chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experienced pain in the arm after receiving the GARDASIL 9 vaccine; This spontaneous report was received from a pharmacist, via a company representative and refers to a 18 year old patient of unknown gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).         On an unknown date, the patient experienced pain in the arm after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine (pain in extremity). It was unknown if the patient received any treatment for the event.       The outcome of pain in extremity was reported as resolved at the reporting time and lasted for 1 week.      The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the event was unknown.      This is one of the 2 reports received form the same source.; Sender's Comments:  US-009507513-1905USA008739:
I had a fever for a day and a half around 102 which is rare for me. I had some breathing issues that wasn't terrible. It was more congestion but I didn't have a cough. After the fever broke it was fatigue and congestion and little breathing issues. It lasted about a week.
Information has been received from a 23 year old female with a shellfish allergy who on 15-FEB-2008 was vaccinated with the first dose of GARDASIL.  The patient found out on 19-FEB-2008 that she was pregnant.  Her LMP is estimated as 19-JAN-2008.  Follow up information has been received from a 23 year old female that reported that in March 2008, she had a miscarriage.  She said she was fine now, and doing well.  Upon internal review miscarriage was determined to be an other important medical event.  Additional information is not expected.
Menstrual cycle; Cold sweats; Pain in lower abdomen; This spontaneous case was reported by an other health care professional and describes the occurrence of MENSTRUAL DISORDER (Menstrual cycle), COLD SWEAT (Cold sweats) and ABDOMINAL PAIN LOWER (Pain in lower abdomen) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced MENSTRUAL DISORDER (Menstrual cycle), COLD SWEAT (Cold sweats) and ABDOMINAL PAIN LOWER (Pain in lower abdomen). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, bid. At the time of the report, MENSTRUAL DISORDER (Menstrual cycle), COLD SWEAT (Cold sweats) and ABDOMINAL PAIN LOWER (Pain in lower abdomen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Patient was accidentally given his first dose of the Moderna COVID vaccine 5 days shy of his eighteenth birthday. Other than the underage administration error, there were no adverse effects to report. The patient received his second dose in the series (Lot # 016M20A) on February 10 (after he turned 18)without incident.
Alerted by vaccination RN at 12:01 PM that the first 8 doses administered of the day had been given in insufficient amount. The RN stated she realized with the last patient of the morning (receiving dose #9) that the syringe was not the 3mL syringe she was used to using, and was in fact a 1mL insulin syringe. She noted that she had been drawing up the vaccine up to 5 (meaning 5 unit, equivalent to 0.05mL) rather than to 50u to give the full dose (0.5mL).  She stated she recognized her error with patient #9 and administered the correct amount (0.5mL) from a 3mL syringe she was used to using.  In addition to contacting health department COVID-19 provider,  the patient was contacted and, using an interpreter, informed of the incident and asked to reschedule to come back in to receive the full dose (per CDC guidance) as soon as possible. The patient's wife (who also received the incorrect dose of the vaccine at the same time), spoke with the HCP and interpreter and stated this patient is at work and she would discuss coming back with him to receive the full dose when he returned home. The patient's wife was informed of walk-in clinic hours and will be contacted again 5/19 to follow-up. At the end of the day, when counting dose administered and factoring in the estimated amount of vaccine wasted due to insufficient dosages, there was just under 9 doses accounted for. The vaccinating RN was questioned again to see if there was any possibility any of the initial 8 patients received a full dose of the vaccine without her realizing it. She stated she did not believe she ever drew up the 1mL syringe to 50u nor administered a 0.5mL dose using the 3mL syringe, though she stated she couldn't say for sure. She said the container holding the syringes had each type divided in one compartment and separated from each other. The COVID-19 provider was informed of this information and additional guidance was requested.
had immun in AM, about 1030AM;about 12noon or 1PM became dizzy, lightheaded, warm;has chills & sweats;lt arm became very sore;sxs cont to present;14NOV95 fatigue lasted 3-4 days;soreness @ site lasted 10 days
Secondary Transmission Nonvaccinee Limited information available regarding vaccinee, date of vaccine, onset of symptoms, etc. Primary vaccinee is in the military and has since deployed. Reports from Health Dept. came in around October 2003. Had intimate contact with female who later devleoped flu-like symptoms, followed by the appearance of blisters on her uppper legs and genital area. Initially was told by her doctor that she had herpes, but culture came back negative. Contact changed vaccination site bandage a couple of times; admits to showering and sleeping together with site not covered.
