chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported feeling faint approx 10 min after receiving vaccine. He disclosed that he had not eaten anything before the vaccination. Monitoring revealed BP of 150/74, HR 52, O2 93%. He felt better after 10 min and was released to self. In follow-up he stated he went home and had something to eat and felt much better. Only sequela was pain at site if injection.
I started getting pain in my left ear that i thought was an ear infection. I went to the E.R. My scalp started to break out with blisters and I went to my primary doctor and she stated it look like shingles. She gave me steroids to clear it up. It was very painful I couldn't brush my hair.
PINS AND NEEDLES IN FEET THAT MOVED UPWARD; GENERALIZED MUSCLE CRAMPING; RAPID HEART RATE; 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, and batch number were not reported) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced pins and needles in feet that moved upward. On APR-2021, the subject experienced generalized muscle cramping. On APR-2021, the subject experienced rapid heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized muscle cramping, pins and needles in feet that moved upward, and rapid heart rate. This report was non-serious.
Received IZ 4/11/00 in the morning and over the next 2-3 days, began experiencing increased pain to the injection site. It was erythematous with a hard patch at 1" in diameter, still present the morning of 4/14/00. Pt states erythema is increasing since yesterday. Prescription for Keflex by PCP for ? cellulitis.
This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (reporting for herself/himself) of unspecified age, gender and race/ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein) (unknown trade name) on an unspecified date, at single dose, for immunization.  Medical history and concomitant medications were not reported. A month after pneumococcal vaccination, on an unspecified date, the patient was hospitalized for 14 days due to pneumonia. Event outcome was unknown at the time of report. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities. No follow-up attempts possible. No further information expected.
Client passed out while receiving 4th vaccination of 4 total vaccines. Showed no symptoms of problem prior to passing out. Staff laid client flat on exam table, administered O2 per protocol. Client recovered after approximately 1-2 minutes. Client remained flat on exam table for 10 minutes, then sat up and remained sitting for another 10 minutes, when client reported feeling well and stable was allowed to stand. Client stood without complications prior to leaving facility. Mother reports client has passed out from previous blood draws.
Shortness of breath. Patient was speaking in full sentences. No other symptoms. Did not take blood pressure medication this morning. EMS arrived. Patient refused transport. Stated that BP usually runs 170s systolic. Advised to schedule appointment with PCP.
got shingles; my right side/ the pain was/still have pains on right side bad; thought I was dying; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles 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, 4 months after receiving Shingles vaccine, the patient experienced shingles (serious criteria hospitalization), pain localized and impending doom. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain localized and impending doom were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain localized and impending doom to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient got the first shot of Shingles vaccine, then in 4 months got shingles. The patient spent two days in hospital and could not find what was wrong. The patient did an ultrasound on the right side and that was where the pain was. The patient thought he/she was dying. The patient said he/she wanted to go home and next day at home, the patient self diagnosed. Till the time of reporting, the patient had pains on right side, which started two years ago.
Vaccines given at 0856 on 8/31/11. Fever started around 8pm, up to 103 degrees F. Parents gave appropriate doses acetaminophen without relief from fever, until the next am 9/1/11. Vomited twice.
7 hours post vaccine administration I developed severe abdominal pain, nausea and vomiting. Called 911 and was taken via ambulance to a local ER and admitted for Severe Ideopathic Pancreatitis. I do not abuse alcohol and did not present with gallstones.
Approx 24 hrs post vaccine develoepd "bubble"on inner area of R eye. Next day began to have fever > 101 axillary, nasal congestion with green discharge and cough. Fever responsive to Motrin. 12/9 seen in clinic eye was resolving but pustule still there, no other rashes, decreased appetite later that day. Today 12/10 appetite returned, still febrile but overall better, eye resolving.
Expired dose of IPOL was accidently administered with no reported adverse event; Initial information received on 22-Nov-2021 regarding an unsolicited valid non-serious case received from physician and other healthcare professional phone via Agency (Reference number- 00868820).  This case involves a 7 years old female patient who accidently administered expired dose of IPV (VERO) [IPOL] (expired product administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and INFLUENZA VACCINE for prophylactic vaccination.  On 22-Nov-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) (total, lot number: R1G101M and expiry date: 08-OCT-2021) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day).  It was reported "Nurse states an expired dose of IPOL was accidently administered to a patient on 22Nov2021, and the dose expired on 08Oct2021. Nurse is looking for information how possible adverse effects, if they need to revaccinate, and any other relevant information."  At the time of reporting, no adverse event reported.  The reporter assessed the causal relationship for event with the IPOL as not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt reports sore arm, welt, redness after injection. Day after woke up with face and neck red - feels hot, throat and eyes itching. To use Benadryl for symptoms per doctor.
