chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vertigo; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received second dose bnt162b2, via an unspecified route of administration on 21Jan2021 11:00 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced vertigo on an unspecified date. Caller stated that she had the second dose of Covid booster yesterday at 11:00. Stated that at 2 AM she woke up with vertigo that she never had before. Wanted to know what she can take for it. Stated that she works at the hospital. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Low grade fever; Wave of blurriness; Dizzy; O2 stats is a little lower; Cool sensation that felt like the drug moving through veins; Throat got a little tight; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Aug-2021 and was forwarded to Moderna on 04-Aug-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of VISION BLURRED (Wave of blurriness), DIZZINESS (Dizzy), OXYGEN SATURATION DECREASED (O2 stats is a little lower), FEELING ABNORMAL (Cool sensation that felt like the drug moving through veins) and THROAT TIGHTNESS (Throat got a little tight) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced VISION BLURRED (Wave of blurriness), DIZZINESS (Dizzy), OXYGEN SATURATION DECREASED (O2 stats is a little lower), FEELING ABNORMAL (Cool sensation that felt like the drug moving through veins) and THROAT TIGHTNESS (Throat got a little tight). On 03-Aug-2021, the patient experienced PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Wave of blurriness), DIZZINESS (Dizzy), OXYGEN SATURATION DECREASED (O2 stats is a little lower), FEELING ABNORMAL (Cool sensation that felt like the drug moving through veins), THROAT TIGHTNESS (Throat got a little tight) and PYREXIA (Low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, Oxygen saturation: 96 (Low) low.     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 medications were reported. No treatment medications were reported.
Screaming, animal sounds awakening in the night after shots, then 2 nights later nothing.
Heart racing; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing), MYALGIA (Body aches) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PALPITATIONS (Heart racing), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, PALPITATIONS (Heart racing) had not resolved and MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Fever, body aches, headache, stomach pains: lasted from 4:00 am to 5 pm Afterwards no symptoms were experienced
extra doses given to patient. documentation error noted after given that third dose was not correctly documented so it did not show up in our records
The injection site bled after the injection (about 3:00PM). A bruise formed on my arm at the injection site by the evening, it was larger in the morning.  I noticed a bit of redness and swelling about  30  hours post injection.  I woke this morning with darker bruising and larger red swollen, and slightly warm  reddening on the arm next to the bruising .  There is tenderness but I can move my arm and aside from fatigue I feel fine.
SUDDEN ONSET OF LARYNGITIS, SCRATCHY THROAT, ITCHY EYES DIAGNOSIS: VIRAL BRONCHITIS
Administered expired dose of MENACTRA with no reported AE; Initial information received on 17-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient who administered expired dose of Menactra with no reported AE while receiving vaccine Meningococcal a-c-y-w135 (d conj) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) for Immunisation.  On 17-Feb-2022, the patient received a dose of suspect Meningococcal a-c-y-w135 (d conj) vaccine at a dose of 0.5 ml (formulation, strength, route and expiry date: unknown) (lot U6787AB; Expiry date: 11-Aug-2021) via intramuscular route in unknown administration site for immunization.  On 17-FEB-2022 the patient had administered expired dose of Menactra with no reported adverse event (expired product administered) following the administration of Meningococcal a-c-y-w135 (d conj) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was unknown for the event expired product administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
pt recvd vax; had sz at noon; T 101.6; has a bad cold, coughing; mom also sick; adm to hosp;
Mom states that by evening of the vaccine the upper left arm started to become red and swollen. By the am the entire limb, from the shoulder to the wrist,  was swollen, red, painful and hot to the touch. Mom took him to an urgent care clinic where he received antibiotics.
Within 15 minutes after receipt of 1st Varicella and 2nd MMR, patient returned to nurse with eyes swollen, lips swollen, and congestion beginning. Called 911, administered 0.3ml Epinephrine and patient transported to ER.
Extreme shaking chills, intense body aches all over pain 10/10, waves of nausea, headache, worst physical pain in lifetime
day 7 at take check patient was identified with a small itchy papule on left forearm.  day 8 no change in papule.  photo of papule on day 8 is available.
gland in neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 31Dec2020 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "GERD", start date: 1957 (ongoing); "Asthma", start date: 2000 (ongoing); "Obesity", start date: 1993 (ongoing); "Allergy", start date: 2000 (ongoing); "illness", start date: 2000 (ongoing). Concomitant medication(s) included: FAMOTIDINE taken for dyspepsia, start date: 2019 (ongoing); MONTELUKAST taken for asthma, start date: 2019 (ongoing). The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "gland in neck". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: It was reported that, patient did not visit the emergency room or did not undergone any surgical treatment. It was also reported that, event information start date or best estimated period: Only slightly in Gland in neck about 8 hour after for about 24hours. Patient was not admitted to hospital.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Loss of appetite, fever, vomiting going on 3 days now, treatment as of right now pedialyte to help prevent dehydration.
