chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose on 18May2022, 3rd on 29Oct2022; 1st dose on 18May2022, 2nd on 27Jun2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old female patient who received HAB (Twinrix) 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, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 29th October 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 27th June 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 27th June 2022, not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device and unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 29th October 2022, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short and drug dose administration interval too long 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: 02-DEC-2022 Reporter's comment: The patient received 1st dose of Twinrix on 18th May 2022. The pharmacist reported that the patient received third dose of Twinrix on 29th October 2022 and second dose on 27th June 2022. The reporter consented to follow up by email. Additional supportive information: The patient received the third dose of Twinrix earlier than the recommended interval, which led to shortening of vaccination schedule. The patient received the second dose of Twinrix later than the recommended interval, which led to lengthening of vaccination schedule.
Swollen, red and hot w/i 48 hrs of vaccine. Benedryl given.
After receiving the Flumist vaccine four days ago, within 24 hours I developed a brief sore throat, followed by severe cold symptoms-stuffed, runny nose-, which continue to this day. I am certain this is not a separate cold because I general only come down with 1-2 colds per year, usually 6 months apart. My most recent cold was only 1.5 months ago and fully recovered over 1 month ago. I have never come down with colds this close together before, and based on the confident this is the cause of my symptoms. The Flumist website and package insert detail some side effects similar to a cold, but make no mention of the potential severity or length of symptoms. Had I known I would be sacrificing my immediate health for the promise of protection from the flue, I would have never purchased the vaccine. I have seen numerous internet postings from others who have had similar reaction to the Flumist vaccine and strongly fell the safety/efficacy of the vaccine should be investigated. At the very least, the manufacture should be required to provided a more accurate description of the potential side effects of Flumist. I think it would give a consumer pause to know that they run the risk of developing what is identical to a severe cold from the Flumist vaccine.
Pt stated 48 hours after vaccine was given he broke out in a rash that spread to other parts of his body. He states it has been three days and it has gotten better. He used calamine lotion. He states he didn't try anything new, or touched anything (poison ivy) that may have caused the reaction. He took a Benadryl which has helped some.
16 year old received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the vaccine). On 12-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
mom reports a few hrs p/receiving HIB/OPV/DTP that pt began fainting & shaking all over & became limp, wouldn't make eye contact & turned pale; seen in ER;
after the shot and there was some clear liquid running down his arm.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 13Apr2021 (Lot number: EW0171, Expiration Date: Aug2021) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), when the patient was 29 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE DISCHARGE (non-serious) with onset 13Apr2021, described as "after the shot and there was some clear liquid running down his arm.".  Additional Information: HCP states patient called today regarding his 2nd Pfizer vaccine dose he received yesterday. The patient stated he removed his band aid a few hours after the shot and there was some clear liquid running down his arm. The HCP is asking if he is sufficiently vaccinated, what should they do. RA number of Covid-19 Vaccine: 59267100001. When probed for the concern, Pharmacist stated "I am calling regard to one of our patient (consumer). I work for Pharmacy (further clarified reporter type as Pharmacist) and we gave a Pfizer vaccine the Covid vaccination to a patient yesterday (April 13th 2021), a couple of hours after getting the vaccination he called vaccine there was some clear liquid coming out or like that was Drug side effect, so fold down his arm and then he was wondering or were not sure at this point, so was the vaccination that came out or it was like fluid from his body, so we are wondering at this point. Do we vaccinate the patient or we hold off, I am not sure what to do.". When probed for the causality, Pharmacist stated, Yes it came out of the injection site. When probed for any treatment for event, Pharmacist stated, No. When probed for consumer's height and weight, Pharmacist stated, That I don't know. When probed for any other medication condition concomitant medication, Pharmacist stated, I believe he is not. (Further not sure). When probed for any laboratory test, Pharmacist stated, I am not sure either.  No follow-up attempts are possible. No further information is expected.
