chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient said that her lips and tongue were tingling 15 minutes after getting vaccine. I offered oral Benadryl. She accepted. She sat with me an extra 15 minutes so I could observe her. She said that she was fine to go home after 30 minutes total.
Pt presented to ER with arm swelling WBC 15.2 Heart rate of 150.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 64-year-old male patient who received Shingrix (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received 23rd May 2018, refer linked case US2018GSK153111). On 13th August 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th August 2018, immediately after receiving Shingrix, the patient experienced injection site pain. On 14th August 2018, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling and injection site pain were unknown. It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix. Additional information was reported as follows: The patient experienced pain in arm immedaitely after the vaccination. The patient also commented that it hurted a little more when compared to the first dose. There was no change in the injection technique for the first and the second dose. The next day after vaccination, the patient expereinced swelling at the injection site. The swelling had reached about 2 inches in diameter.
injection site red hive; Injection site redness; This case was reported by a consumer via call center representative and described the occurrence of injection site hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site hives and injection site erythema. On an unknown date, the outcome of the injection site hives and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site hives and injection site erythema to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that her sister received dose 1 of Shingrix and developed an injection site red hive that never went away. The reporter did not consent to follow up. This case has been linked to US2020004013, reported by the same reporter.
Headache ever since however not severe; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache ever since however not severe) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01D021A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced HEADACHE (Headache ever since however not severe). At the time of the report, HEADACHE (Headache ever since however not severe) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
2 days after receiving the shot both feet began swelling up, by day 3 i could no longer walk and it lasted almost a week - I went into urgent care on Tuesday (shot was on a Thursday, feet began swelling on a Saturday) and they believed it to be my heart.   Thursday I went into my local dr and she believed it to be congenital heart failure.  The swelling went down, but then came back with veins sticking out and noticeable on my left leg  (red and purple)  starting may 23rd - I went into my local dr on Friday may 28th and they thought it was an artery disease .  I have test scheduled for June 22
Patient c/o soreness 2 weeks after vaccine was injected to her left arm. Patient declined xray, physical therapy or ortho referral: she is taking diclofenac for pain.
Got exposure to her son in law that is positive in covid-19; Swelling; Numbing; Itching; This is a spontaneous report from a non-contactable consumer (patient) or other non-healthcare professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 28Aug2021, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got exposure to her son in law that was positive in Covid-19. After first dose of vaccination the patient experienced swelling and numbing and also itching. Patient was asked if this was a delayed reaction to the vaccine or a symptom because patient had exposure to a covid-19 positive. Patient said that she will call her doctor first. The clinical outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. got red cheeks, forehead, nose and especially upper lip within 5 minutes of recieving MMR, Varicella and Hep B. Was given Benadryl 12.5mg via GT 10 minutes after vaccine administration. Monitored Pulse Oximetry and pulse and direct observation x 45 minutes post vaccines.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose was received on 17th May 2018, refer US2018182631). On 28th September 2018, the patient received the 2nd dose of SHINGRIX. On 28th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 29th September 2018, the patient experienced erythema and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were recovered/resolved and the outcome of the erythema was recovering/resolving. It was unknown if the reporter considered the pain in arm, erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on left arm. The SHINGRIX was administered in the late afternoon. The patient experienced the soreness in her arm that lasted about 4 days. The patient's arm also became red from the shoulder area to an inch above her elbow and she had flu like symptoms. Both of these events presented the day after the injection.  The flu like symptoms lasted for 2 days. There was a small amount of redness present at the time of reporting. The patient's physician was her husband.
Patient stated that she had a red injection site reaction the day of vaccine on 10/27 but since vaccine injection site reaction has grown in size to about 4 to 5 inches wide. Told patient to keep an eye on injection site and treat any pain with a cold compress and pain reliever and to seek medical attention if it continues to spread. Patient is monitoring
Pt arm swollen and red below injection site at deltoid and above elbow. Entire upper arm affected and erythematous to touch. Pt had fever of 101 degrees F evening after receiving immunization.
Pt was givn immun immediately prior to discharge; Adverse rxn was not reported back to DTP;
Cried for 6 hours straight with a painful cry. Unrelieved with Tylenol or holding. Would fall asleep and wake again with same cry.
Seizure lasting approximately 10 minutes. Excessive vomiting. Lethargic.
8 days post vaccination, developed an itchy rash with mild swelling at vaccination site on the left shoulder and simultaneously developed moderate pain in the left armpit. Has lasted two days at this time. Armpit pain is resolving close to 48 hours later, rash is still present with decrease in itch 24 hours after it developed.
