chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial initially stored in refrigerator on 08-Mar-2022 and vaccine administered on 20-May-2022; Dose administered after 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 08-Mar-2022 and vaccine administered on 20-May-2022) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis.     It was reported that patient had been neither diagnosed nor tested COVID-19 test positive. No chronic or long standing health conditions were reported.     On 20-May-2022 at 10:30 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-May-2022 at 10:30 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 08-Mar-2022 and vaccine administered on 20-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 08-Mar-2022 and vaccine administered on 20-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  No. of doses/vials were 6 vials. The vial was initially stored in the refrigerator on 08-Mar-2022.  No the vial did not undergo any temperature excursions.  No treatment medications were reported by the reporter.
slept off and on all day; Taste was terrible; felt zapped; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (slept off and on all day), AGEUSIA (Taste was terrible), FEELING ABNORMAL (felt zapped) and FATIGUE (Fatigue) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced INSOMNIA (slept off and on all day), AGEUSIA (Taste was terrible), FEELING ABNORMAL (felt zapped) and FATIGUE (Fatigue). On 07-Feb-2021, INSOMNIA (slept off and on all day), AGEUSIA (Taste was terrible), FEELING ABNORMAL (felt zapped) and FATIGUE (Fatigue) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-016705 (Patient Link).
Received this Moderna as booster vaccine (1st dose was Janssen/J&J on May 24, 2021). Migraines on-and-off that are are different in intensity and frequency than migraines I've had in the past. Migraines resolve and then come back. Symptoms: headache, pressure, sensitivity to light & sound, tired & trouble focusing, tingly/numbness, mild nausea & diarrhea. Assessment: Migraine without aura, intractable, without status migrainosus. Suspect migraine exacerbated by COVID vaccine. Potential need to use magnesium as a prophylactic for small amount of time. Neurological exam is normal, despite some pressure related symptoms. Differentials could also include sinus pressure secondary to COVID vaccine.
Pt had localized reaction s/p Tdap. 9cm x 5cm erythema. No warmth/edema/tenderness.
Hives on trunk of body, arm, and legs. Claritin taken in am x 5 days. Benadryl taken in pm x 5 days.
I got my shot Thursday afternoon... beginning while I was sleeping that night until I woke up I was freezing and then woke up sweating. On Friday, I had a headache when I woke up as well as body aches and pains. Additionally a large swollen, red, warm spot appeared at the injection shot. It is very itchy. I googled it and found that it is considered ?Covid Arm?. Saturday I still had a headache and achey body and both friday and saturday i was very tired. I also developed a deep, junky cough on Friday which I think was due to the shot.
Pain; Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (a mild case of shingles the year before).   On 11-FEB-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 13-FEB-2023, 2 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). On 22-FEB-2023, the patient experienced pain (Verbatim: Pain). The patient was treated with valaciclovir (Valacyclovir) and gabapentin (Gabapentine). The outcome of the shingles was unknown and the outcome of the pain was resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.     It was unknown if the company considered the shingles and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-MAY-2023 The patient received 1st dose and she came down with a pretty bad cases of Shingles, which she diagnosed herself as she was the registered nurse and had a mild case of shingles the year before (no specific date was provided). The patient went to doctor the next day on February 14, 20232, and was put on Valacyclovir (no further information) that day. The patient reported started of having shingles pain (no specified location) and about a week later on February 22, 2023, and went for physician checkup. On March 6, 2023, she was put on Gabapentin (no further information), for about two weeks, but that did not work. The patient went to clinic on March 20, 2023 and gave her a prescription for something else (unknown product), that she did pick up from the pharmacy, but never took. The pain of the shingles was recovered on mid-April (no specific date provided). The reporter consented to follow up with the health care professionals.
