chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AE reported; she was unsure if any of these vaccines had been administered since the excursion occurred; This spontaneous report has been received from a medical assistant, concerning a 5-months-old female of patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 22-AUG-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent oral liquid (strength, dose, frequency, vaccination scheme, route of administration, and anatomical location were not provided) (lot number 1742420 has been verified to be valid; expiration date reported and established as 31-JAN-2023). The administered dose of the vaccine was stored at a temperature of 52.2 degrees Fahrenheit (F), during a time frame of 2 hours and 53 minutes, and at a temperature of 33.6 F, during a time frame of 4 hours and 59 minutes. There was no previous temperature excursion reported. There was no adverse effect reported.  This is one of 5 reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA004932:MSD US-009507513-2210USA009377:MSD US-009507513-2210USA009380:MSD US-009507513-2210USA009378:MSD
This spontaneous case was reported by a consumer and describes the occurrence of RASH (5 rashes on my behind - started as "little bumps like a pimple) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced RASH (5 rashes on my behind - started as "little bumps like a pimple). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (5 rashes on my behind - started as "little bumps like a pimple) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Benadryl; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the event, a causal relationship cannot be excluded. The reported event is consistent with the product safety profile
This spontaneous report was received from a registered nurse and refers to an adult patient of unknown gender (exact age was not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JAN-2017, the patient was inadvertently administered with 1 ml of an expired dose of VAQTA 50/1 U/ ml (lot # L048222, expiration date: 19-DEC-2016) (route of administration and injection site were not reported). No adverse effects were reported. Product quality complaint  (PQC) was not involved. Additional information has been requested.
This is 1 of 3 infants from this facility to devel high fever,inconsolable crying & irritability p/vax w/lot #447832
I recieved the shot around 12pm and after a couple hours my arm felt really sore I got achy and felt stiff in my joints. Then my legs and feet were extremely swollen around 9pm that same night and it was painful it felt like my legs were being squeezed tightly. It continued for 3 days and after the three days it went away.
This case was reported by a consumer and described the occurrence of fever in a 2-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included live attenuated oral poliomyelitis vaccine (manufacturer unspecified) given on an unspecified date, but the same day as PEDIARIX. On an unspecified date the subject received unspecified dose of PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced fever and accidental asymptomatic overdose. The child received a dose of oral polio vaccine the same day. At the time of reporting the outcome of fever was unspecified.
I had a little sleep disturbance, stuffy nose with sniffles, a tickle in the back of throat that prompted a horrible sounding cough. The strongest symptom was head congestion which went into my ears. I tested positive for COVID-19 on November 07, 2022.  I took Dayquil, Motrin and Sudafed as well as Vitamin C. My oxygen rate remained 96% or above and I never ran a fever. I was symptom free after 7 days.
From faxed correspondence received at manufacturer on 1/2/03 it was reported that a pt who received Imovax Rabies Vaccine in August 2002 and shortly after developed symptoms of multiple sclerosis (exact date not provided). The pt was seen by the consulting neurologist in November 2002. No other info was available from the physician. (OMIC)Follow up on 08/12/2003: "Administrative case closure (no additional information anticipated)."
NEUROPATHY ACUTE HYPOXEMIC RESPIRATORY FAILURE  12/27/2021 --  RECURRENCE OF SAME SYMPTOMS
1) Injection site red, hot, itchy, hard (size 2 inch x 1 inch big) with brown color. Lasted x2 weeks post vaccination. 2) Left eye infection (granulomatous uveitis, per doctor). Pt first noticed 12/19/14, diagnosed on 12/22/14. Treated with Valtrex 1gm, homatropine eyedrops, timolol eye drops, DUREZOL eyedrops.
Information has been received from a licensed practical nurse concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On unknown dates, the patients were administered improperly stored doses of ZOSTAVAX lot # M032139, expiration date 02-OCT-2017, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. The doses of ZOSTAVAX were exposed to 21.3 degrees C for 1 hour. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of several reports from the same source.
