chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the vials were stored in the fridge was 14-Mar-2023 and the vaccine was given 25-Apr-2023; no adverse events have been reported; Dose of moderna vaccine given beyond use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose of moderna vaccine given beyond use by date), PRODUCT STORAGE ERROR (the vials were stored in the fridge was 14-Mar-2023 and the vaccine was given 25-Apr-2023) and NO ADVERSE EVENT (no adverse events have been reported) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 066H22A and AS7163B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Apr-2023, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .5 milliliter. On 25-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose of moderna vaccine given beyond use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vials were stored in the fridge was 14-Mar-2023 and the vaccine was given 25-Apr-2023) and NO ADVERSE EVENT (no adverse events have been reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose of moderna vaccine given beyond use by date), PRODUCT STORAGE ERROR (the vials were stored in the fridge was 14-Mar-2023 and the vaccine was given 25-Apr-2023) and NO ADVERSE EVENT (no adverse events have been reported) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse events have been reported) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose of moderna vaccine given beyond use by date) and PRODUCT STORAGE ERROR (the vials were stored in the fridge was 14-Mar-2023 and the vaccine was given 25-Apr-2023).    No concomitant medications were reported.  Dose of the Moderna vaccine was given beyond the use by date. The bud was 13-Apr-2023 and the vaccine was given on 25-Apr-2023.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721275 (Linked Report). This case was linked to MOD-2023-722201 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721275:Master case
Information has been received from a health professional concerning a 25 year old female with no pertinent medical history reported and no known drug allergies, who on 12-AUG-2009 was vaccinated SC with a 0.5mL dose of VARIVAX (Merck) (lot number 663943/0246Y) and SC with 0.5mL dose of MMR II (lot number 663928/0427Y). Concomitant therapy included TWINRIX and DTaP (manufacturer unknown). About three weeks after receiving the doses of VARIVAX (Merck) and MMR II, on approximately 02-SEP-2009, the patient developed a rash on her arms and chest. The rash lasted about 12 hours and then resolved. No lab studies were performed. The patient sought medical attention by contacting the office. This is one of several reports from the same source. Additional information has been requested.
p/vax pt died from vax;it was noted that there was uncertainty regarding the truthfulness of this claim;
HYPOXEMIA 5/14/2022 ALTERED MENTAL STATUS, UNSPECIFIED ALLERGIC REACTION, INIT 5/14/2022 ALTERED MENTAL STATUS, UNSPECIFIED ALLERGIC REACTION, SUBSEQ 5/14/2022 ALTERED MENTAL STATUS, UNSPECIFIED HYPOXEMIA 5/14/2022 ABNL CHEST CT SCAN ALLERGIC REACTION, INIT 5/14/2022 ABNL CHEST CT SCAN ALLERGIC REACTION, SUBSEQ 5/14/2022 ABNL CHEST CT SCAN HYPOXEMIA 5/14/2022 NONTRAUMATIC ACUTE KIDNEY INJURY ALLERGIC REACTION, INIT 5/14/2022 NONTRAUMATIC ACUTE KIDNEY INJURY ALLERGIC REACTION, SUBSEQ 5/14/2022 NONTRAUMATIC ACUTE KIDNEY INJURY
CLIENT STATES 9:15AM ON 2-5-21 SHE WAS PASSENGER IN CAR AND HUSBAND NOTICED THAT SHE HAD STOPPED TALKING AND WAS JUST STARRING X 2 MIN, THEN BECAME RESPONSIVE AND TALKATIVE AGAIN. SHE WAS 'NOT QUITE HERSELF FOR ABOUT 3 DAYS'. MRI, MRA, CT OF BRAIN & U.S. OF CAROTIDS DONE. DX WITH RT TEMPORAL/PARIETAL CVA. NOW ON PLAVIX & ASA 81MG. HAS APPT WITH NEUROLOGIST 2-17-21. REMAINS 'NOT QUITE HERSELF AND OFF BALANCE'.
severe pain; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received her second dose of bnt162b2 (BNT162B2 reported Covid-19 Vaccine; unknown lot number and expiration date) at unknown age of vaccination via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of bnt162b2 (BNT162B2 reported Covid-19 Vaccine; unknown lot number and expiration date) at unknown age of vaccination via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient reported that she herself had severe pain after getting second dose (unspecified date) so she's worried about giving the patient. She also reported "The covid vaccine that had the breast removal- Wondering if we have any recommendations for the patient". The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Havrix being used for skin allergy testing / prior to administration of COVID vaccines; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in an unspecified number of patients who received HAV (Havrix 1440 adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2021, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 15th April 2021, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Pharmacist reported that Havrix being used for skin allergy testing on adults prior to administration of COVID vaccines, which led to off label use.  Testing was done for polysorbate 20 allergies in adult patients.  No further information reported. Reporter consented to follow up
Dizziness, Headache, Myalgia, NauseaVomiting, dehydration, could not eat, runny nose, sore throat-employee  reported being off work since the day of her injection Narrative:
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 68-year-old male patient who received SHINGRIX (batch number T5242, expiry date March 2020). On 9th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 1 day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. The reporter considered the pain in arm to be possibly related to SHINGRIX. Additional details were provided as follows: The patient experienced pain in the right arm, especially while sleeping. The health care professional believed the symptoms started the day after. On 21st May 2018, the patient stopped in the pharmacy while picking up his wife's prescription and mentioned that the pain had not gone away.
