chrisvoncsefalvay/vaers-outcomes huggingface dataset:
13 YO got Twinrix administered to a pediatric patient; 13 YO got Twinrix administered to a pediatric patient; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 13-year-old male patient who received HAB (Twinrix adult) (batch number 2KE55, expiry date 22nd September 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th November 2022, the patient received Twinrix adult and Twinrix Pre-Filled Syringe Device. On 7th November 2022, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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: 8-Nov-2022 Reporter's comment: The pharmacist called to reported that an adult dose of Twinrix had been administered to a pediatric patient, given at the same site and by a different pharmacist than the one giving the report. The vaccine administration facility was the same as primary reporter. The call was escalated to second line. The reporter consented to follow-up. Additional supportive information: An adult dose of Twinrix had been administered to a pediatric patient, which led to overdose and adult product administered to child.
Day 1-- felt normal reactions--aches/fatigue/arm pain/lymph pain. Worked from home Day2--felt better but still fatigued/arm pain/lymph pain/GI issues, no fever but continued sweats--left work at lunch and slept through the afternoon Day3--not feeling back to 100%. Arm pain/lymph pain and slightly fatigued/tired, but not sleeping through the night
Nausea, sweating,sick to my stomach, sick for about 4 hours and started to feel better after laying down
2 and a half days after receiving the first shot of the Moderna Covid vaccine I developed strong flu-like symptoms including low fever, chills, fatigue, muscle and joint aches, and headache. I vomited once, and this was followed by diarrhea. which I am still experiencing 3 days later. The other symptoms were gone or much less after the first day, except for fatigue.
administration of improperly stored vaccines; This spontaneous report was received from a medical assistant, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 31-AUG-2020, the patient was vaccinated with improperly stored VARIVAX injection (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T002848, expiration date 23-JAN-2022) as prophylaxis (product storage error). No further adverse event information provided.  The vaccine underwent a temperature excursion between 6 degrees Fahrenheit (F) to 14F (10.56F) for 50 minutes. There was a previous temperature excursion between 6F to 14F (8.47F) for 30 minutes, as recorded by a data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000777: US-009507513-2009USA000747: US-009507513-2009USA000676: US-009507513-2009USA000699: US-009507513-2009USA000749:
LEFT ARM  LUMP REDDISH SKIN ERUPTION VERY ITCHY AND STING SENSATION.TODAY IS JANUARY 15,2021, AND THE AREA LOOKS BETTER AFTER USING HYDROCHORTIZONE OINTMENT PLACING COLD PADS AND DRINKING ONLY ONE DOSE OF ALEVE. NO FEVER OR CHILLS PRESENT AT ANY MOMENT , NIETHER PAIN.
After vaccination with varicella and hep A, site immediately developed sneezing, nasal congestion, eye redness and swelling and hives.
My arm was sore for only a day after receiving the vaccine. But then the area on my arm near the injection site started to itch, and a small mosquito bite-like hive was forming.  Today, 4/14, the hive has grown to about a 2 inch x 1 inch oval. It is slightly raised, slightly red in color,  warm to the touch and occasionally itchy.   I have not attempted to treat it in any way as it is not much of a nuisance however I still wanted to report.
Lightheadedness, nausea, vomiting, sweats, and chills.
Initial and follow-up information has been received from a female pharmacist, also the pt, "in her 50s" who "in October or November 2004" was vaccinated with a dose of Pneumovax 23 (lot # unknown). Subsequently, the pt developed "swelling and pain at the injection site which subsided without treatment." The pt sought unspecified medical attention. The pt recovered on an unspecified date. There was no product quality complaint involved. Follow-up information from the pharmacist indicated that there was "no problem". Additional information is not expected.
