chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experienced migraines for 14 days straight; blood pressure also went up for about 5 days; really dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (experienced migraines for 14 days straight), BLOOD PRESSURE INCREASED (blood pressure also went up for about 5 days) and DEHYDRATION (really dehydrated) in a 50-year-old male adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant product exposures included HYDROCHLOROTHIAZIDE and ATORVASTATIN for an unknown indication.    On 27-Mar-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the adult was diagnosed with MIGRAINE (experienced migraines for 14 days straight), BLOOD PRESSURE INCREASED (blood pressure also went up for about 5 days) and DEHYDRATION (really dehydrated). The adult was treated with LISINOPRIL for Hypertension, at an unspecified dose and frequency. At the time of the report, MIGRAINE (experienced migraines for 14 days straight), BLOOD PRESSURE INCREASED (blood pressure also went up for about 5 days) and DEHYDRATION (really dehydrated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Lisinopril dose was increased from 10 mg to 40 mg.
Severe unilateral HA behind left eye w/ light sensitivity, intermittent and throbbing which started the day after his 2nd dose. HA occurred multiple times/day and lasted 5-60 minutes before spontaneously resolving.
noticed vaginal bleed (~1mL) appeared 3hours or so after vaccine received. Not pregnant and menstrual cycle not slated to start until 10 days later.
Warm and red at injection site 9 days later. The  warm ness started on day 8, but no redness until day nine. The size is about the size and shape of a goose egg. Sore to touch.
This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. Information on patient's concurrent conditions, medical pertinent history and drug reactions was not provided. On 23-DEC-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose, route of administration, anatomical location, lot # and expiration date not provided). Concomitant medications were not provided. Subsequently, on 23-FEB-2016, the patient was vaccinated with a dose of GARDASIL. However, no adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 21st August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a month after receiving SHINGRIX, the patient experienced nasal soreness. On 21st August 2018, the patient experienced pharyngeal paresthesia. On an unknown date, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms and pharyngeal paresthesia were unknown and the outcome of the nasal soreness was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, nasal soreness and pharyngeal paresthesia to be related to SHINGRIX. Additional information was received as follows: The healthcare professional reported that the patient experienced flu-like symptoms, the sore nose which lasted for one week, and tingling in throat which began about one hour after receiving the vaccine. No further details were reported regarding the event.
The day after my second vaccine I had 101.6 and had COVID Arm painful  large swollen red area from elbow to shoulder.  Fever lasted for 3 days and all my bones hurt. Could barely get out of bed and had headache needed to stay in dark quiet room.
Fatigue, fever (101.7F), nausea w/o vomit, headache
swollen upper lip; dry mouth; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen upper lip) and DRY MOUTH (dry mouth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (swollen upper lip) and DRY MOUTH (dry mouth). At the time of the report, LIP SWELLING (swollen upper lip) and DRY MOUTH (dry mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt recvd vax & w/in 48hrs exp severe mini-stroke w/lt-sided weakness,mononucleosis,coughing,& HTN;pt was seen in ER;lt eye blacking out & lightheadedness x 5mins;dx lt eye blindness consistent w/amaurosis fugax/transient ischemic attack;
Expired Engerix B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 9-year-old female patient who received HBV (Engerix B) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th October 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 26th October 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Engerix-B on the day of reporting, which led to expired vaccine used.
Patient came in with Chest pain, SOB, dizziness, headache, tachycardia following 1st dose Pfizer vaccine. Diagnosis: subsegmental pulmonary embolism in right lower lobe.
High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
HEART RACING FEELING; PRESSURE IN THE BACK; TIGHTNESS IN THE BACK; SEVERE HEADACHE LOCALIZED TO TOP OF HEAD; COULD NOT SLEEP OVER NIGHT; This spontaneous report received from a patient. The patient's concurrent conditions included hypertension, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced could not sleep over night. On 11-APR-2021 21:00, the subject experienced pressure in the back. On 11-APR-2021 21:00, the subject experienced tightness in the back. On 11-APR-2021 21:00, the subject experienced severe headache localized to top of head. On 12-APR-2021, treatment medications included: paracetamol. On 12-APR-2021 10:00, the subject experienced heart racing feeling. Treatment medications included: ibuprofen. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 68. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep over night, had not recovered from severe headache localized to top of head, and heart racing feeling, and the outcome of pressure in the back and tightness in the back was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
9 days after receiving the SPV, the pt noticed a generalized outbreak of small, red papules located over arms, torso, face, legs and palms. He complains of pruritus only. He denies fever, chills, myalgias, headache, fatigue, malaise, shortness of breath, chest pain, visual changes. The lesions have begun to form vesicles. All lesions involved with the generalized rash are of the same stage. No treatment has been given. The primary vaccine site is well into the pustule stage.
