chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm aches; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (3 years ago). Previously administered products included Zostavax with an associated reaction of pain (received zostavax on an unknown date experienced pain and redness on site of injection) and Shingrix (1st dose refer case US2019AMR122681).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week 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.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient read that Zostavax loses efficacy after a couple of years so the patient decided to take Shingrix. The 1st dose of Shingrix put the patient out of commission, fever, pain, fatigue, headaches for 2 days and felt better after 4 days. The patient figured that the patient would react less on the 2nd shot since the patient would have some immunity from the first shot. The patient was completely wrong the second shot was worse; to the point it had been 5 days since the shot and the patient was barely getting over the worst and the patients arm still aches. The patient recommended not to take Shingrix due to its side effects. The patient advised to get Zostavax shot every 2 years and side step these horrible side effect of Shingrix.
lethargic, loss of appetite given APAP every 4hr-103 temp-incessant crying-inconsolable;12hr later fever inc & started to vomit cont APAP regularly temp remained;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2007, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a clinic, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 24-SEP-2016, the patient was treated by the clinic for a severe vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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.
Swelling in lymph nodes from my left arm up; sore throat on the left side; sores in mouth on the left side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Feb2021 (Batch/Lot number: EM9810) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (ongoing); "Allergy to penicillin" (unspecified if ongoing); "High cholesterol" (ongoing); "Sulfa allergy" (ongoing). Concomitant medication(s) included: GLIMEPIRIDE; ATORVASTATIN. Past drug history included: Levaquin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (1st dose, Batch/Lot number: EL1283, Anatomical Site of injection: Left arm, Route of administration: Intramuscular), administration date: 23Jan2021, when the patient was 77 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 15Feb2021, outcome "recovered" (19Feb2021), described as "Swelling in lymph nodes from my left arm up"; OROPHARYNGEAL PAIN (non-serious) with onset 15Feb2021, outcome "recovered" (19Feb2021), described as "sore throat on the left side"; STOMATITIS (non-serious) with onset 15Feb2021, outcome "recovered" (19Feb2021), described as "sores in mouth on the left side". The events "swelling in lymph nodes from my left arm up", "sore throat on the left side" and "sores in mouth on the left side" were evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy, oropharyngeal pain, stomatitis.  Additional information: The patient had not received any other vaccines within 4 weeks. The patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since the vaccination. Antibiotics (unspecified) for 3 days were received as treatments for the events.  No follow-up attempts are possible. No further information is expected.
"I received my flu shot during the October clinic and my right arm still hurts. I told the nurse after he administered the shot that it hurt pretty bad.  He said he thought he hit a nerve.  It hurts to rasie my arm above my head.  I will continue to stretch my shoulder out and see if that works."
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (lot #N021583 and expiration date: 18-NOV-2019). In October 2017 (reported as on 17-OCT-2017, 19-OCT-2017, 26-OCT-2017 or 27-OCT-2017, the patient was vaccinated with unspecified doses of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N019133 and expiration date: 22-JUN-2019). Reporter informed that, there was multiple temperature excursions for the VARIVAX as follows, on 02-OCT-2017, temperature excursion was at 14 F for the duration of 2 hours, on 03-OCT-2017, temperature excursion was at 16.7 F for the duration of 2 hours, on 04-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 05-OCT-2017, temperature excursion was at 16.7 F for the duration of 1 hour, on 10-OCT-2017, temperature excursion was at 17.1 F for the duration of 0.5 hours, on 11-OCT-2017, temperature excursion was at 18.1 F for the duration of 4 hours, on 16-OCT-2017, temperature excursion was at 19.2 F for the duration of 1 hour, on 17-OCT-2017, temperature excursion was at 19.40 F for the duration of 2 hours, on 18-OCT-2017, temperature excursion was at 17.40 F for the duration of 1 hour, on 19-OCT-2017, temperature excursion was at 21.90 F for the duration of 1 hour, on 20-OCT-2017, temperature excursion was at 17.10 F for the duration of 2 hours, on 24-OCT-2017, temperature excursion was at 5.80 F for the duration of 0.5 hours, On 25-OCT-2017, temperature excursion was at 8.20 F for the duration of 0.5 hours, on 26-OCT-2017, temperature excursion was at 17.80 F for the duration of 0.5 hours, on 27-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour, On 30-OCT-2017, temperature excursion was at 16.90 F for the duration of 2 hours and on 31-OCT-2017, temperature excursion was at 14.40 F for the duration of 1 hour. It was reported that there was multiple previous excursions for the VARIVAX. Reporter did not state that sterile diluent was improperly stored. No adverse effects (no adverse event) reported. No product quality complaint was involved. No further information was provided. This is one of the 8 reports (Same reporter link). Sender's Comments: US-009507513-1802USA003097: US-009507513-1802USA005084: US-009507513-1802USA005085: US-009507513-1802USA005086: US-009507513-1802USA005088: US-009507513-1802USA005089: US-009507513-1802USA005090: US-009507513-1802USA005088: US-009507513-1802USA007559.
