chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to 4 children patients of unknown age and gender. On an unknown date those patients were vaccinated with an improperly stored PEDVAXHIB (dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects were reported at the time of reporting. Follow up information has been received from medical assistant. This report refers to a 1 month old patient. On 19-AUG-2014 the patient was vaccinated with PEDVAXHIB (lot no. J01343, expiry: 14-AUG-2016). No concomitant medication was reported. On an unknown date the patient was vaccinated with improperly stored PEDVAXHIB. No adverse effects were reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 30-JUN-2021, the subject experienced chills. On 30-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and fever was not reported. This report was non-serious.
a lot worse and heavier than her normal periods; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (a lot worse and heavier than her normal periods) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MENSTRUAL DISORDER (a lot worse and heavier than her normal periods). At the time of the report, MENSTRUAL DISORDER (a lot worse and heavier than her normal periods) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Last night 01/24/2021 broke out in red bump that itch on my knee and legs and on my arms, on my hips and butt all the way down back of  my legs.  Called EMS and was given Benadryl and thats it.
One day after DaPT #3, HIB #3 and Hep B #1 developed hives.
Pt received H1N1 IM at 19:00, 01/13/10. At 22:00, pt started vomiting every 15 minutes through the night and has developed diarrhea. No fever. Mom feels H1N1 vaccine caused these symptoms. No known ill contacts. The entire family received H1N1 vac yesterday. No one else is ill.
p/vax pr exp periorbital edema w/vesicular, papular type lesions around eyes & a fever;there was no inj site rxn;pt sought unspecified medical attention;
Hives, asthma exacerbation and angioedema requiring ER evaluation and treatment. Referral to allergist.
Upper left arm became very sore the next day--MUCH sorer than in previous flu shots (I get one every year). Soreness increased over next several days. Soreness/pain has continued since 9/6. Limited range of motion. Pain when lifting heavy objects. When using hiking poles, downward placement of left pole too painful--4-5 weeks after injection. Discomfort at night--could not sleep on side or change positions without pain. Went to clinic and MD said try a week on Ibuprofen--said he thought it was bursitis from midplaced needle. Ibuprofen helped but pain returned when dc'd after 1 week. Called pharmacist at pharmacy. He said try antihistamine for 5 days. Didn't help at all. Later, ALEVE helped. Pain has decreased since using ALEVE but still sore. No itching. Could not see any swelling.
Onset of pruritic maculopapular rash 2 days after receipt of vaccine.  Seen  the following day at which time also reported sensation of mild lip swelling.  Added 2nd antihistamine to medications along w/ PO steroid.
pt recvd vax & lt deltoid (large area) was reddened, swollen & painful; pt was tkaen to an MD 18MAY94 & started on ATB; PHN noted approx 3" x 4" area on lt deltoid (red & swollen);
Worsened tinnitus.  I had tinnitus that had largely resolved and since the vaccine, it's been extremely loud - more loud than ever before.  I don't have any other lifestyle issues that would've aggravated the tinnitus.
expired vaccine administered to 14 patients; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020. Previously administered products included for an unreported indication: INFLUENZA in September 2021. Concurrent medical conditions included Allergy to antibiotic (Allergy to Sulfa).    On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 14 patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.; Sender's Comments: This is a spontaneous case of expired product administered for this 83-year-old, male patient with no relevant medical history. No adverse event was reported after administration of the second dose of the Moderna mRNA-1273. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.
PATIENT SAYS ARM BECAME SORE THE NEIGHT AFTER RECEIVING VACCINE. THAT PAIN CONTINUED OVER THE NEXT SEVERAL DAYS AND RADIATED UP INTO THE SHOULDER. AFTER ABOUT TWO WEEKS, THE PAIN BEGAN ALSO IN THE UNVACCINATED SHOULDER. PATIENT SAYS PAIN CONTINUES IN BOTH ARMS, MAKING HIM UNABLE TO RAISE HIS ARMS ABOVE SHOULDER LEVEL.