Information has been received from a physician concerning a female in her 60's who about 2 years ago (approximately 2008) was vaccinated with a dose of ZOSTAVAX (Merck). The patient developed shingles after receiving the dose of ZOSTAVAX (Merck). It was also reported that the patient had "a really bad case of shingles and developed post herpetic neuralgia". The patient sought medical attention through an office visit. The patient's outcome was unknown. Follow up information received from a physician indicated that the patient was a 63 year old real real estate agent, customer service representative, with hypertension, osteopenia, no illness at the time of vaccination and with no significant underlying medical issues. There was no recent exposure to chickenpox or herpes zoster. On 21-DEC-2006 the patient was vaccinated with a first dose of ZOSTAVAX (Merck) (lot # 654603/1405F) into the left arm. On 26-MAR-2010 the patient developed severe herpes zoster in her right V1 distribution; V1 dermatome, the patient developed numerous multiple lesions (nearly contiguous) over her right forehead, upper eyelid and right frontal temporal parietal scalp. The rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. The patient's pain was quantified as 10. The patient also developed severe neuralgia. No direct fluorescent antibody done; no specimen was collected for PCR. At the time of this report the patient was improving but still ongoing and requiring medications (considered partially recovered). Post herpetic neuralgia and shingles were considered to be disabling. Additional information has been requested.
(Was also given a seasonal flu shot). About 3 hour after I began to feel hot with some chills, normal virus type symptoms I occasionally get with a flu shot, plus ache around the injection site (left bicep) which spread & worsened as night went on. Woke up about 3 am, and the pain extended from my left elbow to half way up the left side of my neck. The skin felt as though it was severely sunburned (worse than the usual dystrophy sensation), and my throat felt as if it was partially swollen (though it appeared normal in a mirror). Internist examination revealed no glandular swelling. He felt there was some reaction to the injections with my reflex sympathetic dystrophy which temporarily exaggerated the pain and touch sensations to their fullest despite my usual medications for symtom relief. It was about 6 days before the additional feelings of pain, swelling and burn subsided to their usual levels.
Alteration in vision, headaches. Left posterior parietooccipital lobe cortical hypodensity suspicious for acute-subacute infarct showing on CT scan. CT a of head showed Wedge-shaped edema posterior left temporal lobe may represent  acute infarction. Attenuated distal branches left posterior  cerebral artery in this distribution. No significant change compared to the noncontrast CT brain earlier today. Right lentiform nucleus and thalamic lacunar infarctions.  Will obtain MRI of head, echocardiogram, and carotid duplex along with further lab workup      These are age indeterminate.
mom came in for patient's next scheduled well visit, at 4 months on 10/14/19, and reported to the doctor that the patient was crying inconsolably after receiving her 2 month old vaccines on 8/15/19. mom never called the office to report the event as it was happening or shortly after.
Patient developed numbness, weakness, imbalance, urinary frequency and neuropathic pain suggestive of transvere myelitis.
patient received a double dose of Acthib and Ipol on the same day / no AE; Initial information received on 15-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 months old female patient who receive double dose of IPV (VERO) [IPOL] (lot number and Expiry date unknown) and HIB (PRP/T) VACCINE [ACT-HIB] (lot number UJ180AA and Expiry date 03-Jul-2021) via unknown route in unknown administration site on an unknown date for Prophylactic vaccination.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due extra dose administered.   At a time of vaccination No adverse events were reported.  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.
4 hours after immunizations given, inconsolable crying, screaming, alternating with periods of lethargy for the next 30 hours. Fever to 103 began about 8 hours after the shots were given. Tylenol given every 4 hours. Fever did not resolve until 24 hours later.
Information has been received from a medical assistant concerning a 38 year old male patient who was inadvertently vaccinated with ZOSTAVAX (Merck) instead of VARIVAX due to nursing error. No adverse effect reported. Follow-up information was received from the medical assistant and physician via telephone call providing patient's name and date of birth. She also provided the vaccine lot number: ZOSTAVAX (Merck) (Lot # 663673/1710X). The physician stated that the ZOSTAVAX (Merck) and VARIVAX were both kept in the freezer. She said that "the nurse thought it was the same vaccine" and that the nurse did not know they were 2 different vaccines. No further information is available.
Patient is fully vaccinated.  COVID + at ED visit 1/17/2022.  50-year-old female presents to the emergency department complaining of chest pain, shortness of breath, body aches, diarrhea, nausea for the last 2 to 3 days.  Symptoms progressively worsening.  Her chest pain is worse with coughing.  Numerous family members are sick with COVID.  She also has fever and chills.  Denies leg pain or swelling, denies history of DVT/PE.  No abdominal pain or constipation.  BP 173/70  | Pulse 64  | Temp 99.7 °F (37.6 °C) (Oral)  | Resp (!) 8  | Ht 165.1 cm (5' 5")  | Wt 98 kg (216 lb)  | LMP 11/10/2009  | SpO2 100%  | BMI 35.94 kg/m² Elevated troponin. EKG: Normal sinus rhythm, possible left atrial enlargement, possible anterior infarct age undetermined. CXR: No acute cardiothoracic process.She was given IV fluids, Toradol, Robaxin, Tessalon, Zofran. Discharged from ED.
