chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 23 year old female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # was not provided) beginning at the age of 10 years. On an unknown date the patient experienced arm cellulitis and tingling and was treated symptomatically and with antibiotics. On unknown date, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (Lot # 662842/1296X) at the age of 23 years. On an unknown date, the patient experienced nausea, malaise, aching, an arm swollen to 2x its normal size from deltoid and to elbow. The patient sought unspecified medical attention. At the time of the report, the outcome of the event was unknown. Follow-up information has been received from the physician concerning a homemaker with an allergy to sulfa who on 25-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 into her right arm at 12:30 PM. Within 24 hours, on 26-AUG-2009 at 7:00 AM, the patient's entire upper arm from deltoid to was edematous (double in size), tender, erythematous and hot and developed cellulitis. She was unable to use her arm for next week. There was no illness at the time of vaccination. The reporting physician considered the patient's cellulitis to have resulted in persistent or significant disability/incapacity. Follow-up information has been received from the physician. It was reported that the patient with heart disease was treated with an antibiotic for the event cellulitis. The patient had recovered from the event four days later. This is one of several reports received from the same source. No further information is available.
Patient states that she got her coronavirus vaccine and about 10 min later she felt very weak diffusely, felt her ears ringing and passed out.  Patient was caught and lowered to a chair, thus did not hit her head.  Patient states she has passed out before but this felt different.  Patient felt her heart racing prior to passing out.
Flu vaccine was administered approx 5 pm 4/2/14. Patient reports waking up at 1 am 4/3/14 lasting until 4 am (approx 3 hrs) with severe body aches and nausea. Now with mild persistent both muscle pain.
Had a rash about 4" long by 2" wide. Occurred about 5 days after the first vaccination. It is fading and less itchy over time. Had the first vaccination 1/14 and scheduled for the second on 2/11. Should I take the second vaccination as scheduled? Are there any meds  or herbs or supplements or food I shouldn't take before the vaccination?
very sleepy; This is a spontaneous report from a non-contactable consumer (the patient's husband) from a Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date in Apr2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose 2-3 days ago, and she was very sleepy (Apr2021). The outcome of the event was unknown.    No follow-up attempts are possible; information about batch/Lot number cannot be obtained.
PATIENT REQUESTED A MODERNA 3RD DOSE SINCE SHE IS immunocompromised , after administering the moderna vaccine she returned and stated she was suppose to ask for pfizer vaccine since she remembered her first 2 doses were pfizer
after two weeks her face become red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (after two weeks her face become red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced ERYTHEMA (after two weeks her face become red). At the time of the report, ERYTHEMA (after two weeks her face become red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported by reporter. No treatment medications were reported.
1 day after vaccine, patient developed muscle spasms and pain in LT arm and LT upper body/torso.  He was unable to work due to the symptoms.  Symptoms lasted 8 days
Pain LT shoulder within 12 hours of receiving flu shot in same shoulder. Persisting 3 wks. Hurts with lifting shoulder with forearm included.
I had a CT scan in March and it showed that the blood clots in my liver came back and I had to go back on medication. I'm still going through this at this time.
Fever, Fatigue, chills, injection site pain and swelling, left side facial swelling Narrative:
10/18/12 patient noticed her left upper arm being vey red, swollen and very painful.  Pt. states she had a lot of itching of the left arm.  Pt. came to the doctor on 10/19/12 and was instructed to use ice pack on the left arm and take Benadryl.  Patient states her arm remained that way until about 10/23/12.
This spontaneous report as received from a consumer refers to a currently 76 years old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On 01-NOV-2010 the patient was vaccinated with the dose of ZOSTAVAX, one time injections (route of administration reported as injection, lot number was not reported), for the prevention of shingles. Concomitant therapies included DIOVAN. On an unknown date the patient developed an itchy rash all over her body called granuloma annulare after receiving ZOSTAVAX. Lab diagnostics studies were performed and included skin biopsy (results not provided). The patient sought medical attention via a doctor visit. The outcome of granuloma annulare was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Large local Rxn 24 hours after flu shot.  Left arm swollen and tense shoulder to elbow, with redness. Warmth, mild discomfort on arm and hand.  Neurovascular intact.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2022 at 14:00 as dose 4 (booster), single (Lot number: 005M21A) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing), notes: other medical history: hypertension; "hypercholesterolemia" (unspecified if ongoing), notes: other medical history: hypercholesterolemia. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (unspecified date) Positive, notes: Retested indicates positive result; (06Jul2022) Negative, notes: Previously on day three last dose was negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid for COVID 19 treatment from 04Jul2022 to 09Jul2022. Severe headache and nasal congestion noted on day 5 from the last dose. Retested indicates positive result. Previously on day three last dose was negative.; Sender's Comments: Based on the known safety profile and Limited information in the case report, a casual association between reported LOE events and the suspect drug cannot be excluded. Case will be reviewed further on receipt of FU information.
Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 12-JUN-2015, the patient was vaccinated with the first doses of GARDASIL (dose, route, lot # and expiration date were unknown). On 20-JUN-2016, the patient was vaccinated with GARDASIL 9 (lot # L036245, expiration date on 09-FEB-2018), 0.5 ml, intramuscular as the second dose, in the vaccination series. No adverse effects were reported. Additional information has been requested.
