chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SECOND VAERS SUBMISSION ON SAME PATIENT: Patient received first Moderna vaccine on 12.30.20 and reports injection site reaction x 1 day. 9 days later (1/8/21) patient reports that the injection site reaction (redness and itchness) reappeared. As of 1.11, the patient is only still experiencing itchiness at the injection site. Patient did not seek medical care. UPDATE: 1.11 - patient reports rash on legs, underarms, stomach - very itchy. Went to the ER on 1.13.21 due to rash. ER gave prednisone, IV pepcid, and IV benadryl. Dispensed 2 weeks worth of oral prednisone. 1.14 rash is not completely gone, but has dramatically improved.
Patient called around 6:50pm on 7/28/21 saying that his left arm has been numb since getting the shot, which he received on 7/24/21. Per patient 10 hours after getting the vaccine he woke up to pain (rated 6-7/10) in both arms which he described as feeling very sore and aching, not burning or tingling or sharp. The pain has continued and has decreased to a 4/10 but is now only in the arm that the vaccine was administered in.  When asking patient if he experienced any other symptoms I should be aware of he mentioned that he felt very dizzy and unbalanced and that it started several hours after getting the vaccine and still hasn't gone away.  Did not mention any other symptoms. Told patient to be seen or to contact his primary care provider but as of now am unsure if patient did or will follow through and be seen.
Child began to have erythema at injection site with rash noted by mother around 9:00PM on 2/4/2014. Mother brough child to the office at 1:00PM on 2/5/2014. Child had nodule noted under injection site on outer left deltoid. Left arm also had erythema present at the injection site and extended approximate 3 inches below the injection site.
4 month-old administered Fluarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number ZC776, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st October 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 31st October 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 Information: GSK Receipt Date: 31-Oct-2022 Reporter's comment: The medical assistant called to inquire regarding any adverse reactions to look for or any studies which were available. The medical assistant reported that the 4 month old patient was inadvertently administered Fluarix today on 31st October 2022 in their facility. The consent to follow up was granted. Additional supportive information: The patient received vaccine at the age of 4 month, hence inappropriate age at vaccine administration was captured. This case was linked with case US2022126175, reported by the same reporter.; Sender's Comments:  US-GSK-US2022126175:Same reporter
This spontaneous report was received from a pharmacist referring to a multiple unspecified patients. No concurrent or historical conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L008664, expiration date 03-NOV-2016) doses, routes, anatomical locations were not reported. No concomitant medications were reported. No adverse effects were reported. No further information was provided. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Moderna COVID-19 vaccine administered on 04-May-2022 was initially stored in the refrigerator on 01-Apr-2022; expiration date of 01-May-2022 but doses were given 04-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expiration date of 01-May-2022 but doses were given 04-May-2022) and PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered on 04-May-2022 was initially stored in the refrigerator on 01-Apr-2022) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expiration date of 01-May-2022 but doses were given 04-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered on 04-May-2022 was initially stored in the refrigerator on 01-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expiration date of 01-May-2022 but doses were given 04-May-2022) and PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered on 04-May-2022 was initially stored in the refrigerator on 01-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Date the vial was initially stored in the refrigerator: 01-Apr-2022.  Vial did not undergo any temperature excursions.  It was started that the patient has not called to report any adverse events.  Treatment medications were not provided.   This case was linked to MOD-2022-558234 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2022: The follow up information received contains no new information.
This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of dizziness (1st dose received on an unknown date, for tolerance see case US2018160836). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction and dizziness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site reaction and dizziness were recovered/resolved. It was unknown if the reporter considered the injection site reaction and dizziness to be related to SHINGRIX. Additional details were provided as follows: The caller was cousin of patient who received both doses of SHINGRIX. The age at vaccination was not reported. The caller reported that after receiving a dose of SHINGRIX the patient experienced dizziness that lasted for 4 to 5 hours as well as injection site reaction and all events were resolved. The lot number, pharmacy information and physician information were not available. The patient had denied permission to contact their physician.
Patient complained that after the vaccination, she experienced numbness and 2 weeks later she saw big boil in her armpit . Then after one week she saw another second boil.
Starting having a cough; Itching at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Starting having a cough) and VACCINATION SITE PRURITUS (Itching at the site of the injection) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (Itching at the site of the injection). On 22-Nov-2021, the patient experienced COUGH (Starting having a cough). On 23-Nov-2021, VACCINATION SITE PRURITUS (Itching at the site of the injection) had resolved. At the time of the report, COUGH (Starting having a cough) outcome was unknown.            Patient had no record of allergies. Patient had taken Moderna booster shot 6 months after second dose. No Concomitant medications were reported. No treatment medications were reported. Patient's itching went away for a few hours then came back. It was coming and going for the past two days. Patient started having a cough after the first day.
