chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After administration of TDaP and MENACTRA, patient passed out. Was assessed by provider - no injuries. Was monitored 20-25 minutes before leaving. Of note- pt was very nervous prior to administrations.
PT RECEIVED FIRST DOSE WHILE UNDER AGE REQUIREMENT. MOTHER SIGNED THE CONSENT FOR PT TO RECEIVE THE SECOND DOSE
6 MONTH OLD WITH  LOCALIZED VACCINE REACTION VERSUS CELLULITIS GIVEN AT THAT SITE -LEFT THIGH.
Red eyes with white pulse, difficulty breathing, slighted elevated temperature, tight throat, heart beating fast, tired.
swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE SWELLING (swelling) outcome was unknown.            No concomitant medications were not reported.
Swelling and pain at injection site, headache, fever and chills for 24 hours.
11:55am-10 minutes after receiving the vaccine patient complained of "heart beating a little fast, SOB and feeling woozy".  Ambulance was called.  BP-115/72, pulse 88, pulse ox 99%, resp 14.  11:59am- LPN administered one 81 mg chewable aspirin per Dr's request.  BP 124/72, pulse 83, pulse ox 99%, resp 14.  11:58am-IV started with NS at KVO per RN.  O2 per NC at 2L.  Patient c/o neck, left shoulder and head pain.  12:10pm-81 mg chewable aspirin given per Dr's orders.  Ambulance arrived and patient transported to Hospital.  Husband notified to meet patient at hospital.
Began feeling warm within a few hours after vaccine.  Was clammy at first, with slightly elevated temperature.   By nighttime, had severe shaking, chills, profuse sweating & unable to sleep.  We didn?t take temperature, but he finally stopped shaking mid-morning the following day.  Was weak and very fatigued two full days.  It was like an instant flu, but it was only the first jab and most reports of reaction seem to follow the 2nd.  Think it may be due to presence of antibodies post-COVID.
Upper arm pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 19Feb2021 at 08:30 AM (Lot Number: EN6201), as single dose, for COVID-19 immunisation. Medical history was none. Patient had no known allergies and did not have COVID-19 prior to vaccination. Concomitant medications included rosuvastatin (unknown manufacturer) and colecalciferol (VITAMIN D). Patient did not receive any other vaccine in four weeks. The patient experienced upper arm pain (non-serious) on 19Feb2021 at 07:00 PM with outcome of recovered. Patient has not been tested for COVID-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
passed out / checked by DR /  closed monitored / offered fluids / went home with a friend in stable condition.
This spontaneous report was received from a Registered Nurse (R.N) concerning a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent condition were not reported. The Registered Nurse reported that on an unspecified dates, these multiple unspecified patients were administered improperly stored doses of VAQTA (Lot # and doses were not reported) which was exposed to 8.8 C but it was unsure of cumulative time out of range and it was every 15 minutes then fluctuating every two hours. (Cumulative: unsure of time frame). There was no previous temperature excursion and the call was made because of a digital data logger. No adverse effects were reported. These is one of several cases from the same source (MARRS# 1607USA004237, 1607USA006260 and 1607USA006261). Additional information has been requested.
Tingling in hands, shaking, inability to sleep, chest paint, numbness in throat, high blood pressure, fast beating heart.
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.
Headache, muscle aches, chills, diarrhea, nausea, loss of appetite, fatigue lasting for over 10 days and continuing. Treated with Tylenol, ibuprofen and rest.
tested positive for covid after receiving the first covid vaccine; tested positive for covid after receiving the first covid vaccine; This is a spontaneous report from a Pfizer sponsored program received from a non-contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included was reported as none. Concomitant medications were not reported. The patient reported that she had tested positive for covid after receiving the first covid vaccine on an unspecified date. The patient underwent lab test which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
gave the liquid component of Menveo only to a patient; Inappropriate dose of vaccine administered; This case was reported by a consumer via sales rep and described the occurrence of inappropriate reconstitution technique in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.  Additional details were received as follows: The age at vaccination was not reported. One of their offices they gave the liquid component of Menveo only to the patient, which led to inappropriate reconstitution technique and inappropriate dose of vaccine. The reported corrected her and showed her there are 2 components. She said she followed up with the practice and they will correct the mal administration and educate the new MA on how to give Menveo.
