chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient's symptoms are like adverse reaction; he developed a rash on his back that resembles a "heat rash"; he developed a fever, sore throat and cough; he developed a fever, sore throat and cough; he developed a fever, sore throat and cough; This spontaneous report was received from a registered nurse referring to a 54 year old male patient. The patient did not have pertinent medical history, concomitant medications, drug reactions and allergies.  On 22-APR-2019, the patient was vaccinated with zoster rge vaccine (mammalian)(SHINGRIX) (strength, dose, anatomical location, route of administration, lot#, expiration date, and indication were not reported) and on 08-JUN-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, anatomical location, and, route of administration were not reported) lot # R031681 with expiration date on 01-NOV-2020, indicated for prophylaxis.    On 18-JUN-2019, the patient developed a fever (pyrexia), sore throat (oropharyngeal pain) and cough (cough) and started taking over the counter guaifenesin (MUCINEX) and ibuprofen with relief.  On 20-JUN-2019, the patient developed a rash on his back that resembled a "heat rash" (miliaria).   The patient had not been treated by a physician and did not seek medical attention.  Laboratory diagnostics and studies were not performed.   The patient went to the emergency room on 20-JUN-2019, where he was seen by the head of infectious disease with department of public health, and it was determined that the patient's symptoms were like adverse reaction (vaccination complication) to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine but absolutely not an active case of measles. The patient was not admitted to the hospital.   The outcome of pyrexia, vaccination complication, miliaria, cough and oropharyngeal pain was reported as not resolved.     The causal relationship between the events with the suspect therapies was not reported.
Pt had remicade tx and felt like he was having a stroke - dizziness, headache, memory loss - same sx as last stroke.
Toileting and had expired while doing so; Severe abdominal pain; Diarrhea; Vomiting; Mild injection site pain; A spontaneous report was received from a healthcare professional concerning an 88-year-old , female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, toileting and had expired while doing so (death), mild injection site pain, severe abdominal pain, diarrhea, and vomiting.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient felt mild pain at the injection site after receiving the vaccine.  On 21 Jan 2021, the patient reported severe abdominal pain, diarrhea and vomiting. These symptoms were intermittent for a week and no other adverse events were noted.  On 27 Jan 2021, the patient passed away while toileting.  Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 27 Jan 2021. The cause of death was unknown. An autopsy was not performed.; Reporter's Comments: The gastrointestinal events were consistent with increased risk associate with elderly age of patient. The cause of death was unknown. Autopsy was not performed. Very limited information regarding the events is available at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death
Information has been received from a consumer concerning a 25-year-old female, approximately 9 weeks gestation, with an allergy to vicadin and other allergies who on 05-MAY-1995, at 14-years-old, was vaccinated with the first of two doses, SC with a 0.5mL dose of Varivax (Merck). Concomitant therapy included Claritin. "Two weeks ago", the patient became pregnant, and on approximately 13-SEP-2006, the patient was tested for antibodies to chickenpox. The test was negative. No additional information was available. Unspecified medical attention was sought. There were no lab diagnostic studies performed. The outcome was not recovered. There was no product quality complaint. Additional information has been requested. Follow-up information indicated that the patient was tested for antibodies to chicken pox and the test was positive. No further information is available.
Hepatitis A vaccine was inadvertently ordered on a 7 month old instead of Hepatitis B. The error was not caught by nursing the the vaccine was administered.
Information has been received from a nurse practitioner concerning an 40 year old female with hypertension and a history of shingles who in April 2008, was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot number, injection site and route not reported).On approximately 29-JUL-2008, also reported as 2 weeks ago, the patient developed shingles. Unspecified medical attention was sought. The outcome of the patient was unspecified. Additional information has been requested.
never received the 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13th May 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's comment: This case was reported by the patient. The patient received only 1st Shingrix and never received the 2nd dose. The patient asked if he or she should get 2nd dose or start the vaccination series over again with the 1st and then 2 to 6 month later to get the 2nd dose. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Moderate pain, swelling, and redness at injection site, flulike symptoms, aches in muscles, stomach ache, headache, left leg pain.