c/o of nausea 24 hrs p/vax w/diarrhea x 2 lasted 24 hrs no temp; no one in fx w/similar sx;
This case is a cluster of 6 unidentified patients who experienced similar adverse events following vaccination with ADACEL. Initial report received from a consumer on 11 August 2010. A group of 6 unidentified patients received an injection of ADACEL on 04 August 2010, lot number sanofi pasteur Ltd. C3314 and lot number sanofi pasteur Inc. U3082AA. All 6 patients experienced varied fever temperatures, "flu-like symptoms", pain at site, reddened arm, swollen arm, and lump at injection site the night of 04 August 2010. The outcome was not reported. This case is 1 of a cluster of 5 (previously reported as 6 unidentified) identified patients who experienced similar adverse events following vaccination with ADACEL. The events for the second patient was captured in case 2010-04836, third patient in 2010-04837, fourth patient in 2010-04838 and fifth patient in 2010-04839. A 38-year-old female patient (age reported as 39 and birth date of 17 November 1971 calculates to an age of 38) received on 04 August 2010 an injection (route and site not provided) of ADACEL, lot number sanofi pasteur Ltd. C3314 and lot number sanofi pasteur Inc. U3082AA. The patient developed flu symptoms, fever, knot and bruise at injection site and muscle pain for one week to 10 days. The outcome was reported as recovered. Documents held by sender: None.
Extreme fatigue, fever of 103, aches and chills, pain at injection site, swollen lymph nodes in neck and arm pit.
17:53: injection administered.  17:03: reported adverse events--hot flashes and sweating.  pt refused epinephrine.  17:08 adverse effect continue.  epinephrine given.  Paramedic called.  61/58 with machine, manually --80/42:   elevated legs.  about 17:15 Paramedics arrived:  b/p 91/60.  pt states that he was getting better.  sweating resolving.  5:22 discharged to the paramedics.
This spontaneous report as received from a other refers to a 12 month old patient. On 12-MAY-2017, the patient was vaccinated with M-M-R II lot # M029230 for prophylaxis which were stored in the range of 47 Fahrenheit degrees to77 Fahrenheit degrees for 11 days). No previous temperature excursion was reported.  No adverse effects were reported. Concomitant therapies included sterile diluent.
Headache, Myalgia, Fever, body aches, muscle spasms, headache, chills, fever to 102.4 used tylenol Narrative:  used tylenol  Other Relevant History:
Janssen COVID-19 Vaccine . I went to bed early, at 8:15pm. Within 5 minutes, I began to have uncontrollable chills. My body shivered and my teeth chattered like never before. I live in cold state and it was not a cold night, relatively speaking. I generally find cold nighttime weather easier to sleep in. I had to turn on a room heater, get fully dressed in warm clothes, and use an extra blanket and heating pad to warm up. Within 4 hours, I became warm. But, then I began to feel too warm, and my body went the opposite direction. Now, I was sweating. I took everything off.  That eventually stopped. Then I developed a head cold, at least that is how it felt. My nose became stuffy. This morning, I woke up at 5:30am and feel better.
Wife reported patient had generalized hives, joint pain, decreased range of motion of arms due to pain, secondary skin infection due to scratching.
Patient admitted 10/18/21, three days after covid booster shot. Female with a history of migraine/hypothyroidism/hypertension/anxiety and depression/mild asthma/obesity who presents with headache.  Over the last several months patient has had difficulty with recurring migraines.  Patient with possible TIA v complicated Migraine in August 2021. Patient is followed by neurology, she had MRI of the brain done 10/14/2021 that showed nonspecific signal abnormalities at the junction of the right frontal and right parietal lobe.  Patient was referred for admission to work-up abnormal MRI. There is concern that perhaps lesions noted on MRI represent a demyelinating process.  Also, cannot exclude mass as previous MRI was done without contrast. Patient with features concerning for SUNCT (Short-lasting neuralgiform headache with conjunctival injection and tearing). Abnormal MRI- noted low grade glial or glioneuroal lesion is favored. Recommend yearly MRIs for surveillance.
