chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA390A, expiry date 31st August 2021) for prophylaxis.   On 11th October 2021, the patient received the 2nd dose of Menveo. On 11th October 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that the patient received an expired dose of Menveo, which was expired on 31st August 2021, which led to expired vaccine used. The reporter did not consent to follow up.
9:30 am received vaccine, c/o dizziness 9:32 pass out - cold pack applied c/o hot, client pale and verbalized she feels like "throwing up". Client hypotensive. Client felt better 15 min later, went to bathroom 30 min after episode and after a few min. started feeling dizzy again. Client drank a coke and began to feel better. left clinic stated felt much better.
pt recvd vax & 27 days later began to exp polyarthritis, morning stiffness, pain in toe & swollen knees; tx w/ASA & intra-articular corticosteroid;
I woke up with my Menstrual cycle, 15 days early, the morning after the vaccine and had extreme night sweats the night of the shot. All other symptoms I had were normal side effects.
started to dizzy about 4 hours after given the shot.  Next morning woke up, throwing up that only lasted  1 hour. The next couple of days, still feeling dizzy, very tired, feeling like y head had a balloon in it.  Nothing serious, did not need medications, just stayed home, put my head down when needed.
No adverse event; Received Moderna Dose on 4-OCT-2022 and 25-OCT-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna Dose on 4-OCT-2022 and 25-OCT-2022) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Shellfish allergy.   On 04-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Oct-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna Dose on 4-OCT-2022 and 25-OCT-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna Dose on 4-OCT-2022 and 25-OCT-2022) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Moderna Dose on 4-OCT-2022 and 25-OCT-2022).    No concomitant medication was reported.  The patient received first and second dose of Moderna vaccine (monovalent variant) on 24-MAR-2021 and 21-APR-2021 respectively.  No treatment medication was reported.
Pt recived vaccine 5pm 2/8/07. Pt begain vomiting and diarrhea 4am 2/9/07. Pt had no fever. Pt given IV fluids.
10 days p/vax pt had febrile sz, t103.2; rash;small pink macular papular lesions (approx 8-10) bilat ear infect;sz precautions;pt education;
The evening of 7/6/2020 the patient developed patches of hives on both arms, both legs, chest and back.  The patient described them as raised red patches, ,more square than round in shape.  He stated that they were a little bit itchy, but not as itchy as bug bites.  The patient called his primary care provider's office before reporting to the pharmacy, and they advised him to take benadryl.
Information has been received from a registered nurse concerning an adult male who was hospitalized for pneumonia who on 30-MAY-2007 or 31-MAY-2007 was vaccinated into the abdomen with a dose of Pneumovax 23. Concomitant therapy included IV antibiotics, IV heparin and pain medication. The nurse wasn't entirely sure if the vaccine administered was Pneumovax 23 but was told it was administered to prevent pneumonia. On 01-JUN-2007, when the patient was discharged from the hospital he had a small, red, hard, hot to touch area at the injection site. The injection site reaction increased to a softball size and later to a football size reaction. The patient was seen by the physician and who said the reaction was an abscess. The patient was given antibiotics, ciprofloxacin hydrochloride (CIPRO) and heat as treatment. At the time of this report, the patient was recovering. No product quality complaint was involved. Injection site abscess was considered to be an other important medical event. Additional information has been requested.
needle was not well attached to the syringe and some of the vaccine leaked out and down the patient's arm.; some of the vaccine leaked out and down the patient's arm; some of the vaccine leaked out and down the patient's arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-NOV-2023, the patient received the 2nd dose of Shingrix. On 01-NOV-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: needle was not well attached to the syringe and some of the vaccine leaked out and down the patient's arm.), exposure via skin contact (Verbatim: some of the vaccine leaked out and down the patient's arm) and inadvertent exposure to vaccine (Verbatim: some of the vaccine leaked out and down the patient's arm). The outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK receipt date: 02-NOV-2023 The pharmacist called with questions regarding a Shingrix vaccination. Her brother (patient) received his 2nd dose of Shingrix yesterday (day before reporting). The needle was not well attached to the syringe and some of the vaccine leaked out and down the patient's arm, which led to incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine. The reporter did not consent to follow-up.
