chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided. Anatomical location for the suspect administration were deltoid.   This case was linked to MOD-2021-313106 (Patient Link).
severe atopic dermatitis; immune reaction; This case was reported by a consumer and described the occurrence of atopic dermatitis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 7th September 2021, 1 year after receiving Shingrix, the patient experienced atopic dermatitis and immune-mediated adverse reaction. On an unknown date, the outcome of the atopic dermatitis and immune-mediated adverse reaction were unknown.   It was unknown if the reporter considered the atopic dermatitis and immune-mediated adverse reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Oct-2022 Reporter's comment: The patient self-reported this case. The patient stated that approximately 1 year after Shingrix caused immune reaction leading to severe atopic dermatitis requiring prescription of 50 thousand per year which the patient could not afford since make 30 thousand per year. The insurance did not cover. The total cost of treatment over lifetime was 1 million. The reporter consent to follow up. Additional Supportive Information: Time to onset was conservatively captured.
Headache and pain like kidney stone on right side. Flu-like symptoms and nausea the next day. Fever. At 2:00 AM 1/2 woke with rash where pain was.
patient was hospitalized and passed away.    **2nd vaccine dose 3/15/2021
I WAS VERY CONGESTED & HAD A BAD COUGH I FELT REALLY BAD I WAITED A DAY OR SO & I CALLED MY DR & HAD A VIRTUAL APPT & PER MY SYMPTOMS I WAS REFERRED TO GO GET A COVID TEST & IT CAME BACK POSITIVE.
Burning feeling when Urinating, cloudy urine. Diagnosed with a UTI 2 days after vaccine
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JUN-2012, the patient received ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 17-MAR-2017. The outcome of the events is unknown. As a direct result of ZOSTAVAX, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of the condition. Further, as a tragic consequence, the patient suffered severe, serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Shingles outbreak, in addition to chronic pain, rash and lesions to various parts of body were considered to be disabling. Additional information has been requested.
injection site had a hard knot under it. area around injection site started to turn red on day 8 and spread and became more red in the following days. I took benadryl and put an ice pack on the site. The area faded a bit but continued to grow in size.
This spontaneous report was received from a medical assistant concerning to a 9 month old patient, of unknown gender. Information regarding concurrent condition, medical history and concomitant medication was not provided. On an unknown date (reported as on an unspecified recent date), the patient was vaccinated with an unspecified dose of VAQTA, intramuscularly, indicated for prophylaxis (strength, dose, lot # and expiration date were not provided). The reporter did not indicate any adverse effects.
Information has been received from a registered nurse concerning a 6 month old female who on 04 Dec 2006 was vaccinated PO with the third dose of rotavirus vaccine. The RN reported that on 08 Dec 2006, the patient developed bloody diarrhea. Unspecified medical attention was sought. At the time of this report, the patients blood diarrhea persisted. Upon internal review, blood diarrhea was determined to be an other important medical event (OMIC). Additional information has been requested.
Initial report received from a nurse in the USA on 15 May 2008. A 41 year old, female patient (with a medical history of eczema behind her left ear and scalp) complained of congestion, headache (moderate), swollen glands,  body aches and intermittent fevers (temperatures 99-101), the next day after she received ADACEL (lot number C2937AA) intramuscularly in the left deltoid and HAVRIX Hepatitis A vaccine (GlaxoSmithKline) intramuscularly in the right deltoid on 30 April 2008 at 10:30 AM. The patient had a TdaP vaccine > 5 years ago. The patient did not have any illness at the time of vaccination. On 07 May 2008, the patient called the reporter with concerns. On 08 May 2008 there was still no change - the patient did not have a recent medical evaluation with her primary care physician. The patient's recovery status was not reported.
Severe vomiting; SEVERE lethargy; little diarrhea; mild fever initially and going up to 103F; severe leg pain; no rash at injection site. Patient will not walk. Headaches.
Pt lost use of limbs, had to drag herself to living room where she passed out and Neighbor was able to awaken her.  Patient refused to go to hospital due to just coming home from there earlier. Was able to recoup at home. Mobility has not fully recovered.
Finished all 4 capsules of Vivotif and did not refrigerate it; A spontaneous report was received from a nurse on 09NOV2022. It described a female patient of unknown age who "finished all 4 capsules of Vivotif and did not refrigerate it" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient had completed the full course of vaccination with Vivotif and the capsules were never kept under refrigeration. Reportedly, the patient would be traveling on Friday (as per the reporting). The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer had taken four capsules of Vivotif and did not refrigerate it (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer had taken four capsules of Vivotif and did not refrigerate it (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.
