chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received his Tdap vaccine first.  It took us 10 minutes after administration of the Tdap to determine he also needed MCV.  This was administered.  Within one minute, he had an episode of syncope which started with paleness and pupil dilation.  He lost consciousness for 5-10 seconds and then regained it.  He began breathing quickly when he regained consciousness.  His pulse was slow and steady throughout the episode. After about 30 seconds he verbalized the need to vomit and then did so.  He was able to talk and drink juice.  He stayed seated for about 20 minutes.  When he left the office he said he was feeling a little weak, but was other wise fine.  He walked to the car without help.  He had no symptoms of allergic reaction and did not fall in the office.  I spoke with mom the following day.  She stated he was still feeling a little weak, but went to school that day.  He was in the nurse's office after about an hour complaining of weakness, feeling shaky and back pain.  She gave him food since he had not had breakfast and finished the day at school.  When he went home he had a slight fever.  No temp was taken.  Mom gave his Ibuprofen and if any other symptoms emerged I told her to call and inform me.
Patient reports she received Janssen Covid 19 vaccine on 8/10 on 8/11 she began to experience jaw pain, left facial numbness and perioral full feeling  This has persisted. She saw the provider for this on 8/23.
Death - coroner's report received on 7/15/2021.  Coroner Dr performed an autopsy and determined the cause of death as brochopneumonia.  Heart disease and drug use also contributed to his death.  The manner of death is natural.
This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced not feeling well and dizziness on Feb 25, 2021. The patient due to get her 2nd dose of COVID-19 vaccine today on Feb 25, 2021. But when she woke up she was not feeling well; she was experiencing dizziness. Now she wants to reschedule her appointment because she will not be able to make it. The outcome of the events: unknown. No follow-up attempts needed. No further information expected. Information about batch/lot cannot be obtained.
Got flu shot Then got flu two weeks later; Initial information received on 13-Nov-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who had got flu shot then got flu two weeks later while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Flu.  On an unknown date the patient developed a non-serious event of got flu shot then got flu two weeks later (influenza) (latency: 2 weeks) following the administration of INFLUENZA VACCINE.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Unknown
Vaccine exp Use by date = 10/7/2022(8wks after defrost) Exp. Date = 10/31/2024
This spontaneous report as received from a healthcare worker refers to an infant patient of unknown age. On 02-APR-2013, the patient was vaccinated (route unknown) with ROTATEQ (lot number and expiry date not reported). On 02-APR-2013, the patient experienced sneezing while or directly following administration. The outcome of sneezing while or directly following administration is unknown. The reporter did not assess the relationship of the event to ROTATEQ. This case is related to case 1304USA002452 (same reporter link). Additional information is not expected.
Received call from patient asking for assistance in treating the following and spoke with patient on his reaction: 39 YO adult male received 2nd AVA vaccine on 2/3/2017. No other vaccines given since 12/29/2017 (AVA1 and VAR). Patient is deploying overseas on 2/25/17. 2/3/2017 patient reported had burning sensation to left arm, similar to first AVA vaccine, with receipt of 2nd AVA vaccination. Next day (Sat. 2/4 evening) his deltoid was hot, red and painful. Redness covered about 1/2 of arm (anterior portion only, did not encircle arm). He reported he had a mild fever day of vaccination, but none on Saturday or since. He advised he had some diffuse joint pain to shoulders and lower back, but has history of back/neck pain. He presented to medical today 2/6 at Clinic with swelling, redness and patient describing upper anterior arm/deltoid as red, warm, and deltoid was hard to touch/indurated with redness extending down to mid humerus close to elbow. No paresthesia, weakness, tingling or restricted ROM in shoulder/elbow. No fever or rash. No axillary lymphadenopathy. No chest pain, headache, difficulty breathing or other systemic symptoms. Symptoms: Localized edema, other skin changes.
slight swelling left side of my face; numbness on the left side of my face/slight numbness in left hand; slight pain on the left side of my jaw; pain injection site left arm; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE (slight swelling left side of my face), HYPOAESTHESIA (numbness on the left side of my face/slight numbness in left hand), PAIN IN JAW (slight pain on the left side of my jaw) and VACCINATION SITE PAIN (pain injection site left arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced SWELLING FACE (slight swelling left side of my face), HYPOAESTHESIA (numbness on the left side of my face/slight numbness in left hand), PAIN IN JAW (slight pain on the left side of my jaw) and VACCINATION SITE PAIN (pain injection site left arm). On 02-May-2021, VACCINATION SITE PAIN (pain injection site left arm) had resolved. At the time of the report, SWELLING FACE (slight swelling left side of my face), HYPOAESTHESIA (numbness on the left side of my face/slight numbness in left hand) and PAIN IN JAW (slight pain on the left side of my jaw) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
This spontaneous report was received from an other referring to a 12 month old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 09-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA008334.