Dr. wanted the patient to have a Pneumonia Vaccine, this nurse checked the chart to see when the last vaccine had been given and the patient had a PCV 13 on 6/19/2019 and per Care Gaps needed a Pneumovax-23. This nurse went into the Immunization room and pulled a Pneumovax 23 went back to Pod 4 and verified with CMA and this nurse had the right vaccine of Pneumovax-23, went into the patient's room and verified the correct patient by name and DOB and gave injection into the Right Deltoid. Went back out to desk to document and while entering the Vaccine error message entered that the Vaccine was expired, this nurse went back to immunization room to verify vaccine and that the vaccine had expired on 1/13/23, pulled out remaining dose and given to Immunization nurse LPN.
Rash on chest pounding headache fever of 104 left side rib pain elevated heart rate 106
This spontaneous report as received from a health care professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL, (dose, route, lot number and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
reports arm pain; red, hot and swollen arm; red, hot and swollen arm; red, hot and swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (reports arm pain), ERYTHEMA (red, hot and swollen arm), FEELING HOT (red, hot and swollen arm) and PERIPHERAL SWELLING (red, hot and swollen arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (reports arm pain), ERYTHEMA (red, hot and swollen arm), FEELING HOT (red, hot and swollen arm) and PERIPHERAL SWELLING (red, hot and swollen arm). At the time of the report, PAIN IN EXTREMITY (reports arm pain), ERYTHEMA (red, hot and swollen arm), FEELING HOT (red, hot and swollen arm) and PERIPHERAL SWELLING (red, hot and swollen arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included Moisturizing cream.
Hospitalization 9/18/22-9/22/22 Weakness, fall, ETOH abuse, UTI, tibial fx,
Localized reaction to the left deltoid region. Redness, pain, pruritis at the injection site.
She got her vaccine, she was sitting in the chair and 4-5 minutes after the shot she started telling her grandfather that she felt nauseated.  She then started feeling dizzy and looked like she was going to pass out and he caught her and he laid on her on the floor on a pillow.   There was a off-duty paramedic to assist her and they suggested to call 9-1-1 and they showed up 5-6 minutes later.  She was then taken to Hospital.  They ran a lot of laboratory tests, urinalysis and everything was negative.   Her white blood cell count was high and her URC's and UBC's were high.  Her albumin was also high.   She was then released from the ER and was told to FU with PCP within 2 days.  She is still having the symptoms of headache, sore throat, and achy bones, the typical flu-like side effects.   She is taking Tylenol for the symptoms, as well as cough drops for her throat.
606 Doses was given after expiration date; Vaccine is placed in refrigerator 18 Oct 2021, expired product date on 13 Oct 2021, administration date on 26 Oct 2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 Doses was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator 18 Oct 2021, expired product date on 13 Oct 2021, administration date on 26 Oct 2021) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator 18 Oct 2021, expired product date on 13 Oct 2021, administration date on 26 Oct 2021). On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 Doses was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 Doses was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator 18 Oct 2021, expired product date on 13 Oct 2021, administration date on 26 Oct 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the date vial placed in refrigerator was on 18-Oct-2021. No concomitant medications were reported. It was reported that patient had no temperature excursion and no adverse event.  No treatment medications were reported.   This case was linked to MOD-2022-491837 (Patient Link).
No additional adverse reactions; expired dose of Varivax was inadvertently administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 23-JUL-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R020651 was verified to be valid, expiration date rerported and established as 18-JUL-2020 (dose, route of administration and anatomical location were not provided) for prophylaxis. Other suspect therapies included sterile diluent (dose, lot number, expiration date and route of administration were not provided).   The patient did not experience any additional adverse reactions.
This spontaneous report was received from a registered nurse, referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. From 01-MAY-2017 to 23-MAY-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # M043581 and expiration date on 28-OCT-2018 and the sterile diluent (DILUENT MRK) injection which had a lot number of L007564 and expiration date on 19-NOV-2017,which was not improperly stored. The reporter stated that, the data logger registered that during 36 minutes, the temperature under the vaccine was stored, was -14° Celsius degree to -10° Celsius degree, there was not prior temperature excursion and no adverse effects were reported. This is one of the two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001793:
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-NOV-2015 the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L033707 with expiry date of 18-MAY-2015. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient states that left arm muscle pain started moderate pain 3 days after deltoid injection in left arm, over 4 wks pain progressed to moderate to mild level occasionally radiating to hand. Taking TYLENOL for it 2-3 times a week.
Approx. 3 min after vaccination Pt felt nauseous and sat down, then went into vasovagal syncope episode, Pt was sweating, tensed up in both arms, minor convulsions last 10 seconds, episode lasted approximately 30-45 seconds. Administer high flow oxygen post-syncope at 12LPM for 10 minutes, took vitals, all normal. Gave 12fl.oz water PO. Pt did not feel nauseous or have any other Sx post syncope.