Swollen lymph nodes in armpit, neck, and near ear on left side of body-same side as vaccine.; Tiredness, aches, and feeling down on energy for 3-4 days after second shot; Tiredness, aches, and feeling down on energy for 3-4 days after second shot; Tiredness, aches, and feeling down on energy for 3-4 days after second shot; This is a spontaneous report from a non-contactable consumer or other non hcp.     A 36-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 07:00 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included migraine. The patient's concomitant medications were not reported. The patient previously took bnt162b2 for covid-19 immunisation, capsaicin and experienced drug hypersensitivity. It was reported that, on 27Apr2021 06:00 patient experienced Swollen lymph nodes in armpit, neck, and near ear on left side of body same side as vaccine. Tiredness, aches, and feeling down on energy for 3-4 days after second shot. The outcome of the events was recovered on unknown date of 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. .
Chills, headache, Fever upto 102.2 degree F, generalized weakness and body ache.
TOOK SECOND DOSE 1 WEEK AFTER THE FIRST DOSE; This spontaneous case report (PVX2019-2503) received from a caregiver on 07-Oct-2019. It described a male consumer who "took second dose 1 week later after the first dose" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid prophylaxis.  Case report: The consumer started oral Vivotif on 30-Sep-2019 and went out of the town without taking his Vivotif. He took the second dose on 07-Oct-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took second dose 1 week later after the first dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose 1 week later after the first dose" was considered as not applicable.
I have been having chronic hives starting may 5th 2022 all over my body, swollen eye lid, lips. I went to the emergency room at hospital and was told they were chronic hives and was given prednisone and when I left then gave me a prescription for prednisone for 5days with 1 refill. I still have these chronic hives till this day  11/18/2022 and I have tried other medications like Allegra, ibuprofen  and Claritin and Zyrtec and the work and then started to not work as much
Began to experience for the first time arthritis pain in my lower back, both hips, neck and ankles,  and a newer pain in my feet and right wrist, and  a lesser pain hands.   I previously had arthritis in my knees, which continued.
After I finished the shot   .  pt fainted and fall down.   It was too fast. I hold one of his arm but he was too heavy  .  his dad was at his side at the time of injection   He fainted for about 5 seconds then his mom woke him up and let him lied down on her thigh.
SICKNESS (WHICH WAS DESCRIBED AS SICKER THAN A DOG); This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced sickness (which was described as sicker than a dog). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sickness (which was described as sicker than a dog) was not reported. This report was non-serious.
My left arm was sore immediately after the vaccine and is still sore 3 days later. I have a raised lump that is red, hot, and itchy, as well as sore. It is limiting my range of motion.
Arm swelled up "the size of a baseball," was very red, hot and had red streaks going down the arm. She called her doctor but he didn't call back so she "let it go." Resolved post 7 days.
temperature; aching arm; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 73-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 (Lot number: S318, Expiration Date: May2021) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose #1 on 01Feb2021 about 2pm in the left arm. Caller does not have NDC or dose to provide. States the CDC cards says lot S318, expiry May2021.), administration date: 01Feb2021, when the patient was 73 years old, for COVID-19 immunisation.  The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 22Feb2021, outcome "recovered" (2021), described as "temperature"; PAIN IN EXTREMITY (non-serious) with onset 22Feb2021, outcome "recovered" (2021), described as "aching arm"; CHILLS (non-serious) with onset 22Feb2021, outcome "recovered" (2021), described as "chills".  Additional Information: Patient History: No. Investigation Assessment: No. Agent relays the caller states after the second dose she had a temperature, chills and aching arm. States that the temperature, aching arm, and chills started by evening that same day, 22Feb2021 and cleared up by the end of the 2nd day, it lasted 24 plus hours. States for treatment she may have taken some Tylenol.  Follow-Up (31Aug2021): Follow-up attempts are completed. No further information is expected.
Information has been received from a consumer referring to her daughter, a 7 month old female patient. The patient was in stage 4 kidney failure. The patient's medical history and concomitant therapy were not reported. On 26-AUG-2016 at about 11 am (reported as "today"), the patient was vaccinated with GARDASIL (dose, lot # and expiration date not reported) intramuscularly instead of RECOMBIVAX HB. The nurse inadvertently administered the wrong vaccine. No adverse event was reported. Additional information has been requested.