chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date.) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date.).    No concomitant medication was provided by reporter. The date the vial was initially stored in the refrigerator 22-Jul-2022. All patients have not reported any symptoms. No patients have received.any additional doses, medications or treatments to the knowledge of the vaccination provider. No temperature excursions.
still ended up in da hospital for 4 days. Got pneumonia; low blood pressure; Initial information received on 18-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer.  This case involves an adult and unknown gender patient who got pneumonia and low blood pressure after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (with unknown formulation, strength, route, lot number, Expiry date and at unknown administration site) for prophylactic vaccination(immunization).  On an unknown date, the patient was diagnosed with  pneumonia (pneumonia) and  low blood pressure (hypotension) (unknown latency) following the administration of influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both events.  At time of reporting, the outcome was Unknown for both events.  Seriousness criteria: hospitalized for both events.; Sender's Comments: Sanofi company comment dated 26-Dec-2022:  This case involves an  Adult and unknown gender patient who got pneumonia and low blood pressure after receiving influenza vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Red, swollen, hot and itching at injection site. Intermittent dizzy spells, nausea, diarrhea and severe pain in left arm pit, arm which radiates down arm and into my neck on the left side. The pain hurts in my breast as well and there is swollen lymph nodes under my arm
Patient desribed pain across shoulders and neck the evening of the vaccination, then a week later the pain increased tremendously and spread to the arms.  Patient reports still being in pain as of 11/03/2016.
Itching all over his body; This case was reported by a other health professional via sales rep and described the occurrence of generalized pruritus in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The age of vaccination was not reported. The reporter was sales representative who was reporting an adverse event about Shingrix with limited information about the event, patient, and vaccine. The reporter stated that a representative from one of her accounts reported that a patient was coming in to be seen due to having itching all over his body after his first Shingrix vaccine (Anatomical Site was reported as unknown). The reporter stated that the patient got the vaccine not from the healthcare professional's office from where he/she was reporting the adverse event. The reporter had no further details to report. The reporter consented to follow up.
After the 2nd dose vaccine, that evening around 6pm, I had flu like symptoms of fever, body aches, pain, and headaches. I did take two ibuprofens at 2am. The next day, I just felt miserable and did not go to work. It took about two days for the symptoms to resolve and for me to feel better to go back to work.  On 4/1/2021, I went to do my normal work out and I noticed my right arm would not abduct with a 5lb weight. I also notice numbness and tingling on my right arm starting my scapula and armpit area down to my hands. I started to go downhill fast. I lost complete ability to retract my shoulder blade and noticed my range of motion has decreased. I contacted my doctor to schedule an MRI. The MRI came back normal. I consulted a shoulder surgeon. X-ray for shoulder and scapula came back normal. I also contacted a neurologist who did bloodwork, and everything came back normal. I did a nerve conduction test, which showed denervation in the right dorsal scapular nerve and right accessory nerve. I went through physical therapy, prescribed prednisone and meloxicam and have recovered. I feel I am recovered 80% and still working on regaining full strength.
Patient presented with itching and redness on left arm, which is the arm that the immunization was given. Upon alerting the pharmacy of the reaction, the patient was given  a 25mg  dose of Diphenhydramine. Shortly after taking the medication, the patients symptoms began to subside.
As a clinical monitor, I was called over to assess a driver slumped over in his seat. He had just received the second dose of the Pfizer vaccine approximately 10 minutes earlier. The passenger (his fiance) said he was acting normal until she heard him grunt and then realized that he was passed out.   While attempting to lay flat, I performed a jaw thrust that yielded a stridulous inspiration but was still unresponsive. He did not have a palpable carotid pulse. Paramedics was summoned emergently. Within 30-45 seconds, he awoke but was confused and amnestic to the event. He had no physical complaints and no significant medical or allergy history.   I auscultated his larynx (no stridor) and his lungs (CTA). His initial vitals: BP 90/51  HR 61  VR 16  SaO2 100% An electrocardiogram demonstrated a sinus rhythm without ischemic changes or evidence of conduction delay. His glucose was 119.   Over the next 30 minutes, he was able to drink two bottles of water and some orange juice. That said, he still said he "felt off." Repeat vital signs:  BP 118/62  HR 69  SaO2 100%.    The medics advised him to follow up with his doctor, preferably today. His fiance agreed to drive him to an ED near their home for a more thorough evaluation. I provided her my phone number to provide to the ED for any questions.   His clinical syndrome was consistent with a syncopal episode associated with orthostatic hypotension. Low suspicion for anaphylaxis.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On an unknown dates these patients were vaccinated with doses of improperly stored ROTATEQ (dose, frequency and lot# were not reported) orally. No adverse effects were reported. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Is it normal for my body temperature to drop; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (Is it normal for my body temperature to drop) in a patient of an unknown age and gender 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 BODY TEMPERATURE DECREASED (Is it normal for my body temperature to drop). At the time of the report, BODY TEMPERATURE DECREASED (Is it normal for my body temperature to drop) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) blood pressure is normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.
