chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered post the expiration or beyond use date; The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022) in a 55-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 039A21A, 043B21A and 034F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 26-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .5 milliliter. On 17-Nov-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .25 milliliter. On 08-Jun-2022 at 10:21 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. In May 2022, the patient experienced PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022). On 08-Jun-2022 at 10:21 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022).    No concomitant medication was reported.  The patient had no known allergies. It was unknown if the patient was diagnosed or tested positive for COVID-19.Also unknown if the patient had acute illnesses at the time of vaccination and up to one month before and chronic or long-standing health conditions, and unknown if prescriptions, over-the-counter medications, dietary supplements or herbal remedies were taken at time of vaccination and/or at the time of the adverse event. It was also unknown if the patient had experienced a similar event in the past.  The vaccines expired on 13-May-2022 and administered on 19-May-2022. The vials were placed in refrigerator on 17-May-2022.  No treatment drug detail  was reported.
Inflammation all over his body; Rash all over his body; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation all over his body) and RASH (Rash all over his body) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history reported.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced INFLAMMATION (Inflammation all over his body) and RASH (Rash all over his body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLAMMATION (Inflammation all over his body) and RASH (Rash all over his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used included Statin.
fever of 102.8 for 20 hours, chills, headache, body aches
Patient woke up the morning after the immunization and felt very weak. He tried to walk his dog and could not stand and ended up falling, even while using a walker. Patient lives in assisted living. Nurse came and did BP and glucose and all labs were within normal limits.
No adverse effects; The 3rd dose" was administered at the age of "35 weeks and 2 days"; This spontaneous report was received from a nurse regarding a 35 weeks old infant patient. Information on patient's medical history, concurrent condition and concomitant therapies was not reported. On 12-JUN-2019 the patient was vaccinated with third dose of virus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency were not reported, lot # R029815 with expiration date 18-JUN-2020) via unknown route for prophylaxis. On an unknown date the patient was administered the first dose of virus vaccine, live, oral, pentavalent (ROTATEQ) at 2 months old age. The second dose was administered at 6 months of age on an unspecified date and the third dose was administered at the age of 35 weeks 2 day (inappropriate schedule of product administration).  No adverse effects were reported (no adverse event). There was no involvement of product quality complaint (PQC).
15 min after injection first vaccine nerve like pain under shoulder blades into rt shoulder... first 48 hrs unbearable like nerve pain then at end of 4 day pain gone. the 13 day i have several chills no temp tingling pricking over entire body which worsen with activity at its worse 13 and 14 day and the past 3 days intermittanty but still present.
Lots of pain after flu shot upper left arm, radiating up to neck and down arm to hand.  Bruising about 1 1/2" across.  Very tender upper arm 1 week later, sleep problems due to pain. Using NSAIDS, Tylenol, ice and heat.  Had a pneumonia shot on upper right arm same time with no pain at all.
Diagnosed with "fixed drug eruption" by PCP. Painful and itchy erythematous patches on hands and feet. Lasted ~2 weeks, out of wokr because could not walk. Treated with benadryl and high dose steroids. Categorized as Type IV Hypersensitivity.
I received the vaccine on 10/9. On 10/10, I began having painful, bleeding gums and soreness under my jaw line, which worsened over the next day or two. When I bent my head forward/down, the front of my neck (under my jaw) felt strange. On 10/12, I saw my dentist because I was very concerned about these symptoms. He examined me, took an x-ray, and said he saw no problems except for gum recession (which is not a new problem for me). He denied that the vaccine could be the cause of bleeding gums, saying, "When gums bleed, it's because of gingivitis." However, he also indicated that he saw no evidence of gingivitis! Nonetheless, he recommended a different toothpaste, specially formulated for bleeding gums. However, the pain and bleeding resolved on its own by 10/14 or 10/15.
Patient up to date on COVID vaccinations who admitted for COVID complications.  Provider discharge note below:  "dx with covid 19 he is ""fully vaccinated and boosted"" and he has had mild URI symptoms with hypoxia on admission. He was placed on decadron and has improved and would like to go home. At rest and ambulatory ox saturation checks day of discharge were 92% or greater. He is discharged on azithromycin Z-pack for a slight increased cough with greenish phlegm production likely bct bronchitis. On the day of discharge he is AO, vss, baseline physical exam ""jumping to get out of here."" He does have a home oximeter and will follow his oxygen saturations to call his physician if <90% and/or increasing SOB"
Five minutes after injection of MMR, developed local urticarial lesions. Given oral Benadryl.
