chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A serious report of pneumonia, pleural effusion, and dehydration has been received from a study investigator concerning a 34-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. The subject received FLUMIST nasally, 0.25 ml per nostril, on 06-Oct-2009. The subject received one dose before the onset of the event. The subject presented to the Emergency department with respiratory distress. Initial symptoms of fever, cough, rhinorrhea, vomiting, and body ache began approximately ten days prior to admission, and this was thought to be influenza. No treatment was initiated at that time. The subject returned four days later with increased work of breathing and continued fever. Chest x-ray demonstrated right lower lobe (RLL) infiltrate, and the subject started on OMNICEF. His fever subsided shortly thereafter, though his breathing continued worsen. The subject's parents noted shallow rapid breathing and difficulty to breath. This prompted their visit to the Emergency department on 30-Oct-2009. At the Emergency department, the subject had tachypnea and shallow breathing, although 02 saturation were stable. He received salbutamol for poor aeration on the right without much improvement. Repeat chest x-rays demonstrated worsening RLL pneumonia and pleural effusion. The subject was treated with intravenous antibiotics. The events were resolved on 03-Nov-2009. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was moderate. Alternative etiology for the events was natural causes. The sponsor also assessed the causality for the events as not related to FLUMIST.
Patient vaccinated on 5-13-21 Moderna  as second dose.    Patient's first dose was Pfizer vaccine on 4-9-21.  She did not bring her immunization card.   She stated on COVID vaccine screening form that her first dose was Moderna.   She signed all Moderna Consent forms.   In the late afternoon on 5-13-21 Su Clinica received call from patient that 1st dose was Pfizer.
Face swollen; Hives and itching, mostly upper body. Chest and arms/Hives all over the body; Swollen gland under the left arm; Arm irritation on the sight of the shot; Itchy scalp, slightly swollen top lip; Itchy scalp, slightly swollen top lip; 3/5 Slight sore throat; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 49-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6199, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 05Mar2021 19:00 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to the vaccination. Medical history included asthma from an unknown date. The patient has allergy to penicillin and omeprazole magnesium. The patient's concomitant medications were not reported. Since the vaccination the patient had not been diagnosed with COVID-19. On 05Mar2021 19:30, post vaccination the patient experienced slight sore throat. On 11Mar2021 19:30, the patient had itchy scalp, slightly swollen top lip. On 12Mar2021, the patient felt arm irritation on the sight of the shot. On 13Mar2021, the patient had swollen gland under the left arm. On 15Mar2021, it was reported that the patient developed hives and itching, mostly upper body, chest and arms/hives all over the body. On 17Mar2021, the patient had her face swollen. On 17Mar2021, the patient had to go to the emergency room due to the events. The patient was treated with Zyrtec, Pepcid IV, Deltasone and Benadryl. The outcome of the events was reported as not recovered at the time of report.  Information on Lot/Batch number was available. Additional information has been requested.
Fevers, Headaches and Chills began 1 day after vaccination. Shortness of breath began 2 days after vaccination. 1 month later I am still experiencing these symptoms despite being treated with an inhaler and Tylenol/Motrin.  09/16/2021: Urgent care for chest xray and UA. 09/16/21: ER visit 09/24/21: started medrol dose pack 09/28/21: started inhaler
Pt recv vax on 9/25/98; on 9/27/98 pt exp itchy rash over body w/ petechia &swelling on right thigh, facial swelling; tx=Prednisone
pt recv 2 doses of vax & 8 wk p/vax both doses pt was negative;no further details were provided;
Pain left upper arm.  Ice pack injection site. Tylenol.  Next night 9/4/2015 pain worse, Pain in shoulder continued and worse at night when lying down.  Saw doctor 9/16/2015 and was told I had reaction to flu shot, skin inflammation.
Critically low platelets presumed ITP Patient had no symptoms.  Presented for routine lab work March 24, 2021.  Platelet Count 10,000 Baseline Platelets 06/2020 261K Treated with dexamethasone 20 BID x 3d.  Repeat platelets 03/29 83k Follow up 04/06 platelets 2,000 Admitted and treated with IVIG Follow up locally, 70K
Information has been received from a 24 year old female who on approximately 21-JAN-2008 was vaccinated intramuscularly with a 0.5 mL third dose of Gardasil.  There was no concomitant medication.  On approximately 26-JAN-2008, "in the last couple of days", the patient had headaches, her mouth was dry, "everything's really stiff", and had a sharp pain in her stomach.  She also developed a rash on her sides, stomach and arms.  The patient reported that she was breast feeding.  The patient did not seek medical attention for her experience.  At the time of reporting, the patient had not recovered.  Additional information has been requested.