Slight headache; achiness to the injection arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EM9810) at the age of 71 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing), notes: High blood pressure Diagnosed for 20 years; "High cholesterol" (ongoing), notes: it wasn't really high, she had a stressful job. Had high cholesterol for the last 10 years; "Arthritis" (ongoing), notes: Arthritis Diagnosed for last 5 years. It's been bothering her. Concomitant medication(s) included: LISINOPRIL taken for hypertension; SIMVASTATIN taken for blood cholesterol increased. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Slight headache"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "achiness to the injection arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pain in extremity.  Additional information: The vaccine has been administered in hospital. The patient had slight headache. Had achiness to the injection arm, put ice on it and it was gone within an hour. The same day as of her Pfizer COVID-19 Vaccines, she took Tylenol 500mg, formulation: blue and red 250mg each capsule administered three hours after the vaccine administration. The patient did not received any prior vaccinations within 4 weeks, nor any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Just took the Flu shot on 03Oct2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201240607 Same patient and drug, different event separated in time;US-PFIZER INC-202201240608 Same patient and drug, different event separated in time;US-PFIZER INC-202201240609 Same patient and drug, different event separated in time;US-PFIZER INC-202201240610 Same patient and drug, different event separated in time;
Fever to 103.5, lethargy with crying off and on. Tx - IV fluids and fever control with TYLENOL, MOTRIN. 1/29//09-records received for DOS 1/20/09-presented to ED with C/O cough and fever and fussy, lethargic. Impression:acute febrile reaction to immunizations.
Broke out in a rash on the back, chest, buttocks. On the 28th, eyelids and upper lip had swelling. Had throat pain when swallowing. Afterwards requested steroids.
Pt. states that after receiving the 3rd Booster dose of Moderna 09/09/2021, started experiencing symptoms 09/10/2021 of fatigue, muscle pain, and itchiness. Injection site hot to the touch. No noted Primary visit. Still experiencing symptoms.
Ct given nasal FLUMIST at mass vaccination clinic. Spoke with ct on 12/09/10, reported no adverse effects.
Large swollen, red, hard area (soft ball size) heat, nausea, fever.
This spontaneous report was received from a consumer concerning his wife of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On unknown dates, the patient suffered multiple miscarriages after receiving GARDASIL. It was unspecified if the patient sought any medical attention. The reporter stated that he believed the ingredients within GARDASIL were the cause of the reproductive difficulty his wife experienced. Upon internal review the event multiple miscarriages was considered as medically significant. Additional information has been requested.
April 7, 2022 Patient was experiencing chest pains and was take by ambulance to the emergency room.  Diagnostics done and she was released after one night of observation.  On a follow up visit to her GP an EKG was taken and she was immediately told to go to the ER, this time her diagnosis was Atrial fibrillation.
Patient got PREVNAR 13 on 11/9/2017. Patient called on 11/17/17 and reported she got a rash that is red, itchy, swollen, bump over the past 3 days on the right arm.
After injection MMR and varivax vaccines. Redness and slight wheals were noted around injection sties - Benadryl 10mg po given at clinic, and Rx given to mom for home.
light headed; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed) 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 Arthritis since an unknown date and Muscle strain since an unknown date.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (light headed). At the time of the report, DIZZINESS (light headed) had resolved. Not Provided          Concomitant information was not provided. No treatment was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-082928 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082928:2nd dose of vaccine
I received the vaccine at 10:30 am at pharmacy at 10:30 am. I started feeling constriction in my throat, numbness/heaviness on the right side of my face (eyelid, cheek) and lips and mild difficulty breathing around 11 am. I contacted the nurse helpline and facility after and was advised to go to an ER. I went in t the ER where I was kept under observation for approximately 4 hours. There was crookedness and drift on the right side of my face/arm observed. A CT scan was performed to rule out clots. The final diagnosis says I have Peripheral Neuropathy. The swelling on the face and tingling has reduced but not completely gone. The constriction in the throat is better.
Patient tested positive; This is a spontaneous report from a contactable pharmacist via a Pfizer-sponsored program. A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date not reported) via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller (HCP) has a patient whose schedule for the 2nd dose of vaccine was today (24Feb2021) but the patient tested positive last 11Feb2021 (1 week after the patient's first dose). The caller is asking if they are going to proceed with the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on the medical history, concurrent conditions and drug allergies of the patient was not reported. On 08-AUG-2016 the patient was vaccinated with improperly stored dose of PROQUAD lot # L051100, expiry date 17-JUN-2017, 0.5 ml, subcutaneously. Concomitant medication were not reported. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. Temperature and time frame at which the administered vaccine was stored was -0.15 degree Centigrade for 5 hours. Additional information has been requested.