chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an 11 years old male patient who accidently received 0.25 ml dose of vaccine, FLUZONE QUADRIVALENT (Suspension for injection). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV Vaccine for Immunisation; IPV for Immunisation; MENACTRA for Immunisation; Varicella Vaccine for Immunisation; and TDAP for Immunisation. On 12-Nov-2018, the patient received a single 0.25 ml instead of 0.5 mL dose of suspect Influenza Quadrival A-B Vaccine, lot UT6259KA (expiry date: 30-Jun-2019) via intramuscular route in the left arm. It was a case of actual medication error due to accidental underdose. It was reported that no adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
pt recvd vax; w/in an hr of vax; pt exp'd neurological symptoms including neurological cold & hot sensations in arm; pt also exp visual disturbance; w/ 3rd dose pt exp recurrence of symptoms; pt lost sight in right eye; dx w/ optic neuritis
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven years old female patient who was vaccinated with a 0.5 ml first dose of QUADRACEL (Batch number: C5222AA, expiration date: 20-Jun-2019, route: intramuscular and site of administration: right gluteus medius, frequency: once) on 09-Oct-2018. The patient's medical history was not reported. The patient received concomitant vaccines HepB and MMR (both by Merck). It was an actual medication error due to inappropriate age at vaccine administration (seven-year-old received QUADRACEL vaccine/No AE). The patient did not experience any adverse events. 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.
pt recvd vax & w/in 15 min started itching; face turned red; rash on face; hives & swelling around inject site; to er; tx w/ atarax;
Left upper extremity swollen swollen and painful on moving blotch the size of a silver dollar. Cool compress, Tylenol for pain. Discomfort 2-3 days at site of pneumococcal injection site.
Reportedly on 1/12/2000, the pt developed a large red area measuring 8cm x 4cm and itchy rash at injection site.
I had a slight headache leading up to my vaccine and the next morning I woke with a terrible migraine (I had never experienced one before). In addition to the migraine, I was nauseous and achey. I felt flu symptoms and had to sleep the day while my husband took care of the kids. I finally woke about 24 hours after receiving my 2nd dose and felt better after some Tylenol and caffeine. The next day I had a red spot show up which now I am reading is known as ?covid arm?... it is red, sore, and warm to the touch.
6 days after Gardasil dose #2, she developed swollen, painful joints in the elbows, wrists, ankles and knees bilaterally.  Has taken Ibuprofen with little relief.  Pain and swelling persists for 3 days now.  Will monitor, no fever.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 47-year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 01Oct2021 13:00 (Lot number: 301458A) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "cerebral spinal fluid leak" (ongoing), notes: Additional Information for Other Conditions: Stated that she needed to get the surgery.; "immunocompromised condition" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, administration date Sep2021. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: EN6198), for Covid-19 Immunization; Bnt162b2 (Dose number: 2, Lot number: ER8727), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 01Oct2021 13:00, outcome "unknown", described as "indication: cerebral spinal fluid leak"; SKIN DISCOLOURATION (non-serious) with onset 02Oct2021, outcome "recovered" (04Oct2021), described as "neck turned pink"; SKIN EXFOLIATION (non-serious) with onset 04Oct2021 06:00, outcome "not recovered", described as "neck is peeling"; SWELLING (non-serious) with onset 02Oct2021, outcome "recovering", described as "neck swollen"; PRURITUS (non-serious) with onset 02Oct2021, outcome "recovering", described as "neck itchy"; SWELLING FACE (non-serious) with onset 02Oct2021, outcome "recovering", described as "face swollen". Therapeutic measures were not taken as a result of skin discoloration, skin exfoliation, swelling, pruritus, swelling face.  Additional Information: The patient received any other vaccines within 4 weeks prior to the COVID vaccine was Flu vaccine. it was reported that she wanted to her adverse reaction to Comirnaty. Stated that her neck turned pink, swollen, itchy and peeling now. Stated that her face was swollen. Stated that this was after her booster dose because of her immunocompromised condition. Stated that she had it before Comirnaty.   No follow-up attempts are possible. No further information is expected.
Description of event: Patient received vaccine in his LUE and was instructed to wait in line to schedule next dose. While standing in line, patient was witnessed falling to the floor. He appeared to land on his hands, denies injury at this time. Patient responded verbally when asked if he was okay. Vitals recorded while patient sitting on floor 1500. Patient stated he was ok to sit in chair. Upon sitting in chair for approximately 30 seconds his head fell forward and he was unresponsive. Patient began agonal breathing, eyes were open with fixed pupils, pulse was weak. Staff assisted patient to floor where he regained consciousness after approximately one minute. Patient appeared diaphoretic and pale, but was responding appropriately. An ambulance was called during this time. The patient was able to give contact information for his wife. The patient personally spoke to her on the phone. Meanwhile patient was resting supine on the floor. Vitals at 1552 146/94 P 70, R 20, 98% RA. Approximately 15 min later patient returned to the chair and has been resting since. BP at 1615 119/65. He refused treatment from EMS and is currently calling his wife to pick him up as staff has advised him not to drive. Patient currently eating a snack and drinking water, states he is feeling better.
Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech Dose Number: 3, Moderna Dose Number: 2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 40 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Apr2020 as dose 1, single (Lot number: 025B21A), in left arm and on 04May2020 as dose 2, single (Lot number: 006C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "bipolar disorder" (unspecified if ongoing); "subclinical hypothyroidism" (unspecified if ongoing); "Antidepressant therapy" (unspecified if ongoing), notes: Other medication in 2weeks product=Antidepressant; "Mood stabiliser" (unspecified if ongoing), notes: Other medication in 2weeks product=Moodstabilizer. Concomitant medication(s) included: WELLBUTRIN taken for antidepressant therapy, start date: Feb2002; PRISTIQ taken for antidepressant therapy, start date: Jan2013; LAMICTAL taken for affective disorder, start date: Sep2004. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Dec2021, outcome "unknown", described as "Pfizer / BioNTech Dose Number: 3, Moderna Dose Number: 2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid for COVID 19 Treatment from 24Dec2022 to 28Dec2022.
Post vax, the medical assistant reported that on 12/12/2000 the patient "broke out with chicken pox". Unspecified medical attention was sought. The patient's siblings had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
I felt fine that afternoon and went to bed and woke up with severe body aches and a headache and some fatigue. I took Ibuprofen about 24 hours after the shot and then felt much better the next morning apart from some fatigue for about a week. Fatigue came back 3-7 days after the shot.
Information has been received from registered nurse (R.N.) concerning a 17 year old female who on 11-AUG-2008 was vaccinated with a dose of GARDASIL. On 11-AUG-2008, when administering GARDASIL, a small account of GARDASIL leaked out from the hub. The nurse reported that the patient had no problems other than reporting a "sore arm". The outcome of the patient was not reported. additional information has been requested.
This spontaneous report was received from a medical assistant and refers to multiple patients of an unknown gender and age. No information regarding the patients' concurrent conditions and medical was provided. On unknown dates (reported as multiple unspecified dates), multiple patients were vaccinated with improperly stored doses of ROTATEQ lot # K014826, expiration date: 28-MAY-2016 (dose and route of administration were not reported). The patients' concomitant therapy was not reported. There were no adverse effects reported. This is one of the reports received from the same reporter. Additional information has been requested.
Experiencing pain in the top of left arm. Next day pain radiated down to wrist. A couple of days later that subsided. Pain is ongoing in arm and shoulder. Prescribed Lidocaine by physician.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 15-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 372 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
5/26/2000 Left shoulder site, 6cm pink, mocular area, tender warm to touch, small firm palpate nodule under skin. Treatment warm compresses. 5/27/00 seen again area 5cm. Given medicine dose pack.
Couldn't stay awake, couldn't hold my head up, nor talk, nor put words together, was very lethargic, arms and body were not working with me. Couldn't make a sentence or function at all. Took me quite some time to get back home fom my grandsons school. My kids asked what was wrong, they could see I was in bad shape, I went to lay down for a few hrs. before I could even get back up. Felt as if my feet had been cut of and all blood drained out. But was wose than I've had before, but the worst was the inability to function, so to speak.
Positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for COVID-19) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced COVID-19 (Positive for COVID-19). On 22-Jan-2021, COVID-19 (Positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  On 11JAN2021 patient had COVID 19 symptoms (eye pain, sore throat and headache).
Dime size hard, swollen, red lump at the injection site (thigh).  Today's date is 10/2/2013 and patient's leg still has a hard lump but it is smaller and no longer red.
Patient presented to the ED and was subsequently hospitalized for left arm pain, chest pain within 6 weeks of receiving COVID vaccination.
