chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose given from expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given from expired vial) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given from expired vial). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Dose given from expired vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Info has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. Additional info has been requested.
Patient developed swelling at the injection site (size of a golf ball). Went to ER to help with the pain and swelling.
I am a pharmacist. I experienced difficulty swallowing for about 1.5 to 2 hours after receiving both doses of my vaccine.  It?s as if my swallowing reflex was off. I could still breath through my nose but swallowing was difficult.  I did not seek medical attention. Symptoms resolved on its own. At first I thought it was just nerves but when it happened after both shots I knew it was something more. Then a few months later I had a patient experience the same thing after receiving  his vaccine.
chills; Headaches; nausea; joint pain/pain in right wrist; numbness in left hand; feeling as if the room is moving sideways; pain in right wrist and finger; chest pain; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 23Dec2020 and ever since the patient had symptoms including chills, headaches, nausea, joint pain, numbness in left hand, pain in right wrist and finger, chest pain and then feeling as if the room is moving sideways from an unknown date. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Vaccine was given at 11am 4/10/2021.  That day I had a slight headache, occasional dizziness, and a sore arm.  Then on  Wednesday  4/21/2021 I woke up at 6am and couldn't function.  I felt so extremely tired that I could barely move, had  a pretty sever headache and chills.  Thursday 4/22/2021 was the same: chills (couldn't get warm), severe headache, and extreme fatigue.  Today, Friday the 23, I still have a slight headache, but the extreme fatigue and chills have gone away.
Soreness, mild swelling at onset, following by increasing swelling, firmness of upper (L) arm, followed 10 hrs later with fever 101-101.8, chills, muscle and joint pain for duration of 48 hours and swelling, warmth at site persisted for 7 days.
When I received the vaccine I had a red spot that went from injection site to my elbow. It didn't hurt or bother me but it was not normal. I didn't take anything, but I did monitor it and it went away after a few days. I was fine for a few months then I started to have skin irritation in the first week of October. I noticed my lips starting to tingle and it felt as if I had a cold sore. It was itching and bothering me. It never had lesions but it didn't ever really heal. It would alternate swelling from inside to outside. At one point it spread to my face. I went to the dermatologist and she prescribed hydrocortisone and advised to use Vaseline.
Initially sore arm; severe headache. positive COVID test on 1/21/2021 - doctors assume he was positive at time of vaccination but we didn't know it yet; severe covid pneumonia; supraventricular tachycardia; diabetes; iron deficiency anemia
chills, fever, body aches and then through out the night developed palpitations... heart rate elevated by > 20 bph at visit
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: could not take meds. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no known allergies  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-202300158016 Same patient/reporter, different dose/events;
received the first dose of GARDASIL 9 one year ago and did not complete the series at that time; No other AE/PQC reported; This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.    On an unknown date in 2020, reported as one year ago, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The patient did not complete the series at that time.  Non-valid due to no patients identifiers.
