chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a little dizzy after the first vaccine; This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer, the patient. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported. On an unknown date the patient was a little dizzy after the first vaccine. The patient reported the dizziness passed after about an hour.  The clinical outcome of the dizziness was recovered on an unknown date.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Left arm swelling, small patch of redness at the injection site and pain not relieved by tylenol. Side effect of pain started few hours after injection and the swelling was seen in the morning.  The pain impacted her ability to sleep since the day of the vaccination.
Increased erythema, pain and swelling. Treated with Clindamycin.
Tinnitus; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided by reporter. Treatment medication use was not provided by reporter.
Moderna COVID-19 Vaccine EUA  Headache began on Saturday and periodically comes back throughout the day.
Vaccine given at 3 PM. By 5 PM patient states "headache, stomach ache, sore arm, achiness, and muscle tenderness in chest developed". Felt "hot" on 3/23/10 at school - temperature 100. Took Advil for fever. At 3/23/10 4:50 PM temperature 97.5 - achiness present. 3/24/10 no temp, "a little achy".
Developed warmth, swelling and pain approximately 10 mm surrounding iz site. Treated with PO Clindamycin for cellulitis.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
patient received the full vial of vaccine 6 doses total. Patient has severe myalgias reported
Bruising that extends down the arm and to the ribcage.  In addition to fever, nausea, and body aches.  No treatment other than monitor and rest at this time.
Ten minutes after receiving vaccination alerted nurse she had breathing issues, nurse observed rapid breathing, anxious; sent to urgent care and was transported via ambulance to where she received treatment (benadryl & epinepherine) for an "allergic reaction", chest x-ray, respiratory work-up.  Prescribed prednisone.
Mild itchy rash with small hives activity on torso, especially sides and around armpits.  Applied triamcinolone ointment to relieve itch.  Resolved after about 4 days.  Did not affect breathing.
Noticeable heart palpations that I have never experienced before after first vaccine on 1/5/21. Physicians assured me that it wasn't related. Said it was probably age despite my very excellent health. Gradually worsening with light headedness and breathlessness. peaked after 2nd vaccine (2/3/21). ER visit on 2/7 due to nearly passing out and sitting on the floor at the grocery store. Increase in frequency and intensity of palpations. Cardiology visit on 3/8/21. Symptoms were improving. Cardiologist said it was age related normal. Symptoms gradually improved through March to now barely ever noticing any palpations.
2 mo old with reported T 105 by mom within 24hrs of vaccination with Dtap. Mom gave Tylenol x1 and temp went down to 100.8. Pt was referred to the ER for full evaluation/sepsis workup.
This spontaneous report was received from nurse prescriber, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 02-DEC-2021, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 1 milliliter, (lot #T017179, which was confirmed to be valid, and expiration date: 26-OCT-2021), administered for prophylaxis (strength, vaccination scheme frequency, anatomical location, and route of administration were not provided) (expired product administered). No additional adverse event was reported.
This spontaneous report was received from a Medical Assistant referring to a 5 year old female patient. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 29-AUG-2018, the patient was vaccinated with the first dose of Oka-Merck PROQUAD per subcutaneous route (dose, lot# and expiration date were not provided) for prophylaxis, and on 12-SEP-2018, a second dose was inadvertently administered (dose unspecified) per subcutaneous route, lot # R011801 for prophylaxis. No adverse effects were reported.
Case number PHEH2014US024976, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 78 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 30 OCT 2014. The  nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was between 46 to 49 degree F during the excursion.
Staff called approx. 0930am after injection and reported dizziness, not able to focus, and nausea.  Staff called PCP and said to stay still for a couple of hours and not better go to ER.
Acute severe vertigo associated with nausea. Approximately 10 events each lasting 1-2 minutes. Treated with OTC meclizine and seems to have resolved. No associated headache. Only other symptoms was moderate pain at the injection site
Administered covid vaccine in error. It was intended for 12 years and older. This patient is 5 years. No adverse reaction occurred.
fever and chills for 12 hours  headache for 24 hours nausea for 12 hours  fatigue and weakness for 24 hours
This spontaneous report was received from a female patient of an unknown age, referring to herself. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was intravenously vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. Subsequently, after receiving the mentioned vaccine, she experienced a red spot on her arm near the injection site. At the time of the report, the outcome of the adverse event was unknown. The causality between the adverse event and ZOSTAVAX was unknown. Additional information is not expected, as no consent to contact the reporter was granted.
Pt rec'd Td at health fair at church. Fever and area turned red at site 4 inches around from site. Started with pain at site. Saw Dr and was given Prednisone. Pt states is allergic to Diphtheria vaccines Pt was given VIS for Td prior to giving vaccine.
Nausea, light-headed. Vaccines make her nervous. Vitals wnl.
