chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received booster from expired vial; On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients; Arm sore for a day; Fatigue for 24 hrs; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm sore for a day), FATIGUE (Fatigue for 24 hrs.), EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Cholesterol and Hypertension. Concomitant products included SIMVASTATIN (ZOCOR) for Hyperlipidemia, ATENOLOL for Hypertension, LEVOTHYROXINE SODIUM (LEVOXYL) for Hypothyroidism.    On 29-Oct-2021 at 1:10 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore for a day) and FATIGUE (Fatigue for 24 hrs.). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm sore for a day) and FATIGUE (Fatigue for 24 hrs.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided. Date the vial was initially stored in the refrigerator: 28-Oct-2021, 4.30pm   This case was linked to MOD-2021-377957 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: reporter information, patient information, medical history, concomitants and events updated.
Information has been received from a pharmacist concerning himself, a 50 year old white male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The reporter indicated that he had a painful area around the injection site about the size of the palm of his hand for a few days. He also noticed some redness. No medical attention was sought and no treatment was required. The event abated and the pt recovered. A product quality complaint was not involved.  Follow up information was received from the pharmacist who indicated that on 06Dec03 at 5:00PM he developed pain at the injection site lasting approximately 48 hours. He subsequently recovered. No further information is expected.
Lump in left breast noticed on 2/25/21. By evening of 3/1/21 noticed discharge from left nipple which appeared to be colostrum and breast milk. By 3/4/21 same discharge from right breast.
anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the sixth of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced anaphylaxis in Dec2020. Therapeutic measures were taken as a result of the event and included administration of epinephrine (MANUFACTURER UNKNOWN).  The clinical outcome of anaphylaxis was unknown.    No follow-up attempts are possible.  No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505820 different patient/same drug/event
Felt like I'm carrying a golf ball under my arm it is so painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 23rd June 2022, the patient received the 1st dose of Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient reported that three days ago (the day before reporting) he/she received a dose of Shingles vaccine, for two days patient felt like he/she carried a golf ball under arm, it was so painful. The patient reported that it should be cleared up in the next day or so. Additional Supportive Information: The follow-up would not possible as no contact details were available.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose number unknown (booster), single (Lot number: GH9697), in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from an unspecified date in Feb2023 to an unspecified date in Feb2023.
Missed second moderna shot march; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second moderna shot march) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    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 PRODUCT DOSE OMISSION ISSUE (Missed second moderna shot march). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second moderna shot march) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was provided
Entire torso and knees consumed with an intense rash; Little bump under my breast; Not progressing as i hoped/doctor expected that my skin should have cleared by now; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 2021, as dose 1, single for COVID-19 immunisation; and received dupilumab (DUPIXENT, Solution for injection, Lot Number: Unknown), via subcutaneous route of administration from 27May2021 to an unspecified date, as dose 1, single for atopic dermatitis. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, following the first intake of BNT162b2 and dupilumab, the patient's entire torso and knees consumed with an intense rash, little bump under my breast. The rashes were not progressing as she had hoped. The doctor expected that her skin should have cleared by now. Dupilumab was continued. The event rash assessed as serious. It was not reported if the patient received a corrective treatment for the events. The clinical outcome of the events entire torso and knees consumed with an intense rash and little bump under my breast was not resolved. The clinical outcome of the event not progressing as i hoped/doctor expected that my skin should have cleared by now, was unknown.  Information on Lot/Batch number has been requested.
Blind spot in left eye appeared suddenly on Sunday, October 9th.  Visited optometrist on October 10th, and followed up with retinal specialist on Friday, October 14th.  Was diagnosed with CRVO (Central Retinal Vein Occlusion).  No treatment exists for CRVO.  Follow up appointment scheduled for 3 months.  Doctor recommended daily low dose aspirin to minimize chance of reoccurrence.  Vision in left eye has improved, but is still blurry.
Syncopal episode 12-15 minutes after vax. Pt was supine for imm, supine though PE, elevated gradually after 5 min, then arose, dressed, walked across room, sat there and fainted.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Apr2021 as dose  2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Sulfur" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) COVID-19. Therapeutic measures were taken as a result of covid-19. Clinical course included: The patient received Paxlovid from 11May2022 to 15May2022 for the treatment of COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd 2 doses of Engerix-B & p/1st dose was given exp pain for 2-3 days; P/recvd 2nd dose exp discomfort @ inject point; Pt is still in pain;
5th day of body aches, low grade fever, night sweats, low appetite, and chills
I went to the pharmacy to receive a TDAP booster vaccine (BOOSTRIX TDAP vaccine syringe, Glaxosmithkline) after an accidental cut on my leg . I asked to get the flu shot along with it (to get it out of the way for this year). I'm not sure if it was the combination of the two vaccines, but a few hours later I was totally wiped out. I had a mild fever, headache, muscle aches, weakness, and chills.  It was brief, through the night, but was extremely uncomfortable. My head was pounding and felt like it was on fire. I'm feeling better today, no fever--just weak and achy. I figured I would report the side effects, in case it helped.
Mom states child woke up the next day with redness and swelling at site of injection. Child was seen in our office today and site measured 9X12 redness. Child was prescribed antibiotic and cream for cellulitis
Moderate pain at injection site within a couple of hours of receiving injection. Woke up 13 hrs later with headache, lowgrade fever, chills, and muscle aches all over. Those symptoms lasted most of that day, and subsided in the evening, 27 hrs after injection.
This is a spontaneous report received from contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the COVID-19 vaccine (primary immunization series complete; manufacturer unknown), for immunization. The patient experienced an adverse reaction (had an immune reaction/diagnosis after getting the booster), with outcome of unknown. Additional information: Adverse reaction after the COVID-19 vaccine booster. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Body aches, mild sore throat, and night chills within 24 hours of vaccine. Took acetaminophen as needed to manage. On day 4, had extreme fatigue, aches, chills, with a "puffy-flushed face and neck sensation," which later in the evening, developed a full body rash resembling hives. Went to ER and took prednisone 50mg, Benadryl 50mg, and famotidine 40mg. On day 5, the rash had progressed in color (brighter red) from head down to my ankles. Had a doctor tell me it was a maculopapular rash which was blanchable on my abdomen/back. My legs were covered down to my ankles with red dots that became purple non-blanchable small bruises the next day (day 6), resembling petechiae.
Patient called to report reaction to TDaP vaccine received in (L) deltoid on 1-9-17. Patient reports that after approximately 6 hours from receiving vaccine, she developed pain/ache in (L) deltoid with a baseball size lump, which she reports has now decreased to the size of a half dollar. She reports injection site was originally erythemic, edematous, and tender to touch. She now reports area as being purple in color, pruritic, with (L) shoulder pain, tingling sensation down left arm and into (L) 4th and 5th digit. She states she had also experienced edema to the (L) side of her neck, jaw and eye, with associated tenderness. She reports those S/S have now dissipated with a small amount of residual tenderness. She reports full ROM to (L) arm, continued tenderness with movement, and no HX of allergic reaction. She denies anaphylaxis, SOB, chest pain, wheezing, difficulty breathing, headache, abdominal pain, N/V/D. She states she read on the CDC website that above stated symptoms are associated with this injection and that she just wanted it documented in her record. Patient triaged with recommendation to be seen by PACT to which she declined, stating S/S are improving. Educated patient as to worsening S/S, anaphylaxis and to seek immediate medical attention. She verbalized understanding. Informed her this nurse would place note for team, and am requesting F/U call for them to discuss with her. She verbalized understanding and was agreeable. Team notified.
3:15 - Pt was leaning against wall c/o being dizzy and going to pass out - Pt was moved to reclining position - BP 144/100, RR 44, HR 120 - No itching ect. - Respirations rapid - O2 62 - Cannula applied - Pt continued c/o thinking he would pass out - Color pink - 3:15 1 cc Benedryl administered in R arm - 3:27 Epi 1 dose (0.7 cc) administered in R thigh - 3:30 EMS arrived - 3:34 EMS transferred pt to Medical Center
At a clinic, a patient's second dose of Moderna vaccine was inadvertently administered 22 days after the initial dose. The initial dose was on 01/06/2021 and the second dose was due 02/04/2021. The patient was observed for 15 minutes and had no reaction to administration.
Got sick with what seems to have been an upper respiratory virus maybe 16-17 days later, after spending time with another family on the holidays (feeling noticeably sick the Sunday after the holidays). Once the upper respiratory symptoms have mostly passed, there is the lingering fatigue of what his wife's tests seem to show is a re-occurance of possibly CMV or some other mono-like, normally latent, virus.   Typical daily activities have not been achievable, and we have both been functioning as much as needed with quite limited energy...such that cooking a meal may be the one task for the day, and that's about it. We trade off and on who takes our little dog out.  --we have both had the Pfizer 2-shot, the first booster, then the bivalent shot. (We skipped the previous booster before the bivalent. No other long-term side effects were noted on the other shots....tho' patient has had a series of weeks of some seemingly viral activity like every month or two for a while now. Never thought that might be related. The wife has not shared those illnesses.)
