chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second dose was scheduled on 30Apr2021. Patient could not get it and it is possible that patient does not get second dose until 22May2021; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose was scheduled on 30Apr2021. Patient could not get it and it is possible that patient does not get second dose until 22May2021) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose was scheduled on 30Apr2021. Patient could not get it and it is possible that patient does not get second dose until 22May2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose was scheduled on 30Apr2021. Patient could not get it and it is possible that patient does not get second dose until 22May2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Client received Extraneous and unnecessary dose of Hepatitis B vaccine by RN on 09/07/2023 at 1659.
4:40PM PT STATES SHE 'FEELS LOOPY & MAY PASS OUT'. A/O X3, PINK, W/D, RESP REG WITH EASE. 5PM STATES 'FEELING BETTER'. CALLED BOYFRIEND TO DRIVE HER HOME. NO ACUTE DISTRESS NOTED. 5:20PM  LEFT WITH BOYFRIEND.
Injection site too low. Injected in bicep. Large red induration of area. Painful and swollen. Complains of shoulder pain and burning in the arm.
Had severe headache first 2 days after 2nd dose with mild nausea, lethargy and dizziness. Symptoms subsided on the 3rd day except for mild headache. Started to experience moderate headache today with sinus pressure, mild nausea and dizziness.
Rash develops when in direct sunlight on exposed skin; The skin appears red; The skin appears mottled; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0164) via an unspecified route of administration in the right arm on 07May2021 at 08:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and covid-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not have known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluticasone propionate (FLONASE), fexofenadine hydrochloride (ALLEGRA) and valsartan (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0164) via an unspecified route of administration in the left arm on 16Apr2021 at 12:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. On 07May2021 at 12:00, the patient experienced rash when in direct sunlight on exposed skin, which did not itch and there were no bumps or lumps. It was reported that the skin appeared red and mottled and in one location the rash resembled a sunburn but was not hot to the touch and did not hurt. It was reported that as soon as the patient went inside or in deep shade the rash disappeared within 15 minutes to a maximum of 30 minutes. 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 rash when in direct sunlight on exposed skin, the skin appeared red and mottled were recovered on 07May2021.   No follow-up attempts are needed. No further information is expected.
About 4 hours after getting vaccine, I started to get a headache and my injection arm started hurting. Then a couple hours after, my skin got sensitive and burning. My muscles started hurting. 10 or 11 hours after getting the vaccine, I got severe chills; migraine; fever; nausea; dizziness. Symptoms lasted through the night. Fever went away 24 hours after receiving vaccine. 14 hours after getting vaccine, headache, arm ache, and body soreness remains.
Feeling lightheaded;  vitals obtained/ stable, rest, po hydration, monitor x 30 minutes symptoms subside/ feels better released w/ daughter to home
A health care professional reported an injection site reaction in a 5-year-old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The reporter submitted a report directly to VAERS (local state department reference number C002-022).  The subject's medical history included recurrent otitis media.  Concurrent conditions and concurrent medications were not specified.  The subject experienced no adverse events following previous vaccinations.  On an unspecified date, the subject received her fifth injection of Infanrix (lot DTAP556622).  The Infanrix injection was administered with a 25 gauge 5/8 inch needle.  Subsequently, on 08/17/2002, the subject experienced an injection site reaction characterized by redness, swelling and warmth which covered 3/4 of her upper arm.  On 08/19/2002, the subject was examined by the physician who prescribed cephalexin monohydrate (Keflex).  The reporter stated that the outcomes of the events were unknown and that they were possibly related to Infanrix administration.  This case is considered serious because the reporter stated that the events jeopardized the patient or required intervention.
My left supraclavicular lymph node was swollen. I waited a couple of days and saw my doctor who thought it was related to the vaccine. It stayed swollen for a month.
Developed a papulosquamous rash across chest and back.; Appeared as pityriasis rosea with larger patch; Very itchy; Malaise; Chills; Headache; This is a spontaneous report from a contactable physician reported for a patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported) via an unspecified route of administration on 24May2021 (at the age of 26-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24May2021, initially after the vaccination, the patient experienced malaise, chills and headache for 24 hours. The patient felt fine for the next two days. On 27May2021, evening of day 4, the patient developed papulosquamous rash across chest and back which appeared as pityriasis rosea with larger patch and surrounding smaller papulosquamous lesions which was described as very itchy. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with benadryl and steroid cream. The clinical outcome of the events malaise, chills and headache were resolved on 25May2021, while the outcome of the events papulosquamous rash across chest and back, appeared as pityriasis rosea and very itchy were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Loss of vision, blurred vision. Stiff neck, general achiness, aches in joints, ache at base of neck between shoulder blades.  Broke out in measles rash over torso.
LEFT ARM REALLY SORE TO PICK UP ANYTHING WITH WEIGHT.  NOTICED WHEN I TRIED TO GROCERY SHOP AND GRABBED A REGULAR BAG OF SUGAR. I NOTICED THE Pain with 1st shot but assumed the pain would eventually go away, but after 2nd shot it increased so I knew it had to be a reaction to vaccine.
