chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in the shoulder (vaccinated arm)), NAUSEA (Nausea) and PYREXIA (Temperature) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain in the shoulder (vaccinated arm)), NAUSEA (Nausea) and PYREXIA (Temperature). At the time of the report, ARTHRALGIA (Pain in the shoulder (vaccinated arm)) and NAUSEA (Nausea) outcome was unknown and PYREXIA (Temperature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.  It took a day and a half for temperature to go away.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling and injection site cellulitis. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling and injection site cellulitis were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling and injection site cellulitis to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. After vaccination, the patient experienced injection site reactions consistent with cellulitis, such as pain, redness and swelling. The reporter was not certain that this case confirmed with cellulitis, but the patient did voluntarily seek treatment from a physician. The pharmacist reported the all events to VAERs. The call center representative advised to reporter, called to GlaxoSmithKline if had any future events. This is one of the 13 cases reported by same reporter.
Client stated, "I was sitting in my chair for 2 minutes and then I began to feel a rush to my head. It felt like a wave of tingling all over my body and I started to feel disoriented for like 10 seconds. I then felt fine but I said to myself I need to get up and let the nurse know." Secondary RN helped transfer client into anti-gravity chair at 12:05 PM. First set of vitals were then taken at that time by Observation RN prior to Co Lead PHN responding to observation room: BP 115/75, pulse 60, O2 SAT 100%, 16 respirations per minute. At 12:08 PM Co Lead PHN advised client to take face mask off and for client to take deep breaths. Client was offered water and snacks but client declined snacks and already had a water bottle. Client stated, "I am not surprised I felt like this after the shot because back when I received my first Janssen shot the next day I felt slight chest tightness while driving. It only lasted for 15 seconds then I felt fine. I am not sure if it was due to the covid-19 vaccine so I didn't feel the need to let my doctor know." Co Lead PHN clarified whether she was short of breath during that experience while driving to which client said "no." Client stated, "I felt like I was gasping for air and not so much choking. It only lasted for 15 seconds while I was driving and I then felt fine." Client then disclosed to Co Lead PHN, "I've had similar experiences with blood draws where I feel like I'm going to faint." Client does not have any medical conditions nor is taking any medications. Client has no history of allergies. Client did state, "I am sensitive to soaps, lotions, and I always take half the dose of any medication." Co Lead PHN observed client to be A&Ox4 throughout entire conversation. Co lead PHN recommended for client to follow up with PCP regarding post vaccination symptoms and to enroll in V-SAFE. Client stated, "I have an appointment with my PCP on Tuesday, I will let them know." At 12:16 PM secondary RN educated the client on when to call 911 or go to urgent care for adverse symptoms of covid-19 vaccination. Client verbalized understanding. Co Lead PHN recommended for client to call a family member to assist the client in driving home to which client declined because she only lives 1 mile away from vaccination site. Co Lead PHN recommended for one last set of vitals after another 10 minutes of monitoring. at 12:27 PM Secondary RN took last set of vitals: BP LA 115/70, pulse 64, O2 SAT 100%. Client expressed she was ready to go home. At 12:31 PM Co Lead PHN walked with client as standby assist towards the exit of vaccination site. Client walked with steady gait and thanked us for assisting her.
WITHIN 5 MINUTES OF 2ND DOSE ,SHE STARTED FAINTING AND MOTHER GOT HOLD OFF HER AND PUT HER ON A CHAIR. SHE DOES NOT REMEMBER WHAT HAPPENED FOR 5 MINUTES WHAT WAS HAPPENING AND ALL. WE GAVE HER 5 ML OF BENADRYL TO ENSURE THERE WAS NO REACTION TO VACCINE.WE DID NOT GIVE EPI-PEN SINCE SHE WAS RESPONDING TO QUESTIONS AND DID NOT LOST CONCIOUSNESS.WE PUT ICEPACKS ON FOREHEAD ,HAND AND LEGS.IN MEAN TIME,PARAMEDICS CAME DUE TO OUR CALL OF 911 AND THEY CHECKED HER VITALS AND THEY WERE ALL NORMAL.PARAMEDICS LEFT AFTER THEIR INTERVENTION AND WE STILL WATCHED HER FOR 30 MINUTES AFTER THEN MOTHER TOOK HER HOME. SHE WAS ABLE TO WALK TO HER CAR.
