chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Awoke on Friday, April 8, 2005 at approximately 7:30 AM and told her mother that her arm was sore and red.  Upon inspection on Friday, April 8, 2005 at 9:30 AM, her right outer triceps area where an IPV and an MMR were administered the previous evening around 5:30 PM was slightly warm and red at both injection sites.  She also complained of nausea shortly after arising on Friday morning around 7:30 AM.  Her mother denied any symptoms of fever.
4cm subcutaneous nodule antecubital fossa left arm, day after 2nd vaccine Plan to monitor over the next month.  If no resolution, get an ultrasound
Seen in our office on 4/1/02 with fever, shoulder/chest pain, abdominal pain and vomiting. Transferred to another hospital with sepsis. Admitted to ICU with overwhelming sepsis, pneumonia. Required pressor support briefly. Discharged on 4/4/02.
Dizziness; Weakness; Blurred vision/inability to focus; Headache; This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), VISION BLURRED (inability to focus ) and HEADACHE (Headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), VISION BLURRED (inability to focus ) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), VISION BLURRED (inability to focus ) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2021: Reporter information of postal code and state added, patient details of age and gender added, in product, Date of vaccination added and events are added.
Rash right arm, muscle pain (arms, legs), neck pain, fever and loss of appetite.
10/3/12 Sore throat, headache, chills, fever. Increased mucus production - felt like she was "choking", burning eyes. 10/4/12 Headache, feeling like "run over by a truck".
Patient reported extreme lethargy, trouble eating, aches, severe tremors, and no fever over the course of 3 days before coming out of it.
Soreness and swelling of arm started by morning after and by evening had a low-grade temperature, headache and dizziness. The next day, the MD ordered Prednisone 20mg bid (1st dose given at 10:30) by 13:30, headache and dizziness were gone. Today, 2/6/02, he feels fine other that arm still swollen and red.
Not focusing very well; Totally dizzy and unable to walk very well because of the dizziness; Totally dizzy and unable to walk very well because of the dizziness; Nauseous; This is a spontaneous report from a contactable consumer (patient) for herself. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Lot Number: EW0150), dose 1 via an unspecified route of administration, administered in Arm Right on 12Apr2021 13:30 as a single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus: Diabetic. Concomitant medications included metformin; acetylsalicylic acid (ASPIRIN); calcium carbonate, colecalciferol (VITAMIN D 2000), and Cholesterol Pill, Blood Pressure Pill (unspecified); all taken for an unspecified indication, from an unknown date and ongoing. The patient experienced totally dizzy and unable to walk very well because of the dizziness on 13Apr2021 with outcome of recovered on 14Apr2021, nauseous on 13Apr2021 with outcome of recovered on 14Apr2021, not focusing very well on 15Apr2021 with outcome of not recovered. Treatment included drinks a lot of fluids. The report is not related to a study or programme. She received the vaccine on Monday 12Apr2021 at 13:00. She drank a lot of fluids and ate and went to bed and slept a full 8 hours straight. When she woke up, she was totally dizzy and unable to walk very well because of the dizziness and she had a nauseous feeling, but never vomited. Stated that was on Tuesday and lasted most of the day, sort of subsiding towards evening. When she woke up, she was still dizzy. She was not focusing very well. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No AE require a visit to Emergency Room or Physician Office. There was AEs following prior vaccinations. No Prior Vaccinations (within 4 weeks). No vaccines were administered on same date of the Pfizer Suspect.   No follow-up attempts are needed. No further information is expected.
Patients mother phoned stated patient reaction at Varicella injection site. Swollen red (aprox 2-2 1/2 in diameter) and warm to touch. Child continues playful Tylenol (Motrin as needed for pain).
Bell's palsy; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was provided regarding medical history, concurrent condition, or concomitant medication. In 2013 the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose number and route was not specified) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as "subsequent to zoster vaccine live (ZOSTAVAX) inoculation"), the patient was treated by a healthcare provider for Bell's palsy. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of Bell's palsy was considered to be medically significant.
