chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tenivac that expired on 24Sep2023 was administered to a patient today with no reported adverse event; Initial information was received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 70 years old female patient who reported that diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac] that expired on 24sep2023 was administered to a patient today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Sep-2023, the patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT lot U7183AA, Expiry date : 24-Sep-2023,strength was unknown) via intramuscular route in unknown administration site for Immunization .  On 26-Sep-2023 the patient developed a non-serious event of tenivac that expired on 24sep2023 was administered to a patient today with no reported adverse event (expired product administered) (latency : same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event tenivac that expired on 24sep2023 was administered to a patient today with no reported 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 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.
A spontaneous report was received from a 72 year old male patient who on 19-DEC-2014, received ZOSTAVAX (route and lot number not provided). Concomitant medications included an unspecified heart medication and high blood pressure medication. Concurrent conditions included "heart condition", high blood pressure and allergy to sulfur medications. The patient reported that he had two previous cases of shingles (dates not reported). In the latter part of October 2014, he came down with a case of the shingles that was worse than his previous two cases. He visited the doctor and was treated with two types of antiviral medications. No labs or diagnostic studies were performed. The outcome of the shingles was recovering. Additional information has been requested.
Pain at injections site, Fever of 100.9, moderate/severe body aches, chills.  No treatment. Symptoms resolved in 48 hours.
Began to feel dizzy, like vertigo. Felt hot/cold/feverish. Body aches, shakes, nauseous, exhausted and extremely sore at injection sight. Extremely sore in right armpit. Was not able to eat anything but bland food on day 2 not so hungry day most days. I?m hoping symptoms are done today (day 3) but as of now I?m still feeling them. Oh significant night sweats on second night
Rapid Cognitive Decline.  Sleep apnea testing, magnesium infusions, lumbar puncture, MRI of the brain, neuropsych testing and a  PET scan on 10/24/2023 Loss of Job, no longer driving, qualified for disability based on cognitive ability  He has been diagnosed with Frontal Temporal Dementia 10/1/2023
I did not have a reaction to the vaccine. I tested positive with a home test for COVID-19 on 08/28/2022. I had a temperature and felt achy. No congestion. I contacted my doctor and got the prescription for PAXLOVID.
Hours after the Shingrix vaccine, the patient developed a rash around the injection site on left arm. The rash spread over the course of one week throughout arm and to chest and thoracic spine, only on  left side.  The rash was associated with neuropathic pain and the healthcare provider easily identified it as Shingles.  Treatment was initiated 7 days after onset when the patient sought out health care.
Client c/o some nausea & of dizziness. Client was positioned in supine position. VS taken lying 109/66 P 67 sitting 93/60 P 60 sitting in chair 94/50 P 80.
I had normal fatigue and soreness in the arm after getting the vaccination. My arm was very sore. Since then my arm has gotten worse and now I have frozen shoulder. I can't lift my arm up past shoulder height (straight out). I am currently in physical therapy seeking treatment.
Shortness of breath that began Wednesday night (date of vaccine). Hx of COPD. Albuterol inhaler given and chest xray obtained. Pt d/c'd to home in stable condition
2nd  dose- I took steroids prednisone. nest day my brain was on fire. one week later feet was swollen and red. Couldn't stand up for long. Veins research said flow was fine. It had blood flow. I put my feet up. They didn't know what was wrong. I sent to my doctor and they sent me to the vein specialist.
I had joint pain, aches, and fatigue. I started to get a severe headache which was a migraine after I went to the Emergency Room. My arm started to swell, and I received neuropathy. I also had a herpes cold sore on my top lip and I received medication for that.