Rash (red, fine, raised) on injection site arm, spreading rest of body. Pt took 2 PO doses of Benadryl that PM and AM for itching and burning. No relief obtained.
Pt recvd vax & devel soreness & induration @ inject site accompanied w/ a 6 inch area of redness; 17FEB93 pt devel soreness & pt also found it hard to move arm;
At 2:00pm patient was given both the FLUVIRIN and PNEUMOVAX administered IM in the left arm spaced about 1 inch apart into the deltoid muscle. Later in the day he developed a stiff arm but still had full range of movement. He slept on his right side to avoid the painful arm that night. The following night by 8:30pm he had developed headache, myalgia, pain upon moving the arm and a painful (not itchy) red raised rash on his arm in the area between the shoulder and elbow. The largest of the patches was about 3-4 inches round. The rash did not appear directly at the injection site but it did appear below it. His on call doctor suspected cellulitis so has prescribed cephalexin for the time being and to follow up with his doctor after the weekend.
pt recv vax;moderate hives on face & torso appearing approx 1 day p/ vax; probable allergic rxn to MMR;
Information has been received from a nurse concerning a 16 year old female who on an unknown date, was vaccinated with second dose of VARIVAX (Merck) (lot# not reported). Subsequently the patient experienced warmth, redness and swelling at the injection site. It was unspecified if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Patient received MENVEO and HPV (GARDASIL) vaccines at well check up on 8/24/15 and developed itchy maculopapular facial rash with some wheals 24 hours later.
4/11/2022 at 1157 Employee called the Employee Health COVID-19 Vaccine Nurse Support Line to report symptoms post COVID-19 booster vaccine. Vaccine Name - Pfizer Vaccine Date ? 4/08/2022  Booster Dose - Yes Location - Left Deltoid Date of Symptom Onset ? 4/08/2022 Symptoms ? Tingling of Neck and Tongue (During Observation Period and Seen By Nurse); Injection Site Burning, Left Arm Pain, Knot to Left Shoulder Blade Last Day of Work and Shift ? Friday, 4/08/22 / Schedule: Mo-We (11a-8p), Th-Fr (10a-6p) / Missed Work: Monday, 4/11/22 (Came in then had to leave due to symptoms) Home Remedies ? Warm compress to Left Shoulder, Neck and Injection Site; Ibuprofen 800 mg Every 4 Hours Any Improvement ? No Recommendation - Treatment per COVID-19 Vaccine Adverse Reaction Triage and Return to Work Procedure algorithm, is to Manage per Illness in the Workplace Policy  Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction - Yes
Syncope post vaccine administration. Patient regained consciousness shortly after. Ice packs were placed on wrist as patient regained composure. Patient is a minor and parent was present stating this is expected reaction to stressful events. Emergency services were refused. Patient was sent home with parent and reported no further symptoms 2 hours post vaccination.
Patient received 1mL dose instead of 0.5mL; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 006D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 milliliter. On 01-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL). At the time of the report, ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported.
Veteran states two days after his first dose (2/12/2021) he developed a rash on his legs. States the rash is now "up to my crotch, abdomen, and now to my belly button." Also states it is very "itchy" and has been using fluocinonide on it. Veteran was encouraged to be seen in Urgent Care to see if the rash was from something other than the vaccination.
site swelling, itching along upper extremities, shoulders, and upper back. Itching treated with Benadryl x 2 doses with positive results
c/o myalgia in ER, temp 100.3 arm soreness at injection site. ER doctor's discharge dx tetanus reaction. Attempted to call pt x2 no answer.
Two days after administration of Td vaccine, she developed a hard lump at the site. It is red, swollen and warm to the touch.
Child seen in office 10/8/07 w/ rash. Broke out in rash on 10/5/07. Verified via exam by physician. Dx measles.