extreme upper respiratory symptoms, cough, congestion, headache, muscle aches,   Began on the 9th of October and continued for 12 days  Complete loss of taste and smell
Soreness; Sore arm after primary Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Soreness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm after primary Covid vaccine".  Additional information: Refers getting the primary series experiencing only soreness. Caller is an audiologist.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201398251 same patient, different vaccine dose/AE.;US-PFIZER INC-202201398399 same patient, different vaccine dose/AE.;
Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case involves a 12 months old female patient who received vaccine PENTACEL. The patient's past medical history and family history were not provided. Concomitant medications included Hep A, Hep B, MMR, PCV 13 and Varicella on 18-Dec-2018. On 18-Dec-2018, the patient received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5545AA, expiry date 06-Oct-2019 via intramuscular route in the right leg. It was an actual medication error due to inappropriate reconstitution technique. It was reported that patient was given the DTaP-IPV portion of PENTACEL and not the ACTHIB portion. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on 01May2021 as dose 2, single (Lot number: ER8736), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: 320308d) at the age of 57 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Parkinson's disease" (unspecified if ongoing); "known allergies: Penicillin tetanus" (unspecified if ongoing), notes: known allergies: Penicillin tetanus. Concomitant medication(s) included: CARBIDOPA AND LEVODOPA. Vaccination history included: Tetanus (known allergies: Penicillin tetanus), for Immunization, reaction(s): "known allergies: Penicillin tetanus". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (unspecified date) Negative; (30Apr2022) Positive. Therapeutic measures were taken as a result of Covid-19.
A few days after my injection a large chunk of skin, the length of the side of my nose came off in my hand when I lightly touched it.
Pt C/o dizziness and passed out due to anxiety. Pts BP was 78/40 HR:44 02:100 @11:24am. Pt stated he has no medical history and did not eat this morning. Patient second set of vitals at 11:30am BP: 113/53 HR: 55 O2:100. EMS arrived at 11:33am due to pt seizing at time of reaction at 11:19am. EMS vitals @11:34 BP 117/58 HR:54 O2:98
Approximately 5 days after shot, chills set in, lasting about a week. Over a 2-week period,   injection site increased gradually in size to approx. a 6" Christmas tree shape. Nasal congestion, sneezing and coughing, and fatigue occurred. Two weeks later,  injection site discoloration is still large, but gradually fading; signs of congestion significantly less.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (In April 2018, 1st dose received and experienced Injection site pain. Please refer the case US2019GSK056615.). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. And, about two months later she received her 2nd dose of SHINGRIX in left arm. She experienced pain at the injection site and that lasted for about one hour and it was less severe than the dose one. The reporter gave consent to follow up. No further details were provided.
Patient had COVID-19 Moderna vaccine on 2/23/21. She states that on 3/3/21 developed a rash on her left arm. She reported rash had grown in size. She states that it spot itches, feels tight and hot to touch.
COVID vaccine breakthrough case. Moderna 5/11/21 043B21A, 6/8/21 005C21A and 8/3/22 052B22A
Fatigue; Sore Arm; Low-Grade Fever; Throwing Up; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 30Jul2021 at 10:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken from an unknown date for an unspecified indication. The patient received some unspecified vaccine on the 30Jul2021. The patient did not have any known allergies to food, medication or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 07Jul2021 at 15:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. On 31Jul2021 at 08:30, the patient experienced fatigue, sore arm, low-grade fever, and throwing up. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, sore arm, low-grade fever, and throwing up were unknown at the time of this report.
employee c/o itching 8MAY96 then left upper became red w/a a blister noted @ inj site;the following day inj site became more redden & wide spread also was hard & itching;
Information has been received from a physician concerning a 9 year old female who on 1/15/97 was vaccinated with a dose of varicella virus vaccine live. On 10/27/04 the patient developed chicken pox rash of about 20 vesicular lesions with some crusting. The rash was spread over her face, upper torso, and groin. It was reported that the patient also had a low grade fever. Unspecified medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
VAX (VACCINE) DAMAGED THE ANTIBODIES; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 patient experienced vax (vaccine) damaged the antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vax (vaccine) damaged the antibodies was not reported. This report was non-serious. This case, from the same reporter is linked to 20221214638.
arm swelling; redness; bruising; diarrhea; This is a spontaneous report from a non-contactable health care professional, the patient. A 27-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3014584) via an unspecified route of administration in the left arm on 03Oct2021 at 16:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies.  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. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: FC3183) via an unspecified route of administration in the left arm on 12Sep2021 at 14:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 05Oct2021 at 18:00, the patient experienced arm swelling, redness, bruising and diarrhea. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm swelling, redness, bruising and diarrhea was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had body aches, a fever, and a headache for about 3 hours for 2 afternoons in a row. Then I tested positive for COVID-19. The next morning, I got the monoclonal antibody infusion which caused a reaction. Within 3 minutes of receiving, it I started getting a warm feeling in my belly. Something went up my body, and I couldn't breathe. I got really hot and really red. Then I ended up in the emergency room. My heart felt weird. I had a little bit of tightness in my chest. After I had recovered from COVID-19 I had cramping in my hands. My arthritis has gotten significantly worse too.
