chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID vaccination for 6month- 4 years administered to patient. Patient was to receive vaccination for ages 5-11y. Notified PCP and PCP allowed the continuation of administration of series with next vaccination to be in the age group 5-11y
Patient developed redness and swelling the evening after the vaccination.  On her own, she put a heating pad over the area.  Called to discuss with Pharmacist on Wednesday 10-25-06, she referred her to another pharmacist.  He advised the patient to take some diphenhydramine and to use cold compress and seek medical treatment if it worsened.  We didn't hear anything else until ARNP from medical association called around 3:00pm 10-25-06 and told us the patient had a documented case of cellulitis.  I phoned the pharmacy's clinical coordinator and she referred me to this form and she was to call our pharmacy district manager.
body aches, fever, weakness, fatigue, headache, nausea began the following day; then shortness of breath/chest pain/pain with deep breath started 3 days after vaccine.  Taken to Hospital ER for evaluation.  Labs collected (D dimer, CBC, CMP, Pregnancy test, PT, PTT); CXR done-noted questionable 6mm nodule; CT Scan Chest done-No pulmonary embolism found, no nodule noted-assumed to be shadowing or artifact.  Symptoms continued and seen by family NP 4/30/21-wheezing noted to left upper lobe, placed on z pak and albuterol inhaler.  Symptoms of shortness of breath, chest pain/pressure with deep breaths continued and started on Prednisone 20mg 5/3/21.  Symptoms continued and seen again by family NP 5/7/21.  Labwork collected (CBC, CMP, Thyroid panel, D Dimer, CRP, ESR, Covid antibodies) and CXR done.  WBC 16 and glucose 130 related to recent steroid use.  CXR normal.  Covid antibodies positive; ordered PFT's and echo (to be completed 6/4/21).  Shortness of breath and pressure with deep breaths continue, slightly improved at this time.
About an hour afterwards I could taste it. Whenever I get IVs I can taste and smell them. I did not expect the same reaction from an intramuscular shot, but I suppose once it got into my bloodstream and got to my olfactory areas, it started up. It really does produce the same taste as when I get an IV. For the past four days since I've gotten the shot, about once a day I get this same taste and smell. It happened again today a few minutes ago, so I thought I would report that after four days as it's going through my system and is still detectable physically. In addition, last night on 4/13/2021, I was a little congested, so I coughed hard to bring up some phlegm. There were two small spots of blood in the phlegm. I coughed five times and had the same amount of blood. I waited a few minutes and coughed again, and it turned into a pink-tinged mucus. Then it cleared up and it hasn't happened again. It was very tiny and I can't say it was from the vaccine, because nothing else has happened. It could be my age and thin tissue and a broken vein from a very deep cough, but yeah. it was very scary and I thought I would report it in case something more happens.
Increased heart rate. Over 100 when resting; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: El9261) via an unspecified route of administration, on the left arm, on 22Jan2021 at 15:30 PM (at the age of 46 years) at a single dose for COVID-19 immunization. Medical history included Hashimoto's disease. The patient did not have any allergies to medications, food, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included liothyronine (LIOTHYRONINE), thyroid (ARMOUR THYROID). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Jan2021 at 16:30 PM, the patient experienced increased heart rate, over 100 when resting. The event was reported as non-serious. The patient had lab tests which included heart rate: over 100 on 22Jan2021. No treatment was given. The clinical outcome of the increased heart rate, over 100 when resting was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Information has been received from a physician concerning a 1 year old male who on approximately 04/18/2001 was vaccinated with a dose of varicella virus vaccine live. On 05/06/2001, 18 days later, the pt was admitted to the hospital with cerebellar ataxia. It was reported that his symptoms were wide gait, ptosis and eye deviations. His MRI was normal and a CSF had no RBC's, 1 WBC, was negative for enterovirus, and a "viral culture ws negative." It was noted that the patient was not treated with acyclovir. It was reported that there was a family history on the pt's maternal side of an uncle that died from VZV encephalitis (no vaccine) and an ant with recurring herpes simplex (no vaccine). Subsequently, the pt fully recovered. The pt's sister subsequently experienced herpes zoster after receiving varicella virus vaccine live (MSD, WAES 0201USA01628).