Patient is a now 6 month old male who was seen at the Pediatric Clinic at Family Health Center on February 25, 2020 for his 4 month old well visit during which time he received immunizations. Per documentation, he received his oral Rotavirus immunization along with intramuscular administration of Pediarix (DTap-Hep B-IPV) in the left thigh, PedVaxHib in left thigh, and Prevnar in right thigh.  On April 17, 2020, a virtual appointment was scheduled for the patient due to COVID-19 pandemic restrictions. During that visit, the mother of patient reported that he was having left thigh redness and swelling. She reported that after his immunizations on February 25, patient did have swelling in both thighs at the sites of the injections. Mother of patient reported that although the right thigh swelling resolved, the left thigh remained slightly red. She noticed that the left thigh progressively became more red and indurated/hard then began to have some dryness of the skin.   Within the week of April 17th leading up to patient's appointment, mom reported that the same area on Patient's left thigh started to become purple/red with what looked like an overlying scab.  She also stated that there appeared to be some pus underneath the skin in the center of the hardened area, almost like a boil or abscess. The swollen area is between pea and marble sized. Not painful to touch.  There was no associated fever reported in relation to this event.   The provider that conducted the April 17th visit, advised mother of patient that the patient needed to be seen by a physician for further evaluation and management of likely abscess and cellulitis of left thigh. Due to the current COVID-19 restrictions during that time and mother's location from clinic, it was advised for her to take the child to urgent care for in-person evaluation.  Patient was seen at Urgent care on April 27, 2020 and diagnosed with an abscess of the left thigh. It was incised and drained with a sample of the drainage sent for bacterial culture. Patient was started on a 2 week course of Amoxicillin. A follow up Telephone Consult was conducted on April 21, 2020 and documentation shows improvement of lesion and symptoms.
5:20pm Post vaccination reports feeling dizzy w/ a brief episode of syncope w/ diaphoresis Medical monitoring w/vital assessment: BP 76/52 P65; rest, po hydration given w/symptom resolve; BP 102/ 71 P 75 Reports "feeling better", released from facility w/ sister
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 1:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:24 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 13-Feb-2021 at 1:40 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 32.74.  Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 9:00 AM temperature was 32 total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 9-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  On 20-Mar-2021, Excursion time was 9AM, 10AM temperature was 34, 37 total doses given for the day was 184 for 9AM, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Not provided, 9 AM:34, 10 AM: 30, 11 AM: 41, 12 AM:45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Wave of disabling fatigue came up and over me. I was so weak I was afraid to stand, for fear of falling. I felt I had to lie down to recover, and I did. It subsided after 20 minutes or so. This was the first of several such episodes.
I feel I have the COVID for the past week, I'm unsure if it's COVID or if is as cold; Sore throat; Coughing; I'm unsure if it's COVID or if is as cold; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED COVID-19 (I feel I have the COVID for the past week, I'm unsure if it's COVID or if is as cold), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing) and NASOPHARYNGITIS (I'm unsure if it's COVID or if is as cold) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (I feel I have the COVID for the past week, I'm unsure if it's COVID or if is as cold), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing) and NASOPHARYNGITIS (I'm unsure if it's COVID or if is as cold). At the time of the report, SUSPECTED COVID-19 (I feel I have the COVID for the past week, I'm unsure if it's COVID or if is as cold), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing) and NASOPHARYNGITIS (I'm unsure if it's COVID or if is as cold) outcome was unknown.            No concomitant and treatment medications were reported.  Patient previous 4 vaccinations were from Moderna which therapy dates and batch numbers were not reported, and that patient had never received the Pfizer COVID-19 vaccine, however patient was scheduled to get a Pfizer COVID-19 booster.  Patient already had the vaccine and booster Moderna and felt having COVID for the past week, but unsure if it was COVID or was cold. Patient symptoms are sore throat and coughing. Patient just had a booster about 4 months ago.   Reporter did not allow further contact
Pfizer BioNTech COVID-19 Vaccine EUA: COVID19 resulting in Hospitalization/ Death  Patient presented to ED on 7/20/2021 complaining of SOB for about two days prior, worsening with increasing cough, abdominal pain and fever.  COVID-19 test administered in ED and returned positive, admitted for acute COVID-19 pneumonia and acute respiratory failure with hypoxia.  CT Angiogram showed no evidence of PE and had patchy ground glass opacities. Treatment included Decadron, antibiotics, Remdesivir.  Patient continued to decline and ultimately expired on 8/2/2021 secondary to Pneumonia due to COVID-19. Vaccines administered on 1/29/2021 & 2/25/2021
Fatigued; 15 years old received the 1st dose of Moderna vaccine; Headaches; A spontaneous report was received from a caregiver, concerning a 15-year-old female patient, who received Moderna's COVID-19 vaccine (Product administered to patient of inappropriate age) and experienced headaches (Headache) and was fatigued (fatigue).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included fluoxetine hydrochloride, oxymetazoline hydrochloride, cetirizine hydrochloride, Hycosamine.  On 23 Mar 2021, prior to the onset of events, the patient received her first of the two planned vaccine doses of mRNA-1273 (lot number 007B21A) via intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 24 Mar 2021, after receiving the first dose, patient was fatigued.   On 25 Mar 2021, she experienced headaches. Treatment medication included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, 15 year old received the 1st dose of Moderna vaccine was considered to be resolved on 23 Mar 2021 and outcome of fatigued and headaches, was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, Headache and Fatigue, a causal relationship cannot be excluded. This report also refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot #: 007B21A.