Patient reported he had never received a dose of COVID-19 vaccine before. He is incarcerated. Inadvertently, the Moderna COVID- 19 Vaccine EUA was adminsitered. When being entered into the computer, it was discovered he had received 2 prior doses of Moderna.
It was awful; body ache; awake all night; stomachache; body chills / side effects; nausea; headache; Fatigue/still having a little bit of fatigue/Patient stated that on day 02/28/2023 she still had fatigue symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of feels awful in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 73PP9, expiry date 30-MAY-2024) for prophylaxis.   On 27-FEB-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 27-FEB-2023, less than a day after receiving Shingrix, the patient experienced feels awful (Verbatim: It was awful), general body pain (Verbatim: body ache), sleeplessness (Verbatim: awake all night), stomach pain (Verbatim: stomachache), chills (Verbatim: body chills / side effects), nausea (Verbatim: nausea), headache (Verbatim: headache) and fatigue (Verbatim: Fatigue/still having a little bit of fatigue/Patient stated that on day 02/28/2023 she still had fatigue symptoms). On 28-FEB-2023, the outcome of the feels awful, general body pain, sleeplessness, stomach pain, chills, nausea and headache were recovered/resolved (duration 1 day). The outcome of the fatigue was not recovered/not resolved.   It was not reported if the reporter considered the feels awful, general body pain, sleeplessness, stomach pain, chills, nausea, headache and fatigue to be related to Shingrix.     It was not reported if the company considered the feels awful, general body pain, sleeplessness, stomach pain, chills, nausea, headache and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-FEB-2023 and 02-MAR-2023 Reporter's comments: The reporter was a consumer who had reported that, she got her 2nd dose of Shingrix vaccine at a pharmacy and was administered in her left arm.  The patient reported having body chills, body ache, fatigue, nausea, stomachache, was awake all night, and headache. The patient had reported that it was awful. All the symptoms had resolved except that patient reported having a little bit of fatigue at the time of reporting and had multiple side effects which lasted about 24 hours.  The reporter had consent to follow-up. Additional supportive information: The event onset for feels awful was captured conservatively based on the reported verbatim It was awful justifying all symptoms.
Pt. is a 4 yr female in for a rash w/ mother. The mother attributes the rash to her 4 yr old vaccinations she received one week ago. The rash started out as a quarter and started to spread. The rash is only on the left thigh. The mother reports the child received the dTap, influenza, measles, and polio. The mother reports the mother applied topical Benadryl ointment and  Benadryl for children., The mother says last night it was the worst it's been hot and raised. The mother reports she is not allergic to anything and they have not given her anything new. The rash is not painful to touch however is itchy. The size is 10 cm x 11 cm. Pt was having no fevers. Give Ibuprofen in replacement of Children's Benadryl to decrease redness and fight inflammatory response. Watch to see changes in coloration, size, elevation. If high fevers seek urgent care immediately. Avoid scratching the rash. If you do, the rash may take longer to heal and you'll be more likely to develop an infection or scar.  WILL DO VAER FORM. S\USPECT NO FURTHER ISSUES WITH Td IN FUTURE BUT CAN REC GIVING TYLENOL BEFORE 11 YR OLD SHOTS.
Fatigue; headache; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Penicillin" (unspecified if ongoing), notes: known allergies penicillin. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Fatigue"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "chills". The events "fatigue", "headache" and "chills" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of fatigue, headache, chills.  Additional Information: The patient had fatigue, headache, chills. Headache after 2nd shot and reoccurred two weeks after getting 2nd vaccine and have not gone away. Adverse event start date: 20Mar2021. The patient was not recovered. The patient does not had treatment. The patient has not had Covid prior vaccination and has not tested Covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother reports infant fussy night of 03/30/00. Laid infant on stomach and patted his back. Infant and mother fell asleep. Mother woke up and infant not breathing. Mother called 911.
10/31/07 Rt arm pain, chills, "passed out", tired, site red and warm - 2.5cm diameter, T-100.4. Keflex 500mg 4x1 day x 10d.
Called patient on 11/13/20, she has some redness at the site of the injection. She was glad we called her + inquired of the situation. She might go and see the MD today just to make sure it is not an infection. Overall she is fine
Patient was 64 years old at the time of vaccination; however, he received FluAd, which is indicated for 65 years and older, by error.
Pt received a FLUZONE QUAD injection at about 10:30 AM. Returned to pharmacy around 4PM c/o swollen/warm area around injection site.
patient received expired ACT-HIB in error with no reported AE; Initial information was received on 27-Oct-2021 regarding an unsolicited valid non-serious case from other health professional and physician via call center via Medical Information (MI) (Reference number- 00831144).  This case involves a 4 months old female patient (date of birth: 20-Jun-2021) who received expired HIB (PRP/T) VACCINE [ACT-HIB] in error (expired product administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [DTAP], PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) [PREVNAR] and POLIO VACCINE (POLIO) for prophylactic vaccination.  On 27-Oct-2021, the patient received a second 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot number not reported and expiry date: 03-OCT-2021) via an intramuscular route in the right leg for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day).  It was reported "caller requesting information regarding revaccination and adverse effects to be look out for, caller declined to add email address".  At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.  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.  There will be no information on batch number for this case.
