chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered to a 1 yr, 11 mo old; Kinrix administered, supposed to receive Dtap and Polio; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 4th August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 5-Aug-2022 Reporter's comment: The patient inadvertently received a dose of Kinrix at an age of 1 year 11 months. The patient was supposed to receive separate doses of Dtap and Polio.  The reporter consented to follow up via postal. Additional supportive information: A 1 year 11 months old patient received a dose of Kinrix instead of Dtap and polio vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Patient experienced swelling and rash at injection site. She returned to clinic the same day as the injection and was given benedryl.
The client arrived to vaccine site for second dose in the vaccination series. Client is a 16 year old female and had received Moderna as initial dose despite being a minor. Registered nurse explained the CDC recommendations for vaccine administration errors and deviations that if client is age 12 to 17 and has received Moderna as initial dose that the second dose may be administered as off-label use. The client is accompanied by her father and both patient and parent consented to receiving second dose and acknowledged the CDC recommendations.
Mild Symptoms; felt a little sick for 12 hours; felt achy for 12 hours; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Mild Symptoms), ILLNESS (felt a little sick for 12 hours) and PAIN (felt achy for 12 hours) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031LZ0A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced IMMUNISATION REACTION (Mild Symptoms), ILLNESS (felt a little sick for 12 hours) and PAIN (felt achy for 12 hours). In February 2021, ILLNESS (felt a little sick for 12 hours) and PAIN (felt achy for 12 hours) had resolved. At the time of the report, IMMUNISATION REACTION (Mild Symptoms) outcome was unknown.            It was reported that patient received first Moderna Covid 19 vaccine on 13 FEB 2021 and on the same day felt a little sick, achy for 12 hours mild symptoms.  Patient received second Moderna Covid 19 vaccine on 13 MAR 2021 and on the same day felt a little sick and achy 12 hours mild Symptoms.  No treatment medications were provided.   This case was linked to MOD-2022-666026, MOD-2022-666027 (Patient Link).
Patient had many auras and a seizure the day after his first vaccine. We needed to use rescue medicine (Nayzilam nasal spray) to stop the seizure. It took him 3 days to fully recover from the seizure. He had a hard time thinking of the correct word and many strange thoughts and experiences. We called his doctor and talked to him over the phone. He told us to watch the patient for further problems.
Big toes hurt, gout; Big toes hurt, gout; Glands in her neck on the right side swollen; Arm is very sore; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL8982) via an unspecified route of administration in left arm on 20Jan2021 mid-afternoon at single dose for COVID-19 immunisation. Medical history included ongoing atrial fibrillation diagnosed about 25 years ago, Canker sore on 18Jan2021 (she did go the doctor for that and the doctor urged her to rinse it with salt water to she's been doing that), some soreness in her month on 18Jan2021, gout reaction. The patient concomitant medications were not reported. No Pfizer vaccine was administered on the same date. Prior Vaccinations (within 4 weeks) was none. The patient got a reaction that she thought should be noted. She has had a very slight history of gout. She woke up this morning on 21Jan2021 and her big toes hurt. She knew that this was a symptom of what she had had in the past which was gout. The patient confirmed her big toes hurting was pretty much staying the same. It's not that uncomfortable. She knew from past experience that this was what happens, like when she ate certain foods like seafood or whatever, she would have this kind of gout reaction. This morning on 21Jan2021, she also felt the glands in her neck on the right side were swollen. The swelling seemed to have gone down. Her arm was also very sore. She stated the soreness began last night, in the evening on 20Jan2021. The soreness had pretty much stayed the same. She expected the soreness, but she didn't expect her toes to hurt. It was important to note "she is able to able the gout". She had only had gout really bad time once and then she's had a little bit every so often. The gout just seems to be connected to the vaccine- she could not say nothing that she ate would indicate other wise. The events did not require visit Emergency Room or Physician Office. She had an appointment for 10Feb2021 to get the second COVID-19 vaccine. The outcome of event glands in her neck on the right side swollen was recovering, outcome of events was not recovered.
Pt recv vax on 10/14/98; on same day pt exp swelling, tenderness, redness of Rt arm; tx=Hydroxyzine
Patient quietly threw her back while sitting in the chair with eye open. Didn?t respond to verbal commands initially but 2 second later slowly she was able to respond.  Diaphoretic. She was transferred to cart safely.and code green was called. Paramedic on site to assess.  V/s bp 94/63 hr 64 rr 16 sao2 100% RA  Had Hx of fainting with shot ( any shot etc. Flu)  1414 Patient responsive and coherent.AO x4
Tingling followed by pain in fingers of left hand followed by a lot of pain & swelling in left hand & arm.  Hand remained swollen especially at night & tends to quiet during the day-  less pain & swelling.  Gets severe at night a comes & goes several times during nite.  Seems to be getting better at ct less episodes at night but still under doctors care. Conts to have pain-under doctors care.
Long term care facility closely monitoring patient.  Given three doses of Covid - Pfizer dose, 01/07/21, 01/28/21, 02/18/21.
PT WAS GIVEN 0.2 ML OF PFIZER ADULT DOSE INSTEAD OF PFIZER 0.2 ML PEDIATRIC DOSE
Pt receive BOOSTRIX instead of FLUARIX at Flu clinic. Pt to F/U with MD.
Patient received Pfizer COVID vaccine from different vendor on 4/11/2021 AND 5/2/2021.  Patient then received J+J vaccine from us (Affiliated Physicians) as listed here on 8/10/2021.
symptoms of low pressure such as shakiness and needing to lie down; symptoms of low pressure such as shakiness and needing to lie down; phlegmy cough coming from lungs; He possibly has discolored urine; arm pain/swelling; fatigue/tiredness; sore arm; slight headache; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for himself that a 28-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 2 via an unspecified route of administration on 26Mar2021 (Age at vaccination 28 years) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : Not reported), via an unknown route of administration on 05Mar2021 as dose 1, single for covid-19 immunisation. On 26Mar2021, the patient experienced sore arm; slight headache; On 29Mar2021, arm pain/swelling; fatigue; tiredness; he possibly has discolored urine; On 30Mar2021, symptoms of low pressure such as shakiness and needing to lie down and phlegmy cough coming from lungs. It was reported that initially he experienced a sore arm and slight headache for the first day to day and a half. Then starting on Monday he developed arm pain/swelling, fatigue that comes and goes, symptoms of low pressure such as shakiness and needing to lie down, and a phlegmy cough coming from lungs. Its been 5 days since receiving my vaccine, how long will this last. He has been having persistent symptoms ever since he got the second dose of the covid vaccine on Friday. It has been 5 days. He has had waves of tiredness and a phlegmy cough. He has had low pressure, and he gets a little shaky without food. He possibly has discolored urine. He was asking if there was any expected time line for his symptoms to persist. Waves of tiredness: Began on Monday night. It was worse yesterday. Today he does not have much to report. He has just woken up recently. Phlegmy cough: Began last night. Today, it was not as bad as yesterday. Possibly has discolored urine: His urine was potentially discolored. He has had a small sample size over the past few days that is different than his normal urine color. Thinks that it could possibly be due to the covid vaccine but he was not totally sure. Investigation Assessment: No. The clinical outcome of event symptoms of low pressure such as shakiness and needing to lie down; phlegmy cough coming from lungs was recovering; outcome of he possibly has discolored urine was not recovered; while other events outcome were unknown.  No follow-up attempts are possible. No further information is expected.
Client became "dizzy" approx. 5 min after vaccination. Vitals taken - WNL. Client drank H2O without difficulty; recovered completely approx 1:40 PM.
Hard time moving my right arm; Nauseous; Chills; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Apr2021 at 17:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis with ovarian cyst and depression. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included unspecified birth control and anti-depression medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04Apr2021 at 15:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 21:00, the patient experienced hard time moving right arm, nauseous and chills. It was reported that the patient was able to sleep. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hard time moving right arm, nauseous and chills were unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Upon receiving the shot, I immediately felt lightheaded, not dizzy or vertigo but just detached from my surroundings. I felt spacey. I felt like that for the rest of the day. I took Tylenol as the clinic recommended. Then after I went to bed later that evening I developed a headache that woke me up around 3:00am. I was very uncomfortable, experienced chills and was sore all over like I had worked out hard. I also experienced joint pain which I don't normally have. I still feel rough this morning and running a slight fever of 100F. I just wanted to report my side effects.
