chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Fatigue; Sore arm; This is a spontaneous report from a contactable other healthcare professional, the Patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6204) via an unspecified route of administration in the right arm on an unknown date (at the age of 33-year-old), as a single dose for COVID-19 immunisation. Medical history included hashimotos thyroiditis and acid reflux. Concomitant medications included ethinylestradiol, norelgestromin (XULANE), sertraline (MANUFACTURER UNKNOWN) and multivitamin(MANUFACTURER UNKNOWN); all for unknown indication from an unknown date. The patient previously took cyclobenzaprine (MANUFACTURER UNKNOWN) and FLAGYL; both on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced headache, fatigue and sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events headache, fatigue and sore arm was recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Humming / vibration in brain Joint stiffness  Joint pain Vision blurring Kidney region pain Headache  Breathing difficulties
tested positive for Covid; Pain in arm; Dry mouth; a little headache; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unspecified, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in right arm on 20Jan2021 at 12:00 as 1st dose, single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unspecified, Expire Date: unknown) via an unspecified route of administration, administered in right arm on 12Feb2021 at 19:00 (at the age of 45-year-old) for COVID-19 immunization. The patient' medical history included former smoker; Verbatim: she used to smoke before, so she was a former smoker and high Prolactin; Verbatim: At that time, she had, high Prolactin and does not think she was on medication at that time. The family medical history reported as none. The prior Vaccinations within 4 weeks was reported as none. Additional Vaccines was not administered on same date of the Pfizer suspect. Concomitant medication(s) included gabapentin (GABAPENTIN) (Lot number: unknown, Expiry date: Discard after 30Apr2022) as 300 mg, 3x/day and Patient stopped taking it maybe 2 months ago. She does not think she was taking it even 3 months. She got tired of took it because she did not saw any improvement and bromocriptine (BROMOCRIPTINE) taken for high prolactin, as 2.5 mg, 1x/day with ongoing, she was taking this now but does not recall if she was taking this prior to the COVID-19 vaccine. On 21Jan2021, the patient experienced pain in arm, dry mouth, a little headache. On 24May2021, the patient had COVID-19 positive. 07Jun2021, Monday, the patient went back for a test again and it was negative. She stated that, she had 2 kids. She was scared of COVID-19 and wanted to be secure and safer. At that time, she had, high Prolactin and does not think she was on medication at that time. Maybe, she was not too sure. She could not recall if she was taking Bromocriptine, she was taking it now. She stated that the only side effect she had was pain in her arm for the first dose, and dry mouth and a little headache. It started the next day and lasted only one day. The patient underwent lab tests and procedures which included COVID-19 test: positive on 24May2021 and COVID-19 test: negative on 07Jun2021. Patient was not received treatment for the adverse event. The outcome of the event tested positive for COVID-19 was recovered on 07Jun2021, all other events was unknown.
Fever, body aches, arm pain (at injection site); bilateral eyelid swelling, lip numbness/swelling
101-104.5 Degree fever for 3 days followed by erythemic maculopapular rash indicative of measles infection. Medicated with children's Advil every 6 hours and cool bath to decrease temperature. Treatment was effective at fever reduction.
Patient came in for 1st dose, was getting notifications of high heart rate during the day. reported no other symptoms. Was feeling fine and wanted to proceed to receive Pfizer vaccine .  Patient stating that she had notifications all day of HR 160s while talking to writer sitting in observation area. Pulse monitor placed on patient finger reading 130s-140 sitting BP 114/76 HR 136 standing ( unable to read BP ) HR 150s patient became dizzy, no fall  patient wheeled to triage room in supine position with ice pack. states feeling much better BP 125/77, HR 106 Patient did not want to go home and requested to go to hospital for eval 911 activated and in to pick up patient to transfer to ER   (This same event has happened before 1 month prior and was seen and evaluated by PCP)
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 18-JAN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
No adverse reaction.  Vaccine temperature excursion. Vaccine was kept at a frozen temperature, not refrigerated temperature upon receipt of shipment.
This spontaneous report as received from a certified medical assistant refers to a 16 years old patient who on 25-JUL-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). It was reported that the patient received ZOSTAVAX in error. No known adverse effects were reported. Additional information has been requested.
