chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Covid arm) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION COMPLICATION (Covid arm). At the time of the report, VACCINATION COMPLICATION (Covid arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-405602 (Patient Link).
About week after vaccine, sore throat, sinus infection, headache, lot of coughing. Telehealth call to doctor, prescribed antibiotic Augmentin,  Robitussin with Codeine.
Stomach issues/upset stomach; Did not feel good; Headache/head hurts; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach issues/upset stomach), MALAISE (Did not feel good) and HEADACHE (Headache/head hurts) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Daily dose: CF, Solution for injection in pre-filled pen. On 09-Mar-2022, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues/upset stomach), MALAISE (Did not feel good) and HEADACHE (Headache/head hurts). At the time of the report, ABDOMINAL DISCOMFORT (Stomach issues/upset stomach) and HEADACHE (Headache/head hurts) had not resolved and MALAISE (Did not feel good) outcome was unknown.            Concomitant Drugs were not reported.  Treatment medications were not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This case was reported by a physician via sales rep and described the occurrence of Guillain Barre syndrome in a elderly male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received SHINGRIX. In June 2018, 7 days after receiving SHINGRIX, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant), fall and weakness generalized. On an unknown date, the outcome of the Guillain Barre syndrome, fall and weakness generalized were unknown. It was unknown if the reporter considered the Guillain Barre syndrome, fall and weakness generalized to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient was administered SHINGRIX in retail a pharmacy. One week post SHINGRIX, the patient felt weakness from head towards legs, collapsed in shower and went to emergency room then released. On 5th June 2018, the patient had MRI (Nuclear magnetic resonance imaging) performed and results expected by early next week. The physician performed a spinal tap and confirmed that the patient has Guillain-Barre syndrome that was believed to be due to the SHINGRIX vaccination.
I experienced a rash on my left arm, my throat start tingling and my tongue swelled up and I start having hot flashes.
Inadvertently administered vaccine after the use by date of 1/11/2023. No adverse outcomes.
2 hrs screaming w/o comfort; t107, no appetite intermitttant temp x 5 days dx by MD w/URI & eye infection;
Narrative:  No documentation located regarding ADE to influenza vaccine as patient did not receive through the clinic.
Limited arm mobility due to pain; Soar upper arm; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 27Feb2021 at 16:30 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included coronary disease and known allergies to penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the arm left on 06Feb2021 at 16:15 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. On 27Feb2021 at 17:30, the patient experienced soar upper arm and limited arm mobility due to pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events limited arm mobility due to pain and soar upper arm were recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse (public health nurse) referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L038522 with expiration date 11-AUG-2017; dose and route were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium
Severe leg cramp from left toes up to hip at 11:00 am lasting approximately 3 minutes.  Relaxed again to wake to another severe cramp on right side leg that lasted approximately 1 1/2 minute. Made it to bathroom where I could not even sit. Still pain in calf area today and unable to walk steps normally. I am finally able to move foot and toes on both legs today.
slightly itchy; slightly red; ball of swelling; COVID arm; Nose bleeds; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleeds), PRURITUS (slightly itchy), ERYTHEMA (slightly red), SWELLING (ball of swelling) and VACCINATION SITE REACTION (COVID arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced EPISTAXIS (Nose bleeds). On 13-Apr-2021, the patient experienced PRURITUS (slightly itchy), ERYTHEMA (slightly red), SWELLING (ball of swelling) and VACCINATION SITE REACTION (COVID arm). At the time of the report, EPISTAXIS (Nose bleeds) had resolved, PRURITUS (slightly itchy), ERYTHEMA (slightly red) and SWELLING (ball of swelling) outcome was unknown and VACCINATION SITE REACTION (COVID arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided. No treatment  was provided.  The nosebleeds have stopped, but the "COVID arm" is still ongoing.