Information has been received from a licensed practical nurse concerning a 83 years old female patient with atrial fibrillation, GERD, iron deficiency and allergy to DARVOCET, who on 02-OCT-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported) at local pharmacy. No other co-suspects were reported. Concomitant medications included INDERAL, trazodone hydrochloride, PRILOSEC, cyanocobalamin and VERAMYST. On 02-OCT-2012, one hour after receiving ZOSTAVAX, patient experienced hives starting in abdomen and then 3 hours after receiving ZOSTAVAX the hives were "all over". ALLEGRA was given as a treatment. Patient was seen in the office where doctor diagnosed hives and diffuse urticaria. No laboratory diagnostic studies were performed. The outcome of hives all over/diffuse urticaria was reported as not recovered/not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Started on Monday morning at 8:30 am started feeling cold chills.  Took 800mg of Ibuprofen and after an hour felt better.  When going to bed around 9:00pm I noticed that my skin was soaking wet and that I had a hot feeling.  When I woke up in the morning  (tuesday April 13, 2021) around 7am I could not fully open my eyes.  I looked in the mirror and noticed that my entire face was swollen and was red in different areas.   I took some benadryl as I thought this was an allergic reaction and went back to bed.  A litter later I started getting cold chills and then hot flashes.   Around noon time I took another benadryl.  By 2:30 I was not feeling any better and I also had body aches and pains and called my doctor.  I was able to get in to the office.  I was told that I was having a reaction to the shot and that I was boarder line for the hospital.  They gave me a shot steriod shot and prescribed Metheylprednisolon tablets (24) to be taken as directed and to continue to take benadryl.   It's now Wednesday morning April 14, 2020 and the swelling has gone down but not fully gone and I have stated on the prescription.  I now have redness in my chest area.  I still have a some chills and hot flashes.
Sore and swollen lymph node in arm of vaccine; Sore and swollen lymph node in arm of vaccine; Slight bruising in the armpit 2 days post shot; Body aches and fever 1 day post shot; Body aches and fever 1 day post shot; 3rd Booster dose; This is a spontaneous report from a contactable other healthcare professional, the patient. A 25-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Oct2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any concomitant medication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Jan2021 (at the age of 24-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Jan2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 10Oct2021, 1 day post shot, the patient experienced body aches and fever. On 11Oct2021, 2 days post shot, the patient experienced sore and swollen lymph node in the arm of vaccine with slight bruising in the armpit. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 sore and swollen lymph node in arm of vaccine with slight bruising in the armpit 2 days post shot and body aches and fever 1 day post shot was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Developed red pruritic blotches to neck and back  - developed  7 minutes after vaccination was given.  Bennadryl 25mg PO administered.  No Respiratory Distress Observed.  Vital Signs within normal limits.  Pt referred to ED for further evaluation
Extreme migraine began within 2 hours of injection, followed by neck stiffness with pain radiating down right scapula, and nausea.  As of this entry the headache/neck pain has been ongoing for 7 days and has not lessened with multiple uses of:  heat, rest, lidocane patch, Ibuprofen, Tylenol, Immitrex, Valium, or  intramuscular Toradol injections.  The nausea subsided after 5 days, but now there is an aversion to eating.
5-13-21 8:00 pm severe pounding headache, extreme fatigue slept from 9:00 pm May 13 until 8:30 May 15. Diahhria and vomiting during the night May 13. Saturday May 15 woke up with swollen lower lip, left side of my tongue 2 large sores, sore throat, pressure in my right ear, felt off balance hand unable to drive and foggy thinking.
could no longer smell; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (could no longer smell) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced ANOSMIA (could no longer smell). At the time of the report, ANOSMIA (could no longer smell) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Coronavirus test: Negative.         Concomitant medication were not reported. Treatment details were not provided.
PHARMACY INADVERTENTLY DISPENSED EXPIRED COVID VACCINE TO NURSING HOME/SENIOR LIVING FACILITY.WHICH WAS ADMINISTERED.
