chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 7 year old female who on 13Nov97 was vaccinated with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. The physician indicated that on 01Mar2004, the pt experience chickenpox with fewer than 20 varicella lesions. The pt was treated with over the counter diphenhydramine hydrochloride (Benadryl). Subsequently, the pt recovered. A product quality complaint was not involved. No further information is expected. Follow up information from the physician ws received who indicated tha on 3/1/2004, the patient was seen for probable varicella. No diagnostic lab test were performed.
Excursion occurred in the refrigerator, temperature reported is in Celsius or Fahrenheit: Min: 1.76 Celsius and Max: 1.97 Celsius; no adverse event; Patient received primary Monovalent dose from red cap vial that experienced excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received primary Monovalent dose from red cap vial that experienced excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred in the refrigerator, temperature reported is in Celsius or Fahrenheit: Min: 1.76 Celsius and Max: 1.97 Celsius) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received primary Monovalent dose from red cap vial that experienced excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred in the refrigerator, temperature reported is in Celsius or Fahrenheit: Min: 1.76 Celsius and Max: 1.97 Celsius) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received primary Monovalent dose from red cap vial that experienced excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred in the refrigerator, temperature reported is in Celsius or Fahrenheit: Min: 1.76 Celsius and Max: 1.97 Celsius) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received primary Monovalent dose from red cap vial that experienced excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred in the refrigerator, temperature reported is in Celsius or Fahrenheit: Min: 1.76 Celsius and Max: 1.97 Celsius).    Concomitant medications were not reported.  The patient received Monovalent primary dose. Excursion occurred in the refrigerator on 03-OCT-2022 involving 1 unpunctured Red Cap Vial. Excursion Duration was: 1 Hour and 40 Minutes. Reporter further stated that it was the first time those vials experienced excursion. Currently none of those vials were stored, some were used and some were discarded. No treatment information was provided by the reporter.  This case contains information for second of three adult patients who received primary monovalent doses described by the reporter.
Dizzy feeling of vertigo sitting up I feel like passing out same for trying to walk    Headache,Muscle aches  Cough.
pt recvd vax;right p/ vax devel paresthesis & numbness in hand which was later dx as mononeuropathy;
Patient's spouse called and said she woke up this morning (3 days post injection) with pain and swelling at the injection site that had moved down her arm almost to her elbow. After speaking to him for peace of mind he took her to the emergency room just to get it checked out. I called back this afternoon to see how she was doing and they said she had gotten an infection/cellulitis.
No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-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 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No relevant concomitant medications were reported. 3 administrations on 22 Jun 2023 and thaw date was 10 Jun 2023. No treatment medication reported.    This case was for the 18th patient out of 30 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received include suspect vaccine details updated and Narrative updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Vesicular rash on arms and legs, chest, back and axilla (all over body).
Inflammation, fatigue, sore throat, headache, abdominal pain, nausea, vomiting.
he got strong dizziness, every thing is spinning/dizziness is so much stronger; he got strong dizziness, every thing is spinning/dizziness is so much stronger; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "brain tumor surgery" (unspecified if ongoing), notes: 15 years ago; "brain tumor" (unspecified if ongoing); "lost one and one half of my eyes" (unspecified if ongoing), notes: can't read anymore, anything looks sideways, upside down, or backwards; "dizziness" (unspecified if ongoing), notes: slight dizziness for many many years; "dyslexia" (unspecified if ongoing), notes: caller thinks; "trouble with short term memory" (unspecified if ongoing); "Caller has broken a bunch of bones" (unspecified if ongoing), notes: used to race motorcycles, so broke a bunch of bones; "lungs collapsed" (unspecified if ongoing), notes: a long time ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 5(BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4(BOOSTER), SINGLE), reaction(s): "COVID-19 immunization"; Bnt162b2 (DOSE 3(BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2023, outcome "not recovered" and all described as "he got strong dizziness, every thing is spinning/dizziness is so much stronger". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: patient stated he had the sixth shot, lately I've got real strong dizziness. Patient had a brain tumor surgery and they made some errors and I lost one and one half of his eyes and he could no longer read and write and he had a really slight dizziness for many years but after the vaccines all of a sudden his dizziness was so much stronger. He also did the flu shot first and then he waited about a week of two weeks and then he got the Pfizer shot. Probably one week later dizziness started and it was pretty strong. Caller mentions that he had the dizziness for two or three days before. Caller was going to call general doctor. Caller had a lot of different medicines but nothing changed.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Pt received pneumovax 23 on 10/5/08 at 1500. Pt developed fever of 101.6 on 10/6/08.  Pt is noted for having erythema/pain/swelling in his right arm.  Pain was rated at 4-6 and increased with movement.  Pt's arm was erythematous in a 10cm x 7cm area.  Physician orders a CT of right arm to rule out abscess.  CT showed cutaneous and subcutaneous soft tissue stranding compatible with recent injection, cellulitis, or foreign body protein reaction.  No IM hematoma.  Pt was started on vancomycin, and then he was discharged from the hospital receiving Augmentin 875 mg twice daily x 5 days. 10/24/08-records received for DOS 10/2-10/7/08-DC DX: Accelerated hypertension improved. Alcohol abuse. Newly diagnosed diabetes type 2. Cellulitis in right arm. Presented with dizziness, near syncope and accelerated hypertension 100-220 systolic. Visual changes. Vertigo and lightheadedness continued. Developed erythema and tenderness, swelling at vaccination site.