COAGULOPATHY, UNSPECIFIED TYPE 10/2/2021 ANEMIA ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 10/8/2021 ANEMIA COAGULOPATHY, UNSPECIFIED TYPE 10/2/2021 ANEMIA ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 10/8/2021 ANEMIA COAGULOPATHY, UNSPECIFIED TYPE 10/2/2021 HEMATURIA ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 10/8/2021 HEMATURIA COAGULOPATHY, UNSPECIFIED TYPE 10/2/2021 CKD STAGE 3B (GFR 30-44) ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 10/8/2021 CKD STAGE 3B (GFR 30-44) COAGULOPATHY, UNSPECIFIED TYPE 10/2/2021 ANEMIA ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 10/8/2021 ANEMIA COAGULOPATHY, UNSPECIFIED TYPE 10/2/2021 SQUAMOUS CELL CARCINOMA, BLADDER, UNSPECIFIED SITE ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 10/8/2021 SQUAMOUS CELL CARCINOMA, BLADDER, UNSPECIFIED SITE COAGULOPATHY, UNSPECIFIED TYPE 10/2/2021 RECTAL FISTULA ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 10/8/2021 RECTAL FISTULA
patient is a 17yo male who experienced a syncopal event approximately 10 minutes after receiving his first dose of the Pfizer covid-19 vaccine. while sitting in the observation area with his mother, patient began to feel light headed and nauseous. patient was assisted to yoga mat on ground with lower extremities elevated. Per pt and mother, patient has a significant history of  anxiety, and also becoming light headed and nauseated, in association with medical procedures, specifically when involving needles. patient's mother also reports patient has "passed out" previously when he experienced a hypoglycemic episode. Patient reports only having  eaten a cookie and a slice of bread for the entire day.  Upon initial assessment, no acute distress noted, AOx4, verbal, able to make needs know, and answers questions appropriately. Respiration even and unlabored, lung sound clear to auscultation. after approx <1 minute, noted progressive decreased level of consciousness, patient was minimally responsive for <15 seconds. Noted patient with significant diaphoresis,  patient skin and lips  were slightly pale & intact. Respiration remained even and unlabored, lung sound clear to auscultation. no sx/sx of allergic reaction. patient's mother Denied any significant past medical history, or allergies. Patient was assessed while laying on yoga mat on ground with bilateral lower extremities elevated,  in observation area. Physical examination and past medical history obtained simultaneously. Initial vital signs @ 1845 95/32 hr 49 O2sat 99% rr17. Patient started to regain consciousness after <15 seconds, with progressive alertness. After approx 1 minute patient was AOx4, verbal and able to make needs known. Patient was provided with a gatorade drink, and encouraged to finish entire drink. Continued to observe patient for an additional 30 minutes. No acute distress noted throughout that time. Respiration remained even and unlabored, lung sound clear to auscultation. denies dizziness, light headedness or other symptoms. Skin warm, dry and color appropriate for ethnicity. V/S@ 1853 111/51 hr 90 O2sat 99% rr18 , AOx4, no acute distress noted.  @ 1900 Patient reported ?feeling better?, denied lightheadedness or nausea. V/S @ 1900 128/66 hr 92 O2sat 99% rr 18.   Instructed patient's mother not to leave patient unattended for remainder of day, and encouraged oral hydration. Instructed to call 911 if experiencing return of initial symptoms, difficulty breathing or loss of consciousness. Educated patient and his mother on sx/sx of allergic reactions, and anaphylaxis. Encouraged patient to follow up with his PCP. patient and his mother expressed understanding of all instructions and education. V/S @ 1930 135/72 hr 83 O2sat 98% rr18, no acute distress noted, patient denied any symptoms at that time. Patient left home with mother @ 1930.
Pt. Received Adacel and Menactra vaccine on 08/25/2005. Patient returned to Clinic on 09/01/2005 with multiple pink macules and wheals with some target lesions. Lesions concentrated on legs and groin area, but also appear on arms and back of hands. CRNP diagnosed pt with erythema multiforme, recommended Zyrtec or Benadryl for itching.
tingling not much of the pain; Pain; late 2nd dose; shingles; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number ZS3D7, expiry date 08-OCT-2024) for prophylaxis.   In OCT-2022, the patient received the 1st dose of Shingrix. On 09-OCT-2023, the patient received the 2nd dose of Shingrix. On 15-AUG-2023, between 9 and 11 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). On 09-OCT-2023, the patient experienced drug dose administration interval too long (Verbatim: late 2nd dose). On an unknown date, the patient experienced tingling (Verbatim: tingling not much of the pain) and pain (Verbatim: Pain).  The outcome of the shingles was not resolved and the outcome of the tingling and pain were not reported and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles, tingling and pain to be related to Shingrix.     It was unknown if the company considered the shingles, tingling and pain to be related to Shingrix.   Additional Information: GSK Receipt date: 09-OCT-2023 A pharmacist reported that a female patient received the 1st dose of Shingrix about a year ago (October 2022), developed shingles about 1.5-2 months ago (Aug 2023), and today (09Oct2023) she received the 2nd dose of Shingrix.  The shingles was mild, tingling not much of the pain, saw doctor and got treatment. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule The reporter consented to follow up by email.