Syncope episode with body movements,], pt. awoke was checked by RN's & MD and given fluids & cookies. (patient stated when she woke up this happens w/ every vaccine)
1. Tingling Pins & needle in arm, hand, finges, toes, leg  2. Shooting pain in area of injection to shoulber especially when I extend arm toward the back of my body to reach or getting dressed or undressed. Sometimes when my arm is just relaxed. It has slowed me down for sure even putting my seat belt on. Pharmacist told me to go to my doctor after speaking to him Dr. Visit 9/16/20 Doctor said injection was given improperly, maybe hitting nerve or muscle, not sure. told me to try heat. I have been told to wait each time I talk to phamacist at corporate office to see if it improves. I have tried to be patient and do what is right. As of today it is still giving me issues. I have been favoring my arm so I won't have pain. I am very afraid to have any more vaccine shots to be honest. pain also below injection site just above elbow. Kind of all over the place.
Information has been received from a respiratory therapist concerning a female (age not provided) who on 10-Nov-2005 was vaccinated IM with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot # 649988/0629P). The patient also received influenza virus vaccine (unspecified) on the opposite arm. No reaction to the influenza virus vaccine was reported. On 10-Nov-2005, the patient developed a little swelling and heat at the injection site. Two hours later the entire arm was swollen and she was unable to drive. She was told by the physician to go to the emergency room (ER). On 11-Nov-2005, a friend drove her to the ER and she was treated there. The patient's outcome was not reported. A little swelling and heat at the injection site and swollen arm were considered to be other important medical events (OMIC) by the reporting respiratory therapist. There was no product quality complaint involved. The respiratory therapist also provided information regarding another patient's experience with pneumococcal 23v polysaccharide vaccine (WAES #0511USA01974,0511USA02334). Additional information has been requested.
pt recv 1st dose of  varicella vax 9/95 & on 4/98 pt exp fever of 101also a case of shingles, lesions on chest which extended around back in a linear fashion, pain w/lesions.
Shoulder pain. Injection  given too high up in the shoulder. It hurt at the injection site when I was  given the injection, but the the shoulder pain started at 5pm the same day. I couldn't raise my arm and moving it hurt. It even hurt when I'm just sitting not moving it. I had to sleep sitting up because it hurt so bad. Today, seven days later, the pain is not as overwhelming, but it's still there.
4 hrs later got dizzy, nausea, stomach ache, got diarrhea, went on liquid diet and took 2 TYLENOL, lasted 24 hrs, ate light for 2 days, arm was sore for the week.
Unknown what if any adverse event may have occurred.   This report is being submitted following a periodic review of death certificates .    Death certificate for this individual indicates "recent COVID vaccine" in   "PART II. OTHER SIGNIFICANT CONDITIONS contributing to death but not resulting in the underlying cause" However, no record of COVID-19 vaccine administration is available in the state's immunization registry or on the death certificate.
Both times like mini version of covid which I had a year ago.; Both times like mini version of covid which I had a year ago.  Now right side of my neck hurts and still inflamed.  Feeling extremely fatigued.  Headaches.  Exhaustion; This is a spontaneous report from a contactable other HCP(patient). A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262 and expiration date was not reported) via unspecified route at right arm on 20Jan2021 at 09:15 AM as single dose for covid-19 immunization. Medical history included arthritis, joint issues, chronic pain in knees and back. The patient's concomitant medications include aspirin or tylenol occasionally. The patient was sensitive to augmentin and allergic to insect stings. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 16Feb2021, at 03:00 AM, both times the patient had like mini version of covid which she had a year ago. Now right side of her neck hurts and still inflamed, feeling extremely fatigued, headaches and exhaustion. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events of drug ineffective, suspected Covid-19 and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Severe tinnitus in both ears.  The ringing has been constant since the day after receiving the vaccine.  I have not made an appointment with any health care provider yet, because all research I have done does not seem to describe any treatment for it.
Began running fever of 100 about ten hours after injection, hyperventilating, extreme discomfort, nausea, headache during even. Vomiting (dry heaves) beginning around 4 am (about 18 hrs after injection). Ambulance called, EKG and vitals checked. offered to transport to ER but decided to wait until local clinic opened at 8 am. Was given anti-emetics and two bags of IV fluids, plus oral tylenol. Discomfort continued throughout the day, headache lasted until about 40 hrs after injection.