I have also contracted COVID after receiving 2 doses of your vaccine; I have been very ill for 2 weeks; Shoulder twitching; eyes irritated very bad; eyes burnt as if I had acid or bleach in eyes; eyes swollen; eyes red; eyes twitching; Vision blurry; diplopia; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (eyes burnt as if I had acid or bleach in eyes), EYE SWELLING (eyes swollen), OCULAR HYPERAEMIA (eyes red), BLEPHAROSPASM (eyes twitching) and VISION BLURRED (Vision blurry) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SIMVASTATIN, GABAPENTIN and FAMOTIDINE for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced EYE IRRITATION (eyes burnt as if I had acid or bleach in eyes), EYE SWELLING (eyes swollen), OCULAR HYPERAEMIA (eyes red), BLEPHAROSPASM (eyes twitching), VISION BLURRED (Vision blurry), DIPLOPIA (diplopia), EYE IRRITATION (eyes irritated very bad) and ARTHRALGIA (Shoulder twitching). On an unknown date, the patient experienced COVID-19 (I have also contracted COVID after receiving 2 doses of your vaccine) and ILLNESS (I have been very ill for 2 weeks). On 20-Apr-2021, EYE IRRITATION (eyes burnt as if I had acid or bleach in eyes), EYE SWELLING (eyes swollen), OCULAR HYPERAEMIA (eyes red) and EYE IRRITATION (eyes irritated very bad) had resolved. At the time of the report, BLEPHAROSPASM (eyes twitching), VISION BLURRED (Vision blurry), DIPLOPIA (diplopia), COVID-19 (I have also contracted COVID after receiving 2 doses of your vaccine), ILLNESS (I have been very ill for 2 weeks) and ARTHRALGIA (Shoulder twitching) outcome was unknown.            No treatment medication was provided.     Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received contains significant information: Events added: COVID 19 and illness On 23-Jul-2021: Follow up received contains No New Information. On 23-Jul-2021: Follow up received contains No New Information.
Pt's , May 27 fell and broke distal fibula , cellulitis then a few weeks later/ after antibiotics (clindamycin)  pt had no energy, said dr told her to stop taking due to side effects.  One evening had severe pain in foot, that was broken  doctor ordered Doppler ultrasound  calf muscle DVT. Took Xarelto  after 6 days her urine was very dark and pink  dr said stop taking Xarelto . due to symptoms. by Friday  went to get another ultrasound. blood clot dissolved Vascular surgeon ordered another ultra sound and said that the other ultrasound was inaccurate and she still had it . now waiting on dr to call
I developed swollen lymph glands on my left side. My husband is a RN and noticed it immediately. I also had a low fever, chills, body aches and tired for 3 days. I slept a day and a half off and on.
On 10-12-08 pt noticed pain and bruising on her Lt upper arm. Each day the bruise get bigger and it is almost to the elbow area. The bruise is very dark in color. Seen Dr on 10-21-08. No treatment ordered.
Patient fainted approximately 5 min after receiving 4 vaccines. Paramedics were at the vaccination clinic and immediately provided care. Pt. remained bradycardic and fainted again in the chair. Pt. was brought to the ER at Hospital at 1:40 PM.
ED Visit  - heart racing and itchy hives 2.5 hours after COVID-19 booster shot. Epinephrine administered.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            Patient took a headache pill to treat symptoms.   Patient takes concomitant medication but did not have them at hand to provide the names.   This case was linked to MOD-2021-283780 (Patient Link).
Pt states Approx 8 PM (11-17-09) started feeling wheezy, and coughing.  She contacted Dr. & app advised to use BENADRYL & TYLENOL.  Used 8:15 PM.  This AM pt states woke up Approx 5:45 AM & face & lips were puffy.  Denies 9:40 breathing prob.  Per Dr. - pt to use BENADRYL 50-75 mg 11-18-09.  8 PM started wheezy & coughing called Dr.  Told to use BENADRYL & TYL - Pt used 1 dose last nite 8:15 & then this AM face / lips puffy - "breathing fine".  Used BENADRYL 5:45 AM still has puffiness.  9:40 call c/o pt - per Dr. - use BENADRYL 50-75 mg, Monitor sx- call if prob persists, don't drive if drowsy - Dr.  11-18-09 1:47 Call to pt check on status, states she used BENADRYL (10:00 am) 50 mg ( earlier) & now states puffiness is decreased, & SOB & wheezing, pt will call if problems.
