chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 50 year old female patient with asthma. No drug reactions/allergies were reported. On 14-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX, (lot# not reported) vial 19400 PFU, 0.65 ml, subcutaneous. Concomitant therapies included glucosamine, TOPROL (reported as "toporol"), aspirin (manufacturer unknown) and MOBIC. The patient went to physician's office. On 15-NOV-2013, the patient's physician prescribed the patient prednisone (manufacturer unknown) to treat her unspecified asthma symptoms. No lab was performed. The outcome of asthma was reported as not recovered. Additional information has been requested.
Pt noticed blisters next day after vaccination. Didn't hurt but was stinging. Pt came in on 12/23 or 12/24 and RPh told her to put ice pack on it and take BENADRYL. This became a sore/infected. Pt went to ER and has appt w/wound care on 1/19/18.
No adverse event; HCP advised that her office administered a vaccine that expired prior to vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administered a vaccine that expired prior to vaccination) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071B22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension.    On 29-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administered a vaccine that expired prior to vaccination). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administered a vaccine that expired prior to vaccination) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administered a vaccine that expired prior to vaccination).    The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication not reported.   Treatment medication not reported.
After receiving Moderna covid-19 vaccine (first dose), patient was experiencing some itching on body, primarily on trunk, arms, and head. No rash visible. Blood pressure elevated at 154/118-has a history of hypertension and reports that she just took her blood pressure medications about 1 hour ago. Pulse within normal range in 70s. Denied any respiratory issues, itching/swelling of tongue/mouth/throat, or nausea/vomiting. Patient stayed her 30 minutes and left at 12:52 p.m. Advised her to seek emergent care should those signs of anaphylaxis occur. Patient verbalized understanding. Medications ordered and administered: Benadryl 25 mg capsule - TAKE 2 CAPSULES BY MOUTH NOW FOR ONE DOSE FOR ITCHING.     Qty: 2 capsule(s)
Immediately after receiving the vaccine, stood up and felt dizzy and could feel headache moving to my scalp.  At bedtime, around 10:30 pm, I could not fall asleep, was freezing, achy, in and out of sleep.  Took temperature at around 2:00 AM.  My temp was 102 deg. F, my pulse was at 125 bpm.  I could feel my heart rate beating rapidly.  Was still dizzy.  At around 6:30 AM, my temp was 101.9 deg. F.  Stayed home from work.  Got out of bed around 2:00 PM.  As I went to the restroom during the morning, early afternoon, my temp gradually decreased, my heart rate gradually decreased.  Still had headache.  Was very fatigued.  The next day, my temp was normal, had mild headache and was still fatigued.
Fever, Chills, headache, nausea, fatigue, and stiff neck lasted about 3 days. Severe muscle pain and joint pain started at the same time as other symptoms but is still happening. Every joint in my body is hurting. Treated at home with rest, fluids, and pain reliever.
Fever, chills, vomiting, diarrhea, rapid resting heartrate (about 180 BPM), dizziness, feeling faint, profuse sweating, extreme body aches and shortness of breath. Body aches began within a couple of hours following vaccination. Other symptoms began that evening and worsened into the night like the first dose. The aforementioned went on for 2 days, and I was weak, dizzy, and experienced shortness of breath for a week after. About 3 or 4 days after vaccination, the injection site became itchy, red and was hot to the touch. This resolved within 2 days. Metrorrhagia began within the week, and I bled for most of the following month. Since then, I still experience irregular bleeding on occasion. This did not happen often prior to COVID-19 vaccination.   I received a flu vaccine on 12/20/2021. I typically do not have adverse reactions to flu vaccines. This time I had some mild adverse reactions (aches, soreness at injection site, felt faint, lethargic, shortness of breath). Shortness of breath has improved some, but it continues especially with exercise, and I have mild discomfort in my left chest. I am unsure if this is related to vaccination.
