chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (swollen arm), hypersensitivity (allergic reaction), pruritus (itchy burn), erythema (red arm) and myalgia (muscle pain) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 016T21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Apr 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 24, 2021, patient experienced myalgia (muscle pain), chills, pyrexia (fever) and injection site pain. On May 1, 2021, patient experienced peripheral swelling (swollen arm), hypersensitivity (allergic reaction) and erythema (red arm). On May 2, 2021, patient experienced pruritus (itchy burn). The patient treated with Tylenol (paracetamol) at an unspecified dose and frequency. On Apr 27, 2021, myalgia (muscle pain), chills and pyrexia (fever) outcome: unknown. At the time of the report, peripheral swelling (swollen arm), hypersensitivity (allergic reaction), pruritus (itchy burn), erythema (red arm) and injection site pain outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication details reported. Reporter did not allow further contact.
I had a sore throat, cough that was odd sounding, a headache and the next day I had a fever. I was very tired. The next morning I completed a home test that was negative. I waited 24 hours and did a 2nd home test. I contacted my doctor at that point and spoke to the nurse and they indicated that they would call me back. Then the pharmacist called back to advise that the doctor called in Benzonatate 200mg  for a cough suppressant and Methyl prednisone which I did not take. I took the cough suppressant for about 4 days and then I no longer needed it. I still have sneezing, a runny nose and low energy. I took over the counter Advil for the headache which it took days for it to go away which was the worst part of my symptoms.
within 5 minutes of having the Ffizer vaccine administered into my Left upper arm I started to feel extremely dizzy and ligththeaded. I also felt as if my vision was blurry. The best way to describe it is if someone took a role of Cerane wrap and tightly wrapped it around my eyes. I had horrible shakes, chills, and rapid heart rate. Extremely weak after the vaccine as well. Symptoms lasted for up to 72 hours. Ongoing Horrible migraines since receiving vaccine with extreme fatigue and nausea.
Patient arrived to the ED on 11/16/2021 with evaluation of shortness of breath.  Patient states for the past 2 days he has had generalized weakness with associated CP, cough, and shortness of breath.  EMS reports patient was hypoxemic with a pulse oximetry of 80% on room air which improved to the low 90s after being placed on oxygen by non-rebreather.  Patient has a history of atrial fibrillation and EMS states patient was in AFib with RVR, rate around 120 during transport.  Patient states for the last 2 days he has had dry cough and also reports generalized anterior pressure-type pain from the chest which is worse with coughing.  Patient denies any leg pain or edema.                         ]
Patient got light-headed, pale with  clammy, cold skin and passed out. EMT's were called.
Vision changed drastically after the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 24Feb2022 12:00 (Lot number: FK9895) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "PVD in right eye" (unspecified if ongoing); "Vitrectomy" (unspecified if ongoing), notes: in the left eye but it receovered very well. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 03Mar2021, when the patient was 48 years old, for COVID-19 Immunization, reaction(s): "Blurred and distorted vision", "Blurred and distorted vision"; BNT162B2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 24Mar2021, when the patient was 48 years old, for COVID-19 Immunization, reaction(s): "Blurred and distorted vision", "Blurred and distorted vision". The following information was reported: VISUAL IMPAIRMENT (disability) with onset 2022, outcome "not recovered", described as "Vision changed drastically after the booster dose". The event "vision changed drastically after the booster dose" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Dec2021) negative, notes: COVID test type: Nasal Swab. Therapeutic measures were not taken as a result of visual impairment. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has seen several ophthalmologists, retina specialists, cornea specialist and they cannot figure out what was wrong. The patient's vision continued deteriorating since last year after the previous COVID-19 vaccinations. The patient dose not relate her vision problem to the vaccines because she was dealing with PVD in right eye. The patient also had a vitrectomy in the left eye, and it recovered very well. She had no issues until right after the COVID-19 vaccines in 2021. She has also been in the emergency room, and they could not figure it out. This year, 2022, her vision changed drastically after the booster dose, that was when she realized that it was related to the vaccine. She did not know where to go to find answers or help. She spoke with the retina specialist, but he seemed not to believe her.  No follow-up attempts are possible. No further information is expected.