71 year old woman at rehabilitation center for physical therapy with history of cirrhosis of the liver, asthma, and heart condition was tested for COVID-19 on 01/07/21, received 1st dose of Pfizer COVID-19 vaccine on 01/08/21, positive test result for COVID-19 received on 01/09/21.  She was sent to the hospital and admitted  on 01/12/21 after O2 was 70% and was in a confused state.   Patient passed away on 01/17/21.
After administration of DTAP (to right thigh) and HIB & Prevnar (to left thigh)-both legs immediately turned red, warm and swelled.  About 10 minutes later, the feet began to turn blue and feel cool.  Child screaming whole time.  Child sent to local ER. One dose of Benadryl given.
muscle pain; Couldn't move arm; Eczema worse; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MYALGIA (muscle pain), LIMB DISCOMFORT (Couldn't move arm) and ECZEMA (Eczema worse) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0741L20-A) for COVID-19 vaccination.     The patient's past medical history included Eczema since an unknown date. Concomitant products included PREDNISONE for an unknown indication.    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 MYALGIA (muscle pain), LIMB DISCOMFORT (Couldn't move arm) and ECZEMA (Eczema worse). At the time of the report, MYALGIA (muscle pain) and LIMB DISCOMFORT (Couldn't move arm) outcome was unknown and ECZEMA (Eczema worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
18 year old, female previously health received a Menomune A/C/Y/W-135, lot# UB154AA, expires 10/19/03,0.5ml administered sub Q at Left post arm for meningitis prophylaxis prior to college. Injection was ineventful within 2-3 minutes. Our office staff heard a thump when we entered the room pt was lying prone, head slightly dorisiflexed, arms on the side of the body, having tonic-clonic movements. Pt suffered laceration of the edge of the tounge, abrasion on right upper lip below nostril, and abrasion or right jaw and left distal leg. Witness episode lasted within 10 seconds. After pt came to she did not remember how she got to the floor she just remembers getting the injection feeling dizzy then waking up on the floor with us over her.
A report has been received from a Health Professional concerning a 7 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 04-Dec-2013. Registered Nurse reported that the patient received expired FLUMIST on 04-Dec-2013 and not reported any symptoms. The outcome of the event of patient received expired FLUMIST is unknown. The report was considered to be non-serious.
(L) arm from injection site down to left hand, mild redness, warmth at injection site, stiffness in hand/trouble grasping.
Moderna 1/25/21, 2/18/21. Positive on 3/4/22
I broke out in hives all over my legs. Since day 5 until today which is day 13; Lymphadenopathy under my left arm which was the vaccination site; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 45-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EW0177 and expiration dates were not reported), via an unspecified route of administration, in arm left on 20May2021 at 16:00 (age at vaccination 45-year-old) as 1ST dose, single for COVID-19 immunization. Facility type vaccine: facility. The patient did not receive any other vaccine in four weeks. The patient unknown whether tested covid prior vaccination and COVID tested post vaccination. The patient medical history was not reported. Concomitant medication(s) included ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]). On 22May2021 at 12:00 the patient experienced broke out in hives all over her legs. Since day 5 until today which is day 13, lymphadenopathy under left arm which was the vaccination site. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jun2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment was not received for the events. The outcome of event was not recovered.
PATIENT AGE IS 17YRS. RECEIVED MODERNA BOOSTER 0.25ML ON 11-19-2021
Severe headaches after four days. Continued mogranes to this date ( 14 days). Pain in right eye. Numbness and tingling throughout body.  Waking up at 1 AM with 110 bpm heart rate. Easy bruising. Blood spots
4 months after Pt had the second dose of the Pfizer Covid vaccine she started with severe back and Knee pain, myalgias and bloating.
inflammation in my lungs; This is a spontaneous report from a contactable Other HCP.   A 55-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) at single dose on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported she missed 14 days of therapy related to receiving the pneumonia vaccine. Adverse event of increased pain, stiffness in back, hips reported from missed doses. She had plan to restart therapy 24Mar2020. MD was aware. On an unspecified date the patient experienced inflammation in her lungs and started on breo inhaler per pulmonologist. The outcome of the events was unknown.   Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence. This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.  Information on the batch number has been requested.
