chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Racing heart, palpitations, flutters. Flutters were experienced most frequently when bending over. Racing heart and palpitations were randomly experienced. Resolved approximately 3 weeks after administration of first dose.
Fever, Body Aches, Chills, Injection site redness, swelling and hot
Right arm pain following injection, next day arm pain, swelling redness.  Recommended treatment ice and NSAIDS.
After my first shot, the only reaction I had was pain around the injection site for about 2-3 days.  My second shot was on May 30th. I started having a reaction on the following day, May 31st. I was extremely tired, had a horrible headache, my entire body hurt, my arm hurt at the injection site, my arm was swollen at the injection site, I had chills and a fever. Today, June 1st, my arm is still swollen at the injection site, I have a rash near the injection site, my arm is still very painful, I have been dizzy all day, I had chills earlier today, I've had a fever most of the day, I've had a headache all day.
Experienced light headedness, cold pale moist facial skin, slight nausea, and had to lie down on floor to prevent fainting for a 10 minutes. Husband came into room and lifted head slightly and give me a piece of banana and a grape for sugar. We took blood pressure with calibrated machine and it was extremely low at 76 over 46. Husband walked me to bed and gave me some salt, felt better in 20 more minutes and BP recovered to 109 over 70.
half amount of dose administered; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (half amount of dose administered) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced UNDERDOSE (half amount of dose administered). On 28-Mar-2021, UNDERDOSE (half amount of dose administered) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Stiff neck; She might have shingles; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age (reported 75: units unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BTN162B2 on an unspecified date, for COVID-19 immunization. On 14Feb2021, the patient experienced stiff neck, so much that she thought she might have shingles. She wanted to know if there is any interaction with the covid vaccine and antiviral/ shingles vaccine. She went to a doctor and wanted to know if it turns out to be shingles and if she can take the anti-virial medication. The outcome of the events was unknown.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
Infanrix as the 6th dose of DTap; 8 year old received Infanrix/ last one at 2 years-old; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 8-year-old female patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTaP (received 5 doses of DTaP on an unknown date).   On 23rd November 2022, the patient received the 6th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 23rd November 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced extra dose administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the extra dose administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Nov-2022 Reporter's comment: Medical assistant inquired that how to proceed and any guidance. This dose was the patient's 6th dose of DTaP. The patient had not the Infanrix since 2 years of age. No other details were provided. The reporter did not consent to follow-up. Additional supportive information: The patient received Infanrix as 6th dose of DTaP at inappropriate age, which led to extra dose administered and inappropriate age at vaccine administration. Suspect dose number was captured as per reported information.
friends who has received the Moderna COVID 19 vaccine and had side effects days later; 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 VACCINATION COMPLICATION (friends who has received the Moderna COVID 19 vaccine and had side effects days later) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 VACCINATION COMPLICATION (friends who has received the Moderna COVID 19 vaccine and had side effects days later). At the time of the report, VACCINATION COMPLICATION (friends who has received the Moderna COVID 19 vaccine and had side effects days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided. Reporter stated that he had friends who have received the Moderna COVID 19 vaccine and had side effects days later. They all had it at different days. No further information was provided.
lt leg swollen, red from knee to hip; crying x 5 1/2 hr;
her sugar numbers are high; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0175), via an unspecified route of administration on 27Apr2021 as 1st dose, single for COVID-19 immunization. Medical history included diabetes (she is a diabetic), IUD (intrauterine contraception, 10 year IUD). The patient's concomitant medications were not reported. She got the first dose of the Pfizer covid 19 vaccine yesterday (27Apr2021). She has 10 year IUD in her, states it is not a hormonal one and she is asking if her IUD could affect anything. Reports her sugar numbers are high, she is a diabetic. She is wondering if the vaccine could affect her sugar. The outcome of the event was unknown.
Redness at site with edema and warm to touch X 2-3 days. Dizziness for 10 minutes, post vax. Rash at site X 3 days with itching. Complete recovery.
Patient described feeling a "fluttering feeling" in her stomach. Vital signs were taken and shown BP 148/108; heart rate 88. Temperature 100.5. Patient stated she felt like she might pass out. Patient's head lowered and she experienced a vasovagal reaction 2 minutes following vaccination. After recovery, the patient was given a granola bar and a bottle of water. Patient's symptoms improved after 30 minutes. Patient was released home with her husband.