patient had a blood titer drawn 1 week ago and the titer level came back less than 3.1; The patient received these vaccines on 8/12/1998, 10/16/1998, and 2/26/1999; This spontaneous report was received from a medical assistant and refers to a 23-year-old female patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 12-AUG-1998, the patient was vaccinated with the first dose of hepatitis B vaccine (recombinant) (manufacturer unknown) for prevention of hepatitis B (exact dose, vaccination site, route of administration, lot # and expiration date were not provided). On 16-OCT-1998, she was vaccinated with the second dose of hepatitis B vaccine (recombinant) (manufacturer unknown). On 26-FEB-1999, she was vaccinated with the third dose of hepatitis B vaccine (recombinant) (manufacturer unknown).  On approximately 14-JUL-2021 (reported as 1 week ago), the patient had a blood titer drawn and the titer level came back less than 3.1 (units not provided). The reporter said the state health department wanted the patient to be revaccinated with another 3 dose series of hepatitis B vaccine (manufacturer unknown). The patient has not received a booster dose with hepatitis B vaccine (recombinant) (RECOMBIVAX HB), but the reporter said the patient was scheduled to come to the office for hepatitis B vaccine (recombinant) (RECOMBIVAX HB) administration on 22-JUL-2021. The patient sought medical attention. No treatment was given. The outcome of the event was unknown.  The causal relationship between the event and the suspect vaccine was not reported.
Patient is 17 years of age and was mistakingly given the Moderna vaccination series dose 1 vs the Pfizer series as is approved by the CDC.   Patient to this point has had no adverse affects but both the Pharmacy and the Dr. are monitoring and will follow CDC guidelines moving forward to ensure patient safety and health.
Wheezing,pneumonia,RSV. Admitted to the hospital 03/18/2010.
tested positive between doses 1 and 2 of the vaccine; tested positive between doses 1 and 2 of the vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported same events for six patients. This is second case of six reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that 6 patients tested positive between doses 1 and 2 of the vaccine, in which the pharmacist was giving Covid vaccinations in a nursing home.  It was reported that the patient was tested positive between doses 1 and 2 of the vaccine, in which the patient was hospitalized and had received antibodies. And had tested negative upon and continuously since returning to the nursing home. Those patients were tested every day. The pharmacist started administering the second doses. One patient was administered the second dose and then somebody said, "Oh, they were given antibodies in the hospital''. A fellow pharmacist in which they said, we're under the impression you wait 90 days if they've been given antibodies after that to give the second dose. One of the patients inadvertently received a second dose, not knowing that they received antibody therapy prior to administering the vaccine. The rest who were hospitalized did not receive their second injection. Caller asked, "What is the policy on antibodies and the second dose? When is the earliest date they can administer that second dose? The individual who was given it inadvertently, should they be given a third injection? Do you give them shot number two or do you start over and give them both shots?'' The outcome of event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information provided, the lack of efficacy cannot be totally excluded for vaccine BNT162B2 administration. The specific test date of positive COVID-19, and the injection date of vaccine BNT162B2 would be helpful for further assessment.,Linked Report(s) : US-PFIZER INC-2021199894 same drug/reporter/event, different patient
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 75-year-old female patient who received SHINGRIX (batch number 3374S, expiry date 22nd November 2020) for prophylaxis. Concomitant products included SHINGRIX. On 3rd August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, 6 days after receiving SHINGRIX, the patient experienced fever, chills, sweating and nausea. On an unknown date, the outcome of the fever, chills, sweating and nausea were unknown. It was unknown if the reporter considered the fever, chills, sweating and nausea to be related to SHINGRIX. Additional details were provided as follows: On 2nd May 2018, the patient received 1st dose. As reported by the healthcare professional, the patient had no problems with the first time (with initial injection). The patient developed fever, sweats, chills and nausea after 2nd dose. No further information was reported regarding the event.
Patient called our clinic on 11/1/21. Reported that she recieved her third dose (booster) on 10/29/21 at 1:00 pm. Reports that when she took a shower, she noticed a blister to the left of the injection site. Reports it is a 1/4 inch around. States she did pop the blister and that there is a scab there now.