FLUZONE intradermal given 1/11/13 came to pharmacy 1/13/13, 4pm arm red, slight swelling & blister formed at shot site told BENADRYL, NEOSPORIN, contact primary doctor.
Neurological:  dexterity in fingers/arms impaired, balance affected, sensation in nasal bone area.  Feeling off, mild headache.
Patient recieved the H1N1 vaccine (nasal) on 12/10/2009.  We noticed a rash starting on her stomach and face 12/12/2009. This rash spread throughout her body including her back, face, ears, stomach, legs & neck which also caused her to itch all over her body.  Patient was seen by her doctor on 12/14/2009 she is currently being treated with Benadryl every 4-6 hours.
Injection site pain; fever; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 18Mar2021 at 11:15 as a single dose for COVID-19 immunisation. The patient medical history included benign prostatic hypertrophy. Concomitant medications included tamsulosin (MANUFACTURER UNKNOWN) and vitamin c (MANUFACTURER UNKNOWN). The patient previously took her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on left arm on 25Feb2021 at 11:15 as a single dose for COVID-19 immunisation. Prior to 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 4 weeks prior to the COVID vaccine. On 18Mar2021 the patient experienced injection site pain and fever. The clinical outcome of the injection site pain and fever recovering/resolving at the time of report. No follow-up attempts are needed. No further information is expected.
w/in 12-14hr p/vax parents noted fever & extreme floppiness had 1 episode emesis-afterwards was floppy & unresponsive w/dusky lips x 1-3min;revived quickly w/tactile stimulation;
Several days after my first vaccine, I started getting terrible headaches ( I am not a headache sufferer).  They progressively got worse instead of better.  I was taking up to 10 Tylenol a day to try to control the pain.  The DAY AFTER my second vaccine, my husband called rescue and I was hospitalized for the "worst headache of my life".  This has continued for SIX months.  All the NSAIDs I have taken for the past six months to control the  headaches, have caused ulcers which led to a GI bleed.  I was hospitalized for this on September 7 while experience life debilitating headaches.  I was hospitalized again September 12 for "the worst headache of my life".  This has affected my life and I cannot function.  All this started immediately after being vaccinated.
Since I received the "jab" my menstrual cycle has been very erratic .  I usually get my period 19th, 20th or 21st.  But over the last few months  it has not been the same. For instance;  This month ( June 2021)  I bled for 1 day on the 4th then 6 days later 6/10 it started back.  Today is the 10th so I can not tell you how long it will last but last month it was the same thing .
They only gave her 0.3 and gave her second shot containing 0.2 three hours later; Soreness in her upper arm; Slight headache; A spontaneous case report was received from a consumer concerning herself, a female patient age 68, who experienced a medication error when she was vaccinated with Moderna Covid-19 Vaccine (mRNA-1273) . She also reported, "some soreness" in her arm and a "slight" headache.  The patient's medical history included  a report of "heart issues" . No other medical history was provided. Concomitant product use was not provided.  On 08-Feb-2021,  (time not provided), prior to the onset of events, the patient received her first dose of mRNA-1273, Lot number 024m20A, intramuscularly into her left arm.  At some time later the same day the patient received a call from the vaccine clinic. The patient stated, "The people who were conducting the vaccine clinic said I should return because I was given the wrong dose"   The patient stated that upon her return to the clinic on 08-Feb-2021, she asked a lot of questions.  She was informed that the nurse had given her 0.3 and she should have given her 0.5. She was "not sure if it was milliliters or what". Some 3 hours after receiving the first wrong dose of 0.3, the patient reported receiving a second injection of 0.2 IM. The patient did not report the site where the second dose was administered or whether the lot number was different.  The patient reported that she developed "some soreness" in her arm and a "slight headache" when she went to bed on 08-Feb-2021. She reported the headache had resolved when she awoke on 09-Feb-2021.   No treatment information was provided regarding her arm soreness or her headache.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the events Product administration error and Pain in extremity were considered unknown. the event Headache was considered resolved.  