chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a little tired; achy for a day; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry dates were not provided), via an unspecified route of administration, on an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient had very little side effects from the vaccine, just a little tired and achy for a day. The outcome of the events was reported as recovered on an unknown date.  Information on lot/batch number has been requested.
Localized pain and some swelling. Swelling is approximately 1.5 cm in diameter and red.
Serious Criteria: Other - Medically Significant (OMIC). Initial report received from a health care professional on 24/Jan/2006. A twenty three month old female patient with no significant past medical history, had received an injection of ActHIB, lot number UE548AA (lot number Y0304), as well as an injection of Varicella vaccine, lot number 0116R, on 06/Jun/2005. That same date (assumed as per the reporter), the patient developed a fever and had a seizure. The temperature and type of seizure were unknown as per the reporter. The child was treated in an emergency room and was not evaluated by the responsible physician. It is unknown if any laboratory or diagnostic testing was performed. The child has recovered from the events.
The patient was tested with Tubersol accidently instead of receiving influenza vaccine, no AE~; The patient was tested with Tubersol intramuscularly, no AE; The patient was tested with 0.5 ml of Tubersol, no AE; Initial information was received on 17-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a patient (demographics unknown) who was tested with 0.5 ml TUBERCULIN TEST [TUBERSOL] intramuscularly instead of receiving a dose of INFLUENZA VACCINE for prophylactic vaccination on an unknown date.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to overdose, product administered at inappropriate site and wrong product administered  At the time of report, no adverse event was reported.  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.  There will be no information available on lot number.
does not remember when his sister first caught Covid-19 but he does know that it was after her first Primary Moderna Covid-19 vaccine; headache; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (does not remember when his sister first caught Covid-19 but he does know that it was after her first Primary Moderna Covid-19 vaccine) and HEADACHE (headache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COVID-19 (does not remember when his sister first caught Covid-19 but he does know that it was after her first Primary Moderna Covid-19 vaccine) and HEADACHE (headache). At the time of the report, COVID-19 (does not remember when his sister first caught Covid-19 but he does know that it was after her first Primary Moderna Covid-19 vaccine) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: first caught Covid-19 after her first Primary Moderna Covid-19 vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter.  The Patient has caught Covid-19 twice since receiving her Moderna Primary Series of vaccine. The caller did not remember when his sister first caught Covid-19 but he did know that it was after her first Primary Moderna Covid-19 vaccine. The caller said that his sister caught her second case of Covid-19 about 6 weeks ago.  No treatment medication was provided.  Company Comment: This is a Spontaneous case reported by a physician concerning an elderly female patient, with no medical history reported, who experienced the unexpected and non-serious AESI of COVID-19, which occurred within the following 11 months after the first dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-610656 (Patient Link).; Sender's Comments: This is a Spontaneous case reported by a physician concerning an elderly female patient, with no medical history reported, who experienced the unexpected and non-serious AESI of COVID-19, which occurred within the following 11 months after the first dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pt states she felt an ache in her left arm on Friday afternoon. She felt a hot touch at the site of injection. Husband told her it was very red.  States she had fever and chills on Saturday.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient with no medical history and no allergies. The patient was vaccinated with ZOSTAVAX (lot # was unknown) in December 2011. No concomitant therapy included. The pharmacist reported that patient was diagnosed with cellulitis for rash she had after receiving ZOSTAVAX back in December 2011. The patient saw physician for medical attention. The outcome of the adverse events was unknown. Additional information has been requested.
Pain in shoulder, hand, chest. Treatment: pain medication (ibuprofen), anti-nausea medication, Physical therapy.