Developed erythematous warm rash in large (5 in.) distributions on medial and anterior thigh bilaterally 2 days after receiving immunizations below in lateral-anterior thighs.
Headache 2 hours after vaccine took Tylenol to relieve Chills 2 hours after vaccine  Lightheadedness began about 2 hours after vaccine and continues.   Sore left arm
Had a side effect after receiving the Zoster vaccine. Extreme body aches. Muscle and joint pain. Stomach pain. Very painful headaches. Also strange spasm like pain in my breast.
concerned about receiving 2nd dose; still has a red outline; raised edge; spreading to most of her upper arm; swollen; chills; lumpy on the injection site; red circle; itching; sore; red spot on her arm; red outline; huge area that is bumpy; diarrhea; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lumpy on the injection site), ERYTHEMA (red circle), PRURITUS (itching), PAIN (sore) and RASH MACULAR (red spot on her arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic kidney disease stage 3 (3rd stage kidney disease) since an unknown date and Rheumatoid arthritis since an unknown date. Concurrent medical conditions included Artificial sweetener intolerance, Drug allergy (antihistamines) and Food allergy (some additives in a "carrot cake mix".).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Feb-2021, the patient experienced VACCINATION SITE MASS (lumpy on the injection site), ERYTHEMA (red circle), PRURITUS (itching), PAIN (sore), RASH MACULAR (red spot on her arm), ERYTHEMA (red outline), VACCINATION SITE MASS (huge area that is bumpy), DIARRHOEA (diarrhea), OEDEMA (raised edge), VACCINATION SITE ERYTHEMA (spreading to most of her upper arm), SWELLING (swollen) and CHILLS (chills). On 11-Feb-2021, the patient experienced ERYTHEMA (still has a red outline) and FEAR (concerned about receiving 2nd dose). At the time of the report, VACCINATION SITE MASS (lumpy on the injection site), ERYTHEMA (red circle), PRURITUS (itching), PAIN (sore), RASH MACULAR (red spot on her arm), ERYTHEMA (red outline), VACCINATION SITE MASS (huge area that is bumpy), DIARRHOEA (diarrhea), ERYTHEMA (still has a red outline), OEDEMA (raised edge), FEAR (concerned about receiving 2nd dose), VACCINATION SITE ERYTHEMA (spreading to most of her upper arm), SWELLING (swollen) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.
Appendicitis with appendectomy on 44 year old male with no history of appendix issues.
Patient received a bivalent Pfizer COVID vaccine when a monovalent COVID vaccine was ordered. No adverse reactions, just incorrect vaccination per CDC recommendations
This spontaneous report received from a consumer concerning a patient of unspecified age and gender. The patient's height, weight and concomitant medications not reported. Medical conditions included no risk factors for lymphedema. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported), dose, start therapy date not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced lymphedema. Laboratory data (dates unspecified) included: Blood test (NR: not provided) not reported. EMG (NR: not provided) not reported. MRI (NR: not provided) not reported. Vascular ultrasound (NR: not provided) not reported and X-ray (NR: not provided) not reported. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of lymphedema not reported.
At 1432 injection given to patient; patient stood and felt lightheaded and dizzy; patient taken to observation area in wheelchair. 1435 vitals taken; patient clammy and ice pack applied; patient lying on cot and states this has happened before. 1446 patient sitting up on cot and eating crackers and drinking water. 1448 patient states feeling "much better' and sitting in observation area for 30 minutes.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 29-OCT-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
He had sudden death on Feb 4th. Unclear if this could be related to vaccination but since it was close in timing report has been filed.  No known immediate reaction to vaccination.
pt recvd vax;mom said swelling of rt eye 17dec94;noted rt eye turned in;to MD who referred to ophtalmologist; plan to observe for 6 mo;tests nl today;
Symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Symptoms) 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.   In February 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 an unknown date, the patient experienced VACCINATION COMPLICATION (Symptoms). At the time of the report, VACCINATION COMPLICATION (Symptoms) outcome was unknown.      No concomitant medications were reported. Treatment medications were not provided by the reporter.
