chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccination done accidentally to 14 years old patient-no ae; Initial information received on 26-Dec-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 14 years old female patient who accidentally received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Product administered to patient of inappropriate age).  Medical history, medical treatments, vaccinations and family history were not provided.   On an unknown date (today), the patient received a dose of suspect received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number and other dosing details were not reported] via unknown route in unknown administration site.  It was a case of actual medication error due to product administered to patient of inappropriate age.  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.  Information on the batch number was requested.
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a female subject of unspecified age who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  On an unspecified dates the subject received the Twinrix series (unknown).  At an unspecified time after vaccination with Twinrix, the subject experienced decreased therapeutic response.  On an unspecified date, post-vaccination titers were performed by a physician which revealed that the subject had not adequately responded to the Twinrix series.  The physician was considering additional Twinrix dose(s) to "boost" the subject's response.  The reporter did not know the timing of the titers after the completion of the vaccination series or if the "non-response" was to hepatitis A, hepatitis B, or both components.  At the time of reporting the outcome of the event was unspecified.
sore arm; back ache; fatigue; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3893794-00.  A 48-year-old male patient received BNT162b2 (BNT162B2, solution for injection), on 08Jul2021 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "back ache"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "sore arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
First dose of vaccine administered to pregnant patient; Little soreness at injection arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (First dose of vaccine administered to pregnant patient) and PAIN IN EXTREMITY (Little soreness at injection arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0104214) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS and CLONAZEPAM (KLONOPIN) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 05-Jun-2021. On 01-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (First dose of vaccine administered to pregnant patient) and PAIN IN EXTREMITY (Little soreness at injection arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  On 01-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (First dose of vaccine administered to pregnant patient) had resolved. In March 2021, PAIN IN EXTREMITY (Little soreness at injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information reported. The patient wanted to go for glucose test at ultrasound clinic lab and her concern was if they would take blood from her right arm  where she received her first dose of vaccine as she had some condition with her left arm. The patient was not sure of her last menstrual period (LMP) and it was reported to be last week of Aug-2020. It was reported that patient developed little soreness at injection site which disappeared in 24 hours.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. Concomitant products included TYLENOL. On 23rd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd October 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, general body pain, chills, fever, headache, influenza-like symptoms, tiredness and stomach pain. On an unknown date, the patient experienced fever blister and weird feeling. The patient was treated with Valacyclovir. On an unknown date, the outcome of the pain in arm, general body pain, chills, fever, headache, influenza-like symptoms, tiredness, stomach pain and weird feeling were recovered/resolved and the outcome of the fever blister was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, general body pain, chills, fever, headache, influenza-like symptoms, tiredness, stomach pain, fever blister and weird feeling to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine in the afternoon and she experienced a sore arm. Several hours later in the middle, the patient had body aches, chills and a fever. The patient had the worse headache that felt like an axe went through her head that lasted for two days. The patient started to feel weird with flu like symptoms. The patient was really tired and all of these symptoms resolved within two days. The patient also had stomach pain which also resolved during this timeframe. The patient later developed three fever blisters in the inside of her lip and she tried creams and supplements and then had to be put on Valacyclovir because they would not resolve. The patient cannot recall the onset date for the blisters. The patient stated that she visited her periodontist and the doctor told her that he had three patients with full blown shingles as well. The reporter did not consent to follow up. The patient preferred to remain anonymous and no additional details were available.
Per patient report, symptoms began approximately one week after administration of first Moderna vaccine. Patient noticed a small grouping of pruritic papular lesions measuring 0.5cm or less over the ventral right wrist. Symptoms acutely worsened following the second vaccine on March 4, extending up the forearm, and growing to involve the bilateral forearms and posterior thighs. He used calamine lotion topically for symptomatic relief of itching. Symptoms were not reported to physician until a routine follow up appointment on 3/16/2021.
Came to office late am 8/7/02. Received multiple injection in LA (DTaP, IPV, MMR) (IPV and MMR were SQ). Arm became swollen, red, hot by 3:30pm 8/8/02. C/O stiffness and soreness. Taking Benadryl and Tylenol. Area is 4-5cm diameter.
Anaphylaxis 2 hours post injection with swollen tongue.  Patient taken to ER.  Patient reported to pharmacy on 10-5-09.
