chrisvoncsefalvay/vaers-outcomes huggingface dataset:
His arm was tender and sore; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (His arm was tender and sore) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (His arm was tender and sore). At the time of the report, VACCINATION SITE PAIN (His arm was tender and sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-027447 (Patient Link).
Pt woke up at 0400 w/ chills and fever "up to 102", also c/o headache, body aches
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Patient received first dose of Pfizer covid vaccine and completed 15 minute observation period. Patient had left vaccine observation but began feeling dizzy and short of breath while walking back to car. Patient walked back to vaccine clinic. Patient appeared in distress and stated her throat was closing. RN administered 1 dose of epi and activated RRT. Patient improved with epi x1. RRT arrived and monitored patient. Patient began having shortness of breath and stating throat is closing again 10-15 minutes later. RRT transferred patient to ER.
Symptoms: Reddish right eye, severe fever and temporary visual blurring for couple of days. Later Diagnosed as Uveitis. Based on the ophthalmologist, visited a GP who diagnosed the I had Auto-immune disease for a long time.
40 minutes following my second dose of Moderna, I felt like I was having a very mild allergic reaction similar to what I?ve experienced with shellfish - Difficulty completing the swallowing process, but no difficulty breathing difficulty completing the swallowing process, but no difficulty breathing .  Very noticeable heart palpitations 18 hours after both the first and second dose of the vaccine. After the first dose, palpitations continued off and on for approximately a week. Following my second dose, palpitations are continuing off and on today.  Following the second dose I?ve also experienced  a Fever (102.1), Bodyaches and dizziness approximately 20 hours after vaccination.  Additionally, sore and swollen lymph node at right clavicle bone noticed approximately 36 hours after vaccination.
Patient stated that she received her vaccine in her left shoulder and then noticed a tingling of her left arm.  Patient remained seated and then states that the next thing she noticed that she was being woken up by bystanders.  Bystanders stated that she lost consciousness fell forward and hit her head on the floor followed by a few shaking/jerking motions and then regained consciousness after approximately 10-15 seconds.  Patient denied any prodromal symptoms leading to her fall such as headaches, vision changes, lightheadedness/dizziness, nausea/vomiting, warmth, chest pain or shortness of breath.  States that after waking up she noticed pain on the left side of her head where she hit her head.   States that after her fall she felt fully aware denies any confused/disoriented state, tongue biting, urination or any other symptoms.  Pt had a 4 x 5 cm scalp hematoma on left forehead and tachycardia. Pt was A&Ox3, was able to ambulate, and was discharged from the Emergency Department.
Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Severe
Information has been received from a 19 year old black female, with no drug allergies, a medical history of an abnormal pap smear, a colposcopy in 2007, one pregnancy, and an elective termination of a subsequent pregnancy in 2002 (LMP was 16 weeks), and a family history of heart disease, hypertension and diabetes.  The patient was vaccinated with her second dose of 0.5 ml of GARDASIL intramuscularly on an unspecified date.  Concomitant therapy during the pregnancy included ferrous sulfate (FeSO4) and prenatal vitamins.  The patient became pregnant sometime after receiving her second dose of GARDASIL.  The patient did not seek medical attention.  No adverse event was reported.  Follow up information has been received from a certified nurse midwife.  The patient sought medical attention and on the 20th of an unspecified month and 18-DEC-2007 ultrasounds were performed which revealed complete previa.  Additional information was not readable.  The comment was that previa was cleared.  Other diagnostic laboratory tests included haemoglobin at 9.5.  The patient was started on ferrous sulfate (FeSO4).  Additional information has been requested.
Back, shoulder, neck, arm and leg aches, chills/teeth chattering without fever, insomnia, restlessness, loss of appetite, fatigue. Pretty severe insomnia on the 3rd night after vaccine administration (unable to sleep 4+ hrs. after usual bedtime). Tylenol to treat pain. Rest. Melatonin and meditation for insomnia - ineffective.
Time course:  Received Pfizer COVID vaccine 1515.  Had immediate reaction.  See next page.
Patient within several hours began having neuralgia in the left leg and the following day showed eruptions consistent with shingles.  This was ultimately diagnosed as shingles by the facility on the following day.
A couple of minutes after vaccine, patient passed out while twitching while sitting, leaning into parent, she was greenish, I went for emergency kit.  By time I got back she was semi-conscious and moaning and holding her head.  No hives or throat constriction...administered Benadryl I'm.  Her color started to improve and the moaning stopped.  After 5 minutes she threw-up.  After cleanup, she continued to improve and gave her a piece of candy. After 45 minutes in store, she went home, Dad said she is doing much better and sleeping. He will follow-up with primary Dr Monday.