Major body aches and night sweats at 3am nigfollowing vaccine. Advil worked wonders. Sore and tired starting a few hours after shot but very rough nights sleep. Better next day and Advil has been only treatment.
Chills; Legs hurt; Woke up drenched in sweat; Varicose veins; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Woke up drenched in sweat), VARICOSE VEIN (Varicose veins), CHILLS (Chills) and PAIN IN EXTREMITY (Legs hurt) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced HYPERHIDROSIS (Woke up drenched in sweat), VARICOSE VEIN (Varicose veins) and PAIN IN EXTREMITY (Legs hurt). On 09-Nov-2021, the patient experienced CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Woke up drenched in sweat), VARICOSE VEIN (Varicose veins), CHILLS (Chills) and PAIN IN EXTREMITY (Legs hurt) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of CHILLS, WOKE UP DRENCHED IN SWEAT, LEGS HURT and VARICOSE VEINS was not provided for SKYRIZI. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
pt recv vax 8JUL97 & 10JUL97 pt exp a h/a, congestion & tightness in chest;
muscle aches; joint aches; headaches; Chills; Short fever; swelling of my eyelids; aching of my general eye area; extreme sensitivity to light; This is a spontaneous report from a contactable consumer (patient). A 34-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) administered in left arm via an unknown route of administration on 27Feb2021 at 11:30 as dose number unknown, single for covid-19 immunisation. Medical history included Chronic Myeloid Leukemia, seasonal allergies. No other vaccine was received in four weeks. Other medications in two weeks included Dasatinib monohydrate (SPRYCEL), Cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). It was reported that the patient did not have a covid prior to vaccination. The patient did not test for covid post vaccination. There were no known allergies. On 28Feb2021 at 03:00, the patient experienced muscle aches, joint aches, headaches, chills, short fever, swelling of my eyelids, aching of my general eye area, extreme sensitivity to light. It was reported that the patient experienced most of the common side effects including muscle aches, joint aches, headaches, chills, short fever. The patient also experienced a swelling of eyelids, aching of general eye area, and extreme sensitivity to light. This was much better by day 3, but still present. No treatment was received for the adverse events. The outcome of all the events was reported as recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe onset of sharp pain in deltoid muscle where vaccine was administered. Continued shoulder/muscle pain and altered mobility/strength x3 months.
Left-sided chest pain onset 2 days after 2nd dose of pfizer covid-19 vaccine. Vaccinated on 01/30/22. pain started 02/01/22. Pain radiates to the left upper extremity. EKG completed at Urgent Care. Pt referred to local ED  for further evaluation, treatment & management (Cardiac work up, enzymes, CXR etc)
Patient called 7/3/2020 around 1030 and states that the vaccine was given in her left deltoid and she is experiencing redness, warmth, pain and swelling around injection site. Advised with provider on duty who states that patient should use ice packs, tylenol and ibuprofen. Advised patient to watch for worsening symptoms such as red streaks appearing on arm. Patient was agreeable to this and states if symptoms worsen and PCP office is not open she will seek evaluation at Urgent Care.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe
Wasn't able to add it above, but I had the COVID 19 (Johnson & Johnson) vaccine.  First night after shot, left arm felt like I was hit by a bat on the entire arm.  I also felt odd, light headed, uncomfortable.  During night (sleeping) woke up with bad headache, extremely cold, coughing.  By morning, I had SOB, coughing, sore arm.  The chills disappeared as did the headache.  Was out of work for entire week.