Severe pain similar to what is expected after receiving a tetanus vaccine was present in my left arm at site of injection. Pain continued for a week. It started to subside and became a dull pain. Two weeks after dull pain started, the pain became severe again with no explanation. Motion continued to be limited during the entire time, with arm motions towards the front of the body and away from the body affected. Muscle weakness and inability to lift objects present. This pain is still present today.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose ZOSTAVAX (lot #, expiration date, dose, indication, route not reported) "every year" since an unspecified date. No adverse effect reported. Additional information is not expected.
Patient experienced an expanded region of about 10 inches with erythema and pruritus within about 6 hours and lasted for 4 days. She also developed a migraine within 10 hours of administration.
1st dose 12/18/2018, not able to come for 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 18th December 2018, received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2022 Reporter's Comments: The patient was not able to come for second dose. The chat ended by healthcare professional before follow up consent obtained. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.
This spontaneous report was received from a 45 years old female patient reporting on herself. The patient's medical history included mitral valve condition, anxiety, high blood pressure, a pleural effusion and a pneumonia six weeks ago (on approximately 04-SEP-2012). The patient had no known drug reactions or allergies. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 on 12-OCT-2012, recommended by her pulmonologist. Route and lot number were not provided. Other suspect therapies included Influenza Virus Vaccine (manufacturer unknown) also administered on 12-OCT-2012. Concomitant medications included hydrocodone, albuterol, WELLBUTRIN, NEXIUM, INNOPRAN, AMBIEN, XANAX, SEASONIQUE and PAXIL. On 12-OCT-2012 (also reported as on Saturday 13-OCT-2012) the patient had developed a raised hard lump along with a cluster 5 inches in diameter red rash, pain, and tenderness at the insertion site. The patient was also weak, fatigued, had difficulty breathing, like walking a flight of stairs. The patient felt like when she had pneumonia. The patient attempted to call the company vaccine hotline on Saturday 13-OCT-2012. She utilized the company care facilities at work and was told it looked like an infection. Treatment given for the adverse events included BENADRYL and TYLENOL. No laboratory tests were performed. At the time of reporting the patient had not recovered. Additional information has been requested.
EXTREME BLISTERING, BLOOD CLOT TYPE OF REACTION AT INJECTION SITE, PAINFUL FOR PT.  RECEIVED TOPICAL ANTIBIOTICS FROM MD FOR TREATMENT
I experienced the same fever and general fog that most do after the vaccine, but the following is what went outside the norm of described vaccine symptoms over the past year: Severe arm pain directly after the vaccine lasting for two weeks (could not lift or move arm). Consistent muscle spasms at injection site the following 10 days (twitching did not subside or let up at any point during this time). Severe fatigue, sleeping  12 hours a day for the following 4 months (June 21-September 21). Randomized episodes of severe fatigue (September 21-March 22). Muscle pain at injection site over the last month (February 22-March 22).
The evening of the pneumonia shot her arm became very red and swollen and painful. Swelling started about an inch below the shot and extended 6-7 inches down her arm per the patient. After six days it has gotten better but still sore in some areas and not as red and swollen. Some itching. Has applied some creams to ease the discomfort. Was not seen in the clinic for this reaction. Told her we would be glad to look at it today but she did not feel it was necessary.
Pain in left arm and breast. Pain underneath left breast into armpit. Went to dr and they advised I get mammogram. Mammogram and breast ultrasound were done. No findings.  Was told it?s likely a reaction to my vaccine
received 1 dose of primary monovalent Pfizer in the past but started to receive Evusheld; immunocompromised; lung transplant; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "received 1 dose of primary monovalent Pfizer in the past but started to receive Evusheld"; LUNG TRANSPLANT (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events interchange of vaccine products, immunodeficiency . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
INTESTINAL NOISES AND DISCOMFORT, AND EXTRA SOFT STOOLS FOR 2 WEEKS SO FAR
Information has been received from a registered nurse concerning an 4 month old patient who on 12-JUN-2006 was vaccinated with a first  oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live.  No symptoms were noted.  It was not specified if medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Pt complains of stiff shoulder with reduced range of motion with discomfort. Pt has taken ibuprofen and used a heating pad with little improvement. Pt will see PCP within a month. (is aware of the condition, SIRVA, and is very deliberate when properly locating the area for vaccination - do not believe this is the cause of Pt's reaction). Pt is planning to follow-up with PCP.