Initial report was received from a healthcare professional on 19 September 2012. An 80-year-old female patient received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE (lot number not reported) on 05 September 2012. On the same day, the patient experienced a fever of 103.8 degrees Fahrenheit (39.9 degrees Celsius), altered mental status, and dehydration. The patient was hospitalized and treated with IV fluids. The discharge diagnosis was transient fever secondary to viral syndrome. The patient received previous doses of "2 trad flu vaccines 2009 and 2009." The patient had no illness at the time of vaccination. The past medical history includes hypothyroidism, hypolipidemia, pacemaker for sick sinus syndrome, left carotid endarterectomy, and blindness in the left eye. The patient is on betablockers and SYNTHROID. Laboratory tests included a chest x-ray (clear), CT of head (normal), urine culture (negative), blood culture (negative), coagulation studies (normal), blood chemistry (normal), and a white blood cell count of 11.6. The patient's outcome was reported as recovered. Documents held by sender: None.
pain in lower part of back around waist down & down leg; same site as bite; feels like a pitched nerve; has been taking 2 advil w/meals w/some relief; bitten in the buttock by raccoon 2AUG; had 5 injects that day then on 12AUG, 19AUG & 3SEP
intense chills; uncontrollable shaking; Could not get warm; Had trouble walking; Had trouble sleeping; Felt warm rest of night; Did not have a chance to take my temperature but probably had a fever; This is a spontaneous report from a contactable healthcare professional.  A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration, at the left arm on Jan2021 09:15 at a single dose for COVID-19 immunization at a hospital.  Medical history included obesity.  Concomitant medications included ibuprofen (ADVIL), methylphenidate & unspecified multivitamins.  The patient previously took tetracycline and experienced allergies. On 06Jan2021 01:00, the patient woke up with intense chills and uncontrollable shaking, could not get warm or stop the shaking, had trouble walking or holding a glass of water shaking was so intense. Patient took ibuprofen helped and symptoms improved after 1-2 hours. The patient also had trouble sleeping and felt warm rest of night. Did not have a chance to take her temperature but probably had a fever. Overslept and missed first work meeting. Patient felt ok by 06Jan2021, 9:30. 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 was not tested for it since the vaccination. The patient recovered from the events on 06Jan2021, 9:30.
Information has been received from a healthcare worker (medical assistant) referring to unspecified patients of unknown age and gender. No pertinent medical history or drug reaction/allergies was reported. On unknown dates since 07-MAY-2015 the patients were vaccinated with PROQUAD (Merck) (lot# L003222, expired date 30-JUL-2016; lot# K023861, expired date 25-MAY-2016, lot# L009209, expired date 17-SEP-2016, dose, frequency were unknown). These vaccines were exposed to temperatures outside of the recommended range. No adverse experience had been reported. This is one of two reports received from the same reporter. Additional information has been requested.
1/28/21 at 11pm I began feeling overall unwell so I checked my temperature orally as soon as feasible, as I had been traveling on airplane, and I noted fever developing. Overnight I experienced increasing fever and chills, noting fever arriving and staying at 102.4 by middle of the night/very early on 1/29/21. Experienced intense headache and whole body aches. On the morning of 1/29/21 when I got out of bed I felt nauseated and vomited. I still had fever of 102, chills, intense headache and whole body aches. I went back to bed and stayed there until  the morning of 1/30/21 continuing to experience all the same symptoms. By 8pm on 1/29/21, I needed relief so I took 500mg acetaminophen. I took 500mg acetaminophen again at 1am and again at 9am on 1/30/21. When I got out of bed the morning of 1/30/21 I noted I still had fever but it was lower at 100.4.  On 1/31/21 fever has gone but headache, fatigue and body aches with general feeling of not feeling well.
Thumb Pain; Redness - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Thumb Pain), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Thumb Pain), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Thumb Pain), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) outcome was unknown.            No relevant concomitant medications were reported.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.
Lightheaded; Head is not clear; Shortness of Breath; Headache; Fatigue; Erroneously received full dose booster; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, FEELING ABNORMAL, DYSPNOEA, HEADACHE, and FATIGUE in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 019B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced DIZZINESS, FEELING ABNORMAL, DYSPNOEA, HEADACHE, FATIGUE, and ACCIDENTAL OVERDOSE. On 25-Oct-2021, ACCIDENTAL OVERDOSE had resolved. At the time of the report, DIZZINESS, FEELING ABNORMAL, DYSPNOEA, HEADACHE, and FATIGUE outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported.
pt recvd vax & temp of 102 w/APAP & had been constantly crying w/high pitched cat-like cry for the past hr; told may try children's Advil @ appropriate dose; the next day reports cried like that for 2 1/2 hrs; then slept throught the noc;
have two shots still got a mild case shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: have two shots still got a mild case shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by the patient via interactive digital media. The patient reported that he or she received two doses of Shingles vaccine and still experienced mild case of shingles. The patient reported that his or her doctor said the vaccine just help it from being so bad. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible, as no contact details were available.
