chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/29/22 12:25pm upon return from lunch O2 sat 87% on 5 liters O2 while up in w/c. no overt s/s noted by nurse.  Resident denied any difficulty breathing and declined transfer to hospital.  1:35 pm CNA notified nurse resident was unresponsive in w/c.  Nurse observed resident with head bowed, no palpable pulse, no respirations, no apical pulse, pupils fixated. MD notified. RN pronounced, time of death 1:40pm. HCP, DON, notified.
From initial info received on 2/26/03 from physician's office regarding an adverse event, it was reported that an elderly female pt received Fluzone (U0906AA(, on an unspecified date. Sometime after vaccination the pt tested positive for influenza type A. No additional info is available at this time.
Before the vaccine and due that I contracted COVID, I was not able to smell anything. After the first dose, everything smells like protein powder, my house, my car, my food. After the second dose, everything taste the same as the smell, and make me nauseous. Any food taste like protein powder.
Fussy, low grade fever.  Patient presented to office on 10/23 as fevers persisted to evening of 10/22.  Afebrile in office with normal exam.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 30-OCT-2017, the patient was vaccinated with an expired dose of M-M-R II lot # L041457, expiration date 22-OCT-2017 (dose and route were not reported) for prophylaxis; administered along with a sterile diluent lot # N003192, expiration date 05-JUL-2019 (dose and route were not reported) for prophylaxis. The reporter stated that there were no temperature excursions. No adverse symptoms were reported.
Bump under injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Bump under injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE MASS (Bump under injection site). At the time of the report, INJECTION SITE MASS (Bump under injection site) outcome was unknown.            Treatment was unknown Action taken with mRNA-1273 in response to the event was not applicable
Red, hot, swollen, itchy, sore, fatigued arm at injection site.
Rash on Back, Legs, Face, Soreness, Fever, Vomiting.
A 43 year old female patient experienced a tingling sensation and numbness after receiving her first dose of RabAvert for post exposure prophylaxis. She received 1 ml RabAvert rabies vaccine intramuscularly in her right arm on the 10/12/04. She has no past medical history apart from being allergic penicillin. There were no concomitant medications. Approximately two hours later she experienced the same symptoms in her left arm, then later in her right leg above the kneecap. The symptoms were persistent and did not improve or worsen. Although the sensation was not painful it gave her discomfort for which she took Benadryl, which did not help. At 2:00am on 10/03/04, she went to the emergency room and was seen by a neurologist. Following up was scheduled for the 10/14/04. The sensation in her arms had improved on the 10/14/04, however her legs still felt weak. She was not planning on continuing with RabAvert vaccinations. Follow up received 10/22/04: The patient received RabAvert in her right arm for post exposure prophylaxis after waking up on 10/12/04 with two spots near her ear that looked like bites. As a caution she went to a health clinic and received a RabAvert injection. On follow up, the patient stated she felt much better. Her neurologist told her he had never seen a reaction to RabAvert like this before. The symptoms in her legs disappeared after a day and her arms were almost completely recovered as well. She confirmed that she did not have any more RabAvert injections.
Patient was siting at the waiting area after about 10 minutes receiving first Covid19 Pfizer shot. Mom reported to pharmacist staff that patient turned pale and felt dizzy. Pharmacist suggested patient to drink water and continued to rest while pharmacist monitored patient. Pharmacist tried to take patient's blood pressure but pharmacy didn't have the right cuff so she was  unable to obtain patient's blood pressure. Patient then was sweating and mom continued to give her water while pharmacist checked patient's temperature (recorded 94.6'F). Few minutes later, patient vomited. Mom gave patient water after she was done vomiting. Patient reported she felt better afterwards. Patient was monitored for about 15 minutes and she was able to walk herself and left the pharmacy waiting area with mother. Pharmacist suggested mother to call doctor for follow up advice.
Approximately 12 hours after administration patient reported feeling body aches, fatigue, and some nausea. Patient stated that she felt back to feeling normal in about 48 hours. This was the SECOND dose in the course. No reaction was reported following the FIRST dose.
Information has been received from a physician concerning an 13 year old female who on 11-JUN-2007 was vaccinated with a first dose of Gardasil (lot number unknown) injection in the right arm and received concomitant suspect therapy which included Vaqta, injection in the left arm. Concomitant therapy included Menactra on the left arm. The physician reported that patient had a low grade fever on 10-JUN-2007 before receiving Gardasil. On 12-JUN-2007 the patient experienced vomiting. Medical attention was sought. The patient was given a medication to control the vomiting. On an unspecified date the patient had recovered. At the time no further adverse event information is available. Additional information has been requested.