pt recvd vax on 27AUG92 w/no noted problem; pt recvd 2nd dose of vax 25SEP92 & 28SEP92 was seen in clinic w/generalized aches, weakness & muscle soreness;
A couple times a day I get very dizzy, light headed, nauseous - I check my blood pressure and blood sugar before and during the events and everything is normal. I increased my water intake and make sure I'm eating on time and nothing helps. This has been going on now for about six weeks.
Patient was admitted for COVID symptoms on 7/15/2022- 7/19/2022.   Medications given included zinc sulfate 50mg PO BID, ascorbic acid 1000mg PO daily, cholecalciferol 25mcg PO daily,
patient was administered with an expired vaccine, no adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professionals via Media Information (under reference number 00814661).  This case was linked to 2021SA345761, 2021SA345306, 2021SA345646 and 2021SA345109 (same reporter).  This case involves an unknown age female patient who was administered with an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given to patient.  On 03-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Total, once, dosage form: PFS (prefilled syringe), lot QFAA2017 and expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "Stated that they gave 15 patients expired Flublok vaccine, and wants to know what to do.There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available."   At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No adverse effects from vaccine - Vaccine was placed in freezer upon receipt from manufacturer, then thawed prior to administration
Pt recv vax on 10/15/98; on 10/15/98 pt exp aching; on 10/17/98 pt exp swelling of legs & ankles, joint & back pain, Achilles tendon pain, difficulty walking, erythema nodosum on shins &ventral aspect wrists
Injection site became red raised and warm to touch as well as pt started feeling sick (headache, left side neck/gland pain/fatigue, nausea) at around 5:30 pm the day she got the vaccine. Rash started 2 days later mid torso under breasts and sternum area.
Pt experienced symptoms of syncope after leaving the pharmacy area about 10 minutes after the 2nd dose was provided.
Elevated heart rate at 7pm on evening of vaccine (administered at noon); tingling sensation all over; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) intramuscularly at right arm on 14Jan2021 12:00 at single dose for COVID-19 immunization. Medical history included none. No known allergies. The patient's concomitant medications were not reported. The patient experienced elevated heart rate at 7pm on evening of vaccine (administered at noon), tingling sensation all over. Laid down and issue resolved within 2 hours. No treatment received. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovered on 14Jan2021.
Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National Vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTaP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09245, -09246, -09247, -09248, -09249 and 2011-09250. A five-month-old female patient had received a DTP vaccination (manufacturer unknown; lot number, route, site and date of administration not reported) and within 24 hours developed onset of seizures, but later manifested developmental delay. The patient died at seven years of age at which time acute anoxic encephalopathy was found and was most likely a consequence of terminal seizures. No lesions that may have accounted for the developmental delay were found. Documents held by sender: None.
Patient developed blurred vision and a headache right after receiving Hep A vaccine. These symptoms continued the next day. This lasted for 3 days.
Itchiness at the injection site; Rash under left arm pit area; Felt light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt light headed), INJECTION SITE PRURITUS (Itchiness at the injection site) and RASH (Rash under left arm pit area) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DIZZINESS (Felt light headed). On an unknown date, the patient experienced INJECTION SITE PRURITUS (Itchiness at the injection site) and RASH (Rash under left arm pit area). At the time of the report, DIZZINESS (Felt light headed), INJECTION SITE PRURITUS (Itchiness at the injection site) and RASH (Rash under left arm pit area) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Red oval (3/8" x l-l/8") around injection site. Forgot to check the site of injection until just now.  12:15 PM 04/18/2009. Zostavax INJ
Patient received yellow fever vaccine 7/10/08. She had a little tenderness at injection site at the time, but no other symptoms. About 10 days later she began to develop hives. These would fade, then new ones would occur up to several days later. Very itchy, but not painful. advised benadryl. No other issues, no other symptoms. Client cannot identify any other new medications, foods, or exposures other than the yellow fever vaccine that could have led to the hives. She has a sulfa allergy only, tolerates all other antibiotics so far. No history of egg allergy.