She said her friend had to be off work for several months.; This is a spontaneous report received from a contactable consumer via a Pfizer-sponsored program COVAX US Support. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that she had a friend who had an adverse reaction after receiving the vaccine. She said her friend had to be off work for several months on an unspecified date. The clinical outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
on the 7th, started experiencing grogginess and gassy stomach. next day on the 8th, symptoms worsened and began to feel dizziness. severe numbness on the right side of her body. right arm/right leg, trouble with breathing and cannot perform daily activities
Injection site was itchy, had a raised hive-like area and was red; Injection site was itchy, had a raised hive-like area and was red; Injection site was black and blue; Injection site was swollen, red, hot, and hurt; Injection site was swollen, red, hot, and hurt; Injection site was swollen, red, hot, and hurt; Injection site was swollen, red, hot, and hurt; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE WARMTH (Injection site was swollen, red, hot, and hurt), URTICARIA (Injection site was itchy, had a raised hive-like area and was red), VACCINATION SITE DISCOLOURATION (Injection site was black and blue), VACCINATION SITE PRURITUS (Injection site was itchy, had a raised hive-like area and was red) and VACCINATION SITE SWELLING (Injection site was swollen, red, hot, and hurt) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was swollen, red, hot, and hurt), VACCINATION SITE SWELLING (Injection site was swollen, red, hot, and hurt), VACCINATION SITE ERYTHEMA (Injection site was swollen, red, hot, and hurt) and VACCINATION SITE PAIN (Injection site was swollen, red, hot, and hurt). On 27-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Injection site was black and blue). On 30-Mar-2021, the patient experienced URTICARIA (Injection site was itchy, had a raised hive-like area and was red) and VACCINATION SITE PRURITUS (Injection site was itchy, had a raised hive-like area and was red). On 27-Mar-2021, VACCINATION SITE WARMTH (Injection site was swollen, red, hot, and hurt) and VACCINATION SITE PAIN (Injection site was swollen, red, hot, and hurt) had resolved. On 29-Mar-2021, VACCINATION SITE DISCOLOURATION (Injection site was black and blue) had resolved. At the time of the report, URTICARIA (Injection site was itchy, had a raised hive-like area and was red), VACCINATION SITE PRURITUS (Injection site was itchy, had a raised hive-like area and was red) and VACCINATION SITE SWELLING (Injection site was swollen, red, hot, and hurt) had not resolved and VACCINATION SITE ERYTHEMA (Injection site was swollen, red, hot, and hurt) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
administered the Moderna COVID-19 vaccine and found out that the vaccine had been expired for 2 weeks; Expired vaccine was stored in refrigerator on 17-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 vaccine and found out that the vaccine had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 076C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen COVID-19 Vaccine (Lot-1805031) on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 Vaccine. Concurrent medical conditions included Iodine allergy and Drug allergy.   On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 vaccine and found out that the vaccine had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 vaccine and found out that the vaccine had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that since the expiration date was not written on the vial, they did not notice it had already expired. The patient did not report any side effects. The patient had no symptoms. The vial was stored in refrigerator on 17-May-2022. The vial did not undergo any temperature excursions.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2022: Follow-up information included patient initials, patient demographics, patient's history and suspect vaccine dosage information.
J40 - Bronchitis, not specified as acute or chronic HEADACHE SHORTNESS OF BREATH CHEST PAIN
First Shot: Left arm shot. High blood pressure after shot. Sore in shoulders. Went away in a day or two. Later on tightness in chest and upper stomach. Random aches in heart that at times are hard to feel but other times they are obviously there. sharp pains below heart.   Second Shot: I was hesitant to get it and mentioned my heart and high blood pressure. They said I was nervous. Had second shot on right arm to keep away from my heart. I tried remain calm throughout to not elevate blood pressure. Soreness at sight of sot that spread down to my lower back for three days which I figured was to be expected. Strange thing is 3 days later the first shot sight bruised up and became incredibly sore. thought that was really interesting. Heart has stronger and more frequent aches and pains since the second dose.  Blood pressure remains a little high.    I don't have a physician.
fever; chills; bodyache; soreness on site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (bodyache) and VACCINATION SITE PAIN (soreness on site of injection) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028C20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (bodyache) and VACCINATION SITE PAIN (soreness on site of injection). At the time of the report, PYREXIA (fever), CHILLS (chills), MYALGIA (bodyache) and VACCINATION SITE PAIN (soreness on site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication reported.
Pt received injection on the 11th, she states she came down with a migraine that pm.  She also c/o joint pain and generalized body aches.  She had pain at the site with redness, she c/o pain radiating down her arm.  She is unsure if she had a fever.
In the first 12 hours after the vaccine I developed left arm pain. Approximately 12 up to 36 hours after the initial vaccine was given, I developed low-grade fevers. headaches, myalgia, chills, and severe fatigue.   It?s now about 48 hours later and I still experience mild fevers occasionally.