Patient states she developed a rash on her chest 02/01/2019 which she describes as "chicken pox looking".
Patient received PREVNAR 13 on 11/05/14 IM, LA. She came to the pharmacy at 11/13/14 with itching and redness. She said that she was swollen and that injection site was sore. MD said hot patches. I recommended cold patches and BENADRYL.
Mother stated pt had fever of 101 around 4 pm on the day he received Hepatitis A vaccine. No redness or swelling at injection site. No rashes. Pt took Tylenol and Motrin as directed by primary MD. Fever subsided by evening.
Narrative: Patient received first dose of COVID-19 vaccine at the facility on 2/23/2021, started to complain of chest pain and throat tightness and a rash on his trunk and sent to facility. Facility gave patient IV methylprednisolone, IV famotidine and IV diphenhydramine and recommended patient go to ED. ED completed repeat EKG and troponin given patients symptoms were improving, ED discharged patient home with a 5 day course of prednisone 60 mg daily and a 7 day course of diphenhydramine 25 mg three times daily.
This event , because so many elderly people have the fillers in their knees should be widely publicized! We have fillers that help so much to be able to walk without pain, but this vaccine has caused me to have extreme pain and burning and not be able to walk without pain for 4 days now. NO ONE has said anything about how this Moderna vaccine would  affect us because of the Hyaronolic Acid injections to our knees. We should have been allowed to get Pfizer!!!! I am so upset about this and extremely disappointed in our government's lack of disclosure.
Patient described pain and tenderness at injection site, spreading to back and then chest throughout several days. Patient is complaining of pain and sensitivity on chest and overall tiredness 6 days post injection.
A Tetanus and Diptheria vaccine was given instead of a Vaxelius.
injection site red and swollen x 1 day, diagnosed with cellulitis at injection site, treated with Sulfatrim x 10 days
pt to ER w/dx of hyperpyrexic react to pertussis vax; sx began around 2000 noc of 22AUG94; pt adm to hosp for observation;
The patient received .3ml of Pediatric Pfizer for 5-<12 year old and should have received the adult 12+ Pfizer.  In addition, the nurses neglected to dilute the vial so he received .3ml of undiluted pediatric vaccine.  The Nurse Manager notified the individual of the error upon discovery 2 hours after administration.  The patient denies an adverse reactions at this time.  The nurse advised to call the health department to report any issues and to seek emergency care if needed.
numbness; back pain; brachial neuritis; neurological issues; This case was reported by a physician via call center representative and described the occurrence of numbness in a elderly female patient who received DTPa (Reduced antigen) (Boostrix) (batch number x2xj7, expiry date 8th August 2021) for prophylaxis.   On 4th November 2020, the patient received the 1st dose of Boostrix. On an unknown date, less than 9 months after receiving Boostrix, the patient experienced numbness, back pain, brachial neuritis and neurological symptom. On an unknown date, the outcome of the numbness, back pain, brachial neuritis and neurological symptom were unknown.   The reporter considered the numbness, back pain, brachial neuritis and neurological symptom to be possibly related to Boostrix.  Additional details provided were as follows: The doctor reported that the patient received first dose of Boostrix and shortly after the patient experienced neurological issues, back pain and numbness. The patient consulted a neurologist and doctor suspected it was from the vaccine and would like to report it.  The neurologist suspect it could be brachial neuritis. Doctor further would like to know about it. Reporter consented to follow-up.
PT states getting the second covid shot yesterday with increasing fever and chest tightness to the middle of the chest without radiation. States shortness of breathe only with "wearing the mask". States shortness of breath is better when it is off
No adverse event reported. Patient mistakenly received Pfizer bivalent for patients 12+, and not the product specific for patients 5-11.