Lower back pain; Fever; headache; fatigue; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of BACK PAIN (Lower back pain), PYREXIA (Fever), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Lower back pain), PYREXIA (Fever), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, BACK PAIN (Lower back pain), PYREXIA (Fever), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
1ST SHOT (LOT3 EN6206-PFIZER) - EXTREME EXHAUSTION/FATIGUE/ACHES 2ND SHOT (LOT ER8733-PFIZER ON 03/24/21-SAME LOCATION) - EXTREME EXHAUSTION (COLDNT GET OUT OF BED FOR 3 DAYS)/FATIGUE/ACHES/MILD FEVER/MAJOR DEBILITATING HEADACHE  ON MY PERIOD AT TIME OF VACCINATION FROM 03/02/21-03/07/21 DID NOT HAVE MY PERIOD AGAIN FOR 6 MONTHS UNTIL 08/25/21-09/13/21, WHICH LASTED 3 WEKES, FIRST 2 WEEKS WERE LIGHT, LAST WEEK WAS VERY HEAVY. i DON'T KNOW WHAT MY NEXT PERIOD WILL BE LIKE.   I REPORTED TO MY PRIMARY CARE AND OBGYN AND THEY DID SOME BLOODWORK, I AM NOT PERI-MENOPAUSAL.
Patient complained of pain and swelling left arm, shoulder, neck.  Seen by PMD and treated with anti-inflammatory meds.  Nerve relaxers and pain meds for inflamed muscle and nerve ending exposure per patient.
Rash-splotchy hive like one leg where shot was given from knee to foot fever 103.4 started midnight same day vomited once 3/8/17.
Dose 2 administered in 17 days after 1st dose; Memory impairment; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Memory impairment) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 administered in 17 days after 1st dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    The patient's past medical history included COVID-19 in March 2021. Concurrent medical conditions included Ulcerative colitis.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced MEMORY IMPAIRMENT (Memory impairment). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 administered in 17 days after 1st dose). At the time of the report, MEMORY IMPAIRMENT (Memory impairment) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 administered in 17 days after 1st dose) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported.  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.  On an unknown date in March 2021, the patient experienced COVID-19. It was unknown if patient was enrolled in COVID-19 Vaccine Trial. The reporter's causality for the event (s) a. of MEMORY FOG was not provided. The reporter's causality for the event of COVID-19 with HUMIRA (ADALIMUMAB) was no reasonable possibility.
6:30pm mom noticed "red bumps" concerned about chicken pox (no known exposure). Seen at Ped clinic at 7p,. Dx allergic reaction probably to one of vac. Prescribed oral Benadryl-1st dose . 8:30pm and 2nd dose 9/10/02. 8am phoned clinic 10am. No improvement-referred.
After receiving 1st injection on 3/19/21, I develeoped severe back pain on 3/20/21.  Pain started in lower back and progressed to mid/upper back, sides and under front ribcage over the next 6 days.   Muscle spasms accompanied back pain.   I had a fever of 99.9 as well.  Fever broke on 3/25/21 and pain has started to lessen somewhat on this date.  This is by far the worst back pain I've ever experienced and was very strange in that it moved from lower to mid back over the course of 5 days.  I've never had back spasms before.
Eyes sore; Stomach pain; sore arm; sweating; diarrhea; gagging; didn't eat for four days; nausea / terrible nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), RETCHING (gagging), FEEDING DISORDER (didn't eat for four days), HYPERHIDROSIS (sweating) and EYE PAIN (Eyes sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 024M20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hay fever and Stenosis (Stenosis in back). Concomitant products included NAPROXEN for Stenosis, LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID) and OMEPRAZOLE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced DIARRHOEA (diarrhea), RETCHING (gagging), FEEDING DISORDER (didn't eat for four days), NAUSEA (nausea / terrible nausea) and CHILLS (chills). On 05-Nov-2021, the patient experienced HYPERHIDROSIS (sweating). On an unknown date, the patient experienced EYE PAIN (Eyes sore), ABDOMINAL PAIN UPPER (Stomach pain) and MYALGIA (sore arm). The patient was treated with ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE (LOMOTIL [ATROPINE SULFATE;DIPHENOXYLATE HYDROCHLORIDE]) from 05-Nov-2021 to 06-Nov-2021 for Diarrhea, at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) on 05-Nov-2021 for Nausea, at an unspecified dose and frequency; PROMETHAZINE HYDROCHLORIDE (PHENERGAN ELIXIR) on 07-Nov-2021 for Stomach pain, at an unspecified dose and frequency and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) for Dehydration, at an unspecified dose and frequency. On 06-Nov-2021, DIARRHOEA (diarrhea) and HYPERHIDROSIS (sweating) had resolved. At the time of the report, RETCHING (gagging) and ABDOMINAL PAIN UPPER (Stomach pain) had not resolved, FEEDING DISORDER (didn't eat for four days), EYE PAIN (Eyes sore), MYALGIA (sore arm) and CHILLS (chills) outcome was unknown and NAUSEA (nausea / terrible nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included OTC for allergy/hay fever.
