chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-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 28-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    Patient was over 18 years of age. No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 28 Jun 2023, 9 doses were administered at administration site 1. No treatment medication reported.  This case was for the 11th patient out of 47 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received suspect vaccine details added, iNarrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case (Patient 1)
Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontinued. Proceeded to PCP office the following day due to face, neck and arm stiffness, edema in hands, legs, and face, continued metallic taste, and elevated BP (160/100). PCP prescribed oral steroids, antihistamine, and Epi-Pen.
Severe muscle and joint pain Severe body aches Skin pain Severe headache  Nausea  Vomiting  Fever  Severe chills Left arm pain Injection site swelling, redness hives around left upper arm Left axillary lymph node swelling
Surgery on Shoulder; Hoarseness / hoarse voice; Coughing Spells; Fever; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FJ5682) at the age of 67 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Glucose tolerance impaired" (ongoing), notes: Well Controlled; "Asthma" (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot: EL3249), administration date: 15Jan2021, for COVID-19 IMMUNIZATION; Bnt162b2 (Second dose, Lot: EL9264), administration date: 05Feb2021, for COVID-19 IMMUNIZATION. The following information was reported: SHOULDER OPERATION (medically significant), outcome "unknown", described as "Surgery on Shoulder"; DYSPHONIA (non-serious) with onset 13Jan2022, outcome "not recovered", described as "Hoarseness / hoarse voice"; COUGH (non-serious) with onset 13Jan2022, outcome "not recovered", described as "Coughing Spells"; PYREXIA (non-serious) with onset 13Jan2022, outcome "not recovered", described as "Fever". Therapeutic measures were taken as a result of dysphonia included Tylenol and Robitussin, drinks warm water and lemon and ginger tea. Clinical course: The patient stated that she received her Booster dose last Wednesday and the following day she had a hoarse voice, some fever and coughing spells. She wants to know if losing your voice is a side effect of the booster dose because she never had this problem with the first two. It has been over a week now and she still feels the side effects. She is on Medical leave because she had surgery on her shoulder and so she hasn't been out, so why should she feel like this?    Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported event Shoulder operation and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: RASH AT INJECTION SITE - GETTING LARGER-Medium
Large >baseball in size red area.  Slightly warm to the touch.  Not raised but itchy
Headache, Myalgia & Fever Narrative: Patient received vaccination 1/11/2021, she reported symptoms the day after; waking up with a low grade fever 99.2 and it went up to 99.8, body aches, headache, malaise She took Aleve, slept and was better by Wednesday.
24 minutes the IPOL was in the excursion with no reported adverse event; vaccine was administered to patient post excursion with no reported adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Child of an unknown gender patient who was administered vaccine post excursion with no reported adverse event  and vaccine had temperature excursion for 24 minutes the ipol was in the excursion with no reported adverse event  vaccine , while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect IPV (VERO) lot number not reported at an unknow dose via unknown route at an unknown administrative site for immunization.  On an unknown date, the reporter stated that her colleague called yesterday about IPOL stability and they realized it was given to a patient (poor quality product administered)(latency: same day)so they want to know what they need to do. it was reported that if it was over 10 minutes they could not use it and they have left the vial out of the refrigerator but they want to know if they need to revaccinate the child. due to nurse doing inventory with a new nurse the door was left open and the vaccine for 24 minutes was in the excursion should they revaccinate the child(product storage error)    Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: unknown for both events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing; I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing; pins and needles and swelling throughout my body; pins and needles; I have burning sensation throughout my body; two weeks after I took the vaccine the chiropractor gave me an alignment and it seemed to make; it feels like a really bad sunburn that travels all around the body; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), PHOTOPSIA (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), SWELLING (pins and needles and swelling throughout my body), PARAESTHESIA (pins and needles) and BURNING SENSATION (I have burning sensation throughout my body) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included Levothyroxine 137mcg for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced STRESS (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), PHOTOPSIA (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), SWELLING (pins and needles and swelling throughout my body), PARAESTHESIA (pins and needles), BURNING SENSATION (I have burning sensation throughout my body), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two weeks after I took the vaccine the chiropractor gave me an alignment and it seemed to make) and SUNBURN (it feels like a really bad sunburn that travels all around the body). At the time of the report, STRESS (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), PHOTOPSIA (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), SWELLING (pins and needles and swelling throughout my body), PARAESTHESIA (pins and needles), BURNING SENSATION (I have burning sensation throughout my body), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two weeks after I took the vaccine the chiropractor gave me an alignment and it seemed to make) and SUNBURN (it feels like a really bad sunburn that travels all around the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Reporter did not allow further contact
Local reaction: injection at 10:00. Pt noticed fever of 100.1 , injection site red, swollen and hot to the touch. Redness covered upper arm.
