chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discomfort in left arm; Painful when moving the left arm; This case was reported by a consumer via call center representative and described the occurrence of arm discomfort in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2021, the patient received the 1st dose of Shingrix (intramuscular). On 29th December 2021, immediately after receiving Shingrix, the patient experienced arm discomfort and pain upon movement. On an unknown date, the outcome of the arm discomfort and pain upon movement were not recovered/not resolved.   It was unknown if the reporter considered the arm discomfort and pain upon movement to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix on left deltoid. After receiving Shingrix patient experienced discomfort in left arm right away after the vaccination and discomfort in arm means painful when moving arm. The symptoms had not resolved. The reporter consented to follow up.
received the Shingles vaccine/ has had 6 bouts of Shingles since / suspected vaccination failure; had 6 bouts of Shingles since then.; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient reported that, she received the Shingles vaccine (Shingrix) some time ago and had 6 bouts of shingles since then. The reporter did not consent to follow up. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
it was rpt that a pt recv vax on 4/13 & exp a swollen leg, redness at inject site w/pain
Had 3 shots and still got them/; Shingles; Had 3 shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had 3 shots and still got them/) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and extra dose administered (Verbatim: Had 3 shots). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that his wife received 3 doses of Shingles vaccine and still experienced Shingles. The patient received extra dose of Shingles vaccine in error, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Pt is a twin, not identical. Both children were nml & healthy for the first year of their life but since they had their 1 yr shots, both are having labial abscesses & low white count. Marrow test show pts antibodies attacking neutrophils. Pt experienced impetigo, and neutropenia. Pt also experienced anderythroid hypoplasia. Pt developed right sided labial erythema, induration of the superior portion of the labia majora with a small punctate area that appears to be an area where potential drainage occurs. Diagnosis is labial cellulitis. 3/30/00 Received medical records from PCP.
Developed red raised painful vesicles on bil. hands/fingers. Approximately 15 pustules.
6-8 hours after injection 6" x 3" redness, edema, pain and itching. Temp ok. Suggested ice/Tylenol.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature) and PRODUCT STORAGE ERROR (vial was first punctured on 30-Jun-2022 10:00am and administered on 01-Jul-2022 01:35pm) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2022 at 1:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2022 at 1:35 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was first punctured on 30-Jun-2022 10:00am and administered on 01-Jul-2022 01:35pm). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature) and PRODUCT STORAGE ERROR (vial was first punctured on 30-Jun-2022 10:00am and administered on 01-Jul-2022 01:35pm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was administered with First Booster. Date the vial was initially stored in the refrigerator was reported as unknown. The vial was stored post puncture at Room temperature in the Pyxis machine. The vial did not undergo any temperature excursions. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-607743 (Patient Link).
No additional AE/PQC.; She received her first dose of GARDASIL 9 around 5 years ago, and just received a second dose today on 06/06/2023; This spontaneous report has been received form a consumer, regarding to herself, a 23-years-old female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.   On an unspecified date on 2019 (reported as about 5 years ago), the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDSIL 9) injection, as prophylaxis (strength, dose, route and anatomical location of administration, lot number and expiration date were not reported).  On 06-JUN-2023, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDSIL 9) injection, as prophylaxis as well (strength, dose, route and anatomical location of administration, lot number and expiration date were not reported) (Inappropriate schedule of product administration).  No additional event or information was reported.
4-22/2021 - 1 am-11am - chills/fever/dull headache - temp - 99.8 - took tylenol -  increased fluids (H20) Noon - chills/fever - temp 100.9 - took tylenol  -  put frozen veggie bag on forehead to cool down  4-23/2021 - fever/chills am - in bed sleeping on & off   4/24/2021 - am fever/chills - afternoon less sweating/chills - resting in bed all day  4/25/2021 - am fever/chills - afternoon no fever chills - feeling somewhat better
Pt felt her heart racing and a flushed feeling over her body. After a few minutes, symptoms resolved without any intervention.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a Non-Health Care Professional. This case is linked to cases 2018SA281638, 2018SA279966, 2018SA281635, 2018SA279965, 2018SA279973, 2018SA281633, 2018SA279967, 2018SA281636, 2018SA281634, 2018SA281632, 2018SA279979, 2018SA281687 and 2018SA281692. This case involves a 6 months old male patient who received vaccine PENTACEL. The patient's past medical history, concomitant medication and family history were not provided. On 11-Sep-2018, the patient received injection of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5507AA, expiry date 05-Sep-2019 via unknown route in unknown administration site. It was an actual medication error due to incorrect product storage. It was reported that patient received vaccine of which had Temperature on 11 Sep 2018 through 13 Sep 2018 was too low at 30 F, below freezing for 4 hours. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Higher dose vaccine. Had arm about 3 hs., lasted until morning after needed ALEVE. Had dizziness on next day. Blood pressure went over 200 & lasted 7-8 days.