Tinnitus and loss of hearing in right ear with dizziness. Identified as viral labyrinthitis.  Not resolved and still continues resulting in need for hearing aid.
sore arm; some laziness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and LAZINESS (some laziness) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and LAZINESS (some laziness). On 28-Feb-2021, PAIN IN EXTREMITY (sore arm) and LAZINESS (some laziness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Has not tried any treatment and does not take prescription medication.   This case was linked to MOD21-066614 (E2B Linked Report).; Sender's Comments:  MOD21-066614:MOD-2021-064178- 2nd Dose of Vaccine
Body cut with flu-like symptoms; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Body cut with flu-like symptoms) and HEADACHE (Headache) 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 09-Feb-2021, the patient received second 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-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Body cut with flu-like symptoms) and HEADACHE (Headache). At the time of the report, INFLUENZA LIKE ILLNESS (Body cut with flu-like symptoms) and HEADACHE (Headache) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
No adverse event; On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     It was unknown if the patient had any acute illnesses at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions.     On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 10-May-2023, the patient experienced UNDERDOSE (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine).    This case corresponds to 23rd patient out of 27 patients as described by the reporter.  The age of the patient was reported as over 65 years.  Concomitant medication of the patient was not reported as it was unknown if the patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination or at the time of the adverse event.  It was reported that on 10-May-2023, 27 patients had received 0.25 ml of bivalent booster instead of 0.5 ml. On 11-May-2023, the patients were contacted and on 12-May-2023, 18 patients received additional 0.25 ml. Vaccine body site was reported as deltoid.  The reporter did not report any other adverse reactions.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
When the patient enbered the observation area within a few minutes she fell to the ground and appeared unresponsive.  When I arrived I noticed foaming around her mouth and she urinated on herself.  No clonal movements noted.  Pulse could not be felt so CPR was initiated.  She woke up in about 30 seconds.  Paramedics called and arrived within 5 minutes.  Patient was awake and oriented.  When asked she indicated that she had a history of a seizure many years ago.   Paramedics transported her to a Medical Center.
01/05/21 Sore arm, severe headaches which was worse if laying down, fatigue, and general aches & pains in joints the very next morning 8:00 am. I took 2 Tylenol 500 mg each & rested. My scalp felt like it was on fire & itched severely.  My scalp was red but no lumps of bumps observed. That evening when changing into pajamas, I noticed both my legs had purple blotches from above my knees down to both feet. It looked worse when I stood. As a nurse, I knew this was mottling. I have never had this in my life. I immediately took 3 baby aspirin 81 mg each. I was so exhausted, I went to bed. 01/06/21 I woke up feeling better. My scalp still itched but not as bad. My legs were still mottled from above my knees down to feet, still worse when I stood. I took 3 baby aspirin 81 mg each at 08:00. My arm still was sore but less severe. Mild headache & ache and pains in joints. The mottling in my legs has continued & improved but I notice it mostly after showering now. I reported these symptoms to my doctor. He has advised not to get second dose & to continue aspirin 81mg daily. Prior to getting the vaccine I informed the infection control nurse about my symptoms that began 12/23/20 & the negative covid test taken on 01/04/21. She recommended I take the vaccine.
9JAN97 pt recv vax 15JAN97 pt father called & had a temp, lt thigh was hard & red & pt cries all the time;family called MD & pt was sent to ER;pt had infect @ inj site placed on ATB;
PC from patient 12/15/11 with report of nausea, diarrhea & chills & vomiting.
I developed Vertigo for the first time in my life beginning on 4-13-21.  I have had chronic Vertigo since.  I don't know if there is a connection, but this is something new for me.
fevers; This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. This physician reported same event for 2 different patients. This is 2nd of 2 cases.  A patient of an unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, Suspension for injection, Batch/Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date as single dose for immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated that she gave meningococcal group b rlp2086 to patient with other adolescent vaccines and patient had fevers following immunizations on an unspecified date. Event took place after use of product. The outcome of event was unknown.  No follow-up attempts are possible. No further information expected.
Patient complained of lightneadedness shortly after receiving his first Pfizer injection.  Monitored for 30 min and at 1:38 pm BP=170/90 108 pulse and 98% pulse oximeter initially.  End VSS: BP-154/98 and 99.  Texted nurse upon arrival home and fully recovered after rested at home.  Wife accompanied patient to clinic.