on about the 8th day after my vaccine, my arm around the  injection site became itchy with redness in a large circular area
Chest pressure/pain; Chest pressure/pain; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the right arm on 11Aug2021 at 10:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the right arm on 21Jul2021 at 10:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 13Aug2021 at 19:00, the patient experienced chest pressure/pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chest pressure/pain was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
pt cried in a high pitched scream for 30 mins; this rxn occurred 17 hrs p/vax
Mom indicated 4hrs post vax child screamed this continued 8-9hrs stopping long enough to take bottle & start again. Taken to Hosp dx allergic rxn to "P" in DTP; mom stated agitated & whiney for 4 days afterwards no fever.
weak; chilled and very cold and then felt hot; headache; problems with chest; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weak), CHEST DISCOMFORT (problems with chest), FEELING OF BODY TEMPERATURE CHANGE (chilled and very cold and then felt hot) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (year ago). Concurrent medical conditions included Dust allergy and Allergy. Concomitant products included INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE for an unknown indication.    On 29-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Sep-2023, the patient experienced CHEST DISCOMFORT (problems with chest). On 29-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ASTHENIA (weak), FEELING OF BODY TEMPERATURE CHANGE (chilled and very cold and then felt hot) and HEADACHE (headache). The patient was treated with GUAIFENESIN (MUCINEX) for Chest discomfort, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. In 2023, HEADACHE (headache) had resolved. At the time of the report, ASTHENIA (weak) and CHEST DISCOMFORT (problems with chest) had not resolved and FEELING OF BODY TEMPERATURE CHANGE (chilled and very cold and then felt hot) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient got the Moderna vaccine in the morning and got very sick the same evening. This was the third day and patient were still very sick. Patient had problems with her chest. Patient could only get out of bed for a short period of time. Patient was weak which was why patient went back to bed. Patient took Mucinex for her chest, but it not helped. Patient used a whole big box of Kleenex it just runs out of her. Patient was not a person who takes pills, but it was so bad that patient had and it did help. Patient called the pharmacy and they said if patient was not better by tomorrow then patient should go to the emergency room (ER) since it was the weekend and there were no doctors available. Patient never had problems before, but this time patient was sick. Patient had no problems with the influenza and pneumonia shot patient got. Patient was chilled and was very cold and then patient was hot.
Soreness in shoulder muscle and joint near site around 7 hours after. 4 hours after that has increased to sever pain in shoulder from any movement as well as decreased range of motion. Yet I have little feeling in my skin up to 6 inches from the site. Also have a low grade fever and body aches.
2 days p/vax pt devel an inj site rxn characterized by a 10cm area of redness, swelling & warmth;pt seen by reporter who prescribed cool compresses;
The day pt was vaccinated and for most of the day after, she did nothing but sleep and when awake exhibited listlessness (no eye contact, appeared druged.  Then for three straight days suffered from congestion, coughing, deep pain in arms at injection sights, extreme irritability and sleeplessness.  Her nervous system was highly exagerrated as well.  She was overly jumpy and scared of every movement and sound and did not take pleasure in or recognize things she did before. While she always seemed to suffer from GI related problems, these also seemed to get worse. It was so bad, that I brought her in to rule out illness or cold.
Pt received 1st dose Moderna COVID vaccine 1/30/21. Reported tingling, heart racing. Discharged after observation, no escalation of care. Entered by PSS for tracking.
Administration error.  Pt is 11.6 years old and received gray top Pfizer covid  bivalent for  12 and older rather than dose for 11 years old.  Pt stayed in clinic for 15 minutes post injection with no complications or adverse reaction.  Attempted phone call to parent for follow up, no answer.
Information has been received from a registered nurse concerning an 11 year old male patient, who is a twin, with no allergies, who has diabetes mellitus and takes insulin, and on 9/12/00 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 634842/1867J). Concomitant therapy included insulin. It was noted that the patient was not ill at the time of vaccination. On 8/2/04, the patient developed a rash on his stomach, which was described as 18-20 lesions. He was afebrile. The registered nurse reported that the patient was treated with diphenhydramine hydrochloride and calamine lotion as needed. Follow up information received from a registered nurse reported that the patient had varicella breakthrough rash on 8/3/04 and described it as 18-20 papular lesions on his chest and abdomen. It was noted there were no blisters. There were no laboratory tests performed. It was noted that within 3-4 days, the patient recovered. The patient sought unspecified medical attention. The registered nurse also reported that the patient's twin sister developed a varicella breakthrough rash of 18-20 lesions on her stomach following vaccination with varicella virus vaccine live (lot # 634842/1867J) (WAES0408USA00663). No additional information is expected.
