chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Vaccine manufacture date of expiry reported was 09-Nov-2021.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up document included no new information.
I've had the worst headache ever since receiving the vaccine. Took a Goody powder this am and presently no pain
Severe Headache; body ache/pain; malaise; nausea; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 16Dec2020 at single dose for Covid-19 immunization. The patient is not pregnant. Medical history was none. The patient had no known allergies. The patient's concomitant medications were not reported. It was unknown if other vaccine was administered in four weeks.  On 07Jan2021, the patient experienced severe headache, body ache, malaise, pain and nausea fit for 30 hours. Prior vaccination the patient had no COVID. It was unknown if the patient was COVID tested post vaccination. No treatment received for the events. The patient recovered from the events on unspecified date in Jan2021.  Information on the batch number has been requested.
Bruising for three days after the injection. On Day 9, my arm began to feel tingly (like pins and needles) On Day 10 (Sunday 1/24), I noticed my the injection aite was swollen, hot to the touch, and red and blotchy.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Patient was inadvertently given 0.5 ml instead of 0.3 ml.  No adverse reaction occurred.
my red blood cell count was off a little bit; This is a spontaneous report from contactable consumer (patient). A 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318, expiry: not reported), via an unspecified route of administration on 22Jan2021 as single dose for covid-19 immunisation on his right arm (at the age of 68 years). Medical history included blood pressure (Investigation Assessment: Yes). Concomitant medication(s) included hydrochlorothiazide (HYDROCHLOROTHIAZIDE); amlodipine; metoprolol succinate (METOPROLOL SUCCINATE ER); olmesartan medoxomil; fluoxetine hydrochloride (PROZAC, 20 mg); oxybutynin chloride (take oxybutynin chloride ER 24 hours). The patient and his wife had their first dose of the Pfizer COVID 19 Vaccine little over three weeks ago and were scheduled to get their second dose on 12th of February (last Friday), which was exactly 3 weeks. On 11-Feb-2021 (Thursday), the patient canceled their second dose appointments (12th appointment for both of us) and was waiting to get another appointment for their second doses through their private insurance company. The patient stated that the lady was very happy that he called in and cancelled, so somebody else could take that spot. But he gave his phone number and said please call me as soon as you get availability for the second dose of the vaccine. That was last Thursday, and no one has called him since then. He called and he was hoping that they would give him a call. The insurance company said always got some opening some place to get your second dose, but he had not heard anything from anybody as of now. They haven't got the second dose yet. His daughter was a nurse and she told him that they only have a 4-day window to receive the second dose of the vaccine in regard to safety so now they were not certain when they should get their second dose and how will it impact the efficacy of the vaccine. They are going to be getting their second doses of vaccine past the 21 days period and it has already been four days after they were supposed to have the shot. The patient stated that he was 172 pounds right now and has lost about 12 pounds (further clarification unknown). On unknown date, his red blood cell count was off a little bit as shown in the lab tests. The outcome of event was unknown.
On 01/27/2005 Pt reports experiencing a continous ache from shoulder to left elbow and slight loss of grip in left hand. No redness, no swelling at injection site, no fever. Used no OTC meds, no compresses, lasted 2 1/2 weeks. Then left arm ok. But 2 weeks later started experiencing tingling from shoulder to fingertips. Not continous but frequently. Has not seen a doctor. Pt states he works out at gym 3-4 times a week and does lift weights. He also travels much.
given quadrivalent Fluzone Standard Dose by mistake; Initial information was received on 06-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) (email received in inbox).  This case involves a 77 years old male patient who was given quadrivalent fluzone standard dose by mistake (wrong product administered), while he received vaccine influenza quadrival a-b vaccine [Fluzone quadrivalent].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patient received influenza quadrival a-b vaccine (with an unknown formulation, strength, dose, frequency, route, lot number and expiration date) for prophylactic vaccination.  Patient was prescribed with quadrivalent Fluzone High Dose flu vaccine for elderly, but was given quadrivalent Fluzone Standard Dose by mistake. Obviously when dealing with drug stores to administer vaccines, you need to better distinguish the different vaccines on the carton/syringe. A druggist was not a doctor or nurse, but rather a clerk dealing with a long line of anxious customers. Note, except for the third word in the four-word name of the vaccines, all the other words are exactly the same. Perhaps, if you put on the cartons "for elderly use" and "for under 65 use"; note one has the word "elderly' and the other has a number "65" then even a clerk can distinguish them.  No laboratory tests were reported.  At the time of report, no adverse event was 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.
Fever, headache, high blood pressure, ear and sinus infection, joint pain, tiredness, pallipations, fatigue
patient has large red patch on right arm , warm to touch.  appeared same day as vaccines given.  Patient will monitor area of redness and will be seen in follow up virtual appointment tomorrow
Vaccine exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
High fever the first night, followed by low grade fever (98.9F-99.6F) for 15 days. Swollen lymph node under left arm (until today it is still noticeable)
I have a large rash approximately 5 inches long by 3 inches wide on my injection site arm. On sunday 2/14/21 the injection site was hard, itchy and red. The size of the rash was 2 inches by 2 inches. As of yesterday 2/18/21 the rash had grown to the current size. It is hot and inflammed, in addition to itchy. I have not taken any medications to combat these effects.