Covid 19 Treatment; Covid 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "Environmental allergies" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "PCNs" (unspecified if ongoing); "Known allergies: adhesives" (unspecified if ongoing); "Known allergies: coconut oil" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PEPCID AC; FLONASE [MOMETASONE FUROATE]. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro"; Biaxin, reaction(s): "Known allergies: Bactrim"; Cephalexin, reaction(s): "Known allergies: Cephalexin".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that the patient received treatment of Paxlovid from 30Nov2022 to 05Dec2022 for of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from an office manager concerning a 15 year old female who on 11-NOV-2008 was vaccinated with the first dose of GARDASIL (Lot#661764/0650X), 0.5ml , IM and the second dose(Lot# 661841/0653X) 0.5ml, IM on 10-FEB-2009. The patient had been losing her hair after the third dose of GARDASIL (Lot#662300/0100Y), 0.5ml, IM in her right arm on 11-MAY-2009. Concomitant therapy included DEPO-PROVERA, 150mg, IM in the left arm. Caller was requesting a lot check of this vaccine due to the patient having adverse experience. The patient had sought medical attention. The outcome was unknown. The Lot Check had been initiated. Additional information has been requested.
eyes looked droopy; felt weak; couldn't hold her arms; stomach hurt; dry mouth; extreme fatigue; pain on her joints; she was so weak, so she hit her head ,she has severe headache; vomiting; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYELID PTOSIS (eyes looked droopy), ASTHENIA (felt weak), LIMB DISCOMFORT (couldn't hold her arms), ABDOMINAL PAIN UPPER (stomach hurt) and DRY MOUTH (dry mouth) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016T21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METHADONE 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 30-Apr-2021, the patient experienced EYELID PTOSIS (eyes looked droopy), ASTHENIA (felt weak), LIMB DISCOMFORT (couldn't hold her arms), ABDOMINAL PAIN UPPER (stomach hurt), DRY MOUTH (dry mouth), FATIGUE (extreme fatigue), ARTHRALGIA (pain on her joints), HEADACHE (she was so weak, so she hit her head ,she has severe headache), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, EYELID PTOSIS (eyes looked droopy), ASTHENIA (felt weak), LIMB DISCOMFORT (couldn't hold her arms), ABDOMINAL PAIN UPPER (stomach hurt), DRY MOUTH (dry mouth), FATIGUE (extreme fatigue) and HEADACHE (she was so weak, so she hit her head ,she has severe headache) outcome was unknown and ARTHRALGIA (pain on her joints), VOMITING (vomiting) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes medicines for her sarcastic episodes.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sore Arms; This is a spontaneous report from a contactable consumer (patient). This 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unknown route on 06Apr2021 at 08:00 (at the age of 22-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included, and concomitant medications not provided. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks and other medication in two weeks. On 18Jan2021, the patient nasal swab COVID test result was positive. On 06Apr2021,after vaccination at 16:00, the patient had sore arms. The patient did not receive any treatment. The outcome of the event sore arms was recovered.   Information on Lot/Batch number has been requested.
Diffuse itching, nausea, hypertension, sweating - No hives Treated with H1/H2 blockers, prednisone burst Discharged from ER after period of observation No epinephrine given
Smell chemical smells (other people nearby do not smell it). Sensing faux chemical smells.   Sense of smell has diminished. (Example: Essential oil diffuser is on, I smell the essential oils very faintly and people nearby smell it strongly).
This spontaneous report as received from a female consumer approximately 59 year old (currently 66 year old at the time of report). In 2006 when she was not 60 years old before the expanded age group to 50 she was vaccinated with ZOSTAVAX dose 1, subcutaneously (lot number and exp. date not reported). The patient reported that she had no side effects. The outcome of the event was unknown. Additional information has been requested.