Fever; Nausea; Chills; Muscle aches; Booster\ received dose 3; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 06Oct2021 at 13:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 08Feb2021 at 13:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 01Mar2021 at 13:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 06Oct2021 at 23:00 the patient experienced fever, nausea and muscle aches. The patient did not receive any treatment for the events. The clinical outcome of the event fever, nausea, chills and muscle aches was resolved on an unknown date in Oct2021.
Within 2 hours of shot on 3.30.21?: severe headache, 1:30 am-2am- body aches fever 103.1F, at 7am high fever 102.6, severe body; heart palpitation, 3.31.21- high fever, heart palpations, sever body aches, headache. 4.1.21: fever is 99.5.
12:10 (10 minutes after 1st dose of Moderna vaccine), patient felt tingling distal to the injection site. 20 minutes later, patient felt left arm heaviness. 12:20, injection site numb. 12:30, postural test performed. 12:40, doctor gave the patient advice to take a non-Benadryl antihistamine if symptoms persist. 13:45, EMS on the scene for evaluation. 13:52, patient transported to ED. Doctor advised no further mRNA vaccine.
Patient suddenly got dizzy, complained of difficulty breathing, eyelids got swollen. Got H1N1 vac and Varicella vaccine around 3:30pm 11-9-09
This case was reported by a physician and described the occurrence of crying in a 7 week old male subject who was vaccainted with Pediarix for prophylaxis. On 01 February 2006 the subject received 1st dose of Pediarix (lot AC21D037CA). Approximately eight hours after receipt of the 1st dose of Pediarix, on 01 February 2006, the subject experienced non stop crying. No fever was reported. At the time of initial reporting, 2/08/2006 the crying was ongoing.
11-12 hours following the shot, I became nauseous and had a low grade fever. Heart raced over night, vomit, diarrhea, chills and aches, fatigue for 26 hours following shot.
Started with back aches. Progressed to 103 fever. Severe dizziness to the point I couldn?t stand up straight. Severe kidney area pain for 3 days then intermittent for 1 week. Severe, incapacitating joint and back pain, headache. Intermittent dizzy spells to the point of near falling for 1 week. Stomach cramping starting 36 hours later. Diarrhea x2 days. Pain in the muscle it was administered in. 48 Hours later, golf ball sized lymph node in armpit with pain. Lasted 10 days. 48 hours later swollen, painful lymph nodes in left side of neck and jaw. Neck pain.
L Deltoid Red swollen + itching 4 - 6 Hours after given DTap to left Deltoid muscle.
3cm area of erythema and induration at site of injection in right deltoid. Treated with Vistaril and Ultracet. Patient improving greatly on 12/2/02.
I had strange vertigo like symptoms ~1 week after both of my vaccines.  The first time it happened, I actually didn't realize that it was from the vaccine.  The vertigo symptoms were especially happening when I would go from lying down in bed, to getting up/out of bed.  The room would spin and I would have to lie back down and then get up more slowly.  The vertigo would occasionally happen while I was standing.  The first time it lasted for ~1 week and I was starting to get worried but then it resolved, however the symptoms recurred ~1 week after my 2nd shot.  The exact same vertigo.  This time, I realized the connection and then looked back and resolved both symptoms occurred ~1 week after my vaccine.  The second time, the vertigo symptoms also lasted ~1 week.  However after the 2nd shot, I also had severe neck pain on the same side as my shot that radiated from my scapular area up to the the base of my skull.  This pain lasted for ~1-2 weeks, then both the vertigo and the neck pain resolved.