Approximately 2 weeks after the administration of the flu vaccine, the patient developed eye movements diagnosed as possible mini seizures.  No EEG changes.  No other illness symptoms.  These lasted for about 1 month and stopped completely.  We are unsure if this was due to the vaccine, but it is possible as there was nothiing else to point to.  No tx was needed for these episodes and they have resolved completely.
patient stated that when she got home, she was very cold, shaking and had goose bumps.  later that day, she said that she fell down because she felt weak.  she has no appetite for the past 2 days
Administered after temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administered after temperature excursion). 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: 4-Apr-2023 The nurse reported that a patient received Boostrix on an unknown data after it was exposed to temperatures between 10 and 16 degrees celsius for an extended period of time which exceeds one week.  A pharmacist reportedly called about this, but it was not known if the adverse event was already reported.  Centers for disease control and prevention (CDC) said to revaccinate.  Caller declined for providing additional information. Did not consent to follow-up. The patient received a dose of Boostrix after temperature excursion, which led to incorrect storage of drug.
Flushing, fingers tingling, fatigue and palpitations started.  Benadryl 50 mg P O offered and taken. Observed for 30 minutes.  Had no issues after 1st dose.  Symptoms resolved and was released.
Pt received MMR vaccine Wednesday morning (5/1/19). Congestion and headache developed by that afternoon. Headache relieved with Extra Strength Tylenol. Patient took Theraflu for symptoms. Started having body aches Thursday. Took another Theraflu. Friday morning noticed a flat rash to torso and arms. Came to clinic Friday late morning. Allergy medication given and instructed patient to go to ER if headache returns or symptoms worsen. Rash was not painful and did not itch. No fever, No eye redness.
About 24 hours, post vax of 1st injection, the pt complains of neck pain. About 12 hours later, he complained of fever and bilateral knee pain and swelling. He contacted his private MD who has prescribed Celebrex.
CHILLS; SORE ARM; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 97 (unit not reported), 100.6 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and fever, and the outcome of sore arm was not reported. This report was non-serious.
Information has been received from a Nurse Practitioner referring to 7 unspecified patients of unknown age and gender. Information about the patient's concurrent condition, medical history, drug reactions/allergies and concomitant medication was unknown. On unknown dates, the patients were each vaccinated with a dose of RECOMBIVAX HB (dose and route were unknown, lot # M010671 with expiration date 02-JUN-2018). No adverse effect was reported. The vaccines had been exposed under temperature 48.9 Fahrenheit for 1 hour. There was no previous excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Within 8 hours of receiving the vaccine she began c/o her skin hurting. The following morning mom noticed hives all over her body and a low grade fever 99.5F ax. No angioedema, no anaphylaxis.  Treatment consisted of applying hydrocortisone topically, and suggested Benadryl for hives.
Ischemic stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ISCHAEMIC STROKE (medically significant) with onset 13Oct2022, outcome "unknown", described as "Ischemic stroke".  Clinical course: Patient was aware that stroke was reported as side effect and thought reporting would be helpful in adding to statistic base.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Shoulder pain and aches a lot; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 19Dec2020 at 10:30, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient wasn't diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Dec2020, the patient experienced shoulder pain and aches a lot. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered with lasting effects (sequel) from the event on an unspecified date.   Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Severe headache, burning inside the chest. Chills and sweating Tiredness, muscle pain. Pain behind the back.
pt got the pfizer vaccine dose 3 .  she immediately experienced tingling and numbness in her left foot. i called her 48 hours later and she was still experiencing the tingling/numbness
NECK, SHOULDER, ARM, HAND PAIN! Extreme and numbness. Pain meds and gabapentin. Now pain #6, no meds, 3 fingers numb.