I had the expected very mild soreness at the injection site for several days.  The headaches came on the night after the vaccine and have continued.  Every night I get a headache with onset sometime between 1 a.m and 4:00 a.m. , making it difficult to sleep.  The headache lasted all day on the 25th and 26th, but since then usually clears with morning coffee.  Last night the headache started at 1:00 a.m. (earliest yet) and at 2:00 I took a Motrin and .125 g. Alprazolam and slept okay the rest of the night.  Is this an interplay with my immunosuppression?  I will eliminate the sleep time tea, but I honestly can?t fathom that would be a cause.  Thank you for taking note of this and for responding if you can.
enlarged lymph node on right side of neck; joint pain all over; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210302000865).  This case involves a 28-year-old female patient who experienced joint pain all over (arthralgia) and enlarged lymph node on right side of neck (lymphadenopathy), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 06-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number: UT7000DA, expiry date not reported] via an intramuscular route at an unknown administration site for prophylactic vaccination.  On 06-Oct-2020, the patient developed a non-serious joint pain all over (arthralgia) on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date, the patient developed a non-serious enlarged lymph node on right side of neck (lymphadenopathy) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome is unknown for both the events.
About 10 seconds after first Pfizer vaccine was administered, patient began to feel dizzy, cold, started sweating, and felt nauseous. Patient's started to slouch and went out for about 5 to 10 seconds and came too. Patient was placed on floor with legs elevated, cold compress was applied to neck. Patient took about 30 minutes before was feeling better enough to leave. Was checked by EMS and heart rate was ok, slightly elevated blood pressure.
This spontaneous report was received from a health care worker referring to  an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical histories were not provided. On an unspecified date since September 2015, the patients were vaccinated with unspecified doses of improperly stored oral, ROTATEQ (route, dose and anatomical site of vaccination was not provided), lot # K0223532, expiration date 21-JUN-2016, then on an unknown date since October 2015, the patients were vaccinated with unspecified doses of improperly stored oral ROTATEQ (route, dose and anatomical site of vaccination was not provided), lot # L008059, expiration date 18-DEC-2016 and then on an unspecified date since December 2015, the patients were vaccinated with unspecified doses of improperly stored oral ROTATEQ (route, dose and anatomical site of vaccination was not provided), lot # L013202, expiration date 27-JAN-2017. No adverse effects were reported. Additional information has been requested.
Swelling, reddness, hard lump and a small blister at point of injection in the right arm.; Swelling, reddness, hard lump and a small blister at point of injection in the right arm.; Swelling, reddness, hard lump and a small blister at point of injection in the right arm.; Swelling, reddness, hard lump and a small blister at point of injection in the right arm.; Severe right shoulder joint pain.; This is a spontaneous report from a contactable consumer, the patient. A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in right arm on Feb2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. Patient was not allergies to medications, food, or other products. Concomitant medication included amlodipine, valsartan, and finasteride. In Feb2021, the patient experienced swelling, redness, hard lump, and a small blister at point of injection in the right arm, severe right shoulder joint pain. Treatment was not received for the adverse event. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient was here for her second dose of COVID vaccine (Moderna), patient c/o itchiness and developed some 2 small hives on the right side of her arm shortly after receving the vaccine. Vaccine clinic physician assessed patient at bedside and ordered 50mg Diphenhydramine PO x1 dose. Patient took the PO Diphenhydramine at 1626 and tolerated medication well. Symptoms improved initially but then developed new symptoms of chest tightness and difficulty breathing 8 minutes after PO Diphenhydramine. Symptoms are consistent with anaphylactic reaction, Epi-Pen 0.3mg administered by RN on patient's right outer thigh x1 at 1635. EMS arrived at 1645. Patient is sent to hospital with EMS at 1700.
Information has been received from a nurse concerning a 17 year old female who was vaccinated with the third dose of Gardasil on an unspecified date. It was reported that the patient experienced seizure like activity after receiving the vaccine. Her eyes rolled back in her head and briefly lost consciousness. The patient sought unspecified medical attention. She recovered 40 minutes after injection. The nurse also reported that the refrigerator where the vaccine was stored was "4 degrees colder than it should have been". Upon internal review, seizure-like activity was considered to be an other important medical event. This report is one of two reports from the same source. Additional information has been requested.
11/18/19 flu like symptoms, by 10:15 pm  Angioedema of the lips lasting 24 hours
Dose administered after more than 30 days of storage in the fridge; Dose administered after more than 30 days of storage in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 30 days of storage in the fridge) and PRODUCT STORAGE ERROR (Dose administered after more than 30 days of storage in the fridge) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 30 days of storage in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after more than 30 days of storage in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 30 days of storage in the fridge) and PRODUCT STORAGE ERROR (Dose administered after more than 30 days of storage in the fridge) outcome 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.  Reporter stated that they found out there are 4 vials form Moderna COVID-19 vaccine that were stored in the fridge for more than 30 days prior to first use. Vials were stored in the fridge since 22-Dec-2021. Patient received booster dose of Moderna COVID-19 vaccine.  No treatment information was provided.