Body aches; Head ache; This is a spontaneous report from a non-contactable consumer. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL 3247 ) via an unspecified route of administration in the left arm on 17Feb2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL 3247) via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to vaccination. On 18Feb2021, the patient experienced body aches and headache. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were 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 body aches and headache was recovered on an unknown date in Feb2021.   No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Lot number: fp4554) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "prostate cancer" (unspecified if ongoing), notes: prostate cancer (4 years ago); "allergy" (unspecified if ongoing). Concomitant medication(s) included: DOXAZOSIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: COVID 19 Treatment; (04Oct2022) Negative, notes: Tested negative 04Oct; (06Oct2022) Negative, notes: Tested negative 06Oct; (08Oct2022) Positive, notes: Tested positive 08Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
10 days apart; A spontaneous report was received from a pharmacist, concerning, a 69- year-old male patient, who received Moderna COVID-19 vaccine (mRNA-1273) 8 days apart from the first dose (Inappropriate schedule of product administration).  The patient's medical history was not reported. Concomitant medication was not reported.  On 26 Feb 2021, prior to onset of events, the patient received his first of the two planned vaccine doses of mRNA-1273 (Lot number:014M20A) via intramuscular route for prophylaxis of COVID-19 infection.  On 08 Mar 2021, prior to onset of events, the patient received his second of the two planned vaccine doses of mRNA-1273 (Lot number:(040A21A) via unknown route for prophylaxis of COVID-19 infection.  On 08 Mar 2021, patient was administered second dose of vaccine, 8 days apart from the first dose. There were no known adverse events experienced.  Laboratory details were not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.  On 08 Mar 2021, outcome of the event, received  second dose of vaccine, 8 days apart from the first dose, was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration,  for mRNA-1273, lot #: 040A21A, with no associated AEs.
This case was reported by a consumer via call center representative and described the occurrence of cold sores lip in a patient who received Herpes zoster (shingrix) for prophylaxis. On an unknown date, the patient received shingrix. On an unknown date, unknown after receiving shingrix, the patient experienced cold sores lip. On an unknown date, the outcome of the cold sores lip was unknown. It was unknown if the reporter considered the cold sores lip to be related to shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient self-reported the case. The patient asked if shingrix shot could cause a cold sore on lip. The patient would connect with doctor first and reach out again if they feel it was related. The follow-up would not possible as no contact details were available.
Mild cellulitis on left arm. Erythema 5.5 cm x 4 cm, warmth and a small amount of induration. No treatment needed cleared up within 4 days per mother.
I waited the requested 15 minutes as requested after my shot and felt fine although in hindsight i realize my finger joints were hurting/swelling. I left the facility as planned and while sitting at a red light  ( about 2 mins after leaving) my cheeks suddenly got very flushed and were burning. I looked in my car mirror they were bright red. The light turned green and I turned then under my chin suddenly felt like a bug bit it and started itching intensely. This sensation reminded me of the last time I reacted to a medication so I pulled into a parking lot and parked. i looked in the mirror again and my neck./ throat had angry red hives/rash all over it , my tongue and throat began feeling strange ( swelling?) and I felt very light headed and shaky. I drove back across the road to the vaccination clinic and showed a nurse. She said I was reacting to the shot. The nurses had me lay down and gave me benedryl. At that time my blood pressure was also very high  ( unusual , I usually have great blood pressure) . All of this happened in the 30 minutes of me leaving the clinic ( 11.00-11.30) I responded positively to the benedryl and my rash/hives and swelling subsided . I had a family member drive me home and I was advised to keep taking benedryl every 6 hrs. I woke up the next day ( March 9th) at 5.00 A.M expecting to feel ok and quickly realized i was really not feeling good. My entire body ached ,and my muscles all down my left side were incredibly painful to move. My joints hurt and my fingers and feet/toes were swollen. My neck /lymph nodes were also swollen and my rash on my neck came back for at 8.30 A.M ( I took more benedryl) . I also had an awful headache and fever and was exhausted. I ended up sleeping most of the day and could not go to work. I woke up at 5,00 A.M today ( March 10th ) and fel weak but much better
Pt received DTaP, IPV, Hib, Hep B, Prevnar at 2 months old on 2/6/02. Approximately six hours later - inconsolable screaming for 3 1/2 hours
following her Moderna booster on 11/1/2021 she developed leg swelling 3 weeks later and was diagnosed with DVT in her right calf in 2 places and is not on eliquis she was on birth control as well and unsure if that was cause but has been on that majority of her life and she is a very active indivdual
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported. Date of refrigeration was reported as 07 May 2021.   This case was linked to MOD-2021-364375 (Patient Link).
admission for Laparoscopic Cecectomy due to 1 benign colon polyp. Hospital admission within 6 weeks of receiving the COVID vaccine.