4 hours after the vaccine was administered, the patient reported having a headache, left arm soreness, and a decreased appetite. The injection site became red, swollen and hot. 48 hours later, soreness continued but the swelling and redness is much improved.
or if it worsens. Patient notified PCP office 7 days after vaccination and was seen via telemedicine on 12/28/2021. She was prescribed Gabapentin for symptoms and given ER precautions. Patient stated symptoms worsened to left arm weakness along with numbness/tingling. Patient went to Medical Center ER on 01/04/2022. She was discharged after 1 day to the care of her husband with recommendation to be evaluated by PCP as soon as possible. She was evaluated by PCP in person on 01/06/2022. Patient reported at the time that the symptoms haven't improved and the neurologist at the hospital wanted her to have MRI brain with and without contrast.  PCP ordered MRI brain as well as MRI cervical spine with and without contrast. MRI brain was completed on 01/07/2022 and it was normal; patient was recommended to follow up with neurology per PCP. MRI cervical spine was completed on 01/12/2022 and showed "C6/C7 level: 3 mm broad-based disc bulge with ligamentum flavum buckling is noted. Mild canal stenosis. Bilateral uncovertebral hypertrophy is noted. There is mild bilateral neuroforaminal narrowing. Facets are normal." Patient was recommended to follow up with spine specialist. She saw spine specialist on 01/20/2022 and he ordered an EMG as well as prescribed Ibuprofen 600 mg, Gabapentin 300 mg, and Baclofen 10 mg to take as prescribed. Patient was advised to return for follow up in 6 weeks.
pt recv vax & exp apnea shortly p/vax;pt hosp;Annual follow-up received on 11/27/00 provided no additional data.
This case was reported by a consumer via call center representative and described the occurrence of migraine in a male patient who received SHINGRIX for prophylaxis. The patient's past medical history included migraine (under control using INDERAL). In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced migraine. On an unknown date, the outcome of the migraine was not recovered/not resolved. It was unknown if the reporter considered the migraine to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient received SHINGRIX four days before the date of reporting and had experienced severe migraines every day since. The patient stated that he understood headaches were a common side effect for the injection. The patient asked that how long reaction typically continued following the injection and was it unwise to took the booster shot if he continued to experience migraines.
After Anthrax shot was administered, I got hot and then starting to have  chills. I laid in bed with a fever of 103 deg and I couldn't stop shaking. Duration of 3 days
We believe 1 vial of Pfizer vaccine was diluted with less than 1.8 mls, but no less than 1.5ml. Based on this info, I called Pfizer and they said the highest possible dose the patient could have gotten was 34.6 mcg. They also said this should not be harmful to the patient, and it should should not effect the efficacy. I have not been able to reach the patient yet, but I will keep trying to call to see how she is doing and to reassure her that it was just a slightly higher possible dose, and to call the pharmacy if she experiences any other symptoms.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Cp initially that resolved in seconds. Then severe muscle aches, fatigue, temp 1 week,excruciating joint pain continues now. Malaise.
Pt reports feeling tight chest, wheezing, red swollen runny eyes and extreme fatigue.  Pt went home and took antihistimines, stayed home from work the following day.
Starting yesterday, I noticed a bump on my arm at the injection site. It grew and became puffy and red. It was mildly itchy. It was more pronounced this morning. I looked up what this could be as it has been several days since my shot but found it is most liked 'Covid arm'. Hydrocortisone cream seems to help and I don't feel the need to contact my doctor for this since it's so mild.
On 6/21/99, the pt experienced a fever of 104. Unspecified medical attention was sought.
