chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 1:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 1:40 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Vial was stored in frozen storage which was in super cold freezer. On 19-Nov-2021 vial was went from super cold freezer to the refrigerator. 70 vials were still in the ultra cold freezer, 8 vials were in the refrigerator, so a total of 78 vials were affected. Vaccine vial state changes were noticed and vial was never refrozen. None of the vials were punctured before the event. Temperature excursion remained for 1 month.  Treatment details were not provided.   This case was linked to MOD-2021-402935 (Patient Link).
Patient received vaccine, next day arm was in pain, slowly over time Lt arm stuck to body, is not able to move freely, can lift only a little.
PFIZER COVID VACCINE #3 GIVEN 10/28/2021, LOT # NOT AVAILABLE; pt admitted, with chest pain, cough, SOB; found to have right pneumothorax, chest tube placed; pt worsened; found to have a second right pneumothorax; 2nd chest tube placed, 1st removed; increasing O2 requirement; found to have a right hydropneumothorax; 3rd chest tube placed, 2nd removed; ABX; transferred; A Fib with RVR; O2 supplementation; tested positive for COVID; deferred remdesivir and steroids; eventually transitioned to comfort measures only; pt passed away in the hospital
temperature excursion of 49.7 degrees F for  11 hours 30 minutes due to refrigerator door left open, no AE; Initial information received on 13-Jul-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Adult female patient which was DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6273AA ,U6217AA and expiry date: 24-Apr-2021, 21-Mar-2021) temperature excursion of 49.7 degrees for 11 hours 30 minutes due to refrigerator door left open (product storage error).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.   This was potential medication error case due to incorrect product storage.   At the time of reporting, it was not reported if the vaccine was not administered or not  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.
On 8/12/01, pt had a headache; on 8/14/01 pt had a headache and a fever; on 8/15/01, the pt was lethargic; on 08/17/01, pt had herniation and on 8/18/01; life support removed. Death certificate states cause of death to be cerebral edema due to viral illness.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles . On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Patient presents with concern for Covid vaccine reaction.  Patient states she had the Johnson & Johnson vaccine about 2 weeks ago.  Patient reports she had a headache about 1 week ago that woke her up from sleep about 1 AM but resolved by 4:30 AM.  Patient denies having a headache since then.  Patient noticed some small red dots on her nose today and was concerned when her friend told her this could be from the vaccine.  Patient called her PCP who advised her to come to the ED for evaluation for thrombotic thrombocytopenia.
Patient had received COVID19 vaccine and has today received Janssen vaccine. Patient also had moderna vaccine in immunization registry, but patient claims someone had used his identity to receive moderna.
Headache, chills, rigors followed by days of GI distress with nausea, vomiting and diarrhea. Imodium for diarrhea and dietary management of GI upset.
This spontaneous report as received from a Nurse refers to a unspecified 44 year old patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 19-JAN-2018, the patient was vaccinated with received the pediatric dose of RECOMBIVAX HB from lot L016959 expiry date 12-MAR-2018 (drug administered to patient of inappropriate age)(incorrect dose administered) for prophylaxis. Nurse reports that dose was given mistakenly, by human error. No adverse effects reported. No additional information was provided.
From initial info received on 5/26/04 from a physician's assistant regarding an adverse event occurring in the USA, it was reported that a 50 year old female pt received a dose of TD ADS ADULT, lot U1019AA, IM, in the left deltoid on 5/23/04. Within 6 hours, the pt's left deltoid area became red, swollen and tender to touch. She was seen 36 hours later, on 5/25/04, and given Benadryl, Motrin and cool compresses. The pt's recovery status was unknown at the time of the report.
1/12/21-3/9/21 during vaccine preparation on occasion a small amount of vaccine was taken from a second vial to complete a dose of vaccine.   All vaccine handled and stored appropriately prior, vaccine of same lot number removed from cold freezer the evening before use to thaw, removed from refrigerator and brought to room temperature, inverted 10 times prior to dilution with 1.8 mL 0.9% preservative free saline, inverted 10 times after saline added and immediately drawn by trained staff. On occasion 0.25-0.28 mL was drawn from one vial and the remainder to make a full dose was drawn from another fresh vial.  Usually 39-78 vials are prepared and drawn at one time then discarded in red medical waste bin prior to any more vaccine being removed from the refrigerator.  Vaccine immediately administered to recipients' and all administered within minutes to 2 hours.
The third dose of Pfizer covid vaccine was 1 day past the "beyond use date".  The patient has not reported any adverse reactions.