4/19/21 patient states she began menstruating (which was a week past due from her normal expected start date of 4/12/21).  On 4/26/21 patient contacted her physician with concerns because the bleeding had not stopped.  Autoimmune flare-up started 4/27/21 and patient began medicine for her flare-up on 4/29/21.  The following week, 5/3/21, patient wen to family doctor regarding the autoimmune flare-up and concerns about the continued bleeding.  MD advised patient to contact OB/GYN about the continued bleeding and to continue on her Dapsone until flare-up had resolved. Also MD advised patient to cancel her second appt for the vaccine and to postpone until a week or two after the completion of Dapsone.  5/7/21 patient spoke to GYN office and nurse advised patient to watch the bleeding until another cycle was supposed to start and finish and to see if the bleeding would resolve on its own given another cycle was supposed to start and finish (expected cycle start date 5/19/21).  Patient kept bleeding and called md back and notified that not only did the bleeding NOT stop, the flow had increased to an alarming rate and amount.  6/1/21 spoke to office again and nurse advised patient to pick up an rx for progesterone to assist in stopping the bleeding.  Patient started the rx on 6/7/21. The patient had increased blood flow and started passing clots and went in for an exam.  MD changed drug and increased dosing.
Got flu vaccine on 10/18. later that evening, site was red w/a knot. Next morning, not as red but bruised at injection site ~ 3 inches in diameter w/hard not, had rash on face. Saw neurologist for apt 10/23 & he advised reporting reaction. As of today, 10/25, rash on face is gone, knot decreasing in size, no pain but bruise still ~ 3 inches in diameter.
84 patients involved Moderna Bivalent Booster was given to 84 patients on 1/11/23. The vaccine vials were in the refridgerator for 41 days, 11 days longer than it was supposed to be. Moderna was contacted and the site filled out the temperature excursion tool assessment. Modernas response was the vials affected maintained activity necessary to protect againt SARs-Vov2-COVID19 virus. But ultimately would be up to the provider that the patients are under. They also recommended we report to VAERS.  After the incident was identified, patients were notfied of the incident on 1/18/23. Interventions are in place for vaccine storage and handleing education. Please see below for more Site: Facility withheld 84 patients involved Moderna Bivalent Booster was given to 84 patients on 1/11/23.  The vaccine vials were in the refridgerator for 41 days, 11 days longer than it was supposed to be.  Vials were placed in fridge from freezer on 12/1/22. Adminsistered 1/11/23.  Moderna was contacted and the site filled out the temperature excursion tool assessment. Modernas response was the vials affected maintained activity necessary to protect againt SARs-Vov2-COVID19 virus. But ultimately would be up to the provider that the patients are under. They also recommended we report to VAERS.  Our provider agreed and decided no additonal booster was needed. After the incident was identified, patients were notfied of the incident on 1/18/23. Interventions are in place for vaccine storage and handleing education.
Patient was given the 12+ dose (30mcg/0.3ml) dose of Pfizer 01/04/2022 at 12:30pm.  He is currently only 11 years old and does not turn 12 until 02/01/2022. Mother was notifed at 7pm 1/04/22 when discovered. No known current adverse events
Case number PHEH2014US004484 is an initial spontaneous report from the consumer received on 28 FEB 2014. This report refers to a 12-year-old male patient who was accidentally vaccinated with FLUCELVAX (batch number: not reported) at a dose of 0.5 ml intramuscularly on 15 AUG 2013. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration). Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 28 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indications as "adult product administered to child".
This case was reported by a pharmacist and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with Engerix-B for prophylaxis. On unspecified dates, the subject received the 1st, 2nd, and 3rd dose of Engerix-B (unknown). At an unspecified time after vaccination with Engerix-B, the subject did not respond to therapy.