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (her left leg started swelling (from her foot to her hip)), RHINORRHOEA (Running noise) and PAIN IN EXTREMITY (Sore arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PERIPHERAL SWELLING (her left leg started swelling (from her foot to her hip)), RHINORRHOEA (Running noise) and PAIN IN EXTREMITY (Sore arm). At the time of the report, PERIPHERAL SWELLING (her left leg started swelling (from her foot to her hip)), RHINORRHOEA (Running noise) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on the way to ER on 19 March 2021. No Relevant concomitant medications was provided. Treatment information was not provided.
This is a spontaneous report received from a contactable reporter(s) (Pharmacist). A 33 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Feb2021 (Lot number: EL9261) at the age of 33 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "light headedness"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "generalized chills"; FEELING HOT (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "warmth to body"; PALPITATIONS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "palpitations". Therapeutic measures were not taken as a result of dizziness, chills, feeling hot, palpitations. Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. No follow-up attempts are possible. No further information is expected.
Extreme Vertigo symptoms for approximately one week with flashes on occasion since; This is a spontaneous report from a contactable female consumer (patient) reported for herself. A 66-years-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0150, Expiration date: unknown), dose 2 via an unspecified route of administration, administered in left arm on 30Mar2021 (at the age of 66-years-old) as 2nd dose, single for COVID-19 immunization. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in left arm on 09Mar2021 as 1st dose, single for COVID-19 immunization. Patient medical history included type 2 diabetes mellitus and known allergy codeine. Concomitant medications included the patient received within 2 weeks of vaccination was metformin (METFORMIN), losartan (LOSARTAN POTASSIUM), atenolol (ATENOLOL) and estradiol (ESTRADIOL). Prior to vaccination, patient diagnosed with COVID-19 was unknown. Since the vaccination, patient was not tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Facility where the most recent COVID-19 vaccine was administered in public health clinic/administration facility. The patient experienced extreme vertigo symptoms for approximately one week with flashes on occasion since on 22Apr2021 at 05:00. The patient did not received any treatment for event. The outcome of event was recovering.  No follow-up attempts are needed. No further information is expected.
On the 6th day I experienced a Headache, severe rash, nausea, body aches, body chills, fever, and a severely swollen lymph node in my left armpit, unable to move my arm. This lasted for 8 days.
VACCINE WAS ADMINISTERED 2 DAYS AFTER THE VIAL WAS PUNCTURED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 04-NOV-2021, the patient experienced vaccine was administered 2 days after the vial was punctured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was administered 2 days after the vial was punctured was not reported. This report was non-serious.
The pt experienced a raised red rash all over the body. Cried for 1 hour post vax. Did not take temp but felt warm for one day. Does not have private physician.
After vaccine, pt hands started getting sweaty, pt also had a headache, stomach cramps and fever. Symptoms improving - only diarrhea currently.
Woke up at a out 4:00 am to Severe pain mid left breast around side to mid back.  Woke with pain, could not turn to side or get out of bed due to pain.  When could get up after one hour, used ice back and took one muscle relaxer pill, TIZANidine.   At about 10:00 am pain was subsiding.
Approx 4 cm round red area at site of DTaP. Skin warm to touch, firm. To use Motrin and cool compresses.
very enlarged lymph node (visibly enlarged) on left side supra clavicular initially, now lymph nodes bilat swollen, bilat inner wrist rashes that are like burns.
got the shot and still got them/Suspected Vaccination Failure; still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shot and still got them/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  The follow up would not possible as no contact details were available.
Brain fog, unclear, mild confusion, brain and physical fatigue. Patient is a life sciences professional engineer with complaints of symptoms that will begin after receiving the vaccine. Patient has reported symptoms to his PCP and the  feedback. Patient says symptoms have been severe enough for him to opt out, miss out on important work activities as he's unable to focus, and respond to activities requiring short-term memory. Symptoms will improve within a week or two after the vaccine has been introduced.
Woke up with muscle pain, dizziness and vomiting that lasted 10-12 hours.  Slept for 10 hours after that and then felt fine with no other symptoms.
