chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 28th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th July 2018, 1 days after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), eye pain, eye pruritus, ear pruritus, multiple allergies, ear pain and shingles. On 3rd August 2018, the patient experienced eye swelling and rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and ophthalmologicals (Eye Drop). On an unknown date, the outcome of the ophthalmic herpes zoster, eye swelling, rash, eye pain, eye pruritus and shingles were not recovered/not resolved and the outcome of the ear pruritus and ear pain were recovered/resolved and the outcome of the multiple allergies was unknown. It was unknown if the reporter considered the ophthalmic herpes zoster, eye swelling, rash, eye pain, eye pruritus, ear pruritus, multiple allergies, ear pain and shingles to be related to SHINGRIX. Additional details were provided as follows: At approximately 11:00 am, the patient received the Shingles vaccine a week ago in the left arm. The following day the patient experienced pain and itching in his eye and ear and his symptoms were similar to allergies. The patient's ear symptoms had resolved but he had the classic face shingles including a rash on his forehead and his right eye was swollen shut. Six days after receiving vaccination, the patient's eye started to swell and had gotten worse. The patient received Valacyclovir and eye drops which he started yesterday. The patient was officially diagnosed with shingles at an urgent care a day before reporting date but his symptoms started the day after the vaccination.
Pt reports hard knot day after vaccine at injection site that resolved and then several days later noticed redness, hard knot and itching in the left arm that is at injection site and then moves down arm toward elbow.  No fever or chills associated with s/s.  Pt was evaluated and note placed in pt chart by MD.
2nd dose less than 4 weeks apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 3rd February 2022, the patient received the 2nd dose of Shingrix. On 3rd February 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date:17-May-2022 Reporter's comments: The patient received 2nd dose of Shingrix less than 4 weeks apart. The recommendation of schedule for Shingrix was to take the 2nd dose 2 to 6 months apart The pharmacist did not have more information about patient and vaccine at the moment of the conversation. The consent to follow up was given. Additional Supportive Information: The patient received 2nd dose of Shingrix earlier than recommended time frame, which led to shortening of interval between vaccine doses.
Muscle aches on the (L) upper arm; redness & tenderness & itchiness on skin around the injection site with skin elevation around the site. No full ROM on (L) arm without pain.
Pt received 0.5 ml flu vaccine at center. 3 hours later pt developed flushing, SOB, and increased heart rate. The pt returned to center and was immediately sent over to hospital to be admitted.
This spontaneous report as received from a registered nurse via company representative refers to a 8 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 19-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Patient returned to the pharmacy on 9/16/2016 and showed me her arm. Her arm was swollen, red, and warm to the touch. I advised her to go see her doctor and she then returned later on in the day with a prescription for an antibiotic.
PATIENT HAD A REACTION SITE REACTION, RED AND WARM. DOCTOR IS TREATING WITH ANTIBIOTIC FOR PREVENTATIVE MEASURE.
About 2 weeks post vaccine, I had a rheumatoid arthritis flare up in my left hand.  Monday, 11/15/2021, I had another flare up on my left shoulder- I can't move my arm. I can't move my fingers. I treated it myself with a lot of ice packs and Aleve.  I had not experienced the rheumatoid arthritis flare ups with the other 2 doses of Moderna.  I called my doctor, on 10/19/2021, and she prescribed Prednisone.
Information has been received from a pharmacist referring to a 55 years old female patient with hypercholesterolaemia and osteoporosis. The patient had a medical history of "eye infection". The patient had none known allergies. Concomitant therapy included pravastatin. On 25-SEP-2016, the patient was vaccinated with ZOSTAVAX (strength, dose and frequency were unknown, lot # L046893, expiration date 23-FEB-2017) subcutaneously. Subsequently on an unknown date in September 2016, the patient received treatment with PROLIA for an unspecified diagnosis. No further information provided. The causal relationship between the adverse event and ZOSTAVAX was unknown. Additional information has been requested.
Within a couple of minutes of receiving the injection my throat started to swell. It got worse for the next 20 minutes and then stopped getting worse. When I got home and looked in my throat it was all swollen and looked like I had developed a round tissue looking white abscess.  I took Benedryly through the night. My asthma began to flare up to an unusual extent. I  had to take my stronger inhaler which is Dulera for several days. I went to my internist the day after the vaccination and she looked at my throat and said it was all swollen tissue related to the vaccine,  She told me to continue with the inhaler.  Today is 2/6/2021 and my throat feels normal and the abscess thing is getting smaller daily but is still visible.  My asthma symptoms have subsided. I have since had a consult with the physician and he advised that I should not take the 2nd dose.
This spontaneous report as received from a pharmacist refers to a child (under 2 years old) patient of unknown age and gender. No medical history and concurrent conditions reported. On an unknown date the child patient was vaccinated with PNEUMOVAX 23 by mistake (dose, route, lot#, expire date not reported). The pharmacist queried whether administration of PREVNAR 13 was safe instead. Additional information has been requested.
left hand is twitching; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (left hand is twitching) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (left hand is twitching). At the time of the report, MUSCLE TWITCHING (left hand is twitching) outcome was unknown.            No concomitant medication was reported. Treatment Information was not provided by the reporter. It was reported that the patient received the second dose yesterday.  No treatment medication was reported .