After first shot, my top joints on middle fingers swelled up and were sore. Still a little sore. Second shot on a Thursday. Saturday in middle of night, back of legs felt swollen and sore.after 2 days, left leg better, but felt like swelling and throbbing for days. Went and did venous Doppler bec. It felt like a vascular blockage. Negative Doppler. Went to one orthopedist twice, went to another last Friday and went to a chiropractor Saturday. It is coming from L5-s1 and sacral area has been sore. Gradually getting better. My knees have felt too swollen to need. Sacral and buttocks were sore. Legs were stiff. Is this coincidental? No injuries or exertion.
Felt burning around left eye; left eye was watering; Feel constantly cold; muscles from arms and legs feeling like burning, lower back like burning and and now went up to the head; nausea; headache/head is killing; chills; joint pain in upper left arm and knees; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Felt burning around left eye), LACRIMATION INCREASED (left eye was watering), FEELING COLD (Feel constantly cold), MYALGIA (muscles from arms and legs feeling like burning, lower back like burning and and now went up to the head) and NAUSEA (nausea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer-BioNTech COVID-19 Vaccine (lot number - ER8727) on 24-Mar-2021 and Pfizer-BioNTech COVID-19 Vaccine (lot number - EW0153) on 14-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine.    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EYE IRRITATION (Felt burning around left eye), LACRIMATION INCREASED (left eye was watering), FEELING COLD (Feel constantly cold), MYALGIA (muscles from arms and legs feeling like burning, lower back like burning and and now went up to the head), NAUSEA (nausea), HEADACHE (headache/head is killing), CHILLS (chills) and ARTHRALGIA (joint pain in upper left arm and knees). The patient was treated with IBUPROFEN at a dose of 800 milligram; 1 or 2. At the time of the report, EYE IRRITATION (Felt burning around left eye), LACRIMATION INCREASED (left eye was watering), FEELING COLD (Feel constantly cold), MYALGIA (muscles from arms and legs feeling like burning, lower back like burning and and now went up to the head), NAUSEA (nausea), HEADACHE (headache/head is killing), CHILLS (chills) and ARTHRALGIA (joint pain in upper left arm and knees) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
fever (topped out at 102), chills, muscle and joint pain, dizziness, nausea, fatigue, shortness of breath  Fever began late day of injection and hit 102 by early morning and stayed at 102 for more than 24 hours. Went down to 101 levels for another day, 100 for part of another day, then back up to 101, fourth day fever was in 99s and stayed there until the following day when I woke up with normal temp. Muscle and joint pain was sharp, stabbing pains that rotated throughout my body. Stomach and intestinal pain. No energy. Felt like I was not in my own body, out of sorts.
patient stated she felt dizzy and throat tightness. by time patient got back in room, throat no longer felt tight but still felt dizzy.  patient did not experience swelling of face or tongue and was able to talk througout whole interaction, so administered benadryl. asked patient if she had anything to eat or drink yet. she said yes. offered crackers and water. she accepted water. monitored bp and hr, was within normal range. observed for 15 minutes in room. counseled pt on s/sx of allergic reaction and to contact 911 if experienced those s/sx at home.
No additional AE; Nurse reporting that MMRII was administered on 8/23/2022 with a labeled expiry of 8/18/2022. No temperature excursion involved. No additional information provided. No additional AE/PQC reported at time of call.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drugs reactions or allergies and concomitant medications were not provided.  On 23-AUG-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) subcutaneous injection, 0.5  milliliters (mL), administered subcutaneously (valid lot number T027937 with an expiration date on 18-AUG-2022) (strength, frequency, and anatomical injection site were not provided) for prophylaxis (expired product administered), and sterile diluent (STERILE DILUENT)  (valid lot number T032311 with an expiration date on 05-MAY-2023).  No additional adverse event (AE) was reported.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. The patient was vaccinated with PNEUMOVAX23(lot#unknown) intramuscular on an unknown date. The patient was given PREVNAR 13 and PNEUMOVAX23 concomitantly. There was no treatment information. The patient did not sought medical attention. Additional information has been requested.
