chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pharmaceutical product complaint; Only  liquid diluent portion of Menveo used; Only the liquid diluent administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA722Z, expiry date 31st August 2023) for prophylaxis. This case was associated with a product complaint.   On 29th September 2022, the patient received Menveo. On 29th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The reporter reporting a possible 7 patients having received only the liquid diluent portion of Menveo. The reporter consented to follow up. Additional Supportive Information: The reporter reporting a possible 7 patients having received only the liquid diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022140220:Same reporter- Patient 1 US-GSK-US2022140223:Same reporter- Patient 3 US-GSK-US2022140222:Same reporter- Patient 2 US-GSK-US2022140231:Same reporter- Patient 5 US-GSK-US2022140233:Same reporter- Patient 6 US-GSK-US2022140243:Same reporter- Patient 7
I had a scratchy throat, congestion, headache and cough. Lightly achy for about a day, fatigue. It lasted probably 6 days. And mostly it was mild but there was a day or two where it was worse than that. I was directly exposed to somebody who had a positive Covid test and is why I took a test. I received monoclonal antibodies.
I am a physician and received 2 doses of the Pfizer COvID vaccine. First dose 12/20/20. Second dose 1/6/2021.  Forty- eight hours after second dose I had moderate to severe under eye swelling at site of dermal fillers I received May 20,2020 requiring steroids and antihistamine. I also had severe myalgias and fever 12 -36 hours after my second dose.
Fever, rash on legs and arms, and canker sores in mouth and throat, over weekend, vaccine was on friday morning. Pt returned to original doctor on Wednesday morning and then to her physician that same day. The canker sores have been a problem for over three weeks.
Confusion; Severe stomach pain; Balance; Body aches; severe vomiting/ puking; Temperature 100.3; Diarrhea; Fatigue; Arm ache; Severe nausea; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old, male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6204) via an unspecified route of administration in the left arm on 16Mar2021 at 13:00 (at the age of 74-years-old), as a single dose for COVID-19 immunisation. The patient medical history included Diabetes, emphysema, HTN, COPD, and COVID-19 on an unspecified date in Nov2020. Concomitant medications were not reported. The patient did not have allergies to food, medication and other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was tested positive for COVID-19 in Nov2020. Since the vaccination, the patient has not been tested for COVID-19. On 16Mar2021, at 1700, the patient experienced events, severe nausea, vomiting, puking, temperature 100.3(Units unspecified), arm ache, body aches, fatigue, severe stomach pain and diarrhea, balance, and confusion, The patient did not receive any treatment as a result of adverse events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care'. The clinical outcome of the events nausea, vomiting, fatigue, loss of balance, confusion, pain in arm, generalized body pains, stomach pain, diarrhea, and increase body temperature was recovered with sequelae.   No follow-up attempts are possible; No further information is expected
Dizzy, numbness in right arm, right leg, and right face.  Increased Blood pressure.
ALTE - admitted to Pedi ICU x 48 hours NL; lab eval, EEG, EGE, head CT 12/17/07-records received for DOS 11/19-20/07-Presented to ED after 2 episodes of unresponsiveness, stopped breathing, eyes rolled back and she became extremely pale, rigidity and jerking. ED DX seizure disorder.
Muscle pain that already existant due to skeletal misalignment (neck, back, hips) increased by a lot, making everyday activities difficult: getting out of bed, bending over, turning my head, walking, etc. This started the third day after the shot, and continued until it started to lessen 7 days after shot, now almost gone.
Patient received TD on 09/03/2009 and developed swelling at the injection site and body aches the following day.  The patient returned to the doctor on 09/08/09 and his symptoms had resolved.
Night of vaccines, 5/16/01, spiked a fever to 103.4F and developed "grunty" breathing. Had a red, blotchy rash on body. Was seen in ER that night and dx'd with bronchitis and given IM Rocephin. Seen by PMD on 5/17/01 and was told it was "moderate reaction" to pertussis. Mother said he was better by 5/17/01.