Patient reports that for the past two days (since date of vaccination) she has felt  dizzy. She also reports ongoing confusion since her surgery for her cerebral aneurysm. She reports that for the past few days she has been bumping into walls and generally feeling off balance as well as experiencing word-finding difficulties.  Patient is being admitted for MRI and neurology evaluation. CT and CTA of the head show no acute abnormalities.
Patient is full vaccinated and boosted.  COVID + at ED visit on 3/4/2022.  Chief complaint: shortness of breath and fall. 61-year-old male with dysphagia, tracheostomy dependent presents with shortness of breath. Brother states that that over the last few days patient has been having increased secretions and cough.His brother states that he usually satts at about 97% but has only been satting in the low 90s. Pt was attempting to use the commode today when his brother heard him fall.Patient is + for tacynpnea, respiratory distress, rhonchi, and copious secretions. CT chest: Extensive multilobar pneumonia throughout the right lung most severe within the right lower lobe. CT head: No acute intracranial hemorrhage/no fracture. Treatment:  nonrebreather mask, antibiotics, fluid, steroids, iopamidol, fentanyl, levophed, epinephrine. Intubated. Transferred to Hospital.
Redness, swelling, itchy, peeling skin, hot to the touch beginning 2/26 and site was really itchy and hot on 2/28. No other side effects. Feels a little better today 3/2/21.
Narrative: 40 year old patient reported on 3/5 (when he received his second dose of pfizer) that he had joint pain, dizziness, fatigue, and a skin rash with first dose of pfizer vaccine (given on 2/13/21). Symptoms self-resolved
after the vacc,pt c/o dizzyness,when seen pt looked pale and sweaty,pulse 55,bp 88/54,pt put on table at trendlenberg position felt better ,bp 99/69,pulse 82
Loss of Balance - unsteady - stagger - dizzy. Is more severe with motion - head up, down, standing up, bending, walking. -- not severe when not in motion - sitting-lying. Nausea when symptoms started but have subsided since the first full day.  Some blurry vision at times and ear ringing - not constant. Does pass but continues with motion. Does not have a time frame as it is continuous when in Up-Down-Bending-etc - motion
12 hours after vaccine around midnight, my symptoms occurred, and I realized I had the headache and at that point I'm in bed but waking up the next morning I still had a headache and I had it for the next 48 hours and then it just disappeared. I also had a sore upper arm.
2/9 1pm swelling of rt lymph nodes in neck           8pm 100.4 temp - tylenol & difficulty breathing when laying down - albuterol inhaler, humidifier   02 at 97-99
Case number PHEH2014US017295 is an initial spontaneous report received from a physician on 26 Aug 2014. This report refers to a patient of unknown age and gender. The patient medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: A14044) intramuscularly on 25 Aug 2014. It was reported that on 26 Aug 2014, the patient experienced large painful swollen area. The event outcome was reported as condition unchanged. The seriousness and causality were not reported.
Stiff neck and headache for 1 week. Had the same reaction with last years flu vaccine.
NO ADVERSE EVENT,  MINOR RECEIVED JANSEN WHEN SHOULD HAVE RECEIVED PFIZER
Information has been received from a head nurse concerning a 24 year old female who on 17-JUL-2007 was vaccinated with the first dose of Gardasil.  The patient received second dose (date and practice unspecified).  Subsequently the patient was experiencing irregular periods following 2 doses.  The patient came into the office for the third dose.  The patient's irregular periods persisted.  No product quality complaint was involved.  Additional information has been requested.
The patient received the 4 vaccines listed below on 6-11-10. On 6-16-10 the mother called in and reported patient had itchy hands and feet the evening on 6-11-10. On 6-12-10 patient had swollen hands and feet and hives on trunk. Went away with BENADRYL. At time of conversation s/s had resolved.
09/20/2019 vaccine was delivered. 09/21/2019 patient noticed dark spots on the same arm but not at the injection site. About 7 dark spots looking like  burn spots dime to quarter size. No pain, no itching. Patient reported to the pharmacy on 09/23/2019. The spots did not change in size but started to become look not as dark as first day. Pharmacist recommended to call PCP. I am not sure if it is a side effect of vaccination or co-incidence. Injection site looks normal, no skin reaction, may be slightly swollen but it is hard to say because skin of the deltoid muscle looks absolutely normal.
PT'S LEFT AREM IS STILL SORE AND PT IS UNABLR TO LIFE ARM ABOUT 90 DEGREES