chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had flu like symptoms for 3-4 days, I also nurse a 9 month old me due to latch issues he ingested some of my blood. Day two or 3 after my shot he had a fever and was fatigued.; I had flu like symptoms for 3-4 days, I also nurse a 9 month old me due to latch issues he ingested some of my blood. Day two or 3 after my shot he had a fever and was fatigued.; I had flu like symptoms for 3-4 days, I also nurse a 9 month old me due to latch issues he ingested some of my blood. Day two or 3 after my shot he had a fever and was fatigued.; This is a spontaneous report from a contactable consumer (parent). A 09-month-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot number: not reported), dose 2 via an unspecified route of administration, administered in arm right on 20Apr2021 at 15:45 as DOSE 2, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration, on 30Mar2021 at 03:45 PM as DOSE 1, SINGLE for covid-19 immunisation and the patient experienced flu after first shot. The patient medical history was not reported. There were no concomitant medications reported. The patient was not administered any other vaccine four weeks prior to the vaccination. Other medications in two weeks was reported as no. Patient did not have covid prior vaccination and had not been tested for covid post vaccination. She (mother) had no known allergies or other medical history. On 21Apr2021 at 04:00 AM, It was reported that, I had flu like symptoms for 3-4 days, I also nurse a 9-month-old me due to latch issues he ingested some of my blood, day two or 3 after my shot he had a fever and was fatigued. Patient did not receive any treatment for the events. Outcome of all the events were recovered in 2021.  Information on the lot/batch number has been requested.
Less than 25 days for administration of second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 25 days for administration of second dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included Colectomy and Cholecystectomy (Patient ended up with some scar tissue, which does bother him from time to time.) in February 2020. Concomitant products included ALOPURINOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), OMEPRAZOLE, AMLODIPINE and VALSARTAN for an unknown indication.    On 07-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 25 days for administration of second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 25 days for administration of second dose) had resolved.            Treatment information was not  provided.   This case was linked to MOD-2021-299901 (Patient Link).
This spontaneous report as received from a medical assistant refers to a 22 year old patient of unknown gender. On 01-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L026602 with expiration date 19-OCT-2017). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
A report has been received from a pharmacist concerning a patient born on 23-APR-2010, male subject, who had been receiving nasal FLUMIST started on an unknown date. The patient experienced expired FLUMIST. The outcome of the event of administered expired FLUMIST is unknown. The report was considered non-serious by the reporter.
Hospitalization: 3/29/2023 - 3/31/2023 (2 days) Presentation to the ED: worsening cough and shortness of breath.  COVID + date: 03/29/2023 Treatment: dexamethasone and remdesivir. Discharge to: HOME. 044A21A 3/22/2021 036B21A 4/15/2021 045J21A 11/24/2021
Vaccination site pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness) in a 61-year-old female 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.    No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, received third 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 VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness). The patient was treated with URSODIOL at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme increased: High.         No concomitant medications was reported.  It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.  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.
Took Moderna COVID-19 vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Took Moderna COVID-19 vaccine while pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rhesus antibodies.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Took Moderna COVID-19 vaccine while pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Took Moderna COVID-19 vaccine while pregnant) had resolved. Not Provided
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On an unknown date, a dose of (wistar ra 27-3) M-M-R II was reconstituted with MECACTRA instead of the diluent (wrong solution used in drug reconstitution). Then the patient was vaccinated with (wistar ra 27-3) M-M-R II (dosage, route and lot # not specified). The reporter had no heard form the patient but was somewhat confident the patient had not had any adverse events after the administration. Additional information has been requested.
Tightness in chest. Onset of symptoms under 1 hour. Patient presented to emergency room.
Right thigh 2cm x 1 cm hard area and large red swelling extending to right knee.