This spontaneous report as received from a pharmacist refers to a 63-year-old female patient. The patient's medical history, concomitant medications and drug allergies were not specified. On 01-OCT-2017 the patient was vaccinated with ZOSTAVAX subcutaneously (dose and injection site unknown), lot # N021172, expiration date 01-NOV-2018 for prevention of shingles. Other suspect therapies included sterile diluent lot # K026802, expiration date 21-OCT-2017. On 03-OCT-2017 the patient began experiencing "warmth and redness" at unspecified injection site. On 04-OCT-2017 the patient was prescribed KEFLEX (dose, frequency, route of administration not provided) by physician. The outcome of the events was unknown. The relatedness between ZOSTAVAX, sterile diluent and the events was not specified.
She had the vaccine, and it woke her up from a sound sleep feeling like she had been punched in the middle of her back as hard as they could.  Her rib cage, stomach muscles were so tight, her shoulders were breaking, feeling like everything was crushing inside of her, between her shoulder blades extremely and in the center of her back and she could not breath.  She literally had to talk herself into breathing pattern so she did not hyperventilate, and couched herself in the nose/out through the mouth for 3 hours, and did not want touched.   She went to sleep and when she woke up she felt heaviness in her chest, but could still feels like she has a target area in the center of her back, and still has this feeling if she takes a deep breath.   Then she had the body aches, a little bit of the cold chills, and the routine side effects.  She fell asleep that night, but when she woke up Saturday morning when she got undressed her entire stomach and back were red as if she had gotten sunburned.  Then about an hour and half after that it went to the inside of her arms with the redness, especially where the elbows bend.  She then went to and spoke with the pharmacist and got some Benadryl and the symptoms subsided except if she takes a deep breath/Inhale real deep can still feel where the area was on the back that was excruciating.  She called the doctor on Monday morning and they told her if she had any  more issues then to go to the ER.
elevated heart rate, very strong heart beat for over one week post vaccine, late period and very severe period cramps and heavy flow.
facial burning / itching, itching redness of ears, face, palms of hands and soles of feet. Trouble breathing. Epinephrine was offered but declined, benadryl 25mg was given, symptoms did not subside.
Started feeling ill on 1/13 with fever, chills, aches and HA.  By Thursday felt nerve tingling (has had previous shingles). By Saturday starting to break out, went to Urgent Care for treatment. Called out 1/18
high blood pressure; tachycardia; Messed up heart and rest of her life; Inability to work; severe body ache; nausea; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure), TACHYCARDIA (tachycardia), CARDIAC DISORDER (Messed up heart and rest of her life), IMPAIRED WORK ABILITY (Inability to work) and MYALGIA (severe body ache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Back pain, Diabetes since 2010, Tachycardia since June 2021, Blood pressure high since June 2021 and Latex allergy. Concomitant products included DICLOFENAC and TIZANIDINE for Back pain, METFORMIN, PRAVASTATIN, MELOXICAM, LOSARTAN and PROPRANOLOL for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (high blood pressure), TACHYCARDIA (tachycardia), CARDIAC DISORDER (Messed up heart and rest of her life), IMPAIRED WORK ABILITY (Inability to work), MYALGIA (severe body ache), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever). At the time of the report, HYPERTENSION (high blood pressure) and TACHYCARDIA (tachycardia) had not resolved and CARDIAC DISORDER (Messed up heart and rest of her life), IMPAIRED WORK ABILITY (Inability to work), MYALGIA (severe body ache), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: positive (Positive) Positive. In 2021, Blood pressure measurement: high (High) blood pressure was really high. In 2021, Heart rate: high (High) pulse was extremely high.         No specific Treatment medication was reported.  Event Tachycardia and high blood pressure started on 06-2021 month unknown.   This case was linked to MOD-2021-393192 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received contain no significant information. On 19-Nov-2021: Follow-up added patient information, lab data, medical history, concomitant drugs and events added.
Hives on stomach and back that started 4-5 days after vaccine. Rash on arm of vaccine that started 5-6 days after, red, spotty.