Symptoms ongoing after 72 hours. Vertigo, tremors, body temperature fluctuations both above and below normal, fatigue, brain fog, appetite reduction, pain persistent at injection site and dry mouth.
PATIENT WAS HOSPITALIZED , DIDNT GET MORE INFORMATION FROM SPOUSE AS SHE WAS MAD AND ACCUSED THE PHARMACY OF GIVING A DISCONTINUED VACCINE AS SHE READ ABOUT IT FROM THE CDC WEBSITE
a little bit of a sore arm; This is a spontaneous report from a non-contactable consumer or other non HCP. A 13-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 27May2021 (13-years age at the time of vaccination) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, On 27May2021, took Pfizer COVID 19 vaccine about 30 minutes ago. She forgot to ask if she could give her medicine like Tylenol if she started having symptoms like body aches and fever. She was not having any side effects except a little bit of a sore arm. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pediarix was given last Baby cried vigorously and became pale but after  a short while slowly regained her color.  She was offered her bottle and took a few sips of the milk. The vaccine site became erythematous spreading to  about 3 inches  in all directions. The erythema also cleared in  a few minutes.My assessment was that she was reacting to the pain from the vaccine.; however the erythema was a concern.The baby the seemed to be stable so after  observing for 20 minutes or so she was allowed to keave; she had fallen asleep before she leftAll this occurred after the adminstration od Pediarix; she did cry a lot after the Ped vax but much more after the Pediarix was given
light grey dot on the thigh; Pediarix, Acthib and Prevnar were given in same leg; This case was reported by a nurse via sales rep and described the occurrence of skin discoloration in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis.   On 28th March 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, ACTHIB and PREVNAR. On 28th March 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comment: Prevnar and Acthib were also given with Pediarix in same leg so were not sure which vaccine caused the reaction. The faint grey dot was the adverse event that followed vaccination. Additional Supportive Information: It was unknown if the reporter considered the skin discoloration to be related to Prevnar and Acthib. This case is linked to the case US2022AMR148962 and US2022AMR148961, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR148962:same reporter US-GSK-US2022AMR148961:same reporter
The oral vaccine is a 7-day course of 4 pills where pills are taken on days 1, 3, 5, and 7.  I noticed slight facial itching on the 5th day of the regimen but did not connect the symptoms to the vaccine, assuming the itching had a different cause. On day 7 approximately 1 hour after taking the last dose, I felt facial itching that intensified into an itchy rash on my face, chest and arms.  I immediately took Benadryl which calmed the reaction.  I visited my physician and received a steroid injection to help with the reaction.
Empty syringe was administered, pharmacist realized it and explained to patient. Patient agreed to receive full vaccination after the event.
Pt. presented to clinic front desk at approx. 1300 hrs today (4/27/2021) w/ c/o full body pruritis and urticaria. Front desk staff notified nursing staff. Pt. escorted by nursing staff to treatment room for assessment and evaluation. No obvious respiratory distress noted. Pt. reported receiving 2nd dose of Moderna COVID -19 vaccine at 0845 today by staff during off-site, COVID-19 mass vaccination event. Notified MD; examined. At 1334hrs, 50mg diphenhydramine given orally per MD order. Pt. is did not endorse any previous reactions to vaccines. Did not endorse any history of  allergic reactions to medications.  Reported previous history of similar symptoms (urticaria and pruritis) that her provider indicated was due to "the wind". VSS at 102/58, HR 124, RR 20, 99% O2 sats. Observed urticaria with small welts to bilateral arms, chest, abdomen, and lower back; worsening in redness and welt size. Pt reported mild facial swelling, redness, and "tight throat". Airway patent; no distress noted. MD ordered to call EMS for transport to ED. At approximately 1345 hrs., mild improvement of urticaria. EMS arrived at 1400 hrs.; 1414 hrs transported via ambulance to ED.
