chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 12:00 as dose 1, single (Lot number: EN6199), in left arm, on 01Apr2021 at 12:00 as dose 2, single (Lot number: ER8734), in left arm, on 29Sep2021 at 16:00 as dose 3 (booster), single (Lot number: FE3992), in right arm and on 17May2022 at 12:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as COVID-19 treatment from afternoon 27Jul2022 to 01Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 05-APR-2017, at age 51, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a healthcare provider. On an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow-up information from the registered nurse who provided patients details. This report refers to a 9 months old infant patient. On 12-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB lot number J016188, expiration date 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Severe Fatigue, Severe Muscle and Joint pain, headache, nausea, low dose fever, 4 days after. Symptoms are not subsiding.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. No concurrent conditions, medical history or concomitant medications were reported. On an unknown date, the unspecified patients were vaccinated with GARDASIL lot# K006960, expiration date 19-FEB-2017 and lot# J008423, expiration ate 21-JAN-2016 (total of 14 doses-number of each Lot # administered were not specified) (dose, strength, administration route were not reported), that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Lymph node on left side of neck a little swollen (bigger than a half dollar); tenderness on left side of neck, on top of collar bone.; Lymph node a little sore on left side of neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node on left side of neck a little swollen (bigger than a half dollar)), TENDERNESS (tenderness on left side of neck, on top of collar bone.) and LYMPH NODE PAIN (Lymph node a little sore on left side of neck) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for an unknown indication.     No medical history reported.  Concomitant products included ATORVASTATIN and FAMOTIDINE (FAMOTIDIN) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph node on left side of neck a little swollen (bigger than a half dollar)), TENDERNESS (tenderness on left side of neck, on top of collar bone.) and LYMPH NODE PAIN (Lymph node a little sore on left side of neck). At the time of the report, LYMPHADENOPATHY (Lymph node on left side of neck a little swollen (bigger than a half dollar)), TENDERNESS (tenderness on left side of neck, on top of collar bone.) and LYMPH NODE PAIN (Lymph node a little sore on left side of neck) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
PATIENT RECEIVED AN EXPIRED DOSE OF THE JANSSEN COVID-19 VACCINE ON 10/27/21. ATTEMPTED TO CONTACT PATIENT TO REVACCINATE BUT PATIENT HAS NOT RETURNED OUR CALL.
a patient received the first dose of Shingrix in 2019 and the 2nd dose on 5Jul2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number K4TG5, expiry date 31-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On 05-JUL-2023, the patient received the 2nd dose of Shingrix. On 05-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: a patient received the first dose of Shingrix in 2019 and the 2nd dose on 5Jul2023).The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 22-SEP-2023 The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not ask about follow up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Patient immediately developed nausea, vomiting followed by nasal congestion which rapidly progressed to dyspnea and SOB and angioedema.  He was given IM Benadryl and SQ epinephrine and observed in the ER for 6 hours.  Sent home with epi pen, undergoing allergy testing.
Vial was initially stored in the refrigerator on 06-Apr-2022 and administered on 09-May-2022; They administer a Moderna COVID-19 vaccine after the 30 day by use date to 4 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They administer a Moderna COVID-19 vaccine after the 30 day by use date to 4 patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 06-Apr-2022 and administered on 09-May-2022) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001m21a) for COVID-19 vaccination.     No allergic history to food and other products were available.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (They administer a Moderna COVID-19 vaccine after the 30 day by use date to 4 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 06-Apr-2022 and administered on 09-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They administer a Moderna COVID-19 vaccine after the 30 day by use date to 4 patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 06-Apr-2022 and administered on 09-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The dose number was reported as 4 doses at 1 vial for four patients.  No concomitant medication information was not reported.  Dose was administered after 30-day Use By Date or after manufacturer date of expiry.  Vial did not undergo any temperature excursion.  It was unknown whether patient had COVID-19 test or diagnosis and also similar event in the past.  No treatment medications were provided.
Pt woke up morning on 12/23 at0800 with rash on arms, thighs and legs. Called Nurse Manager, and primary doctor. Took 25mg PO Benadryl at 0815. Claritin 10mg PO at 0820. Took Pepcid 20mg at 0915. Had telehealth visit with primary doctor at 1000. Primary doctor informed patient that he believed this was an allergic reaction as the rash was spreading, patient was itching and had trouble swallowing pills in AM (unusual for patient to have that problem, resolved 1 hr post benadryl). MD informed patient to take 25mg PO of benadryl Q4H until rash disappeared. Ordered steroid dose pack if patient felt the benadryl did not help. Rash went away after 5 doses of 25mg PO Benadryl.
