chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of edema in a adult patient who received SHINGRIX for prophylaxis. On 29th March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced feeling bad. On an unknown date, the patient experienced edema and headache. In March 2019, the outcome of the feeling bad was recovered/resolved. On an unknown date, the outcome of the edema and headache were unknown. It was unknown if the reporter considered the edema, headache and feeling bad to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX on Friday and had experienced edema headaches and felt so bad the entire weekend. The patient left the chat before providing any additional information due to the connection lost.
Shingles; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172, Expiration date: unknown) via intramuscular route, administered in Arm Left on 23May2021 around 13-13:30 (at the age of 46-years) as single dose for covid-19 immunization. The patient had no relevant medical history (Further clarified). The patient was not receiving any medications. The patient did not receive other vaccinations within 4 weeks prior to the first administration of the suspect vaccine. The patient's concomitant medications were not reported. Height and weight reported as 5 foot 136 and confirmed height as 130 pounds (further clarified; captured 136 cm as height and 130 pounds as weight). On an unspecified date in 2021, the patient experienced shingles. The clinical course included: on 23May2021, the patient received Pfizer vaccine and believed there was a correlation between the vaccine and the patient was totally trying to blank. She had a received a side effect and was totally blanking it out. She was on medication for it right now. That she had to do was chicken pox (Not further clarified hence not captured in tab) it was called, she doesn't know why she was blanking at. Yes, it was shingles. So, she went to urgent care like five day succeed, five days after and so she had shingles for which she was on medication for and the doctor who told to believe that there was a correlation and so she wants to know what the recommendation is as far as the receiving the second vaccination. When probed for the second shot, she stated, she was not due to take that until the 13th. The patient received treatment with Valaciclovir for shingles. The patient underwent lab tests and procedures which included blood work on yesterday (01Jun2021)- results unknown (Further not clarified). The outcome of the event was unknown.  Follow attempt needed; Further information has been requested.
Patient is hospital employee who completed screening form for COVID-19 vaccine by answering "no" to all contraindication questions.   Approx 10 minutes after receiving COVID-19 vaccine dose # 1, patient was still in vaccine clinic area and complained of dizziness, palpitations and flushing.  I observed patient fanning herself with papers.  She was escorted out of the immediate clinic room, and assessed by paramedics present as having an anaphylactic reaction.  Epinephrine 0.3 mg IM and diphenhydramine 50 mg IV given in clinic, Rapid Response was called overhead and patient immediately transported down the hall to the Emergency Dept. In ED, pt was noted as having swollen tongue, large areas of erythema on face, arms and chest, shortness of breath, nausea, dizziness (per ED physician notes).  Pt reported being hospitalized in ICU with COVID disease more than 3 months ago, including intubation (not treated at this hospital), and has been back at work since August 2020.  ED physical exam noted bilateral wheezing and patient in acute distress.  In ED, pt administered racemic epinephrine 2.25% 0.5 mL via neb, epinephrine 0.3 mg IM, diphenhydramine 50 mg IV, Solu-Medrol 125 mg IV, famotidine 20 mg IV and epinephrine 5 mg/250 mL IV drip (started at 0.118 mcg/kg/min).  Acute symptoms reported to resolve in ED.  COVID test was negative.  ED physician discovered that pt had history of multiple medications, including previous anaphylactic reaction to radiocontrast dye requiring intubation (which was not disclosed on the vaccine screening form).  Pt admitted to Telemetry floor for observation.   Overnight course was unremarkable, and patient was discharged the following day with prescription for Prednisone taper and prescription for Epi-pen.  Advised not to return for second dose of COVID vaccine.  EMR updated to reflect possible anaphylactic reaction to Moderna COVID-19 vaccine.
Patient presenting for c/o - nasal congestion, subjective fever, headache, back ache, and hives since second COVID vaccine on 5/25 (Moderna). Administered at (Name) site. Nasal congestion stopped today. Hives came on 1 week ago and have continued. Reports headache since first dose. She did not get hives with the first COVID vaccine. Works as a CNA and has been out x 2 weeks besides last weekend due to these uncomfortable hives. She is currently taking atarax and omeprazole for these, but no other medications.
no pain at injection stie; however very severe chills began 12 hours after vaccine, temperature 99.1,  brutal joint pain (wrists, hips, knees, ankles, burning & stinging sensation in  around nerves and muscles, mild nausea/headache, no sleep for 24 hours. symptoms improved after 48 hours; mild chills, joint/muscle/nerve pain (however, i had some of these symptoms from the chemotherapy and they are now back to that level)  i tried to forego pain relievers, but i  had to take 2 advil and 2 benadryl 16  hours after the vaccine (around midnight) and took 2 more of each about 12  hours later. drank lots of lemon water to stay rehydrated. normal appetite.
