chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered after use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Narrative: Patient received Moderna vaccine dose 1 outside the facility on 1/6/21. He called to report a swollen throat the day after the vaccination that did not require emergent care.
Sudden and severe exruciating pelvic pain, felt like pain coming from uterus or ovaries. I collapsed and vomitted, mostly dry-heaving. The pain was 1000x more severe than any other pain I'd ever had in my life. The severest pain lasted 30 minutes, with no waves of relief. I went into shock from the pain, shaking and teeth chattering. I took ample OTC pain medications and took a hot bath, getting pain under control. I continued to have nausea afterwards for a week. I was just starting my period this day but had never had this type of pain before, and the flow of this particular period was light, including the time when I was in sever
mild fever; body and joint aches; body and joint aches; This is a spontaneous report from a non-contactable physician. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, an unspecified route of administration, from 26Dec2020 at a single dose, for COVID-19 immunization. Medical history included penicillin allergies. The patient's concomitant medications were not reported. On 26Dec2020 20:00, the patient experienced mild fever and "body and joint aches", lasted for 24 hours. Therapeutic measures were taken as a result of the events included tylenol and advil. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
Patient states approximately 5 minutes after received shot her hands started itching, developed hives on arms and abdomen, eyes and lips swollen, fingers swollen to twice their size. She states her throat felt like it was closing. Went immediately to ER, treated and released. Instructed her to follow up with own physician.
First injection on 02/27/21 only symptom was feeling tired for two or so days.  Second injection was on 04/02/21 around noon on Friday.  Saturday around 4am-ish, I woke in extreme all over body pain with chills and feeling slightly feverish and with a foggy brain.  Took OTC pain meds and went back to sleep.  Continued this cycle of pain, chills, chills and feverishness, waking to take OTC and eat lightly.  Each cycle was a little bit better.  Woke Monday feeling very tired and very very stiff but no more feverishness, pain, chills.  Noticed specific pain in left arm on Sunday but did not look at my arm.  On Monday I looked at the area on my left arm that was in pain and noticed that where the pain was a hard, hot, red area the size of my palm. At this writing, Tuesday, that area is tender and a bit warm but not red, hot, or hard. I'm also not anymore tired than usual but still stiff.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown), on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "OSA" (unspecified if ongoing), notes: OSA on CPAP; "CPAP" (unspecified if ongoing), notes: OSA on CPAP; "obesity" (unspecified if ongoing); "hypersomnia" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; ESCITALOPRAM. The following information was reported: VACCINATION FAILURE (medically significant) with onset 08Aug2022, outcome "unknown", COVID-19 (medically significant) with onset 08Aug2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2022) Positive, notes: Symptoms of COVID started 08Aug2022; (19Aug2022) Positive, notes: Patient tested positive again on 19Aug2022. Therapeutic measures were taken as a result of covid-19 with Paxlovid from 09Aug2022 to 13Aug2022.  Additional information: The patient was treated with Paxlovid (Treatment start date: 09Aug2022; Treatment stop date: 13Aug2022; lot number unknown) orally for Indication: Treatment of COVID-19. Symptoms of COVID started 08Aug2022. Paxlovid initiated 09Aug2022. Completed 5 day course on 13Aug2022 with improvement in symptoms. Symptoms returned 15Aug2022. Patient tested positive again on 19Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Pt complained of nausea, fever, chills, headache, body ache. Redness, warmth and swelling at injection side.  Took tylenol / ibprofen.   Swelling and redness improved on 3rd day after vaccination.  Other symptoms resolved.
On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 30-Aug-2022; No adverse event; The patient received dose after 30 day use date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 30-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Dose 01), COVID-19 Vaccine (Dose 03 (Booster dose)) and COVID-19 Vaccine (Dose 02). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, COVID-19 Vaccine and COVID-19 Vaccine.    On 30-Aug-2022 at 3:41 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Aug-2022 at 3:41 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 30-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 30-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received dose after 30 day use date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 30-Aug-2022).    No concomitant medications was reported.  The vaccine was delivered and placed into the freezer on 18-Apr-2022.  Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 13-Sep-2022, vial was removed from the freezer and placed into the refrigerator on 12-Sep-2022. The vial did not undergo any temperature excursion.  No treatment drug details was reported.
Pt was seen for a routine recheck on 10/5/21 with her pcp and noted the following: She does describe an adverse reaction to the Shingrix vaccine. She states that the day after she got her Shingrix vaccine she noted that she had a significant localized reaction with swelling and erythema, circumferential around her left arm extending down from the shoulder to the elbow. She also developed a cough, feeling fatigued and weak. She states she has had weakness ever since and this was roughly a month ago. The rash has resolved.