Pt states that she woke up to find redness @ right arm approx 1.5 x 2 inches in size.  By that evening it was 2.5 X 3 inches in size. By next Am, redness was 5 X 6 inches, "about the size of a lemon", between her elbow and underarm.  Stated it looked like cellulitis, had a black dot in the center, was very itchy.  c/o headache.  Went to facility, was given Benadryl and Prednisone.  Also used ice, hydrocortisone cream and Advil.
injection site has pain /left arm injection site has pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DC924, expiry date 26th October 2020) for prophylaxis.   On 14th March 2020, the patient received Boostrix (intramuscular). On 14th March 2020, less than a day after receiving Boostrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced left arm injection site pain. Till the time of reporting, the pain was ongoing and was not resolved. The reporter consented to follow up.
Accumulating fluid starting; swelling and accumulating fluid; constipation; Chills; arm pain; body aches; glands under neck swelled/glands under right arm swelled; extremely tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), FLUID RETENTION (Accumulating fluid starting), SWELLING (swelling and accumulating fluid), MYALGIA (body aches) and LYMPHADENOPATHY (glands under neck swelled/glands under right arm swelled) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical History reported by the reporter.  Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), TELMISARTAN, VERAPAMIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) 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-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain), MYALGIA (body aches), LYMPHADENOPATHY (glands under neck swelled/glands under right arm swelled), FATIGUE (extremely tired) and HEADACHE (headache). On 25-Feb-2021, the patient experienced CONSTIPATION (constipation) and CHILLS (Chills). On 08-Mar-2021, the patient experienced SWELLING (swelling and accumulating fluid). On 13-Mar-2021, the patient experienced FLUID RETENTION (Accumulating fluid starting). On 02-Mar-2021, CONSTIPATION (constipation) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain), FLUID RETENTION (Accumulating fluid starting), SWELLING (swelling and accumulating fluid), MYALGIA (body aches), LYMPHADENOPATHY (glands under neck swelled/glands under right arm swelled), FATIGUE (extremely tired) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Platelet count: elevated (High) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.       Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Follow-up received on 17-MAR-2021; Lab data Added, New events updated
Red - indurated - pruritic 12 X 6 cm swelling of leg just inferiorly to DTAP injection one day after administration
warm to touch; Small red, raised, palpable lump warm to touch about the size of the dime by 6pm on same day as injection; Severe burning with injection followed by mild soreness at arm; Severe burning with injection followed by mild soreness at arm; redness; moderate soreness; Itchy; This is a spontaneous report from a contactable Other HCP (patient). This 36-year-old female (not pregnant) patient received 2nd dose of BNT162B2 (Covid vaccine, lot number=EK4176 on 09Jan2021 09:30 AM on Left arm for covid-19 immunization. Medical history was migraines. Concomitant drug was sumatriptan succinate (IMITREX) for migraines, ethinylestradiol norgestimate (SPRINTEC). Historical Vaccine was 1st dose of BNT162B2 on 19Dec2020 08:15 AM (lot number=EK 5730, vaccine location=Left arm) and experienced moderate soreness at injection site only x2 days. It was reported that patient experienced Severe burning with injection followed by mild soreness at arm. Small red, raised, palpable lump warm to touch about the size of the dime by 6pm on same day as injection. 10Jan2021 - moderate soreness. Area remains bright red, raised, warm to touch increased in size to 1"x1" 24 hours after vaccine. 11Jan2021 - 48 hours post vaccine area further enlarged to 2"x2". Moderate soreness. Itchy. Warm to touch. Palpable area extending to edge of redness. 12Jan2021 - 72 hours. No soreness except when touching injection site. Redness less in color and size. No longer itchy. Palpable lump smaller. Quarter size. Treatment was Tylenol. Outcome of the event palpable lump, Redness was recovering, for itchy was recovered, for other events was Not recovered. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are needed. No further information is expected.
Rash that continues to grow on my left arm, about an inch lower than the injection site. Swollen around the edges, itchy and continues to grow. Warm to the touch and feels like a bruise but just seems red. Felt like a bruise Monday, March 8th and I noticed a red blotchy mark on my arm. It is now the size of my entire hand.
I got them and I got the shot; I got them; awful painful; got pain in my arm; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles (had shingles).   On an unknown date, the patient received Shingles vaccine. In July 2019, less than 2 years after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got shingles and the patient got the shot. The shot did not help the patient, one bit somehow there awful painful and still got pain in arm since July 19. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. Follow up would not be possible as no contact details were provided.