Per the clinical lead the Flu and Hepatitis A vaccine was transported to clinic in the brown portable cooler. A vaccine excursion occurred with the brown portable cooler. The temperature on the data logger attached to the brown portable cooler went out of range according to Havrix and Flulaval manufacturer recommendations. The portable cooler was reconditioned and the Flu and Hepatitis A vaccine was administered to the patient. Manufacturer contacted by Health Department representative. Per the Health Department they were advised by GlaxoSmithKline that the Flu and Hepatitis A vaccine was not viable and the patient needed to be re-vaccinated.
Pt was given undiluted Pfizer bivalent vaccine for 6month-4years. Pt experienced no adverse events.
Information has been received from a health care provider concerning a 12 month old male pt with no past medical history who on 08/27/2001 was vaccinated SC with a first dose of varicella vaccine. There was no illness at the time of vaccination. On 09/04/2001 his fever started and on 09/06/2001 the pt's mother reported he had a rash all over the torso and legs. On exam, he had a few vesicules in his throat and sparse spots on his trunk. No other lab tests were done. Additional info has been requested.
Approx. 8 centimeter area of erythema and edema at injection site.  Private physician prescribed topical cortisone.
That morning I had taken amlodipine for the 2nd time in my life to help Raynaud's.  Both times I have taken amlodipine now I have felt lightheaded and less cognitively sharp than normal basically the entire day.  I received the above Pfizer COVID-19 vaccine around 12:45 PM, within about 3-5 minutes of receiving the vaccine and standing in line to check out I suddenly felt I was going to loss consciousness/collapse so started lowering myself to the ground and then became unconscious and fell.  Healthcare staff informed me I was unconscious for about 20-30 seconds. I woke up and initially felt confused, but quickly realized what had happened.  Then I felt nauseated, had some stomach cramps and thought I was going to have diarrhea.  They considered giving me Epi for possible anaphylaxis, but I requested they observe further for any skin reaction/hives, airway symptoms, etc given I was skeptical the syncope may have been fully or partially related to the amlodipine I took that morning.  Symptoms slowly improved over 20-30 minutes, but the lightheaded feeling and nauseated lasted hours.  No Epipen, medications, or interventions were needed.
This spontaneous report was received from a registered pharmacist refers to a 68-year-old male patient with no pertinent medical history. On 27-SEP-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX (lot#, and expiration date was not reported), subcutaneously. Concomitant therapies included COREG. Approximately on 03-OCT-2013 (reported as "about six days later") the patient experienced a dry rash that was not itchy or painful over his entire stomach and chest area which was "similar to measles or chickenpox". Treatment was not rendered for the events. No laboratory or diagnostic studies were performed. The outcome of rash was unknown. Causality was not reported. Additional information has been requested.
tingling; This is a spontaneous report via Pfizer  from a contactable consumer or other non-HCP (patient, self-reporting).   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced tingling. The patient experiencing adverse reactions after receiving the 1st dose of vaccine including tingling wanted to know what to expect with the 2nd dose. The outcome of event was unknown.    No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Although this page requires me to enter the vaccination and I did, it only represents my attempt because I don't know which flu vaccination I was given. Hives appeared shortly after receiving the vaccination. I noticed the hives the day of receiving the shot approximately 6 hours or more after receiving it when taking a shower after working out at the gym. I did not think much of it, just keep an eye on it. Now, two days later the rash or hives have spread from just below both pectorals and above my navel to my arm pits, shoulders blades, sides of my back, and shoulders. Rightfully so, now, I am a little concerned that the problem may not go away without assistance and I wanted to inform the CDC for accurate information concerning vaccinations administered, as especially, one as common as the flu vaccination. My intent is not harm anyone, but to ensure my safety and others by telling the appropriate people.