Diagnosis date 4/12/2022, Admit date 4/12/2022, discharged 4/15/2022, no symptoms, signs listed
Severe swollen throat next morning, throat closing feeling, choking when swallowing water  Swollen face 48 hours later, severe chills for days
Felt confused; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Felt confused) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Felt confused). At the time of the report, CONFUSIONAL STATE (Felt confused) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-123936 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-123936:crosslinked
Child's mother called this morning and states "arm is all swollen, red and warm to touch.  She got her shots there on Friday.  I called the Pediatrician yesterday and he told me to use a heating pad on the arm last night.  I did and it doesn't look any better today."  Instructed Mom to call the Pediatrician back today and have him take a look at the arm today, and let us know what he decides to do about the redness and swelling. Mom verbalized good understanding.
bone pain; body pain; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone pain) and PAIN (body pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 BONE PAIN (bone pain) and PAIN (body pain).
patient presented to emergency department on 1/23/22 with toxic metabolic encephalopathy patient was admitted for further management of  altered mental status patient did not require treatment for symptoms associated with covid-19 patient was discharged to home on 1/25/22
Two days post vax, the pt developed a faint rash which was noted on chest described as sand paper, fine papules. Contact dermatitis or heat rash; doubt IZ reaction. Treated with anti-histamine. Then 4/17, more out break of chicken pox. Treated with Benadryl and Tylenol.
sleeping for 3 days; weak; really thirsty; tired; Fever; real achy; terrible headache; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; left arm hot, red, and swollen at injection site; This is a spontaneous report from a contactable Nurse (patient).  A 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:00 (Batch/Lot Number: ER8734) as SINGLE DOSE (at the age of 67 years) for covid-19 immunisation.   The patient had the first dose of BNT162B2 for COVID-19 immunisation in the left arm lot number EP7534 and the patient experienced peripheral swelling in left leg and blood clot.   Medical history included ongoing thalassaemia beta Caller stated she was diagnosed with this in her later 20s or early 30s.     The patient's concomitant medications were not reported.  The patient experienced fever (disability) on 06Apr2021 20:00 with outcome of recovered, real achy (disability) on 06Apr2021 with outcome of recovered, terrible headache (disability) on 06Apr2021 with outcome of recovered, weak (disability) on 07Apr2021 with outcome of recovering, really thirsty (medically significant) on 07Apr2021 with outcome of recovered, tired (disability) on 07Apr2021 with outcome of recovered, sleeping for 3 days on an unspecified date with outcome of unknown, left arm hot, red, and swollen at injection site on 06Apr2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included body temperature: 102, body temperature: 101.9, body temperature: 106, body temperature: 101.6.  Therapeutic measures were taken as a result of fever, real achy, terrible headache, weak. Treatment: Advil. The patient is not in a study or programme. No Additional vaccines administered within last 4 weeks. Events were considered related for real achy, terrible headache, weak, really thirsty, tired, and left arm hot, red, and swollen at injection site.  Follow-up attempts completed: case closed.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for fever and other reported events.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/16/2022 BPH W LOWER URINARY TRACT SYMPTOMS J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/16/2022 MITRAL VALVE REGURGITATION J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/16/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Left thigh red and swollen seen by Dr. and treated with ice, hydrocortisone cream and KEFLEX.
Chills Fever Hot Flashes Headache Dizzy Nauseous  Hand felt frostbite Fatigue  Visions of me helping someone roll away the boulder at the tomb
Case number PHEH2013US016163, is an initial spontaneous report received from medical assistant on 26 JUL 2013 with a combined follow up information received from medical assistant on 27 AUG 2013 and 29 AUG 2013. This report refers to a 17-years-old female patient. It was reported that the patient received MENVEO (batch number M11071, expiry date: DEC 2013) that had a temperature excursion of 33F for 4-6 hours at a dose of 0.5 ml in the right deltoid on 11 JUL 2013. No adverse event was reported following this maladministration. No further information was provided.   Combined follow up information received on 27 AUG 2013 and 29 AUG 2013. Vaccination site updated.