chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a patient and describes the occurrence of EPISTAXIS (Nosebleed), NASAL DISCOMFORT (She kept feeling something in her nose/The capillaries in her nose started to get very red and inflamed, like getting a nosebleed), CAPILLARY FRAGILITY (She noticed broken capillaries on the side), PAIN (Pain in all of my body/ she had minor pains in her body) and PAIN IN EXTREMITY (Pains in my legs/Pain was excruciating in my thighs/ The pain was excruciating and she couldn't walk. It was unbelievable pain) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Non-smoker. Previously administered products included for Product used for unknown indication: Flu shot (A month before the Moderna bivalent.) in September 2022. Past adverse reactions to the above products included No adverse effect with Flu shot. Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for an unknown indication.             Company comment: This spontaneous case concerns a 48-year-old female patient, with no reported medical history, who experienced the non-serious unexpected  of arthritis (like inflammation, arthritis) after receiving a dose of mRNA-1273.222 vaccine. Patient states that after vaccination she experienced pain in the legs and head and all of her body, like inflammation, arthritis. She says her doctor has told her to give it time and has been using heating pads and paracetamol as treatment. No further information on diagnostic tests or clinical assessment was provided. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 48-year-old female patient, with no reported medical history, who experienced the non-serious unexpected of arthritis (like inflammation, arthritis) after receiving a dose of mRNA-1273.222 vaccine. Patient states that after vaccination she experienced pain in the legs and head and all of her body, like inflammation, arthritis. She says her doctor has told her to give it time and has been using heating pads and paracetamol as treatment. No further information on diagnostic tests or clinical assessment was provided. The benefit-risk relationship of vaccine is not affected by this report.
after shot given arm (at injection site) swelled to size of golf ball and began bleeding. Swelling decreased after several hours - forearm and wrist have pain difficulty rotating wrist very painful - pain continues after 2 weeks.
February 4 : Debilitating vertigo, tinnitus, diarrhea, vomiting,  low fever 92F. Tinnitus, fatigue, nausea continued for 2 weeks  March 4: Tinnitus,  nausea March 5: Tinnitus, nausea March 6: Tinnitus, vertigo, nausea, vomiting , diarrhea and it contintues
Note: Any requests for follow-up information on this case should be sent directly to the sponsor or this study, Sanofi Pasteur. This study case was received from the investigator (MILVAX) on 09 January 2013. A 21-year-old male subject received on 27 October 2012 the following vaccinations: an injection of ACAM2000 (lot number not reported); and concomitant vaccines: INFLUENZA, SEASONAL INJ, (manufacturer unknown, lot number not reported), and an ANTHRAX 1 (other manufacturer, lot number not reported). The subject had no significant medical history. On 12 October 2012, fifteen days post vaccination, the subject was diagnosed with Non-specific myocarditis. Laboratory testing included a Troponin 1 blood test on 10 October 2012 with an abnormal result of highest value of 03.09. On 12 October 2012, an electrocardiogram (ECG) and Echocardiogram were both reported as normal. Treatments were not reported. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional study. Documents held by sender: None.
I had the shot Friday, April 16th about 7:30 pm.  No affects didn't even feel it.  Saturday, April 17th I woke up with a headache and was very tired.  Sunday, April 18th I woke up again with a headache, my body hurt, I was very tired, and my shot site had gotten red.  I was also swollen, hard, hot, itchy and had red spots all around it.  Monday, April 19th  and Tuesday, April 20th I still had a headache, my body hurt, and I was extremely tired.  Wednesday, April 21st I called into work because my head hurt so bad, I was having problems seeing, my stomach was very upset, I had diarrhea, my body hurt, and I was extremely tired.  Thursday, April 22nd, and Friday, April 23rd I still had a headache, but I felt better and the red on my arm finally went away.   Saturday, April 24th I woke up again with a headache worse than Thursday and Friday but not as bad as Wednesday and I was extremely tired.  Saturday Evening about 5:00pm my injection site started to itch again, get hot and get red all around it.  My stomach started to hurt, and my headache got worse and made it hard to see straight.  Sunday, April 25th I again woke up with a headache, was extremely tired, had extreme body aches and my rash on my arm was still itchy, hot, hard, and swollen.  Monday, April 26th I woke up feeling the same: headache, was extremely tired, had extreme body aches and my rash on my arm was still itchy, hot, hard, and swollen.  Today I also feel disorientated, my head is extremely fuzzy.