Lumbar/back pain; A spontaneous report was received from a non-health professional concerning a 34-year-old, female patient who received Moderna's COVID-19 vaccine and developed lumbar back pain.  The patient's medical history included allergies to dust, pollen, and soymilk. Concomitant product use was not provided by the reporter.  On 12 Jan 2021, approximately 07:15am prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039KZ04) intramuscularly in the left shoulder for prophylaxis of COVID-19 infection.    On 12 Jan 2021, four hours after receiving the vaccine, the patient developed lumbar/ back pain. The patient also reported having the flu vaccine, on 09 Dec 2020. Treatment for the event included ibuprofen.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the event, lumbar back pain, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Red itchy rash on upper arm around the injection site, warm to touch,  arm feels sore and heavy
headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Congestion surgery) in November 2020.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). At the time of the report, HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided.  The patient did not receive any treatment because by 22-Jan-2021 he started feeling better.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI
chills; fever of 100.4 degrees Fahrenheit; Sweating; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Feb2021 (Lot Number: EN6201) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included joint pain from an unknown date and unknown if ongoing. Concomitant medications included naproxen taken for joint pain, start and stop date were not reported. The patient experienced mild side effects of chills and a fever of 100.4 degrees Fahrenheit. The patient stated that on unspecified date, "I am having chills overnight, I am sweating and I am running a low grade fever of 100.4. I am due to have a small family gathering this afternoon. Am I putting my family at risk if I go to that gathering?" When asked for event treatment, the patient stated, "No that is what the other part of the question that I wanted to ask but I have to call this other number and ask them what I have to." The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Digestional  issue  started fairly soon after I received my shot and were resolved within 7 hours. I do not know if this was related to the vaccine shot.soreness at I je toon site on the arm started 9-10 hours after vaccination.  Fever, chills, moderate to severe body aches, swollen/painful lymph node in armpit of left arm onset approximately 24 hours after shot. All are being  managed with Tylenol and have not completely subsided now 24 hours out from their onset.
expired vaccine administered past 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered past 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered past 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered past 12 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment medication were provided.
This case was reported by a healthcare professional (office manager and subject) via sales representative and described the occurrence of fever in a female subject aged between 40 and 49 years old ("around 45 years old") who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (1 "adult dose", unknown details). On the same day as vaccination with BOOSTRIX, the subject experienced fever and pain (described as "aches and pain"). The reporter stated that the events were systemic. At the time of reporting the events were resolved within 48 hours. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX.
Flu like symptoms: achy, lethargy, loss of appetite, slight fever for 2 days.. second day a lot less serious
pt recv vax 30SEP98 mom stated child has T100.7 & photosensitivity;8OCT pt temp remains 100.7 w/red & irritated eyes;no rash;
OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned an adult male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 18:45 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.
did not sleep; Pain; It feels like she has a bad case of the flu; She has never been this sick since she can remember; had diarrhea; terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (did not sleep), PAIN (Pain), INFLUENZA LIKE ILLNESS (It feels like she has a bad case of the flu), ILLNESS (She has never been this sick since she can remember) and DIARRHOEA (had diarrhea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (did not sleep), PAIN (Pain), INFLUENZA LIKE ILLNESS (It feels like she has a bad case of the flu), ILLNESS (She has never been this sick since she can remember), DIARRHOEA (had diarrhea) and HEADACHE (terrible headache). At the time of the report, INSOMNIA (did not sleep), PAIN (Pain), INFLUENZA LIKE ILLNESS (It feels like she has a bad case of the flu), ILLNESS (She has never been this sick since she can remember), DIARRHOEA (had diarrhea) and HEADACHE (terrible headache) outcome was unknown.            Concomitant medications details were not reported by the reporter. Patient might be taking ibuprofen as a treatment drug.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (experienced after 1st dose, refer case US2018149792). On 16th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient stated that SHINGRIX shot was painful. The pain was resolved within 48 hours. The patient declined demographic details and any other questions. Only information given was that reported. For tolerance after 2nd dose refer case US2018GSK152775.
The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 12 months old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 06-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Dose of the Covid Bivalent Booster was given 4 days after the BUD.  The vial had been in the refrigerator since 1/11/23 and should have been salvaged on 2/10/23.  Vaccine was given 2/14/23.  Patient states that she had a headache and some nausea and was in bed for 1 day, but states that she feels fine now.  Reported no swelling or redness.