her legs gave away and she sat down on the floor and was unconscious; felt groggy and nauseated and her stomach acting funny.; felt groggy and nauseated and her stomach acting funny.; felt groggy and nauseated and her stomach acting funny.; light pain in her head; legs gave away; This is as spontaneous report received from a contactable consumer (patients husband). A female patient on unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/Expiration date: not reported) via unspecified route on 23Mar2021 at 15:00 and patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot/Batch number: not reported) on an unspecified date as single dose for COVID-19 immunization. Relevant medical history and concomitant medications were unkown. It was reported that the patient who received her second dose vaccine was fine until next day early morning. The following day in the morning the patient felt groggy and nauseated also her stomach acted funny while she was brushing. She tried to throw up but could not. Then her legs gave away and she sat down on the floor and was unconscious. The patients husband started to call 911 but his wife was only unconscious for a few seconds and then became alert again and had been fine since then except for a light pain in her head.  Information on the lot/batch number has been requested.
Case number PHHY2011US29832 is an initial spontaneous report received from a physician on 06 Apr 2011. This report concerns a 12 year old male patient. He was vaccinated with MENVEO (batch number: unknown) intramuscularly on unspecified date. The patient received only the Men A lyophilized powder component of MENVEO without reconstituting it with Men CYW liquid conjugate. No adverse event was reported following this drug administration error.
Information has been received from a health professional concerning an approximately 7 year old male with no allergies or medical history who on 11-DEC-1998 was vaccinated SC with a 0.5 mL dose of Varivax (lot # 627333/1244H). There was no concomitant medication. When in the second grade, in approximately 2004, the patient developed chickenpox from which he fully recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old male patient who received SHINGRIX for prophylaxis. On 19th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th November 2018, unknown after receiving SHINGRIX, the patient experienced accidental underdose. On 20th November 2018, the patient experienced pain in arm. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the accidental underdose was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient noticed in the morning of reporting date that his left arm was sore. The patient stated that he took Ibuprofen for the soreness. The patient stated that while he was getting the vaccine, the pharmacist told him that something happened with the needle and 2 or 3 drops of the vaccine did not get injected. The patient stated that the pharmacist checked with someone else there at the pharmacy and determined that the patient should be okay although the 2 or 3 drops did not get injected, which led to accidental underdose. The reporter gave consent to follow up.
Approximately 1 hour after receiving injection, patient developed blurred vision and decreased level of consciousness with inability to sit up straight, talk normally or walk.  She subsequently had nausea and vomiting which was worse when she opened her eyes.  Patient has history of seizures but this was not like her normal seizure in that she was responsive and did not have any tonic/clonic movements.     She was brought to ER where  exam was normal except for truncal ataxia.  Labs/EKG/CT head  and MRI revealed no new findings.  She was monitored and her symptoms resolved by 9:30 PM the same day.  She was discharged home from the ER in improved condition and her symptoms have not returned.  She does have more palpitations since her COVID vaccine, however, and these are getting worked up.
On Monday 8/8/2016 I gave a 13 year old INFANRIX instead of ADACEL. No adverse reactions observed or reported. Age of patient at time of event: 13 years.
Initial Report Received: 14-Jun-2018 Patient is a 31-year-old woman (race not provided) who was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  The patient reported that she developed the non-serious events of rash on both arms, rash on head and chest, rash on neck, red rash, and itchy rash. Relevant medical history and concomitant medications were not provided. The patient received the first injection of HEPLISAV-B (Lot # 1033384, expiration 06-Apr-2019) on 17-Apr-2018. The patient experienced no symptoms. The patient received the second injection of HEPLISAV-B (same lot #/expiration as first dose) on 18-May-2018. In May-2018, 1 to 2 days after the second administration of HEPLISAV-B, the patient developed a rash with small red bumps. The rash gradually presented on both arms, chest, head, and neck, and was red and itchy.  The rash worsened over the week and the patient visited her dermatologist.  She was treated with Elidel cream (pimecrolimus) and oral Xyzal antihistamine (levoceterizine).  No other information was provided. At the time of the report, the outcome of the events were unknown. The reporter did not provide a seriousness assessment for the events. Company comment:  The company assessed all events as non-serious. The events of rash, rash erythematous and rash pruritic are unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed all events as non-serious. The events of rash, rash erythematous and rash pruritic are unlisted per HEPLISAV-B USPI.