Information has been received from a nurse practitioner concerning a male with diabetes, history of heart disease, chronic lung disease (not related to smoking), sleep apnoea, hypertension, chronic insomnia, benign prostatic hyperplasia, osteoarthritis, history of pulmonary embolism and cerebrovascular accident and no known allergies who on 09-OCT-2007 was vaccinated subcutaneously with "one dose" of ZOSTAVAX (lot # 658212/0887U). There were no illnesses at the time of vaccination. Concomitant therapy included LIPITOR, AMARYL, LUNESTA, LYRICA, RODEX, ACTOS, ALEXAN, atenolol (MSD), FLOMAX, DIOVAN HCT, ENABLEX, PERCOCET and influenza virus vaccine (unspecified) that was administered in the left deltoid on 09-OCT-2007 in the morning(lot # U2446AA). On 11-OCT-2007 the patient developed shingles within 49 hours post vaccination. On 13-OCT-2007 the patient was seen again via an office visit and was treated with ZOVIRAX and steroids. On 16-OCT-2007 the patient was seen again via an office visit with the NP and there was no improvement in his symptoms. No diagnostic labs were performed. On an unspecified date the patient recovered. A product quality complaint was not involved. This is one two reports from the same source. Additional information is not expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown dates, the patients were vaccinated with VAQTA (dose, dose number, lot number and route of administration were not reported), which were exposed to temperatures outside of range. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information is not expected, because the permission to contact was not given.
Patient brought to ED after found unresponsive and bradycardia.  Patient admitted to hospital for Covid and cardiac workup.
Patient first experienced symptoms of fatigue, nausea, and vomiting 4 hours after receiving the vaccine. She reported that symptoms persisted for 4 days afterwards. She took time off work to stay home during that time. She did not take any medication for the nausea. She also reported feeling "achy joints". She took ibuprofen for the achy joints and those symptoms went away after 2 days.  She had not had any changes in her diet prior to vaccination. Patient called on 3/8/21 to talk to me (the pharmacist) about her symptoms. She informed me that she sent a message to her primary care doctor to inform them of her symptoms. I suggested that she go to an urgent care since her symptoms had not gone away and that she should schedule an appointment with her primary care doctor. I called the patient on 3/9/21 to follow up, but she did not answer her phone.
pt recv 3 vax & approx 5min post vax pt became weak & lost consciousness & was incontinent;pt was put to the floor & then awoke & was crying;
Metallic taste 2 min later.  High blood pressure 5 min later. Swollen lymph mode on collarbone 10 days later.
Cellulitis at injection site, red, swollen, hot to touch, fever and chills
pt recvd vax & had beefy red 8x8 cm discoloration at inject site; itch & tender;
HYPOXIA  2/7/2023 -- RECURRENCE OF SAME SYMPTOMS
Patient given 0.5ml instead of correct dose of 0.3ml. No adverse events experienced.
Fatigue Headache Swollen lymph nodes in right armpit  Pain throughout  arm down to fingertips
Seizure activity 6 hrs after Tdap-full motor involvement. Was seen at ER. Post-ictal for remainder of day. Pending appointment with neurologist for further evaluation.
chills; vomiting; headache; body aches; nauseous; Pain at injection site; This is a spontaneous report from a contactable health care professional also reporter as contactable consumer, the patient. A 46-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EM9810),  via an unspecified route of administration, administered in Arm Left on 19Feb2021 at 14:45  as SINGLE DOSE for covid-19 immunization. Facility in which the vaccine in was administered was (name of facility) Clinic. The patient medical history was not reported. Concomitant medications included bupropion (BUPROPION) , clonazepam (CLONAZEPAM), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL),  ergocalciferol (VIT D), ascorbic acid (VIT C).  The patient previously took Imitrex and experienced allergy. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Feb2021 01:00 The patient experienced nauseous and On 20Feb2021 at 02:00 patient experienced chills, vomiting, headache, body aches  and  pain at injection site. The clinical course is as follows At approximately 1AM, I was nauseous. 2AM vomiting followed by chills, headache and body aches (no fever). Pain at injection site. The patient underwent lab tests and procedures which included sars-cov-1 test: negative  on 11Dec2020 'Nasal Swab'.  No treatment was given for the events. The clinical outcome of the event was nauseous,  vomiting, chills, headache,  body aches (no fever) and  Pain at injection site was not recovered.
Patient received Moderna Vaccine  (lot: 001B21A) on 3/9/21. Patient  noted within history form that he had Pfizer Vaccine as dose #1.  Pfizer Vaccine (lot: ER8735) administered as a second dose on 5/5/21.  Patient denies any possible Side Effects at time of vaccination. States he had a mild headache on his way to work following 15-minute observation period, which has since ceased.