.On 5/9/2021 I fainted and on 6/2/2021 I fainted again, this time with extreme fatigue, lightheadedness, dizzyness, and blood pressure changes while standing up.
BODY ACHE; ALLERGIC REACTION; FEVER; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, allergic reaction, fever, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, fatigue, headache, body ache and allergic reaction was not reported. This report was non-serious.
bad fatigue; chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "bad fatigue"; CHILLS (non-serious), outcome "unknown", described as "chills". Additional information: Patient had bad fatigue and was in bed because the chills doesn't go away.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On Day 2 after the vaccine I started my menstrual cycle a week early. I am never early. I had cramps, breast tenderness, and began bleeding.
Hospitalized 1/7/22-1/12/22 Abdominal swelling, SOB, hypoxia, fatigue, cough, decreased appetite, PNA, UTI
Information has been received from a physician concerning a 9 year old male who when he was 5 years old (approximately 2003), he was vaccinated with a second 0.5 mL. dose of varicella virus vaccine live (Oka/Merck). On 23-JAN-2008, he developed "breakouts". Five days later (28-JAN-2008), he was seen at the clinic, and it was indicated had developed shingles on his right T7 anterior and posterior dermatome. Medical treatment and current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Body aches, muscle spasms, headache, fever 99F, chills, sweats, red rash on the torso but not painful or itchy, major fatigue (stayed in bed ),  painful and red injection site.
Lethargic; night sweats; Rash on arm; swollen lymph node under arm; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), NIGHT SWEATS (night sweats), RASH (Rash on arm), LYMPHADENOPATHY (swollen lymph node under arm) and NAUSEA (nauseous) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Allergy. Concomitant products included CITALOPRAM, CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ZYRTEC-D) and LEVONORGESTREL for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced LETHARGY (Lethargic), NIGHT SWEATS (night sweats), RASH (Rash on arm), LYMPHADENOPATHY (swollen lymph node under arm) and NAUSEA (nauseous). At the time of the report, LETHARGY (Lethargic), NIGHT SWEATS (night sweats), RASH (Rash on arm), LYMPHADENOPATHY (swollen lymph node under arm) and NAUSEA (nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Steroid cream and benedryl
Information has been received from a registered nurse concerning a 6 year old female who on 03/14/1999 was vaccinated with varicella virus vaccine live. On 03/12/2002, the pt presented to the physician's office with a scattered, red, raised rash. The pt had between 15-25 papular lesions, some with atypical vesicles in the center. Lesions were presented on her face, trunk, extremities and near the vulve. No pruritis was associated with the lesions. Additional info has been requested.
This spontaneous report as received from a other healthcare worker refers to a patient of unknown age. On 02-OCT-2014 the patient was vaccinated with expired does of PNEUMOVAX23 lot # J009827, expiry 10-OCT-2014 0.5 ml. No concomitant medication was reported. On an unknown date the patient received expired dose of PNEUMOVAX23. No adverse effects were reported. Product quality complaint was not reported. The outcome of events was unknown. Additional information has been requested.
15 mins post shot intensive upper torso & upper extremity tremors: knees felt stiff; inc Bp & P: 1 cm enduration noted @ inject site, warm to touch; seen by MD
The patient reported mild tenderness at the site of injection. Symptoms generalized weakness, chills and subject fever were also reported. The patient was advised to increase fluid intake, to rest and take TYLENOL or MOTRIN as needed. No further event was noted.