Pt presented to facility to get a Janssen COVID vaccine.  Pt reports history of vasovagal reactions to flu vaccines in the past.  Patient began feeling hot and became diaphoretic within 5 minutes of receiving the vaccine.  Nurse noted pallor, tachypnea, and hypotension.  Patient c/o tingling extremities, headache, and fatigue.  Patient remained alert and oriented.  He began to improve without further intervention within 10 minutes of injection, and fully recovered "feeling better" within 30 minutes of injection.  Patient reported fatigue, but otherwise feeling well two hours later by phone on follow-up.
Started with high fever 100.7 when I woke up the next day.  Dizzy.  Took Tylenol, reduced it to 99.4; temp went back up later in afternoon to 100.4, more Tylenol reduced fever to 99.2.  Slept a lot that day.  On Sunday, woke up with monster headache, started throwing up at noon.  Contacted doctor ... took Zofron.  Sell more.  Threw up again at 4 pm.  And by midnight could not tolerate water ... throwing it up too.  Monday continued throwing up.  But started feeling better that evening and tolerated jello.  Cautious today but on the mend. My arm was a brilliant red, very tender, swollen, and developed a hard knot.  Finally swelling going down today.
Shots given 10/30/17 Monday on 11/06/17 Monday left side cheek pain began on 11/7/17 stick neck developed and top of head and rear of head pain. Pressure to get off bed was too much. 11/8/17 left side of face and eye lid swollen and cheek pain. Loss of appetite and tiredness  since 11/6/17.
Sore, itching red mark around needle point. started with the size of a quarter-spreaded all down the arm to maybe approx. 6" long and 3" wide. Very red and hurtful.
Pt came in for 2nd dose of Pfizer vaccine, pt reported itchiness on right arm. Provider informed, assessed pt's arm and torso and determined that the patient had hives that begin on her neck, and spread throughout her torso. Provider recommended she follow up with urgent care to manage the hives, and reschedule second dose of Pfizer vaccine to a later date.
Lymph gland under left arm & at base of neck at collar bone are swollen & tender
I started noticing about an hour 1 and 1/2 later, I had chills. I was extremely achy with pain throughout my body. I felt like I was getting a bad case of the flu. I was very lethargic. The site itself was inflamed and warm. I couldn't function, so I went to bed and let my boss know I was having some sort of reaction. From that point I wasn't well. I eventually tested positive for COVID and now I have a sinus infection. The swelling at the site started to go down about 5 days later and my symptoms we residing as well for my arm itself. I still had body aches, fever, cough, brain fog, respiratory and sinus issues. I also had intermittent mild nausea.  Symptoms were alleviated  about a week ago.  I still have symptoms, but they are residual. I was on antibiotics prescribed by Dr. via Telemed.
My daughter received the Gardisil vaccine on May 19, 2007. The next day her menstrual cycle started and lasted 6 weeks. I called the doctor and they assured me it was just coincidence. She had the second booster on July 19, 2007. The following day, her menstrual cycle started again and lasted 4 weeks this time. Up to this date, she had always had regular cycles. We never went back for the final vaccination. She has had regular cycles since then.
Patient indicated that Moderna was his first dose. Pharmacist vaccinated patient with Moderna. As pharmacist went to fill the card, noticed that the patient had Pfizer as his first dose. In summary, patient was vaccinated with Moderna instead of Pfizer.