Patient tested positive for COVID-19 after completing the full Moderna vaccine series, 68 days after 2nd dose.   Patient received 2nd dose of COVID vaccine on 1/20/21 .   Tested positive on 3/29/21.   NOT hospitalized. "First COVID positive test Had contact with someone confirmed/suspected for COVID-19" (husband)  Symptoms reported: runny nose, sore throat, weakness
t103.5, ?cyanotic lips, ? mottled appearance-all witnessed by parents-temp @ office 3hr p/shot 103 R;
Itchy, painful muscle, red rash 7x3? Lasting for 9 days at present, ongoing
Headache, Arthralgia, Fever, FATIGUE, CHILLS,PAIN/SWELLING INJ SITE Narrative:  Other Relevant History:
Hypotension; Few episodes of hives each day/full body hives; Tachycardia; Low grade fever; This spontaneous case was reported by a nurse and describes the occurrence of HYPOTENSION (Hypotension) in a 32-year-old female patient 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOTENSION (Hypotension) (seriousness criterion medically significant), URTICARIA (Few episodes of hives each day/full body hives), TACHYCARDIA (Tachycardia) and PYREXIA (Low grade fever). At the time of the report, HYPOTENSION (Hypotension), URTICARIA (Few episodes of hives each day/full body hives), TACHYCARDIA (Tachycardia) and PYREXIA (Low grade fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. About 10 days after  injection, the patient began experiencing a few episodes of hives each day for 3 days. On day 4, she had full body hives with hypotension, tachycardia, and low-grade fever. It continued for the next 3 days. She had a couple days of getting better, then it got worse. Treatment for the event included IV fluid and steroid.  Company Comment: Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 20th January 2020). On 19th January 2018, the patient received SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site pain and injection site erythema. On an unknown date, the outcome of the influenza-like symptoms, injection site pain and injection site erythema were recovering/resolving. It was unknown if the reporter considered the influenza-like symptoms, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that a patient experienced an adverse reaction after receiving SHINGRIX and was unsure of what specific reaction that the patient was experienced. The patient did not required a doctor's visit, hospitalization, or other intervention and the reaction was not believed to be life threatening or disabling.
chest tightness, sweating, nausea, arm pain, light headedness, dizziness.  these symptoms were occurred minutes after receiving the vaccine and lasted for several minutes. was the patient was able, she was escorted by family members to the nearest urgent care clinic for further evaluation.
Monovalent given as booster after regulatory authority recommenations changed on 9/2/22.  Bivalent was not yet available at the time of administration.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX. Concurrent medical conditions included hypertension. Concomitant products included metoprolol. On 10th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th March 2018, 6 hrs after receiving SHINGRIX, the patient experienced fever, pain in arm, bone pain, chills, muscle pain and mobility pain and mobility decreased. The patient was treated with ibuprofen. On 11th March 2018, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the pain in arm, bone pain, muscle pain and mobility decreased were recovered/resolved. The reporter considered the fever, pain in arm, bone pain, chills, muscle pain and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported that within an hour after receiving SHINGRIX experienced soreness in her left arm, which lasted for 4 to 5 days. The patient reported that approximately 6 hours after receiving a does of SHINGRIX experienced bone and muscle pain, that was very painful and the patient could barely move, which lasted for 6 to 8 hours. The patient had taken ibuprofen and it got better. The patient stated that by the next day the pain was much better. The patient also reported that approximately 6 hours after receiving SHINGRIX, she experienced chills and fever and by the next day of vaccination, she was fine. The patient had denied the permission to contact with her physician.
I have had daily severe and disabling migraine headaches that began the day after my second Pfizer Covid vaccine.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left Sore arm) and ORAL HERPES (Herpes lesion) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 048A21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Calcium, Codeine, Prevacid, Toprop xl,), Penicillin allergy, Blood pressure high since 2000 and Premain. Concomitant products included AMLODIPINE and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) for Blood pressure, POTASSIUM, FISH OIL, BIOTIN, ASPIRIN [ACETYLSALICYLIC ACID], FOLIC ACID and ASA for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Left Sore arm). On 21-Mar-2021, the patient experienced ORAL HERPES (Herpes lesion). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 600 mg and ACYCLOVIR [ACICLOVIR] at an unspecified dose and frequency. On 26-Feb-2021, PAIN IN EXTREMITY (Left Sore arm) had resolved. At the time of the report, ORAL HERPES (Herpes lesion) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Allergy also included Premain. Concomitant medication included Blood Pressure Medication. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information received on 14-MAY-2021. ADR Form received. Added patient details, medical history, concomitant medications, second dose details and event outcome. On 16-Jun-2021: Follow-up information received on16-JUN-2021 no new information was provided.
Despite having received both COVID vaccination doses as of 1/27/2021, patient tested + for COVID-19 on 3/9/2021, roughly one week after exposure to his grandson who was positive.
approx 30 hrs p/vax pt ran fever of 104.5 & had several episodes of vomiting; taken to Er where was given APAP supp which lowered temp to 100; dx viral illness;