Fever, vomiting sore throat. Mom states baby cries when he coughs. Up all night vomiting x3 diarrhea x2. Mom states had had fever - gave TYLENOL last 1 hr ago. Temp. 99 degrees. Referred to MD. Received meds for sore throat. 12/22/09.
When I went to the ER  on the 22nd they told me to take Motrin and Tylenol , I had really tired and a really bad headache, my heart was intermittently having palpitations, hands and feet were cold and tingling almost immediately after the vaccine, and I was out of breath and dizzy. When they took my BP it was 135/95 and before it was 110/70, My symptoms got better that evening of the 23rd my symptoms got better and then it completely went away
This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 58-year-old female patient who received SHINGRIX (batch number D294J, expiry date 22nd March 2021) for prophylaxis. On 26th January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced blister. On an unknown date, the outcome of the blister was recovering/resolving. It was unknown if the reporter considered the blister to be related to SHINGRIX. Additional details were provided as follows: The patient experienced blisters on her forearm, also up in her shoulder, above an inch or so away from the injection site. The blisters were healing, but could be seen where they were present. This case has been linked with case US2019020324, reported by the same reporter.
Received the vaccine with 15 years of age; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the vaccine with 15 years of age) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), MONTELUKAST SODIUM (SINGULAIR) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Asthma, CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for an unknown indication.    On 31-Jul-2021, the patient received first 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 (Received the vaccine with 15 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the vaccine with 15 years of age) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     They went to another facility to get the second dose they refused to give it to him due to his age.
Information has been received from a physician concerning a male child who was vaccinated with a dose of varicella virus vaccine live. In approximately March 2006, the patient broke out with a severe cases of varicella >200 lesions. The lesions were everywhere including in his mouth and in his ears. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Pt received Tdap and Pnuem. on 10/15/07. Today caller states that she has a hive-like mass on l. deltoid area, larger than a quarter in size, red, swollen, and extremely itchy. Pt states she took benadryl last pm w/ no relief. TOday she took a warm shower and that has seemed to help relieve the itching. Pt referred to PCP for F/U and instructed to return call back to this supervisor with case disposition.
Moderate muscle soreness with painful localized lymphadenopathy (supraclavicular and axillary lymph nodes)
mouth sore; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 18:45 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient had no known allergies to food, medications, or other products.  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 an unknown date, as a single dose for COVID-19 immunisation. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 06:00 (the day after second vaccine), the patient experienced mouth sore, which he never had one before. It was reported that the patient's sister did as well and it took one month to go away. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care The patient did not receive any treatment for the reported event. The clinical outcome of the event mouth sore was resolved on an unknown date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366615 Same reporter/ drug/ AE, different patient
Rash, fever. Grandparents reported rash on baby's trunk started from today, can not think of any new food/clothes/detergent/bed sheets etc. Baby does not seem itching, no fever/chills, no cough, is active, eating well.
Angioedema (facial swelling) occurred at 5 am the morning after receiving vaccine. Left eye completely swollen shut and right eye almost completely closed
I am being denied my second shot because employee at Health center is saying she can't validate my first shot. I need my second shot ASAP. She will not validate the shot because she said I wasn't invited to the clinic.
On the tenth day after the second covid vaccine,  I woke up with left foot pain.  No injury.   Pain and difficulty walking increased on a daily basis.  Sought medical help.  Diagnosis of tendonitis.   Had X-ray, then MRI.  Results showed two tendon tears in foot.  I consider these to be spontaneous.   Also having pains in both arms.
Patient was standing in pharmacy lobby after receiving Moderna vaccine during observation period. At about the 10 minute point, he fainted and fell to the floor. I attended him within about 45 seconds. he was conscious, but confused. Pharmacy staff called 911, and he was attended by myself and a physician assistant who was shopping. Paramedics arrived in less than 10 minutes. Patient was treated by paramedics for about 20 minutes and was determined to be unhurt from the fall, and had recovered from his episode of syncope. He was released into the care of his mother, who was in store with him.