Pt. given routine PNEUMOVAX, has localized (L) increased arm redness, approx. 3" x 3", advised to take 25mg BENADRYL PO, also advised of advancing allergic reaction S/Sx i.e.: swollen tongue, throat closing.
No known adverse effects; 51 year old male patient received a dose of Gardasil 9; This spontaneous report was received from a nurse practitioner and refers to a 51-year-old male patient. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On 19-JUN-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, strength, exact dose, site and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). There was no known adverse effect.
Approximately 6 hours post vaccination, pt started to experience dizziness, chills, headache. Pt took ADVIL for headache.
Patient is a 69-year-old female who reports a history of hayfever who is coming in today after recent Covid vaccination with concerns of facial swelling also complaining of the rash and itching to her chest.  On exam the patient has obvious facial swelling.  She has what appears to be an urticarial rash on her chest.  While she does have swelling around her lips and face otherwise she does not appear to have any obvious signs of airway involvement with no swelling of her tongue or uvula, she has good phonation with normal respirations without difficulty.  Does not appear to be having reactive airway disease exacerbation at this time.  Does not appear to have impending respiratory distress.  She otherwise does have some skin changes in her bilateral lower extremities that she reports is baseline with her history of eczema.  Primary concern at this time is for possible allergic reaction.  Patient appears to have angioedema.  Does not appear to have anaphylaxis.  Other abnormalities are considered.  Patient will be connected to cardiac and respiratory monitors.  IV access will be obtained.  The patient will be given a 1 L IV fluid bolus.  She will be given Benadryl, Solu-Medrol, and famotidine.  Patient be monitored for response.  Labs have been ordered to evaluate.  EKG as well as chest x-ray will be obtained.  We will file VARES report.   Chest x-ray obtained.  There is no acute cardiac no acute pulmonary pathology on my interpretation.  Laboratory evaluation has returned.  The patient's CBC is reassuring.  CMP shows a glucose of 78, otherwise reassuring without significant abnormality.  Troponin within normal limits.  Covid, influenza, RSV testing is negative.  On repeat evaluation the patient is resting comfortably.  She reports that the itching has resolved.  Her face feels less uncomfortable.  She has had no progression of the swelling.  On repeat examination she continues to have facial swelling as well as swelling around her lips however she has no tongue swelling, no swelling within her posterior oropharynx, and her phonation continues to be normal.  She and her friend were informed of the initial findings.  Plan at this time is to admit for further evaluation and treatment.
Patient with 2 COVID vaccinations who admitted to hospital with complications from COVID.  Provider d/c note:  "39 year-old male with pmhx of paraplegia with chronic indwelling suprapubic Foley and colostomy, morbid obesity,anxiety, and asthma presented to emergency department with fever, chills, shortness of breath, cough that started 8 hours prior to arrival. He was worried about COVID as his daughter has it. He is vaccinated without booster. In the ED, patient tested positive for COVID and was hypoxic requiring supplemental Oxygen. Decadron and Remdesivir were initiated. He was given 2L fluids in ED, though did not get 30cc/kg bolus due to having COVID. Hospitalist service was asked to admit for sepsis due to COVID. Patient completed five day Remdesivir and no longer requiring supplemental O2 via nasal cannula. Patient is to continue Decadron for 3 more days. Due to concern for underlying OSA and self-reported snoring, a referral to sleep medicine for further OSA evaluation has been placed. Patient is to follow with house calls.  Patient discharged home in stable condition."
headaches, body ache, teeth aches, fever, severe fatigue, soreness and pain where I received the vax.
Headache, Fever, FATIGUE, BODY ACHES, CHILLS Narrative:
I have never been more sick than I was after receiving dose #2. I had COVID-19 approximately 9 months prior, and I had a pretty severe case of it, and it was NOWHERE near as sick as I felt after receiving the vaccine (dose #2 especially). It knocked me out for just as long as COVID-19 did and I felt 50x worse than I did with COVID-19. I have never had a headache like the headache that I had after receiving the injection, and NOTHING would lessen the pain. I also experienced chest pain and shortness of breath. Overall, it was one of the worst experiences of my life. I have not felt well since receiving this vaccine over 6 months ago. It has 100% had adverse side effects that will haunt me the rest of my life.
she felt that he injected the vaccine more towards her shoulder bone then her muscle; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (she felt that he injected the vaccine more towards her shoulder bone then her muscle) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 30-Mar-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (she felt that he injected the vaccine more towards her shoulder bone then her muscle). On 30-Mar-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (she felt that he injected the vaccine more towards her shoulder bone then her muscle) had resolved.            Patient called pharmacy same day and pharmacist confirmed that the dose was properly administered.  Concomitant medications were not reported.  This report refers to a case of Product administered at Inappropriate site, for mRNA-1273, lot # 002B21A, with no associated AEs.; Sender's Comments: This report refers to a case of Product administered at Inappropriate site, for mRNA-1273, lot # 002B21A, with no associated AEs.
