chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT)(no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787 US-009507513-1805USA009900:Original Case : 1805USA006787 US-009507513-1805USA009901:Original Case : 1805USA006787 US-009507513-1805USA009902:Original Case : 1805USA006787 US-009507513-1805USA009903:Original Case : 1805USA006787 US-009507513-1805USA006787:Original Case : 1805USA006787 US-009507513-1805USA009905:Original Case : 1805USA006787 US-009507513-1805USA009906:Original Case : 1805USA006787 US-009507513-1805USA009907:Original Case : 1805USA006787 US-009507513-1805USA009908:Original Case : 1805USA006787 US-009507513-1805USA009909:Original Case : 1805USA006787 US-009507513-1805USA009910:Original Case : 1805USA006787 US-009507513-1805USA009911:Original Case : 1805USA006787 US-009507513-1805USA009912:Original Case : 1805USA006787 US-009507513-1805USA009913:Original Case : 1805USA006787 US-009507513-1805USA009914:Original Case : 1805USA006787 US-009507513-1805USA009915:Original Case : 1805USA006787 US-009507513-1805USA009916:Original Case : 1805USA006787 US-009507513-1805USA009917:Original Case : 1805USA006787 US-009507513-1805USA009918:Original Case : 1805USA006787 US-009507513-1805USA009919:Original Case : 1805USA006787 US-009507513-1805USA009920:Original Case : 1805USA006787 US-009507513-1805USA009921:Original Case : 1805USA006787 US-009507513-1805USA009922:Original Case : 1805USA006787 US-009507513-1805USA009923:Original Case : 1805USA006787 US-009507513-1805USA009924:Original Case : 1805USA006787 US-009507513-1805USA009925:Original Case : 1805USA006787 US-009507513-1805USA009926:Original Case : 1805USA006787 US-009507513-1805USA009927:Original Case : 1805USA006787 US-009507513-1805USA009928:Original Case : 1805USA006787 US-009507513-1805USA009929:Original Case : 1805USA006787 US-009507513-1805USA009930:Original Case : 1805USA006787 US-009507513-1805USA009931:Original Case : 1805USA006787 US-009507513-1805USA009932:Original Case : 1805USA006787 US-009507513-1805USA009933.
swollen lymp nodes in neck; Cold sores on lips; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sores on lips) and LYMPHADENOPATHY (swollen lymp nodes in neck) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M204) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 30-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 30-Jan-2021, the patient experienced ORAL HERPES (Cold sores on lips). On 01-Feb-2021, the patient experienced LYMPHADENOPATHY (swollen lymp nodes in neck). At the time of the report, ORAL HERPES (Cold sores on lips) and LYMPHADENOPATHY (swollen lymp nodes in neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment medication was unknown.
Background: pharmacy received 49 vials of Pfizer COVID vaccine (Lot number EN6199) on 5 March 2021 and stored them in the pharmacy refrigerator.   The doses were labeled with an expiration date of 10 March 2021 at 0701.   Since starting the COVID-19 vaccine program, the facility has always used the doses before they approached the expiration date. This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses.  On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer?s recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.    When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.
Received Flu vaccine on Oct 16th at public clinic. Given in right upper deltoid.  That evening complained of right arm discomfort and ache.  Pain radiated to right breast and then to the right side of neck but this has subsided. The pain in sporadic and occurs between the right shoulder and elbow.  Using Buster-R cream to help pain.
9/6/16 office visit for cellulitis, antibiotic. 9/6/16 ED for cellulitis, IV antibiotic given. 9/7/16 OV for follow up. 9/8/16 OV for follow up.
COVID-19 positive on 10/17/2022 I started feeling congested; extremely tired; fatigue; dizziness; sore throat and a headache. I slept on and off for 4 days. I was given an antibody infusion and was feeling better however within the past 3 weeks I have developed difficulty breathing. I was prescribed an inhaler and prednisone.
I tested positive for COVID-19 on 10/10/22. On 10/8/22, I woke up with a sore throat and tested negative with an at home test.  On 10/9/22, I had coughing, headache, congestion, fatigue and this continued until 10/10/22. I started having visions of going on a ventilator and I became concerned about my breathing. I went to the clinic and was prescribed Albuterol Sulfate, and 20mg Prednisone twice a day for five days. My primary doctor started me on Paxlovid for five days. I have two more doses to finish that up. I have steadily started to feel better, but I am still testing positive at this time.