Pt was feeling hot and flushing also had fast heartbeat - gave her water and called 911 - measured BP (it was high = 172).
Red raised rash with itching left leg started out red than turned to raised and itchy. Benadryl. Still present 10 days after vaccine, 6x8cm redness, erythema.
3/8: Sore arm on day of first injection 3/9: Approximately 4 pm- Fever, chills, lethargic - 100 degree temperature day 2
Chronic Lymes, tired, weak, aching bones, osteo arthritis in left shoulder. Fast heart rate memory loss, focus eye problems. Skin lesions Chronic respiratory cough. Additional symptoms noted: cognitive problems, sleeping alot, anxiety, depression. Per follow up report received on 05/16/2005:  Patient still had Lyme's Disease.  Still being treated with antibiotics.  Has vision problems and vertigo on a regular basis.  Short term memory loss.  Left shoulder has arthritis.  Diagnosed with Degenerative Arthiritis in left AC joint. Per follow up report- Patient still suffers from including but not limited to dizziness, eye sight problems, head pressure with head aches, brain fog. Nausea, weakness, trembling. Difficult word finding, heart palpitations. Disorganization with thoughts. Depressed and tired. Muscle twitching, skin rashes. Joint pain in my back, knees, shoulders mostly. Now question of seizures? Just want to feel better. Be able to work out at the gym and not suffer from it. This has been going on for too long. Trouble sleeping.
Nausea; dizziness; Headache; muscle pain from shoulder to hand; fast heart beat; shortness of breath; feeling flushed/hot; tired; not feeling well in general; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 31-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EIU6202, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:45 (age at vaccination was 31 years) as dose 1, single for COVID-19 immunization. The patient's medical history included, food allergy and drug hypersensitivity (Allergy to Sulfamethoxazole) from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took trimethoprim, azithromycin. Patient took allergy medicine as other medications in two weeks. Patient received second dose of BNT162B2 on 26Apr2021 at 14:30. On 07Apr2021 at 14:00 the patient experienced nausea, dizziness, headache, muscle pain from shoulder to hand, fast heart beat, shortness of breath, feeling flushed/hot, tired and not feeling well in general. The patient underwent lab tests and procedures which included nucleic acid test which showed negative result on 19Apr2021. No treatment was received for the adverse events. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
pt recv vax & presented w/an inj site rash which was 3.25cm by 2.5cm in size;pt was treated w/ATB;following day pt devel approx 10 lesions on leg;
Pain, numbness, paresthesias, weakness-hands-also clumsy.  Numbness, paresthesias-legs, lumbar region.  Paresthesias-torso.  Symptoms started approximately one week before flu vaccine.  8/22/08 Reviewed PCP office records which included neuro & ophth consults. FINAL DX: multiple sclerosis, pre-existing, exacerbated by flu shot. Records reveal patient experienced recent mild case of right hip/waist herpes zoster when seen for vax.  Neuro consult done for post vaccinal complaints which began approx 1 wk s/p flu shot.  No reaction to prior flu shots.  Now w/complaints of tingling paresthesias of finger tips & toes, pins & needles of left shoulder, aching pain of left arm & cramping of left fingers, urinary hesitancy, bifrontal dull HA.  Neuro exam on 1/14/08 WNL.  Returned to neuro on 1/23/08 for increased weakness of right hand & prominent paresthesias of chest & abd.  Neuro exam remained WNL but referred for spinal cord MRI, LP & EMG/NCV of LE's.  Returned to neuro 2/6/2008 & tx w/IV steroids x 3 days.  Also referred to neuro-ophthalmic & seen 3/20/2008 where exam was WNL.
I've gotten two shots and they still lingering/Suspected vaccination failure; They still lingering; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient gotten two shingles shots and they still lingering (shingles). The reporter also took three times a day Gabapentin. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2022AMR030529, reported by the same reporter, for a different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR030529:Person mentioned in the report
sudden feelings of nausea; dizziness; rapid heart rate; sweating; tingly sensation in extremities; sudden fatigue; confusion; Chest tightness and pressure; This is a spontaneous report from a contactable healthcare professional (patient herself). A 24-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN9581) on 13Feb2021 12:30 PM, via unknown route of administration, at the age of 24-year-old at single dose in Left arm for COVID-19 immunization. The patient medical history includes known allergies: Penicillin, Sulfur meds. The patient concomitant drug includes desvenlafaxine succinate (PRISTIQ). 10 mins after shot (as reported), the patient experienced sudden feelings of nausea, dizziness, rapid heart rate, sweating, tingly sensation in extremities, sudden fatigue, confusion. Chest tightness and pressure lasting 4 days. All the events reported started at 13Feb2021 12:45 PM, resulted in: [Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization)]. Treatment was reported as no. No COVID prior vaccination. No COVID tested post vaccination. The event outcome of 'Chest tightness and pressure' was recovered on 17Feb2021 and the rest of event was recovered in Feb2021.; Sender's Comments: Based on the temporal relationship, the reasonable possibility of an association between reported events and suspect product BNT162B2 cannot be ruled out.  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.