Started 1week after shot. Arm wasn't swollen Just swelling of hand. She said redness on inside of arm. Not on outside of arm. Lasted one + 1/2 month long.  This was 3rd shot Booster. "Hospital said wasn't give shot because no studies To support"
CNS problems, personality change, SOB & vertigo are reported in a pt who recvd flu vax  on 15OCT91; w/in 6 hr pt exp CNS problems, personality changes, SOB, vertigo; w/in 24 hrs pt had fever & chills; pt tx w/DPH & Theodur & recovered hrs;
Patient needed vaccine for school. She is 23 years old and I gave her a pediatric dose of Hep B when she needed the adult dose.
The red spot is warm to the touch and getting bigger; Vaccine site started to get itchy and red; Vaccine site started to get itchy and red; She felt fatigued and then she was fine; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The red spot is warm to the touch and getting bigger), VACCINATION SITE PRURITUS (Vaccine site started to get itchy and red), FATIGUE (She felt fatigued and then she was fine), VACCINATION SITE PAIN (arm hurt) and VACCINATION SITE ERYTHEMA (Vaccine site started to get itchy and red) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced FATIGUE (She felt fatigued and then she was fine) and VACCINATION SITE PAIN (arm hurt). On 07-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccine site started to get itchy and red) and VACCINATION SITE ERYTHEMA (Vaccine site started to get itchy and red). On an unknown date, the patient experienced VACCINATION SITE WARMTH (The red spot is warm to the touch and getting bigger). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL CHILDREN [DIPHENHYDRAMINE HYDROCHLORIDE;PSEUDOEPHEDRINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (The red spot is warm to the touch and getting bigger), VACCINATION SITE PRURITUS (Vaccine site started to get itchy and red), VACCINATION SITE PAIN (arm hurt) and VACCINATION SITE ERYTHEMA (Vaccine site started to get itchy and red) outcome was unknown and FATIGUE (She felt fatigued and then she was fine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored (oka-merck) PROQUAD (dose, route and lot number were not provided). No adverse effects were noted. Follow up information was received from the registered nurse. The registered nurse stated that she did not have patient identifiers or dates of vaccine administration available at this time. On an unknown date unspecified number of patients were vaccinated with (oka-merck) PROQUAD (lot# K005883, expiration date 24-OCT-2015). No further information was available at this time. This is one of several reports received from the same reporter. Additional information has been requested.
Mrs. called to ask if she should be coming in to get her second Moderna vaccine today because she was still experiencing side effect from the first dose on April 26. Per Pt, she has mild arm pain and numbing that haven't gotten better until now. When she is resting she has no pain but when she is trying to lift something she feels the pain in her left wrist and left arm. The pain comes and goes about every 2 to 3 days. The numbing is more constant per patient. When I asked her to describe the numbing she said it feels somewhat tight and heavy as if she is grabbing something. She is also experiencing stuffy nose mainly on her left nostril that comes and goes. She is not sure if it is an adverse reaction to the vaccine or her allergy because she has chronic allergy and sinus problem. For now I advised patient to hold off from getting the second dose until she feels better. I called her primary care physician Dr. office from the office to let them know about patient's adverse reaction.
severe loose runny stools/Diarrhea; flu like symptoms; joint pain; muscle pain; tiredness; rash at injectoin site; stomach pain; ugh; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 12Feb2021 (Batch/Lot number was not reported) (at the age of 54-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation and experienced runny, loose stool specified as diarrhea, weight loss, stomach pain, ugh. In Feb2021, the patient experienced severe loose runny stools, flu-like symptoms including joint/muscle pain, tiredness, a giant rash at the injection site. Diarrhea that has lasted for 4 days, ugh, stomach pain as well. Normally she does not have GI issues. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
HYPOTENSION 11/18/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
After using vaccine with no adverse effects for 7 months, last dose (new batch) burned upon injection. Experienced severe flu-like symptoms immediately afterward.
pt recv vax 9JUL97 & 18 days later had itchy hives for 2 days all over body;
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 73 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-hodgkin's b cell lymphoma, immunocompromised, non-alcoholic, and non-smoker. The patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-JUN-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) negative.  The consumer said the patient's team of oncologists are aware of the results of the antibody testing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with the RA number 90000184174.; Sender's Comments: V0 20210660913-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE, SPECIAL SITUATIONS.