She got her vaccine, after about 4 hours she started profusely throwing up and had diarrhea, having hot and cold flashes, hot and cold sweats.  She started having heart palpitations.  She took 2 aspirins that calmed down those reactions.  About 26 hours she started feeling better.  Then about a couple of months later she developed boils on the front of her legs, one on each side, she had a total of 3, one in her mouth, one in the upper part of her mouth and on her arm.  She had never had any such lesions in the past, and is still getting them.  She states they are in the weirdest locations.  She saw her doctor and was treated with Keflex 500 mg, which did help but did have to take 2 courses of it.  It was all across her entire leg.  It was on the front of both thighs.  Those initial lesions did go away, and does get them periodically, one last week on her arm.   Nobody in her family has ever had these type of lesions, and states that they were huge, extremely painful for weeks.  She called the CDC and the lady that she spoke with told her not to get anymore of the vaccines.  She always gets her vaccines, and has never had any problems in the past.
Chest pain, neck pain, tongue and throat felt "strange" Dizziness, Headache, Lightheadedness, Weakness Requires emergency room visit or hospitalization Shortness of Breath, Myalgia
Headaches, body aches and pain, intermittent nausea vomiting.  Severe fatigue.
Injection site localized lump with slight surrounding inflammation and some redness. Sometimes it aches and sometimes it itches.
Non-Responder to 6 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021  In a case series, patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and the results of post-vaccination tests were collected from existing health records within the specified health system.    Patient received an initial hepatitis B series at 59-years-old and a second hepatitis B series at 63-years-old.   A total of 6 doses of the standard hepatitis B vaccine were administered.  The patient was considered a non-responder.  At 66-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Rash; Numbness on the left arm from her wrist down; Not feeling well; Pain at the injection site; Numbness on the left arm from her wrist down; Fever; Pain; Achiness; Chills; Parts of her face feeling funny; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), INJECTION SITE PAIN (Pain at the injection site), the first episode of HYPOAESTHESIA (Numbness on the left arm from her wrist down), PYREXIA (Fever) and PAIN (Pain) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20-A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced MALAISE (Not feeling well), INJECTION SITE PAIN (Pain at the injection site), the first episode of HYPOAESTHESIA (Numbness on the left arm from her wrist down), PYREXIA (Fever), PAIN (Pain), PAIN (Achiness), CHILLS (Chills), FACIAL DISCOMFORT (Parts of her face feeling funny) and the second episode of HYPOAESTHESIA (Numbness on the left arm from her wrist down). On 02-Jan-2021, the patient experienced RASH (Rash). At the time of the report, MALAISE (Not feeling well), INJECTION SITE PAIN (Pain at the injection site), PYREXIA (Fever), PAIN (Pain), PAIN (Achiness), CHILLS (Chills), FACIAL DISCOMFORT (Parts of her face feeling funny), RASH (Rash) and the last episode of HYPOAESTHESIA (Numbness on the left arm from her wrist down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
arm pain/feeling like a sprain; The patient's blood pressure measured lower than is normal for him yesterday and; dizziness; Tingling was felt in the left arm/both feet, and bottom of the right foot; pain, redness, swelling and hot to touch at the injection site; redness, swelling and hot to touch at the injection site; hot to touch at the injection site; swelling and hot to touch at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2020, the patient received the 2nd dose of Shingrix .5 ml. On 23rd August 2020, 6 hrs after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth and injection site swelling. On 24th August 2020, the patient experienced tingling of extremity. On 26th August 2020, the patient experienced dizziness and blood pressure decreased. On 27th August 2020, the patient experienced pain in arm. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth and injection site swelling were recovering/resolving and the outcome of the dizziness was not recovered/not resolved and the outcome of the tingling of extremity was recovered/resolved and the outcome of the pain in arm and blood pressure decreased were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, injection site swelling, dizziness, tingling of extremity, pain in arm and blood pressure decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had pain, redness, swelling and hot to touch at the injection site. The patient had Tingling was felt in the left arm, both feet, and bottom of the right foot and lasted a couple of hours.  The dizziness started day before reporting and still present but not as bad. The patient's blood pressure measured lower than was normal and had increased slightly. The arm pain present was described feeling like a sprain. The reporter consented to follow up.
My injection site swelled within ten minutes of the shot, and it?s caused my Erythromelalgia to flare badly. Erythromelalgia is a rare neurovascular condition that makes my skin turn red and get so warm that it can blister, and I?ve been stuck in one of those Erythromelalgia episodes since the injection. I?m also very tired and my leg muscles are weak and sore.