I suffered a stroke due to formation of a blood clot in a major artery leading to my brain. It is unknown as to whether this event correlates to the vaccines especially because the date of vaccination and the date of this event are separated by approx. 8 mos. I am reporting this as a precaution in the vent other adverse events similarly occurred in other people. It should be noted that all available heart tests have been performed with negative results thus the cause of this clot is unknown.
Experiencing frequent chest pains describing it as 'headache for heart'; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 9 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Experiencing frequent chest pains describing it as 'headache for heart'".  Additional Information: Experiencing frequent chest pains describing it as 'headache for heart' Occurring throughout the day when sitting or laying down.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt received PREVNAR at Public Health on 9-8-17, within a week had severe back and leg pain with leg swelling and difficulty walking. Was seen in ER, on 9-15-17, had ct scan unremarkable and u/a unremarkable, and sent home with rest and antiinflammatories.  Pt still feels pain and fatigue.
This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a male patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine quadrivalent unspecified season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist said that the consumer's spouse had filled out a form at the pharmacy that her husband had had a long time ago a previous allergic reaction to a flu shot. No further specific details were provided to the pharmacist regarding product or type of allergic reaction. The consumer had no record of the referenced vaccination at her pharmacy, and she did not know the manufacturer of the product referenced. The call was transferred to the GSK medical information team regarding the reporter's current inquiry of whether or not there would be any issue in terms of the ingredients of SHINGRIX in administering SHINGRIX to a consumer with a history of allergy reaction to a flu vaccine. The pharmacist gave permission for follow up contact for. No further details were known, so there would be no further detail beyond this information.
Pain (left shoulder/left arm) and bruising (left arm) for first 3 days after vaccine. Nine days after vaccine could see bruise healing and no pain at that time.
quarter sized blister on right thigh; her leg started itching; It is not red, but kind of stings; burning just caught her attention; This is the spontaneous report from a contactable other health care professional (Nurse), reporting for herself. A 75-years-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch no: not reported, Lot Number: EL9269; expiration date: unknown) via an unknown route of administration, administered in left arm on 25Feb2021 (at the age of 75-years-old) as dose 2, single for covid-19 immunization. Patient medical history included Kidney stones, below normal kidney function and thyroid disease and concomitant medications were not reported. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch no: not reported /Lot Number: EL9269, expiration date: unknown) administered via unknown route on 04Feb2021 as dose 1, single for COVID-19 immunization. Patient stated that she had the second COVID vaccine on 25Feb2021 and on 26Feb2021, patient experienced quarter sized blister on her right thigh, when she woke up in morning. It was not red, but kind of stings. With the second COVID Vaccine there really was no problem and had no pain after the injection. But her leg started itching and noticed the big size blister. Seriousness was reported as not life threatening but the burning just caught her attention. Patient was asking could that be a reaction from the COVID Vaccine. Investigation Assessment was reported as No. Treatment included with cleaned out the blister and applied Neosporin. The outcome of the events is unknown.  No follow-up attempts are possible. No further information is expected.
Shortness of breath, he didn't want to say anything but now he's worried about getting the 2nd shot.  He does get out of breath easy because he use to smoke, but this is getting worse.
11/6/2021 Later that evening I had a fever. My blurred vision from my previous vaccination became worse. I felt really sick. Ever since then, I have seen my PCP and a Neurologist because of the blurred vision, light headedness, dizziness, light sensitivity, numbness, tingling around my mouth, off balance and shortness of breath with activity. All symptoms get worse with heat and when I get up and move around. The blurred vision gets so bad that I cannot drive. At the end of November, I fell and broke my ankle. Bloodwork, EEG, MRI were all normal. I see a Cardiologist at the end of this month. I still have not recovered.
Information has been received from a physician concerning a male patient, who on 03-MAY-2010, was vaccinated in the right upper arm with a dose of PNEUMOVAX 23 (dose, route and lot number not provided). On 04-MAY-2010, "1 day after receiving PNEUMOVAX 23, the patient developed "mild inflammation" at the injection site. Additionally, there was a 3 cms X 1 cm red, raised area, 2 cm distal to the injection site. The patient also noticed discomfort in the right chest area, which the physician had diagnosed as myalgia. A electrocardiogram (EKG) and an X-ray was performed and the results were normal. At the time of reporting, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
My hand on which I had the shot is numb kind of my hand is kind of shaky; My hand on which I had the shot is numb kind of my hand is kind of shaky; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 (Lot number: EW0162) 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: TREMOR (non-serious), HYPOAESTHESIA (non-serious) all with onset 21Apr2021, outcome "unknown" and all described as "My hand on which I had the shot is numb kind of my hand is kind of shaky".  No follow-up attempts are possible. No further information is expected.
