chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Strange feeling in mouth and throat and then felt strange and horrible all over. Pharmacist took blood pressure and it was 206/1?0. Due to extremely high blood pressure, pharmacist did not want to give me epipen and called 911. EMTs didn't want to give epipen either since bp still over 200. They said they saw beginning of hives on my face and abdomen. My throat felt weird but they did not see any swelling. They gave me a shot of Benadryl and I started to feel better after about 15 minutes. They said I should go to hospital. By the time I got to hospital I was feeling bad again. Blood pressure still high around 185, ECG ok, and oxygen ok. They gave me more Benadryl, steroids, and Pepcid via IV and Zyrtec by mouth. After a few hours I was feeling better and they discharged me with prescription for prednisone and told me to continue Benadryl as needed and Zyrtec for several days. The ER documented my mouth and throat symptoms as tingling, but it was much worse than that. Can't really describe how awful I felt.
Vaccine administered to the patient, was given in error beyond the recommended expiration date. We are consulting with Moderna if it is advised to have the patient repeat vaccine dose.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756522A, A0756525A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Client is a 17 year old male with a history of passing out after vaccinations per Client's mother. Client was upright in the passenger seat when he was reported to be unresponsive to verbal stimuli. Nurse reclined the seat and attached a pulse-ox.  Pule-ox did not read. manual vitals taken @ 14:33.  BP 90/60  HR: 72. Breathing unlabored. Ammonia ampule administered 14:35. Client became responsive to verbal stimuli and oriented x2. Juice administered 14:36. Client color and orientation continued to improve. 14:39 vitals taken HR 61, BP 110/80, O2 sat 99%.  Client oriented x4.
Nausea; Headache; extreme headache; Tiredness; Brain fog; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 2Apr2021 at 13:15(at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient did not have any allergies to medications, food, or other products. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE), cetirizine hydrochloride (ZYRTEC), guaifenesin, pseudoephedrine hydrochloride (SUDAFED), multivitamin (UNKNOWN MANUFACTURER), Ademetionine 1,4-butanedisulfonate (SAMe); all from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 2Apr2021 at 20:30, the patient experienced, on the night of the injection, nausea, and on the following night headache, following morning extreme headache, tiredness and brain fog. The patient did not receive any treatment for the event.  The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events nausea, headache/extreme headache, tiredness and brain fog were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
PATIENT WAS ADMINISTERED 0.3ML OF UNDILUTED PFIZER VACCINE. PT WILL BE  OFFERED AN MD EVALUATING TO INCLUDE AN EKG AND TROPONIN LEVEL. WE HAVE BEEN UNABLE TO CONTACT PATIENT.
Violent chills starting at 9p, appx 13 hrs after injection, followed by fevers, shakes, myalgia, arthralgias, malaise. Pounding headache for appx 12 hrs until the following morning, Appx 12 hrs after symptoms began was left with myalgias, arthralgias and fatigue that lasted another 24 hrs. Fevers as high as 101.6 during the first 12 hrs when symptoms began.
Red, hot, swollen area encompassing arm at site of DTaP (Daptacel).
Patient was given the Moderna vaccine for 6 months to 6 years instead of the COVID vaccine for ages 5 years to 11 years. Mother was notified at the time of the error. Mother verbally stated she understood that the patient received a lower formulation of the Moderna vaccine and should have no adverse effects following administration.  Mother agreed to return at a later date to receive the COVID vaccine for the patient's appropriate age.
Syncope episode with fall and hit to back of head.  911 was called and attended the scene.  Patient and patient guardian signed refusal for transport after evaluation by medical staff onboard and ambulance crew.
Got shingles after shot/Suspected vaccination failure; Got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles after shot/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter stated that he/she knew people that got the shingles after getting the so called shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
right thumb twitching; tremors; moderate to extreme dizziness; episodic blurry vision; regular headaches/ mild to moderate headaches; nausea w/o vomiting; nausea w/o vomiting; This is a spontaneous report from a contactable Physician (patient).   A 49-years-old female patient (non-pregnant) received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as, Second dose single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: ER8732, Expiration date) via an unspecified route of administration in left arm on 03Feb2021 at 4:00 as, first dose single dose for COVID-19 immunization and experienced episodic dizziness, alcohol intolerance and mild caffeine intolerance on Feb2021. No known allergies reported. Prior to vaccination patient was diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination and did not receive any vaccines within two weeks prior to the vaccination. On an unspecified date after patient experienced regular headaches and then 5 weeks after right thumb twitching, tremors, moderate to extreme dizziness, mild to moderate headaches, episodic blurry vision, nausea, vomiting and so extreme on 25May21. patient went to the emergency room or department or urgent care. The patient underwent lab tests and procedures which included blood test: MRI of two regions including vasculature and CT scan of neck along with blood work. Symptoms better upon rising and worsen as the day goes on. Extreme with very small amount of alcohol or caffeine. Therapeutic measures were taken as a result of the events included aspirin per day. The outcome of events was not recovered.  Follow-up attempts needed. Further information is expected.