Got 2nd shot 04/23/2021 knew I'd be fatigued for a few days. Never got any better at one point could barely lift my arms. Started having shortness of breath that continued  until I went to ER.  (May 18, 2021). They diagnosed me with enlarged heart, water around my heart, and weakened heart muscle, congestive heart failure after going through many tests. As of right now, I am wearing a defibrillator vest 24/7 in case of heart attack! Hopefully get this off at the end of August then I'm not sure. DR put me on Entresto, Furosemide, Metoprolol, Spironolactone and low doe aspirin. Also, after being in the emergency room I developed a BAD cough that lasted approx. 2 and half months
(L) upper arm 6 cm x 5 cm area of swelling redness & warmth after varicella vaccine. Reaction started after vaccine on 11/24/10 now 2 days 11/26/10.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-DEC-2015 at 15:28, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 5.2 and 4.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Knots within the palms of our left hands; joint pain in all my fingers; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (Knots within the palms of our left hands) and ARTHRALGIA (joint pain in all my fingers) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB MASS (Knots within the palms of our left hands) and ARTHRALGIA (joint pain in all my fingers). At the time of the report, LIMB MASS (Knots within the palms of our left hands) and ARTHRALGIA (joint pain in all my fingers) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 antibody test: positive (Positive) Positive.         No concomitant medication reported. No treatment information was provided.  Within a week, there were knots within the palms of left hands. The patient states that they are going up his fingers. The patient reports that he has joint pain in all his fingers but he doesn't have arthritis. He states it was weird that they were both positive for COVID when they received their first vaccination. They tested positive on 29Dec2020.   This case was linked to MOD-2021-272986 (Patient Link).
Pt states that she has a red spot at the site of the injection as well as a bump.  Pt also reports being hoarse.
Rash across left side-posterior back spreading to anterior front, following dermatone, erythematous vesicles, painful.
diarrhea; massive headache; weakness; shortness of breath; chest pain; chest pressure; cough; tested positive for Covid; hyposmia; postnasal drip; stiffness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for Covid), UPPER-AIRWAY COUGH SYNDROME (postnasal drip), MUSCULOSKELETAL STIFFNESS (stiffness), HYPOSMIA (hyposmia) and DIARRHOEA (diarrhea) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2020, the patient experienced UPPER-AIRWAY COUGH SYNDROME (postnasal drip) and MUSCULOSKELETAL STIFFNESS (stiffness). On 30-Dec-2020, the patient experienced HYPOSMIA (hyposmia). On 31-Dec-2020, the patient experienced COVID-19 (tested positive for Covid), DIARRHOEA (diarrhea), HEADACHE (massive headache), ASTHENIA (weakness), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest pressure) and COUGH (cough). At the time of the report, COVID-19 (tested positive for Covid), UPPER-AIRWAY COUGH SYNDROME (postnasal drip), MUSCULOSKELETAL STIFFNESS (stiffness), HYPOSMIA (hyposmia), DIARRHOEA (diarrhea), HEADACHE (massive headache), ASTHENIA (weakness), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain) and COUGH (cough) outcome was unknown. Not Provided      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.   Treatment medications include Sudafed, Tylenol, zinc , vitamin c, Z-pak and inhaler. No concomitant medications were provided by reporter.
Very high fever, seizures, foaming at the mouth. Went to emergency room 8/29 was released. Had another seizure 8/30. Was admitted to hospital.
got Covid symptoms again and tested positive; got Covid symptoms again and tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Feb2021 as dose 1, single (Lot number: 031M20A), in right arm and on 20Mar2021 as dose 2, single (Lot number: 045A21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. Concomitant medication (other medication in 2weeks product) included: ASPRIN, start date: 29Apr2022, stop date: 01May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08May2022 at 12:00 and all described as "got Covid symptoms again and tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (unspecified date) Positive, notes: After taking Paxlovid and testing negative for consecutive days/Brand: Paxlovid/Indication: Treatment of Covid-19; (08May2022) Positive, notes: got Covid symptoms again and tested positive; (2022) Negative, notes: After taking Paxlovid and testing negative for consecutive days. Therapeutic measures were not taken as a result of drug ineffective, covid-19. On 02May2022, he started Paxlovid for Covid-19 and stopped on 06May2022. After taking Paxlovid and testing negative for consecutive days, got covid symptoms again and tested positive.  No follow-up attempts are possible. No further information is expected.
severe headache; Severe reaction with extreme pain and myalgia; Severe reaction with extreme pain and myalgia; This is a spontaneous report from a contactable physician. This Physician reported similar events for four patients. This is report 1st of four reports. A 17-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, lot# 809020), via an unspecified route of administration on 26Aug2020 at single dose for immunisation. Medical history and concomitant medications were none. The patient experienced severe headache, and severe reaction with extreme pain and myalgia on an unspecified date of Aug2020 with outcome of unknown. The doctor stated this was getting ridiculous 50% of shot causing headache and myalgia. Something must be wrong.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020335060 Same reporter/drug, similar event, different patient;US-PFIZER INC-2020335065 Same reporter/drug, similar event, different patient;US-PFIZER INC-2020335482 Same reporter/drug, similar event, different patient
I tested positive for COVID on 12/09/2020, symptoms began 12/02/2020. At the time, I list my sense of smell and taste. They returned around 12/20/2020. When I got my Covid vaccine on 3/2/2021, and hour later, I began smelling smoke. I don?t smoke, nobody in my household smokes, it is not coming in from the vents, and nobody in my household can smell it. It?s nauseous and it won?t go away.