On Sunday 11/13/2022, I was starting to feel rundown and tired with a sore throat. On Sunday evening I started to come down with chills without a fever. The next morning I had a sore throat and chills and decided to test myself with an at home test for COVID-19, it came out positive. I reached out to my doctor to have a telehealth visit and she was able to prescribe PAXLOVID for me to take. After the telehealth visit I needed a confirmation PCR test. My doctor scheduled one and then it also came back positive as well. I started the PAXLOVID the afternoon on Monday and took it for the five days. As of now I am feeling fine, however, during the first couple of days I was extremely tired and my throat was hurting extremely bad. I lost my voice as well and could not speak however it did come back quickly.
This spontaneous report was received from a physician and refers to multiple patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patients were vaccinated with GARDASIL 9 ( (lot# M011117, expiration date: 17-DEC-2017, dose and route of administration were not provided) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Lymphadenopathy, neck tenderness  + stiffness, even painful in places.
This spontaneous case reported by a patient, describes the occurrence of epistaxis (patient had nosebleeds after the 1st Moderna shot) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No reported medical history. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; unspecified dose. On an unknown date, patient experienced epistaxis (patient had nosebleeds after the 1st Moderna shot). At the time of the report, epistaxis (patient had nosebleeds after the 1st Moderna shot) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
the form doesnt allow me to state it was Gardasil 4 /  within 12 months, patient developed stomach pains, weakness in her limbs and fatigue. It led to severe leg numbness, which then came of went, along with bouts of fatigue and headaches. With stress and activities - the symptoms reappear to a point she needs bedrest and medical attention . through other medical people, we  just where told of the connection between the vaccine and these horrible symptoms.    Been years of struggle with these symptoms with little help.
patient felt hot and tongue felt like she had eaten a hot pepper, within 10 minutes she said symptoms subsided. She was being kept for observation for 30 minutes due to drug allergy.
diffuse joint swelling began 7APR98;pt w/arthritis-joint swelling-effusion;joint fluid sterile;resolved w/PT/NSAIDS;hosp 7 days;still disabled but improving;
Per patient on January 28, 2010 :aches and pains all over and progressively worsened to the flu, vomiting, diarrhea and fever (101.2 temp.) After about 6 weeks, the pain left most areas of her body, but remained in the left hip and the patient still had difficulty standing and walking over the course of this issue.  Patient recently went to a physiologist and was told that the muscle is inflamed.
Running up a hill and became severely short of breath with significant chest pain in center of chest.  Had to lie on the ground to rest and catch breath.  Several minutes to catch breath and about 10 minutes for chest pain to resolve.   One month later had chest pain in center of chest... went to urgent care... EKG and vital signs showed normal. Two months after vaccine, started having forceful heart beat, lightheadedness, fatigue, pins/needles neuropathy in right foot... Lightheadedness and neuropathy was episodic, sometimes for hours, for a week... Fatigue was worse for a week then gradually eased but remains mild to moderate fluctuating... Forceful heart beat has continued but was worse 3 weeks ago and is always worse lying down and improves when sitting up though can be mildly present sitting up... and continues today. Seeing my primary care doctor to assess.   Went to clinic 3 times in last month for this... vitals always normal and one additional EKG normal.
PT RECEIVED VACC AROUND 4:30PM TUESDAY THE 23. PT STARTED EXPERIENCING FLU LIKE SYMPTOMS 1;00 THE NEXT DAY. FEVER OF 101. CHILLS, MUSCLE PAIN.
redness at the injection site / redness still present; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2021, the patient received the 2nd dose of Shingrix. On 15th May 2021, 1 days after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 2nd dose of Shingrix and the next day she noticed redness at the injection site and redness was still present. The reporter did not consent to follow-up with her healthcare professional. The reporter consented follow up with her.
Mild body aches; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunisation. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Mild body aches"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue". Events took place 1 day after receiving dose 2 of the Pfizer-BioNTech vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Painful palm lesions - Painful aphthous ulcer- Periorbital erythema (L) - Painful vaginal lesions.
About an hour after receiving vax, she developed marked swelling of upper and lower eye lids with slight redness of the bulbar conjunctivae. Slight cough.
Initial and follow up information has been received from a physician and a nurse, concerning an unknown number of female patients who were vaccinated with a dose of Gardasil.  The physician indicated that 10 to 15 minutes after the vaccination was administered, "about a quarter" (25%) of the patients had fainted.  At the time of this report, the outcome of the events were unknown.  The patients did not seek medical attention.  Follow up information from the nurse indicated that there was no "trend" to the patients fainting, and it occurred with different lot numbers.  She stated that they will keep track of these episodes in the future.  No further information on individual patients was available.  No further information is expected.
Left deltoid pain, swelling and redness evening and night of administration. Improved next afternoon. Advised ice and Ibuprofen.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Red round circle at injection site that is warm to touch. Informed pt to mark circle to check for spreading and to call DR office.