chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine/ The vials were in refrigerator for over 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 24-Aug-2021, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-337484 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2021-337484:Master case (same reporter)
10 hours after injection I became shivery  and couldn't get warm.  My body started shaking uncontrollably from head to toe. It was very intense. Muscles spasms with cramps. I felt very dizzy and nauseous with headache and pains in arms and legs. I had feverish hot sweats and chills which continued all night with intermittent fitful sleep. Next day I felt better but very weak with aches and pains.
Initial report was received from a consumer, who was also the patient's parent, on 16 January 2012. A male patient (age at time of vaccination not reported) received an injection of DTP and Hib vaccines (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced seizures. In addition, the patient has been experiencing autism-like symptoms (unspecified) ever since vaccination. Currently the patient is 18-years-old and "has not been the same". No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Began having hives that would come and go at various times.  On 11/26/2009 went to Emergency room at Hospital as hives were on trunk of body and in lip and mouth.  Put on prednisone for 10 days along with benadryl. After completing prednison hives began to recur.  12/11 doctor suggested claritin bid, and referred to allergist.
1/20/22 pt brought to ED with increasing SOB; positive COVID test; (pt also had a positive COVID test on 1/12/22); COVID pneumonia; O2 supplementation; dexamethasone; AKI - IV fluids; pt was made a DNR/DNI, comfort measures; transferred to an inpatient hospice bed, where she passed away
Per report, patient received first Moderna vaccine on 2/26/21, second Moderna vaccine on 3/26/21and a third vaccine on 4/26/21. Report doesn't say who gave the third vaccine or what type/brand vaccine it was, no lot # either.
Redness on arms and legs; Redness at injection site; Fatigue; General weakness; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number Y573z, expiry date 30-SEP-2023) for prophylaxis.   On 06-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 07-MAR-2023, 1 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at injection site), fatigue (Verbatim: Fatigue) and weakness (Verbatim: General weakness). On 08-MAR-2023, the patient experienced erythema of extremities (Verbatim: Redness on arms and legs). The outcome of the injection site erythema and erythema of extremities were not recovered/not resolved and the outcome of the fatigue and weakness were unknown.   The reporter considered the injection site erythema to be related to Shingrix. It was unknown if the reporter considered the fatigue, weakness and erythema of extremities to be related to Shingrix.     The company considered the injection site erythema to be related to Shingrix. It was unknown if the company considered the fatigue, weakness and erythema of extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAR-2023. The nurse practitioner stated that she gave a patient first dose of Shingrix vaccine and the next day the patient experienced redness at the injection site, fatigue and general weakness. On the day of reporting 2 days after vaccination the patient experienced redness on both arms and legs. The patient did not complain of any itching or pain. The reporter did not indicate if the patient still had fatigue or weakness. The reporter consented to follow up.
pt turned pale & limp, momentarily, a couple of mins p/vax HR178, RR40 no sz activity noted; Epi given;
Patient presented today with a bruise on arm that was approximately 1.5 to 2 inches in diameter. Said it is not getting better and it has been since 10-6-16. He said he had no pain from it but was concerned since it wasn't getting better. Also reported cold-like symptoms. Counseled that shot doesn't make sick and that he probably came into contact with a different virus.
After a few hours of getting the 1st dose, I started feeling pain on the injection site. As the night goes on and up to the next day I could barely lift my left arm.  The pain was too painful I had to take ibuprofen. On the second night, I started feeling chills and possibly slight fever which went away after a couple of hours. The arm pain lasted 4days (the first 2 days was the worst). Then after a week of getting the vaccine, I started feeling pain on the injection site again and that lasted for 2 days.
Red Rash the size of an orange. It feels warm and hard.  Painful.  Difficult to lift arm.
Headache & Fever Narrative: Breakthrough. COVID19 positive on 8/3/2021
This is an adult patient of Dr. who is coming in today with receiving the flu vaccine yesterday. At 2:00am she woke up complaining of left axilla pain. She also has red streaks going down her left arm. She was out picking tomatoes yesterday, so it is hard to know what is actually triggering this. The actual injection site is not red. It is slightly swollen. Female in no acute distress. Weight 130. Temp 96.5 BP 164/92. Pulse 80. I do believe more of the elevated BP is due to her dsicomfort and worry about the streaks on her arm. She has red streaks that start on the top of her hand, go up her forearm, and up underneath her axilla. She does have a swollen lymph node up under there. We did draw a black circle around this. We don't actually see a site on her hand. I would suspect there is somethin microscopic there. We did see the site for the flu shot. It is swollen but no redness. Cellulitits. Keflex 500mg TID for 10 days and Zyrtec just to insure there is not an allergic reaction going on. She will follow-up with Dr. or us on Friday and sooner if it starts to spread, swell or anything gets worse. She was instructed to ether see us or go to the ER.
10/3 at 10 AM. Pat. called 10/3 and said she was on her way to the doctor. Felt ok until 10/2 at 3 PM. Noticed red raised bump. Currently has a fever of 102. Sx completely resolved by 10/5/07.