moderately severe reaction to the first Shingrix vaccine received (chills, sweats, malaise, HA) for 3 days; moderately severe reaction to the first Shingrix vaccine received (chills, sweats, malaise, HA) for 3 days; moderately severe reaction to the first Shingrix vaccine received (chills, sweats, malaise, HA) for 3 days; moderately severe reaction to the first Shingrix vaccine received (chills, sweats, malaise, HA) for 3 days; This case was reported by a other health professional via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, sweating, malaise and headache. On an unknown date, the outcome of the chills, sweating, malaise and headache were recovered/resolved.   It was unknown if the reporter considered the chills, sweating, malaise and headache to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reorted. The patient experienced a moderately severe reaction of chills, sweats, malaise and headache for 3 days. The patient denied respiratory issues, anaphylactic type symptoms or muscle weakness. The reporter consented to follow up.
warm to the touch; Reaction was red; sore arm; Warm arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INJECTION SITE WARMTH (warm to the touch), FEELING HOT (Warm arm) and ERYTHEMA (Reaction was red) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FEELING HOT (Warm arm). On 27-Feb-2021, the patient experienced INJECTION SITE WARMTH (warm to the touch) and ERYTHEMA (Reaction was red). At the time of the report, PAIN IN EXTREMITY (sore arm), INJECTION SITE WARMTH (warm to the touch), FEELING HOT (Warm arm) and ERYTHEMA (Reaction was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Pt is alert and oriented with a GCS of 15.  Pt able to answer questions appropriately, name, DOB and any complaints, which pt stated no complaints.  Staff stated pt wasn't speaking to them prior to arrival and pt's strength and ability to move from her bed to her wheel chair and vice versa has been compromised since she received first dose of COVID vaccination on the 12th.  911 was called when it appeared she could not speak and noted her left eye was no longer staying open.  Pt able to speak clearly with EMS, but noted left eye continued to stay shut.  No recent trauma, no ocular hx and no changes to recent medications.  Assessment documented above, stroke scale negative.  Speech was excellent, symmetrical smile, negative on arm drift, good grip strength and good push and pull with feet.  BG of 103.  Pt is wheelchair bound but independent for transferring from chair to bed but has been on a steady decline in terms of independence and needed 1-2 person assist for a week.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 1st March 2018 10:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 16 hrs after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site warmth. In March 2018, the outcome of the injection site pain, injection site erythema and injection site warmth were recovered/resolved. The reporter considered the injection site pain, injection site erythema and injection site warmth to be almost certainly related to SHINGRIX. Additional information were received as follows: The patient received the vaccine in the left deltoid. At 2:00, the patient experienced pain, redness and some warmth at the injection site after receiving a dose of SHINGRIX. The health care professional (HCP) stated that the involved area was described as the size of a large orange. The health care professional reported that the reaction resolved in approximately one week. The HCP stated that this event was previously reported by VAERS.
After Dose 2 I had a scan of my mouth and was diagnosed with cancer. I have the type of cancer that spreads so I went for treatment in September 2021 for radiation and chemotherapy. In January 2022 started chemotherapy with chemotherapy with immunotherapy. I went to local Care Health and Cancer Treatment & Research location.
Fever, chills, body aches, joint pain, headache, extreme fatigue, brain fog, flare up of MS symptoms, skin hurt to the touch.
This spontaneous report as received from a consumer refers to a 6 month old patient of unknown gender, who on unknown date was vaccinated accidentally with a dose of M-M-R II and (Oka/Merck) VARIVAX. Additional information has been requested.
This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 05-year-old child patient of unspecified gender. On an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 01-Feb-2018, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, batch number: 195236, expiry date: 30-May-2018 and anatomical location: right deltoid and dose: not reported) which was stored out of recommended temperature. The reporter was not aware of any adverse event after the vaccination. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realised that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
A non-serious report has been received from a consumer concerning upper respiratory infection with congestion, purulent sinuses and fever in a 48-year-old female. No medical history nor concomitant medications were reported. The consumer received FluMist on 20-Dec-2007. Four days later, she developed congestion, "green pus is running out of my nose", fever and an "upper respiratory infection". The reporter stated that she was "sick for two weeks" after she received FluMist last year. The symptoms became more severe and persisted at the time of the report. Additional FluMist dosing is not indicated for the 2007-2008 influenza season. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Information regarding PREVNAR was received from a physician regarding 6 Down's patients who have not responded, even after 5, 6 or 7 doses of PREVNAR.  The patients received doses on unspecified dates.  The patient's concurrent condition includes trisomy 21.  Product was administered on an unspecified date.  Concomitant medications were not reported.  Six Down's patients have not responded even after 5, 7 or 7 doses of PREVNAR.  The outcome is unknown.  No additional information was available at the time of this report.
fever up to 99.5, chills, body aches, neck pain, head ache. Chills and body ached lasted 2 days, neck pain and headache 3 days. Feeling closer to normal 4 th day.