Intense pain on side of injection, wide spread muscle pain and joint ache, head ache, nausea
Uncontrolled projectile  vomiting 20 hours/ temp 101.4/Diarrhea/migraine/extreme fatigue/sore throat/joint pain as if someone was sticking a machete and elbow and ankle Joints/ heart arrhythmia and palpitations  . my first vaccine these effects lasted for a continuous 10 days without subsiding.... I seriously was thinking about not taking the second shot their reactions were that bad!
Immediately upon vaccination, patient exhibited signs of lightheadedness/fainting, as she began to rock back in her chair. I called for assistance from technician and we supported patient. I opened smelling salts and patient revived quickly, asking, "what happened?" She then bent over in her chair and placed her head between her knees, asking for a bucket to vomit.  I did not see that she actually vomited.  We offered the patient water, which she accepted and began to sip.  Within 3-5 minutes, patient said that she was feeling much better, and after approximately 5 minutes,  patient indicated that she felt comfortable transitioning to a lying down position, where she remained comfortable and engaged with me for 20 additional minutes. After this time, she stood and reported no lingering effects or concerns. I confirmed that patient would remain in-store to have something to eat. I encouraged her to call or return to the pharmacy if she needed additional assistance.  patient indicated that she was feeling fine upon departure and that she would stay in store to have breakfast and that she would consult with pharmacy staff if she had any lingering effect or concern
inadvertently administer the vaccine 11 days after expiration date, to 16 patients; The vial was initially stored in the refrigerator on 27-May-2022 and an expired vaccine from 11 days of expiration date was inadvertently administered on 31-May-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, to 16 patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-May-2022 and an expired vaccine from 11 days of expiration date was inadvertently administered on 31-May-2022) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 030m20a and 026L20A) for COVID-19 prophylaxis.     It was unknown if patient ever had COVID positive test or diagnosis. There was no history related to adverse event and both Acute and Chronic illnesses at the time of vaccination. It was unknown if other vaccines were given to patient within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Latex allergy and Drug allergy (Lisinopril allergy).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-May-2022 and an expired vaccine from 11 days of expiration date was inadvertently administered on 31-May-2022). On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, to 16 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer the vaccine 11 days after expiration date, to 16 patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-May-2022 and an expired vaccine from 11 days of expiration date was inadvertently administered on 31-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial was initially stored in the refrigerator on 27-May-2022. Dose administered after 30 days use by date or after manufacturer date of expiry.  The number of vial was reported as 1. The vial did not undergo any temperature excursions. It was unknown if patient seek medical care.  No treatment medications were provided.
This is a spontaneous report from non-contactable nurse on a behalf of her mother, via Pfizer sales representative. A 88-year-old female patient received PREVNAR 13 single dose and Flu vaccine (unspecified), both via an unspecified route of administration on the same unspecified date. Medical history included diabetes mellitus since a weeks or two before vaccination. The patient's concomitant medications were not reported. In the middle of night of the vaccination date, the patient experienced extremely high blood sugar. The outcome of the event was unknown. No follow up attempts possible. No further information expected.
Pt was seen on 2.28.21 after asking for emergent apt for left arm pain 9 out of 10. There is not duration documented in this encounter, unsure patient's pain had been occurring. Significantly elevated BP compared to baseline. Pt reporting electrical pain down the arm worse with movement, palpation of the axilla, and deep breath. EKG was NSR at that time. Pt was treated for acute pain.  Pt returned to clinic 3.1.21 and was seen by this provider at that time with visibly enlarged Left axillary lymph nodes. Vs had returned to normal at that time. Pt's pain had improved to an intermittent 7 out of 10. Evidence at that time showed that axillary lymphadenopathy was occurring in 11-16% of patients. Pt was treated supportively for pain management and instructed to FU PRN.  When pt received his second dose of this injection (COVID 19 Moderna) he had the same reaction within two weeks.