Large red circular area covering most of left upper thigh, skin soft. No tenderness noted. Vaccine adverse reaction. Continue Benadryl every 6 hours as needed for itching/swelling. Observe area for tenderness or fever.
6 wks after receiving the vaccine began having progressive weakness and numbness in legs and fingertips. Few days prior to admission to hosptial 1/26/2011 unable to walk.
This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received both vaccines and is pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination. No Medical History information was reported. On 19-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 14-Dec-2020 and the estimated date of delivery was 20-Sep-2021. On 19-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received both vaccines and is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. On 19-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received both vaccines and is pregnant) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided.
ADACEL administered was already approximately two weeks expired; Initial information received on 25-Mar-2021 regarding an unsolicited valid non-serious case from a pharmacist.  It was reported that DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] Suspension For Injection) was administered to a patient which was already approximately two weeks expired, on an unknown date via an unknown route for prophylactic vaccination (expired vaccine used).  It was a case of actual medication error due to expired product administered.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  There will be no information available on batch number for this case.
Patient reports that on 7/16/2022 that she was standing her kitchen when the looked like it was going sideways and she had to grab the counter to keep from falling.  She felt dizzy at times through out the day.  She continued to rest and felt better the next day.  On 7/21/22 she called to report her reaction to the clinic.
An attendee fainted after receiving vaccine Pfizer 1st dose. She didn?t lose her airway. The business called 911 they assessed the situation and said she was ok. Patient up walking around.
Ringing in the ears.  Did two burst and tapers of oral prednisone, but once down to 20 mg daily the ringing would return. Went to ENT 2 weeks ago and they injected a steroid to the ear drum, this helped for 1 week and 2 days, now the ringing is back.
Case number PHEH2015US013180 is an initial spontaneous report from a healthcare professional received on 07 JUL 2015. This report refers to a 24-year-old female patient. Medical history and concomitant medications were not provided. She was vaccinated with RABAVERT (batch number unknown) first dose on 01 JUL 2015. On 05 JUL 2015 she started feeling feverish, dizzy and weak. On 07 JUL 2015 her temperature was 102.7. She did not go to doctor or received any medical attention. Her second dose was going to be withheld because of fever. The reporter was not sure if the vaccine caused these events. The outcome of the events was reported as "unresolved". The events were reported as non-serios. Causality was unknown. The case was lost to follow up.
Arm from injection site down was inflamed and extremely red. Never checked fever, but had chills. This lasted almost 3.5 days -A knot the size of half of lemon present.
watering eyes, sneezing immed in few hrs; nausea mostly, vomiting x 1 & wheezing, coughing in 24-48 hrs required ATB for bronchitis-like sx; severe fatigue, general malaise, flu like sx;
Redness at injection site; Swelling at Injection site; Pain at Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at Injection site) and VACCINATION SITE PAIN (Pain at Injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for Sleeping sickness, LISINOPRIL and SERTRALINE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at Injection site) and VACCINATION SITE PAIN (Pain at Injection site). On 14-Mar-2021, VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at Injection site) and VACCINATION SITE PAIN (Pain at Injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Starting in the evening on the day of vaccine Friday 9/18 - arm pain that became quite severe, couldn't lift arm. On Saturday evening pain was better, pain was gone on Sunday. On Sunday noticed a rash underneath her arm (area around armpit) was red, gradually spread around right breast and onto back. On Monday spread down arm, to abdomen, and backs of legs. Not itchy, flat red rash. Rash went away on Wednesday. Took ibuprofen to treat pain on Friday which helped a little bit. No treatment given for rash.
pt devel t101.7 orally @ clinic when seen by MD temp reported as 103 430PM;c/o h/a, chills, n/v;adm to hosp late afternoon for observation;
Heart palpitations lasting 5-10 minutes. Presented when exercises but continued when at a standstill. They had not occurred previously or since.
I went to bed early because I was starting to feel some minor side effects of my vaccine. Around 10pm (12 hours after my booster shot), my Watch woke me up because a high heart rate had been detected for 20 minutes. My heart rate is typically in the 60's, but this time it was 168. It stayed there for about 4 hours before eventually falling down to around 100. I went to the doctor 2 days later, on Monday 11/8 and had an EKG done. It was normal, but the doctor recommended a 48 hour holter monitor test to be sure, but I could not get the monitor until after my second episode, which was about a week after my first (this time, my heart rate climbed into the 150's). The holter monitor showed inappropriate sinus tachychardia. A month later, I had another episode, but not quite as high (around 130). And a month after that, I had one last episode around 120. All in all, I felt "off" for about a month total - my heart rate was higher than usual and my chest felt full. Each "big" episode was in the middle of the night, when I was asleep and awoke to my heart racing for no reason.