COVID-19 pneumonia; Foggy feeling in head; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) in a 57-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 25-Jul-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (Foggy feeling in head). At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonia) was resolving and FEELING ABNORMAL (Foggy feeling in head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 57-year-old female patient with no relevant medical history, who experienced the unexpected, serious (hospitalization and medically significant) adverse event of special interest of COVID-19 pneumonia, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, clinical course and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 57-year-old female patient with no relevant medical history, who experienced the unexpected, serious (hospitalization and medically significant) adverse event of special interest of COVID-19 pneumonia, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, clinical course and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient noticed a large, red, bump on tricep that was hard and warm to the touch. Came back in to clinic where the nurse and provider looked at it and marked it with a black pen and was told to put heat packs and compression on arm. Pt was instructed to return to clinic first thing the next morning if it had spread outside the area that was marked by the black pen. Pt returned due to swelling getting bigger, pt now says there is discomfort that feels numb and tingling that radiates up and down tricep. Pt saw provider and nurse this morning and is being treated for cellulitis.
Case previously recorded as MA2009-4805. Initial case report received from a nurse on 18 NOV 2009. A 53-week-old female patient was vaccinated with S-OIV FOCETRIA (batch no. 102125P1) on 17 NOV 2009. The outcome was reported as not applicable.
painful and swollen armpits, worse after the second shot; painful and swollen armpits, worse after the second shot; painful and swollen armpits, worse after the second shot; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: FA6780; Expiration date: unknown) via an unspecified route of administration on 17Jul2021 10:00 (at the age of 60-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had not any known allergies. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0198; Expiration date: unknown) via an unspecified route of administration on Arm right on 17Jul2021 10:00 as DOSE 1, SINGLE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced painful and swollen armpits, worse after the second shot on 08Aug2021. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The outcome of events was not recovered.
Nausea, shaking chills, red swollen painful injection site for 4 days.
2nd booster given to patient  48 years old.  Currently 2nd booster only approved to 50 years of age & older.
APPROXIMATELY 6 HOURS AFTER ADMINISTRATION, SORE ARM, FEVER, CHILLS, AND FATIGUE BEGAN. THE FEVER AND CHILLS CONTINUED FOR 24 HOURS. APPROXIMATELY 45 HOURS AFTER ADMINISTRATION, MY ARM BECAME RED AND ITCHY AT THE ADMINISTRATION SITE. I USED 2 DOSES OF NAPROXEN FOR THE FEVER.
As I was administering the vaccine in the left deltoid, about 3 to 4 drops of the vaccine leaked from the base of the needle where it connects to the syringe. The patient and I were concerned. I let another nurse know what had happened and what I should do. She instructed me to chart it in the patients chart and also in VAMS. I charted that a few drops did not make it in her arm. I also noted on the patients vaccination card that those drops did not make it as well.
I had a cough, fever of 102.6, lost my balance, and dizzy. I tested positive for COVID-19. I called my doctor, and she didn't get back to me until 3 days. Three days after taking PAXLOVID, I lost my smell and taste. I had to go to the ER because I felt so weak. When I got to the ER, they EKG, chest x-ray, and blood work. Everything came back normal.
It was reported that a 48 year old female pt received a TD Adult vaccination on 01/26/2001 at 1:30pm Reportedly later that evening between 6-7pm, the pt developed 2cm of redness with 3cm of induration on her right forearm. Treatment of Benadryl per oral was prescribed. The pt reportedly recovered from this experience. From follow up #1 correspondence recieved on 03 Apr 2001, no further information was provided. See reports U2001-00435, U2001-00436, U2001-00438, U2001-00447, U2001-00449 through U2001-00454 and U2001-00456 through U2001-00461, same reporter.
3/30, Day 12, started with mild rash, redness, soreness, mild warmth of injection site,   3/31, Day 13, increase of all symptoms noted on Day 12.  4/1, Day 14 increase of all symptoms, more than previous day; however, warmth of injection site lessened.  4/2,  Day 15, no change from previous day.  4/3, Day 16, increased size of area with redness, still mild rash to area,  pain less at actual injection site. 4/4,  Day 17, increased size of red area, no warmth, very mild pain at actual injection site; area is 8 cm x 9 cm.  (Counting 03/19/2021 as Day 1)
Subjective fever and chills with uncontrollable shivering and  body aches starting the evening of the day he had the injection, left arm localized pain worse with movement and weak arm at or above shoulder level.  No swelling or rash seen.  Patient states he had symptoms that prevented him from going out of his home/to work for the following day.  Symptoms slowly improved over a few days and by 1 week following the injection he reported symptoms resolved.