Patient came to pharmacy 8/20/18 to ask if she should get second dose of SHINGRIX based on events that occurred 1 month after she received the first dose. She stated that she started experiencing symptoms of high blood pressure the week of 6/4/18-lightheadedness, head pressure, and weakness in arms. Another episode happened on 6/11/18. She went to her primary care physician and saw the nurse practitioner who prescribed HCTZ 12.5 mg qd. On 6/15/18, she had 2 more episodes of high blood pressure for which she called her doctor and was instructed to go to the ER. She had a CT scan and work up and everything was normal except for blood pressure. On 6/19/18, she was started on metoprolol er 25 mg qd. Then on 6/21/18 she had another episode of the same symptoms as before but also with blurred vision. She went to the ER and had a CT with dye which was normal. She had her last episode of high blood pressure symptoms on 7/6/18 and has been controlled on the previously prescribed meds since that time.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Pain in lower back and legs difficulty breathing at first but went away before I could administer epipen-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt stated she felt like she couldn't breath so I ran out to her and she said she felt like her face was numb. While getting the epipen, I told her to  take deep breaths. She said her breathing was fine so I did not administer Epinephrine, she then stated her lower back was hurting and her legs were hurting and she needed to stand up. I checked her vitals, temp was  97.3 and BP was 131/93 pulse 99. Pt followed up with MD and is ok per phone call
C/O generalize weakness/fatigue, loss of appetite. Hospitalized due to CKD stage 4, acute UTI, hypomagnesemia, hypercalcemia, hyperthyroidism
pt states she developed chills, fever, sore muscles along with loss of taste and smell.  Fever and chills lasted about 48 hours but the sore muscles and loss of taste and smell lasted four weeks.   Pt went to her clinic and she was treated with Tylenol.  This seemed to help relieve her symptoms.  Pt no longer has any symptoms other than a sore left arm.
Information has been received from a physician concerning a 24 year old female healthcare worker with dizziness and sleep disorder and a history of pain who on 02-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy included ROZEREM. Subsequently, the patient experienced more severe dizziness after her first dose. The patient sought medical attention, saw a physician and had an eye check performed. At the time of reporting, the patient's dizziness persisted. No additional AE information provided. Additional information has been requested.
Shot #1 12/18, Shot #2 1/15. 2 white lesion appeared on tongue on 1/25. No associated loss of taste, smell, ulceration, pain, fever. Remained unchanged. Perhaps increased tongue sensitivity. 2/17 photos evaluated by Derm colleagues, concern for COVID tongue, recommended ENT evaluation. 2/18 dentist full oral exam, concern for lichen planus, recommended ENT evaluation. 2/19 evaluated by ENT, concern for lichenoid reaction d/t vaccine. Oral topical steroids started (dexamethasone swish and swallow). Today is day 7 of 9 day course. Appreciable near resolution of lesions. Resolving tongue hypersensitivity.
PAIN IN UPPER LEFT SHOULDER/BACK (SAME SIDE AS SHOT WAS GIVEN IN THAT ARM).  PAIN REMAINED IN THAT AREA AND ALSO IN LOWER BACK FOR ALMOST 5 DAYS NOW.
DIARRHEA; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 10-APR-2021 12:20 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.9 (not reported). On 11-APR-2021 05:00, the subject experienced diarrhea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, body aches, and fever, and had not recovered from diarrhea. This report was non-serious.
Information has been received from a healthcare worker(medical assistant) referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On 22-JUL-2015 the patient inadvertently received a dose of PROQUAD (Merck) (dose, route not reported, lot # K025766 with expiration date 08-JUN-2016) instead of an intended dose of VARIVAX (Merck) (wrong vaccine administered). The patient also received a dose of M-M-R II during the same visit on 22-JUL-2015. No adverse effects were reported. Additional information has been requested.
Itchy sensation all over body where there was welts and swelling; burning sensation all over body where there was welts and swelling; Welts turned into rashes; Welts all over the body; Swollen toes and feet; Whole right side became inflamed; Rash on right and left shoulder; A spontaneous report was received from a consumer concerning herself, who is a 39-years-old male patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events whole right side became inflamed, rash on right and left shoulder, welts all over the body, swollen toes and feet, itchy sensation all over body where there was welts and swelling, burning sensation all over body where there was welts and swelling, welts turned into rashes.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received a doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the events whole right side became inflamed, rash on right and left shoulder on 17 Feb 2021, on  18 Feb 201 welts all over body, swollen toes and feet, itchy burning sensation all over body where there was welts and swelling, welts turned into rashes.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events whole right side became inflamed, rash on right and left shoulder, welts all over the body, swollen toes and feet, itchy sensation all over body where there was welts and swelling, burning sensation all over body where there was welts and swelling, welts turned into rashes was unknown.