Within 10 minutes of receiving the vaccines, patient developed hives on his head and then experienced shortness of breath, wheezing and his lips turned blue. He went limp, losing consciousness. He went into anaphylactic shock, required an epi pen, oxygen, benedryl and then was taken in critical condition by ambulance to hospital. He was treated in the emergency room, had an IV placed in his head, several breathing treatments, more drugs and was then admitted to the hospital for three days. 4/20/09-records received for DOS 4/2-4/4/09-DC DX: Anaphylaxis. Allergic reaction.  Ten minutes after receiving vaccines, developed hives on head and had trouble breathing turned blue and cyanotic around mouth and dusky all over, eyes rolled back and went limp and passed out. PE: wheezing, shortness of breath and labored breathing, rash erythema all over, cyanotic episode and hypertonia. Scratching all over.
Rash occurring at day 12 with normal progression, fever and three C's rash started on head.
The first was the Janssen on 3/19/21 in which I felt fever-like symptoms that was mainly an achy, weak body that begin about 12 hours since the shot and lasted for 36 hours. This was the most sever experience.  The second was the Pfizer on 6/30/21 in which I felt fever-like symptoms again in the same way as above 12 hours after getting the shot, which lasted for about a day.  The third was the second Pfizer on 7/21//21 in which I felt the same as above except it began 6 hours after the shot and, though less sever than the previous two, it lingered for 2 and a half days.
patient brought to ED for multitude of symptoms not feeling well for approx 2 weeks, maybe 1 week prior for Covid like s/s.
This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection; batch/lot# and expiration date not reported), via an unspecified route of administration, on Jul 3, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced body rash and shingles on an unspecified date in 2021. The patient hasn't taken the 2nd dose yet because of the side effects. She would like to know what she needed to do before taking the 2nd dose. The outcome of the events: unknown. The lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up.
I started feeling really sick. I was congested and sneezing. I had a headache with red eyes and I lost my taste. I was not able to eat much and had to force myself to eat. I ended up going to three ER's when this started. They did not really do much for me at the first one so I went to the second one and they stated it was a head cold. I ended up going to a third one for antibiotics cause my ear was clogged and really could not hear much. I am still coughing up a yellow mucus as well.
Day following vaccine, a red, itchy, raised bump appeared and was hot to the touch. It was approximately 1 1/2 inch by 1 inch. Lasted approximately 4 days. Completely went away for 2 days, then reappeared on day 7 with a red, itchy, raised bump also 1 1/2 inch by 1 inch. Took 325 mg Tylenol on occasion and applied hydrocortisone cream.  No issues with this pregnancy. Have not seen OB since I received the first vaccine. First dose of vaccine given at 20 weeks, due date July 4 2021.
Information has been received from a physician concerning a 15 month old male with a history of sepsis treated at birth who on 07-AUG-2008 was vaccinated with an expired MMR (Oka/Merck upgrade process).  The vaccine was expired on 18-JUN-2008.  The patient was supposed to receive a dose of VARIVAX.  He instead was given MMR (Oka/Merck upgrade process).  Concomitant therapy included the first dose of VAQTA (inactive) (lot no. 653875/0926U) given intramuscularly into the thigh at 5:34 PM, the fourth dose of IPOL (lot no. ACB36) given intramuscularly into the thigh at 5:32 PM and TRIPEDIA (lot no. C2956BA) given intramuscularly into the thigh at 5:31 PM.  The patient did not experience any adverse event from this.  It was unknown if the patient sought medical attention or not.  Additional information is not expected.
Pain and swelling to injection site affecting L shoulder/upper arm movement, diagnosed with multiple tears to shoulder and upper arm months later.
continued soreness in arm, and irritated, redness at injection site approximately size of a nickle. somewhat itchy
I started having muscle twitches and spasms my legs. They then started expanding to my legs arm back neck, abdomen, everywhere. I had some numbness in my hands and feet. For a month they continued at a lesser level. Currently, those symptoms persist at a lower level. I had multiple tests and imaging done. I am currently attending physical therapy. It has not really helped with my symptoms.
