chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Low titer/received the results Rubella 4.89, Measles was 84.3 and Mumps IGG less than 9 showed immunity from infection or vaccination; Low titer/received the results Rubella 4.89, Measles was 84.3 and Mumps IGG less than 9 showed immunity from infection or vaccination; Low titer/received the results Rubella 4.89, Measles was 84.3 and Mumps IGG less than 9 showed immunity from infection or vaccination; This spontaneous report was received from a currently 33-year-old male patient, referring to himself.  The patient did not have any medical history and drug reactions/allergies. The patient's concurrent conditions and concomitant therapies were unknown.  On 01-OCT-1987, the patient was vaccinated with the last dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, lot/batch # and expiry date were not reported) for prophylaxis (reported as "doctor recommendation"). The patient reported that he recently had titers drawn and results revealed Rubella 4.89 (units not provided), Measles 84.3 (units not provided) and Mumps Immunoglobulin G (IgG) less than 9 (units not provided) which showed immunity from infection or vaccination (rubella antibody negative, mumps antibody test negative and measles antibody negative). Additionally, tuberculosis (TB) test, varicella and quantiferon TB tests were performed and the results were not reported. The patient sought medical attention and he did not receive any treatment. No product quality complaint (PQC) was involved. The outcome of all the events was unknown. The causality assessment was not provided.
swelling, redness at injection site, pain, fever, chills, dizziness, pale, hard to take deep bbreath
she experienced pain in her right leg and had DVT; she experienced pain in her right leg and had DVT; This is a spontaneous report from a Pfizer sponsored program.. A 61-year-old contactable female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 05Apr2021 (at 61years old) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The second dose is scheduled on 26Apr2021 (correct dosing schedule). Patient missed her second dose because she had 2 ultrasounds after her first dose. In addition, she experienced pain in her right leg and had DVT on unspecified dates. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
DIZZINESS, BLURRED VISION, LOSS OF CONSCIOUSNESS, VOMITING.  HAPPENED IN THAT SUCCESSION APPROXIMATELY 5 MINUTES AFTER VACCINATION.  PARAMEDICS WERE CALLED AND BLOOD PRESSURE+GLUCOSE TAKEN.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 19-NOV-2008 and 02-FEB-2009, the patient was inoculated with ZOSTAVAX (lot numbers, dosages and routes of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-SEP-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed gabapentin for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Hives across back, sides, chest, waist, pelvis, inner thighs, face, feet that spread for 48 hours. Highly raised white edges. Essentially everywhere but my shins. Injection site swelling over entire deltoid. Deltoid firm to the touch. Radiating pain down entire forearm into ring and pinky fingers.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 63-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 04-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Reports Symptoms:  10064366:EXTRA DOSE ADMINISTERED;    Narrative:  The patient demanded a booster of the bivalent vaccine even though it is not authorized.  He already got a bivalent vaccine dose
He called yesterday reporting erythema, pain, and some 3 red streaks, told to take NSAID and apply ice and if not improved to come in today. He is improved with less discomfort though some generalized soreness in (R) shoulder, there is now one localized area of erythema about 3 cm medial to the site of injection, no fever, no adenopathy. Naproxen.
Moderna Covid-19 Vaccine EUA  On Day 8 after receiving the first dose of Moderna Vaccine, an itchy rash developed on left arm near the injection site. Skin was irritated and red. Treated with Hydrocortisone cream for approximately 24 hours. Rash disappeared after about 36 hours.
Every afternoon since the 22nd, I have felt like I'm coming down with a cold. Fatigue, runny nose, depressed, headache. No fever. Seem to feel okay in the morning and evening.
erythematous rash that spread over both legs to ankles-mild swelling all alleviated w/DPH;
Blurred vision. I have an absolutely perfect vision normally. For several days after vaccination I would try to focus really hard, but was unable to fully. Since 4 days ago my legs started getting numb at night and yesterday - during the day. Yesterday my left leg started going numb and giving way a little. Also got tingling sensation in fingers and weird feeling in muscles, as if they were "restless", for about an hour in the evening had to pay attention to typing, otherwise fingers would not type right (whereas usually I don't have to consciously think about it). Also rushes of hot blood to the legs and sweats at night.