Narrative: COVID infection following COVID vaccine series 01/18, Pfizer, dose #1 02/09, Pfizer, dose#2 08/21 pt cc: chills, cough, fatigue, fever, headache, loss of taste or smell, myalgias, rhinorrhea exposure: unknown 08/23 COVID swab, result: detected 08/23 SARS-COV-2 Variant Sequencing result: pending
Chills, fever , body aches the first few days. Next two periods not normal. Having extremely heavy menses with large blood clots that are not usual for me.  Extreme fatigue due to blood loss. Still have not stopped  bleeding
The patient had no adverse events immediately after the vaccination.  He walked to the checkout and fainted a few minutes later.
Guillain-Barre syndrome; This case was reported by a other health professional via call center representative and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's comment: Medical student reported that the patient developed Guillain-Barre syndrome after receiving the second dose of Shingrix. It was not sure that the syndrome was related to vaccination and patient had no previous medical history of it.  The reporter did not have patient's identifiers, nor vaccine lot number, expiration date and date of administration. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
Diarrhea the next day, nausea, headache, soreness at injection site.   Diarrhea and nausea gone by 5pm, headache continued into the second day after along with soreness at injection site .
Patient received first dose of Pfizer on 9/6. 16 days after vaccination, patient began experiencing excessive coughing, extreme nausea, chills, fatigue and shortness of breath. Patient went for COVID test and came back positive on 9/24.
Pt had KINRIX and MMR administered on 8/19/14 in Lt. leg. Mom called on 8/20/14 stating that area was red, hard lump, itchy to child. Advised cook pack, anti-itch cream to area and if got any worse needs to be seen.
Pain, swelling ,soreness at injection site  4x6inches, aching , back ache , low grade  temp.    Started   8 to 12 hours post injection. Swelling lasted > 50 hours.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:51 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 33.16.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The  explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 30-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. DILUENT MRK INJ was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381:Original Case : 1808USA001261 US-009507513-1808USA004382:Original Case : 1808USA001261 US-009507513-1808USA004383:Original Case : 1808USA001261 US-009507513-1808USA004384:Original Case : 1808USA001261 US-009507513-1808USA004385:Original Case : 1808USA001261 US-009507513-1808USA004380:Original Case : 1808USA001261 US-009507513-1808USA004379:Original Case : 1808USA001261 US-009507513-1808USA004376:Original Case : 1808USA001261 US-009507513-1808USA004377:Original Case : 1808USA001261 US-009507513-1808USA004378:Original Case : 1808USA001261 US-009507513-1808USA004386:Original Case : 1808USA001261 US-009507513-1808USA004387:Original Case : 1808USA001261 US-009507513-1808USA004388:Original Case : 1808USA001261 US-009507513-1808USA004362:Original Case : 1808USA001261 US-009507513-1808USA004363:Original Case : 1808USA001261 US-009507513-1808USA004389:Original Case : 1808USA001261 US-009507513-1808USA004390:Original Case : 1808USA001261 US-009507513-1808USA004391:Original Case : 1808USA001261 US-009507513-1808USA004364:Original Case : 1808USA001261 US-009507513-1808USA004392:Original Case : 1808USA001261 US-009507513-1808USA004393:Original Case : 1808USA001261 US-009507513-1808USA004394:Original Case : 1808USA001261 US-009507513-1808USA004395:Original Case : 1808USA001261 US-009507513-1808USA004396:Original Case : 1808USA001261 US-009507513-1808USA004365:Original Case : 1808USA001261 US-009507513-1808USA004366:Original Case : 1808USA001261 US-009507513-1808USA004367:Original Case : 1808USA001261 US-009507513-1808USA004398:Original Case : 1808USA001261 US-009507513-1808USA004399:Original Case : 1808USA001261 US-009507513-1808USA004368:Original Case : 1808USA001261 US-009507513-1808USA004369:Original Case : 1808USA001261 US-009507513-1808USA004400:Original Case : 1808USA001261 US-009507513-1808USA004401:Original Case : 1808USA001261 US-009507513-1808USA004370:Original Case : 1808USA00126.
I felt groggy directly after receiving the shot. Later in the evening the muscle aches were so bad I was in tears.  In the middle of the night I felt like I was going to vomit I went to the bathroom, fainted hit my head, vomited and was taken to the hospital by ambulance.
As I injected the patient with the dose, the needle was loose on the syringe and the vaccine had leaked out and patient was not given full dose and no was to tell how much actually went in the patients left arm. I was instructed to give a full dose in the patients right arm.
-this is a 38-year-old male with no significant past medical history.  Came to the hospital with a chief complaint of progressive worsening shortness of breath over the last 8 days.  Initially the symptoms started on Sunday the week before.   Initially the symptoms were intermittent fevers, chills, cough,.  Few days after this the patient started having some shortness of breath which progressively got worse over the course of the last 3-4 days.  Due to worsening shortness of breath the patient decided come to the emergency room.  He was prescribed some empiric antibiotic  9/25/2021 tested positive
Numbness at back of her neck to the face; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness at back of her neck to the face) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included MS.    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 HYPOAESTHESIA (Numbness at back of her neck to the face) and FATIGUE (fatigue). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLU-MEDROL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness at back of her neck to the face) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.   This case was linked to MOD-2021-037116 (Patient Link).
headache for 7 days taking ibuprofen and tylenol around the clock without relief
Information has been received from a registered nurse (R.N.) concerning a 5-year-old female who on 27-AUG-2002 was vaccinated subcutaneously with a 0.5 ml Varivax (Oka/Merck) (lot number reported as "1294C"). No concomitant medications were given. On 02-FEB-2007 the patient developed vesicles on her neck and back. It was reported that the child had been exposed to varicella at school. The patient recovered within a week, on 09-FEB-2007. The incident was described as "uneventful illness". Additional information is not expected.