BODY ACHES; LOW GRADE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and low grade fever. This report was non-serious.
little soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot no: EL3248 or EL3298), via an unspecified route of administration in the left arm on 27Jan2021 as a single dose for covid-19 immunization. The patient had no medical history and concomitant medication. No additional vaccines were administered prior to Pfizer vaccine within four weeks. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No family history was reported. On 27Jan2021, the patient added he had a little soreness at the injection site that started late last night. The patient did not make any visit to the physician office. Just enough to make him remember he got it. It has improved. The patient enquired whether he could consume alcohol and he is asking can he drink? The patient was scheduled to receive the second dose of the vaccine on 17Feb2021. No laboratory tests were done. The outcome of the event was recovering.    Information on the batch/lot number has been requested
Adult ES to inpatient (reports having +COVID test "about 10 days ago" to medical team)                 Dx: The primary encounter diagnosis was UGIB (upper gastrointestinal bleed). A diagnosis of Acute blood loss anemia was also pertinent to this visit.        Vaccine - Primary x2 (last dose 1/28/2021) Tested positive on 6/19/22
Chill, Back pain, Arm pain, Sciatica, and Eczema.
The customer stated she had no monthly period for three months after HPV#2 dose rececived on 09/22/2009.
Had side effect and I just fall a sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 (Lot number: EW0175) at the age of 30 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing), notes: Verbatim: AFib. There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Had side effect and I just fall a sick". Therapeutic measures were taken as a result of illness.  Additional information: When probed for the concern, patient stated I had been a side effect of Covid vaccine, on a first day I just fall a sick and I was trying to see, what are the protocol. When probed for any treatment for the event, patient stated I took Tylenol.   Follow-Up: Follow-up attempts are completed. No further information is expected.
Miscarriage occurred following 2nd covid shot; 2nd shot received on 11/17/21 and miscarriage on 11/20/21. Was approximately 7-8 weeks pregnant at time of 2nd covid shot. EDD was June 2022. No previous history of miscarriage. Following the second shot patient experienced fever, chills, burning pain in left arm, pain at injection site, loss of appetite and cramping.
2 and 1/2 inch diameter warm red swollen mark around injection site. Noticed it about 2 hours after shot was administered. Still there the next morning and gave ADVIL. Went to the school nurse and she applied ice.
This case was reported by a pharmacist via call center representative and described the occurrence of upper extremity mass in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 22nd March 2019, the patient received the 1st dose of SHINGRIX. On 22nd March 2019, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 23rd March 2019, the patient experienced upper extremity mass and injection site erythema. On an unknown date, the outcome of the upper extremity mass and injection site erythema were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the upper extremity mass, injection site erythema and vaccine administered at inappropriate site to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine on left side. One day after receiving SHINGRIX, the patient experienced golf ball sized bump on her crease at the elbow. The injection site was also red. The pharmacist who injected noted that the patient was very thin, and he injected the dose into the triceps area rather than the deltoid, which led to vaccine administered at inappropriate site. The reporter consented to follow up.
I wonder if I got my 2nd shot.  I didn't feel any bump on my left arm at all.  I felt tiny tiny pain from the needle when was injected.  I could lift my arm normally with no pain at all.  I could also continue doing my normal activity, even push the manual lawn mower over 2 hours.   The 2nd shot didn't give me a painful hard bump on my left arm like the first shot.    Should I get another one to replace the 2nd shot?
7 patients within 2 weeks have reported joint pain & tenderness which radiated up to the shoulder, redness & slight swelling @ injection site, no treatment prescribed, 1 patient is due to visit a neurologist for shoulder. Vaccines routine
High Fever 103,  droopy right side of mouth, slurred words,  reduced use of right leg.  inability to stay awake, extreme headache,  These symptoms are improving
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 2.5 ml/five dose vial, lot # K007773 and expiration date 01-MAY-2015 (administration route was not provided). No adverse effects were reported. The vaccine had one temperature excursion of 48 hours with a lowest recorded temperature of 1 Fahrenheit (F) (1 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
After I had already given the booster shot, as I was filling in the vaccination card, I realized from the lot number of the pt's 3rd shot that she had already gotten the bivalent booster shot on 10/1/22.
Two nosebleeds, one was second night after vaccine, sometime in the middle of the night and the second was on day 2 or 3 after the vaccine.