Patient stated that 4 days after immunization she had swelling and pain in her arm pit.  She went to her doctor who said her lymph node was swollen and there was a 10% chance of that happening.  Then it spread to her neck.  I am not sure how long this lasted.
Nonfebrile tonic clonic seizure 4 days after DTaP, IPV, Hep B, PNC 13.
Fever, chills, diarrhea, nausea.  I just let it run its course, no treatment, lasted approx 6 to 8 hous.
Employee tested COVID positive greater than 14 post second vaccine on 3/16  Narrative:
I had bloodwork on 28Jul2021-CRP cardiac-and the result was 9.64 on a scale of 0.00-3.00; My naturopath said it was cardiac inflammation from the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 23Jul2021 10:00, at 60-year-old, as single dose (Lot Number: FW6780) for covid-19 immunisation. Medical history included Raynaud's, osteoarthritis, Mitral valve prolapse (MVP). Known allergies was erythromycin and augmentin. No other vaccine in four weeks. Prior vaccination the patient had no covid. The patient had no covid tested post vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 23Jul2021 at 10:00AM, at 60-year-old, as single dose (Lot Number: FW6780) for covid-19 immunisation. Concomitant drugs included curcuma longa rhizome (TURMERIC), calcium and vitamins. The patient stated she had bloodwork on 28Jul2021 included Protein C (CPR) cardiac: the result was 9.64 on a scale of 0.00 to 3.00. The patient' naturopath said it was cardiac inflammation from the vaccine on 23Jul2021(as reported). Those events resulted in physician office visit. The patient got no treatment. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
This case was reported by a consumer and described the occurrence of palms felt numb in a 43-year-old female patient who received FLUARIX. Previously administered products included FLUZONE with an associated reaction of pain and FLUZONE with an associated reaction of nausea. Concurrent medical conditions included sulfonamide allergy (No other drug allergies). Concomitant products included ZYRTEC, ibuprofen and ALEVE. On 7th October 2014 10:30, the patient received FLUARIX .5 ml. On 7th October 2014, less than a day after receiving FLUARIX, the patient experienced palms felt numb, arm burned, joints ached, nerve tingling and sleep unwell. On an unknown date, the outcome of the palms felt numb, joints ached and nerve tingling were not recovered/not resolved and the outcome of the arm burned was recovering/resolving and the outcome of the sleep unwell was unknown. It was unknown if the reporter considered the palms felt numb, arm burned, joints ached, nerve tingling and sleep unwell to be related to FLUARIX. Additional information received on 08 October 2014: The patient took 1 ALEVE 30 minutes before receiving the FLUARIX vaccination at 10:30 AM. The injection itself did not hurt, but a few minutes later she felt a vibration that progressed to her elbow that felt like jammed nerves and tingling. By 2 PM the sensation subsided, but her palms felt numb. She could not sleep well last night and around 2 AM she was feeling achier than she normally gets after her previous FLUZONE vaccinations. This morning the tingling feeling is back. Doctor's office was required as medical attention.
Not technically and adverse event: Mother provided consent form for the child with date of (age 12). Mother was asked to present insurance and provided the information. In attempt to bill the pt plan, we received a rejection. We called the plan and had the pt's age (11 yo and would not qualify for the vaccine). The mother was insistent that the child was indeed 12 (child was standing with mom) and she would contact the plan to correct the date. Vaccine was administered to the child with no problems (waited 15 minutes after). Pt/Child has never returned for 2nd dose nor has the DOB with insurance been corrected after numerous (5 at least) calls to the pt provided number.
Tingling in both hands and fingers for 2 days, then decreased to tingling in only ring and pinky fingers of both hands for subsequent 4 days.
Shaking; pain in your arm; This is a spontaneous report from a contactable consumer (daughter). This female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL8982, expiration date: unknown),  dose 1, single dose via an unspecified route of administration on 16Jan2021 for COVID-19 vaccination. There was no relevant medical history reported. On an unknown date in Jan2021, the patient experienced pain in the arm and shaking the first night after the vaccine which lasted about 5 minutes on an unknown date. The clinical outcome of the events pain in the arm and shaking was unknown.