Sudden onset of a burning sensation radiating from epigastrium to substernal.  Rapid heart rate. Vitals obtained and patient was observed for 30 minutes.  Patient stated symptoms subsided and vitals returned to normal.
became sick w/flu which turned into pneumonia, which prolonged until became unable to breathe which resulted in hosp in which they did a lung biopsy, finding out pt had sarcoidosis;tx large doses of steroids since JUN96;has had to retire;
Flu-like symptons; 101 Fever; Chills; body ache; fatigue; headache; Arm injection site extremely sore; Arm injection site extremely sore, to the point of arm immobility; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6204) via an unspecified route of administration in the right arm on 20Mar2021 at 13:15 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the right arm on 27Feb201 at 18:30 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. The patient did not have any allergies to food, medications, or other products. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. On 20Mar2021, after 5 hours of second shot, patient experienced arm injection site extremely sore, to the point of arm immobility. On 21Mar2021, the patient experienced flu-like symptoms the day after second shot, 101 fever, chills, body aches, fatigue, headache. The patient underwent lab tests and procedures which included body temperature and result was 101 fever (units not specified). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment was not received as a result of reported events. The clinical outcome of flu-like symptoms, fever, chills, general body pain, fatigue, headache, vaccination site pain and movement reduced (arm immobility) were resolved on an unknown date of Mar2021, at the time of this report. No follow-up attempts are possible. No further information is expected.
slight fever; This is a spontaneous report from a contactable consumer or other non-HCP who reported for his wife.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, single for COVID-19 immunization. On an unspecified date, the patient experienced slight fever. The reporter stated he and his wife had the second dose of the vaccine 2 weeks ago. His wife, had a slight fever and was wondering if it could be connected to the vaccine even though it is 13 days later. He stated that his daughter had a reaction a week later and wanted him to call to ask about his wife (did not specify which vaccine this was to). The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous report (MOD-2020-001709) received from a non-healthcare professional,  concerning a 48-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273). She experienced pain in left arm when raised, soreness and muscle pain in the left arm. The patient's medical history, as provided by the reporter, included underactive thyroid and borderline diabetes. Concomitant medications reported included levothyroxine. Dec 28, 2020, patient received their first of two planned doses of mRNA-1273 (batch/lot# 039K20A), intramuscularly, in the left arm, for prophylaxis of COVID-19 infection. Dec 28, 2020, patient experienced pain in the left arm when raised, soreness and muscle pain in the left arm. She stated she feels the pain when she tries to raise her arm. Treatment for the events included Tylenol. The second dose of mRNA-1273 vaccine scheduled for Jan 25, 2021. The outcome of the events, and experienced pain in left arm when raised, soreness and muscle pain in the left arm considered not resolved. Reporter's comments: 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.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
flushed appearance;  history of rash;  Benadryl 25 mg po
shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. In 2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and zoster-related conditions, as prescribed and/or administered by a healthcare provider at a hospital. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.
I suffered a Cardio Myopathy on 2/24/2021, four days after received my second dose of the vaccine..
The day following the 2nd injection I experienced visual disturbance (similar to prior to a Migraine headache) followed by a moderate headache and generally not feeling well,  This has occurred once daily now for 11 days.  Two Tylenol and resting alleviates the issue.  I have also noted many episodes of the atrial tachycardia through out each day.  No treatment other than rest/relaxation.
48 hours after vaccine, patient began feeling very ill. She went to bed and did not feel like doing anything. She developed a rash on both arms, breasts, and left leg. On the same arm as the vaccine, she had a huge bruse with a welp around it, but the bruise and welp were on the under side of her arm.  Patient went to walk in clinic then to ER.  They gave her a steroid shot, and prescribed oral and topical benadryl and a steroid pack.  As of 4/29, the patient was improving.
asymptomatic at  time of hospitalization. was having a stroke and tested at hospital at time of admit
Within 5 minutes of vaccine, felt rush through my body, became flushed, dizzy, throat heavy and uncomfortable, nausea to the point of almost puking, rigors, shaky, light headed,. Was given epi, zofran, Benadryl in IV and 911 was called to take me to emergency room
Patient experienced vasovagal syncope approximately 5 minutes following vaccination. Patient regained consciousness but was standing at time of incident and has a cut above eye after falling. He was taken by EMS to attend to the cut.