Company comment: the reported events Product administration error was considered not applicable with regard to mRNA-1273.  The events Pain in extremity and Headache were considered possibly related to mRNA-1273.; Reporter's Comments: This report refers to a 68 Y/O female who had an NS unexpected event of Product administration error (mRNA-1273 lot # unknown) with NS unexpected pain in extremity and NS expected headache. Event onset the same day as second dose mRNA-1273. Reporter stated that 3 hours after first wrong dose of 0.3, she had a second dose of 0.2 IM. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Client received 1st dose of COVID vaccine of Pfizer (Lot #EW0187, expiration 06/27/21). At 1806, Client reported a minor burning sensation at injection site (left arm). At 1807, EMT and EMT responded to this event. At 1807, vital signs are blood pressure 112/78, heart rate 75, oxygen saturation 99%. At 1808, RN responded to this event. Client reported in taking a Benadryl this morning for a runny nose. Client reports no past medical history and no medications taken routinely. Client reports no blurred vision, no chest pain, no shortness of breath, no dizziness, no nausea, no headache. RN educated Client about ED precautions and common adverse effects of COVID vaccine. RN provided ice pack compress to injection site (left arm). At 1827, vital signs are blood pressure 110/80, heart rate 73, oxygen saturation 100%. Client reports burning sensation is subsiding. Client stood up with no complains and walked out of facility with a steady gait at 1832.
Rash to left forearm - patch of papular ery rash and to buttocks, upper legs and at waist line.
Swelling & redness of (L) upper arm that started the day after the Tdap was given.
Patient describes adverse effect after both shots, started with first pfizer shot and got progressively worse through and after the second.  She describes having dizziness that would not go away, it was mild at first and started the day of the first shot, but then progressively worsened , especially after second shot.  She also describes being bedridden temporarily after both shots.  Plus, she developed high blood pressure that she doesn't quite remember exactly when it started, but started somewhere after the first shot and before the second shot.  She now has to take meclizine twice a day every day for almost a year straight now to help her with the dizziness and had to take a new medication , valsartan, for the newly diagnosed blood pressure issue.  She said she felt the pressure go up in her own head after getting the shot, and clinically never had high blood pressure before until after she got the shot, which her doctor confirmed as she was started on valsartan.  She was told by her physician that this may be a long term health condition that she now has to deal with.  She said if she misses any doses of the meclizine she notices she gets severe dizziness that impairs her ability to do every day things.
Seizures; A spontaneous report was received from a consumer concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced seizures.  The patient's medical history was not provided. Concomitant product use was not provided.  On an undisclosed date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   A social media message was received from a consumer concerning a female patient who developed seizures after receiving the Moderna COVID-19 vaccine. The report stated that the patient was still in this condition more than a week after receiving the vaccine and that she was sent home from the hospital.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, seizures, was considered unknown.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of seizure. The event occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment details were not provided.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Redness and swelling in left arm. Pt. took 2 doses of BENADRYL. Completely resolved by next day.
involuntary movements of the mouth, jaw, and tongue Narrative: Pt had 2nd COVID SHOT ON 3/10/21. A few days later he started having involuntary movements of the mouth and jaw-jutting out jaw and moving tongue back and forth. Potential causes/confounding factors: - Patient is taking risperdal (wife confirms patient is taking) - Per patient's wife, 3-4 years ago patient saw neurologist because patient was having memory problems and making comments in conversation that did not make sense. Head MRI showed Patient had "more white matter then he should and some lesions." Patient and wife were it could be early signs of Parkinson's or MS. Neurology an Psychiatry consulted, Head CT orders, Records being requested from previous neurologist.