Started 2hrs after vaccine-arm/shoulder pain. Numbness. Tingling into fingers. Given pain medication & sling for support. Pain, poor motion in shoulder & deltoid 1 days pain 7/1/10.
Fever up to 103.5 late that night following vaccinations. Decreased appetite that evening into the next morning.  No signs of clinical dehydration.  Tylenol given for treatment of fever.  Flu test was negative.
Information has been received from a physician for the pregnancy Registry for GARDASIL concerning a 20 year old female patient with no known drug allergies and with bartholin's cyst, low grade dysplasia who on 19-JUL-2011, was vaccinated with the first dose of GARDASIL (route and dose not reported) (Lot number 099Z is an invalid lot number for GARDASIL Exp: 14-OCT-2012). There was no concomitant medication. The patient was pregnant, at this same office visit a follow up papanicolaou test (PAP) was performed (results not provided). In February 2011 papanicolaou test was taken which was abnormal. The patient sought medical attention by called to the office. At the time of vaccination, the physician stated client verbalized that her LMP was 12-JUL-2011, but now told physician her LMP might had been in June 2011. EDD: 07-MAR-2012. The physician stated she prescribed antibiotics for the patient's cyst, but the patient did not take them. The physician stated that the patient had not experienced any adverse effects. Follow-up information has been received via outcome pregnancy questionnaire from a health care professional who reported that on an unspecified date the patient experienced an elective termination of pregnancy. At the time of the report, the patient's outcome from elective termination of pregnancy was unknown. Upon internal review, elective termination of pregnancy was considered to be an other important medical event. Additional information has been requested.
two weeks after the second shot my leukemia came back with a vengeance; two weeks after the second shot my leukemia came back with a vengeance; This spontaneous case was reported by a patient and describes the occurrence of LEUKAEMIA (two weeks after the second shot my leukemia came back with a vengeance) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Leukemia.    On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced LEUKAEMIA (two weeks after the second shot my leukemia came back with a vengeance) (seriousness criterion medically significant) and CONDITION AGGRAVATED (two weeks after the second shot my leukemia came back with a vengeance). The patient was treated with BOSUTINIB (BOSULIF) at an unspecified dose and frequency. At the time of the report, LEUKAEMIA (two weeks after the second shot my leukemia came back with a vengeance) and CONDITION AGGRAVATED (two weeks after the second shot my leukemia came back with a vengeance) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: White cell count went from 6,000 to 30,000 in two weeks..         No relevant concomitant medications were reported. When patient was put on the Bosulif and took care of it, but patient went from a maintenance dose from 1 pill a day to 3 with the new drug cause that covid, it was the Moderna not the Pfizer vaccine.  Company comment:  This spontaneous case concerns a patient (unknown age and gender), with medical history of leukaemia, who experienced the unexpected, serious (medically significant) event of Leukaemia. Condition aggravated was also considered. The event occurred approximately 2 weeks after a dose of mRNA  1273 original vaccine; no information about previous immunisation schedule was provided. The report stated that after the second shot patient´s leukemia "came back with a vengeance" which required treatment with Bosutinib and patient´s maintenance dose changed "from 1 pill a day to 3". Patient´s white cell count went from 6,000 to 30,000 in two weeks. No further clinical details were provided for medical reviewing. Patient´s medical history remains as risk factor for the event. The benefit-risk relationship of mRNA  1273 original vaccine is not affected by this report.
Within a few hours of injection site was very sore.  Within in 24 hours painful area on arm expanded.  Within 48 hours 4 inches medially and below had swelling, redness, and warm skin.
pain  at site of shot, Chills, Tiredness, Headache, Muscle and joint pain
Stridor and bronchospasm gave Racemic Epi 1/2 vial in 2cc NS via nebulizer. Pt responded well- No stridor after tx.
Chills, febrile (101.3), headache, body aches, enlarged lymph nodes on left side.
Patient has a 1 out of 10 on the pain scale on the arm that comes and goes
pt recv vax 26AUG98 & fever noted by parents 2SEP98 & 3SEP98 ;no fever thereafter;6SEP98 limp followed by clonic movement of extremities;also shaking episode from 4-8mo age;2nd sz 15SEP98;