Itch on her left arm; sore/severe pain; Covid arm; Could not lift her left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Covid arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her left arm), VACCINATION SITE PRURITUS (Itch on her left arm) and VACCINATION SITE PAIN (sore/severe pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 78C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced VACCINATION COMPLICATION (Covid arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her left arm) and VACCINATION SITE PAIN (sore/severe pain). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itch on her left arm). At the time of the report, VACCINATION COMPLICATION (Covid arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her left arm), VACCINATION SITE PRURITUS (Itch on her left arm) and VACCINATION SITE PAIN (sore/severe pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medication information was reported. No treatment medications were provided.  Patient stated that she was experiencing pain and itching alternatively.   This case was linked to MOD-2021-310868 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow-up received contains non significant information
No other AE/no PQC/had no adverse effects or symptoms; caller mentioned that patient received a dose of GARDASIL 9 as a third dose; caller mentioned that patient received a dose of GARDASIL 9 as a third dose; a patient received her second dose of GARDASIL too early; This spontaneous report was received from a medical assistant and referred to a female patient of unknown age. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 04-OCT-2008, the patient received the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (strength, dose, and route of administration were not provided; lot #0570X, expiration date was not reported, upon internal validation established as 02-NOV-2010; once).  On 12-NOV-2008, the patient received her second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (strength, dose, and route of administration were not provided; lot #0548X, expiration date was not reported, upon internal validation established as 29-NOV-2010; once) too early (inappropriate schedule of product administration). The patient had no adverse effects or symptoms due to early dose.  On 28-APR-2022, the patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as a third dose in her series for prophylaxis (strength, lot #, expiry date, and route of administration were not provided; once) (inappropriate schedule of product administration and interchange of vaccine products).  No other adverse event was reported.
Local HD in house to assist with COVID booster clinic for our facility.  First series of Moderna had been administered on 3/2/22. Pt was administered a Bivalent vaccine instead of his required 2nd dose. This error was discussed with LHD and I was advised of: If a bivalent Moderna vaccine is administered for a primary dose: Repeat the dose immediately (no minimum interval) with a monovalent Moderna vaccine because administration of the bivalent Moderna vaccine will result in a lower-than-authorized primary series dosage. Some experts suggest delaying the repeat dose for 8 weeks after the invalid dose. After the dose has been repeated, continue with the recommended vaccination schedule (i.e., complete the primary series with a monovalent Moderna vaccine, then administer a bivalent booster dose at least 2 months after completion of the primary series). A monovalent dose was administered immediately per this recommendation
Patient said she started to feel soreness around injection site a couple of days after getting vaccine and that it spread.  She reports there is also redness on her upper mid arm.  One week after vaccine she is still experiencing redness and soreness and it has gotten worse.
This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in an unspecified number of patients who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site erythema, contusion and joint range of motion decreased. On an unknown date, the outcome of the injection site erythema, contusion and joint range of motion decreased were unknown. It was unknown if the reporter considered the injection site erythema, contusion and joint range of motion decreased to be related to BEXSERO. Additional details were provided as follows: The health care professional could not provide patients demographics, lot number or expiration dates. The age at vaccination was not provided. After receiving BEXSERO, the patients experienced redness at and around injection site, bruising and limited range of motion. This case has been linked to the case US2019051643, reported by the same reporter.
Pain and burning at injection site (didn't happen the first time). Total body joint pain and lethargy, general malaise, headache, light headed, weakness. Intermittent chest pains, kidney pains. Lasted until Monday at 1300 when I went into a full sweat. Only symptom remaining is soreness and tightness at base of skull/neck.
POSITIVE FOR COVID-19 INFECTION; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a consumer concerned a 17 year old female. Initial information was processed with the additional information received on 14-DEC-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) .5 ml, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced product administered to patient of inappropriate age, and off label use. On 07-DEC-2021, the patient experienced positive for covid-19 infection. Laboratory data included: Body temperature (NR: not provided) 103 F. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from positive for covid-19 infection, and the outcome of product administered to patient of inappropriate age and off label use was not reported. This report was non-serious. This case is associated with product quality complaint number 90000206738. This case, from the same reporter is linked to 20211230837 and 20211232501.; Sender's Comments: V0- Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Extreme low energy; Feels like my heart is over working; Extremely tired; Muscle ache; Hard to breathe sometimes; Lack of sleep; Cold hands & feet; almost like my heart beat is off; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: ASTHENIA (non-serious), outcome "unknown", described as "Extreme low energy"; HEART ALTERNATION (non-serious), outcome "unknown", described as "Feels like my heart is over working"; FATIGUE (non-serious), outcome "unknown", described as "Extremely tired"; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache"; DYSPNOEA (non-serious), outcome "unknown", described as "Hard to breathe sometimes"; INSOMNIA (non-serious), outcome "unknown", described as "Lack of sleep"; PERIPHERAL COLDNESS (non-serious), outcome "unknown", described as "Cold hands & feet"; HEART RATE ABNORMAL (non-serious), outcome "unknown", described as "almost like my heart beat is off".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt complained of knot at injection site that was warm to the touch. i recommended applying cold compress and seeking medical attention
Patient with episodes described by parent as shaking ("startling") of body lasting up to 30 seconds during which the patient was not responsive to name being called. Mother of child reports that during each episode patient was noted to have fever. The fever and shaking episodes started 6 days after MMR and varivax given.