PERICARDITIS; HEADACHE; UNWELL FEELING; This spontaneous report received from a patient concerned a 70 year (69 year at the time of vaccination) old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure but under control, diabetes but under control, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient had no heart problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  The patient was not feeling well for 3 weeks after vaccination. The patient indicated he was experiencing headaches and was not feeling well about 1 week prior hospitalization. The patient had thought that he had Covid and went to urgent care. Then patient had underwent an electrocardiogram test and everyone thought patient was had heart attack. After that patient underwent catheterization procedure which had indicated everything fine with patient's heart but diagnosed with pericarditis. On 9-APR-2021, patient was hospitalized for pericarditis, unwell feeling and headaches. On 10-APR-2021, the patient was discharged from hospital (Duration of hospitalization was 1 day). The patient had indicated that he was still taking colchicine twice a day for this condition. The patient had visited the cardiologist after he was released from hospital. He was told by his cardiologist that the pericarditis was a virus which can get anywhere in the body. The patient did not feel that the pericarditis was related to the vaccine and because patient believed it would had happened earlier. The patient had a follow up with his cardiologist in OCT-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pericarditis, and the outcome of unwell feeling and headache was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210860091-Covid-19 vaccine ad26.cov2.s-Pericarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210860091-Covid-19 vaccine ad26.cov2.s-Unwell feeling, Headache. This event(s) is labeled per RSI and is therefore considered potentially related.
At 5 pm had achy arms bilaterally, later at 10:30 PM got severe shaking chills, fever 103, went to bed, woke during night with nausea, got up and vomited quite a few times, but only bile.  Achy all over, slight headache, stomach queasy.
The day after the employee received her 2nd COVID vaccine, she woke up with swollen, itchy eyelids.  She had a telehealth visit with doctor on  1/10/21 - she reported that the itchiness and swelling were along her upper eyelid near the brow line.  Denied ocular pain, EOMI,  conjunctive is not infected.  Noted slight particles in the corners of her eye but it was not crusting.  Had used hydrocortisone cream on the area but was advised by doctor to stop.  Dr encouraged cold compresses, increased fluid intake and avoid salt/caffeine.
Feeling lazier; The arm was sore after the first dose ,not quite as bad after the second dose / arm was not that sore as after the first dose; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LAZINESS (Feeling lazier), PAIN IN EXTREMITY (The arm was sore after the first dose ,not quite as bad after the second dose / arm was not that sore as after the first dose) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Cholesterol.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LAZINESS (Feeling lazier), PAIN IN EXTREMITY (The arm was sore after the first dose ,not quite as bad after the second dose / arm was not that sore as after the first dose) and PYREXIA (Fever). At the time of the report, LAZINESS (Feeling lazier), PAIN IN EXTREMITY (The arm was sore after the first dose ,not quite as bad after the second dose / arm was not that sore as after the first dose) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use included medications for cholesterol and thyroid.  Treatment information was not provided.   This case was linked to MOD-2021-363179, MOD-2021-363315 (Patient Link).
right frontal/temporal throbbing headache on 2/3/2021 (day of vaccine) followed by right eye optic neuritis on 2/8/2021. No history of demyelinating disease.
Jynneos vaccine administered intradermally; Case reference number US-BN-2022-003939 is a spontaneous case report initially received on 07-Oct-2022 from a nurse via Communication (reference number: USBAV22-1658) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose and site of administration, intradermally for unknown indication (explicitly coded as 'intradermal injection').  At the time of this report, it was unknown which dose was this supposed to be or if patient experienced any adverse event due to Jynneos.  The case is linked with US-BN-2022-003940 (same reporter).  No further information received.; Reporter's Comments: A patient of unknown demographics was vaccinated with Jynneos at unknown dose and site of administration, for unknown indication, intradermally (which is considered as intradermal injection). Injection is considered listed per company convention. At this point, it was unknown which dose was this supposed to be or if patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with Jynneos at unknown dose and site of administration, for unknown indication, intradermally (which is considered as intradermal injection). Injection is considered listed per company convention. At this point, it was unknown which dose was this supposed to be or if patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Information has been received from a 69 year old female patient with pollen allergy who on 15-JUN-2009 was vaccinated with a single dose of PNEUMOVAX 23 (lot number, route and site not reported). Concomitant therapy included allergy shots. On 15-JUN-2009, the night after received PNEUMOVAX 23 vaccine, the patient experienced a lot of pain in her shoulder and was having problems sleeping because of the pain, so she put some ice on her shoulder. Then, the next day, the patient's shoulder pain felt better, but the pain went down to her elbow and it felt like her arm "froze" because she could not move it, and she had a very red rash under her armpit. The patient took some ADVIL (manufacturer unspecified). Then the next day, the patient had bumps on the roof of her mouth that were very sore, so she went and saw her physician who took a flash light to the roof of her mouth and saw the bumps. The physician did not know why she had the bumps. The patient was given prednisone (manufacturer unspecified). No lab diagnostic study was performed. At the time of report, the patient still had some soreness on the top of her mouth, but she was recovering from the bumps and the soreness of arm. Additional information has been requested.