pt recv vax 3/3/98 & on 3/29 pt found out she was pregnant was rpt the only pregnancy complication was a mid trimester bleed which resolved. delivery had mild postpartum hemorrhage only.
pt recv vax; erythema appeared 1 hr later on arms & legs; no redness; MD called; to clinic;no T; f/u next am, mom reports no difficulties;
1/6/2021: Started around 9:30pm with fever, Chills, Headache and body aches  1/7/2021: Continues with same symptoms mentioned above including nausea.  Fever range from 101 - 102.4 Continued to take Tylenol and hydrate 1/8/2021: No fever in am. Started with a slight fever around 2:00pm at 99.5
Approx. 6 hours after vaccine was administered (Pnemovax 23) patient c/o fever, soreness around injection site and nausea. On 3/27/2015 around 2:00 pm L arm had become red and somewhat swollen. Erythema widespread around injection site as well as mild swelling. 3/28/2015 Patient seeked treatment at acute care clinic. C/o increased redness, fever, pain, and itching. Tx. was Kenalog IM injection, and antibx. and anti itch RX's if needed. FYI - Patient had received a Prevnar 13 vaccine via IM route to L arm 8 weeks prior to this vaccine.
The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 07-DEC-2017, the patient was vaccinated with ROTATEQ (strength were unknown, lot# N004815 and expiration date 07-OCT-2018) 1 dose form orally for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 was 47 degree Celsius for max 15 hours. And on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Myalgia, Arthralgia, Fever, SkinRash, total body hives, throat swelled up, took Benadryl and improved Narrative:
Other cereb infrc due to occls or stenosis of small artery on 2023-08-04, Other cereb infrc due to occls or stenosis of small artery on 2023-08-04, Flaccid hemiplegia affecting right dominant side on 2023-08-07, Flaccid hemiplegia affecting right dominant side on 2023-08-21.
Information has been received from a health department registered nurse who was told by an unspecified school nurse that a 9 year old male on the morning of 14-APR-2000 was vaccinated with the first dose of VARIVAX (Oka/Merck) (Lot number# 632616/1688J) subcutaneous in the right arm. On 11-MAR-2008 the patient developed chickenpox. No specific symptoms or treatment reported. This is one of several reports received from the same source. Additional information has been requested.
sore arm; fever; body aches; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and MYALGIA (body aches) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (pain in chest), LYMPHADENOPATHY (lymph node swelling), FATIGUE (significant fatigue), HEADACHE (headache) and PYREXIA (fever) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (pain in chest), LYMPHADENOPATHY (lymph node swelling), FATIGUE (significant fatigue), HEADACHE (headache) and PYREXIA (fever). At the time of the report, CHEST PAIN (pain in chest), LYMPHADENOPATHY (lymph node swelling), FATIGUE (significant fatigue), HEADACHE (headache) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Additional information received
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 12-JAN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (INJ 120Y) at 46.6F for 64 hours (lot#, expiration date, dose and route were unknown). No adverse events were reported. The outcome of the events was unknown. Additional information has been requested.
Hives on neck and chest, injection site red, warm to touch, itching at area and on palms of hands.
Pain and numbness in the right arm and hand. 3 specific fingers: thumb and next 2 fingers.
5 hours after administration she had chills and left side chest pain which continued through the night until the following morning. On 11/30/18 she had inflammation in her left wrist and elbow which continued through 11/30/18. Patient did not take any medication for symptoms.