This non-serious spontaneous case, was received on 18-Oct-2017, from other health professional, concerning a patient of an unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128 and expiry date: 30-Apr, route of administration, anatomical location: not reported). On 04-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it turned upside down and upon injecting air, vial was dripping from the rubber seal (explicitly considered as product leakage). The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses (explicitly considered as drug administration error). There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user.  Follow-up on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction was received 18-Oct-2017: The verbatim of the events "The vial is dripping from the rubber seal/vaccine from a vial that leaked/after piercing the vial, turn it upside down, injected air and it started leaking" and 'employees were given vaccine from a vial that leaked' were corrected and labeling, causality assessment was done.
Initial and follow-up information has been received from a licensed practical nurse for the pregnancy registry for VARIVAX (Merck) concerning a 15 year old female with no pertinent medical history and no allergies who was vaccinated with the first dose of VARIVAX (Merck) as a child. On 07-MAR-2008 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # 659355/1518U) 0.5 ml SC and then discovered that she was pregnant. There was no concomitant medication. The last menstrual period was 03-JAN-2008. The estimated due date is 09-OCT-2008. No adverse effects reported. The prenatal ultrasound showed no problems. The baby was breech at this time and a C-section was scheduled soon (dates not provided). The patient sought medical attention in the office visit. Follow-up information was received. On 13-AUG-2008 and 17-SEP-2008 ultrasounds were performed with no problems. Other medication use during pregnancy included FeSO4 325mg twice a day for anemia on 25-AUG-2008. The serum alpha fetoprotein test (MSAFP) was performed too late. The patient with a history of 0 pregnancies 0 and 0 pre-term births on 24-OCT-2008 delivered a male baby weighing 7 pounds 11 ounces at 41 weeks. There was no complication during pregnancy and labor/delivery. There was no feature of congenital varicella zoster syndrome. Additional information is not expected.
Information has been received from a pharmacist via Pfizer (manufacturer control# 2015058208) referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (route, lot#, dose and frequency were unknown). On an unknown date the patient experienced allergic reaction after being administered PNEUMOVAX 23. The symptoms of the allergic reaction were unknown. It was unspecified if the patient sought for medical attention. The outcome of allergic reaction was unknown. The relationship between the adverse event and PNEUMOVAX 23 was not reported. Additional information has been requested.
migraine headache; diarrhea; discharge was liquid; achy all over; tired; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DISCHARGE (discharge was liquid), MIGRAINE (migraine headache), MYALGIA (achy all over) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced MYALGIA (achy all over) and FATIGUE (tired). On 05-Apr-2021, the patient experienced DIARRHOEA (diarrhea) and DISCHARGE (discharge was liquid). On 06-Apr-2021, the patient experienced MIGRAINE (migraine headache). At the time of the report, DIARRHOEA (diarrhea), DISCHARGE (discharge was liquid), MIGRAINE (migraine headache) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Imodium, probiotic fluids, Tylenol.
PATIENT'S MOTHER HAD CALLED AND ALERTED CLINIC THAT PATIENT HAS HISTORY OF SEIZURE ACTIVITY AFTER VACCINATIONS. PATIENT HAD LAYED DOWN ON THE FLOOR DURING OBSERVATION AND STATED HE WAS FEELING NAUSEATED. WAS VERBALLY RESPONDING APPROPRIATELY TO SIMPLE YES/NO QUESTIONS. NURSE ELEVATED FEET, PLACED ICE PACK BEHIND HEAD AND SECOND NURSE GOT PILLOW FOR HEAD. INITIAL BP 110/71 AT 1726. AT 1728, HE LOST CONSCIOUSNESS, NURSE DID STERNAL RUB & HE USED HIS HAND TO REMOVE NURSES HAND. BEGAN VERBALLY RESPONDING AGAIN TO SIMPLE YES/NO QUESTIONS WITHIN 2 MINUTES. WAS NOT ABLE TO OPEN EYES AT THE TIME. NOTED INVOLUNTARY MOVEMENT OF BOTH ARMS AND EYES WHILE STILL RESPONDING AT REDUCED LEVEL OF CONSCIOUSNESS. AT 1730, BP WAS 120/83. INVOLUNTARY MOVEMENTS REDUCING, AND CONTINUED TO IMPROVE UNTIL 1745 WHEN HE WAS ABLE TO OPEN HIS EYES, SIT UP, AND TAKE SIPS OF JUICE WITH BP 119/83. HAD STATED THIS IS TYPICAL RESPONSE PER HIS BASELINE REACTION TO VACCINES, HAS NOT REQUIRED EMERGENCY ASSISTANCE AND WAS A&O X3 AT TIME OF DEPARTURE WITH SISTER ACCOMPANYING AND DRIVING HIM.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2014, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Information has been received from a physician concerning a 16 year old female who on 28-OCT-1996 was vaccinated with a first dose of MMR II HSA (route, site, dose and lot number not reported). On 24-SEP-1997, the patient was vaccinated with a second dose of MMR II HSA (route, site, dose and lot number not reported). On 22-NOV-2009 the patient experienced mumps. Mumps was diagnosed on 12-NOV-2009. The patient was afebrile. The outcome for mumps was not reported. Follow up information has been received reporting that the patient who was vaccinated with first and second dose of MMR II HSA (route, site, dose and lot number not reported) on 26-OCT-1995 (previously reported as 28-OCT-1996) and on 24-SEP-1997 respectively. On 02-JAN-2010 (previously reported as 22-NOV-2009) the patient experienced mumps. Mumps was diagnosed on 03-JAN-2010 (previously reported as 12-NOV-2009). The patient was afebrile and had right parotitis. At the time of the report the patient's outcome was unspecified. No further information is available.