Started with sore throat at 2pm and went to school nurse. Then at 4pm I picked him up from school and he was unable to speak (had no voice) wheezing, stridor and retracting. Had a croupy cough and stated "I can't breathe". I am a peds nurse and I new he was in distress I gave him Benadryl and took him to urgent care. He was given dexamethasone there. He still has a tight cough off and on and has dark circles under his eyes.
Patient complained of dizziness immediately following vaccine, then lips felt puffy, nausea, and shortness of breath
Date of Admission: 10/14/2022   Date of Discharge: 10/22/2022   Diagnoses on Admission Order: SOB, AKI, COVID   Hospital Principal Problem (Discharge Diagnoses): Dyspnea
Fridge temp out of range 1-9-17. No adverse reaction. No re-vax recommended.
5NOV93 bilateral arm pain & weakness, 5NOV93 admitted to hosp, 7NOV93 transferred to Med ctr, 9NOV93 on ventilator in ICU w/DX of GBS undergoing plasmapheresis
VERY SICK; COVID ARM SWELLING; Fever; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (VERY SICK), VACCINATION SITE SWELLING (COVID ARM SWELLING), PYREXIA (Fever) and COVID-19 (COVID-19) in a 51-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) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In December 2020, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ILLNESS (VERY SICK), VACCINATION SITE SWELLING (COVID ARM SWELLING) and PYREXIA (Fever). At the time of the report, ILLNESS (VERY SICK), VACCINATION SITE SWELLING (COVID ARM SWELLING), PYREXIA (Fever) and COVID-19 (COVID-19) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA007325:
PATIENT REPORTS HER ARM IS HURTING AND MAKES HER VERY UNCOMFORTABLE. THE PAIN HAS BEEN CONSTANT OVER THE PAST WEEK OR SO. PATIENT REPORTS THAT SOMETIMES THE PAIN RADIATES INTO NECK.
Received Moderna vaccine when he wanted Pfizer vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (Received Moderna vaccine when he wanted Pfizer vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced NO ADVERSE EVENT (Received Moderna vaccine when he wanted Pfizer vaccine). At the time of the report, NO ADVERSE EVENT (Received Moderna vaccine when he wanted Pfizer vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided. This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (Received Moderna vaccine when he wanted Pfizer vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced NO ADVERSE EVENT (Received Moderna vaccine when he wanted Pfizer vaccine). At the time of the report, NO ADVERSE EVENT (Received Moderna vaccine when he wanted Pfizer vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
12 hrs p/recvd 2nd dose of Engerix-B vax devel swelling & joint pain;
12 minutes after vaccination pt began to feel flushed, blurred vision, SOB, increased perspiration, shaky. Vitals at 1:36 pm were: 55 HR, 102/60, 95% on room air. Pt given water and laid down.  At 1:45 pm pt feeling better, not fully recovered but vision back to normal. Vitals at 1:45 pm were: 68 HR, 104/62, 100% on room air.  pt given snack at 1:55 pm. BP at 2:00 pm 100/60. Pt feeling well at this time. Pt will remain in  office for additional 30 min for observation.
No Adverse Event; Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR7479B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border).    This case contains information for 1st of 3 adult patients described by the reporter.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. NDC was provided. No concomitant product was reported. No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2023-698245, MODERNATX, INC.-MOD-2023-698247 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698245:2nd adult patient MODERNATX, INC.-MOD-2023-698247:3rd adult patient
Woke up from sleep screaming and had about a minute long shaking episode followed by a period of lethargy. Face was flushed, fever 100.3.
Reaction at the site of injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (Reaction at the site of injection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 VACCINATION SITE REACTION (Reaction at the site of injection). At the time of the report, VACCINATION SITE REACTION (Reaction at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.    Reporter did not allow further contact
Red circle on upper part of my arm, warm to the touch and hard.  It has gotten better each day.  Headache as well.
REDNESS, SWELLING, HOT, PRURITUS IN AREA WHERE VACCINE WAS GIVEN.