Information has been received from a consumer concerning her 4 month old female infant with no pertinent medical history who in October 2007, was vaccinated with a first dose of PedvaxHIB. The patient did not have irritability or crying. On 10-DEC-2007 the patient was vaccinated with a second dose of PedvaxHIB. Concomitant vaccinations on the same day included DTaP and poliovirus vaccine. On 10-DEC-2007 the patient had an increase in irritability and increased crying. There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. At the time of the report the patient had not recovered. Additional information has been requested.
I also had a flu shot at the time of the vaccine in Oct,  my arms were sore and it went away one or two days later.Jan2023 my fingers, wrists and knuckles were swollen. I could not close my hands. It started being painful in my wrists on 23Jan23 and I was put on steroids then the medicine finished and it swell up again until my elbows. I was on steroid again and they did x-rays and more bloodwork. When this finished in addition to my hands, elbows and now the knees. I could not even put my seatbelt. I have Rheumatoid Arthritis and De Quervain's Tenosynovitis.
pt felt off balance, dull tight feeling in head, tired, back pain, right elbow discomfort, jittery, muscle weakness
Injection site is swollen, red, fluid dropped to elbow site. Doctor recommended hydrocortisone cream but it made her itchy. SARNA recommended by RPh. Very warm to touch for a couple of days.
roving itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (roving itchiness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PRURITUS (roving itchiness). At the time of the report, PRURITUS (roving itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient also took an unspecified cholesterol medication and inhaler concomitantly. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: non significant follow up received on 06-Jul-2021 in which email address and street address were updated.
Friday MA mom reported redness @ site of DTAP advised warm compresses & APAP;Friday evening site was red & swollen;child felt warm to touch;c/o tiredness & h/a x 2 days;mom called PMD who advised child sensitive to tetanus;
tested positive for Covid 19 again/Getting COVID After the Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid 19 again/Getting COVID After the Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    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 SARS-COV-2 TEST POSITIVE (tested positive for Covid 19 again/Getting COVID After the Vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid 19 again/Getting COVID After the Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
My first Pfizer vaccine was on March 31, 2021. The second Pfizer vaccine was on April 23, 2021. I understand us to have conceived our baby on February 26, 2021. I saw the baby's heartbeat at the doctors office on May 5, 2021. I had started light spotting on Tuesday, May 4. Around 1 am on Mothers Day I started cramping which resulted in a full miscarriage by 7 am that morning of May 9, 2021.
App 15 hours after injection, patient awoke to severe pain in leg. She experienced dizziness and shortly thereafter fainted. Pt was lethargic. Also had difficulty breathing 6 hours after injection. Pain subsided but still present after 48 hours.
Cancer; Drug dose administration interval too long; This case was reported by a other health professional via call center representative and described the occurrence of cancer in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix.   On 16th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant) and drug dose administration interval too long. On an unknown date, the outcome of the cancer and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: A Pharmacy Intern reports that a patient received a new diagnosis of cancer (unspecified type or region) 1 week after receiving the second dose of Shingrix. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.  The reporter consented to follow up. The pharmacy intern acknowledged that follow-up will be needed for additional data. TTO was updated to less than a week as per startdate of vaccine and reporting dateand also clarification was raised.
This case was reported by a healthcare professional via a sales representative and described the occurrence of hepatitis b antibody negative in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On October 2010 the subject completed the TWINRIX series (1st dose, 2nd dose and 3rd dose). Serological testing performed on 19 June 2011 showed antibodies to to hepatitis A vaccine, but was non-reactive for hepatitis B vaccine (hepatitis b antibody negative). The subject had not responded to therapy. No additional details were provided. Follow-up information was received via a nurse on 15 August 2011. It was reported that the subject was a 29 year old male. He received intramuscular TWINRIX on 09 September 2009, 09 October 2009 and a third dose on 09 March 2010. The subject was tested on 19 July 2011, 16 months after completion of the TWINRIX series, and was found to have not responded to the hepatitis B component of the TWINRIX vaccine. The subject was hepatitis B antigen and antibody non reactive. Medical history of hepatitis C virus and allergy to penicillin were reported.