Information has been received from a healthcare professional concerning a 16 month old male who on 06-DEC-2007 was vaccinated (route and site not reported) with CONVAX (lot # not reported). On 09-DEC-2007, post vaccination, the patient contracted herpes. The patient received unspecified medical attention. At the time of this report the patient had not recovered. Additional information has been requested.
Pt called PRP office requesting to see her primary care provider.  Stated she awakened this am with hives and a rash on her arms, chest and legs.  Denied dyspnea, cough, dysphagia, or edema.  Pt referred to MD for evaluation ASAP.
pt recvd Engerix-B & on 18AP92 & 13MAY92 & 14MAY92 arm was swollen around deltoid & elbow; felt like arthritis;
Indurated, erythematous mass - 2cm in diameter at injection site 2 days later.
Sore/Pain on the Left Arm from shoulder to elbow; Covid arm; Itchy; Rash on the Left Arm from shoulder to elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore/Pain on the Left Arm from shoulder to elbow), VACCINATION COMPLICATION (Covid arm), PRURITUS (Itchy) and RASH (Rash on the Left Arm from shoulder to elbow) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN (Sore/Pain on the Left Arm from shoulder to elbow), VACCINATION COMPLICATION (Covid arm), PRURITUS (Itchy) and RASH (Rash on the Left Arm from shoulder to elbow). On 21-Mar-2021, PAIN (Sore/Pain on the Left Arm from shoulder to elbow) and RASH (Rash on the Left Arm from shoulder to elbow) had resolved. At the time of the report, VACCINATION COMPLICATION (Covid arm) and PRURITUS (Itchy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received included reporter details, suspect product details, update on initial adverse events and new adverse event.
Pt received FLULAVAL (influenza virus vaccine) 2009/2010 formula. No reaction or adverse reaction noted. (For ages 19 and over).
This is an 84-year-old male with a past medical history of CVA, hypertension, left lung base scarring, chronic kidney disease stage 3 who presents to the emergency room complaining of a cough and sore throat earlier in the day. He states he took some pain medication and when EMS arrived they found him unresponsive and was given Narcan with improvement. His oxygen was initially 84% with complaint of some shortness of breath and generalized weakness.  He denied any fever, chills, chest pain, abdominal pain or changes in bowel or urination.   Patient states he may have had a syncopal episode or fall earlier in the day.  Patient is a rather poor historian and therefore much of my information is being taken from
pt began screaming @ about 3PM & cont until about 8PM;t99;mom gave APAP & phoned MD;
Per patient report on 10/21/13: c/o left deltoid swelling, "hive", hot to touch, fever of 102, general malaise. Patient treated herself with PO BENADRYL and rest. Symptoms cleared by 10/21/13.
Driving home throat started to feel like something in it.; The right side of my neck my glands became swollen; Sore throat (r); Slight right ear ache.; My sinuses have also been bad but that is not new they are always like that; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 09Mar2021 at 15:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune hepatitis, thyroid cancer from past 20 years ago, reflux, sinus issues, and COVID-19 from Dec2020 to an unknown date. The patient had known allergies to contrast dye. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. On 09Mar2021 at 15:45, the patient was allergic to contrast dye, they made her stay for half-an-hour. Driving home her throat started to feel like something in it. The right side of her neck her glands became swollen, sore throat right (r), slight right ear ache. It had been a week and her glands were still swollen, slight ear ache and occasionally sore throat (r). The patient sinuses had also been bad but that was not new they were always like that. It was also reported that she already had COVID in December and did not feel that was the situation. The patient was not sure what to do or if she should get the next vaccine. The events did not result in doctor or other health care professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events throat started to feel like something in it, neck glands became swollen, sore throat (r), slight ear ache and bad sinus were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt vaccinated with DTP developed fever & injection site pain within 2 hrs of injection of DTP. Screaming & crying x 24 hrs after injection.
Had mild tingling on the left side of my face. Started close to the ear and spread across the left side to the middle of eyebrow.  It started about 45-1hr after getting the 1st dose.  Felt like getting a shot of novocaine from the dentist. It was mild but still concerning. I received acupuncture and after the session the tingling had gone.
Pt received HPV #3 on 1/4/08, has had continued pain at inj site since day after vaccine.  On approx 1/9/08 developed "numbness" in hand (small & ring finger) which has persisted. On 1/16/08 reports spreading "numbness" to middle finger.  Injection & numbness both on pts left upper extremity.
Patient had their booster too early. First dose on 9/20/21, Second dose 10/11/2021.
Information has been received from a registered pharmacist concerning an over 60 years old male with left leg atrophy and a history of polio who on 04-AUG-2008 the patient felt that his legs were heavy and rubbery. The patient's symptoms persisted. It was unspecified if the patient was sought medical attention. Additional information has been requested.