A small rash started on my right leg. I thought it might go away but it got bigger. Looks like an eczema with small pimple like formations. Very pink.
reactions of 4-5cm swelling; This case was reported by a pharmacist via sales rep and described the occurrence of local swelling in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   On an unknown date, the patient received the 1st dose of FluLaval Tetra 2019-2020 season. On an unknown date, less than a year after receiving FluLaval Tetra 2019-2020 season, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was unknown.   It was unknown if the reporter considered the local swelling to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that they just had their first flu clinic (having given about 170 doses). She stated that they saw a little less than 10 percent of patients (might be 10 patients) had local reactions of 4 to 5cm swelling.  She wanted to confirm that this was normal and the sales representative gave information from package insert trials. The reporter did note that their provider was inexperienced (not confident) and the reactions were mostly in the first patients of the day (she felt this was a contributing factor). The reporter did not consent to follow up.
Received liquid component only; Received liquid component only; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 1st March 2023, the patient received Menveo. On 1st March 2023, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 02-Mar-2023 Reporter comment: The physician reported that a patient received the Menveo liquid component only, without reconstituting with lyophilized component.  The healthcare professional did not have the patient's information of gender, date of birth and the lot or expiration at the time of report.  The healthcare professional declined to store name and phone number but consented to follow-up via email. Additional supportive information: The patient received the Menveo liquid component only, without reconstituting with lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Acute Pancreatitis - developed fever and moderate abdominal pain 8 days after vaccine administration. 10 days after vaccination, sought medical care due to abdominal pain. Was diagnosed with pancreatitis based on lipase result and symptoms.
administered the diluent portion of vaccine and not the powder portion; administered the diluent portion of vaccine and not the powder portion; This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received only diluent portion of Shingrix vaccine and not the powder portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No other detail of vaccine available. The reporter consented to follow up.
Administered with vaccine that has been refrozen; A spontaneous report was received from a nurse, concerning a  69-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 69 year old, female patient.  The patient's medical history is not provided.  The event occurred on 28 Dec 2020, when the patient was given the first dose of the mRNA-1273 (Lot: 025J20-2A) . This report refers to a case of storage error where refrozen mRNA-1273  had been administered to the patient.
She got her vaccine, around 10:00 PM she started to feel nauseous and went to bed, got a severe headache which lasted most of the night . She had chills, fever, was very nauseous with this and was nauseated the whole next day where she could not eat anything, and could only drink a few sips of clear soda.  She slept most of the next day.  Today she is feeling better, she is able to eat today.  She did not take anything for her symptoms.  She is still feeling a little tired due to not able to eat and lying around and feels that she will be fine by tomorrow.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot # L019836 with expiration date 24-MAR-2017 and lot # 048265 with expiration date 10-JUN-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented to clinic requesting Pfizer Bivalent Booster COVID-19 vaccine.  He was inadvertently given Pfizer monovalent vaccine.  He had no ill effects and was informed that he could return to the clinic in 2 months for the bivalent vaccine.
Headache, Sedation, Myalgia, Arthralgia, Fever, Chills, Pain/redness/swelling@ injection site  Narrative:
AFTER RECEIVING THE LAST VACCINE, PATIENT STATED THAT SHE MAY LOOSE CONSCIOUSNESS AND THAT HER FACE AND RIGHT HAND FELT LIKE THEY WERE LOCKED. I STAYED WITH THE PATIENT AND FANNED HER FACE AND NECK TO MAKE AIR MOVING. SHE STAYED AWAKE AND MAYBE 5-7 MINUTES LATER STARTED FEELING BETTER AND WAS ABLE TO  WALK. I GAVE PATIENT SOME WATER AND ASKED HER TO REMAIN IN THE WAITING ROOM FOR ANOTHER 30 MINUTES. I CALLED PATIENT AT 8:25 PM AND SHE STATED SHE DID NOT HAVE ANY ISSUES AND WAS FEELING FINE.
8.0 cm L x 5.0 W erythema warm to touch redness, tender to touch.  Left anterior thigh.
fever, nausea, diarrhea, arm pain, myalgia,  Narrative: