chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIVER DISORDER (Discrepancy near her liver), URTICARIA (Hives) and PRURITUS (Hives were itchy) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced URTICARIA (Hives) and PRURITUS (Hives were itchy). On an unknown date, the patient experienced LIVER DISORDER (Discrepancy near her liver). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency; CLAVULANATE POTASSIUM for Adverse event, at an unspecified dose and frequency; VITAMINS NOS for Adverse event, at an unspecified dose and frequency and PROBIOTICS NOS for Adverse event, at an unspecified dose and frequency. At the time of the report, LIVER DISORDER (Discrepancy near her liver), URTICARIA (Hives) and PRURITUS (Hives were itchy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high (High) high. No concomitant medications were reported.
limited range of motion; pain to both arms and hands; This is a spontaneous report from a contactable nurse. A 92-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 24Jan2021 (Batch/Lot Number: EN5318) at a single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient had the first dose in left arm (LOT EJ1686) on 03Jan2021. The nurse reported that patient is in a long term care facility and began with complaints of left arm pain on 26Jan2021 then complained of pain to both arms and hands on 01Feb2021. She says the patient has limited range of motion from unknown date and still, and is complaining of pain still. She says that the patient was started on ibuprofen 600mg every 8 hours as needed by mouth, and was sent to the ER on the 10th for evaluation, where they did a CT and lab work, which came back ok, and he was sent back to the facility. The patient was not admitted when he went to the ER, he was evaluated, then sent back, he returned the same day. The reporter mentioned that it seems the events were a little more than a minor reaction. The reporter mentioned the events does not meet the VAERS criteria for a serious event, but it did disrupt the patient's ability to do normal function, as he has needed help getting dressed. At first he reported 10/10 pain and was requesting to go to the hospital, and now his right arm is much better, he says a 5/10 pain level and left an 8/10 pain level. She says that he admitted to pain this morning, but he did decline pain medication, so pain is still remaining. Outcome of pain in extremity was recovering , limited range of motion was not recovered. Therapeutic measures were taken as a result of pain in extremity.
Reaction- local swelling in right arm (BPAT). Swelling from elbow to shoulder. Seen in ER 05/04/2003. Placed on Augmentin, Vaccine given 05/03/2003
The vial which was expired on 11-Mar-2023 was initially stored in refrigerator on 17-Mar-2023 and was administered to patient on 24-Mar-2023; No adverse event; Administered an expired Moderna monovalent vaccine to one patient as their second primary dose.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered an expired Moderna monovalent vaccine to one patient as their second primary dose.), PRODUCT STORAGE ERROR (The vial which was expired on 11-Mar-2023 was initially stored in refrigerator on 17-Mar-2023 and was administered to patient on 24-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 074B22A and 074B22A) for COVID-19 prophylaxis.     It was unknown if patient had allergies or was tested positive for COVID-19. It was also unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 24-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Mar-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered an expired Moderna monovalent vaccine to one patient as their second primary dose.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial which was expired on 11-Mar-2023 was initially stored in refrigerator on 17-Mar-2023 and was administered to patient on 24-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered an expired Moderna monovalent vaccine to one patient as their second primary dose.), PRODUCT STORAGE ERROR (The vial which was expired on 11-Mar-2023 was initially stored in refrigerator on 17-Mar-2023 and was administered to patient on 24-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered an expired Moderna monovalent vaccine to one patient as their second primary dose.) and PRODUCT STORAGE ERROR (The vial which was expired on 11-Mar-2023 was initially stored in refrigerator on 17-Mar-2023 and was administered to patient on 24-Mar-2023).    Concomitant drugs were not reported.  It was reported that a monovalent multi dose vial of size 5.5 ml was not exposed to any temperature excursion.  Treatment medications were not provided.
Received 2nd COVID vaccine on 02/10/2021. Healthcare provider received phone call on  2/15/21 from patient stating that her arm is red, warm to the touch and itchy.  No respiratory issues.
DIZZY; BAD FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced dizzy, bad fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad fever, headache and dizzy was not reported. This report was non-serious.
severe diarrhea for 3 wks, including 5 nites up all nite w/ diarrhea, headaches, weak, nausea, severe aching besides pain from injuries. unable to eat as it caused immediately more diarrhea.
Information has been received from office staff concerning a 4 year old caucasion male with no relevant medical history who on 06/27/2000 was vaccinated on the left side with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 632724/0087K).  Concomitant therapy on 06/27/2000 included a second dose on the right side of measles virus vaccine, live mumps virus vaccine, live rubella virus vaccine.  There was no illness at the time of vaccination.  On 03/16/2004, at 14:40, the patient developed a rash that erupted on the trunk area, hand and face with approximately 40 lesions.  It was noted that during the office visit at 14:40 some lesions had vesicular tops with fluid filled tops and itched.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No further information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a 15 month old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on 15-DEC-2014, the patient was vaccinated with VARIVAX (Merck) inj that was improperly stored (0.5 ml once, subcutaneously; lot number not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
RUE EDEMA, R AXILLA LYMPHNODE EDEMA & TENDERNESS.
Anxiety (systemic effects); Sleeplessness (systemic effects); This case was reported by a pharmacist via call center representative and described the occurrence of anxiety in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included medication unknown (Epidural).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced anxiety and sleeplessness. On an unknown date, the outcome of the anxiety and sleeplessness were unknown.   It was unknown if the reporter considered the anxiety and sleeplessness to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: She had a patient who had epidurals in their neck and was experiencing symptoms of anxiety, sleeplessness, etc.  She was certain patient was having systemic effects.  She was wondering if this was a good time for patient to receive 2nd dose of Shingrix.  The reporter attempted to callback RPh (registered pharmacist) 3 times at the time of reporting but unable to reach RPh (registered pharmacist). The reporter consented to follow up.
Headache; Sore throat; recently got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Lot number: EN6208) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "not recovered", described as "Headache"; OROPHARYNGEAL PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "Sore throat"; ILLNESS (non-serious) with onset Apr2021, outcome "unknown", described as "recently got sick".  Additional Information: The events started about 4 or 5 days before the day of report. Because of the events, the patient cannot attend his second dose. He was not feeling healthy to get it so was asking for rescheduling the second dose.  No follow-up attempts are possible. No further information is expected.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/6/2021 and 3/27/2021. Patient started having cough and sneezing around 8/11 after going out of town.  She then developed nausea, vomiting, and diarrhea on 8/12.  Patient presented to ED on 8/17, o2 sat was 75% on room air.  She was placed on a non-rebreather but was saturating at 100%. Imaging showed multifocal pneumonia. Patient was treated with dexamethasone, remdesivir, and baricitinib . Patient continued to experience respiratory failure. Patient developed AKI and acute delirium and was unable to safely swallow. Dobhoff tube was placed, and she received enteral nutrition. She developed worsening hypoxia on 8/25/21. Patient continued to have acute worsening of breathing, became apneic, and expired on 8/25/21.
This spontaneous report was received from a consumer, a 27 year old female patient reporting on herself. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately 2001 ("15 years ago"), the patient was vaccinated with VARIVAX (dose, route, lot # and expiration date unknown). In approximately April 2016 (about three weeks ago), the patient had routine blood work done which showed no titers (antibody test negative) after receiving VARIVAX. The patient had visited her physician however she did not receive any treatment for the event. No product quality complaint was involved. The patient had not recovered at the time of this report. Causality was not provided by the reporter. Additional information has been requested.
Local irritation at the vaccination area; redness, warm to touch, painful, itching, swollen.
Malaise, generalized arthralgia, headache, nausea (no vomiting), fatigue
eye floater; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (eye floater) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM, MAGNESIUM, VITAMIN E NOS (VITAMIN E + MAGNESIUM), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), MULTIVITAMIN & MINERAL, ASCORBIC ACID, VACCINIUM MACROCARPON (CRANBERRY + C) and NAPROXEN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VITREOUS FLOATERS (eye floater). At the time of the report, VITREOUS FLOATERS (eye floater) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details was included.
Post vax, teh pt developed a vesicular reaction at the injection site. The pt sought unspecified medical attention.
Pt recvd vax 26JUN92 & w/in a 1/2 hr exp urticarial react; approx 6 hrs later devel swollen uvula & palate; seen by MD dx angioneurotic edema;
a patient 12 years old came in for the second dose and after 5 minutes of giving her dose she had a split second syncope while she was waiting for her post vaccination observation time. She was ok after that split second and waited for 30 minutes with her dad. While waiting dad mentioned that she had experienced similar syncope last time with her non-covid vaccine as she gets very very nervous and anxious with immunizations. They were checked upon continuously and she was doing ok. After 30 minutes her dad confirmed she was ok and they left.
Patient came to ED with increasing cough and back pain.  Patient was admitted for Covid and increased troponin.
The vaccine that was administered on 12/22/2022 had expired on 12/20/2022.  The recommendation is to repeat the dose if an expired vaccine was given to a patient. The patient can get the repeat dose as soon as possible. There is no need to wait a minimum interval between the expired dose and the repeat dose with an inactivated vaccine.
V/S stable. Minimal erythema around left eye bite mark. Allergy vs hives secondary to insect bites.
Acute reaction a few minutes after FLULAVAL was administered. Patient experienced diaphoresis, shortness of breath, flushing, dizziness, and feeling as if she was going to pass out. Monitored for 2 hours. BP, HR, O2 sat, cardiac enzymes, EKG all stayed stable. Slowly improved with O2 and Sl. Nitro. No rash/hives. Monitored for 2 more hours, stable and tired condition.
Lightheaded, fatigue, headache, body aches, injection site pain. Beginning at approximately 6 hours after injection. By 24 hours, easing of symptoms noted but not completely gone. Treated with Tylenol. Did not experience any fever.
shingles "in her head"; Caller states that she is not feeling well; tired with a headache; nauseated; headache; experienced vomiting; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on 20May2021 as 1st dose, single dose for covid-19 immunization. Medical history included rheumatoid arthritis and fibromyalgia. The patient's concomitant medications were not reported. The patient stated that she had first dose Thursday, she felt fine Friday no side effects on Thursday or Friday. On 22May2021, Saturday she felt really nauseated, and had a really bad headache. She started vomiting Saturday night. Sunday she was still nauseated. On 24May202, Monday her nausea was gone but she was very tired and still had a headache. She states she has a history of Rheumatoid Arthritis and Fibromyalgia and wants to know if those could be contributing to her adverse events. She also states she is just getting over shingles in her head.  she is still tired and has a headache. Patient asked how long she can expect this to last. She stated that she was not feeling well at this time and would rather call back later when she feels better to do a report. The outcome of the event nauseated was recovered on 24May2021. The outcome of the event tired with a headache was not recovered and outcome of the events vomiting, shingles in her head, not feeling well was unknown.
Case number PHEH2016US030194, is an initial spontaneous report from a consumer received on 15 Nov 2016. This report refers to an 82 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1618501) into left arm, at a dose of 0.5 ml, intramuscularly on 24 Oct 2016. On 05 Nov 2016, the patient left knee started hurting and having excruciating pain. The outcome of the events was reported as unknown. The seriousness of the event was reported as serious (disability). The causality of the events was not reported. This case was lost to follow up.
The patient called me today, 2/24/22, and stated that she was hospitalized shortly after receiving the first dose of the Moderna vaccine on 1/28/22 because she was throwing up blood. She said she was then rushed to dialysis (she is a regular dialysis patient). This is all the information that she gave me about the incident. She has recovered as of 2/24/22.
Dizziness, nausea, headache & arm numb about 10-15 minutes after injection. About 4 hours after injection I had the shakes and my muscles kept cramping esp in my feet, I also kept falling asleep from exhaustion. About 8 hours after injection I was completely exhausted but shivering, I took my temperature & it was 100. Now I am approx 24 hours after injection and my head hurts so bad it feels like someone hammered some nails into my skull, my skin in blotchy in color, my eyes are puffy, I keep shivering and my vision is blurry.
This case was received from a consumer (the patient's grandmother) on 03 November 2008. Seriousness Criteria: Other-Medically Significant. A three-year-old male patient received an injection of FLUZONE SV '2005-'2006 USP (lot number U1747AA) on 28 October 2005. On 05 November 2005, approximately eight days after vaccination, the patient developed paralysis of the left leg and mouth. According to the reporter, the patient was seen by neurologists and other specialists, and underwent numerous scans and tests, but no diagnosis was given (test results and treatment were not reported). He also developed ADHD and ticks, which were reported as ongoing. By April 2006 the patient was walking and eating by mouth again. Of note, the patient was discovered to have only one kidney in March 2006, which had been causing hypertension per the reporter. He received FLUZONE SV '2008-2009' on 28 October 2008; at the time of the report, no adverse events had been noted.  1/15/09 Received medical records as part of follow-up. Office visit 11/7/2005 states pt limping & no weight bearing left leg for 3 days.  Received fluzone 01747AA in left arm on 11/7/05.   RTC 11/8/2005 & referred.  1/15/09 Received medical records as part of follow-up. Office visit 11/7/2005 states pt limping & no weight bearing left leg for 3 days.  Received fluzone 01747AA in left arm on 11/7/05.   RTC 11/8/2005 & referred.
Background: (Name) 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  MOB 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.
Developed papular rash approx 5 d post Twinrix vaccine with generalized urticaria. Rx cantihistamine-resolved over 2 days.
Patients mother took child to Urgent Care 11-17-07 for limping - redness to site of vaccines. They measured a 5 x 2 1/2" reddened area to (L) anterior mid thigh. Injections given 1 1/2" measured apart sites.
I started reacting  5 hours after my vaccination and intensity increased to its fullest over night.  I became very ill for 48 hours.  I couldn't eat, or drink, I slept most of the time.I developed  severe joint, long bone and muscle pain.  My pain was much more severe than my Lupus flares.  My dailey pain management  did nothing for this pain which also happened  during the first month I was sick with covid.  I sweated intensly.  I had severe headache  and nausea.  The site of injection swelled and became red hot and tender to the touch.  It was a ful week before  I recovered from this injection.  I slept continuously  for 4 days.