With the first shot, I experienced mild nausea about 30 minutes after the shot. With the 2nd shot, the nausea came on really strong the following day and persisted all day.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male 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 21Mar2021 at 11:15 (at the age of 46-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Apr2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not receive any concomitant medications within two weeks of the COVID vaccine. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and clindamycin (MANUFACTURER UNKNOWN) for unknown indications and on unknown dates and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Apr2021, the patient reported that with the first shot, he experienced mild nausea about 30 minutes after the shot. With the 2nd shot, the nausea came on really strong the following day and persisted all day. About 2 weeks after the 2nd shot, he began feeling nausea every day. Some days were very mild. Some were more severe - similar to the day after the 2nd shot. But, it was pretty much with him all the time now, to some degree. The reason he wrote was because it was not something that he normally experienced. He was not sure what to make of it but thought he would pass on the information in case it was necessary to know.  On 10May2021, the patient underwent Covid-19 test (nasal swab) and the result was negative. The event did not result in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. The clinical outcome of the event nausea was not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Fainted three times the morning after vaccine (between 6:45-7:15 am); slight fever and chills following fainting episodes. I drank water, took ibuprofen and went back to bed. Then I got up at 2 pm, no further fainting or dizziness.
redness, a little bit of soreness, swelling, and small lump directly at injection site; redness, a little bit of soreness, swelling, and small lump directly at injection site; redness, a little bit of soreness, swelling, and small lump directly at injection site; redness, a little bit of soreness, swelling, and small lump directly at injection site; the patient was administered an expired dose on PNEUMOVAX 23; This spontaneous report was received from a pharmacist and refers to a 68-year-old female patient. No details regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided. On 10-MAY-2019, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 1 dose 0.5 milliliter, lot # N025656, expiration date 19-APR-2019, intramuscularly in the right deltoid (strength and dose number were not reported) for prevention of pneumonia. On 11-MAY-2019, the patient developed redness, a little bit of soreness, swelling and small lump directly at injection site. The outcome of the events was reported as recovering.  The causality assessment between the suspect therapy and the events was not provided.
Client received Typhoid vaccine at 1020. Returned to immunization Rm at 10:30 walking around, verbalizing PT wanted to walk out but instructed to sit down. She began rubbing her chest and C/O SOB. Medic was called and EPI PEN administered at 1055 at (L) anterior thigh. 9-1-1 called. Transferred to hospital 11:10.
DIZZINESS; TROUBLE BREATHING; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced dizziness, trouble breathing, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, trouble breathing and headache was not reported. This report was non-serious.
First night: body muscle aches, significant upper right arm pain, sweating, nausea. Next 2 days: Slept most of the day, no appetite, nausea, fever stayed around 100 degrees, no energy, headache, couldn't move my arm due to pain, all over body aching, shivering from feeling cold.
Still have 2 inch oval redness at injection site after two weeks.Is not painful.; This is a spontaneous report received from a contactable consumer (patient herself). A 73-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9267), via an unspecified route of administration on 20Feb2021 15:30 (age at vaccination: 73 years) as SINGLE DOSE for covid-19 immunisation. The patient's medical history included pre-diabetic, high cholesterol and Hashimoto's disease. Concomitant medication(s) included levothyroxine, metformin and simvastatin. The patient did not have any known allergies. On 21Feb2021, the patient experienced still have 2-inch oval redness at injection site after two weeks was not painful. The patient did not receive any treatment for adverse events. The patient did not receive any other vaccine in four weeks. The patient did not have covid prior to vaccination nor was tested for covid post vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Information was received from a pharmacist, post vaccine pt experienced back spasms, flu like symptoms and dark urine. Pt was examined in the ER and was confirmed hepatitis with liver function test and clinical examination.
Patient received dose #1 GARDASIL on 10/29/9 - mother stated pt had flu-like s/s for 2 days post injection, did not report such to our office until after 2nd immuz. On 12/29/2009 received 2nd GARDASIL injection (diagnosed with mononucleosis on 12/4/2009), developed CP, SOB, nausea, vomiting on 2/5/10. Seen by Dr (cardiologist) dx with pericarditis, placed on ibuprofen 800 mg PO TID and taken out of sports, spoke to mother on 2/10/10 - Patient better, mother convinced recurrent s/s related to adverse effect from #2 GARDASIL.