Information has been received from a medical assistant referring to a 15 months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
No adverse event. The vaccine administered on 3/30/22 expired on 3/17/22. Moderna tested the stability of the same lot number and determined that the dose given was still protective against the COVID-19 virus,
12/21/07 Patient received Typhoid V.  12/28/07 complained of neck and shoulder soreness and pain.  ER visit for pain relief.  Received steroid injection, muscle relaxant and dose pack steroid with relief.  Pain returned and called 1/15/08, advised flu with PCP.
Information has been received from a physician's assistant concerning a 1 year old male who on 08/28/2001 was vaccinated with varicella vaccine. Concomitant vaccination on 08/28/2001 included Prevnar. The physician's assistant reported that both vaccinations were received in one leg. Subsequently, the pt developed an injection site reaction described as a knob with a pustule. The pt was seen in the physician's office on 09/07/2001. In follow-up, a physician reported that the "local vesicular reactions" were "not atypical or adverse." It was noted that two other pts had similar experienced following exposure to varicella vaccine. No further info is available.
On Jan. 30, 2021, my mom's blood pressure dropped, she was placed on oxygen support, and a blood panel indicated elevated risk of blood clotting. This was shortly after receiving a dose of Moderna COVID vaccine on or about Jan. 27. These symptoms seemed very similar to what she had experienced in December when she contracted COVID.
Starting six hours after receiving vaccine, I felt nausea and extreme fatigue. My concern is that the fatigue lasted full 72 hours. (9/24, 9/25, and 9/26) I had to come home from work  early on 9/26 to take 2.5 hour nap and went to bed early. I slept 9 hours and experienced severe night sweating. Today, 9/27 is first day I have energy back.
heavy chills lasting 6 to 8 hours, nausea, headache, skin sensitivity, lethargy.
5th Covid vaccination 11/18/22.  Tested positive for Covid-19 on 12/25/22 with a home 20 minute test. Mild symptoms. Runny nose, congestion, coughing.
BREAKTHROUGH COVID INFECTION. PATIENT TESTED POSITIVE ON 08/31/2021. PATIENT WAS FULLY VACCINATED ON 05/06/2021.
patient complained of itching redness and swelling at the injection site the day after administration. the reaction was improving and we discussed ibuprofen, benadryl and a cold compress
10 days (1/27/2021)  after my Covid19 (Moderna) shot, my left arm around the shot location became a pinkish rash and was a little sore. The rash and minor soreness continued until yesterday (2/4/2021). My left arm is fine now.
No additional AE; Inbound call from HCP stating that a dose of GARDASIL 9 was inadvertently administered past it's expiration date. No additional AE details or PQC.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-APR-2022, the patient had inadvertently administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #S028738, expiration date: 03-APR-2022, administered for prophylaxis (dose, strength, and route of administration were not provided) past the expiry date (Expired product administered). No additional adverse event (AE) reported.
Heart palpitations; Rapid heart rate; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the right arm on 31Aug2021 at 18:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included aortic valve replacement (AVR), asthma, hypertension, diabetes, high cholesterol and allergy to shellfish. 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-19 vaccine. The patient received unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 09Aug2021 at 18:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient previously received levofloxacin (LEVAQUIN) and amiodarone (MANUFACTURER UNKNOWN) and experienced drug allergy. On 31Aug2021 at 12:00 about 6-8 hours after injection, the patient had heart palpitations and rapid heart rate. It still happened on the day of report, but the heart rate was slowing down some. 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 rapid heart rate and heart palpitations were not resolved at the time of this report.
Rash in their armpit; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash in their armpit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash in their armpit). At the time of the report, RASH (Rash in their armpit) 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. The reporter stated that the symptom was a bad reaction.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow up information was received. Patient gender added.
he received his first dose of PFE covid-19 vaccine in (state name) and 2 weeks later, but before his 2nd PFE vaccine dose, he tested positive for covid-19; he received his first dose of PFE covid-19 vaccine and 2 weeks later, but before his 2nd PFE vaccine dose, he tested positive for covid-19; This is a spontaneous report from a contactable consumer or other non-health care professional. A 34-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that yesterday I spoke with a friend (34 year old male) who indicated that back in Apr2021, he received his first dose of PFE covid-19 vaccine in (state name) and 2 weeks later, but before his 2nd PFE vaccine dose, he tested positive for covid-19. I learned of this yesterday. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The clinical outcome of the events was reported as unknown.  Information on lot/batch number has been requested.
Tendonitis and weakness in L forearm.  Daily pain and weakness with use of L hand.  No interventions.
Reported feeling lightheaded approx. 10 minutes after vaccines; rested supine x 20 minutes; BP and  HR monitored while lying down; returned to baseline after 20 minutes; reported feeling better after lying supine first 5 minutes; left clinic with mother reportedly feeling well/good condition; no loss of consciousness or alteration in mental status.