Felt like had the flu,  second day after shot had extreme chills where full body tensed up and thought i was going to have a seizure, i am now left with trouble with breathing hard to take full breath, a swollen lungs, on the 5th day since shot still really fatigue
BACK PAIN/LOWER AND UPPER BACK ACHINESS; WHOLE BODY ACHES; MILD HEADACHE; MILD NAUSEA; FEELING REALLY TIRED; FEVER; FLU-LIKE SYMPTOMS; WRIST PAIN; ARM PAIN/HAND /PAINFUL FEET/PAIN IN BACK OF THIG/LEG PAIN; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included some back problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced arm pain/hand /painful feet/pain in back of thig/leg pain. On 12-APR-2021, the subject experienced flu-like symptoms. On 12-APR-2021, the subject experienced wrist pain. On 12-APR-2021, the subject experienced back pain/lower and upper back achiness. On 12-APR-2021, the subject experienced whole body aches. On 12-APR-2021, the subject experienced mild headache. On 12-APR-2021, the subject experienced mild nausea. On 12-APR-2021, the subject experienced feeling really tired. On 12-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, back pain/lower and upper back achiness, and whole body aches on 15-APR-2021, and wrist pain, mild headache, mild nausea, feeling really tired, and fever on 13-APR-2021, and was recovering from arm pain/hand /painful feet/pain in back of thig/leg pain. This report was non-serious. This case, from the same reporter is linked to.
Case number PHEH2014US017926, is an initial spontaneous report from a pharmacist received on 04 Sep 2014. This report refers to a 73-year-old female patient. Past medical history and concomitant medications were not reported. On 04 Sep 2014, the patient received an intramuscular dose of FLUVIRIN (batch number: 145302). It was reported that prefilled syringe leaked out during administration and the patient did not received full dose. No adverse event was reported following this medication error (underdose).
This spontaneous report was received from a pharmacist via a company representative. The pharmacist was referring to herself, a female patient of unknown age. No pertinent medical history, drug reactions or allergies were reported. The pharmacist stated that on an unknown date she was vaccinated with ZOSTAVAX (lot number, expiration date, dose, route and frequency were unknown). No other suspect therapies or concomitant medications were reported. ON an unknown date after the vaccination with ZOSTAVAX, she developed a welt at the injection site, the welt was several inches in diameter. It was reported that the reaction resolved after 1 week without requiring medical treatment. The reporting pharmacist did not provide a causality between the welt at injection site and ZOSTAVAX. No product quality complaint was reported. Additional information is not expected since the reporter does not want to be contacted.
Information has been received from a registered nurse, via health department, concerning a patient who was vaccinated with VARIVAX (Merck).  "Within the last 2 weeks" the patient developed erythema at the injection site after receiving VARIVAX (Merck).  The patient had sought medical attention.  The outcome of the patient's adverse effect was not reported.  In follow-up the registered nurse did not provide specific identifying information as she reported that information was already sent.  This is one of several reports from the same source.  Additional information has been requested.