General malaise; Eyes were achy; Decreased appetite; Stomach was hurting; Indigestion; Took expired Aleve; Arm was sore after getting the injection; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Formulation: Solution for injection; Lot number: EL9267, Expiration date: 31May2021 via unspecified route of administration in Arm Left on 12Feb2021, at 11:30 (Age at vaccination: 67-years-old) as dose 1, single for COVID-19 immunization and patient received ALEVE (NAPROXEN SODIUM; Lot number: NAA5E5D, Expiration date: Mar2020) via oral route of administration on 12Feb2021 for her sore arm. The patient's medical history included osteoporosis. She takes medication for osteoporosis. Concomitant medications were not reported. On 12Feb2021, patient stated arm was sore after getting the injection, took expired Aleve, on 15Feb2021 after 3 days, patient had Indigestion. on 16Feb2021, after 4 days patient experienced stomach was hurting, Decreased appetite. on 17Feb2021, 5 days after second dose patient experienced General malaise, eyes were achy. Patient stated she took the first dose of the Covid-19 vaccine on Friday 12Feb2021. She received it around 11:30am. Her arm was sore that day. She moved it around and also used the rowing machine. She took 2 Aleve at bedtime. She woke up feeling great. On Monday she had indigestion which she has from time to time. She is healthy. She has annual check ups. She takes medication for osteoporosis. She adds that her stomach hurt. She did not have any aches or nausea. She was careful about what she ate. She felt worse yesterday and her stomach hurt more. It was like with having the flu. She had general malaise and her eyes were achy. She didn't see that these were reactions to the first dose. Her stomach felt better with food. She was still eating but she wasn't as hungry as normal. Two to three weeks ago she had food poisoning and was throwing up. She has a sensitive digestive system. She took Aleve the night that she received the vaccine. Prior vaccinations (within 4 weeks) were none. Relevant test was none. The outcome of events Decreased appetite, General malaise, Stomach was hurting, was recovered on 18Feb2021, outcome of event Indigestion recovered with Sequel on 18Feb2021, outcome of evet arm was sore after getting the injection recovered on 14Feb2021, outcome of event eyes were achy was recovering, while outcome of other event was unknown.  Follow-up attempts completed. No further information expected.
Patient came in with hot, red, swollen arm; same arm as the one vaccinations given. She went to ER and was diagnosed with cellulitis, given antibiotics and released.
Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD which undergone a temperature excursion (lot # M007961 and expiration date 15-AUG-2017; dose was unknown) subcutaneously in the back of the arm. The patient did not experience any adverse reactions. It was unknown if there was any relevant laboratory data. At the time of reporting, it was unknown if the patient continued to receive PROQUAD. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.     On 13-Feb-2021 at 9:42 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 9:42 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  The age of patient was provided as 46.68  On 02-Mar-2021, Excursion time was 9A temperature was 32 total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 16 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
pt stated when she woke up the day after receiving the vax she had a sharp pain on her right side around rib area.  Pt said the pain has since subsided.
I discovered a lump on left side of my neck, presumably a swollen lymph node, about the size of a marble.   It is not painful.
No adverse event; received PREVNAR 13 when they should have received PNEUMOVAX 23; This spontaneous report was received from a pharmacist referring to a 72 years old patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 08-OCT-2019, the patient was vaccinated with the first dose of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13). On 17-SEP-2020, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (1 dose, lot# cm1131 with expiration date30-APR-2022; route and indication were not reported) instead of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (wrong product administered). The patient did not have any other adverse events.
third dose of Shingrix by mistake; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose on an unknown date).   On 17th February 2022, the patient received the 3rd dose of Shingrix. On 17th February 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 3rd dose of Shingrix by mistake, which led to extra dose administered.   The reporter asked if the patient had anything particular to be concerned about. The reporter disconnected after call center representative asked for credentials.  No additional information was available. The reporter did not consent to follow up.
Began getting hives at 6am on arm of injection site as well as face, right arm, and both legs. Took a Benadryl to combat hives reaction and drank lots of fluids. Took ibuprofen (400mg) to assist in pain experienced at the injection site.
Pt. states that she started with neck pain, then her face was swelling and numb for 5-6 days. Doctor gave pt Prednisone after 5 days for reaction.
Swollen glands under arm pit area, collar bone, and arm had about 4 inch hard area. Still on 12/8/15 can still feel where shot was given. A lot of pain under arm pit area and left side of breast.