Approx 10-15 minutes after receiving Covid-19 vaccine dose # 1 ; The patient started developing a red rash on her chin; chest  and neck.  Resolved with Benadryl 50mg IM. No additional complaints reported.  No further rash noted and started to fade  after 15 minutes. follow-up phone call at 3:30pm- rash resolving and no additional symptoms reported
FLU LIKE SYMPTOMS; SHORTNESS OF BREATH PERIODICALLY DURING THE NIGHT; WAKE FROM SLEEP; This spontaneous report received from a consumer concerned a 21 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of vaccination. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms, shortness of breath periodically during the night, and wake from sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and shortness of breath periodically during the night on 06-APR-2021, and the outcome of wake from sleep was not reported. This report was non-serious.
Onset of lightheadedness, sweaty and nausea. Non-syncopal event that was self-limiting. Vital signs stable throughout. No orthostasis. Mild vasovagal event.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 01-AUG-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 6 degree Fahrenheit (F) to 14 F for 30 minutes on 01-AUG-2018. There was previous temperature excursion reported: 15 F to 46 F for 14 hours on 16-JUN-2018. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381: Original Case: 1808USA001261; US-009507513-1808USA004382: Original Case: 1808USA001261; US-009507513-1808USA004383: Original Case: 1808USA001261; US-009507513-1808USA004384: Original Case: 1808USA001261; US-009507513-1808USA004385: Original Case: 1808USA001261; US-009507513-1808USA004380: Original Case: 1808USA001261; US-009507513-1808USA004379: Original Case: 1808USA001261; US-009507513-1808USA004376: Original Case: 1808USA001261; US-009507513-1808USA004377: Original Case: 1808USA001261; US-009507513-1808USA004378: Original Case: 1808USA001261; US-009507513-1808USA004386: Original Case: 1808USA001261; US-009507513-1808USA004387: Original Case: 1808USA001261; US-009507513-1808USA004362: Original Case: 1808USA001261; US-009507513-1808USA004363: Original Case: 1808USA001261; US-009507513-1808USA004388: Original Case: 1808USA001261; US-009507513-1808USA004389: Original Case: 1808USA001261; US-009507513-1808USA004390: Original Case: 1808USA001261; US-009507513-1808USA004391: Original Case: 1808USA001261; US-009507513-1808USA004364: Original Case: 1808USA001261; US-009507513-1808USA004392: Original Case: 1808USA001261; US-009507513-1808USA004393: Original Case: 1808USA001261; US-009507513-1808USA004394: Original Case: 1808USA001261; US-009507513-1808USA004395: Original Case: 1808USA001261; US-009507513-1808USA004396: Original Case: 1808USA001261; US-009507513-1808USA004365: Original Case: 1808USA001261; US-009507513-1808USA004366: Original Case: 1808USA001261; US-009507513-1808USA004367: Original Case: 1808USA001261; US-009507513-1808USA004397: Original Case: 1808USA001261; US-009507513-1808USA004398: Original Case: 1808USA001261; US-009507513-1808USA004399: Original Case: 1808USA001261; US-009507513-1808USA004368: Original Case: 1808USA001261; US-009507513-1808USA004369: Original Case: 1808USA001261; US-009507513-1808USA004400: Original Case: 1808USA001261; US-009507513-1808USA001261: Original Case: 1808USA00126.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the unspecified amount of clients were vaccinated with improperly stored RECOMBIVAX HB (lot# and expiration date not provided) (dose not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
HYPOTENSION 1/31/2023 &  1/10/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
itching, large red welp, hot to touch; fingers cool & discolored; (on arm of vax); To er 19FEB93; DPH & Pred given;
localized rash (approx 2" area) devel next day in all three inj sites, accompanied by itching;visible to date;itching has subsided;APAP was given once on immun date & once the next day;parents reports pt had sl fever, temp not taken;
Severe pain in the left arm at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain in the left arm at the site of the injection) 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 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (Severe pain in the left arm at the site of the injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Severe pain in the left arm at the site of the injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment medication reported included acetaminophen.
Initial report received on 29 October 2007 from a health care professional. Five adult patients (demographics not provided) with unknown medical histories, had received an intramuscular dose of DECAVAC (Lot number U1981AA) in the deltoid (left or right not reported) between August to September 2007. At an unspecified amount of time later, all patients experienced redness, swelling, pain, and perisitent nodules at the injection site. None of the patients sought medical sought medical attention. Treatment received, and diagnostic testing's performed were not provided. The recovery status of the patients were not reported.
Dx Covid-19 Screening  ? Generalized Body Aches ? Fever  ? Nausea
11 minutes into the vaccination, patient noted to have tongue and mouth tingling and heart racing.  No noted tongue/lip/throat swelling, dyspnea, n/v, abdominal pain, rash, near-syncope. Started to improve after 30 seconds.. H/o tachycardia secondary to salmon, no prior anaphylaxis or use of epinephrine in the past. Sent to ED for evaulation