Cellulitis of the right shoulder. Patient received CEPHALEXIN 500mg four times daily for 10 days on 10/29/11. Pain, fatigue, fever.
flu; Initial information was received on 23-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media (under reference number US-SA-SAC20211027000391).  This case involves a patient of unknown demographics who experienced flu (influenza) after receiving INFLUENZA VACCINE.  The patient's past vaccination included INFLUENZA VACCINE.  The patient's medical history, past medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got the flu shot 3 years ago then got the flu. The only time in over ten years I got your shot I got sick."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome was unknown for the event (influenza).  There will be no information available on the batch number for this case.
Severe stomach cramping and pain, dizzy, light headed, diarrhea, extreme fatigue (sleeping almost 20 hours a day).
3 stools that were yellow with black streaks; patient was "fussy"; stools were "mushy"; This spontaneous report was received from a pediatrician and refers to a 8 week old female patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies or concurrent conditions. Concomitant therapies included vitamin d.  On 08-JUN-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1, orally for prophylaxis (strength, frequency, lot# and expiration date were not reported). On the same date the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) dose 1, for prophylaxis (strength, frequency, route of administration, lot# and expiration date were not reported); diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid(PEDIARIX) for prophylaxis (dose, strength, frequency, route of administration, lot# and expiration date were not reported); and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) for prophylaxis (dose, strength, frequency, route of administration, lot# and expiration date were not reported).   Overnight following the administration, patient was "fussy" (irritability) and experienced at least 3 stools that were yellow with black streaks "like a mashed banana". The pediatrician explained that the stools were "mushy" (diarrhoea) but that was normal for the patient. The patient was brought in to the office on 09-JUN-2020, her physical exam was normal, and the stool was tested for occult blood which was negative. Pediatrician recommended monitoring of stools and advised parents to contact the office with photos of diapers if this continued. The last photo she had received showed the stools were resolving with less black streaks, but there was no follow up from the parents beyond that. Pediatrician believed the issue resolved (discrepant information) after a couple days but did not know the exact date. It was mentioned that the parents had looked up information online and believed the rotavirus vaccine, live, oral, pentavalent(ROTATEQ) might be related to the change in stools.  The causal relationship between rotavirus vaccine, live, oral, pentavalent(ROTATEQ) and the event irritability was unknown. The causal relationship between the mentioned events and the other suspect therapies was unknown. The outcome of irritability was unknown.
Pain in neck and shoulders limiting range of motion and liminiting activités of daily life like dressing, drinking from a cup, work at my desk
Patient passed out shortly after receiving.  The representative with him caught him and laid him on the floor.  He did not lose consciousness but was sweating profusely, so we gave him an ice pack, a blanket for his head and propped his legs on the chair.  He said this happens frequently with needles and his anxiety, so did not want us to call 911. After about 10 minutes he was able to sit back up in the chair.  We had him remain there for at least 30 more minutes, at which time he felt fine to leave.
No adverse event, however the monovalent vaccine was inadvertently given instead of the bivalent.
Information has been received from a registered nurse concerning an infant who was vaccinated orally with Rotateq (Lot not provided). Concomitant therapy included other vaccines concomitantly. Subsequently, the patient had unspecified intestinal surgery and was hospitalized. The reporter felt that intestinal surgery was not related to therapy with Rotateq. It was unspecified how long the infant was in the hospital. The outcome of the intestinal surgery was not provided. Additional has been requested.
This spontaneous case, initially received from other healthcare professional (nurse) on 26-Oct-2018, concerns a 62-year-old, adult female patient. The patient's current condition included chronic obstructive pulmonary disease (COPD). The patient's concomitant medications included, XARELTO, Torasemide, terbinafine, potassium chloride, PROAIR and iron. On 26-Oct-2018, the patient was administered expired vaccine FLUCELVAX QIVc [dose: 0.5 ml (frequency unknown), route of administration: intramuscular, anatomical location: deltoid, batch number: 195245, expiry date: 18-Jun-2018]. At the time of this report, no adverse event was reported after the vaccine administration. The reporter assessed this case as non-serious. This case was linked to case 201804880 owing to the same reporter.
The right thigh was swollen, red, guarded to touch. No fever per dad. Patient started on Keflex 3 ml for 10 days for infection/possible cellulitis per MD.