Patient is complaining of tingling and numb feeling in right side of face, right arm, right leg.
pt recvd vax 20DEC94 & pt devel a local rxn the size of an egg;MD stated that the pt was not administered any other inject that day & was concerned about the rapidity of the rxn;
pt recvd vax;exp pain, redness at inject site; med affairs comment:flu shield is labelled for IM adm only;
This was a booster. Area for the booster sore,  headache, then full body aches, severe chills and dizziness
Lot Number N022727 is NOT valid for Gardasil 9, it is valid for GARGASIL; No adverse event; the patient was inadvertently administered a dose of Gardasil 9 that was expired; Information has been received from the nurse prescribing, concerning an 18-year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 23-JUN-2020, patient was inadvertently administered an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, dose number, and route were not provided) for prophylaxis (expired vaccine used). The reporter reported HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) Lot # N022727 with expiration date on 12-JUN-2020 which was not valid for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) but valid for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (product lot number issue). No additional adverse event was reported.
cluster of vesicles just below vax site; reddened base but no induration; tender to pressure; no drainage; no other rash inject site lt arm;
Patient at 3 months was given vaccinations by Dr. Less than 24 hours, patient screamed in his sleep a high pitch sound, which he never screamed prior in his young life. He also had fevers to which I gave him TYLENOL every 4-6 hours for 24 hours as advised by his Pediatrician at the time. When patient awoke in the morning, he made no eye contact and did not respond to me calling his name and stared into space for about 15 minutes. I immediately knew something was wrong and yelled to my mother for help who was visiting. I told her I was taking him to the ER and she persuaded me to stay home and monitor him. He finally just snapped out of what seemed like a trance and suddenly made eye contact and became engaging. I was just so grateful that he was okay and cried tears of joy, but I knew the vaccinations and his seizure episode was related, even though I did not know it was a seizure at the time in 2013. I decided it was in his best interest in order to save his life, and to prevent this from ever happening again, with the possibility of something worse, to terminate him receiving vaccinations. Given vaccines in 2013 at 3 months old. That night had fevers given TYLENOL every 4-6 hours around the clock for 24 hours as advised by his pediatrician Dr. Screamed in his sleep a high pitch sound never heard before. That morning no eye contact. That morning no response to my engagement with him. That morning I rushed to my mother to make her aware and ask for help. Told her I was taking him to the ER. She said to relax, breathe, give him time and he would be okay. He was in a non-responsive/non engaging/no eye contact state for about 15 minutes. When he "snapped" out of it I thought he was okay and had no idea that it was a seizure. I learned when he was in preschool in casual conversation that he had an absence (staring) seizure. My instincts and intuition knew that the vaccinations were related and I never took him back to be to receive additional shots.
tried to exercise, and her heart rate (HR) and blood pressure (BP) were extremely high; tried to exercise, and her heart rate (HR) and blood pressure (BP) were extremely high; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 02Apr2021 as dose 2, single (at the age of 62-years-old) for covid-19 immunisation. Medical history included high blood pressure (under control with medicine before), supraventricular tachycardia (under control with medicine before) and allergies to almonds (all from an unknown date and unknown if ongoing). Historical vaccine included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP6955 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 05Mar2021 at 13:30 hours as dose 1, single (at the age of 62-years-old) for covid-19 immunisation and patient blood pressure (BP) had been quite high and hard to control. Patient had now added Lisinopril and actually tried an anxiety pill because of the stress of the high BP. Patient was also wearing an event monitor now. Concomitant medication(s) within 2 weeks of vaccination included metoprolol tartrate taken for high blood pressure and supraventricular tachycardia, start and stop date were not reported and multivitamin for unknown indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 03Apr2021, the day after the second shot, patient tried to exercise, and her heart rate (HR) and blood pressure (BP) were extremely high, and patient could not get her heart rate (HR) back to normal after her workout. Events were assessed as non-serious by the reporter. The outcome of both the events was unknown.  No follow-up attempts are needed. No further information is expected.
2nd dose of Shingrix 1 month after the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comment: The reporter reported that, a patient received their 2nd dose of Shingrix 1 month after the first dose was given.  The reporter wanted to know that, does the patient need to be redosed. The reporter stated that, he was an intermediary and did not have any additional information on the patient during the encounter. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a patient received their 2nd dose of Shingrix 1 month after the first dose was given, which led to shortening of vaccination schedule.