Chills, headache, fever of 100.7, very tired. Took EXCEDRIN and slept a lot. Felt 100% by the following morning.
Patient stated it started itching first then the redness came along with a little swelling in the area. He did not feel good! He went to his doctor office & he put neosporin/gauze/tape over area.
After receiving both the HPV and men B vaccine, patient stated she started feeling nauseous. I laid the patient down on the table to prevent patient from falling and passing out and possibly hurting her head. Patient closed her eyes for about five seconds and woke up stating she had a full blown out dream. After patient woke up, she laid down on the table and I took her vitals to make sure she was stabel. BP- 113/69, HR- 64, spo2- 100%. Patient stated the nausea went away after I was done taking her vitals. She felt shaky and tired. Patient stayed for a full 30 minutes to make sure she was okay and was not going to have any other type of adverse reaction.
Palpations. Sinus tachycardia. Systemic reaction to flu shot.
34 yo female who received Pfizer BioNTech #1 on 08 JUN (EW0186) and a small anterior pericardial effusion and bilat pleural effusions were an incidental finding in an ER visit for abdominal pain on 15 JUN 2021 (day 7). She had also been experiencing dyspnea and intermittent positional CP, mid-chest, right of sternum estimated starting about June 09 (day 1),and symptoms have continued. Troponins were negative and echo showed normal anatomy, EF 50-55% with the effusion. Cardiology diagnosed acute nonspecific idiopathic pericarditis starting in May 2021, prior to COVID vaccine receipt.
No adverse event; Administered vaccine 6 days after the 30 day beyond use date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine 6 days after the 30 day beyond use 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. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, 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. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine 6 days after the 30 day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine 6 days after the 30 day beyond use date.) had not resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 (Administered vaccine 6 days after the 30 day beyond use date.).    No concomitant medications were reported. On 15-Dec-2022 6:05PM: Nurse was called to ask a question and website states that vials are viable 7 days after the 30-day storage in the refrigerator. Reporter states that they administered a bivalent Moderna COVID-19 vaccine to an adult patient 6 days after the 30 day beyond use date. Dose administered after 30-day Use By Date.   Vial size? 0.4 mL, 2.5 mL or 5.5 mL: Bivalent blue cap adult. No vial was undergone to any temperature excursions.  No treatment medications were reported.
No additional adverse events reported.; GARDASIL9 was administered during a temperature excursion; Information has been received from a medical assistant, referring to a 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 18-DEC-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S033308, expiration date on 08-APR-2022, 0.5 milliliter (administration route and anatomical location were not reported)for prophylaxis.  The reporting medical assistant stated that the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was administered during a temperature excursion that was later found supported. No additional adverse events reported. The temperature excursion was 8.5 Celsius degrees (C), during a time frame of 3 minutes. It was confirmed that no previous temperature excursions occurred and no digital data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033308; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
LEFT EAR TINNITUS  Narrative:  Patient presents to extended monitoring for intermittent tinnitus in left ear a few minutes after receiving first dose of Pfizer covid vaccine. Symptoms resolved few minutes after presenting to extended monitoring. No other symptoms. Patient released and advised to consult PCP of symptoms return.
Patient received vaccine while pregnant. Patient did not know she was pregnant at the time she got vaccine administered.
This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date the patient were vaccinated with a dose of PEDVAXHIB (lot#, expiration date and route not reported). The vaccine was exposed to an unsupported temperature excursion (48.9 Fahrenheit (F) for 10 days). No adverse effect reported. No further information is available. This is one of the several reports from the same source. Additional information has been requested.
Pt reported pain at time of administration, localized redness afterwards....gave 25 mg diphenhydramine HCl. In evening pt experienced blistering of forearm, especially at injection site, swelling and redness of entire forearm. Reported to PCP next day...suggested maintaining diphenhydramine therapy.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 12-NOV-2013 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-AUG-2016, the patient was treated by a Physician Assistant for the onset of a severe vesicular rash, pain and itching accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 22-AUG-2016 the patient sought subsequent treatment from a physician for ongoing and worsening pain and progressive symptoms unresponsive to treatment attempts, at which time she was diagnosed with herpes zoster in the right thoracic dermatome and post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections.  The patient has been prescribed tramadol, VICODIN, and hydrocodone for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Received 2nd dose of Pfizer COVID vaccine on 1/13/2021.  On 4/13/2021 developed chills, cough, headache, nausea/vomiting, and rhinorrhea.  Tested positive for COVID.
Dizziness, Headache, Myalgia, Fever, NauseaVomiting, Fatigue Narrative:
pt recvd vax & rt arm was sl sore,warm to touch,& itchy;addl rt arm was discolored 3 inches below the inj site;sx were treated w/warm compresses;
Erythema, swelling, pain developed in left upper arm on the night the injection was given. Referred to hospital treated with clindamycin for cellulitis.