S: About 20 minutes after shot, she felt like her arm "exploded", like the shot was going through her body. She checked on the site in the bathroom, and it looked fine. She did not notify the nurse right away. When the nurse checked on her, she reported that she also had an itchy scalp. BP 160/98, HR 66 and regular. EMS called. Denied difficulty breathing. O2 stats wnl. Increased red mottled skin noticed on chest, left arm, pt transported to hospital for follow up care. B: Pt reported PMH of hives,itchiness and high BP and having a shot of benadryl with her first Pfizer shot. Without anaphlaxis. Pt consulted with her doctor afterwards, and the doctor recommended premedicating with two allegras prior to getting
This spontaneous report was received from a licensed practical nurse and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter mentioned that on an unknown date, this indeterminate number of patients received a dose of RECOMBIVAX HB (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided) for prophylaxis; which had been exposed to excursion temperatures of 8.6 Celsius degrees on two different occasions (one for 15 minutes and the other for 3 hours). No adverse effects were reported. There was no product quality complaint involved. This is one of four reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014012: US-009507513-1704USA014013: US-009507513-1704USA014014:
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NODULE (knot on the leg) in a female patient of an unknown age 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NODULE (knot on the leg) (seriousness criterion medically significant) and BLOOD GLUCOSE INCREASED (high blood sugar). At the time of the report, NODULE (knot on the leg) and BLOOD GLUCOSE INCREASED (high blood sugar) outcome was unknown. Which was operated on.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high blood sugar (High) high blood sugar.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had visited the surgeon's office for a knot on her leg and she was operated on.  Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
No monthly period after receiving second Moderna vaccine. Visited OBGYN in June and ran blood work. Very high levels of FSH and low estradiol. Still no period on August 23, 2021 and a preliminary diagnosis of ovarian insufficiency.
pt recvd vax approx 930AM & became irritable w/crying; approx 2PM, same day, started w/tonic-clonic sz of upper extremities;
PATIENT HAD ITCHINESS IN SCALP AND A RASH IN AREAS. CAME INTO THE PHARMACY ON THURSDAY 12/6. SHE WENT TO THE PHYSICIAN ON 12/7 AND WAS DIAGNOSED WITH SHINGLES AND PRESCRIBED VALACYCLOVIR.
Swelling and redness approx. 4.0cm x 3.0 cm swelling , sore warm to touch. Started this am. Declines to have evaluated at this time.
Rash on left arm . Red and circular about 2 inches. It's itching and seems to be getting larger. No treatment other than observation.
LITTLE PAIN AT INJECTION SHOT; This spontaneous report received from a consumer concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcoholic, and other pre-existing medical conditions included: Patient had no known drug allergies and did not had any drug abuse or illicit drug use. The patient was previously treated with tetanus vaccine. 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the patient experienced little pain at injection shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little pain at injection shot. This report was non-serious. This case, from the same reporter is linked to 20210900297, and 20210900823.
16 hours after dosage: Chest (heart) pain & Elevated heart rate:  100 beats per minute at complete rest (along with fever, fatigue & muscle pain) 30 hours after dosage:  resting heart rate of 85-90 with chest pain & other symptoms reduced 54 hours after dosage: resting heart rate of 70 with symptoms almost gone
discomfort while sleeping; pain - pain level 3 on a pain scale of 1-10; small bump on his head; swelling of the lymph node on the right side of the head/swelling of the lymph node all the way back to the top of the right ear; arm is sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (discomfort while sleeping), PAIN (pain - pain level 3 on a pain scale of 1-10), SWELLING (small bump on his head), VACCINATION SITE PAIN (arm is sore at the injection site) and LYMPHADENOPATHY (swelling of the lymph node on the right side of the head/swelling of the lymph node all the way back to the top of the right ear) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm is sore at the injection site). On 21-Mar-2021, the patient experienced INSOMNIA (discomfort while sleeping), PAIN (pain - pain level 3 on a pain scale of 1-10), SWELLING (small bump on his head) and LYMPHADENOPATHY (swelling of the lymph node on the right side of the head/swelling of the lymph node all the way back to the top of the right ear). At the time of the report, INSOMNIA (discomfort while sleeping), PAIN (pain - pain level 3 on a pain scale of 1-10), SWELLING (small bump on his head), VACCINATION SITE PAIN (arm is sore at the injection site) and LYMPHADENOPATHY (swelling of the lymph node on the right side of the head/swelling of the lymph node all the way back to the top of the right ear) outcome was unknown.        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 and treatment medication information was reported.