About 6 PM the day I received the vaccine, the arm started to become extremely sore. It was achy feeling and it radiated down to my wrist. This lasted until Sunday and it started to fade. Today it is just some soreness left at the injection site. I was taking OTC Acetaminophen 500MG between 100 MG for pain. It was difficult to sleep due to the pain. I was also putting cool compresses on it.  The pain worse when I was trying to clean my car and shovel the snow. However the cold compress and stretching did help with some of the pain. I also felt agitated for different periods times after vaccination, I felt like my hormones were out of whack and I wanted to "bite someone's head off" this lasted for about an 1 hour or so. I also had mild headaches.
7/29/09  - 2Pm Shots.  Fever - mid. of night (not extreme acc. to Mom). Total of 4 doses tylenol from shots til morning of 7/30/09.  Then did not need any.  7/30/09 12 noon - blotchy red unraised rash all over body acc. to Mom. No other complaints.  7/30/09 To ER at 5:30 PM (Generalized macular papular rash acc. to ER -Told Mom it wasn't really hives. T. 96.3 - Rect.  7/31/09 Rash cleared.  Mom said had only had 1 dose of tylenol previously since born.
Facial Palsy, patient initially went to ED, was treated with valacyclovir for Bell's Palsy. The patient followed up with us at the clinic, with no improvement. Then after PO steroids improved. Neurology was referred then as well and MRI was negative 09/2021.
no adverse event; Nurse administered expired dose of Moderna bivalent. Exp: 06Jun2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse administered expired dose of Moderna bivalent. Exp: 06Jun2023) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse administered expired dose of Moderna bivalent. Exp: 06Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse administered expired dose of Moderna bivalent. Exp: 06Jun2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Nurse administered expired dose of Moderna bivalent. Exp: 06Jun2023).    Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Warm, erythematous area to posterior right arm measuring 16cm x 15cm, with blisters to center of erythema consistent to varicella.
Hallucination, vomiting, swollen, past-out with dizziness , fever
None, Immunization should be subcutaneous but was administered IM. I called information line I was told to report to VAERS.
Patient seen in office today for seizure yesterday after vaccines; took child to ER for fever of 104.3 and developed seizure.
Extreme menstrual pain that has continued since and extremely irregular periods. It feels like an autoimmune disease where I get a low grade fever and pain in my pelvis and lower back that radiants down my legs for about 10 days over my period.  I had never had cramps before and regular periods.
No adverse event, but was given wrong form. Was given primary series version rather than new bivalent dose. She opted to return in 2 months for the bivalent version.
heaviness on left side; Headache; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received 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 03Apr2021 at 13:15 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have a history of allergies to any food or medications or others products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) and METFORMIN (MANUFACTURER UNKNOWN) both started on an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced headache and heaviness on left side. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of the event headache and heaviness on left side was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot number cannot be obtained. No further information is expected.
The Moderna Covid vaccine was administered from a vial that was accessed for greater than 24 hours.  The vial was punctured at 0803 am on 12/29/22 and a dose was given to the patient from the vial at 1001 am on 12/30/22
Very rapid onset of severe nose congestion, slight runny nose and sneezing. Lasted about 12 hours. Severe skin sensitivity ( pain when touched)  on right side of back and eventually stomach area. Took two different over the counter allergy pills over 2 days (claritin was one) , two Advil cold and Sinus pills and eventually before bed a decongestant nasal spray. The spray was the most effective. By next day symptoms were better but not gone. By third day this had cleared up. I was also tired and a bit achy for two days.
received the first covid shot on 9/27/2021 at 815AM.  I began having symptoms on 9/28/2021 at midnight. my symptoms include: left side chest pain, tingly fingers/legs/toes, severe body aches, severe headache and dizziness,  shivering, chills, sweating, could not move from my bed, plugged ears, severe exhaustion. I was not sick at the time of vaccine nor was I around anyone that had been sick. I am a very healthy person, and currently not on any medications. I tried taking Tylenol every 4 hours, and that did not help with anything.