No adverse effects were reported; the 17 year old patient was inadvertently administered an adult dose of VAQTA; This spontaneous report was received from a registered nurse referring to a 17 year old patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 14-AUG-2019, also reported as "yesterday", the patient was inadvertently administered an adult dose of hepatitis a vaccine, inactivated (VAQTA) lot # S007265 (verified to be a valid lot number), expiration date reported as 20-JUL-2020, but upon internal validation established as 07-JUL-2020, for prophylaxis. No adverse effects were reported.
Severe bodyaches, chills, fatigue, nausea last in two days. Used Tylenol and ibuprofen to treat symptoms. Still have left arm soreness on day 2 after injection . Body aches are better on the day 2 but not resolved yet, so his fatigue.
Soreness at injection site on the first day, around 24 hours later developed all over aches, lightheadedness, chills, and weakness to the point of not being able to ambulate. This lasted for two days, then started getting extremely swollen, sore lymph nodes under left arm to the point of not being able to tolerate wearing a bra along with dizziness and nausea. This has persisted for two days so far.
pt high chair & devel chill bumps & shaking all over;pt had panic look on face;pt became mottled on arms & soon became lethargic w/shallow breathing;lips became darker in color p/5min to ER;pt head hit on car door;pt crying, irritable;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: elo140), in right arm, on 17Jan2021 as dose 2, single (Lot number: el3302), in right arm, on 03Sep2021 as dose 3 (booster), single (Lot number: fc3184), in left arm and on 21Apr2022 as dose 4 (booster), single (Lot number: fk9894) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOCETIRIZINE; TOPIRAMATE. Past drug history included: Biaxin, reaction(s): "Known allergies: biaxin", notes: Known allergies: biaxin. The following information was reported: VACCINATION FAILURE(medically significant), COVID-19 (medically significant), 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) Positive, notes: Indication=Treatment of COVID-19; (07Sep2022) Negative, notes: Tested negative for covid on day 5; (10Sep2022) Positive, notes: 3 days later tested positive for covid again for another 4 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events vaccination failure, COVID-19 and the use of suspect product cannot be fully excluded.
Received KINRIX on 6-28-17 in right deltoid. Mother noted swelling and redness to right shoulder yesterday. Localized swelling to right deltoid with associated mild flushing to skin with increase in warmth. Non tender to palpation. Was advised to apply cool compress 2-3 times per day, elevate right arm, MOTRIN for pain. Seen in office by APN.
Woke up the next morning and she felt numbness in her ear.  She could hear, but it felt muffled.  As the day went on she realized that her ear was ringing.  It started as a buzzing and now a high pitched ringing that she still has in her left ear.  She also had a nose bleed that occurred twice on her right nostril.  She has had nose bleeds in the past, but none recently.   She was sitting working and her nose just started bleeding.  The vaccine site itself was sore, minor and not unbearable.  It's just the humming and buzzing in her ear that will not go away.
12/28/2021 I did not feel nothing bad, but when I drink a beer, I started feeling itchy and all my body broke out in hives. My throat was itching, and I started having trouble breathing. I took Benadryl and everything went away.
fever & rash;runny nose;pt wearing a rt eye patch;lt pupil is deformed;apparently born w/cataracts;bitten lt inner cheek;some whitish spots surrounding that which could represent koplik's spots or other ulceration;morbiliform rash;
FEVER, RASH,EXCESSIVE SLEEPING,CALLED NURSE AND ASSURED ME THIS WAS NORMAL A REACTION. WHEN MY CHILD CONTINUED TO GET WORSE I CALLED THE DOCTORS OFFICE BACK AND INSISTED HE BE SEEN AND CHECKED OUT SO SHE TOLD ME TO BRING HIM INTO THE OFFICE.
Initial report received from a nurse on 18 Mar 2011: This patient was vaccinated with only the MenCWY liquid conjugate component of MENVEO (batch number: X10030) intramuscularly without being reconstituted with the MenA lyophilized conjugate component on 15 Mar 2011. No adverse events were noted following this medication error.