Information has been received from a registered nurse concerning a 32 year old male patient. There were no drug reactions/allergies, pertinent medical history and concomitant medication. The patient received unspecified doses of MMR II (strength, dose, route and lot # unknown) as a child at unspecified date. The nurse stated that the patient had titers drawn for MMR II on 23-APR-2013, "which was required for employment" and the titer showed no immunity to rubella or mumps. The nurse stated that the patient was administered a dose of MMR II on 07-MAR-2016 (rHA, lot #K016154, Expiration Date 24-SEP-2016, 0.5ml, subcutaneous) due to the titer showing no immunity to rubella or mumps. The nurse stated that the patient had titers drawn for MMR on 27-APR-2016 and the titer showed that the patient did have immunity to measles, mumps and rubella. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recvd a sereis of 3 Engerix-B inject last yr & pt did not respond; Pt will be given booster & titer will be taken again;
his feces are liquid; this is taking the energy out of his body; he has lost a lot of weight; he is dehydrated; diarrhea; vomit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date 23Apr2021 (Batch/Lot number: unknown) 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 of the Pfizer Covid 19 vaccine), for Covid-19 immunisation. The following information was reported: DIARRHOEA (non-serious) with onset 24Apr2021, outcome "unknown", described as "diarrhea"; VOMITING (non-serious) with onset 24Apr2021, outcome "unknown", described as "vomit"; DIARRHOEA (non-serious), outcome "unknown", described as "his feces are liquid"; DEHYDRATION (non-serious) with onset 24Apr2021, outcome "unknown", described as "he is dehydrated"; ASTHENIA (non-serious), outcome "unknown", described as "this is taking the energy out of his body"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "he has lost a lot of weight". The events "diarrhea", "vomit", "his feces are liquid", "he is dehydrated", "this is taking the energy out of his body" and "he has lost a lot of weight" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea, vomiting, diarrhoea, dehydration, asthenia, weight decreased.  Additional information: The patient stated he received the second dose of the Pfizer Covid 19 vaccine on 23Apr. Since 24Apr, he has had diarrhea, vomit and he is dehydrated, two days in a row he had diarrhea and vomit at the same time. He went to the ER on 05May to get a blood test but the doctors couldn't find anything on his system that could explain the diarrhea. He stated his dad (84) had the vaccine in but didn't experience any of this reactions. He stated he's been taking pepto bismol and other medications that do nothing for his condition. The diarrhea wakes him up, he cannot keep anything in his stomach, his feces are liquid, it is like water coming out, he is dehydrated and this is taking the energy out of his body, he has lost a lot of weight, he stated he never had any kind of stomach problems before. He also stated he had heard a lot of people complaining about this and asked could this be related to the vaccine.  Information on lot/ batch number has been requested.  Follow-up (01Jul2021): Follow-up attempts completed. No further information expected.
A non-serious spontaneous report of '29 patients received expired FLUMIST" was received from a physician concerning a five-year-old female. The patients' medical history included no history of asthma. Concomitant medication were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are
Ringing in ears. Has not stopped. Did not report originally as a side effect because did not think was related but did report to my dr
fever, rt arm swelling, pain w/extension to rt anterior chest, neck/day p/arm swelling day of vax;cough 2 days p/vax;
1/12/09 received call from mother she states that about 34 hours post vaccination hives appeared on arms, BENADRYL given with relief. On 1/12/09 hives appeared on face BENADRYL given. Upon returning home from school child had hives on torso, back and face. BENADRYL given. 1/13/09 child awoke with hives on face and arms BENADRYL given with no further outbreaks.
Information has been received from a physician concerning her 4 year old son who, at age one, in approximately 2002, was vaccinated with a dose of varicella virus vaccine live. It was reported that the patient just came down with a mild case of chickenpox, on approximately 5/23/2005. No other information was provided. Follow up information from the physician indicated that she did not have any knowledge of the experienced. Additional information is not expected.
This spontaneous report was received via a social media from a consumer (the mother of the patient) concerning her 12 year old daughter who received GARDASIL on an unspecified date(s). Concomitant medications and medical history were not provided. The reporter made the following statements on the social media site: "[Daughter's name] menstrual cycle after GARDASIL-constant bleeding/pain like birthing a porcupine, infertility?" "[Daughter's name] life matters. GARDASIL destroyed her/suffering 5 years". "Anxiety, ADHD, bipolar, severe memory loss, depression, suicidal after losing soccer/school/friends". "Headaches, muscle/joint pain, SOB [shortness of breath], excruciating back/rib.shoulder/legs/chest pain, abnormal sensations". "Athlete now has gastroparesis/imagine at 15 your stomach virus is 24/7/365 forever". "Vomits daily, malnourished, nauseated, debilitating pain, chronic fatigue". "My teen is up to date including GARDASIL. Played Russian Roulette/destroyed my daughter's life". "My 12 year old daughter did and is still suffering now at 16 1/2. What she endured is inhumane". The outcome of the events were not recovered. Upon internal review, suicidal after losing soccer/school/friends was considered medically significant. Excruciating back/rib/knee/shoulder/leg pain/debilitating pain was considered disabling. Additional information is not expected.