The pfizer vaccine was not diluted prior to administration. 0.2ml of the undiluted vaccine was administered in the left deltoid at 9:14am. This was caught by a coworker in less than an hour and reported to the lead provider. The patient, pfizer manufacturing and poison control were all contacted promptly.
No Adverse Event; 10 year old came in to get the primary series of Moderna. Instead of giving the primary series they needed, they ended up giving them the bivalent booster shot; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (10 year old came in to get the primary series of Moderna. Instead of giving the primary series they needed, they ended up giving them the bivalent booster shot) and NO ADVERSE EVENT (No Adverse Event) in a 10-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (10 year old came in to get the primary series of Moderna. Instead of giving the primary series they needed, they ended up giving them the bivalent booster shot). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (10 year old came in to get the primary series of Moderna. Instead of giving the primary series they needed, they ended up giving them the bivalent booster shot) and NO ADVERSE EVENT (No Adverse Event) outcome 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 WRONG PRODUCT ADMINISTERED (10 year old came in to get the primary series of Moderna. Instead of giving the primary series they needed, they ended up giving them the bivalent booster shot).    No concomitant medications were reported. HCP reported a 10 year old came in to get the primary series of Moderna but instead of giving the primary series he needed, they ended up giving him the bivalent booster shot. Patient had no previous Covid vaccines. No treatment medications were reported.
Information has been received from a physician concerning a 13 year old female who in February 2008, was vaccinated with the third dose of GARDASIL, 0.5 milliliter intramuscular. In "August 2008", the patient developed a seizure.  The patient sought medical attention, she contacted the doctor.  Upon internal review, seizure was determined to be an other important medical event.  Additional information has been requested. 11/11/08-records received-seen in office 8/20/08-after ER visit for seizure.Assessment questionalbe seizures.Gardasil #3 given on 2/21/08. UA showed blood at time of sports physical, also trying to loose weight.
Patient was a resident of a Healthcare, with a hx of insulin-dependent diabetes, stable hypertension, hypothyroidism, dyslipidemia.  Patient tested positive for Covid-19 at NHC on 11/12/2021.  Patient was not hospitalized for this, and expired at the facility on 12/29/2021.
No adverse event: 2-month old infant was given Hepatitis-A, which should have not been given until 1 yr. of age.
This is what the employee let me know about signs and symptoms -"At about 1am, I started feeling nauseous. Then I woke up at 4am I have had very bad HA, body aches, Dizziness and tachycardic. My heart rate is staying 129-140 and I?ve been vomiting. I talked with my Doctor and he ordered some medication for me to take." Names and types of medication was not disclosed.
Flu symptoms-chills, "freezing to death" Face/swollen around the whole head-Took BENADRYL Monday and eye swollen 6 hrs Tues am-called MD for MEDROL Dose pak.
2 days ago patient received Hep B #3 and Pneumo #3 in right thigh; Mom noticed redness site of injection after 7 hours; today notices also swelling and mild increasing redness; patient playful, active; no fever.
Within 3 days began diarrhea like discharge 3-4 times a day with loose stool, water & gas. Continued for 3 weeks and became less frequent in fourth week
Pt described redness that appeared like a sunburn beneath both breasts (no itch or pain), rash on back (itchy), and a red colored circle about the size of a baseball surrounding her site of administration
On 10/4/23, I had a Spivax 50 MCG/0.5 SUSY vaccination and also a Fluarix Quad .5 ML flu vaccine. Almost 48 hours later, I suddenly experienced a case of extreme fatigue, restless legs, and vertigo. This lasted about 12 hours. Vertigo is something I have never experienced before. It occurred almost exactly 29 hours after I have the flu/Covid (Moderna) shots.
11/19/2021 I noticed a pain in the injection site, the entire shoulder of the left side, and I had chills that night, but no fever. 11/20/2021 Woke up to my lymph nodes swollen in the left armpit, pain was closer to the chest, diarrhea, chills and fatigue.  11/21/2021 The swelling in left armpit was now the size of a softball, the pain progressed to the shoulder area, chills and fatigue; took Advil before bed.  11/22/2021 The swelling had gone down to about baseball size, pain had mostly subsided, but still fatigue. I went to the doctor this day and told me just to take Aleve twice a day. Still just a bit of tenderness on the left side as of today.