I am reporting as I best remember. The above listed vaccines were given on 3/24/2021, second dose 4/15/2021, and booster 12/17/2021. After receiving first does I felt an itch on my neck and my lower chin, dismissing it as reaction from shaving, no rash. After the second shot on 4/15/2021, I again an occasional itch on my neck, chin and inner arms, front of elbow, (cubital fossa). After my booster, however, within days I started severe, intense itching, and welts swelling all over my body. I still did not correlate it to my shots, and suspected I was eating something, or it was the water I wash showering in. I cant sleep at night. I have prescription of Dupixent being sent to me, which is due on 3/29/2022.
This spontaneous report as received from a community nursing service refers to a patient of unknown age and gender. No information regarding the patient's medical history was provided. On an unknown date the patient was vaccinated with PROQUAD with valid lot # J004322 (expiry date 17-OCT-214). Total dosage was not reported. No concomitant medication was reported. It was reported that the vaccine had been stored improperly. No outcome was reported. Additional information has been requested.
Administered the ZostaVax IM.  Patient reported dizziness and tingling in hands and feet.  Observed patient for 45 min, then took the patient to see a physician for further assessment.
Pain in arm injected severe, pain in all joints severe, intense headache, fatigue, all persisting for a day and a half. First night was unable to sleep except for very short intervals. Was told by nurse giving shot not to take medication. Did say I could call doctor if needed, told her I'd probably just tough it out. Was told that was best. And that's what I did. It was awful.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots"; PROTEIN S DEFICIENCY (medically significant), outcome "unknown", described as "S-protein deficiency"; ASTHENIA (non-serious), outcome "unknown", described as "experienced not being able to drive, use legs and arms, he says he couldn't put his cap when he even used to take and pick literal engines up". The event "s-protein deficiency" was evaluated at the physician office visit. Caller said they want to talk to a corporate vaccine technician, the group who put up the Pfizer Covid vaccine according to him. Reporter said he have a rare blood disorder called S-protein deficiency and that the same protein is being used in the vaccine which he doesn't have; caller said he has had 4 shots of the vaccine already and experienced blood clots where he also experienced not being able to drive, use legs and arms, he says he couldn't put his cap when he even used to take and pick literal engines up. Reporter said he went to a vascular surgeon and was checked for 2 days and was confirmed that he have S-protein deficiency. Reporter said he wants to talk to the corporate vaccine technician as he found out from his self-research that the vaccine apparently strips away the S-protein from his body which he doesn't have in the first place. Reporter displays propane language towards the vaccine calling it junk and related words. He was concerned that he got the vaccine and was not informed about the vaccine "stripping away" something in his body which he lacks in the first place, and that he also mention "BNT" compound being in his body and wanting to get it out of his system. Reporter said he didn't want to be backdoored again and would want to speak to the one who made the vaccine or threatens that he will go to the media with regards to this. Tried to reason with caller but they were hesitant on the information that was provided, saying that the information we have is wrong and that the one he has is right. Tried to give caller Pfizer's legal department's address to write his claim but caller dropped the line abruptly. "The nucleoside-modified mRNA in COMIRNATY is formulated in lipid particles, which enable delivery of the mRNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19". The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Hives) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE URTICARIA (Hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
80 year old woman with PMHx of DM, HTN, hypothyroid, Breast CA, OA, osteoporosis, venous stasis, fatty liver, reflux, hiatal hernia, B/L mastectomy presented to the ED by BLS for evaluation of back pain. Reported 1 day of sharp pain on L side of back that is worsening associated nausea. in the ED underwent CT A/P and CXR with findings concerning for B/L pneumonia suspicious for COVID. She is COVID vaccinated Pfizer 7/19/2021 2nd dose. COVID Ag positive in the ED, inflammatory markers elevated. Consulted for further recommendations.
High heart rate, shortness of breath, chest pains, and swollen hands. Could possibly have heart inflammation; waiting to hear back from doctor.
Currently Pregnant with estimated due date April 11th; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of PREGNANCY (Currently Pregnant) and MATERNAL EXPOSURE DURING PREGNANCY (Currently Pregnant with estimated due date April 11th) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, METOCLOPRAMIDE HYDROCHLORIDE (REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]) for Gastroesophageal reflux.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 11-Apr-2021. On 29-Dec-2020, the patient experienced PREGNANCY (Currently Pregnant) and MATERNAL EXPOSURE DURING PREGNANCY (Currently Pregnant with estimated due date April 11th). On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Currently Pregnant with estimated due date April 11th) had resolved. At the time of the report, PREGNANCY (Currently Pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not reported.