chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extra warmth on my upper arm; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (extra warmth on my upper arm) and VACCINATION SITE ERYTHEMA (Redness) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (extra warmth on my upper arm) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE WARMTH (extra warmth on my upper arm) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Patient came in to get booster covid shot. She stated that last time she received the covid vaccination, she passed out for 10 seconds. The EMT was present on site where it was a drive thru clinic. The EMT concluded that her fainting was more of the summer heat vs the vaccination. Based on the information provided, I moved forward with the vaccination. Post shot, I asked her to stay at the vaccination booth and not to stand. Her companion was getting her water and a candy bar. I asked mutilple time was she feeling okay. She replied yes. I stepped away and the technician on duty went over. The technician observed and asked was she feeling okay where the same response was given, yes. The tecnician stepped away and 20 seconds later, a collapse was heard. I ran towards her to find her laid out on the floor unconscious. I tapped on her continuously for 20 seconds and she then responded. ED was called and arrived about 10 minutes later. They asked her a few questions and asked her to slowly stand. She stated she was fine so EMT left. Event Details
Shoulder tightness; chest pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-May-2021 and was forwarded to Moderna on 28-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Shoulder tightness) and CHEST PAIN (chest pain) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Shoulder tightness) and CHEST PAIN (chest pain). At the time of the report, CHEST DISCOMFORT (Shoulder tightness) and CHEST PAIN (chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
On Day 12 after vaccination, patient got rash. Was seen by a family friend who is ER doc (not PCP) and given child's dose of liquid Benadryl Rash cleared up about 90%, then returned the next day. Benadryl given just before calling facility to alert us to reaction. States this happened after 3rd Dtap also, Not reported.
This spontaneous report as received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ which had Lot number  M007301 with expiry date on 19-NOV-2017 and lot # M034799 with expiry date on 01-FEB-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of > 8 but <25 Centigrade range for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1703USA008046: US-009507513-1703USA008047: US-009507513-1703USA008048: US-009507513-1703USA001850: US-009507513-1703USA008051: US-009507513-1703USA008052: US-009507513-1703USA001827:
TIA; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "TIA". Clinical course: My husband had a TIA (Transient ischemic attack) right after getting the Covid shot. No residuals now.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Received the COVID vaccination on 1/28/2021, that evening developed chest pain that went patient spoke with her father, the decision was made for further evaluation, she was transported to ER via ambulance and admitted for overnight observation, cardiac workup was negative and chest pain was attributed to a vaccine reaction.
Complained his throat felt funny. Asked to explain and he said "scratchy." Went to class after monitored x 45min with no problems.
Facial and chest redness  b/p180/90  Heart rate 97  pso2  98%   Reported some itching  released at 2:19 redness continues for further report of itching.  b/p 142/78 heart rate 86 pso2 97% Respirations even and unlabored, skin pink warm and dry. Patient stated she was ready to go home.  Informed to seek medical attention for further problems.
Headache, NauseaVomiting, Fatigue and body ache. Narrative:
HEADACHE, LOW GRADE FEVER (100.1), VERY TIRED, SLEPT ALOT - LASTED ALL DAY OF 4/11/2018 - FELT BETTER THE NEXT DAY.
A now 4 month old female pt who reports that after 2 month vaccines, within 1 1/2 hours, the pt experienced high-pitched crying for 3 hours. She was fine afterwards.
The day after Fluzone was administered, the arm that the vaccine was placed in became swollen, itchy, red, and hot to touch.
3"rash around site, chills and fever after 30 minutes of injection, fever for 36 hrs, then hives started on Monday 3/1, Went to emergency in early evening they gave me intravenous meds and released me 3 hours later.  On Tues 3/2/21 about 5:00 pm hives and itching continued and got worst. I went back to emergency and they treated me will pill form medications and released me about 3 hours later. I was still with hives and some itching. On Wed morning 3/3/21 I woke up with severe hives and itching and my face and lips had now blown up and were getting worst. about 3 times the size. We returned to Hospital and the admitted me. I stayed untill Sat morning 3/6/21. I was treated with high doses of steroids, wore a heart monitor because my heart rate dropped to 40 at night.
Fever 102-103 for 18 hours Chills for 5  hours Malaise Severe myalgia headache vertigo odd taste of food/drink loss of appetite
2 series shot is a doozy; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.  Additional case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. After the 1st shot patient was doozy, but so much better than contracting shingles. The follow up was not required. For tolerance of 2nd dose refer case US2021AMR178148.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178148:same reporter, same patient, 2nd dose
Dose 1, Dose 2, Dose 3 :Moderna / Dose 4: Covid19 Bivalent booster; agitation; activation; insomnia; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "melanoma of the eye" (unspecified if ongoing); "hyperthyroidism" (unspecified if ongoing); "adrenal insufficiency" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing); "blindness" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna coviD-19 vaccine (DOSE 1, SINGLE), administration date: 03Mar2021, for COVID-19 Immunization; moderna coviD-19 vaccine (DOSE 2, SINGLE), administration date: 31Mar2021, for COVID-19 Immunization; moderna coviD-19 vaccine (DOSE 3, SINGLE), administration date: 24Aug2021, for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Dose 1, Dose 2, Dose 3 :Moderna / Dose 4: Covid19 Bivalent booster"; AGITATION (non-serious), outcome "recovered"; ACTIVATION SYNDROME (non-serious), outcome "recovered", described as "activation"; INSOMNIA (non-serious), outcome "recovered".  Additional information: It was reported that a 61 yo female experienced agitation/activation/insomnia for lasting 4 hours the same day after receiving her covid-19 booster. Patient did not seek physician care at office or hospital. Patient has fully recovered. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
LEFT UPPER ARM AT VACCINE SITE WITH DRAINING PUSTULE REDNESS FIRM AND WARM TO TOUCH AND STREAKING PRESENT.