Minimal amount of left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Minimal amount of left arm soreness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder and Psoriatic arthritis. Concomitant products included CERTOLIZUMAB PEGOL (CIMZIA) for Psoriatic arthritis.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (Minimal amount of left arm soreness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Minimal amount of left arm soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, SARS-CoV-2 antibody test: negative (Negative) Negative test results for COVID antibodies 6 weeks after having 2nd dose..   The patient was taking quite a few concomitant medications but did not list them out.
Exposed at 30°F to 45°F, vaccines were administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 32P2F, expiry date 30th June 2023) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Havrix, Engerix B, Boostrix, Kinrix, Kinrix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Havrix, Engerix B, Boostrix, Kinrix, Kinrix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 13-Oct-2022 Reporter's comment: The certified clinical medical assistant reported that since 16th September 2022 until the day of reporting, the refrigerator alarm was triggered several times.  The lowest temperature was 30 degree Fahrenheit and the highest was 45 degree Fahrenheit.  The vaccines involved were Pediarix, Havrix, Engerix-B, Boostrix, Kinrix, Fluarix QIV and Bexsero.  The vaccines were administered to patients.  No more data was available. The reporter consented to follow up via email. Additional supportive information: The patients received Pediarix, Havrix, Engerix-B, Boostrix, Kinrix, Fluarix QIV and Bexsero after temperature excursion, which led to incorrect storage of drug.
side effects lasted 24 hours. 12 hours after second dose, chills occurred. this was followed by fever and muscle aches. Highest fever was 101.7 F.  side effects were bad enough to affect ability to do ADLs and to be able to go to work. Swollen lymph node in left clavicle since first dose got bigger and firmer. since symptoms have resolved swollen lymph node still there.
Inflammatory symptoms - discomfort through back and neck musculature primarily, ribcage pain, worsening of symptoms with and post activity, tenderness of skin, diffuse/bilateral feeling of inflammation- "flulike" achiness since approximately 12 hours after receiving vaccine. This has changed somewhat over the past 12 month but has not subsided/eased. Not able to continue hobbies of soccer/running/dance/yoga. Difficulty performing active job as physical therapist but still going to work. Not able to participate in other life stuff such as making plans with friends as am limited by discomfort.
had the flu shot and got flu; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from non-healthcare professional via social media.  This case is linked with 2020SA293945 and 2020SA293953.  This case involves a male patient of unknown age who had the INFLUENZA VACCINE (flu shot) and got the flu (influenza).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome was unknown for the event.  There will be no information available for the batch number.
No adverse event; Second dose in the Moderna Covid-19 vaccine primary series given to a Male patient 22 days after his first Primary Series Vaccine.; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose in the Moderna Covid-19 vaccine primary series given to a Male patient 22 days after his first Primary Series Vaccine.) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B and AX1414B) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose in the Moderna Covid-19 vaccine primary series given to a Male patient 22 days after his first Primary Series Vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose in the Moderna Covid-19 vaccine primary series given to a Male patient 22 days after his first Primary Series Vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose in the Moderna Covid-19 vaccine primary series given to a Male patient 22 days after his first Primary Series Vaccine.).    No concomitant medications were reported. Patient received first dose of vaccine in right leg and second dose of vaccine in left leg. Patient did not report any other adverse reactions. No treatment medications were reported.
Discussed with patient what vaccine she needed stated HPV acknowledged  visit booked as #3 HPV
Patient present with 6cm diameter of redness, lump and warmth to leg vaccine site.