This initial spontaneous report was received from a healthcare professional referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on multiple unspecified dates, the patients were administered improperly stored doses of M-M-R II injection (lot # K004949 with expiration date 04-APR-2016, albumin status rHA and lot # K016153 with expiration date 24-SEP-2016 albumin status rHA; dose and route were not reported). No adverse effects were reported. IT was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax & devel a fever of 103-105 100 days p/vax; No further details were provided; MD reported 15 similar pts;
I experienced a auto immune response to a allergy in the vaccination with fever, swollen lymph nodes, inflammatory acne and tinnitus
Chronic Cluster/ Migraine headaches everyday; Chronic Cluster/ Migraine headaches everyday; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Dec2020 13:00 (Lot number: EK9231) at the age of 29 years as dose 1, single, intramuscular, administered in arm right, administration date 20Jan2021 14:00 (Lot number: EL3246) as dose 2, signgle and intramuscular, administered in leg left, administration date 13Feb2022 10:30 (Lot number: FK9896) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: CT Contrast" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: EMGALITY [GALCANEZUMAB]; PREDNISONE; NORLYDA. The following information was reported: MIGRAINE (non-serious), CLUSTER HEADACHE (non-serious), outcome "not recovered" and all described as "Chronic Cluster/ Migraine headaches everyday". The event "chronic cluster/ migraine headaches everyday" and "chronic cluster/ migraine headaches everyday" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, cluster headache.  Additional Information: It was reported that that patient had Chronic Cluster/ Migraine headaches every day. 5-8 Times a Day for the past year. Headaches continue to get worse after getting Vaccinated. Started after my first vaccine. With slight headaches as time went by the headaches progressed with intensity. But after every Vaccine Dose the pain is simply unbearable. Medications and Botox are taken as treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient was tested for COVID-19. Prior the vaccination, the patient was not  tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
screaming inconsolably for 24hr;2hr of sleep in 36hr;dehydration;
Pt had chicken pox vaccine 7/6/00. On 12/5/05 she presented with every mild scattered vesicular rash partially immune chicken pox. The problem is that about 20 children in this community all vaccinated for chicken pox have had this and because it is not do to social have exposed several non immune persons. We wanted you to be aware of this. Pt herself is fine.
Pt. received (1) Tdap in (L) arm then MENACTRA and VZV Rt arm. Then immediately had projectile vomiting. Pt. then fainted and vomited again while unconscious. Pt. then woke up and started crying stating "what happened to me"? V/S stable and remained in office x 30 min. No tx. given.
This case was reported by a nurse via sales rep and described the occurrence of shingles in a 68-year-old female patient who received Shingrix for prophylaxis. In August 2018, the patient received the 1st dose of Shingrix. In August 2018, 1 day after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to Shingrix. Additional details were reported as follows: A day after given dose of Shingrix, the patient broke out in rash on left hand and foot and then it proceeded to abdomen and was considered as suspected shingles. The office called CDC to advise whether or not to give patient 2nd dose. It was left clinically up to provider. The patient had not received 2nd dose till the time of reporting. The GlaxoSmithKline MI number was given to the reporter. The reporter agreed to be follow up from GlaxoSmithKline.
That next day, I had a sore throat. The day after that, I was tired and had body ache. In the end of August, I got COVID-19. I was tired, fever, and congestive. I had a running nose. I had sinus pressure. On Saturday, I lost my taste and smell.  I had a headache. I felt horrible. On Sunday, I got tested for COVID-19, positive result. I also have another test and PCR test, positive result. On Monday, I had not fever. But I was very congestive and fatigue. I had no energy. On the 25th, I got the antibiotic shot. On the 26th, I wake up that day and felt a little better. On Sunday 29th, I went and got another PCR test, came back negative.
This pt reportedly experienced cellulitis around the injection site and was hospitalized. Onset occurred 2 days post vax.  Follow up 10/28/2002: "It was reported that the patient's recovery status is unknown.  "I forwarded information to (physician's) office they also filed a VAERS."  From additional correspondence received on 12/03/2001, no further information is available regarding this patient or this case.  This case is closed.  08/26/2002: During internal review of all files, it was deemed necessary to amend the report by updating the narrative from a 57-year-old female to the correct age of 55-year-old female.  Also, this case was upgraded to a 15-Day Alert Report due to unlabeled events."