I had my vaccination on 02/25/2021. A few hours later on 02/25/2021 I started to experience fever, fatigue and chills. This lasted about 24 hours. I did take TYLENOL to remedy the symptoms.
Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 08-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were provided   This case was linked to MOD21-115609  (Patient Link).
Pt. in office on 11/9, received flu vaccine.  We then realized pt. already received flu vaccine on 10/19/07.  There were no adverse reactions per mom.
Shortly after receiving vaccine, patient complained of being light headed and not feeling well.  After a few minutes, patient decided to sit on floor where he started to say that his arms were locked up and chest tight.  Patient continued to talk to pharmacist.  EMS was notified and pharmacist stayed with patient.  Once EMT were on the scene, the EMTS started interview the patient more and patient allowed vitals to be taken (where as the patient was hesitate with rph doing BP).  During interview, it was discussed the patient in the past has had panic attack.  However, not this severe of locked arms /seized muscles.  EMTs eventually let patient leave on his own accord
POSSIBLE INFECTION DUE TO LOW IMMUNITY; CAUGHT ANOTHER VIRUS; CONSTIPATION; FELT VERY BAD; NAUSEA; This spontaneous report received from a parent concerned a 22 year old male. The patient's height, and weight were not reported. The patient's past medical history included pneumonia, and other pre-existing medical conditions included no known drug allergies and was not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and expiry: Unknown) dose was not reported, 1 total administered on 10-APR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the patient felt very bad, had some constipation followed by nausea and it continued until 12-APR-2021. On 13-APR-2021, the patient felt better, then On 15-APR-2021, the patient got admitted to the hospital for possible infection due to low immunity and caught another virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from constipation, felt very bad, and nausea on 13-APR-2021, and the outcome of possible infection due to low immunity, caught another virus was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210431111-Covid-19 vaccine ad26.cov2.s-Possible infection due to low immunity and caught another virus. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
As soon as got flu shot about 10 min later had tachycardia, flushing and tactile fever. Subjective SOB,  lump in throat, and hives on neck and face. Confusion. Lasted until the next day. Took Benadryl. Around midnight symptoms returned. Was scheduled to work Saturday, but was unable to do it. Symptoms were resolved by Sunday. Rash alsoresolved. Now 100% better.
Pediatric Pfizer vaccine was left out at room temperature for more than 36 hours / temperature excursion happened the previous day. However, vaccine was placed back in the fridge by accident and the following day a second pharmacist gave a dose of the vaccine to the patient not knowing that the vaccine might have been spoiled previously. Patient was not harmed however a less effective vaccine was given to patient. Market director contacted the parents for revaccination and to re-assure the no harm is done for the child who received the vaccine.
Shingles outbreak on bottom of left shoulder blade.  Painful stinging 8 - 10 lesions.
rt hand wrist drop-polyneuropathy cont for 2 or 3mo then rt foot drop, numbness in both feet & both hands;dx chronic demyelinating polyneuropathy;numerous severe migraine h/a; per follow-up info extreme exhaustion and fatigue, weakness, atrophy, and memory loss.
patient said "I'm supposed to tell you that I might pass out after a shot." I asked him some questions about when this typically occurs. He states that he has about 30 seconds to know if he is going to pass out. His wife who was right beside the patient said he also he skin turns color as well. I gave him his vaccination. I had him sit in chair to see how he was feeling. He said he was feeling fine. I had him sit about five feet from me in supportive, armed chair. I was preparing to vaccinate his wife. We looked over and his face started turning pale and green. His wife and I immediately went to both his sides to support him and lower his head to his lap. He became conscious about 5-10 seconds later. This all occurred within 3 minutes of the administration of the shot. I gave him a drink. I continued to observe him for 15 minutes until he left. He was alert and fine when leaving the store. I called the patient's home on April 25, 2021. Patient was at work. I spoke with his wife who said he was feeling fine. I recommended he check in with his doctor regarding second shot.
10 minutes after vaccine pt developed sob, tachycardia, vomiting - taken to ED
pt recv vax 7JUL97 & the next day pt exp a large local rxn described as red, swollen, warm & raised;
I have a big lump at the injection spot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (Vaccination site lump) 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.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Vaccination site lump). At the time of the report, VACCINATION SITE MASS (Vaccination site lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided   Reporter did not allow further contact
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA
Several hours, post vax, pt felt tired and soreness at injection site. She became progressively more tired that evening. Awoke the next morning with soreness at the injection site and aching in arms and legs. Temperature was 101F. She self-administered Tylenol and fever subsided. The following day, she felt weak and tired, but was alright on the 3rd day.
10 minutes after vaccine I got a warm rush up left neck to left side of head with and instant severe headache which I would rate 9/10, dizziness, nausea and felt like I was about to pass out. After about 10 minutes the headache and dizziness eased but headache remained at 6/10. 40minutes after vaccine the nausea returned much worse, my ears felt full & tongue felt weird. Took 2 Benadryl, slept 12hours. Next morning: I still have headache which migraine medicine not Aleves are helping. My tongue still feels weird, my lips and nose feel numb.