Began to notice night time fevers on 10 Oct and by 12 Oct he noticed a sore throat and left knee pain. On 17 Oct his sx increased. On 25 Oct, he began to experience high fevers and night sweats. On 01 Nov he was evaluated with c/o increase temp and night sweats. His WBC was 17.14 with 82.5 neutrophils. He was diagnosed as having fever of unknown origin. At an internal medicine f/u on Jan 24, he was experiencing pain in bil wrists, bil shoulders, rt knee and calf, and noticing difficulty lifting both legs. He was assessed as having arthritis multiple sites with synovial inflammation. Since February 2011 he has had frequent visits with rheumatology, and multiple medication adjustments. He is currently taking CELLCEPT and PREDNISONE. Pt continues to experience episodes of fever and pain and has been diagnosed with undifferentiated connective tissue disease.
1 1/2 hours after the vaccination, pt began to have swollen eye, face, hives all over her body, began to have coughing & difficulty breathing. Immediately saw in E.R. was treated with EPIPEN and steroid.
Pt. had localized swelling, redness and fever after having both vaccines administered in office. Patient developed cellulitis requiring antibiotic treatment . Pt preference for both in same arm.
Patient broke out with shingles 7 days after it was administered. No treatment provided. Mom wanted this reported.
Monday night, sore arm at injection site that kept me up all night anytime I turned the pain woke me up., Tuesday morning around 10 am - Started with stuffy clogged nose and dizziness, spacey feeling, then sore throat, then ear ache. Muscle and joint aches, fatigue quickly followed. Nauseas, Low grade fever 99.5 degrees. In about an hour after the first symptom was completely miserable - I felt really bad. Went to bed and stayed there until Wednesday morning. Feeling a little better. By Wednesday late afternoon felt normal again. Injection site still hurts as of today, Friday. This was my Booster - dose #3. Way worse & different side effects than my second shot.
Syncope, dizziness, BP 130/90 (pulse 61), O2 sat 99%. Hit left forehead, 1.5 inch gash along eyebrow. Sent to ED.
Dizzy and stumbled to floor, patient felt sizzy and after receiving vaccine and felt faint, and fell to floor but did not appear to lose consciousness.
I have an injury from the SHINGRIX vaccine; getting my SHINGRIX vaccine and then immediately experiencing side effects / Face began to swell; Face began to itch, possibly a case of shingles; This case was reported by a consumer and described the occurrence of facial swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 10 hrs after receiving Shingrix, the patient experienced facial swelling, pruritus facial and injury. The patient was treated with ophthalmologicals (nos) (Eye Drops (Nos)). On an unknown date, the outcome of the facial swelling and pruritus facial were recovered/resolved and the outcome of the injury was unknown.   It was unknown if the reporter considered the facial swelling and pruritus facial to be related to Shingrix. The reporter considered the injury to be possibly related to Shingrix.     Linked case(s) involving the same patient: US2022AMR094423   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: This case was self-reported by patient. The patient received first dose of Shingrix vaccine into unknown arm about 18 months ago from reporting. The patient reported that about ten hours after receiving the Shingrix vaccine face began to swell and itch near to left eye. The patient went to her eye doctor. The doctor tried several eye drops before swelling and itching cleared up about 8 weeks later.  At that time, the eye doctor told to the patient that he was suspicious that it was related to the Shingrix vaccine and possibly a case of shingles. Shingles was never diagnosed by anyone. The patient strongly suspect that she had an injury less than 2 years from the Shingrix vaccine.  The reporter consented to follow up both her and her eye doctor. Additional supportive Information: This case had been linked with case US2022AMR094423 reported by same reporter for 2nd episodes of adverse events.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094423:Same reporter. 2nd episode of AEs.
I had running nose and a lot coughing that was clear. I tested positive for COVID-19 at home and I tested positive. On the same I called my doctor and told him I had COVID-19. He prescribed me low dose of Paxlovid.
Patient came in the store complaining of a red arm and rash that seems to have gotten worse since she got the shot.
Inconsolable crying for 5 hrs beginning 1 hour after 2 mo set immunizations.
The patient was not immunocompromised person but she thought over 60 years of age were all immunocompromised. She got full dose (0.5ml instead of 0.25ml for her 1st booster). She had flu like symptoms, fatigue like other series of vaccines (1st and 2nd shots)