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-FEB-2014, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-MAR-2015, he was treated at the same clinic for a severe vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for management of his painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received first dose from a vial that was punctured on 3MAY2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.  No Medical History information was reported. On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received first dose from a vial that was punctured on 3MAY2021). On 06-May-2021, EXPIRED PRODUCT ADMINISTERED (patient received first dose from a vial that was punctured on 3MAY2021) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to US-MODERNATX, INC.-MOD-2021-109454 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information  received on  13 May 2021 contains information regarding  they miss reported this as a Moderna Vaccine administration but it was actually J&J.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-109454:
This spontaneous report as received from a physician refers to an 11 year old female patient. On an unknown date, the patient was vaccinated with a second 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly. The physician reported that the patient had not a menstrual period for the past 3 months after receiving GARDASIL. The outcome of had not a menstrual period for the past 3 months was reported as not recovered/not resolved. Additional information has been requested.
FELT TIRED; This spontaneous report received from a 70 year old male patient. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number: 1808609, expiry: 04-FEB-2022) dose was not reported, administered 1 in total to the left arm on 17-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 70 years old. On 18-MAR-2021, the patient felt tired after vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 182281 expiry: UNKNOWN) dose was not reported, administered 1 in total to the left arm on 28-OCT-2021 for covid-19 prophylaxis. Age at time of vaccination 70 years old. No concomitant medications were reported.  On 29-OCT-2021, the patient felt tired following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 2). Patient said he had to drive 60 to 65 miles to get both the vaccine, and it could have been as a result of driving, as patient was 71 years old. Patient did not contact his physician after the shots. Patient did talk to his physician a few weeks ago about getting another booster, and his physician told him he was approved to receive another Janssen Covid-19 booster, and he thinks the CDC (Centers for Disease Control) guidelines says he can get it because he would otherwise not receive another booster since Patient wants the Janssen 2nd booster. Patient also reported that he was not in the age range of 65 to 68 for thrombosis issues, and was not concerned about another booster. Patient also mentioned that he was not in the category for blood clots as that was for ages under 60. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt tired was not reported. This report was non-serious. This case, involving the same patient is linked to 20220744486.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age. From 07-OCT-2013 to 16-DEC-2013, the unspecified number of patients might have vaccinated with doses of GARDASIL (lot number unspecified) (dose, route unspecified) that were exposed to temperature outside of the prescribed information which were not supported. No adverse effects were reported. It was unknown if the patient had sought medical attention. This is one of several reports received from same source. Additional information has been requested.
Sore arm at injection site, Headache, Body Aches, Fatigue, Joint Pain, increased heart rate, etc. Ovarian/Menstruation issues starting approximately a week after injection = irregular and increased bleeding, cramping, previously regular menstruation cycles are now shorter/more frequent with increased and irregular bleeding and cramping. Also developed a parauterine cyst/abnormality that required 3 visits to a urologist including extensive exam/procedure.
Site of injection was very sore, red, warm to the touch and knot just below skin.
After my usual reaction to shot (swelling, redness, tenderness at inj site and fatigue, fever,chills) lasing 3 days, I woke up 6/18 with my left axilla filled with large, soft lymph nodes filling the entire axilla.  I was worried about plague( there are prairie dogs around communal pond but neither me nor my cats have had direct contact, no nodes on cats) but the nodes filled only left axilla- I had small hard nodes in other places (R axilla and groin due to gardening).  NP at Urgent care felt the lymph node enlargement was due to the vax and found no cellulitis at inj site.  Since that time I have not had fever, or other such nodes appear- the nodes have diminished over time(not reddened ever) and are pretty much resolved today
After receiving vaccine, patient fainted.  She recovered after about 10 seconds and immediately became sick to her stomach, shaky, and clammy.
Pt reports that 23 hrs after receiving the vaccine he experienced " a massive seizure"  and was transported by paramedic to the Hospital. A neurologist he saw mentioned that he had seen "other seizures like this ' and they presumed he meant after COVID vaccines
Patient was at Dr. office for something else and had PA look at arm where PNEUMOVAX 23 was administered. It was red, hot, and swollen. Approx 6 inch by 5 inch on deltoid.