Sore throat - first symptom 2/1 11pm Fever to 103 - early morning 2/3 shaking chills  nausea  muscle aches lymphadenopathy
11/16/18: patient received the vaccine. 11/17/18: Patient reported bumps on the tongue. 11/18/18: Patient reported "cottage cheese" covered top of tongue. 11/19-20/18: Patient was given an Rx from the doctor for a version of Magic Mouthwash. Now the patient reports that the mouth is less painful and only half covered. May have had a slight fever on 11/21/18.
6 days p/vax pt started w/a mixed rash that soon became more devel w/100's of red raised dots;taken to MD dx chickenpox;they spread to legs, mouth, stomach, back, underarms, side;pt irritable;
Stabbing pains in my back all day long for 3-4 days per week for the first two months. Then, for the next two months, it only happened once a week. Then, for the next two months, it only happened about 1-2 per month. Then it only happened about once a month for the last 4 months to bring us to date. The pain was significant, about a 5 and there was no treatment.
Moderna Booster given outside recommended intervals \. Second dose received on 9/27/21. Patient was informed and advised  that booster does not need to be repeat .
Started with joint aching, progressed to right knee pain and swelling over the next few days.  Responded to Ibuprofen.  Seen at ER 6/30 and had labs that were normal except increased sed rate and CRP.  Xray normal.  Knee tapped and no crystals or infection.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patient's medical history or concurrent conditions was provided. On an unspecified dates since 30-NOV-2015, doses ROTATEQ (lot # L002042, expiration date 28-JUL-2016) (dose was not provided) which were exposed to temperatures outside the recommended rage, were orally administered to unspecified patients. No adverse experience was reported. This is the one of the several reports from the same reporter source. Additional information has been requested.
I received the injection 8 days ago.  Initially my arm was minimally sore with a slight rash about the size of a quarter and slightly raised.  It diminished and only a slight rash remained.  On day 7 there was a small stained rash, with only a bump that was a small dot at the injection site.  On day 8 it started getting redder and feverish.  A lump started rising in the area of the vaccine.  The rash is now about 3 inches in diameter, with a rather large lump under it, the arm is sore to the touch, and feverish to the touch .  Symptoms are currently ongoing, with no results or outcome at this time.
SOB, wheezing, swelling throat, rash, tachycardia, and coughing following Pfizer COVID-19 mRNA vaccine (first dose) IM.  Took to ED for evaluation. epinephrine 0.3 mg IM given in addition to methylprednisolone 125 mg IV and diphenhydramine 50 mg IV and famotidine 20 mg IV with a slight improvement in anxiety, throat tightness breath, however patient with persistent wheezing and cough. Albuterol 5 mg trialed without significant improvement in symptoms. Given persistent respiratory symptoms, repeat epinephrine 0.3 mg IM given with continued improvement in symptoms. Monitored patient for 4 hours and symptoms completely resolved. Discharged patient in care of granddaughter with outpatient epinephrine IM prescription.
Adverse effect of other bacterial vaccines, init encntr on 2016-08-18.
Information has been received from a physician concerning a pediatric patient who was vaccinated subcutaneously with the second 0.5ml dose of VARIVAX (Oka/Merck) over the last six months. The patient developed injection site reactions after being vaccinated with the second dose. The reactions included redness, swelling and local heat. The outcome was unknown. The patient sought medical attention and was treated with antibiotics. This is one of several reports received from the same source. Additional information has been requested.
Took first dose at 20:00 on April 18, 2018, as prescribed. Awoke at 1:00 April 19, 2018 with severe abdominal cramping and nausea. I had to go to the ER for pain as I could not walk and barely could talk due to pain. Best way to describe pain is if I were to drink bleach. Pain lasted 3 days.
Pt experienced a Vasovagal response including dizziness, brief altered conscientiousness,  nausea and vomiting.  We laid him down on his side and he spent 45 minutes recovering, was examined by EMS, drank electrolytes and left with a family member.