Myalgia & Arthralgia  Narrative: Symptoms initially resolved but returned a week later  for neck numbness/tingling. These initiated post injuection 30-60  minutes.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On 07-MAR-2016, the patient was vaccinated with an expired dose of ZOSTAVAX injection (lot# K010967, expiration date 06-NOV-2015, dose, anatomical location and route of administration were not reported). The reporter also stated that the ZOSTAVAX did not have any previous temperature excursions. No adverse symptoms reported. Additional information has been requested.
Narrative: Myalgia  dayl slept @ 12n, woke 11:30p, fatigue, weak, day 2 woke 3a hot, t 102.5,  chills; woke 5a 101.7, drank water; woke 7a temp 99.7, L entire side hurt head to  below knee: HA, shoulder, back, hip thigh pain, by morning pain better, L Arm  sore, swollen still,
At about 3:00 AM on 3/31/2019 I awoke feeling nauseous. It wasn't long before I was vomiting. I only vomited once but felt nauseous for about 4 hours. I also had 2-3 episodes of diarrhea and a slight fever. Minor adverse event was a very sore spot at the sight of the injection along with slight general muscle and joint pain.
my associate administer a vaccine who is not 18 until July; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (my associate administer a vaccine who is not 18 until July) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (my associate administer a vaccine who is not 18 until July). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (my associate administer a vaccine who is not 18 until July) outcome was unknown. Not Provided    Concomitant and treatment details were not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
got covid about 3 days after first dose; This is a spontaneous report from a contactable consumer (Patient) via Pfizer Sponsored Program . A male patient of an unspecified age received first dose of BNT162B2 (PFIZER COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on 26Feb2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 01Mar2021 (3 days after vaccine first dose), the patient was tested positive for COVID-19. The patient underwent lab tests which included SARS-COV-2 test: Positive on 01Mar2021. The patient second dose was scheduled on 26Mar2021 and he wanted to know if he should still get second dose. The outcome of the event was unknown.  Information on lot/batch number has been requested.
This report was received from an agency and was assigned manufacturer report number (5581814), refers to a 64 year old male patient. On 16-JAN-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # H014196, expiration date was 19-MAR-2014). On 18-JAN-2013 the patient experienced local reaction red swelling and local reaction redness and went to the emergency room. While at the emergency room he was administered an antibiotic because they thought it may have been colitis and they also gave him cool compresses to the arm that he received the injection in and TYLENOL. He was discharged from the emergency room the same day and he was doing okay on 11-FEB-2013. The original reporting source was not provided. This is one of the several reports from the same source. Additional information has been requested.
Pt did not respond to Engerix-B vax series; 7JAN92 Hep B surface antibody titer-neg; booster given;
Rash/Hives all over torso; Rash/Hives all over torso; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA1484) via an unspecified route of administration in the left arm on 03Aug2021 at 15:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity and allergies to latex, adhesive and multiple foods. The patient previously received codeine (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications within two weeks of the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 04Aug2021 at 13:30, the patient experienced rash/hives all over torso. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events rash/hives all over torso was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Pt recvd vax & exp h/a which persisted for 24 hrs; No further details were provided;
Pt recv vax on 8/6/98; on the same day pt exp hot &indurated LA. On 8/7/98 pt saw M.D. w/ swollen LA, reddened injection site. Pt dx=shot rx vs. cellulitis;tx=Duricef 250mg/5cc/2xdy/10dys & Benadryl 1 tsp/every 6 hrs for 24 hrs.
Information has been received from a RN concerning a 72 year old female hospital volunteer who on 04/30/03 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 642720/0172M). The reporter indicated that within 24 hours the pt developed swelling, redness and possible cellulitis at the injection site.  The pt was treated with IV cefazolin sodium (Ancef). Unspecified medical attention was sought. The pt subsequently recovered. A product quality complaint was not involved. Upon internal review, possible cellulitis was determined to be an other important medical event (OMIC). Additional information has been requested.
Severe muscle aches (stiffness) in neck, upper back & R/shoulder blade, starting day after shot & continued 4-5 days & eased. Eve of 5th day, tenderness in R/testicle. Dx:Epididymitis, tx: Cilebrex & Doxycycline, Prolactin, Testosterone.
Red, itchy rash that started about 40 hours after shot. The rash is on the injection arm, but not right at the injection site (about 4 inches below injection site). Itching is mild to moderate. I am now eight days past the shot and the rash has not gone away.
Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: PVC-Medium
A physician reported that her 1 year old son received an injection of Prevnar on 10/29/00. That same day, he developed irritability, restlessness, decreased appetite, drowsiness, fatigue, hyperactivity and an unspecified injection site reaction. The reporter also believes that her child may have experienced hypotonic-hyporesponsive episodes as "he looked a little floppy last night". As of 10/24/00, the symptoms had not resolved.
Severe pain deep in left buttocks hip area. Began 01/14/21 am and continuing Now. Taking Aleve every 12 hours for some relief Pfizer COVID Vaccination on 01/13/21 at 7:27 am at medical center. Vaccination in right arm. I am 77.5 years old. Is there a drug interaction between Valtrex and the COVID vaccine?? I take Valtrex daily. Help
Case number PHEH2013US025388 is an initial spontaneous report received from a pharmacist on 05 Dec 2013: This report refers to a 15-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 010021A) intramuscularly on 04 Dec 2013. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 05 Dec 2013: The labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
1 day following vax pt devel generalized hives. Treated with Benadryl and recovered. Reporter notes: Pt finished 10 days of Ceclor 24 hr prior to vax. Began using new shampoo 3 days prior to vax.
Information has been received from a registered nurse concerning a 6 month old white male with no pre-existing allergies, birth defects, medical conditions, who on 14-AUG-2007 at 9:15 AM was vaccinated po with a third dose of Rotateq (lot number: 653661/0138F). The patient was hospitalized for intussusception. There were no relevant diagnostic tests and laboratory data. There was no illness at time of vaccination. There were no adverse events following prior vaccinations. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested. 12/26/07-records received for DOS 10/4-10/5/07- DC DX: Intussusception of large bowel, reduced. Viral gastroenteritis. Mild dehyrdation. Successfully reduced by barium enema. Presented to ED with nausea, projectile vomiting and stomach cramps. In ED one small bloody diarrheal stool.
Lethargic, spiked 104.4 fever that lasted exactly 24 hrs from admin of vaccines. Eyes rolling back thru out 24 hr period, starring off. Behavioral changes - abnormal.
Diffuse Urticarial rashes to chest and extremities 45 mins after application Tx: Solumedrol 40mg IM to Left gluteal area Benadryl 25mg PO x1 given
stabbing pain over lt breast more twoards sterum;breaking out clammy sweat w/nausea;
Received vaccine at 10AM Thursday (12/13/2018). Started having chills, aches, shakes, and swelling in the arm (injection area and around). This area was also very red and hot to the touch. I took 4 ibuprofen and went to bed and felt better by morning. However, swelling, redness, and hurt to the touch remained. I waited until Sunday eve and went to urgent care. I received a 7 day supply of Prednisone 20MG and a 10 day supply (30 pills) of Cephalexin 500 MG. I am starting the pills tonight 12-16-2018.
Started developing a sore in the corner of my lip Friday night/Saturday morning (vaccination was on Thursday morning).  The little sores continued to emerge along my lower lip and continued to come out on the top lip.  It?s almost following in a line across the middle of my upper and lower lip.  The little sores hurt seem swollen and are red.  They are all now forming little scabs and appears to be shingles.
Bright red blood and blood clots in urine on 4 consecutive days; Bright red blood and blood clots in urine on 4 consecutive days; This is a spontaneous report from a contactable nurse (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 71 years of age), dose 2 via an unspecified route of administration, administered in arm left on 18Apr2021 10:30 (Batch/Lot Number: ER8733) as a single dose for COVID-19 immunisation. Medical history included hypertension and penicilline allergy, both from an unknown date and unknown if ongoing. Concomitant medication included bisoprolol taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2, dose 1 via an unspecified route of administration, administered in arm left on 22Mar2021 14:30 (Batch/Lot Number: ER8737) (at 70 years of age) for COVID-19 immunisation. The patient had no other vaccine in four weeks prior to covid vaccine. He had no covid prior vaccination. He had not been tested for covid post vaccination. It was reported that the patient experienced bright red blood and blood clots in urine on 4 consecutive days. The events started on 19Apr2021 10:30 AM with outcome of not recovered. The patient had not received any treatment for the events.
PT. RETURNED 5 DAYS AFTER RECEIVING FLU SHOT STATING THAT ARM WAS BRUISED AND SWOLLEN. IT WAS EXPLAINED THAT THIS COULD BE A NORMAL SIDE EFFECT - BUT PT. WAS UPSET. PT. WAS REFUNDED BECAUSE OF CUSTOMER SERVICE
pain on left side of her neck; I can't swallow; when I swallow it hurts. I hurts like the top, but on the left side where you swallow; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.   A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (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: NECK PAIN (non-serious) with onset 16Mar2021, outcome "unknown", described as "pain on left side of her neck"; DYSPHAGIA (non-serious) with onset 16Mar2021, outcome "unknown", described as "I can't swallow"; ODYNOPHAGIA (non-serious) with onset 16Mar2021, outcome "unknown", described as "when I swallow it hurts. I hurts like the top, but on the left side where you swallow".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.