Employee complained of dizziness and nausea and then began vomiting. Employee states that she had only eaten a kolache and nutri-grain bar this morning. Employee states after reaction that she had donated plasma this morning and was told that she was dehydrated. This information was not disclosed prior to vaccination.
Information has been received from a health professional concerning an 8 yr old male who on 05Aug97 was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt developed chickenpox lesions, in June 2005, after his brother experienced chickenpox following vaccination with varicella virus vaccine live. (WAES0506USA03232). It was noted that the pt was generally healthy. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. The pt's other brother experienced chickenpox lesions and a red left eye following vaccination with varicella virus vaccine live (WAES0506USA03092). Additional information has been requested.
Case number PHHY2011US69373 is an initial spontaneous report received from a health care professional on 29 Jul 2011 with a follow up physician report received on 19 Aug 2011. This report refers to an adolescent male patient. His medical history includes allergies (unspecified). He was given only the MenA powder conjugate component of MENVEO vaccine (batch number: M10053 and expiry date: Jan 2013) reconstituted with a sterile diluent instead of MenCWY liquid conjugate component, 0.5 ml intramuscularly in the right arm on 28 Jul 2011. No other adverse reaction was reported. Follow up report received on 19 August 2011: The patient demographics, suspect drug information and medical history were updated.
This case was reported by a other health professional via call center representative and described the occurrence of anaphylaxis in a adult female patient who received FLULAVAL QUADRIVALENT (batch number 222FX, expiry date 30th April 2018). On 4th October 2017, the patient received FLULAVAL QUADRIVALENT. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT, the patient experienced anaphylaxis (serious criteria GSK medically significant), chest tightness, pain in arm and hypotension. The patient was treated with EPIPEN, BENADRYL and oxygen. On an unknown date, the outcome of the anaphylaxis, chest tightness, pain in arm and hypotension were unknown. It was unknown if the reporter considered the anaphylaxis, chest tightness, pain in arm and hypotension to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The reporter stated that patient received the FLULAVAL QUADRIVALENT in left arm and experienced pain same arm. The patient went to the emergency room and was given EPIPEN, oxygen and BENADRYL. Then the patient recovered 2 to 3 hours after the treatment given. On 14th November 2017, the patient underwent a skin test and experienced anaphylaxis again. The reporter would like to know if we have literature on this topic. No additional information was provided.
Pt complaining of swelling, redness and heat in deltoid area of right arm, 48 hours, post vax. Treated with steroid cream and cold cloth to area and Tylenol. Saw doctor and had no more problems.
1. The first 24 hours (date of vaccination 12/29/2020:  Minor Pain at the injection site, minor Hot flashes, Moderate Headache (took Tylenol 1 gm po x 2 doses),  lack of energy, anxiety.   2. 01/16/2021 @ 20:00: Swallen Lynph node in left armpit.
Redness, swelling, some hardness developed about 5 hours, post vax, in right deltoid. No reaction in left deltoid. Parent gave child Tylenol. Child can move shoulder/arm without difficulty. Assessment: cellulitis. Plan is to treat with Keflex.
Teeth sensitivity that progressed into pressure and pain on right side of face.  Top lip and right side nostril have been numb since Sunday. Unable to bite into anything due to constant pressure felt on front teeth and ocasional right ear discomfort.
a doctor died of low platelet and brain bleed 16 days after the vaccine; a doctor died of low platelet and brain bleed 16 days after the vaccine; The is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient (doctor) died of low platelet and brain bleed 16 days after the vaccine. It was not reported if an autopsy was performed.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: a doctor died of low platelet and brain bleed 16 days after the vaccine; a doctor died of low platelet and brain bleed 16 days after the vaccine
After my vaccination my arm was sore, which I expected, but about three weeks later I felt like both of my arms were really really heavy. I had a lot of upper body pain, in my shoulders and arms. I couldn't lift my arms, it felt like something was pressing down on them. I also started to experience fatigue, headaches and just a general not feeling well. I saw my doctor in August for my physical and I started talking about my symptoms. She performed some blood work. Because I have other health issues it was difficult to treat all the symptoms. She was looking at my thyroid and some other stuff. The pain and other stuff wasn't addressed because she was concerned about a new thyroid issue that had turned into what she thought was Hashimoto's. I've had 4 steroid injections into my spine since August 2021 for back pain with a pain specialist at Hospital for the osteoarthritis but since 4/21 it has definitely gotten progressively worse, so I needed the shots. I did go to the ER at some point for sciatic spasms, the fatigue and pain. I was having issues walking- I think that was possibly in August 2021.  Diagnosed in June 2022 with PMR. I have been on Prednisone ever since. All of the symptoms I have been experiencing are related to the PMR, except issues with my cervical spine, and the side effects I've been having from the prednisone.