Information has been received from a physician and a registered nurse concerning a 10 years old female patient who on 06-MAR-2008, was vaccinated with the third doe of GARDASIL vaccine (lot no. 659653/1448U) (route not reported). The nurse reported that on the same date of vaccination the patient had a routine physical exam and a PAP smear was done, results of the PAP smear showed atypical squamous changes (ASCUS) and Human papilloma virus was detected. The patient was treated with vaginal antibiotics (unspecified). It was reported that in September 2008 another PAP smear was done which showed ASCUS however the Human papilloma virus was not detected. In March 2009 a PAP smear was done and it came back negative. The nurse did not have information on the first two doses of GARDASIL vaccine as they were not administered at this doctor's office. The registered nurse considered the patient recovered. Additional information has been requested.
Soreness at injection site; This is a spontaneous report from a contactable consumer (patient) reported in response to the non-HCP letter sent. A 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL3246; Expiration date was not reported), via intramuscular, administered in Left arm (left shoulder) on 15Jan2021 15:00 (at the age of 72-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none. Concomitant medication(s) included lisinopril (LISINOPRIL); amlodipine (AMLODIPINE); hydralazine (HYDRALAZINE) taken for hypertension; allopurinol (ALLOPURINOL) taken for gout from an unspecified start date and ongoing. Family medical History; prior Vaccinations: (within 4 weeks); relevant tests included none. The patient experienced soreness at injection site on the same day of vaccination, 15Jan2021. Event was not serious. The event did not require the initiation of new medication/other treatment/procedure. Date of recovery was about 3 days. Clinical outcome of event was recovered on 18Jan2021.  No follow-up attempts are possible. No further information is expected
Dose 1:6/20/22, Dose 3: 8/17/2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 1-month-old female patient who received HBV (Engerix B) (batch number CM294, expiry date 19th April 2024) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B) and HEPATITIS B VACCINE (ENGERIX B).   On 17th August 2022, the patient received the 3rd dose of Engerix B. On 17th August 2022, unknown after receiving Engerix B, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comments: On 20th June 2022, the patient received 1st dose and on 19th July 2022, the patient received 2nd dose. The reporter consented to follow up. Additional Supportive Information: The patient received 3rd dose earlier than the recommended schedule, which led to shortening of the vaccination schedule.
Approximately 2 months after vaccine I started having pains in my muscles mainly my arms when active. I went to my PCP when these problems seemed to be getting worse. After several visits within a few weeks for the same complaint they started doing blood work. I don't know what all I was tested for but the first diagnosis was Rheumatoid Arthritis. I started seeing a Rheumatologist after diagnosed. Over the course of the next 6 months maybe 1 year. I had blood drawn 8 to 10 times. I have been diagnosed now with...Rheumatoid Arthritis, Fibromyalgia, Low Testosterone, Diabetes Type 2, Increased Anxiety/Depression, Cognitive issues.
Tested positive with Covid 19 30Aug2021; Tested positive with Covid 19 30Aug2021; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation Solution for injection, Lot number: EP7533 Expiry date: Unknown, Age at vaccination: 60 Years) via intramuscularly on 31Mar2021 as dose 2, single for COVID-19 immunisation. The patient previously took bnt162b2 (BNT162B2, Lot number: EN6202, Expiry date: Unknown) via an unspecified route of administration on 10Mar2021 as dose 1 single, for COVID-19 immunisation. The patient medical history was none and concomitant medications were not reported. The patient had no known allergies. The patient was not positive for COVID-19 prior to vaccination and had been tested post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Aug2021, the patient tested positive with covid 19. The patient underwent lab tests and procedures which included sars-cov-2 test, positive on 30Aug2021, Nasal Swab. The adverse events resulted in Emergency room/department or urgent care. It was unknown if patient received treatment for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.