11/30/2001-Rash on abnormal up to patient's neck 12/01/2001-Welts on patient's back
Child fainted for 30 seconds and was stiff. No vomiting, did lose control of bladder in fact but she was pale and slightly disorientated, confused for 30 seconds.
About 24 hours after shot was given, injection site began to form hives that were red and warm to touch. On day one and two it continued to grow to about the size of the vaccine card. On evening of day one Allegra was taken but it had no effect. On day three 1% hydrocortisone cream and Benadryl were used for treatment. It is day 4, area is still warm and red, there are still hives but they have calmed down. The area is slightly smaller than the vaccination card given.   I've also had slight soreness when moving my arm but that's also average.
pt recv vax 1FEB96&noticed bruising @ site of PPD 2FEB96;had blood drawn wouldn't stop bleeding&had bruising around site 3/4";had fingerstick done&bruised there;taken ibuprofen;
Morning after shots patient got a very bad headache, slight fever, sore arm and rash right arm and vomiting.
p/ pt recv 2nd dose of vax pt devel chickenpox described as small vesicular-papular rash all over
So I noticed a small growth on my ankle bone near my foot and it was not normal of anything I seen on my body. I went the doctor and showed him at my check up and he did not know what it was and would recommend monitor it the left foot. It is not painful but it has seemed to grown a little since February.
vaccine administered and temperature exposure > 24 hours; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered and temperature exposure > 24 hours) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021 at 8:19 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021 at 8:19 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered and temperature exposure > 24 hours). On 20-Aug-2021 at 8:19 AM, EXPIRED PRODUCT ADMINISTERED (vaccine administered and temperature exposure > 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (vaccine administered and temperature exposure > 24 hours) to be possibly related.    It was reported that the vial was punctured on 11-Aug-2021 and kept in fridge for 9 days. The expired vaccine was administered to five patients.  Concomitant drug was not reported. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Sep-2021: Follow-up information contains additional reporter, patient initials, dose details, event details and Race.
had Pfizer covid vaccine (purple cap) thawed and undiluted in the refrigerator. "31 days in the refrigerator was yesterday. I inadvertently administered it today on day 32; booster dose; had Pfizer covid vaccine (purple cap) thawed and undiluted in the refrigerator. "31 days in the refrigerator was yesterday. I inadvertently administered it today on day 32; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 22 year-old male patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) at the age of 22 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "booster dose"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 14Dec2021, outcome "unknown", PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "had Pfizer covid vaccine (purple cap) thawed and undiluted in the refrigerator. "31 days in the refrigerator was yesterday. I inadvertently administered it today on day 32". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101780965 same reporter/product/event, diff patients
needed heart surgery; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, dose number unknown, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, three weeks after the shot, the patient needed heart surgery. At the time of the report the event outcome was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Symptoms of tightness in chest and throat reported by patient at 6:15pm. Blood pressure at 6:15pm 185/91 and heart rate 73. Gave Benadryl 50 mg oral at 6:21 pm as symptoms were not subsiding. No improvement in symptoms and at 6:38 pm, patient reported now feeling tingling and dry throat. Called EMS at 6:39pm. Blood pressure at 6:49pm 168/98 and oxy sat 98%. Patient still reporting tightness in throat/chest and difficulty taking deep breaths. EMS recommended patient go to the hospital and she denied and went home.
pt recv vax 31MAY96 & 23DEC97 pt devel a moderate case of chickenpox & was seen by MD;pt recovered;
He remained chronically critically ill and medically complex. Mental status remained very poor. He made some progress with vent weaning, tolerating 8 hours off the ventilator 7/22. He had hypokalemia and non-anion gap metabolic acidosis attributed to diarrhea. K and bicarb repleted. He was tolerating TF and having BMs. I updated his daughter twice. She was able to do a televisit 7/22 and felt he looked better, and that his abdomen was less distended.   He suffered a sudden brady-PEA arrest 7/22 in the evening. He was DNR per my prior discussion with his daughter on the day of admission.