Case completed Covid primary series in January 20212, then was hospitalized for Covid in September 2021. At a local Hospital. Discharging physician: MD.  * COVID-19 Assessment & Plan Onset symptoms 9/23. Positivie test 9/24 AM. CXR on arrival more consistent with cardiomegaly and pulmonary congestion. Small right pleural effusion. Repeat CXR unchanged but she did have a fever, likely from covid, during admission. She presented without respiratory complaints treated with Decadron. Encourage use of CPAP at night but she doesn't tolerate. Earlier in hospital stay had periods of requiring oxygen supplementation at 1 to 2 L/min, and now has persistently been oxygenating adequately on room air. Completed treatment with Decadron, not continue at discharge
Initial unsolicited report received from a pharmacist (Director of Pharmacy) on 12 October 2016. THIS CASE IS LINKED WITH 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. (same reporter, same vaccine, same lot number). This case involves a patient of unknown age and gender, who was vaccinated with a dose of FLUZONE (batch number: UI669AA, expiry date: 30-JUN-2017 and site of administration was not reported) via intramuscularly on 04 October 2016 (also reported as over the past month). Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. On unspecified date (also reported as over the past month), following vaccination, the patient had upper respiratory issures, like bad sinus headaches, go to bed with ice on head. Abnormal amounts of phlegm in throat, runny nose and cough. It was reported that the patient required emergency room or doctor visit. Lab data was not reported. Corrective treatment was reported as no. It was also reported as patient go to bed with ice on head. The outcome of the events was reported as unknown. List of documents held by sender: none.
In March 2022 I noticed I had what looked like a mole trying to develop on my left breast. In early June 2022 it turned red and itchy and a bit swollen. On June 14th I had a mammogram scheduled and the technician stated that it may be a  sebaceous cyst. I had already reached out to my dermatologist before the mammogram. I saw the dermatologist on June 21, 2022. It was indeed a sebaceous cyst. My options were steroids or have it cut out. I received an injection of steroids on the same day. As of today the redness and swelling have decreased in the cyst. It is a little raised but not irritated. I will get another injection depending on the doctor's advice at next appointment.
Shot taken on Wednesday (Oct 15). 4 days later started having congestion, coughing and sore throat. Very aching body. Loss of appetite. Lung area very tender and painful. One round (10 days) of Tequin tablets 400 mg. Need another. (Temperature).
Approximately nine days after receiving the vaccination the injection site became raised, hot, itchy and with a 3 inch rash. This lasted for three days.
Upper left arm bright red and warm to touch lasting to 2nd vaccine in 04/2021.  By June my hearing decreased significantly prompting testing and my tinnitus has become almost intolerable.  And now, my employment has made Booster mandatory.
Received immunizations on 6/24/11. Reacted with (L) large limb swelling, pruritus and (R) arm cellulitis, pain, demarcated erythema. Tx BENADRYL, Ibuprofen, arnica.
No additional AEs were reported; The patient received first MMR II and VARIVAX  on 1/3/2023 and second MMR II and VARIVAX on 1/16/2023.; This spontaneous report has been received from another health professional referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 03-JAN-2023 the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #U015682 had been verified to be a valid number; expiration date 18-MAY-2023, and upon internal validation established as the same date) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #U039664 had been verified to be a valid number; expiration date 15-DEC-2023, and upon internal validation established as the same date) both vaccines administered for prophylaxis (dose, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported). Other suspect therapies included sterile diluent (STERILE DILUENT).   On 16-JAN-2023, 14 days after the first dose the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #U015682 had been verified to be a valid number; expiration date 18-MAY-2023, and upon internal validation established as the same date) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #U039664 had been verified to be a valid number; expiration date 15-DEC-2023, and upon internal validation established as the same date) both vaccines administered for prophylaxis (dose, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported) (inappropriate schedule of product administration). Other suspect therapies included sterile diluent (STERILE DILUENT). There was no adverse effect reported.
Given expired dose of Janssen vaccine, expired 1/20/22 4:16pm and stored in refrigerator overnight. Discovered approximately 30 minutes after patient left pharmacy. Spoke with pharmacy, no adverse effects noted. Will come in for re-vaccination
booster shot; my throat has been hurting/I have a sore on the left side of my throat/sore throat; This is a spontaneous report received from a contactable reporter(Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (Pfizer-BioNTech COVID-19), administration date 27Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021, outcome "unknown", described as "booster shot"; OROPHARYNGEAL PAIN (non-serious) with onset 27Nov2021, outcome "not recovered", described as "my throat has been hurting/I have a sore on the left side of my throat/sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: the patient have no fever no other symptoms.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Neurological: Twitching of right side of face, primarily near and at the mouth area. This continued intermittently for about a week.