chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client is age 12 and received the Pfizer 5-11 formulation at an offsite clinic. Multiple safeguards to prevent this type of error were in place, including color-coded wristbands, staff education prior to the clinic and just-in-time training at clinic, only one vaccine type per vaccinator station, and at least 2 points in clinic flow where age and vaccine type are verified. This error was discovered upon record review, and the client's guardian was informed immediately upon discovery.   Per CDC guidance, the client may receive an age-appropriate dose of Pfizer vaccine in 21 days to complete the vaccine series; this was discussed with the client's guardian. Client's guardian reported that client experienced a headache for 1-2 days following vaccination. At the time of this submission, no known adverse effects have occurred. This error will be discussed with the vaccine team to identify any adjustments to offsite clinic processes to prevent this type of error in the future.
Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016561061)on 19-Dec-2016. This case involves a 77-year-old female patient, who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, route and site of administration: not reported) on 16-Nov-16. Patient's medical history and concomitant medications were not reported. On an unspecified date of Nov-2016, after the vaccination patient had flu like symptoms, upper respiratory congestion, fever, chills, muscle ached all over, coughing. It was also reported that patient thought of some flu like symptoms diagnosis upon visit in Stat Care facility. Patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were not reported. Patient got recovered from the event coughing on 01-Dec-2016 and also got improved from all other events. List of documents held by sender: none.
A report has been received from a Health Professional concerning a Child, patient of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter reported that children under the age of 8 received a second dose of FLUMIST and should not have. The outcome of the event of children under 8 years old received a second dose of FLUMIST is unknown. The report was considered to be non-serious.
Pt presented to clinic today 72 post vaccine. CPX admin on 4-25-17. Reports red raised area at site of vaccine admin. Approx 2.5 inch in diam with minimal redness. No treatment required.
Headache (x 2 days), full body aches (x 1 day). Resolved on its own with only minimal intervention (OTC NSAID). Onset of symptoms was approx. 30-45 minutes post-injection.
The chills/shakes started about 2:00am (11 hours) after the second dose. Woke up to go to the bathroom. Came back and was shaking uncontrollably in my full body. Lasted about 2 hours really bad, continued mildly until next night about 28 hours after. Couldn?t hold my phone still when bad.  Have never had shakes/chills that bad. Would have gone to hospital in any other circumstance except that I knew it was a potential side effect.   Fever up to 101.4  and mild headache came with it from about 11 hours to 40 hours after. Fever gone by day 2  Chills/shakes of that degree were not expected.
Bad side effects with the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad side effects with the first dose) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad side effects with the first dose). At the time of the report, VACCINATION COMPLICATION (Bad side effects with the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
I thought I just had a cold, nothing severe. Was admitted into the hospital for sepsis and also had a UTI. While in ER, I was tested for COVID-19 and was positive. I was in the hospital for 1 week. Was getting treated for COVID-19, sepsis, and UTI. I was getting antibiotics through IV.
about 24hr p/vax pt c/o pruritus, sneezing & lightheadedness & feels these sx are r/t the vax;
To whom it may concern: The following is a copy of the letter sent to Moderna on June 23rd 2021:  Earlier today, I called customer service about my adverse effects, to the second dose of this vaccine. I spoke to customer service agent and was assigned a case number: MOD21-114859. I received both doses of the Moderna vaccine. First dose: April 23rd 2021 Lot No: 014C21A. The second dose, May 21st 2021 Lot No:009C21A. I started to experience side-effects approximately one week after the second dose, which included severe Vertigo and extreme weakness on the right side. On wednesday June 16th, the Vertigo became so severe, I was rushed to the ER. A battery of tests were performed, including a Lumbar Puncture. The results of last two test are pending. There is a high degree of suspicion of Guillian-Barre Syndrome. I was discharged from the hospital two days later with : A walker, orders for both Physical and Occupational Therapy, and a referral to a neurologist. I would appreciate any help that can be given, since I am no longer able to work.   Sincerely,
Sore, swollen, red puffy, 2 inch in diameter. Treating with tylenol and claritin and will ice. Outcome unknown at this point.
@ 0950 pt c/o of dizziness, nausea, lethergy, diaphoretic .  Pt was provided cold compresses that were applied to the axillia and nape of the neck.  Pt was able to rest his head down on a table.  Pt declined oral hydration.  @ 1000 Pt's partner encouraged him to stand up and go back to his appartment.  Our clinical staff encouraged the pt to remain seated and remain in the clinic area until he was able to walk independently.   Pt declined and was able to rise from the chair independently and ambulate with assistance from his partner.    Pt was able to communicate during the entire event. no LOC was observed.  The patient left the clinic area 1005.
Patient's mother stated that her left arm "started to go numb while she was at work, about 7 pm and continues to go numb."
Breakthrough case admission after 2 vaccines ; Moderna 3/31/21 Lot# 017B21A;  Moderna 4/26/21 006C21A
Left arm swelling- inflammation around site- 5" long. Right arm- 4" wide and 3" long swelling and inflammation and tenderness.
Herpes Zoster; Products liability: manufacturing defect/defective design; This Information has been received regarding a case in litigation from a lawyer and refers to a currently 79-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 31-JUL-2012 9also reported as on about that date), the patient was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date the patient experienced herpes zoster and was treated by a physician due to that event. The patient claimed damages as a result of: injury to themselves; economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; punitive damages. The outcome of the events was unknown.  The reporter consider the event of herpes zoster to be related to the suspect vaccine. The causality between the product quality issue and zoster vaccine live (ZOSTAVAX) was nor provided.