This spontaneous report was received from a pharmacist referring to a 72 year old female patient. The patient had none pertinent medical history or drug reactions or allergies. On 31-OCT-2017, the patient was vaccinated with PNEUMOVAX23 (lot # N012127, expiration date: 20-JAN-2019), intramuscularly in the right arm for prophylaxis. Concomitant therapies included a nicotine patch which was administered before PNEUMOVAX 23 on an unspecified area on her right arm. The area where the nicotine patch was used was wiped with alcohol swab. On 01-NOV-2017, the patient experienced a large pink area approximately 6 centimeters by 3 centimeters in an unspecified area on her right arm (erythema). It was also reported that she had pain so severe that she could not move her right arm (pain in extremity, movement disorder), along with swelling from her right shoulder to her right elbow (peripheral swelling). Despite the fact that the patient had not seen her healthcare provider in regards to her experience, she was self-treated with ice packs and acetaminophen (TYLENOL) every eight hours. No laboratory diagnostics were performed. Additionally, it was reported that no intervention to prevent serious criteria was necessary, that the patient was not hospitalized and that the patient experience was not significant disability or incapacity or life threatening. At the time of the report, it was mentioned that swelling was not as bad, and that pink area had almost disappeared, however, the outcome of pain in extremity, peripheral swelling, movement disorder and erythema was reported as not recovered. The relatedness assessment between PNEUMOVAX 23 and the aforementioned adverse events was not provided.
Experienced severe left arm (deltoid area) radiating into left shoulder. Pain continues. Have been treated with methylpred 4 mg - twice. Pain returns after off prednisone after 4-5 days. Difficult sleeping because of pain.
I had stress test, that showed a total occlusion on left interior descending. They had to go in and put a catheter in my heart to open the occlusion. I had a stress test where they monitored my heart before I was released to full exercise. I feel like I am fully recovered.
Information has been received from a nurse via a company representative referring to a patient of unknown age and gender. On 17-AUG-2015 the patient received one dose of GARDASIL (dose, route and lot# were not reported), dose two was then administered on 25-NOV-2015 at which time GARDASIL 9 (dose, route and lot# were not reported) was used (interchange of vaccine products), and the patient then received a final dose on 10-MAR-2016 at which time GARDASIL (dose, route and lot# were not reported) was used. No adverse event was reported. Additional information has been requested.
pt recvd vax & exp central nervous system injury & debilitating physical injuries (unspecified);
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FJ1614), as dose 2, single (Lot number: EWO175) and as dose 3 (booster), single (Lot number: EWO169), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing); "Multiple Sclerosis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; TRINTELLIX; VITAMIN D3 (Other medication in 2weeks). Past drug history included: Tetanus for Immunization, reaction(s): "Known allergies: Tetanus"; Morphine, reaction(s): "Known allergies: Morphine"; Prednisone, reaction(s): "Known allergies: Prednisone". Vaccination history included: Influenza vaccine, for Immunization, reaction(s): "Known allergies: Influenza Vaccine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 of Paxlovid started from 06Aug2022 to 12Aug2022
After the shot was given the nurse told my son to go in the next room and wait for the 15 min within 4 min my son  faint  on the floor everyone rush in the room and got him to wake up he had breakfast and lunch so we was sure why he fainted  and we decided it's best to take him to the  ER
1) Paresthesia of face 2) Swelling, pain  and erythema of the vaccination site
feels rotten/feeling so rotten; running a temperature; both arms are hurting; headache; so tired; diarrhea; loss of appetite; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 75-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN9581, Expiry date, NDC number: unknown) via an unspecified route of administration, administered in left arm on 25Feb2021 (age at vaccination was 75 years) as dose 2, single for COVID-19 immunisation. The patient medical history includes congestive heart failure on an unspecified date in Aug2018, unknown and unknown if ongoing and rheumatoid arthritis, diagnosed 10 years; both were from an unknown date and unknown if ongoing. Concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (Lot Number: unknown) in left arm on 04Feb2021 (age at vaccination was 75 years) for COVID-19 immunisation. On 25Feb2021, the patient was feeling so rotten this morning and was running a temperature, wants to know could this be normal, states patient was miserable last night, that the injection was in the left arm and both arms was hurting, states patient couldn't sleep on either side and developed a headache, her temperature this morning around 9 AM 99.8 degrees F. Also feels so tired and experienced loss of appetite. Had some diarrhea last night before bed, not bothering her this morning. The patient treated her symptoms with Tylenol, that her temperature went from 99.8 degrees to 88.8 degrees F after the Tylenol. The patient was asking are these are common side effects. No investigation assessment. Outcome of the event diarrhea was resolving, events feels rotten/feeling so rotten and loss of appetite were unknown and remaining events were not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
December 17, 2021: Dizzines, presyncopal episode - ER visit. Abnormal results at that time: Elevated DDimer December 29, 2021: Made an appointment with my PCP secondary to continued neurologic symptoms.  January 3, 2022: Brain MRI showed potential aneurysm January 6, 2022: Brain MRA confirmed aneurysm March 9, 2022: Flow Diverter stent placement at aneurysm site.
ZOSTAVAX given (L) arm 8/3, swelling noted next day. By 8/8, noted "hot flashes" without fever.