Nausea; tired; feeling hot (sweating); feeling hot (sweating); weak; loss of appetite; diarrhea; feeling unwell; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 at 14:30 as dose 5 (booster), single (Lot number: GH9646) at the age of 64 years, in right arm for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: SHINGRIX, on 04Sep2022 as dose number unknown, single. Past drug history included: Batrim, reaction: "known allergies: Batrim". Vaccination history included: BNT162b2 (Dose 1, Lot Number:  EN6198), administration date: 05Mar2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Lot Number: EN6208), administration date: 26Mar2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3, Lot Number: 301308H), administration date: 24Sep2021, when the patient was 63-year-old, for COVID-19 Immunization; BNT162b2 (Dose 4, Lot Number: FT4989), for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 12Sep2022, outcome "not recovered"; DIARRHOEA (non-serious) with onset 12Sep2022, outcome "not recovered", described as "diarrhea"; FEELING HOT (non-serious), HYPERHIDROSIS (non-serious) all with onset 12Sep2022, outcome "not recovered" and all described as "feeling hot (sweating)"; MALAISE (non-serious) with onset 12Sep2022, outcome "not recovered", described as "feeling unwell"; DECREASED APPETITE (non-serious) with onset 12Sep2022, outcome "not recovered", described as "loss of appetite"; FATIGUE (non-serious) with onset 12Sep2022, outcome "not recovered", described as "tired"; ASTHENIA (non-serious) with onset 12Sep2022, outcome "not recovered", described as "weak". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Symptoms have not improved in over a week. The patient had no COVID prior vaccination.  Follow-up attempts are completed. No further information is expected.
Headache, Myalgia, Fever, stiff neck, sore arm Narrative:  Other Relevant History:
Received vaccines 08/10/04-approximately 4 hours later high pitch cry as if in pain (on and off), feet and lower legs swollen. Pink from injection site to toes. Bilateral legs, fever to 100.2-went to ER-Motrin-fever resolved, crying resolved. 1cm to feet-swelling/redness of legs resolved 12 hours later.
Client states that 5 minutes post vaccination he began to feel swelling of the throat, dizziness and nausea. Observation area leads alerted by  nurse and MD notified. Client evaluated by observation leads and given Benadryl 50 mg/1ml. Symptoms improved and client released by Dr.
Within 2-5 minutes of receiving H1N1 injection to R deltoid, pt began experiencing pain up and down arm along with feeling dizzy, pale, sweaty, did not improve 30 minutes supine in clinic. + nausea, no vomiting. Taken via ambulance to ED, given IVF, states she is recovered 11/16. She verifies correct IV location.
Didn't get the second half; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (Shingles runs in patient's family). Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The patient self-reported this case. The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Multiple papules and patches on head, neck, arms, legs, chest, face, and back.
Product storage error; dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, there was a confusion between the expiration date printed in the carton the expiration date when the QR code was scanned.   The vial was initially refrigerated on 26-Oct-2021, the vial did not undergo any temperature excursion and patient did not experience any adverse events.  No treatment medications were reported.
Redness, warmth and swelling up to 3? X 4? oval across the upper arm. Lasted 7 days, then slight bruising; Hardness at injection site, 1? Slight pain and itching.
Swelling of upper arm (at site of injection) from elbow to shoulder- warm to touch pt seen by MD who prescribed antibiotic.
pt recvd vax 8JUL95 & 20jul95 pt exp generalized rash; no further details were provided;
Mild soreness at injection site following second dose of vaccine, otherwise, no symptoms or problems until Monday, June 28, 2021 at 9pm. Along with many other athlete participants, I experienced severe, acute, urgent, frequent watery diarrhea which lasted for 10 days. The Health Department investigated the outbreak. Suspcion was a parasite or bacterial infection acquired from a lake. Symptoms resolved with Metronidazole and Zofran.
Sore left arm; Leg muscle pain; Fatigue; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 27Apr2021 at 10:00 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included norethisterone acetate; ethinylestradiol (JUNEL FE 24), levothyroxine 112 micrograms (MANUFACTURER UNKNOWN) and metformin hydrochloride (METFORMIN ER 500) all for an unknown indication from an unknown date. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 06Apr2021 at 10:00 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Apr2021 at 20:00, the patient experienced sore left arm for 48 hours, leg muscle pain for 08 hours, fatigue for 24 hours and low-grade fever for 30 hours. The clinical outcome of the events muscle pain was resolved on 28Apr2021 at 04:00;  fatigue was resolved on 28Apr2021 at 20:00; low grade fever was resolved on 29Apr2021 at 02:00 and sore left arm was resolved on 29Apr2021 at 20:00.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.