chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 Vaccine   *01/04/21 11:50am Less than 10 mins after vaccine I became very hot, clammy, ringing in ears, tingling lips.  Started to feel anxious which made me feel faintish, in need of the restroom.  Ride home felt very hot, rolled windows down in 50 degree weather sleeveless.  Arrived home 30 mins after shot, used the restroom, felt pressure in my throat and jaw line by ears, ringing in my ears.  I?m scared  45 mins after shot, freezing and shaking, feel tired, pain in both arms/muscle, pain on side of neck/muscle  Ringing in ears Called out of work remainder of the day  3:00pm-  Slept for 2.5 hrs from 3-5 Woke to flu like symptoms  Woke at 5pm  to aches in joints. My hands, knuckles, and elbow on my left arm- same arm as shot sore throat  Headache  Muscle aches in neck and both arms Diarrhea  nasal pressure - face Jaw pain by ears Very tired Switching between hot and freezing Took Tylenol   6:15pm Still suffering flu symptoms  Ringing in ears Strong urge to vomit Weak Bottom of feet ache  Eyes watering   7:34pm Ate a little and feel a little better, coming in waves   9:30pm Feeling better Flu symptoms and nausea is gone Just very tired and very sore at injecting site. About a 6 on a 1-10 scale for pain when touched.  Hoping for a better tomorrow   *1/5/21 Day-2 7am  Called out of work for a late start  Could not sleep due to pain at injection site as well as achy joints/muscle in hands and arms. Any movement would shock me awake  Arthritis in hands seemed inflamed  Nightmares Very tired/fatigued   10am Called out of work for the remainder of the day. Very tired/fatigued difficulty getting out of bed.  Pain at injection site about an 8 when touched even by a blanket Took more Tylenol   4:30 Feeling okay... just sluggish and soreness at injection site. About a 5   Curious if maybe I already had the virus and so this first shot was like a booster which caused the flu like symptoms?? Or maybe my autoimmune disorders?  8:30pm Feeling so much better!!  Still some soreness at injection site but tolerable. Feeling better about being protected!    *1/6/21 Day-3 Generally feel okay but fatigued  Slept an unusual amount  8pm This Evening had shooting pain down my right arm (injection site) and also pain on my right in chest, heart area.  Had lots of palpitations and was concerned about having a heart attack My Apple watch recoded spikes in blood pressure over 107 while being inactive    *1/7/21 Feel okay today Light soreness at injection site.. like a bruise when touched   *1/8/21 Better but hesitant to receive the second dose scheduled Feb 1st
Severe cellulitis of Left upper arm. Patient initially treated as an OP with Septra and Keflex on 22 JAN 14. Cellulitis did not improve, patient evaluated in ED on 24 JAN 14 and admitted. Patient discharged on 25 JAN 14 with improving cellulitis following two doses of Vancomycin. Patient presented to the ED again on 28 JAN 14 and admitted. Patient was restarted on Vancomycin and is currently an inpatient.
swollen lymph nodes underarm right side; Chills; Head ache; Low grade fever; sleepy; Light headed; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 27Mar2021 at 13:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included Multiple Sclerosis (MS) and high blood pressure. The patient was allergic to medications, food and other products. The patient received an unspecified concomitant medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not tested for COVID-19. On 27Mar2021, the patient experienced chills, headache, low grade fever, sleepy and light headed. On 29Mar2021, the patient experienced swollen lymph nodes under arm on the right side. The event neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events chills, headache, low grade fever, sleepy, light headed and swollen lymph nodes under arm on the right side was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
it was rpt fr pharmD concerning a pt who approx 1995 was vax & on 28dec98 lab tests revealed neg titers
Red, warm lump about two inches below and two inches to the inside of the injection site, which grew to a non-raised area of about 2 1/2 inches wide by 4 1/2 inches long a day later.  Seemed to be going away until I woke up today (day 6), and it was redder and warmer than at any time.  Not raised, no other symptoms.
developed a rash on his left leg; the rash became more itchy and they look like little bites; The first was on 26Feb2021 while the second one was on 09Mar2021.; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at an unknown route on 09Mar2021, dose 2, single and first dose at an unknown route on 26Feb2021 as dose 1, single for COVID-19 immunization. The patient was allergy to sulfa. The patient medical history and concomitant medications were not reported. The patient had the first was on 26Feb2021 while the second one was on 09Mar2021, developed a rash on his left leg and the rash became more itchy and they look like little bites. The patient had gotten both doses of the Pfizer COVID-19 vaccine. The first was on 26Feb2021 while the second one was on 09Mar2021. After getting both doses, he developed a rash on his left leg. At first he was not worried about it but as days went by, the rash became more itchy and they look like little bites. He had applied topical steroid ointment and he was expecting it to subside but the rash got worse. It only occured in one leg. The patient said he did not go to the woods and he can only attribute the rash to the vaccine. The patient received treatment for rash became more itchy and they look like little bites. The outcome of events was unknown.  Information about batch/lot number has been requested.