slight tenderness at injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age:78; unit: unknown) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient is scheduled 4 weeks out for second dose of Covid Vaccine and wanted to know if thats okay. She experienced a slight tenderness at injection site. The patient  and her husband received the vaccine. They scheduled the 2nd dose in 4 weeks instead of 3 weeks, they were asking if it was ok. They went to the clinic. It was very well organized. She asked if the next appointment going to be 3 weeks where they administered the vaccine. They were told that they are getting the Pfizer one and it's going to be 4 weeks. Then they waited for 15 minutes and went to the open computers for scheduling of the 2nd shot. The next shot is scheduled for 15Feb or 16Feb whichever one is a Wednesday works better for them. This morning her husband was reading the newspaper and it stated it cannot be given more than 23 days, this is going to be 32 days. They asked if they can reschedule. They will call the hospital or maybe change their appointment using the website/app. They were asking what is the timing of the 2nd dose of vaccine. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
No adverse event. Patient got the vaccine too early. First dose was on 4/29/21 and then again on 5/20/21. Patient traveled from a long distance to get the vaccine. He was a week early. Patient was not on the schedule but when he showed up, the vaccinator gave it to him. Patient was on our schedule today and did not show up. When I went into the state immunization schedule/program I noticed he was several days early to get vaccine (patient was to return on 5/27/21 at 1:30 pm).
Patient recieved vaccines on Weds 9/25 in clinic.  Symptoms started on Saturday, 9/28. Called on call provider Sunday,  9/29 with complaints of fever of 103F, myalgias and swelling and redness at injection site  on right arm. Advised to go to ED. Seen at Hospital ED on 9/29.  Reported RUQ tenderness. CBC with elevated WBCs, no other concerning lab results or DIs. Negative mono. Discharged with suspected serum sickness versus viral illness. Seen at clinic by this provider on 9/30 with continuing fever, lethargy, myalgias, significant swelling of right axillary node and moderate swelling of left axillary node, RUQ tenderness. Blood cultures drawn which were negative. Started on Doxycycline 100 mg BID PO x 10 days and prednisone taper (first dose 60 mgs) x 12 days.  Patient canceled f/u appt in 4 days.  Rescheduled for 10/10, seen in clinic. Symptoms improving - no fever, myalgias or left axillary swelling. Continues to have minimal right sided submandibular and axillary lymphadenopathy., fatigue, headache  and sweating. Prescribed Indomethacin 50 mg BID PRN x 14 days and Pantoprazole  20 mg QD x 14 days. Encouraged f/u PRN.
Information has been received from a pharmacist concerning a 70 year old female with high blood pressure, high cholesterol and diabetes who on 07-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included clonidine, ezetimibe (+) simvastatin (MSD), MICARDIS, alendronate sodium (MSD), metformin, metoprolol and minoxidil. Two weeks after injection, the patient developed a rash that went down her arm. It was indicated the patient's rash improved. Unspecified medical attention was sought. No further information is available.
Hives on (L) upper arm and around underarm below where I had the pneumonia vaccine. (L) arm hot and painful to raise (L) arm soreness in arm lasted 4 day? Hives for about a week. No treatment.
still having lymph node pain in her groin, chest and axilla. Followed up with pt, who stated that the pain and swelling is still there. She rates it a 6 out of 10, 10 being severe pain. She has been taking Ibuprofen 800mg TID although she has not contacted her PCP. I recommended that she did. Her 2nd shot is due 3/17 and wonders if it would get worse or if she should get it at all. She thanked me for my call back and I informed her to call us back if she has any questions or issues.
AT 3PM, DEVELOPED HEADACHEAND CHILLS THAT LASTED 24 HOURS.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown demographics. Information regarding the patients' concurrent conditions and medical history was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, which had a lot number of L007560 and expiration date on 15-JUN-2017 (dose, route of administration and anatomical location were not reported. There were no concomitant medications reported. The details of the temperature excursion noted a temperature of 32.3 degrees Fahrenheit (F) for 11 hours. No adverse effects reported. There was no product quality issue involved. Additional information has been requested.
Immediately after receiving the vaccine, I became severely nauseated, light headed, sweaty, warm and dizzy. My hands became tingly/numb as well as my legs. This lasted about a half hour where I felt I could faint at any moment. My arm is currently sore 7 hours later and I am fatigued.
patient had 1 dose 3 years ago and never received a 2nd dose; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 14Aug2019, this case now contains all required information to be considered valid.   This is a follow-up spontaneous report from a Pfizer-sponsored program (Call Center for HCPs). A contactable pharmacist reported that a 20-year old male patient received as immunization the first dose of meningococcal group b rlp2086 (TRUMENBA) at single dose, on an unspecified date (3 years before this report) but never received a 2nd dose.   The information on the lot number has been requested.
neuropathy in her left foot; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.  A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Jan2021, both at arm left via an unspecified route of administration at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced neuropathy in her left foot on an unspecified date after both doses (the second time worse). The patient outcome of the event was unknown.  The information on the batch number has been requested.
Blood clot; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 49-years-old male patient received bnt162b2 (BNT162B2 Pfizer covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: ewolf3), via an unspecified route of administration on 30Apr2021(at the age of 49-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On Jun2021, the patient experienced blood clot. The patient was hospitalized for blood clot (thrombosis) for 1 days. The outcome of the event was unknown.