Information has been received from a physician concerning a 25 year old female who on an unspecified dated was vaccinated with the first dose of GARDASIL vaccine. The physician reported that the patient fainted in the office after receiving vaccine. The outcome was unspecified. Additional information has been requested.
Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a two- months old patient who was vaccinated with a dose of BOOSTRIX instead of DTaP (lot number, expiry date, dose, dose in series, route and site of administration was not reported on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. The Doctor in the ER ordered DTap and the nurse gave BOOSTRIX. It was reported that patient already received Hib and polio portion. It was not reported whether the patient experienced any adverse reactions following the vaccination. 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. Documents held by sender: none.
WEAKNESS; THROBBING PAIN IN HANDS; FELT NEEDLES IN FINGER TIPS OF LEFT HAND; COLD BODY/FELT COLD ALL OVER BODY/HANDS BECAME VERY COLD AND WERE FREEZING; HEADACHE; FELT TIRED; This spontaneous report received from a patient concerned a 59 year old female of unspecified ethnicity.  Initial information was processed along with the additional information received on 06-DEC-2021.  The patient's height, and weight were not reported. The patient's past medical history included: cancer on unspecified date in 2014, she was also diagnosed with cancer in 2019, The patient was in remission from cancer. Chemotherapy has created peripheral nerve issues, but they had resolved. The patient was under the care of a neurologist and was normal.    The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, (dose number in series was 1), 1 total, administered on 12-APR-2021 to left arm for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient felt cold all over her body, had a headache and felt tired following vaccination (dose number in series was 1).  The patient received booster dose of covid-19 vaccine ad26.cov2.s vaccine (suspension for injection, route of admin not reported, batch number: 1855194, expiry: UNKNOWN) dose was not reported, (dose number in series was 2), 1 total, administered on 29-NOV-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 29-NOV-2021, the same night after vaccination with covid-19 vaccine ad26.cov2.s, the patient felt cold all over her body, had a headache and felt tired. Her hands and feet got colder and colder, the cold was extreme to the point of hurting. On 30-NOV-2021, later on morning while she was washing her hands in cool water, she felt needles in finger tips of her left hand and was resolved. 0n 03-DEC-2021, when she was washing her hands in cold water, her hands became very cold and were freezing. It took a long time over 15 minutes for them to warm up. This happened while she was at a grocery store. She tried to warm her hands by putting them in her pockets. When she got in her car, her hands started warming. She felt throbbing pain in hands as they were warming up. On an unspecified date, the patient also experienced weaknesses in certain areas that may have got triggered due to vaccination (dose number in series was 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from felt needles in finger tips of left hand, and the outcome of throbbing pain in hands, cold body/felt cold all over body/hands became very cold and were freezing, headache, felt tired and weakness was not reported.  This report was non-serious.  This report was associated with a product quality complaint (PQC): 90000205465.  The suspected product quality complaint has been confirmed to be void (does not meet PQC criteria) based on the PQC evaluation/investigation performed.  This case, involving the same patient is linked to 20211231019.
After I  received the shingles and the flu shot together I got terrible flu like symptoms Body aches for over a day and a half. I spoke with my md and they ignored my symptoms and would not talk to me
Inj was admin with proper technique. I Felt well until 13° after inoculation. I developed chills and rigors and slight body aches which I expected some. Hands went numb and tingled and turned white(Raynaud?s). Then sudden onset of severe nausea came on followed by pallor, abdominal Pressure, hypotension-vasovagal, near-syncope then stooling and diaphoresis and profound weakness. Lasted maybe 10? Minutes then BP went up to 99/64 and O2 sats were good at mid-90?s.
1 yr old received vaccines listed below. Mother and child returned to clinic 2 hrs post vaccination. Child presents with wheals on legs and arms and generalized rash on abdomen. Dr notified and child given oral Benadryl (12.5mg) at 2:20PM. Parent given written instructions to continue oral Benadryl for 24 hrs post vaccination. Child wt 29lbs. Telephone call today to parent. Pt recovered. Rash and wheals subsided. Child eating and drinking. No fever, fully recovered. Mother instructed to pre-medicate child prior to next vaccinations. Give Benadryl 30 min to 1 hr prior to vaccinations.