I got an Embolic stroke on 4/4/2021- 9 days after I got the vaccines from Hospital.  On 4/3/2021 afternoon, I suddenly couldn?t see well, felt dizziness.  At 3 AM on 4/4/4021,  called 911 because I couldn?t feel my left side.   I couldn?t see well on my left eyes, couldn?t feel left hand, left leg, left face, and the rest  of my left side are numbed and I am not able to move after I was brought to the hospital.  I am now at  rehab Center.
Pt recvd DT inject & couple of seconds p/inject, no verbal response, color pale, slumped over, legs stiffened & had fine tremors noted w/no resp distress; Aroused p/15sec approx, very anxious w/HR 120, BP 150/80; Seen by MD;
Received vaccine #3 on 2/20/08.  Tolerated well.  Friday PM, had diarrhea for 24 hours.  No fever.  Seen at clinic.  Reassured patient.  She is a teacher and could have easily picked up a viral illness.  Doing well now.
minor heart stitches; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 16Jun2021 as dose 1, single (Lot number: FC3095) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ANGINA PECTORIS (medically significant), outcome "unknown", described as "minor heart stitches"; FATIGUE (non-serious), outcome "unknown".  Clinical course: The patient had first 2 vaccinations in 2021 and had passed without much incident. The patient did have minor heart stitches and fatigue but these complaints were not that severe.  No follow-up attempts are possible. No further information is expected.
As with many patients during the 2nd dose, on 5/3/21, I had fever, sweats, chills, and muscle pain, But on 5/5/21, I developed a rash and itching on my back and chest. The rash faded by 5/7/21 but the ITCHING continued, all over, esp my face, chest and back and lasted 5/11/2021.  Per my Dr, I was taking Claritin 10mg BID and Benadryl 25mg every 6 hrs to treat the itching with little relief.
Fatigue; Dizziness; Diarrhea; Excessive gas; Nausea; Headaches; Chills; Night sweats; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 09May2021 at 16:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and anxiety. The patient previously took Doxycycline and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone (MANUFACTURER UNKNOWN) and buspirone (MANUFACTURER UNKNOWN) both for unknown indications from an unknown start date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 18Apr2021 at 16:45 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10May2021, for 14 days following the second dose the patient experienced fatigue, dizziness, diarrhea, excessive gas, nausea, headaches and on occasion had chills and night sweats. The events resulted in doctor or other health care professional office/clinic visit and emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. On 14May2021, the patient underwent PCR oral swab test and the result was negative. The clinical outcome of the events fatigue, dizziness, diarrhea, excessive gas, nausea, chills, night sweats and headaches were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Received first dose Pfizer vaccine on 3/9/2021.  Advised by family member of covid exposure and tested neg on 3/12/2021.   On 3/18/2021 dev mild cough.  Repeat covid test neg.  On 3/19/2021  dev fatigue, fever 101.6.   3/22/2021 Eval by Dr  and had a neg rapid covid test.  Started on Bactrim x 10 days and adm a steroid inj.    On 3/23/ 2021 pm his "temp was high 99's ".   He has remained afebrile since.   He feels well and has only an occ mild cough.
Patient was very dizzy, nausea and became very pale within minutes will sitting in the chair after the vaccine.  Was offered water which he drank but the wanted to lie on the floor and he vomited.  Ambulance and 911 was called and they took his vitals/oxygen levels and watched for 20 minutes.  Patient became sick again but said did not want to go to hospital despite medical advice.
sick for 12 hours [after second shot]; bugging in his head; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 12 hours [after second shot]), HEAD DISCOMFORT (bugging in his head) and PYREXIA (fever) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 007B21A) for COVID-19 vaccination.     Concomitant products included CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (sick for 12 hours [after second shot]), HEAD DISCOMFORT (bugging in his head) and PYREXIA (fever). At the time of the report, ILLNESS (sick for 12 hours [after second shot]), HEAD DISCOMFORT (bugging in his head) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had never had a history of indigestion or problems eating, but he swung from eating a full meal and going for a run to having terrible indigestion. No medical history was reported. Patient took Moderna booster (lot 027H21B) on 20-NOV-2021. No treatment medications were reported.   This case was linked to MOD-2022-440894 (Patient Link).
08/31/22 presents to ED for "left hip pain". PMHx of "alzheimers, CHF, breast ca, DM, HTN, HLD"
Stiffening of left leg within ten minutes. Fever of 103 for three days. Involuntary stretching. Reappearance of HPV wart.
Pt had fever for about 12 hours, took nap, and was found several hours later with no pulse, respiration.
Pt recvd vax on 19SEP91 & a few days following vax devel pain in the lt tricep; on 4OCT91 c/o ache in arm which was felt mostly @ noc; at time of report pain persisted;