Leg cramps on and off on both legs, from knee to toes, happened after she got vaccine, from 10PM to 2PM, painful. She got vaccine at 1:14 PM on 9-15-2014.
Fever of 103F; A spontaneous report was received from a pharmacist, concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 103F.  The patient's medical history was not provided. Concomitant medications were not reported.  On 05 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (batch unknown) for prophylaxis of COVID-19 infection.  On 05 JAN 2021, the patient received the vaccine and two days later, on 07 JAN 2021, she experienced fever of 103F. The reporter hung up and declined to provide any additional information upon outbound of the call.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, fever of 103F, was considered unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender who experienced a NS expected event of fever.  Event onset occurred 3 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt recv vax & that same evening pt became extremely fussy for 2hr;both eyes became puffy & red (upper & lower eyelids);for the next 2wk pt was fuzzy & ate poorly;MD notified by parent on 17NOV97 & was advised to cont APAP;
When patient came for her second dose of her Moderna shot today, she reported that she got a rash from her first dose. The rash occurred 1 week after her first dose. She stated the rash was around the injection site and progressed around her deltoid muscle.  She said the rash was red and painful to the touch. She said she put Hydrocortisone cream around the area and took one dose of Benadryl. The rash lasted 1 week per the patient. She did not seek any medical attention after she noticed the rash. This reaction seems like common reaction referred to as "Covid arm." The CDC still recommends that patients should get the second dose of the Covid shot even if they had this reaction. The patient received the second dose of the vaccine and was told that if she did get a reaction to let us know and to report it to VSAFE.
For two days, I had extreme tiredness. Mild headache. Extreme muscle pain.  Moderate chills. Mild Fever. Nauseous.  Mild vertigo.
Flu vaccine administered at 1:20 PM. Patient left the clinic at 1:35 PM. She returned at 2:05 PM with c/o diffuse, blotchy, non raised pruritic red rash to arms, legs, trunk, neck w/ assoc shortness of breath. BENADRYL 50mg PO administered. Sent to ER for medical evaluation.
Swelling and red rash and near the site on the injection arm turn purple. by 3pm I could not move my arm. Tried ice and heat and could not sleep or move my shoulder due to swelling and neck swelling. 4/25/2014 schedule apt with provider to report and evaluate my arm.
Hep A #2 was given 1 min pt.'s (R) arm about 10 minutes later pt. has swelling, burning, site redness.
Weakness; Discomfort in Arm,under left Armpit; Slight pain in the body; Swelling in left armpit near lymph glands; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DISCOMFORT (Discomfort in Arm, under left Armpit), PAIN (Slight pain in the body), LYMPHADENOPATHY (Swelling in left armpit near lymph glands) and FATIGUE (Tiredness) 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 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, the patient experienced ASTHENIA (Weakness), DISCOMFORT (Discomfort in Arm, under left Armpit), PAIN (Slight pain in the body), LYMPHADENOPATHY (Swelling in left armpit near lymph glands) and FATIGUE (Tiredness). At the time of the report, ASTHENIA (Weakness), DISCOMFORT (Discomfort in Arm,under left Armpit), PAIN (Slight pain in the body) and FATIGUE (Tiredness) outcome was unknown and LYMPHADENOPATHY (Swelling in left armpit near lymph glands) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was provided. No treatment information was provided by the reporter.
Patient tested COVID positive on 8/8/21 after being fully vaccinated with the Pfizer COVID19 vaccine: dose 1 on 1/12/21 and dose 2 on 2/2/21.  Patient reported mild symptoms including: Head congestion, fever, change in taste and smell, headache, and mild cough  starting 8/7/21 and tested COVID positive via PCR NP swab on 8/8/21 at Urgent Care
Perioral tingling and tightness sensation around eyes, onset 30 minutes after injection, lasted for 24 hours.
Induration, erythema and warmth on both thighs 5cm x 3 cm began 4 hrs after vaccine.
I experienced tenderness, sensitivity to touch, swelling, and numbness (ALL SLIGHT) to the left side of my face, including around my eye, jaw, and lips.
Symptoms of a stroke. Left side of face drop  Numbness and tingling High levels of anxiety  Treatment; prescribed Ativan for anxiety Sonogram MRI CAT scan lab work EKG
This is a spontaneous report from a noncontactable consumer or other non-HCP (reporter's wife). A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unspecified date (one week after first dose), patient experienced nosebleed. Caller reported on behalf of wife who experienced nosebleed 7-8 days after the first dose. Unsure as their room is also humid. Asked if this is normal and if she should still get the second dose. Said in the news she heard that nosebleed is normal. Wanted to know if a nosebleed one week after the first Pfizer COVID-19 vaccine is an adverse event; and if you have this reaction, do you still get the second dose. The outcome of event: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.