So, I had pain and stuffiness in my neck and all of my joint areas to my knee's. I couldn't get out of bed and when I did, it hurt really bad. The doctor said that I have PMR, it's a auto immune disease. The doctor prescribe me prednisone and I will have to take that for the next year. My husband and I have been out a lot of money for taking a free vaccine.
ON 12/31/20, DEVELOPED MID  BACK PAIN, JOINT PAIN, MASSIVE HEADACHE, AND INJECTION SIGHT PAIN. LASTED 48-72 HOURS BEFORE RESOLVING.
This spontaneous report as received from a pharmacist refers to a 64 year old male patient with drug hypersensitivity. The patient was allergic to penicillin. On 22-JUN-2015, the patient was vaccinated with PNEUMOVAX 23 0.5 ml/1 dose (lot # K020795 and expiry date of 19-MAR-2016), intramuscular in the left deltoid. On 23-JUN-2015, 2 days after onset of therapy the patient experienced rash and swelling at injection site and had a red streak running from the injection site and around the back of the arm and into the armpit. The patient sought medical attention and called the pharmacist and was advised to "seek medical attention if he feels he needs to". No treatment was received in response to the events. The outcome of the events was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
stuffy nose; eyes are watering; This is a spontaneous report from a contactable consumer (patient). A 95-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in Left arm on 08Feb2021 13:10 (age at the time of vaccination 95-years-old), as a single dose for COVID-19 immunization. The patient's medical history included blood pressure. The patient's concomitant medication was blood pressure pills. On 09Feb2021, the patient experienced stuffy nose, and eyes are watering. The outcome for all the events was not recovered.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Initial misuse report received from health care professional on 22 Oct 2013. A 69 year old patient had received a dose of FLUZONE ID on an unspecified date. No adverse event was reported. List of documents held by sender: none.
I had the usual pain after this booster, on day two, the usual flu type symptoms, but I woke up three times on Wednesday night, the 8th with my whole left side numb. It was frightening so I called the my Dr the next day and she had me come in. My blood pressure was high and she was very concerned with the numbness. Its would go away when I laid on my other side that night but for three nights in a row, if I laid on my left side - the side of the shot, my side went numb. My Dr. asked me of my history of high blood pressure - I had only had HBP when I had a retinal bleed on May 10th of 2021 in my left eye. I'd had my first booster (Prizer) on April the 2nd of 2021. When I went to the Urgent care they thought I was having a stroke because of my very high BP, but I explained that anyone with a bleed in their eye like mine would freak out! This was before I started seeing a Dr. on a regular basis - I started with Dr. in early 2022. Dr. thinks that my retinal bleed which came out of nowhere with no warning signs so soon after my booster may be related to the booster. She has diagnosed me with disseminated intravascular coagulation and has me scheduled for a carotid artery ultrasound and has me taking Xanax as needed to keep me calm as she's afraid I'll have a stroke or something. I',m also not supposed to lift anything or lower my head much. I've never had HBP before but it has been on the high end since I started taking it last week and at my two appointments with my Dr.
Nausea, headache, muscle aches, swollen lymph under Left arm, and low grade fever.
Suspected vaccine-induced thrombocytopenia; required ICU level of care, treated with IV steroids; platelet nadir 11 on 5/19/21
At 5:15 pm Friday - 7 hours & 45 minutes after getting the injection I was dizzy & felt like I was going to pass out.  My hands were swollen.  By  6 pm I had the chills, muscle aches, joint pains, a headache and was exhausted. I went to bed at 7:30 pm. I could not warm up. At 10:30 pm I had a temperature of 101.5. I gave in and toke Motrin.  About 1:30 am Saturday morning I had finally warmed up with the help of an electric blanket.  The Saturday and Sunday  I still had a mild headache, no energy, joint pain in my hands and muscle aches .  Monday I was better but still exhausted and  had a headache off and on.