This is a spontaneous report received from non-contactable reporter(s) (Other HCP) for a Pfizer sponsored program. A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for Covid-19 immunisation; palbociclib (IBRANCE), administration date 04Feb2020 (Batch/Lot number: unknown) as 125 mg, 1x/day for breast cancer. Relevant medical history included: "hard time sleeping with some bruising/swelling/irritated breast/chest/abdominal skin" (unspecified if ongoing); "tired" (unspecified if ongoing); "decreased appetite" (unspecified if ongoing); "weight stable" (unspecified if ongoing); "hip/back pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: 13Mar2021, for Covid-19 immunisation, reaction(s): "increased headache". The following information was reported: FATIGUE (non-serious), LIMB DISCOMFORT (non-serious), outcome "recovered" and all described as "she was more tired with sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Patient reports Ibrance on hold for 1 week 17Mar2021-24Mar2021. Patient reported that Ibrance manufactured by Pfizer. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received 1mL dose instead of 0.5mL; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On 01-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL). On 01-Sep-2021, 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 medication were reported.   No treatment information was provided by the reporter.
The morning after the vaccine was administered, I developed a severe sore throat, followed by nasal congestion and cough. I also developed a slight fever. I took ROBITUSSIN DM, cough drops, CLARITIN, and antibiotics over a time frame of several weeks. The cough and nasal congestion would not let up. It finally dissipated. On it's own.
Pt returned to the Clinic 1 hour post vaccination and stated his throat was feeling tight and if he looked down it would close off his airway. While in Clinic Pt's speech changed and an EpiPen was administered, per vaccine administrator and then transported via ambulance to ED.
See urgent care record attached. * Mom declines all additional doses of MENVEO. D/T severe reaction. Swelling to (L) arm, got shots done the 15th. Began with local swelling right after shot. Swelling around arm & down to elbow.
This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. 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.
shingles; Other Zoster Conidtions; death; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 10-APR-2014, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the prophylaxis.  On an unspecified date, subsequent to the patient vaccination, the patient was experienced shingles and other zoster related conditions as a result of the receipt of the zoster vaccine live (ZOSTAVAX) vaccine. On 07-APR-2021, the patient died due to an unknown reason; it was unknown if an autopsy was performed. At the patient's death, the outcome of shingles and other zoster related conditions were not reported.   The reporter considered the events of shingles and other zoster related conditions to be related to zoster vaccine live (ZOSTAVAX). The causality assessment between the patient's death and the vaccine was not reported.
11/24/2021 went into episodes of AFIB that lasted about an hour. By the time I had gotten to the ER around 12:45 AM it was back into normal sinus rhythm. Followed up the next morning with Dr.'s assistant. Everything was okay. Had a cardiac monitor that I wore for 2 weeks. Came back with episodes of Atrial tachycardia.
Onset of fever 6 hrs p/vax on 13JUL92; 14JUL persisting fever, irritability; 15JUL fever 103-104 & irritable; dec feeding adm to hosp; 16JUL fever 99-100 still fussy; 17JUL d/c home;
Line of hives extending from top to bottom of back of the neck. Directly down center of the back of the neck.  They are not itchy and are not raised much the following morning.
Information has been received from a physician concerning an adult pt who on 17Oct05 was vaccinated IM with 0.5mL pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). On 17Oct05 the pt developed an injection site reaction included redness and swelling. Unspecified medical attention was sought. Outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested.
This is a spontaneous report from a Non Clinical Study Program from a contactable consumer who reported for her son. A male patient of an unspecified age received a single dose of TRUMENBA via an unspecified route of administration in the arm on an unspecified date as Meningitis vaccine. The patient medical history and concomitant medications were not reported. After the vaccination on an unspecified date the patient experienced fever, headache, stiff neck, back pain, muscle pain, he was dizzy, lot of pain in the arm and area where vaccine was injected, pain in hand, lot of fatigue, sensitivity to light, he was unstable. The reporter mentioned that her son had multiple effects and she was wondering how long these side effects would have lasted and expected to last and whether they were normal. Outcome of events was unknown. Follow-up (06MAY2015): Follow-up attempts completed. No further information expected.
Patient was given Kinrix vaccine inadvertently at appointment today. Patient did not have any signs or symptoms of adverse reaction to vaccine when leaving clinic. Patients mother informed to advise clinic of any adverse reactions that may occur over the next 7-10 days.