On 3/27/21 this patient came to a COVID Vaccine clinic at our health center at that  time the person may have received a dose of Pfizer vaccine diluted with Sterile Water rather than the  saline solutuon diluent from the manufacturer. Our office was shipped 26 vials of vaccine and 25 vails or  diluent as the State DOH reported there was a diluent shortage at the time. Under the direction of  the stage DOH the sterile water solution was used. Later we were contacted to report this to both the  patients and VAERS by the state DOH, as they later questioned their original desecion.   The were 30 to 36 doses with this solution and this person is 1 of 72 others who may have had a  dose of this mix
lesion on my 3rd nerve; a brain lesion on the base left side of my brain; my right arm and hand are all numb for the last year and a half; The initial case was missing the following minimum criteria: This case has been considered invalid as - Unspecified product. Upon receipt of follow-up information on (28Sep2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IIIRD NERVE INJURY (medically significant), outcome "unknown", described as "lesion on my 3rd nerve"; CENTRAL NERVOUS SYSTEM LESION (non-serious), outcome "recovered with sequelae", described as "a brain lesion on the base left side of my brain"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "my right arm and hand are all numb for the last year and a half".  Additional information: Initially on 04Sep2021, patient stated Pfizer shot gave me a lesion on my 3rd nerve. I'm incapacitated now for over 4 months. Upon FU on 28Sep2022, patient stated I had an immune reaction to the first series of the covid-19 shot. I was diagnosed with a brain lesion on the base left side of my brain. The lesion is gone but where the lesion was a 1 cm hole remains. This controls my motor skills my vision my sense of awareness my mouth and taste. my right arm and hand are all numb for the last year and a half. I've seen five neurologists and they all say it's an immune reaction. Presently seeing a neurologist at (withheld) in (city withheld) who agrees.  Follow-up attempts completed. No further information expected.  Follow-up (28Sep2022): This is a spontaneous follow-up report received from the contactable consumer.  Updated information included: Reporter information (Alternate phone number in slider#1 added and address updated). Patient details (address updated). Event (a brain lesion on the base left side of my brain and my right arm and hand are all numb for the last year and a half added).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swollen arm, arm has red rash spreading around arm more each day, warm to touch, patient hasn't felt well since injection.
3x3 cm erythema, puffiness, pain at injection site beginning on 2/11. Rx'd AUGMENTIN 875/125 BID x 5 days.
Limpness, vacant stare for 5 min; Temp 102-103F;
This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Apr 16, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. After she received the first dose of the Pfizer COVID-19 vaccine, the next Tuesday she started having muscle and joint pain. After 2 weeks, she has had joint pain ever since. The pain is not going away. She would like to know when will it end. The outcome of the events: unknown. No follow-up attempts needed. Information about batch/lot number cannot be obtained.
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Subsequently, the patient developed shingles.  The reporter also mentioned another patient who developed shingles post vaccination with varicella virus vaccine live (Oka/Merck). Additional information has been requested.
Swelling of right side lymph node and throat, difficulty swallowing, burning while breathing. Steroid injection, antibiotics, penicillin injection.
Pt called to complain of sore arm and asked what to do to help relieve pain.
25% sick1 day after 1st dose.  In June and July 2021  I was very fatigued most afternoons. I was getting plenty of sleep. I fell asleep driving at least once. Almost fell asleep from driving home from work other days. I would nap at least 2 days a week.I normally only nap unless I'm behind on sleep and/or sick.
Expired vaccine given. No treatment. no need for revaccination. As per call to Merck these are supported through 6 months after date of expiration. Potency remains unchanged
Extreme tiredness Headache Chilly then extreme chills By 6:00pm Fever spiked to 102.1 Vomiting  & Diarrhea Convulsions Trouble breathing Called ambulance and taken to ER Sent home 4 hours later after being on IV. Next morning, huge welts were coming and going across my back, arms, legs. Went to see my regular doctor, who prescribed steriods for 4 days.  Only took steroids for2 days.  Felt extremely tired for the following week.
Itchiness; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and RASH (Rash) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PRURITUS (Itchiness) and RASH (Rash). At the time of the report, PRURITUS (Itchiness) and RASH (Rash) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
The pt received DTaP #2 on 04/24/2002 in left leg. HIB and IPV were given in right leg. The pt presents with marked swelling on left thigh with mild warmth, no erythema, no signs of infection. Has full range of motion of knees, hips and ankles without pain. Mom states pt would not walk or bear weight last night but now walks and bears weight without limp or evidence of pain.
recv vax from MD states pt had t102.2;has macular papular raised rash over most of body;MD states put on DPH & does recommend pt to recv vax as scheduled
Patient received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. The reporter mentioned that there was incident because of miscommunication that the expirations date had been extended. The patient received expired dose and it was patient's second booster dose of Moderna COVID-19 Vaccine.  No treatment information was provided.
side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-398481 (Patient Link).
Constitutional symptoms on evening of vaccine. Then with development of rash on chest and forearms the following day.
Patient said that approximately 5 hours after receiving the PNEUMOVAX vaccination she experienced pain & swelling in her upper arm / shoulder area. She applied heat, iced it, & took an unknown pain reliever.