Administered PROQUAD to R Thigh on 6/27/07 patients mother then called clinic on 6-28-07 at closing to inform me that thigh was swollen et painful to touch. Presented to clinic on 6-29 am same symptoms
Angioedema of the lips and cheeks beginning around 5:00 PM on 12/12/21 and getting worse overnight.  Swelling was worst around 8:00 AM on 12/13/21.  Swelling began to decrease around 12:00 PM on 12/13/21 and completely went away by 8:00PM on 12/13/21.
24 hours after injection administered in upper left arm, patient experience swelling in, deep pain in, and inability to move left arm; numbness in extremities; shortness of breath; severe lethargy and malaise.
Very heavy bleeding with period 2 weeks after vaccine. Low ferritin/iron levels developed, became symptomatic for low iron for several months and was discovered in blood work in June.
Pt. received flu sot on 9/11/16 and 15 mins. later (L) arm started to swell, she reports that 3 hours later had body aches. By midnight she had fever, coughing and a runny nose. States later on had a bloody nose x 4 hours. Didn't get medical care was feeling better by 9/13/16,
Approximately 2-1-19 patient started with redness around shot site. Redness increased to about 2 inches and blisters appeared in clusters about pea sized. No fever. Pt. seen in our office 2-4-19. No fever. Round area of mild erythema was noted with cluster of dried vesicles. No swelling, but seems tender to touch. Pictures available to view.
Four hours after injection side effects of redness, edema at site for two days. Also soreness.
Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies. etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Circumstances regarding potential cause of death not evident in charge. Note from 1/21/21 states patient has had poor appetite since May 2020 and has lost 30 pounds. Patient was 78 with Parkinson's Disease and dementia, CAD w/ multiple stents, and anemia.
Information has been received from a pharmacist concerning a mid 30 years old female nurse who on 27-JUN-2007 was drawing up a dose of Zostavax (Oka/Merck) and a small amount of the vaccine splashed onto her left forearm above the level of her gloves.  The patient washed the affected area.  On 28-JUN-2007 the patient developed small blister like areas with a pinpoint white centers.  The blisters were at the area of the splash and did not spread any further.  It was reported that the patient had a topical exposure.  There were no complaints of itching or pain at the blister site.  Unspecified medical attention was undertaken.  At the time of report the patient was recovering.  A product quality complaint was not involved.  Additional information has been requested.
Information has been received from a pharmacist concerning a female patient who about one years ago (in 2009) was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently, the patient had shingles on her head extending towards her eye. The patient contacted a physician for medical attention. At the time of the report, the patient had recovered. The patient and her brother in law were both vaccinated by the same physician (WAES#1006USA00017). This is one of several reports received from the same source. Additional information has been requested.
Pt fell within 24 hours after vaccine. was sent to hospital. pt was  found to be hypoxic with multifocal opacities on CT scan
Started out extremely tired with a headache and achy joints throughout my body.  Decided to take a warm shower to wake up and attempt to relieve pain. Started feeling disoriented and got out of shower and sat down for a few minutes. Got back in shower and blacked out, falling onto the shower floor. Husband heard the noise and came to help me up. Took a few minutes to gain my bearings and figure out how to best get up from the floor safely. No more than stood up and passed out again, ending up back on the floor. The rest of the day I was severely fatigued and just rested. Felt just fine the next morning.
PATIENT REFERS HEADACHE, EDEMA IN THROAT THAT LASTED FOR 1 1/2 DAYS. ALSO REFERS BURNING SENSATION IN RIGHT ARM AND RIGHT LEG AND FATIGUE.  PATIENT REFERS THAT SHE TOOK NAPROXEN THREE TIMES.