This spontaneous report as received from a pharmacist refers to a 38 year old female patient. None concurrent conditions, pertinent medical history, drug reaction or allergies were reported. On 08-MAY-2015 the patient was vaccinated with GARDASIL 0.5 ml, once, intramuscular, lot # K008621, expiration date 04-MAR-2017, (dose number and anatomical location were unspecified), which was considered an inappropriate schedule of drug administration, and experienced an injection site leaking as an unspecified amount of GARDASIL leaked out of the injection site onto the patient's skin. No treatment was given for the adverse event and no laboratory diagnostic studies were performed. The patient did not seek medical attention. The outcome of injection site leaking and inappropriate schedule of drug administration was unknown. The relatedness between injection site leaking and GARDASIL was not reported. Additional information has been requested.
woke up and arm was swollen and hard(size of a baseball), chest pains and trouble breathing, went to cardiologist and was diagnosed with pericarditis, swollen lymph nods, joint pain, went to er after cardiologist and her level of inflammation on body was 35%
Patient was given the 5-11 dosing of the 23/24 Covid vaccine instead of the 12+ dosing. There have been no adverse reactions at this time.
On 12/24 @3am I started vomiting and did so on and off for the next 4 hours.  A felt very fatigued the rest of the day. On 12/25 I developed a macular pruritic rash to my chest  that progressed throughout the day that covered my torso. By 9pm on 12/25 I was experiencing fatigue, headaches, muscle aches and chills. I took Tylenol and ibuprofen and went to bed.  I current have  a headache, worse pruritic rash and upper tooth pain .
Red with swelling, itchy, stinging and tender to the touch around the injection site (right upper arm) it's about 2-3 inches in diameter.
Breakthrough case admission after third vaccine 1/22/21 Pfizer Lot#EL3249 2/12/21 Pfizer Lot# EL9267 11/18/21 Moderna Lot# 069F21A
p/vax pt devel fever; induration & erythema from lt shoulder to elbow; inj site was not affected; tx w/pred & DPH;
bell's palsy; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date in or around 2016, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date, shortly after receiving the vaccine, the patient suffered Bell's Palsy. As a direct and proximate result of the plaintiff's symptoms had resulted in physical limitations not present prior to using the vaccine. Plaintiff also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), plaintiff sustained severe and permanent personal injuries. Further, as a tragic consequence of Merck's wrongful conduct, Plaintiff suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the event Bell's Palsy to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, Bell's Palsy was determined to be medically significant.
Nine days after receiving the shot, patient broke out in hives on his abdomen. The hospital told him to take Benadryl which did not reduce the hives. The hives continued to spread over his abdomen and become itchier. On day 11 after the shot, his lips began to swell. On day 12, January 26, he went to the emergency room due to the lip swelling and hives. They prescribed 10mg Cetirizine HCL twice per day. He took it for three days. The lip swelling went down and the hives started to subside the day he started to take the Cetirizine.  Note: He had two hives appear on his chest within 24 hours of the second dose. That was COVID-19 (Moderna) 013M20A on February 11, 2021. He immediately took the Citirizine for three days and they did not get any worse and cleared up.
Medication Administration Error. Patient received 0.25 mL of Moderna bivalent vaccine instead of 0.5 mL at visit. The patient was contacted the next day to notify of the error and returned to the clinic to receive an additional 0.25 mL for full dose.
Receiving 4 yo vaccines. DTaP right thigh. 48 hours later marked swelling and edema
Pt experienced red eyes with drainage. Pt also experienced a raw throat and sensation to cough to clear it.
Patient was given first dose of vaccination. Pt was not yet 18 years old.  Mother was contacted by phone within hours of vaccinations. Mother was advised that pt was given vaccine before 18 years of age and vaccine is not indicated for patients under 18. Mother was with patient when given vaccine and mother indicated she wanted patient to be vaccinated.  I gave follow up call the next day to verify how patient was doing. Patient said he was doing fine with the exception of a sore arm.
Myalgia, Arthralgia & NauseaVomiting Narrative:  chills, chest tightness/pain, fatigue. in bed for 2-3 days, off work one day. No previous reaction to dose #1
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", 0.5 ml, lot # L007720 with expiration date of 08-JUL-2016 (strength, route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 168 hours, with a lowest recorded temperature of 1 F (also reported as 1 Celsius degree). There were also another excursion on an unknown date which lasted 96 hours with a lowest recorded temperature of -1 F (also reported as -1 Celsius degree). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
Scheduled to have a surgery; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Scheduled to have a surgery) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Scheduled to have a surgery). At the time of the report, VACCINATION COMPLICATION (Scheduled to have a surgery) outcome was unknown.      No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter
Left arm localized reaction to Menactra. 3inx 2in red raised hot to the touch. Diagnosis: Allergic. Prescribed treatment: Benadryl.