Then experienced incredible all over body pain/inflammation, nausea, flushed, and fatigue from about 1600 hours Monday through about 2100 Tuesday evening. Only slight fever (99.6) that night. Pain continued through today with upper body joint pain/inflammation / chest pain in deep breathing with decreasing fatigue. Currently continue with site induration of 4 inch by 2 inch, overall raised about 1/4 inch above regular surface. Only telling you b/c I am reporting my adverse effects on website for "vaccine adverse effect reporting" and if website is actually organized enough to contact my PCP (highly doubtful) you should know from me first. Thanks.
Approx. one minute after administering vaccines, pt developed erythema accompanied by hives. Pt scratched some areas. Pt was without s/s of respiratory distress. Pt given Benadryl 12/5 5ml po and Prelone 5ml po. Pt monitored for over a hour. Pt given referral to allergist, rx for benadryl and return appointment for tomorrow.
Case number PHEH2012US021376 is an initial spontaneous report from nurse received on 18 Oct 2012 with a follow up information received on 18 Oct 2012. This case refers to an adult male patient. The patient received MENVEO (batch number: M12010, expiry date: 20 Feb 2014) intramuscularly on 15 Oct 2010. The patient received only the MenA lyophilized conjugate vaccine component of MENVEO reconstituted with sterile water. The patient did not receive the MenCYW-135 liquid conjugate vaccine component of the MENVEO. No adverse reaction had occurred.
After 3/4 days. Severe pain in left shoulder that continues today. After 1 day a red rash appeared exactly on the injection site. This rash turned out to be basal cell carcinoma that required Mohs surgery treatment. Physical therapy and cortisone for shoulder.
Patient experienced a large, red rash and complained about pain in and around injection. Has been using MOTRIN for pain relief.
This spontaneous report has been received from a pharmacist and referred to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The pharmacist reported that from 21-JAN-2017 to 21-APR-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M038350, expiration date 06-DEC-2017; dose, route of administration, and frequency were not reported), for prophylaxis which were reconstituted with a properly stored sterile diluent (manufacturer unknown) (lot numbers and expiration dates were not reported). The vaccine data logger measured a temperature range from 6°F to 14°F for a total time frame of 2 hours. There was no previous temperature excursion. No adverse effects were reported, and a product quality complaint (PQC) was not involved. Additional information has been requested.
The patient reported that the injection site (from flu shot) became warm and swollen starting about 3 hours after immunizations were given. Body aches, especially of the joints, began around the same time. Issues have gradually gotten better with time over the next 2 days. On the 3rd day after immunizations were given, there is still some warmth around the injection site but the swelling is mostly down. The patient does report some shooting pain down the arm that happened later but has not happened again yet today on the 3rd day after immunizations. The patient tried to reach out to his doctor but his doctor did not respond so he has not seen anyone and he does not want to go to the emergency room.
runny nose; sneezing; tired; fever 100.9; she had a terrible sore arm; she had during the night chills that she couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she had a terrible sore arm), CHILLS (she had during the night chills that she couldn't sleep), PYREXIA (fever 100.9), FATIGUE (tired) and RHINORRHOEA (runny nose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction. Concomitant products included PARACETAMOL (TYLENOL).   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (she had a terrible sore arm) and CHILLS (she had during the night chills that she couldn't sleep). On 04-Apr-2021, the patient experienced PYREXIA (fever 100.9). On 05-Apr-2021, the patient experienced FATIGUE (tired). On 06-Apr-2021, the patient experienced RHINORRHOEA (runny nose) and SNEEZING (sneezing). At the time of the report, PAIN IN EXTREMITY (she had a terrible sore arm), CHILLS (she had during the night chills that she couldn't sleep), PYREXIA (fever 100.9), FATIGUE (tired), RHINORRHOEA (runny nose) and SNEEZING (sneezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient does not received any treatment.   This case was linked to MOD-2021-073801 (Patient Link).   Reporter did not allow further contact
I had injection site soreness for a couple of days and that was it. I started having systems on 10/24/2022 and tested positive for COVID-19 that day. I reported my positive test to my doctor, had a telehealth visit and got a prescription for PAXLOVID. I started feeling better with a few days. As of today, I continue to have sinus congestion and an occasional headache.