Tiredness and mild headache last night; Tiredness and mild headache last night; The patient received third (Booster) dose of BNT162b2; This is a spontaneous report from a contactable consumer. A 20-year-old male patient received third (BOOSTER) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration on 08Oct2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines with tiredness, cognitive and physical disabilities as well, that can make communicating as how the patient felt was difficult. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FN6205) via an unspecified route of administration on 01Mar2021 (at the age of 19-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on 23Mar2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. On 13Oct2021 at 21:00, the night before this report, the patient experienced tiredness and mild headache. He had an extra busy day and the weather was warm. The patient's hydration was monitored. The reporter obtained permission to file basic report from the patient's mother/legal guardian. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with over the counter (OTC) pain medication (unspecified) at home, based on medical history. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness and mild headache were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
WEAKNESS, ALLERGIES, SICK, COULD NOT SLEEP FOR DAYS, BODY PAIN, THEN I HAVE TO GO TO THE HOSPITAL WITH AN INFECTION. VISITED THE ER.