I NOTICED A LITTLE SWELLING IMMEDIATELY AFTER THE INJECTION. WE GAVE BENADRYL AND THE PATIENT WAS INSTRUCTED AFTER THE IMMUNIZATION OF SIDE EFFECTS AND WHAT THINGS TO WATCH FOR, AND WHAT  SHOULD BE REPORTED TO US.  PATIENT CALLED BACK 12-03-03 IN THE AFTERNOON AFTER RECEIVING HER SHOT AND STATED THAT SHE SAW A LITTLE REDNESS AND SWELLING AROUND THE INJECTION SITE. WE ADVISED HER ON MONITORING, THE SITE AND WHAT TO DO IF THINGS WORSENED. ALSO PROMISED TO FOLLOW UP WITH HER THE NEXT DAY.  CALLED ON 12-04-03 AND SPOKE WITH PATIENT AND SHE STATED EVERY THING HAD CLEARED UP AND SHE WAS FINE.
chills and aches; chills and aches; my heart was racing; my heart was racing/ went up to 150 and never got below 70 while resting/ resting heart rate is 58 normally/ would jump to 90 to 120 to 150 and then just keep going up and down; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered on the left arm, on 30Mar2021 (lot number: ER8727) as 1st dose, single and on 19Apr2021 09:00 (lot number: ER8731) as 2nd dose, single for COVID-19 immunization. The patient had no medical history. Concomitant medications included levothyroxine sodium (UNITHROID) and gabapentin. 12 hours after vaccination on 20Apr2021 08:00, patient got the chills and aches. When she woke up the next day her heart was racing. It went up to 150 and never got below 70 while resting. Her resting heart rate was 58 normally. The whole day it was racing. If she would stand up it would jump to 90 to 120 to 150 and then just keep going up and down. When she called her doctor, they told her to go to the ER because she could go into Cardiac Arrest. She chose to wait to see if she would be better the next day. It was so, she never did end up going. No treatment was received for the events. Patient was not pregnant at the time of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was recovered on an unspecified date.
The day I received my first COVID vaccine (May 5th) I started bleeding irregularly as if I was spotting or beginning my menstruation cycle. However, the blood was VERY dark, like maroon in color. The bleeding continued until May 24th. My previous period in April was a regular period that had begun on April 23rd and lasted for 6 days. My irregular bleeding during the entire month of May was accompanied by infrequent cramping and breast tenderness.
Dose administered after exposure to room temperature >24 hours; temperature excursion that occurred on Oct6th. Fridge's door was not closed all the way, and temperature was out of range for about 1 hour and 20 minutes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours) and PRODUCT STORAGE ERROR (temperature excursion that occurred on Oct6th. Fridge's door was not closed all the way, and temperature was out of range for about 1 hour and 20 minutes) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours) and PRODUCT STORAGE ERROR (temperature excursion that occurred on Oct6th. Fridge's door was not closed all the way, and temperature was out of range for about 1 hour and 20 minutes). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours) and PRODUCT STORAGE ERROR (temperature excursion that occurred on Oct6th. Fridge's door was not closed all the way, and temperature was out of range for about 1 hour and 20 minutes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter.  No Treatment Information were provided by the reporter.   This case was linked to MOD-2021-374037, MOD-2021-374037 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow-up received Contains suspect start date were given
I received my booster shot on 1/27/2022 around late Thursday night. On Saturday night, I had a sore throat, heart irritation, and cold sweats with no fever, however I did have a slight headache. My AFib was 130-150 which was very irregular, my heart beating was very high. On Monday I saw my oncologist who offered me to go the hospital, my husband took me to the ER. I was given 2 bags of Cardizem through my IV to slow down my heart rate. I was eventually admitted after my heart rate went back up following it slowing down for a minute. While I was there I was being monitored regularly and taken off of Cardizem. On Wednesday night my heart rate went back to normal and I was discharged on Thursday.
On 03/05/2021- after the vaccine I was told to wait in the 30 minute waiting period because I have had adverse reactions to antibiotics and opioids. I was doing well  within 10 to 15  minutes in.  The EMT at the facility  asked me why I was clearing my throat. It felt as though I had a shot of Novocain.  My mouth was dry and it started to feel like it was getting numb and I started to itch. A doctor gave me Benadryl and they wanted to wait to see if the Benadryl worked. And it worked right away. Then the numbness in my throat cleared up but the itchiness only got worse.  And the next day the itchiness got worse and my doctor gave me Prednisone. The itchiness took like 5 to 7 days before it all went away. My doctors say I can't take the 2nd dose of the COVID-19 vaccine  because I would have a more adverse event.
woke up to chills, fever, muscle aches, queasiness.  Fever was around 101 for about 20 hours, now at 100 still at 32 hours.  at it's highest was 101.8, several times.  Dizziness and heart palpitations most of the day.  Really sore body.
Twenty-four hours after my second Moderna dose, I lost the ability to speak and process mentally for a few seconds in the midst of a presentation. By the end of the third day, I experienced stroke-like symptoms landing me in the hospital. I had right leg and right arm numbness, confusion, slurred speech, rapid heartbeat, difficulty swallowing, and elevated blood pressure. I ended up in the hospital for 3 days and 2 nights.