Metallic taste in the back of throat between 15-20 minutes post vaccination, noticeable swallowing and throat irritation at 20-25 minutes post vaccination, tongue and lip numbness and throat tightness at 25-30 minutes, dry hacking cough at 30 minutes. Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions, coughing, speaking 1-2 word sentences, with tachycardia and tachypnea. Treated with IM epinephrine, IV solumedrol and IV Benadryl and IV Benadryl with marked improvement in symptoms.
103 fever, chills, shakes, sweats, headache. 100.2 temperature started at 5pm. By 7pm, fever rose to 103. Temperature did not drop below 100 degrees until 9am on 2-4-2021. Sweats ended by noon on 2-4-2021. All symptoms resolved by 9pm on 2-4-2021.   Only medication taken was Tylenol starting at 9pm on 2-3-2021. 2 pills every 6 hours. 3 doses of Tylenol total.
Patient experienced a 104* fever along with nausea and vomiting following her second Moderna COVID-19 vaccination.  She also developed hives all over her body and continues to have random moments of anaphylaxis.
6 days after receiving the vaccine, I developed mastitis rapidly in my left breast. I am not nursing, pumping, or pregnant. Treated with 7 days of antibiotics and it resolved within 7 days.
Case number PHEH2012US007087, is an initial spontaneous report received from medical assistant on 28 Mar 2012 with a follow up received on 16 Apr 2012: This case refers 11-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were unspecified. He was received only partial dose of Men A lyophilized conjugate component of MENVEO (batch number: M11053) intramuscularly on to right arm on 27 Mar 2012, which did not reconstituted well with Men C, Y, W-135 liquid conjugate component and half of powder stuck to the bottom of the vial. No adverse reaction had occurred following this administration error. No other information was provided. Follow up received on 16 Apr 2012: Patient demographics updated (height and weight) and site of vaccine administration.
p/ pt recv vax the following day pt exp fever up to 102f. treated w/tylenol
Early in September I began to feel sick and as if I had seasonal allergies, however I began developing a cough on the 5th of September and tested positive for COVID-19. I had no fever however nasal congestion, deep rattling cough, body aches and muscle pains, extreme lethargy, brain fog, loss of smell and taste. I received monoclonal antibodies on September 9th 2021, after this infusion, there was a symptom spike of body aches and lethargy for 2 days afterwards, and then symptoms became less severe. Symptoms have improved however still lethargic and smell and taste are still low as well and brain fog in and out.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 11-OCT-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose and route of administration were not reported, lot # M012991 with expiration date 14-MAR-2018). The dose was exposed to temperature exposure of 16 Celsius degrees for 135 hours 33 minutes. There was no previous temperature excursion and the data logger was not involved. No adverse effects were reported. Additional information has been requested.
she got such a bad headache; she couldn't even drive; she can't bare; it is still very sour, her head; she started running out of great fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 16 years. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEAD DISCOMFORT (non-serious) with onset Apr2022, outcome "not recovered", described as "she can't bare; it is still very sour, her head"; PYREXIA (non-serious) with onset Apr2022, outcome "not recovered", described as "she started running out of great fever"; HEADACHE (non-serious) with onset 26Apr2022, outcome "not recovered", described as "she got such a bad headache; she couldn't even drive". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, head discomfort, pyrexia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever; sore arm; This is a spontaneous report from a Pfizer . A non-contactable consumer reported that a male patient (dad) of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced fever and a sore arm, which was normal. Events outcome was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Systemic: Blood Disorder (diagnosed by MD)-Medium, Additional Details: Patient reported that within 1 hour of receiving vaccine, she noticed leg pain and swelling. She went to the ER where she was diagnosis with a blod clot in the lower leg. The patient was started on a blood thinner (Eliquis) to treat DVT and prevent further clotting. Patient reported that she swelling and leg pain has gone down significantly but she still notes some swelling at the site of the clot.
About 5 days after vaccine - headache - Day 6 - fever and swelling of lymphnodes, also pain & sensitivity behind (R) knee. Pt. is now experiencing pain in and around the site with a nodule formed around the (L) collarbone.