Encounter for screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
15 minutes after receiving vaccine patient started complaining of itching and was scratching all over. No rash, mild redness at injection site, no throat swelling or difficulty breathing. Benadryl 50mg IM given for increased itching and scratching, vitals stable BP 147/73, HR 79,  sat 99% on room air. Patient then reported dry throat, lungs clear, O2 sat stable, no sob. PA ordered solumedrol 125 mg IM and was given. Patient discharged home with driver after being monitoring for over 1.5 hours and symptoms of itching  improved and dry throat feeling resolved.
INJECTION SITE RED AND WARM WITH NO PAIN, RECOMMENDED COLD PACK AND BENADRYL OTC.
chills, fever 101, nausea, aching,  Symptoms remitted within 24 hours
Development of hand eczema approximately 2 months following second vaccine.; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the parent.   A 6-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 29Nov2021 (Lot number: FK5127)at the age of 5 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? : Yes. Concomitant medications included: INFLUENZA taken for Immunisation, start date: 02Nov2021, stop date: 02Nov2021 and unspecified daily vitamin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: FK5127; Anatomical site: Left arm; Route of administration: Unspecified.), administration date: 08Nov2021, when the patient was 5 years old, for COVID-19 immunisation.  The following information was reported: HAND DERMATITIS (non-serious) with onset 18Jan2022, outcome "recovering", described as "Development of hand eczema approximately 2 months following second vaccine". Therapeutic measures were taken as a result of hand dermatitis.  Additional Information: The patient had no known allergies. The patient received other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was reported that patient had no prior history of eczema. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment included over the counter (OTC) hydrocortisone cream.
Dizziness; Nausea; Felt like she had the flu; Felt sick; Headache; Chills; Body aches; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), INFLUENZA LIKE ILLNESS (Felt like she had the flu), MALAISE (Felt sick), DIZZINESS (Dizziness) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FISH OIL, MONASCUS PURPUREUS (RED YEAST RICE), OMEGA-3 NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D [VITAMIN D NOS], CALCIUM, ESCITALOPRAM OXALATE (LEXAPRO) and ATENOLOL for an unknown indication.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 10-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu), MALAISE (Felt sick), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches). On 23-Feb-2021, the patient experienced DIZZINESS (Dizziness) and NAUSEA (Nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 12-Feb-2021, INFLUENZA LIKE ILLNESS (Felt like she had the flu), MALAISE (Felt sick), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches) had resolved. On 14-Feb-2021, PAIN IN EXTREMITY (Arm soreness) had resolved. At the time of the report, DIZZINESS (Dizziness) and NAUSEA (Nausea) had not resolved.            This case was linked to MOD-2021-023223 (Patient Link).
Initial case received 25 January 2010 from a healthcare professional. An 11 year old female patient received a right arm injection of MENACTRA (lot number 03334AA) on 25 January 2010 and experienced immediately a cold sensation down the arm and tingling of fingers. The patient had no reported illness at the time of the vaccination. She had no known allergies and no medical history was reported. Her concomitant medication included Singulair and Veramyst for unspecified indications. It was unknown if the patient recovered from the adverse events. Documents held by sender: none
I was having a sore neck and neck pain. I thought it may have to do some dental work I had done but then it did not go away. Then I started a sore throat and I ended up going to urgent care and I was tested for Strep and it was positive. The provider said I also had "strawberry tongue" and that is how they knew it was strep. I also had a horrible headache during this. The sore throat and all that is gone but my neck still hurts.
She states she woke at 02:00am with her palms of her hands, bottom of her feet, and toes all itching and burning, like they  were on fire. She took 2 Benadryl. It eased up and she back to sleep. She woke about 8:00am with rash on her arm around her wrist area that was itching and had welts. This rash progressed up the inside of her arm, to her back, and on both insides of her legs down to her ankles. Her lips swelled, but not her tongue. She was treated at Emergency Room with Steroids and more Benadryl and given Rx for Steroids. She states she also developed a blister on her top lip and inside her right nostril both of those lasted about 4 weeks. Her rash resolved after taking the Steroids for 5 days.  She states every now and then she still has some tingling in her finger tips.  She follow up with her Primary Care Provider's office and told not to get the 2nd dose of the vaccine.
Approximately five minutes after vaccination the patient developed linear erythema extending into the right distal forearm and ulnar aspect of the hand.  This was mildly pruritic.  there were no other systemic cardiac, respiratory, or GI symptoms. Vital signs remained stable and WNL. Treatment was started with 25 mg PO Benadryl.  Over the next 30 minutes the symptoms significantly lessened. Patient was discharged without further signs.
About 7-8 hours after receiving my first dose of the Pfizer Covid 19 Vaccine, I began my menstrual cycle 10 days early.  For several days following this, I had the heaviest period that I have had in decades.  At one point, large blood clots were present and I typically do not experience them at all during my  menstrual cycle.