About round the last week of October 2022, I started getting heart palpitations. I waited on 10/31/2022 I saw my PCP and she recommended that I was connected to a Holter heart monitor for three days and they found that I had PVC's and I had 8% of my heart rate was PVC. I was prescribed a beta blocker.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4420988-00.  A 26-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 01Nov2017 (ongoing) (Batch/Lot number: unknown) at single (unk (citrate free)), subcutaneous for crohn's disease. The patient's relevant medical history included: "Moderate to Severe Adult Crohn's Disease" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "recovered" (2022) and all described as "COVID-19". The action taken for adalimumab was dosage not changed. Clinical course: The patient reported in May2022, the patient experienced Bowel obstruction and COVID-19. In 2022, the COVID-19 resolved. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of bowel obstruction and COVID-19 with Humira (Adalimumab) was no reasonable possibility. Agency's opinion is that  there is no reasonable possibility that the events of bowel obstruction and COVID-19 are related to Humira (Adalimumab).  The reporter considered "covid-19" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and drug ineffective, Covid 19 cannot be completely excluded.
About 25 hours after vaccine, I developed a rapid heart rate that lasted about 5 minutes, and then 2 weeks later I had another incident of rapid heart rate of 166 for 15 minutes at resting. My primary Doctor told me to stop all caffeine and phentermine. The second time it happened I was referred to a cardiologist. I'm an active person, I have run marathons, and I have never had heart issues before this.
pt had a local rxn @ site of inj;10cm in diameter area of erythema & tenderness 48hr post vax;5x3cm area of induration to upper, outter border of site;local rxn to anthrax vaccination;
Fever of 103 day after. Cold chills for 2 days. Headache for 4 days. On third day horrible blisters inside mouth and on lips.  Still there and worsening  on fourth day. Lots of fatigue.  Sinus headaches even too day 4 after.  Horrible muscle ache day after which did subside.
PATIENT EXPERIENCED A SALINE TASTE IN HER MOUTH, SHE REFUSED EXTENDED OBSERVATION.
Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Headache, Myalgia, Arthralgia, fatigue chills Narrative:
This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 20-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 1080 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt Receive 2nd dose of Pfizer Per Request. Pt should have Received Moderna.
Fully vaccinated patient with additional history of COVID infection in January positive for COVID and admitted for COVID PNA.
Pt reports have chest pain, chest tightness and fast heart rate about a week after getting his first Pfizer dose and again recently, and he thinks it might be a side effect of the vaccine because he had never had those symptoms prior to the vaccine
Knee pain and tear several weeks after shot. Appendicitis about a month later, emergency surgery,  prescribed pain meds but did not take any
She stated the PUI started to have symptoms on 09/10/2021 with cough, fatigue and brain confusions. She stated as of today the PUI is not doing so well. PUI is hospitalized at Hospital since 09/11/2021. She said she think the only reason why he still in the hospital is due to his brain cancer and since having COVID it has made things worse. Patient is fully vaccinated.
Temp between 103-104.6 shaking bumps rapid heart beat vomiting.
This patient had seizure like activity, no focusing times 1 with clonic and tonic movements of her extremities. Sent for EEG.
pain in her arm; Pretty bad fever; Chills; Lower body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), PYREXIA (Pretty bad fever), CHILLS (Chills) and MYALGIA (Lower body aches) 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in her arm), PYREXIA (Pretty bad fever), CHILLS (Chills) and MYALGIA (Lower body aches). At the time of the report, PAIN IN EXTREMITY (pain in her arm), PYREXIA (Pretty bad fever), CHILLS (Chills) and MYALGIA (Lower body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
5-6-04 Mom said 15 min after shots started first raised welt on right arm. Then, kept getting more. She called ER. They said to use Benadryl. 4hours and watch for SOB. Called me in AM brought child. Had raised welts scaterred on body (back, chest, legs, arms, hands) . Told to take to Dr. Went to doctor. she said allergic reaction to MMR. Not to take dose 2 and to continue benadry. i told her to be careful with newomycin and gelatin use. Went to doctor  later 5-6-04.