I have ringing in my ears after getting the vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jul2022 at 17:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: None" (unspecified if ongoing), notes: Known allergies: No. Concomitant medication(s) included: RESTASIS; FISH OIL. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "I have ringing in my ears after getting the vaccine.". Therapeutic measures were not taken as a result of tinnitus.
PARENTS LIED ABOUT THEIR KIDS AGE.  WE COULDN'T VERIFY ACCURATE DOB
shingles; head to toe rash; severe pain/agony; itch; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 32ZG4, expiry date 9th July 2021) and (batch number GG9SB, expiry date unknown) for prophylaxis.   On 9th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles, generalized rash, pain and generalized pruritus. The patient was treated with prednisone, triamcinolone (Triamcinolone Cream), sulfamethoxazole + trimethoprim (Bactrim), valaciclovir hydrochloride (Valtrex), gabapentin and atarax (nos) (Atarax). On an unknown date, the outcome of the shingles, generalized rash, pain and generalized pruritus were recovered/resolved.   It was unknown if the reporter considered the shingles, generalized rash, pain and generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The caller was the pharmacist who reported that the patient received Shingrix and then developed a head to toe rash, itch, severe pain she was in agony. She went to the emergency room and had 2 rounds of prednisone, triamcinolone cream, Bactrim, Valtrex and gabapentin. She also had to use Atarax. She would not be getting the 2nd shot per her doctor who said she got the Shingles. The patient was finally ok at the time of reporting.  She was in a study. Did not consent to follow up.
Metallic/chemical taste and smell developed three days after vaccination and continues today 6/21/2021. Headache, weakness, fatigue, slight nausea for 2 days prior, no fever.  No treatment.  Today, metallic and chemical taste/smell has reduced but still there.  Best way patient can describe it as bathroom cleanser - suppose to be pleasant but you don't want to eat it.
Swelling; Itching; Redness; Pain at injection site; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (Swelling), PRURITUS (Itching), ERYTHEMA (Redness) and VACCINATION SITE PAIN (Pain at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 13-Jan-2021, the patient experienced SWELLING (Swelling), PRURITUS (Itching) and ERYTHEMA (Redness). On 06-Jan-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, SWELLING (Swelling), PRURITUS (Itching) and ERYTHEMA (Redness) 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.   Concomitant medication details not reported by the reporter. Treatment details not reported by the reported.; Sender's Comments: 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.
Post vax, the pt presented with red rash around injection site on right upper arm; mild cellulitis.
Information has been received from a physician concerning a 15 month old patient who was vaccinated IM with a first dose of VARIVAX. Concomitant therapy within the same visit included MMR vaccine. Within 24 hours post vaccination, the patient developed a fever of 103 and experienced redness swelling at site of injection. Unspecified medical attention was sought. Subsequently, the patient recovered from the events; it was noted "cleared on its own". Additional information has been requested.
1st dose   core  temp felt cold  for approx 2 weeks 2nd dose 5:00 pm feeling  a little off; 7:00 pm had severe body convulsions  between and 1-2minutes; felt really cold  and weak; approx 930 pm took temp up to 105.5 for the next 48  hours  it  fluctuated  between 100- 105.5. i had bad  "brain fog" severe  for 8 days; started having  headache and still have  several headaches  a day some  are mild some are  very intense, some are a few  minutes some are  hours long, still having today; i have had  burning  and tightness  in my  chest and abdomen, it was  contstant for the first  4 weeks, then off and on through the day, along with the burning i have had nasuea and acid  reflux with minimal vomiting; continued below