Spinal stenosis; Degenerative disc disease; BULGING DISC; TROUBLE SPOTS ON ELBOWS AND KNEES; Psoriasis flare-up; ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES; ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL STENOSIS (Spinal stenosis), INTERVERTEBRAL DISC DEGENERATION (Degenerative disc disease), INTERVERTEBRAL DISC PROTRUSION (BULGING DISC), ARTHROPATHY (TROUBLE SPOTS ON ELBOWS AND KNEES) and PSORIASIS (Psoriasis flare-up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced SPINAL STENOSIS (Spinal stenosis), INTERVERTEBRAL DISC DEGENERATION (Degenerative disc disease), INTERVERTEBRAL DISC PROTRUSION (BULGING DISC), ARTHROPATHY (TROUBLE SPOTS ON ELBOWS AND KNEES), PSORIASIS (Psoriasis flare-up), ASTHMA (ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES) and DRUG HYPERSENSITIVITY (ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES). At the time of the report, SPINAL STENOSIS (Spinal stenosis), INTERVERTEBRAL DISC DEGENERATION (Degenerative disc disease) and INTERVERTEBRAL DISC PROTRUSION (BULGING DISC) had not resolved, ARTHROPATHY (TROUBLE SPOTS ON ELBOWS AND KNEES) outcome was unknown, PSORIASIS (Psoriasis flare-up) was resolving and ASTHMA (ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES) and DRUG HYPERSENSITIVITY (ALLERGIC REACTION TO THE MODERNA/ALLERGY RELATED ASTHMA/BREATHING ISSUES) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No known allergies. Concomitant Drugs Not Reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Psorasis flare ups when it get close to the next dosage. Respiratory disorder (BREATHING ISSUES ) was the reported symptom of the event Asthma. No treatment information was provided. 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.
ONSET OF S/S 02-16-06 0300 AWOKE WITH CHILLS, BODY ACHES, FEVER, HEADACHE. S/S PROGRESSED THROUGH-OUT DAY, BECAME VERY TIRED, NAUSEA AT DINNER. S/S SLIGHTLY IMPROVED ON 2/17/06. OUT OF WORK 2/16/06 AND 2/17/06.
p/pt recv vax later that day vomited several times; devel fever of 100.8f; then devel diarrhea which persisted for 1 week;
Had temp of 104 the day p/immun given 6SEP91 went to ER 10SEP91 for persistent fever-38.7 R; septic work up done-it was neg; exam today 8NOV91-normal;
Pt received vaccinations during office visit with PCP on 10/8/19. Pt requested to have both vaccines administered in the LUE due to being right hand dominant.  Pt presented in clinic on 10/10/19 for an office visit with another provider. While being roomed by medical assistant pt reported her left arm at injection site was red and warm to the touch. Medical Assistant reported this to PCP, PA-C who recommended pt be evaluated today by our RN.
1/2 hour after administration of vaccine pt calls c/o rash, itching, and dizziness. Referred to PCP. T/C later that night, Pt states "taking Benadryl and getting better at home"
Parkinson's-like reaction; she cannot walk.; This is a spontaneous report from a contactable consumer (patient's friend). The reporter reported two reports, this is the 2nd of 2 reports. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration in 2019 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient had a Parkinson's-like reaction to pneumococcal 13-val conj vac (dipht crm197 protein) a year ago (in 2019) where she cannot walk. The outcome of events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020327996 same reporter/drug, different patient/event
This spontaneous report as received from a nurse practitioner (A.P.N.) via a company representative refers to an over 80 year old male patient with leukemia. On an unknown date the patient was vaccinated subcutaneously with ZOSTAVAX (lot # not reported). It was reported that while on ZOSTAVAX, the patient developed shingles. It was unspecified whether the patient sought for medication. The outcome was unknown. Additional information is not expected.
First day after very tired that night started throwing up for three nights with extreme vertigo and exhaustion, stop throwing up after three days , got medicine for the vertigo four days after shot took it for three days slowly the vertigo went away but just reappeared today
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Rash began 3/22/04 on trunk, scalp, arms.  Multiple sized skin lesions, some hive like, some excoriated vesicular lesions. Not all lesions classic for varicella but had vaccine 5 weeks ago. No treatment.
Woke up violently shaking from being cold, difficulty breathing, still having breathing issues but not as badly as on yesterday
I received the vaccine around 12 pm. By 9 pm I felt like I had a severe flu. Severe chills and aching occurred. By the next morning I could barely lift my head up. I took some Advil and went to work and made it most ok until about 1:30 pm. I left work and went straight to bed. The next morning I felt extremely nauseous. Walking made me want to vomit. I never did though. This lasted all day. By the next day I noticed a difference in my breathing. I felt like I was breathing as I always have but it was like I wasn?t able to accept the entire breath I was breathing in. This lasted through the next day, and then I was back to normal. Although I have never had any trouble with the flu vaccine, I had severe anxiety after getting it as a result of my 2nd COVID shot.
Member received vaccine 3/18/21 and called office today 5/6/21 to report that left shoulder has been aching constantly beginning on day 2 of receiving vaccination. States decreased ROM with pain in shoulder when moving arm across body and too painful to move arm behind body.