Bilateral leg numbness, starting from toes to hips. feeling of pins and needles under feet. No reflex in feet or knees. High amount of protein in CSF through lumbar puncture. Urinary retention, constipation.  Was admitted to hospital from November 6 -9th and received 2 dose of steroids through IV. Still in process of seeing a neurologist and neurosurgeon.
Per report from patient's mother, at unknown time the same day as vaccination, began feeling "sick" and developed a headache. Later felt shortness of breath and was seen in the emergency room and diagnosed with an allergic reaction.  His mother was vaccinated on the same day and had the same symptoms and also was diagnosed as having an allergic reaction (VAERS report submitted).  Received nebulizer treatment in the ER (no other medication).  Discharged home the same day. Received report from patient's mother one month after event occurred.
About 2 weeks after recieving my first dose I developed rashes all of my body. The second day in addition to the rash, my lips were very swollen.
redness and itching besides appeared a little over a week after being vaccinated the sore arm which was expected
Nausea; Vomiting; Body aches; Chills; Low grade fever 99.8; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported for herself that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. The patient medical and concomitant medications were not reported.  The patient experienced nausea, vomiting, body aches, chills, and low grade fever 99.8 on 08Jan2021. She stated that she has been afebrile for 24 hours. She was scheduled to receive the second dose on 10Jan2021. She did have a PCR send off test for COVID-19 but had not yet received the results. She stated that she did not think she has COVID-19 but she was not sure. She was wondering if she should still get the second dose of the vaccine on 10Jan2021. The outcome of fever was recovered in Jan2021, of the other events was unknown. She stated that her institution was telling her if she delay getting her second dose of the COVID-19 vaccine then she would need to restart the vaccination series. She would like to know if this information was accurate.  Information on the batch number has been requested.
Grapefruit size inflammed area, very hot to touch; hardening of tissue & quarter size bruising on right arm
Storage date range for Lot number 33038D in freezer was miscalculated by an additional 2 weeks. Vaccine should have been pulled from freezer to be stored in fridge by 12/13/2021. The error was not discovered until 1/13/2022. All vaccines that were given after 12/13/2021 that were affected by the extended freezer storage were determined by Pfizer that they should not be used. Health Centers determined the best course of action was to offer revaccination to all affected clients.
Administered after the expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 44-year-old female patient who received HBV (Engerix B) (batch number K2L79, expiry date 12th August 2022) for prophylaxis.   On 22nd August 2022, the patient received the 1st dose of Engerix B. On 22nd August 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 23-Aug-2022 Reporter's comment: The pharmacist stated that Engerix-B was administered to a patient after expiration date. The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Shaking, confusion, muscle tics lasting for 36-48 hours. No fever. Nausea without vomiting. Fatigue with sleep interruption due to the muscle tics. Diffuse but more involving the legs bilaterally. No swelling at the injection site. Some tingling to both arms and carpal spasm both hands transiently. No swelling, headache, dysphagia, chest pain or dyspnea.
Pain all over; Felt like a truck sat on their chest; Anxiety; Back Pain/Pain in lower back; Could only get from bed to bathroom (limited mobility); Felt stung during second vaccine dose administration; Low grade fever; Chills; Headache; Tiredness; Dizzy/Lightheaded; Arm was warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain all over), CHEST DISCOMFORT (Felt like a truck sat on their chest), ANXIETY (Anxiety), BACK PAIN (Back Pain/Pain in lower back) and MOBILITY DECREASED (Could only get from bed to bathroom (limited mobility)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE and PARACETAMOL (TYLENOL) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced DIZZINESS (Dizzy/Lightheaded), VACCINATION SITE WARMTH (Arm was warm to the touch) and FATIGUE (Tiredness). On 20-May-2021, the patient experienced PAIN (Pain all over), CHEST DISCOMFORT (Felt like a truck sat on their chest), ANXIETY (Anxiety), BACK PAIN (Back Pain/Pain in lower back), MOBILITY DECREASED (Could only get from bed to bathroom (limited mobility)), FEELING ABNORMAL (Felt stung during second vaccine dose administration), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache). On 21-May-2021, PAIN (Pain all over), CHEST DISCOMFORT (Felt like a truck sat on their chest), ANXIETY (Anxiety), MOBILITY DECREASED (Could only get from bed to bathroom (limited mobility)), DIZZINESS (Dizzy/Lightheaded), VACCINATION SITE WARMTH (Arm was warm to the touch), FEELING ABNORMAL (Felt stung during second vaccine dose administration), PYREXIA (Low grade fever), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (Headache) had resolved. At the time of the report, BACK PAIN (Back Pain/Pain in lower back) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
pt recv vax 31OCT97 & 2NOV97 pt reported to the ER w/4 blisters & on 4NOV97 pt returned the ER w/20-30 blisters;the blisters reminded her of chickenpox;
Headache, Myalgia, Arthralgia, Fever, Localized pain, fatigue Narrative:
This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers to 08 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
This spontaneous case reported by a pharmacist, describes the occurrence of underdose (some dose leaked out the injection point) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 027C21A) for COVID-19 immunization. No medical history reported. On May 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 26, 2021, patient experienced underdose (some dose leaked out the injection point). On May 26, 2021, underdose (some dose leaked out the injection point) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant product use or treatment information.