Information has been received from an RN concerning an 80 yr old pt who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The RN reported that the pt developed fever and swelling at the injection site. The pt complained of the symptoms after receipt of the pneumococcal 23v polysaccharide vaccine . The RN reported that she did not have access to the pt medical records and knows nothing of the pts history. There was no product quality complaint involved.  Unspecified medical attention was sought. Additional information has been requested.
hair loss; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair loss). At the time of the report, ALOPECIA (hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
The day after the vaccine started feeling severe flu symptoms; Was worse than previous COVID-19 vaccine reactions; Took a COVID-19 test and it was negative; Reaction lasted for 2 weeks; Over the next couple of months started having heart palpitation's with extreme fatigue and weight gain, GI problems and stopped getting period; Went to doctor to rule out Pregnancy; Doctor ran blood testing and it was determined that Thyroid levels were off; Was sent to Endocrinologist and was diagnosed with Hashimoto's Syndrome; Was prescribed levothyroxine, propranolol and started taking magnesium; Was given a Colonoscopy because of new Gastro problems.
This spontaneous report as received from a nurse practitioner refers to an unknown number of patients of unknown demographics. On an unknown date the patients were vaccinated with RECOMBIVAX HB. The nurse reported that she had had an unknown number of patients who had presented with negative Hepatitis B antibody titers after receiving a complete hepatitis B vaccine series. Sometimes the negative titers were about 2 months after completion of the vaccine series, and sometimes the negative titers were many years after completion of the vaccine series. The nurse practitioner also stated that in some cases, a patient may have initially had a positive hepatitis B titer and then have a negative titer many years later. The nurse practitioner did not know which brand of hepatitis B vaccine was used in these cases. The outcome of the event was unknown. This case is linked to 1401USA013354 by same reporter. Additional information is not expected.
9/21: at night time pt experienced redness on site of administration of vaccine, chills, body aches, nausea.  9/26 She continues experiencing body aches, chills.  Pt has been taking Tylenol 500 mg .
Inappropriate schedule of vaccine administration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administration) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administration). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.
Worsening of  decrease hearing in both ears after 2nd Booster; Worsening of Tinnitus in both ears after 2nd Booster; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Worsening of  decrease hearing in both ears after 2nd Booster) and TINNITUS (Worsening of Tinnitus in both ears after 2nd Booster) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J COVID-19 vaccine (1 Primary dose) on 05-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J COVID-19 vaccine.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced HYPOACUSIS (Worsening of  decrease hearing in both ears after 2nd Booster) and TINNITUS (Worsening of Tinnitus in both ears after 2nd Booster). At the time of the report, HYPOACUSIS (Worsening of  decrease hearing in both ears after 2nd Booster) and TINNITUS (Worsening of Tinnitus in both ears after 2nd Booster) outcome was unknown.            No concomitant medications were reported. The patient did not call the doctor. No treatment  medications were reported.   This case was linked to MOD-2022-550259 (Patient Link).
Shingle shot 5 years ago had shingles/Suspected vaccination failure; Had it in eyes; Hearing loss; Shingles on scalp; Blisters in forehead; pounding headache on right side of head; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingle shot 5 years ago had shingles/Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Had it in eyes) (serious criteria GSK medically significant), hearing loss (Verbatim: Hearing loss) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on scalp), blister (Verbatim: Blisters in forehead), pounding in head (Verbatim: pounding headache on right side of head) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, hearing loss, shingles, blister and pounding in head were not reported and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, hearing loss, shingles, blister, pounding in head and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, hearing loss, shingles, blister, pounding in head and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine five years ago. The patient experienced shingles in his/her eyes and scalp head area, horrible blisters in his/her forehead, pounding headache on right side and hearing loss that was five months old and it was still painful. The patient stated that nobody told him/her that the shingles vaccine was ineffective. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Information has been received from a nurse practitioner concerning an 11 year old female who was vaccinated with RECOMBIVAX HB (manufacturer unknown). Subsequently the patient experienced a severe fever post vaccination and was hospitalized at the time. Subsequently, the patient recovered. Additional information has been requested.