Patient developed infection in the arm from injection site. pt had redness and swelling of the injection site followed by pain. was prescribed augmentin for treatment of infection.
Painful lump in his groin 3 days after receiving a 3rd dose; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (Painful lump in his groin 3 days after receiving a 3rd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Painful lump in his groin 3 days after receiving a 3rd dose). At the time of the report, LYMPHADENOPATHY (Painful lump in his groin 3 days after receiving a 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  Patient had a painful lump in groin three days after receiving a third dose. Reporter enquired if this could be vaccine related.   Reporter did not allow further contact
Presented on 10/4/05 with reports of red raised lesions to the body. Lesions noted to the R hand, neck, head, and L foot and L knee. Reported elevated temp of 103 2 days ago with headache which he was seen in the local ER for. Reports that pustules are painful. States that small blisters presented last week and that they began rupturing 1-2 days after they developed. Lesions were scraped for culturing. Smallpox vaccination site is 10cm in diameter. There is localized swelling and redness encompassing the vast majority of his upper left arm and down to the elbow area. Placed on quarters til lesions scab over and culture results are in.
Pt called stating after receiving TDAP, she felt ill with a fever of 101.0, body aches, diarrhea and hives (face). pt is feeling better now. Symptoms lasted 2 wks.
Fever, chills, headache, body on day after vaccination. The persistent ventricular ectopy and anxiety days 2-4 after vaccination.
Patient woke up 6 days after vaccine with a red warm arm injection site reaction.  Her arm was sore after vaccine for a few days but it became red 4-19-23.
At beginning of second week, white pustules appeared on right upper eyelid, across my lower lip, and a few on both lower arms.  By the third week, all but my eyelid have healed up. Eyelid was the largest and is still large and white, however is not red and inflamed as in the beginning.
Approximately 35 hrs after vaccine, had severe vomiting and stomach cramping - some diarrhea. After 5 hrs went to ER and received anti-nausea and cramping medicine. As well as fluids. After 4 hrs in ER, recovered rapidly.
COUGH, SHORTNESS OF BREATH, FATIGUE, WEAK.  ER VISIT
Fever, shakes, sweats, body aches, arm soreness for 36 hours
Black stool; fever; A spontaneous report was received from a consumer (patient) concerning a 56-years-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed black stool and fever.  No medical history was provided. On 24 Feb 2021, the patient received fluphenazine. No concomitant medications were provided.  On 26 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided), intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced, black stool and fever.  The treatment medication included paliperidone.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events of black stool and fever was unknown.   The reporter did not provide assessment for the events of black stool and fever.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Lt arm swollen, hard, red, warm to touch, itchy started within 24 hrs of DTaP injection to Lt arm-IM. 6/21/07 arm swollen past elbow
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 64-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 11th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-Oct-2022 Reporter's comment: The registered nurse reported that the patient received 1st dose of an expired Havrix vaccine.  The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
p/vax pt dx w/varicella rash on 9/30/99;rx zovirax x 5 days;rash lasted only 2-3 days;
administered dose reconstituted with a non-supplied diluent; administered dose reconstituted with a non-supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA673A, expiry date 31st March 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's Comments: The medical assistant reported that the clinic staff discovered that box of Menveo vaccines had an extra vial of diluent, so they believe a patient was administered a dose that was reconstituted with a non-supplied diluent. At the time of reporting, the reporter only knew that it was a pediatric patient, but were not sure yet which patient it was, or what date it was administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient received Menveo that was reconstituted with a non-supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Starting 01/10/2022, I felt like I had the flu. I was miserable, coughing, sneezing and having trouble breathing. I was achy all over. I tried to go to sleep that night, so I had my husband take me to the ER because I was hurting so bad. They tested me for COVID-19 and I was told it was positive. I got a steroid shot and then was discharged, and told to stay in the house for 5 days. The symptoms lasted about a week.
Head and neck pressure/stiffness. Feels like my head was twitching or spasming. My gag reflex is gone. Chest pains.
Patient states he received the vaccine at pharmacy on the morning of 5/14/21 and noticed having symptoms of chest pain. He then went to the ER for care.
Information has been received from a 25 year old female patient who on an unspecified date was vaccinated with the second dose of GARDASIL (Lot# not reported). The patient stated that she was unable to complete the 3 series because she had a negative reaction to the second injection. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
I have never had any problem with my annual Flu shot. On Sept 9, 2015 I was given the high dose shot because of my age. This was not an allergic reaction, but days of weakness and full body pain which gradually abated. 6 mo later I still have pain in that arm and lack full range of motion!