Information has been received from a health professional concerning a 13 month old male who on approx 08Feb06, at 12 months of age was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. On 14Feb06 the pt experienced breakthrough chickenpox with 10-20 lesions. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
7 patients ages 6mo-5yr were given Moderna Bivalent Pink cap/yellow label 0.2ml/10ug for dose 1 and/or dose 2. The correct dose should have been Moderna Bivalent Blue cap/gray label 0.25ml/25ug.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (7 patients ages 6mo-5yr were given Moderna Bivalent Pink cap/yellow label 0.2ml/10ug for dose 1 and/or dose 2. The correct dose should have been Moderna Bivalent Blue cap/gray label 0.25ml/25ug.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (7 patients ages 6mo-5yr were given Moderna Bivalent Pink cap/yellow label 0.2ml/10ug for dose 1 and/or dose 2. The correct dose should have been Moderna Bivalent Blue cap/gray label 0.25ml/25ug.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (7 patients ages 6mo-5yr were given Moderna Bivalent Pink cap/yellow label 0.2ml/10ug for dose 1 and/or dose 2. The correct dose should have been Moderna Bivalent Blue cap/gray label 0.25ml/25ug.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (7 patients ages 6mo-5yr were given Moderna Bivalent Pink cap/yellow label 0.2ml/10ug for dose 1 and/or dose 2. The correct dose should have been Moderna Bivalent Blue cap/gray label 0.25ml/25ug.).    Concomitant drugs were not reported. It was reported that patients were of age 6 months to 5 years. It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment medications were not provided. This case was reported for patient 5th out of 7.   This case was linked to DE-MODERNATX, INC.-MOD-2023-724290 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2023: Follow up received contains updated reporter country, country of incidence and  suspect product coding. On 11-May-2023: Followup received contains No New Information On 12-May-2023: Live Significant Follow-up received contains updated age group and route of administration On 16-May-2023: Followup received contains No New Information On 16-May-2023: Followup received contains No New Information; Sender's Comments:  DE-MODERNATX, INC.-MOD-2023-724290:Patient 1(Master case)
Vaccine that was kept for more than 30 days in the refrigerator was administered; Vaccine that was kept for more than 30 days in the refrigerator was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that was kept for more than 30 days in the refrigerator was administered) and PRODUCT STORAGE ERROR (Vaccine that was kept for more than 30 days in the refrigerator was administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.    No Medical History information was reported.  On 31-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that was kept for more than 30 days in the refrigerator was administered) and PRODUCT STORAGE ERROR (Vaccine that was kept for more than 30 days in the refrigerator was administered). On 31-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Vaccine that was kept for more than 30 days in the refrigerator was administered) and PRODUCT STORAGE ERROR (Vaccine that was kept for more than 30 days in the refrigerator was administered) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   There was no information on previous doses for the patient. Date the vial was initially stored in the refrigerator was 29-Dec-21 and the vial did not undergo any temperature excursions.
This is a spontaneous report from a contactable consumer (patient's husband). A 72-year-old female patient received the 2nd dose of PREVNAR 13, via an unspecified route of administration in the right arm, on 29Nov2016, at 0.5 ml single, for immunisation and FLU VACCINE VII injection, via an unspecified route of administration in the left arm, on 28Nov2016, at single dose, for immunisation. PREVNAR 13 was given at the pharmacy. Relevant medical history included ongoing bipolar disorder since about 25 years, ongoing high cholesterol started 2 or 3 years before, water retention, supplementation therapy and heart disorder. Previously the patient received 1st dose of PREVNAR 13, in 2015, for immunisation, with no adverse effect and a total of 8 doses of Influenza vaccine in the past, for immunisation with no adverse effect. Concomitant medications included oxybutynin hydrochloride, from an unspecified date (two or three years before) and ongoing, for unspecified indication; simvastatin (unspecified trade name), from an unspecified date (two or three years before) and ongoing, for high cholesterol; risperidone (unspecified trade name), from an unspecified date (six or seven years before) and ongoing, for bipolar disorder; hydrochlorothiazide (HCTZ), from an unspecified date (four or five years before) and ongoing, for water retention; carvedilol (unspecified trade name), from an unspecified date (three or four years before) and ongoing, for cardiac disorder; acetylsalicylic acid, from an unspecified date (three or four years before) and ongoing, for unspecified indication; calcium (unspecified trade name), from an unspecified date (three or four years before) and ongoing, for supplementation therapy; fish oil (unspecified trade name), from an unspecified date (four or five years before) and ongoing, for supplementation therapy and multivitamins (unspecified trade name), from an unspecified date (eight or ten years before) and ongoing, for unspecified indication. The patient experienced pain in her right arm on 29Nov2016 with outcome of not recovered. Early in the morning her right arm became sore. The event was evaluated at physician office. The reporter stated that about the next day after she received the injection, her right arm was sore. It had progressively gotten worse. The patient was given an antiinflammatory when she was seen at an urgent care facility, after she saw NP because her right arm hurt so bad. Patient saw her primary care nurse practitioner first, and was given combination pain pill/antiinflammatory Diclofenac Potassium 50 mg tablet, at 1 tablet by mouth twice a day. These products helped some. The patient saw an orthopedic doctor on 11Jan2017 and he prescribed Celecoxib 200 mg, at 1 capsule by mouth a day. The patient underwent lab tests and procedures which included: x-ray of right arm (Dec2016), x-ray of right arm (11Jan2017).