Incorrect route of drug administration (LLT: IM formulation administered by other route). This case was considered medically important (OMIC) for event of petechiae. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 14 month old female pt who developed petechiae all over her body. At 14 months of age, the pt received the second dose of Prevnar (administered via the subcutaneous route) along with the first dose of MMR (measles mumps and rubella vaccine) in Feb 2006. The pt's concurrent illnesses include von Willebrand's disease, adoption and hepatic enzyme increased (developed after first Prevnar vaccination (November 2005), with a past history of petechiae (developed after first Prevnar vaccination (Nov 2005). No known allergies and no blood transfusions. Indication for Prevnar was immunization. Product was administration in Feb 2006. Dose regimen was 1 dose 1 time per day (SC). Concomitant medications were not reported. The pt's mother reported that her daughter developed petechiae all over her body after receiving a second dose of Prevnar in Feb06. The vaccine was administered subcutaneously (incorrect route of drug administration) because of child's coagulation disorder. The petechiae reportedly increased until  they covered every inch of her body.  The child was taken to the emergency room 2.5 weeks post immunization for increasing petechiae. Blood work revealed platelets within normal limits; there was no cranial bleeding. Treatment was not given. Recovery is unk. Platelet count (results: revealed platelets wnl) was done in Feb06. Additionally, blood test (results: prior to adoption- no abnormal blood work) was done on an unspecified date.
Right thigh where injection was given was red, swollen, hot/hard to touch and size of quarter.
Four hours after receiving the first dose I experienced  substantial swelling , redness, heat, and a very heavy upper left arm. I was unable to sleep on that side for a week. The redness , swelling and heat lasted 14 days. My doctor looked at my arm on day 11 , and was surprised seeing the bright redness and feeling the heat 11 days after vaccination. The full healing  finally occurred on day 15. Hence  I opted not to get the second dose since the reaction might be far greater.
during medical monitoring, 5 minutes after receiving vaccine client started having chest tightness, dizziness. Pt was evaluate don site by medics and 911 was called. Pt was transported to Hospital.
Severe cramps; Heavy menstrual bleeding; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Severe cramps) and HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSMENORRHOEA (Severe cramps) and HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding). At the time of the report, DYSMENORRHOEA (Severe cramps) and HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were reported. No Treatment Medications were reported.
This spontaneous report was received from a back office lead and refers to a 27 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-APR-2016, the patient was vaccinated with an improperly stored dose of VAQTA lot # L014265, expiration date: 28-APR-2017, 1 ml, intramuscularly, in right deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot # L040459, expiration date 06-APR-2017; lot# K010215, expiration date 05-MAY-2017; lot# K008931, expiration date 04-MAR-2017; dose and route were unknown). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Got my booster around 12:30pm on 11/23 - also got my flu shot in the same arm (right) By 10-11pm, I had chills, fever, body aches and lasted until the morning. Also woke up with a massive headache on the right side - sharp strong pain, made it hard to see in the sun/bright lit areas  Fever went away around 1-2pm but still had really bad headache.  Took an Advil around 4pm. Went away around 6pm.  Arm was still sore then 2-3 days later started to get a rash close to where I was poked. The rash was warm and lasted for about a week. Then arm bruised for 5-7 days. Bruise is getting smaller but still visible until today.
A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving FLUMIST quadrivalent (intranasal) 0.2 mL (0.1 mL in each nostril), once/single administration. FLUMIST quadrivalent started on an unknown date. The patient experienced patient number thirteen given FLUMIST that underwent a temperature excursion and it was unknown if the dose of 0.1ml was given in each nostril. FLUMIST quadrivalent was continued. The outcome of the event of patient number thirteen given FLUMIST that underwent a temperature excursion and it is unknown if the dose of 0.1ml was given in each nostril is unknown. The report was considered to be non-serious.
The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022; The patient received vaccine past its 30 days of an expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2022 at 1:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Feb-2022 at 1:05 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had received the vaccine dose number as booster.  No Concomitant medication reported.  It was reported that a series of approximately 540 patients had received lot 066H21A past its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and this lot number was no longer possessed.  No Treatment medication was reported.
5 month old patient was administer Kinrix, which is approved for ages 4-6 years. Patient/patient's parent has not reported any adverse reactions from the shot or other health concerns.
Pt developed erythematous area about 20cm X 15cm in right thigh, around the injection site. No swelling but mildly warmer on the right more than on the left. Not pruritic area. Skin is smooth with no fluctuation. Treated with Duricef 250/5ml 3.5ml po BID.
LEFT BREAST SORE; LEFT ARMPIT SORE; BODY ACHES; RASH; INJECTION SITE SORE; This spontaneous report received from a patient of unspecified age and sex. 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: 1802070, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced left breast sore, left armpit sore, body aches, rash and injection site sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left breast sore, left armpit sore, injection site sore, body aches and rash was not reported. This report was non-serious.