Headache, fever, chills, aches and pains, extreme fatigue, dizziness, numb tongue
Patient had an appointment for 2nd COVID Moderna shot. The previous one she had gotten at a different pharmacy. Patient stated she lost her CDC Vaccination Record Card. We looked up but site was down at the time. We called the other pharmacy to obtain the information from them instead and gave the shot. She was told it was her 2nd Moderna shot and mentioned that she had gotten COVID after her first and had to wait 90 days since she got antibodies from the hospital. She stated she was told by her physician she had to restart the series but we thought she meant she was completing it now. Later, after the shot was given we checked once it was up again and saw she had actually gotten a first shot back on 03/11/21 and then again at our other store on 07/02/21 making today mistakenly her third shot
Red, raised area, warm to the touch on left thigh. Measured 3cm x 3cm.
Delayed period. After the month of how my cycle ends, I will make an appointment to my healthcare provider and talk about these changes and if my fertility is affected or if my period will come back.
This spontaneous report was received from a pharmacist refers to a 6 unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 28-APR-2016, one patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # L044475 (expiry date: 12-MAY-2017) (dosage not reported). The temperature excursion was -0.5 (unspecified units) for 7 days. No previous excursion was reported. No adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). The 54-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included vitamin d3 and multivitamins and some other supplement. The patient previously received first dose of bnt162b2 on 12Mar2021 at single dose for Covid-19 immunization. Reported as: She is in a delicate health situation that was discovered, she is losing weight from something else that was detected, pancreatitis-like, they located a mass on the pancreas on 16Mar2021, they saw some-thing like an ulcer on the pancreas head, with cancer cells, it is localized, it is serious, and she received chemo after the first dose. The patient experienced she feels tired today, she's in pain and she's barely adjusting on an unspecified date. Reported as: This came up from an accident she had in January, the airbag opened and hit her stomach. She didn't sleep well last night, she feels tired today, they did an endoscopy, she's in pain and she's barely adjusting. Yesterday she was given her first strong medicine, but she usually takes as little medicine as possible. The outcome of the event was unknonw.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Chest pain, shortness of breath, fatigue, 13-18 current day  April 2021
Fatigue began first lasting for 24 hrs.  Fever noticed after first 12 hours along with chills.  Took one Tylenol  15 hrs after first symptom which did not provide any relief.  At hour 20 the fever returned to normal and fatigue and chills subsided.
Very light scratchy throat progressed into severe head cold sinus congestion, sinus headache sore throat and fatigue, body aches skin was sore to the touch, Paxlovid left metallic taste in mouth for 5 days.
Patient noted mid left side of tongue slight numbness . denies difficulty swallowing, nor resp. distress. Patient given benadryl 25 mg po at 0950. Patient handed to parametics with continued monitoring. Remains alert and oriented x3, VSS 138/80 HR 90 and O2 at 99%, no evidence of rash/hives at present. At 1020 BP 142/78 HR 72 with no worsening of S&S, speech clear, tolerating po fluids without difficulty, no change of tongue .AT 1040, dose of benadryl 25 elixir given per patient request due to concerns that no change of tongue numbness. Accessed tongue to be within nml findings. At 1050, patient cleared for discharge to home with her friend. Gait stable and patient as well.
pt recvd 1st dose of Hep B vax on 17DEC91 & 15 mins follwoing vax pt devel a severe h/a on the lt side; over the next 4 hrs h/a resolved; no further details were provided;
Swollen arm, dizziness, weak, body aches, fever, vomiting and stomach ache.