My adverse symptoms were the same as those I had with my shot #2:  severe exhaustion, muscle and body aches, severe headache.  Later in the day I developed severe heartburn, just as I did with shot #2.  Due to the heartburn I threw up seven times.  The first time was  a natural occurance, the other six times was forced to relieve myself of the stomach acid.  That helped the last time with shot #2.  I was unable to sleep both the night of the shot and the following night.  I am now on my third full day and still feel tired and a bit foggy, but much better.  As with shot #2 for this booster shot #3 I felt at times I needed to go to the ER, but I did not.  I am thankful I made it though!
Pt came to ER with confusion, nausea, fever one week prior, loss of appetite, on/off pressure to chest.
02/06/21 - Moderna Round 1 administered  (no adverse reactions reported) 03/05/21 12:25 pm - Moderna Round 2 administered 03/09/21 10:00am - Patient reports itching and urticaria (arms, back, stomach). Seen by MD and prescribed prednisone (20 mg QD 1 week) and diphenhydramine (25 mg BIDx1 week) 03/10/21 09:00am - Seen by MD for follow up of hives, patient reported improvement yesterday but woke up today with worsening. Meds changed to Prednisone 60 mg QD and Diphenhydramine 25mg q6hr 03/11/21 06:00 am - Patient again woke up with increased urticaria, as well as lip swelling, itching, and chest tightness. Patient was transferred out 911. 03/11/21 10:30 am - Patient returned from hospital with prescriptions for prednisone 40 mg QD, Famotidine 40 mg QD, Diphenhydramine 25 mg q8h
31JAN pt seen in clinic;no prior hx of tetanus rxn recv DT lt upper arm;2FEB husband called MD c/o swelling & redness down arm to hand;DPH; 9FEB seen in ER c/o arm swelling, redness, stiffness, edema/erythema down arm to hand;dx cellulitis
Area at injection site, L deltoid, approximately 2 inches in diameter, red swollen and c/o painful to touch.
headache; soreness; nausea; phlegm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; PAIN (non-serious), outcome "unknown", described as "soreness"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "phlegm".  Additional information: The patient's age was reported as 20, no unit provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Body Aches; Lower Back Pain; menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches), BACK PAIN (Lower Back Pain) and MENSTRUAL CYCLE MANAGEMENT (menstrual cycle) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body Aches), BACK PAIN (Lower Back Pain) and MENSTRUAL CYCLE MANAGEMENT (menstrual cycle). At the time of the report, PAIN (Body Aches), BACK PAIN (Lower Back Pain) and MENSTRUAL CYCLE MANAGEMENT (menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
DOLOR EN AMBOS AXILAS Y EL CUERPO. PRESENTA HEMATOMAS EN AREA DE AXILAS EN AMBOS BRAZOS.
Vial of Covid 19 6m-4yr vaccine was not diluted with sodium chloride and all 10 doses were given to the patient in one injection.
REDNESS & SWELLING & WARM TO THE TOUCH PRESENT IN BOTH ARMS; WORSE IN LEFT ARM NEAR IM (DTAP/IPV) INJECTION SITE; NO NOTICABLE RXN AT SITE OF MMR OR VARICELLA VACCINATIONS;  currently SIZE OF SWELLING = "HALF OF AN EGG" & painful to touch; NO REPORT OF FEVER, LETHARGY, NO CHANGE IN APPETITE; ICE PACK APPLIED AFTER CLT ARRIVED HOME 7/21/10; SWELLING IS LARGER 24 HOURS POST VACCINATION; was slight bruising on left arm immed following vaccination; mother will continue to monitor and seek appropriate care.
The pt received 2 injections. Immediately after receiving the 2nd injection (IPV), the pt passed out for about 30 seconds and then regained consciousness. He was pale and slightly blue around the mouth. He was examined at that point, by a physician, who dx'd a vasovagal response. The pt left the clinic much improved and in good spirits.
No additional AE or PQC reported; PROQUAD was administered to 7 month old infant.; This spontaneous report has been received from a medical assistant concerning to a 7-month-old patient of unknown gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not provided.  On 23-MAY-2022, the patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5 mL, lot # U030590, expiration date 29-MAR-2023 (route of administration and anatomical location were not provided) as prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) was reported.
I thought I was having my seasonal allergies as the pollen count has been up. I only tested because I was going to be visiting my mother in law for mothers day and wanted to be cautious. I had just been having a runny nose and sneezing. I tested positive on a home test on the 5th which led me to reach out to my PCP. I went in for a PCR test because due to my lack of symptoms he wanted to make sure it was not a false positive. I did end up positive on the PCR test as well.