Patient in after having vaccine related skin reaction after COVID vaccine, initially spreading and cellulitis like near vaccination site upper L arm, but no painful but itching sometimes. Patient got injection on 01/29/2021. Woke up on 02/06/2021 with itchiness and was scratching injection site. She noticed redness and small bump on injection site and just below injection site. Contacted provider who prescribed Zithromax and Bactrim. Pt seen in office on 02/09/2021 to assess Injection site reaction. Pt to continue Zithromax and DC Bactrim after one day due to secondary rash. Also prescribed Loratadine 10mg on 02/09/2021.
chills, fever, pain under the arms (armpits) and part of the side area; Headache, pain in the arm and a feeling of heaviness, fatigue, itching feeling of heaviness, tiredness, itchiness; Headache, pain in the arm and a feeling of heaviness, fatigue, itching feeling of heaviness, tiredness, itchiness; Headache, pain in the arm and a feeling of heaviness, fatigue, itching feeling of heaviness, tiredness, itchiness; Headache, pain in the arm and a feeling of heaviness, fatigue, itching feeling of heaviness, tiredness, itchiness; Headache, pain in the arm and a feeling of heaviness, fatigue, itching feeling of heaviness, tiredness, itchiness; Headache, pain in the arm and a feeling of heaviness, fatigue, itching feeling of heaviness, tiredness, itchiness; chills, fever, pain under the arms (armpits) and part of the side area; chills, fever, pain under the arms (armpits) and part of the side area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Jul2021 19:15 (Lot number: EW0198) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diverticulos" (unspecified if ongoing); "sinusitis" (unspecified if ongoing); "Known allergies: Penicilina" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: AXILLARY PAIN (non-serious), CHILLS (non-serious), PYREXIA (non-serious) all with onset 16Jul2021, outcome "recovered with sequelae" and all described as "chills, fever, pain under the arms (armpits) and part of the side area"; LIMB DISCOMFORT (non-serious), HEADACHE (non-serious), PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious), INJECTION SITE PRURITUS (non-serious), FATIGUE (non-serious) all with onset 16Jul2021, outcome "recovered with sequelae" and all described as "Headache, pain in the arm and a feeling of heaviness, fatigue, itching feeling of heaviness, tiredness, itchiness". Therapeutic measures were taken as a result of axillary pain, limb discomfort, headache, pain in extremity, fatigue, injection site pruritus, fatigue, chills, pyrexia.  Additional information: Facility type vaccine was Other. If other vaccine in four weeks: No. If COVID prior vaccination: No. If COVID tested post vaccination: No. AE resulted in: None of the above.  No follow-up attempts are possible. No further information is expected.
At the end of February a few months after the vaccine. I started with limited range of motion and pain in both shoulders and progressively got worse. The left shoulder continued to improve however the right shoulder continued to get worse. My right arm can't even get my wallet out of my right back pocket. I have only had one series of treatment, and my range of motion and pain has been helping and progressively getting better. It is still popping and cracking as well.
administrated with  only the liquid component of Menveo; administrated with  only the liquid component of Menveo; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 65-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva639a, expiry date 8th October 2022) for prophylaxis.   On 13th April 2022, the patient received Menveo. On 13th April 2022, 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: 13-Apr-2022 Reporter's Comments: Nurse reported on 13th April 2022 that a male patient was administrated with  only the liquid component of Menveo without the powder.  No adverse event was reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient was administrated with only the liquid component of Menveo without the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from a physician referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date the patient received an unspecified dose of PNEUMOVAX 23 (route, strength, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis and had significant arm swelling and fever for two days. The outcome of the events was reported as unknown. The causality between the events and PNEUMOVAX 23 was not reported.
I developed cold like symptoms with a cough and stuffy nose. I used over the counter medications to try and get relief. I went to the doctor on November 29, 2022, since my symptoms did not improve. The cough lingered. I was given Z-PAK and benzonatate to treat my symptoms. My symptoms improved after about a week, but the cough still lingered. I went to the doctor on Wednesday, and he prescribed the same medications and added prednisone. My ear was seeping fluid and I am not hearing well in the ear. It is a little better.
My skin broke out in severe skin rash and extremely itchy skin.  Went back to pharmacy and they recommend taking Panadol.  This worked but it requires taking it everyday.  They then recommend taking Claritin 10mg.   This worked and initially every 2 days then reduced to 3 days and now I have to take it at least once a week.   If I stop then the rash and itchy skin returns.