Swelling in her mouth; Sore neck periodically; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (Swelling in her mouth) and NECK PAIN (Sore neck periodically) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOUTH SWELLING (Swelling in her mouth) and NECK PAIN (Sore neck periodically). At the time of the report, MOUTH SWELLING (Swelling in her mouth) and NECK PAIN (Sore neck periodically) 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.
Blood red under skin about 8 inches long and 5 inches wide. Patient reported itchiness but no pain.
Ear Pain; This case was reported by a consumer via interactive digital media and described the occurrence of ear pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced ear pain. On an unknown date, the outcome of the ear pain was unknown.   It was unknown if the reporter considered the ear pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient had ear pain.
Breakthrough case after three vaccines Pfizer 3/12/21 Lot# EN6207;  Pfizer 3/31/21 Lot# EP7533;  Pfizer 10/2/21 Lot# FF2587
No additional AE; Physician reporting an AE for VARIVAX being administered after the expiration. No additional AE. No PQC.; This spontaneous report has been received from a physician, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 22-NOV-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) Subcutaneous Injection, at a dose of 0.5 milliliters as prophylaxis (lot number: T038830, which was determined to be valid, with an expiration date on 17-NOV-2022) (strength, scheme, route and anatomical location of administration were not reported) (Expired product administered). No additional adverse event was reported.
9/2-9/3/20 patient has been experiencing short intermittent shock pains in her arms, legs stomach and chest.  She otherwise has no symptoms  patient contacted via phone but no response
Periodic pressure  and tightness across chest and diaphragm especially on day of vaccination and following 2 days. Rapid heart beat followed by afib that was not terminated with normal medications. Dizziness and shortness of breath. Hospitalized with atrial fibrillation with rapid ventricular response. It resolved after getting two injections of a medication called diltiazem in the emergency department, after which I was monitored overnight in the hospital. Underwent stress test and echocardiogram - results  normal. On the day I write this (March 1) continue to have  shorter periods of rise in blood pressure and heart rate,  diaphragm tightness, insomnia and lethargy.
Employee received a flu vaccine and 2 hours later developed ocular rosacea. Symptoms included dry itchy eyes, red and swollen eye lids. Symptoms resolved after 4 days.  No treatment provided.
sick; Nauseated; Vomited a lot; Massive headache; acid reflux; Not eaten; very weak; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), NAUSEA (Nauseated), VOMITING (Vomited a lot), HEADACHE (Massive headache) and GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ILLNESS (sick), NAUSEA (Nauseated), VOMITING (Vomited a lot), HEADACHE (Massive headache), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), EATING DISORDER (Not eaten), ASTHENIA (very weak) and ARTHRALGIA (Joint pain). On 06-Feb-2021, VOMITING (Vomited a lot) had resolved. At the time of the report, ILLNESS (sick), NAUSEA (Nauseated), HEADACHE (Massive headache), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), EATING DISORDER (Not eaten), ASTHENIA (very weak) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Received influenza vaccination on 10/30/07.  On 11/3/07,1:30AM, awakeded with hives with itching on chest, arms and hands - not difficulty breathing.  Took OTC benadryl.  At 12 noon 11/3, no improvement. Went to private MD and was advised to take OTC antihistamines and Rx for steroid which was not used. That day also ate fresh cranberry relish (immediate allergic reaction when eats fresh fruit, applesauce, etc).
Janssen covid vaccination given to individual younger than approved age. Unknown is any ADE's manifested.
Woke up and felt weak and "numb all over" tingling sensation in his arms and hands, some on his face. c/o some non-specific chest heaviness, but it is difficult to ascertain from patient if this is new. Just had flu shot yesterday.
Patient noticed pain in the right arm the next day and also redness and swelling around the injection site. The redness and swelling spread down the arm to the elbow joint and wrapped around the arm. The pain and the redness and swelling resolved within a few days and she was fine. She did not see a medical doctor.
Having a pins and needles sensation in both feet and hands for 1 week. Heart flutters/palpitations that persisted longer than I?ve ever experienced before. I also had burning in my bladder and stomach issues 3 days after vaccine was administered that lasted about a week.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 14th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 17th December 2018, the patient experienced shivering and cold. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the shivering and cold were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, shivering and cold to be related to SHINGRIX. Additional details were provided as follows: On Friday, the patient received SHINGRIX on the left arm and experienced soreness at the injection site on Friday, Saturday, and a little bit on Sunday. On Monday night, three days after receiving SHINGRIX, the patient began to experience shivering and cold. The patient did not consent to follow-up.
Chills, aches, nausea, back pain on spine, headache, severe pain in arm.
I need to know what side effects to be looking for and for how long.  AND for pharmacy to never let this happen again