Information has been received from a physician concerning a approximately 12 month  old female who on 01-APR-2009 was vaccinated with MMR. Concomitant therapy included VARIVAX (Merck) and poliovirus vaccine inactivated (unspecified) "IPV". The patient had been "agitated and has had lack of eye contact" since she was given MMR. The physician also stated the patient had not been sleeping at night. Lab diagnostics were performed which revealed "lymphocytosis and low iron". The patient's events persisted. The patient sought medical attention and visited to the physician. Additional information has been requested.
Patient developed fever 101 -> 102.7 with dizziness and headache. Site of injection (L) arm swollen, feels hot and tender. 12/08 Temp 101. 12/09 Temp 102.7.
18-20 hours later my skin start itching; burning again; I have achy joint on wrist; I have non-stop hives everyday (all over the body, especially where I scratched, down my feet and wrist); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (18-20 hours later my skin start itching), SKIN BURNING SENSATION (burning again), URTICARIA (I have non-stop hives everyday (all over the body, especially where I scratched, down my feet and wrist)) and ARTHRALGIA (I have achy joint on wrist) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 046821A and 047AZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (I have non-stop hives everyday (all over the body, especially where I scratched, down my feet and wrist)). On an unknown date, the patient experienced PRURITUS (18-20 hours later my skin start itching), SKIN BURNING SENSATION (burning again) and ARTHRALGIA (I have achy joint on wrist). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (18-20 hours later my skin start itching), SKIN BURNING SENSATION (burning again) and ARTHRALGIA (I have achy joint on wrist) outcome was unknown and URTICARIA (I have non-stop hives everyday (all over the body, especially where I scratched, down my feet and wrist)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) negative to all bloodwork.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient takes antihistamine (Zyrtec) everyday. Patient had been to doctor's office twice and this is the first time patient had hives.
The same day of the vax, the pt developed a fever and shoulder joint pain. She also developed redness at the injection site.
6 pts recvd Engerix-B in AUG91, SEP91, FEB92 & pt reported as being non-responders;
lightheadedness on the 5th day after 2nd shot.  Feels like the top of head is missing and pressure around and behind eyes.
15 minutes after child received vaccines she began coughing, stated heart hurt, began vomiting, generalized erythroderma and hives.
Approximately 9 days following vaccine developed a rash around his torso/trunk that spread to his back and arms. Small pink bumps slightly raised. Minor sore throat. No other symptoms.
At 9pm on 9/17/04, pt's mother noted redness, swelling and streaking on patient's right arm. She notified doctor.
arm pain; patches that looks like shingles; pain migrated across their back; shoulder pain; rash burning area; itching rash; burning at the site of the rash area; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number K9DX5, expiry date 8th August 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 92M54, expiry date unknown) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMOVAX) for prophylaxis.   On 15th April 2019, the patient received Boostrix (intramuscular). On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 15th April 2019, the patient received PNEUMOVAX. On an unknown date, less than a month after receiving Boostrix and Shingrix, the patient experienced pain in arm, vesicular rash, back pain, shoulder pain, burning sensation, itchy rash and rash. On an unknown date, the outcome of the pain in arm, vesicular rash, back pain, shoulder pain, burning sensation, itchy rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, vesicular rash, back pain, shoulder pain, burning sensation, itchy rash and rash to be related to Boostrix and Shingrix.  Additional details were provided as follows: The patient received Boostrix and Pneumovax spaced one inch apart in the right deltoid and the patient received Shingrix two days later in the same arm. The patient's pain began in their right arm, and it has since migrated across their back and to their left arm. Symptoms were still present at time of call. After transfer of call to second line agent, the reporting pharmacist also reported that the patient having patches that looks like shingles, burning at the site of the rash area, and was burning and itching. Did not consent to follow up. Postal follow up declined. Phone call would be okay. The number was provided by Governance, risk and compliance Quoted text from second line. The MI agent who reported new symptom to the patient after transfer. Repeat Shingrix in suspect vaccines was due to case not being able to upload to system if no GSK suspect was listed according to management. Only one dose of Shingrix was administered, and the reporter was not able to find Pneumovax in search for suspect vaccines.
Pt's arm was swollen to twice its normal size the next morning when she woke up on 12/06/2017.  Became dizzy, fell and cut her forehead. Went to her primary md who referred her to the ER.