My head was numb on the top right side for 3 days. It is still vaguely numb but nowhere near as noticeable.  I developed tinnitus in my ears. It was more noticeable for the first several days but it has subsided a bit. I can still hear the ringing though. It can still be very distracting.  I will likely visit a doctor for the tinnitus if it does not go away within a couple weeks.
This spontaneous report as received from pharmacist refers to a female patient of unknown age with an unspecified pre-existing medical condition. Within the last week, in approximately September 2013, the patient was vaccinated with ZOSTAVAX, (dose, route and lot number were not reported). Concomitant medications were not reported. The pharmacist reported that the patient developed pain and inflammation from a pre-existing medical condition (name of pre-existing medical condition was unspecified) a few days after a vaccination with ZOSTAVAX, in September 2013. The outcome of pain and inflammation was unknown. The relationship between ZOSTAVAX and the events was not reported. Additional information is not expected.
3 days post vax, the pt experienced a sore bump in the groin area which lasted for 2 weeks. The "bump" then disappeared. The pt has had a complete testicular and groin exam. No nodules and no tenderness were noted. Lymph node reactive process has resolved.
patient began to fill severely ill immediately after receiving the vaccine. Symptoms included nausea, severe back pain, burning sensation from neck to stomach, and dizziness. We called 911, and ems took the patient to the ER.
Swollen Arm, Warm to touch, pain, cellulitis. Treatment: OTC Benadryl , Hydrocortisone cream, Tylenol
Extreme fast heart beat 140-150 occurred 4:00am in evening after 2:00pm previous day vaccine Accelerated heart rate lasted for 7-8 minutes after taking an 12.5 mg metoprolol pill This was followed by shakes for a few hours Concerned about taking 2nd dose in light of supposed more pronounced reactions  Worry about extreme heart rate not returning to normal, Afib or even worse Would ask if you would advise not to take 2nd dose If okay to take 2nd dose I would want to take it in a hospital setting -  Hospital which also administers Pfizer vaccine - Can you schedule here for me? Thank you
possible unset of dementia following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (possible unset of dementia following vaccination) in a male patient of an unknown age 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) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEMENTIA (possible unset of dementia following vaccination) (seriousness criterion medically significant). At the time of the report, DEMENTIA (possible unset of dementia following vaccination) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.  Patient lost his vaccination card because of him suffering dementia. He had received two doses of the Moderna COVID19 vaccine and she was looking for assistance on how to get the booster dose.  Company Comment: Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of PNEUMOVAX 23 injection (dose, lot number, expiration date, route and anatomical location of administration were not reported), which were improperly stored. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received form the same reporter. Additional information has been requested.
Patient felt light headed.  Put his head down on table.  Responded to his name after repeating name once.  Patient stated he was dizzy, light headed.  Gave him a bottle of water and M & M's.  Patient had forehead sweating and was pale.   Patient drank the water, had a few M &M's, got cold.  Patient finished M& M's and his color.  Offered to call 911 or someone for patient.  Patient refused.  Patient remained seated for approximately 12 more minutes and left on his own accord.  Patient stated before leaving he felt fine now and refused medical treatment or an offer to call someone again.
Within 24 hours, he started a fever reaching 101.0, headache, cold, sleepy.  Looks to have lasted the day after vaccine was given. So far on 7/17/20, he is not having any symptoms except for a very light headache.   This was his first dose of the HPV vaccine
feeling flushed; facial swelling; This is a spontaneous report from a contactable physician reported for self. This 29-year-old female (No pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 23Dec2020 14:30 at single dose for COVID-19 immunization. No COVID prior vaccination, No COVID tested post vaccination. No known allergies or other medical history. No other vaccine in four weeks, No other medications in two weeks. The patient got the vaccine Wednesday afternoon (on 23Dec2020 14:30), then Thursday evening (>24h, 24Dec2020 07:45 PM) started feeling flushed and had facial swelling after dinner. No other symptoms. Resolved with Benadryl. Then again Saturday morning while brushing teeth and Saturday evening after dinner. One more time Sunday morning during breakfast. Each time the symptoms were milder than before. Took Benadryl as needed. No new foods, meds etc. The outcome of event was recovered.
The evening of the 16th she got cold chills and started shaking yet she was hot. On the 17th she woke up feeling a little better. On the 18th she started with the chills again. When we got back home on the 19th I took her to the health center and they did a blood draw. The center called the next day and told me to take her to the ER because her white cells were low and possible infection.
Fever, chills, muscle aches, arm numbness, underarm pain and swelling.
really fast heart rate; 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 HEART RATE INCREASED (really fast heart rate) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (really fast heart rate). At the time of the report, HEART RATE INCREASED (really fast heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) Fast heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.