The patient received the shot today around 6:00pm and I had him sit down after the shot.  I explained to him that he had to wait 15 minutes just to make sure he was okay.  As I was putting the sharp container back.  He fainted and fell on the floor.  I immediately ran out and sat him back down because he had gotten up off the floor.  I saw he was still sweating, I told him don't move and laid his head back on the bench.  I got the ice pack and a bottle of water for him.  He said his eyes was blurry as I continued to hold the ice pack and give him water.  He then told me he felt like he wanted to vomit, I ran back in the pharmacy looking for a garbage can but didn't see one, so I grabbed a bunch of paper towels and as I got back to him he was vomiting.  I put the ice pack back to his head for about 5 more minutes and he then said he was feeling much better and he could hold the water bottle and drink some by himself.  I asked him when was the last time he had eaten and he said for breakfast and it was 6pm now.  I told him that he should have at least eaten lunch before getting the shot and he is a college student and he said he was saving the little money he had for food.  I wanted to send him home with some Tylenol just in case he developed a fever or got chills later because he said he was cold.  I bought him some Tylenol and had him sit for 30 more minutes and when he left I had my technician walk him to the door to make sure he was still okay to drive.
I received the Gardasil vaccine when I was 17 or 18 (2007 or 2008) and symptoms began in 2009. I was diagnosed with dermatomyositis in 2011.
PRESENTED IN OFFICE ON 12/01/2005 WITH RASH. EXPOSED TO CHICKEN POX APPROX. 2 WKS AGO.
tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patients mother) reported for a 27-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685), via an unspecified route of administration in the left arm on 17Dec2020 at single dose, for Covid-19 immunisation. Medical history included was sick 4-5 days in Feb2020 or Mar2020. There were no concomitant medications. After the 1st dose, the patient had fatigue after the 3rd day. After a week she felt like she had loose motions in other words diarrhea. She lost her smell and taste both (thought it was 27Dec2020). She got herself tested and it was positive. She tested positive on 28Dec2020. The outcome of event was unknown.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 19-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
colds; Feeling sick; body ache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), PAIN (body ache) and NASOPHARYNGITIS (colds) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    no known allergies were reported.  The patient's past medical history included Bronchitis, Joint swelling from July 2020 to September 2020, COVID-19 from July 2020 to September 2020, Arthritic pains from July 2020 to September 2020, Body temperature (104 F) in July 2020 and COVID-19 PCR test in July 2020. Concurrent medical conditions included Asthma, Non-smoker and Alcohol use (one to two drinks a year).   In September 2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 17-Apr-2021, the patient experienced MALAISE (Feeling sick). 17-Apr-2021, the patient experienced PAIN (body ache). In December 2021, the patient experienced NASOPHARYNGITIS (colds). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, ETHANOL, GUAIFENESIN (ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE;ETHANOL;GUAIFENESIN]) at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Apr-2021, MALAISE (Feeling sick) and PAIN (body ache) had resolved. In December 2021, NASOPHARYNGITIS (colds) had resolved.            Concomitant product use was not provided by the reporter.  Action was drug withdrawal for all the events with respect to co-suspect drug  ADALIMUMAB (HUMIRA).  The reporter's causality for the events of felt sick, colds and general body pain  with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
PATIENT CAME INTO THE PHARMACY WITH A SEVERE SWOLLEN RIGHT EYE. VERY RED AND SWOLLEN
C/O feeling hot, HA, eyes burning then blacked out. Woke up on floor. Also w/ rash on abdomen and thigh.
HSP: Petechiue, Purpura, Abdominal pain, headache, joint pain.
Has second bout of covid infection, after 5-week hospitalization for covid pneumonia with PE/DVTs, 11 & 12/2021.
Redness, swelling and pain at injection site L lower arm Received Rx for Abx and advised to use cool compress and OTC antihistamine.
woke up in the am on 10/31/21 coughing , sore throat, chest congestion went to get tested for covid, tests come back negative.
POSSIBLE WRONG ROUTE OF ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) once a total dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 26-MAR-2021, the subject experienced possible wrong route of administration. On 26-MAR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible wrong route of administration and off label use was not reported. This report was non-serious.
I have never really had any type of health issues and rarely get sick.  I am having severe hives.  Nothing new changed in my diet, products or anything else. Heartburn is extreme and it's not like my typical heartburn.  It's a very sharp stabbing pain. I am taking Singulair, Allegra and Pepcid and that keeps the hives away for the most part.  I do not like taking medication every day so I stop here and there to see if the hives come back and they do, but they are not as bad as they were before.   When they first came on, I felt like I could not swallow and felt like something was just stuck in my chest area.