Extreme fatigue 48 hours after shot. Nausea/vomiting and headache. Flu like symptoms lasted about 24 hours and then subsided. Self treated with Tylenol, hydration and rest and felt better. The symptoms seemed to develop suddenly after I went for a 8 mile run on Saturday afternoon 1/9/21 about 48 hours after getting the shot.
Patient had received a dose of Moderna vaccine on 1/18/21 prior to dose of pfizer vaccine.  No severe reaction was noted by patient.
A physician reported that a female received her 1st dose of Prevnar and subsequently, developed a fever. She recovered. This is 1 of 2 pts from this facility who experienced fever following receipt of Prevnar.
fever of 99.4; feeling kind of rotten; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received bnt162b2 on 14Jan2021 10:00 am first dose intramuscularly on left arm at single dose for Covid-19 immunization. Vaccination Facility Type was Health Department. Vaccine Administered not at Military Facility. Medical history included ongoing Congestive heart failure diagnosed a few weeks ago and had covid in Apr2020. Concomitant medications were none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations: reaction with pneumonia vaccine, could not use his arm for a few days and they told him that was normal. She does not know the name of the vaccine she thinks it was the pneumococcal and does not have lot, ndc, or expiration. She is wondering if it is normal to not have side effects till two days after. She is calling for a male that is 90 years old and cannot hear very well. States he got the vaccine on Thursday (14Jan2021) and he has a fever of 99.4 degrees, she clarified this is one day later (15Jan2021), not two days later. He was feeling kind of rotten all day and he just realized about 30 minutes ago that he had a fever. He had covid in Apr2020. Doctor thinks he is a long hauler. He did not have heart trouble before covid and now he has congestive failure which was diagnosed a few weeks ago. Adverse events not require a visit to Emergency Room or Physician Office. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
05/29/04: Engerix vaccine IM given right arm. 06/15/04: Pt experienced Bells Palsy, facial drooping, weakness right side face.
Pt called back Sunday Nov 3, reporting rash, bump around her waistline, sound like an event of shingles. Itching and a little swelling at the injection sites. So I advised pt to use Benadryl for tonight to relieve rash and call MD asap tommorow. I will call her back her on Wed to follow up.
One day post vax, pts mom called and stated child had reaction - came in to see physician. Pts right thigh reddened, swollen, treated with Elocon and Histex.
Taken to ER by mother 3 hours after injection. Injection site swollen- all the way from thight to ear and face. Rash all over body. Pt given benadryl in ER.
Noticed itching and swelling at injection site on the morning of 5-29-08.  Applied ice to area without improvement.  Upon exam at physician visit noticed erythema with induration measuring 8.5 cm.  Benadryl advised with antibiotic if no improvement.  On 5-30-08 redness had gotten larger and antibiotic was started.
Feet turned black blood thinner  3 blood clots in lungs 1 clot in heart
Mom noted fever (99-100), pain in both thighs, slight swelling as well as small "spots" on both facial cheeks within 24 hours after receiving vaccines. Pain in thighs gradually improved over next 48-72 hours. Spots on face disappeared by time of appt. Pt had f/u appt on 21 Nov 12 - normal exam at that time.
arm soreness and pain with movement, "super sleepy"  " I could not  speak tomy daughter" headache, throbbing arm pain
Difficulty walking; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 12-year-old male patient received bnt162b2 (BNT162B2), administered in left arm (Lot number: unknown) at the age of 12 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Egg allergy" (unspecified if ongoing), notes: Known allergies: Egg products and "Milk allergy" (unspecified if ongoing), notes: Known allergies: Dairy products. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical site: Left arm), for COVID-19 immunisation. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Difficulty walking". The event "Difficulty walking " was evaluated at the physician office visit. Therapeutic measures were taken as a result of gait disturbance.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Treatment included physical therapy for GAIT DISTURBANCE. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.