Rash at the injection site, and lump under the skin showed up a week after the shot.
Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a health professional. This case involves female patient who was vaccinated with ADACEL (batch number, expiration date, dose, route and site of administration was not reported) each week for five week, on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to Wrong technique in product usage process. It was unknown whether the patient had any adverse 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 Directive and Module VI of the 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. List of documents held by sender: none.
Administrated only with the the adjuvant; Administrated only with the the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) (batch number 7292M, expiry date 16th April 2022) for prophylaxis.   On 31st March 2021, the patient received Shingrix. On 31st March 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: No patient's identifiers provided. The age at vaccination was not reported. The age group opf the patient was not reported but selected as an adult as per vaccine indication. The reporter stated that, patient was administrated only with the the adjuvant component of the shingrix, which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered. No adverse event was reported. The reporter consented to follow up.
Child awoke with rash and swelling of lips and eyes. Mom carried child to Emergency Room where she was given injection of steroid and placed on Benadryl.
Ruptured Cerebral Aneurysm Left Middle Cerebral Artery Circulation (02/25/2022) leading to death (02/27/2022)
Pt initially with axillary swelling, then developed high fever and pain with movement of Right arm.  Presented to 86 CSH on 2/24.  Observed to have large axillary mass that was enlarging.  Ultrasound (only thing available) revealed 4 cm mass.  24 hours later found to have expanding area on right chest of fullness, warmth and painful movement with shoulder and arm.  Sent for eval of possible Necrotizing fasciitis.  Fever to 103.7, without any other rashes or dermal involvement.  No other recent illness or symptoms, except for severe pain and significant swelling of the right chest and supraclivicular/ axillary regions.
Patient previously was diagnosed with COVID-19 and recovered in 12/20. Patient received MODERNA COVID-19 vaccine 72 hours PTA. Patient developed soreness and achiness and fevers 48 hours PTA. This was followed by progressive redness of the skin on left upper arm at vaccine injection site. Patient was then admitted with left upper arm cellulitis with sepsis criteria.
Red, warm area longer than palm size, tender notes to L auxilla, low grade temp + malaise
flu like symptoms (chills, headache and tiredness); flu like symptoms (chills, headache and tiredness); flu like symptoms (chills, headache and tiredness); flu like symptoms (chills, headache and tiredness); Dose number: 1; Administration date: 26Jan2021/ Dose number: 2; Administration date: 09Feb2021; Dose number: 1; Administration date: 26Jan2021/ Dose number: 2; Administration date: 09Feb2021; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via unknown route of administration on 09Feb2021 at 09:30 AM as a single dose in the left arm for covid-19 immunisation at Workplace clinic. The patient medical history was not reported. No covid prior vaccination. The patient was not pregnant at the time of vaccination. There were no known allergies. No other vaccine in four weeks. Concomitant medications were reported as none. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 26Jan2021 at 09:30 AM in left arm for covid-19 immunisation. On 09Feb2021 at approximately 09:00 PM, the patient experienced flu like symptoms which included chills, headache and tiredness. The patient did not receive any treatment for the events. No covid tested post vaccination. The outcome of events inappropriate schedule of vaccine administered and off label use was unknown, while for other events was recovered on 10Feb2021 (reported as the next day) at around 5pm.  Information on the lot/batch number has been requested.