Employee began to feel poorly at 4AM on Wednesday morning. Symptoms included headache, fatigue, stuffy nose and head. Throat slightly red, afebrile. She took FluMist on Tuesday afternoon. She is talking Tylenol for headache. She has not seen a doctor.
This spontaneous report was received from a certified medical assistant regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (dose and route were not reported, lot # K015970 with expiration date 23-SEP-2016 or lot # K021847 with expiration date 13-JAN-2017) which were exposed to temperatures outside of the recommended range. There was no adverse event reported. Additional information has been requested.
1/20 developed 3 itchy papules 48 hrs. after vaccine. 4th papule and fever - 101 degrees - 72 hrs. after vaccine. All resolved by 1/26.
shot in arm 3:30pm withing 20 min severe pain started. tried ice hea Pain 10 out of 10. Husband had a Percoset I took it or I would have gone to Emergency room. inable to move arm at all severe pain slept in my bra and clothes with a sleeping pill Next day pain was not as severe but could not raise or use my "L" Arm At All. Took picture of BandAid on upper arm because I though it looked way too high. It appeared to be on my shoulder. I used Ibuprofen for pain called orthopedic Dr on Monday and I started shoulder pulley (my husband had from a shoulder Replacement used that pulley to try to get the ABility to RAise my ARM. Saw ortho DR on 3/31. He did AN XRAY SAid it WAs Acute BURSitis from the injection. Told to continue stretching And come back if I wanted a steroid? injection. My shoulder still has pain 1 or 2 out of 10. Not getting any injection near there.
Was taken to Emergency Room because unable to void. Catheterized for 400ml of urine.
he did get Covid about a year ago; he did get Covid about a year ago; This is a spontaneous report received from a non-contactable consumer from medical information team. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "he did get Covid about a year ago". The patient has had two primary doses of the Pfizer Covid 19 vaccine and 2 booster doses. The last booster dose was around 6 months ago. He relays that he did get Covid about a year ago. Reports no problems with the vaccines. He would like to know if he should get another booster dose?   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Minor arrived from facility with 2 covid vaccines. Name of vaccine is Sinophram and his 1st dose was on 11/22/2021 and the 2nd dose was on 12/22/2021. Minor was administered 1st dose of Pfizer vaccine on 1/25/2022 on his first medical appointment. Minor did not have any fever, or cough, nor runny nose  , nor other symptoms.
Narrative:  50 year old male with no known medical history reported having dizziness (2/10) after the first dose of COVID19 PFIZER vaccine during the 15 minutes observation period. BP 145/97, HR 86, 02 97%, temp 98.2, denies pain and shortness of breath. Patient was given water to drink and monitored for thirty minutes. Re-take BP 133/85, HR 87. Upon release, patient reported 1/10 dizziness and was ambulatory. Vaccine administered without complications. The patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy.
Initially irritability and soreness, then vomiting and high fever.  High fever and vomiting continue.  Difficulty sleeping.
Pediatric dose given to adult patient; Pediatric dose given to adult patient; This case was reported by a pharmacist and described the occurrence of adult use of a child product in a 23-year-old male patient who received HBV (Engerix B) (batch number p7294, expiry date 3rd January 2022) for prophylaxis.   On 6th October 2021, the patient received the 1st dose of Engerix B 10 mcg. On 6th October 2021, unknown after receiving Engerix B, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   Additional details were reported as follows: This case was reported by the pharmacist. The pharmacist reported that engerix-b was given to a patient, which led to adult use of a child product and underdose. The pharmacist consented to follow-up.
Within 10 minutes, itching at the site.  Itching spread to arm and trunk, then noted rash down arm and trunk.  Within 2 hours, Itching began on lips, body aches began and care was provided to reduce the reaction, Hydroxyzine 50 mg po.  Symptoms resolved but body aches continued x 2 days.