Patient's program supervisor called the morning of Wednesday, December 15th to inform me that staff at the group home where patient lives had told her I administered a Pfizer COVID-19 booster to the wrong  client on Tuesday, December 14th.  I explained to her that patient was the client the staff had at the dining table where the shot was to be administered and they did not stop me as I was preparing her arm for or administering the shot.  I am a fault, as well, for not verifying the client's name/DOB. She did not state that patient was having any adverse reactions. The program supervisor will be brining the correct patient to the pharmacy on Thursday, December 16th to receive her booster shot and brining the other patient's vaccination card to be updated.
Started with itching of ears and head, spread to face and chest with redness and itching, watery eyes and stuff nose. Went to Urgent care at 4:45pm, received 50mg of diphenhydramine (Benadryl) at 4:56pm and then given dexamethasone (Decadron) at 5:41pm and famotidine (PEPCID) at 5:41pm and was sent home at 6:35pm after been monitored 30 minutes after meds were given to make sure no more side effects. Took 50mg Benadryl at 10:30pm for the massive itching. Took 10mg Cetirizine at 1:30am to help with the stuffy nose and watering eyes still. Took another 50mg of Benadryl at 4:20am. Went to see my PCP Dr. at Clinic. He gave my a prescription for 16 days worth of Prednisone 10mg tablets ( 4 tablets by mouth once a daily for 4 days, 3 tablets by mouth once daily for 4 days, 2 tablets by mouth once daily for 4 days, 1 tablet by mouth once daily for 4 days) and 25mg-50mg every 4 -6 hours.  Took 4 Prednisone and 50mg of Benadryl at 10am on 10-4-22. I will continue with the 16 day course of Prednisone and Benadryl 25-50mg  also as needed. Tried going down to 25mg of Benadryl on 10-6-22 at 6am, and again at 10am but itching was not stopping.
Initial unsolicited case received from a physician on 12-Oct-2016. This case involves patient who was vaccinated with a dose of ADACEL and a dose of MENACTRA (batch number, expiry date, route and site of administration: not reported for both vaccines) on an unspecified date (reported as in last week). Patient's medical history and concomitant medications were not reported. On an unspecified date, at the same time (of vaccination) and the patients eyes rolled back and they started shaking. Patient's lab data and corrective treatment was not reported. The outcome of the events was not reported. List of documents held by sender: none.
Initial ringing of bilateral ears s/p injection lasting 3 hours.   Next day tempt 100.1-101 with fatigue, malaise, chills and headache. Starting 1/22 episodes of flushing, chest tightness, dull head pain and dizziness.  Episodes come and go.  Will often have numbness in bilateral arms during and after dizziness.  No LOC at this time.
Initial healthcare professional report received on 25 Mar 2010: This patient vaccinated with S-OIV FLUVIRIN (batch 10073803), intramuscular, on 29 Oct 2009. On an unknown date (for several days after vaccination), this patient could not sleep. The outcome of event was not reported.
A consumer report has been received. The report concerns a Male consumer, who had been received FLUMIST quadrivalent, (intranasal). FLUMIST quadrivalent, (intranasal) started on 19-Nov-2015. The patient experienced mild sneezing and mild runny nose. FLUMIST quadrivalent, (intranasal) was discontinued on 19-Nov-2015. The patient recovered from the event of sneezing and runny nose on 22-Nov-2015. The report was considered to be non-serious.
Ankylosing spondylitis flare up; Tendons thick/ ridged from inflammation; Tendon thickening/ Tendons thick/ ridged from inflammation; Joint stiffness; FACILITATED COLLECT  This is a Solicited report based on the information received by Pfizer from Facilitating Company from a contactable male consumer reporting for himself.  A 53-year-old male subject received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 01May2021 (Batch/Lot number was not reported) (at the age of 53-year-old) as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date and ongoing (Batch/Lot number was not reported), at unspecified dose for ankylosing spondylitis.  Medical history included surgery for spinal cord stimulator from Feb2021 and ongoing, ongoing ankylosing spondylitis. The subject's concomitant medications were not reported. The subject previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 01Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation and experienced fatigue. The subject experienced ankylosing spondylitis flare up on an unspecified date with outcome of not recovered, tendons thick/ ridged from inflammation on an unspecified date with outcome of not recovered, tendon thickening/ tendons thick/ridged from inflammation on an unspecified date with outcome of not recovered and joint stiffness on 02May2021 with outcome of unknown.  The action taken in response to the events for adalimumab was dose not changed. The reporter's causality for the events tendons thick/ridged from inflammation unknown onset, tendons thick/ridged from inflammation unknown onset and ankylosing spondylitis flare up with adalimumab (HUMIRA) was a reasonable possibility. The reporter's causality for the event stiff joints with adalimumab (HUMIRA) was no reasonable possibility.  The reporter's assessment of the causal relationship of the event with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and considering drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the reported events Ankylosing spondylitis flare up, Tendonitis, Tendon thickening, and Joint stiffness cannot be completely excluded. Case will be reassessed upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.