Given 8/29/13. Pain, swelling and redness at site. Occurred later in evening of same day of vaccination. Patient advised to take BENADRYL and apply cool pack to area. Still sore and red on 9/1/13.
On Saturday, 4/10/21, approximately 2 hours post vaccination, patient noted a knot on her left lower leg.  No pain, redness or swelling noted to left lower leg.  Patient took it easy the rest of the day.  On Sunday, 4/11/21, patient began to have N/V, diarrhea and fatigue.  No fever noted at this time or up to time of this report.  As of 4/13/21, at 12:00pm the knot still remains present on left lower leg, along with fatigue and nausea.  Patient was instructed to call PCP.  Patient has an appointment with PCP on 4/14/21 at 1030am.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GT5342), in left arm and on 09May2023 as dose 6 (booster), single (Lot number: WAG#TU308) at the age of 78 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 02Feb2021 as dose 2, single (Lot number: EL9262), in left arm, on 21Sep2021 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 14Jun2022 as dose 4 (booster), single (Lot number: fm9992), in right arm for covid-19 immunisation. The patient had no relevant medical history. Patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included PAXLOVID treatment from 30May2023 to 03Jun2023.
Slight pain in left arm where he received the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Slight pain in left arm where he received the injection) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN and ATORVASTATIN 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 an unknown date, the patient experienced VACCINATION SITE PAIN (Slight pain in left arm where he received the injection). At the time of the report, VACCINATION SITE PAIN (Slight pain in left arm where he received the injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, SARS-CoV-2 test positive: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication: AMLIDOPIN- 25mg 00-00-2020 ongoing. No treatment medication were reported.   This case was linked to MOD-2021-259995 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Significant Follow-up includes patient age, height, weight, concomitant drugs and lab tests.
sore in the arm; Off label use; Drug use in unapproved population; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore in the arm"; OFF LABEL USE (non-serious), outcome "unknown", described as "Off label use"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "Drug use in unapproved population".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was diagnosed with lung cancer in late November and had my first Chemotherapy in early December. So a few of these symptoms may be a side effect of Chemotherapy. On 12/17 I started having slight sinus congestion, headache, nausea, sore throat however no fever. On 12/19 I tested positive for COVID-19. I was prescribed a course of PAXLOVID and took MUCINEX DM daily for 7 days. I have recovered from COVID-19 at this time.
pt recvd vax; was adm to hosp 24nov95 w/ dx of GBS;
Hurting every metal piece in my body, ankle, knees, and neck. Everything has gone away except my neck. This started two days after I received my third vaccine. Very low energy, fatigued to the point that I did do a COVID-19 test and it was positive just to check and it was negative. I have to see a doctor on 05/11/2022 for the continued pain in my neck. I found out I had COVID-19 about 01/01/2022, I could not get a doctor appointment until 01/11/2022. They said at that time I still had it, so I had to quarantine another 10 days. Achy, coughing, sniffling nose, and fever of about 101-102. My symptoms were pretty much gone when I went to the doctor, and the test was positive, so I had to quarantine again. I feel it would have been a whole lot worse if I had not gotten it.
Shoulder pain; Swollen Lymph Node under Arm; Headache; This is a spontaneous report from a non-contactable consumer reporting for herself. A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EL9264; Expiration date was not reported), dose 1 via an unspecified route of administration, in left arm on 07Feb2021 at 10:30 (at the age of 59-years-old) as 1ST DOSE, SINGLE for COVID-19 immunisation. Patient received no other vaccine in four weeks. The patient was not diagnosed with COVID, prior vaccination and the patient was not tested for COVID, post vaccination. The patient medical history and concomitant medications were not reported. The patient previously took Penicillin and experienced drug hypersensitivity (allergies). The patient had experienced shoulder pain, swollen lymph node under arm, headache on an unspecified date. Patient did not received treatment for the events. The outcome of the events was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
SWELLING AND ERYTHEMA, ITCHING AT INJECTION SITE.  TREATED WITH BENADRYL AND COOL COMPRESS.
I contracted COVID-19 on 07/31/22 with symptoms of severe sore throat, fever, headache, myalgia, and fatigue. I was prescribed PAXLOVID on 08/02/22. I was ill for 5 days before my symptoms resolved. I did have 1 day of rebound symptoms 10 days after I finished my round of PAXLOVID. I am now fully recovered with no lingering symptoms.
couldn't sleep last night; arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep last night) and VACCINATION SITE PAIN (arm hurts) 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 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced INSOMNIA (couldn't sleep last night) and VACCINATION SITE PAIN (arm hurts). At the time of the report, INSOMNIA (couldn't sleep last night) and VACCINATION SITE PAIN (arm hurts) outcome was unknown.            Concomitant medication history not provided. Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was not applicable. .   This case was linked to MOD-2021-132231 (Patient Link).
GARDASIL. Redness, swelling area hard around vaccine. Had open heart surgery 6/27/09. Suffered brain injury. Lactic acids raised to brain, abnormal white matter.  7/13/2009 MR received from PCP 6/20-/2009.  In for WCC on 6/20/09. For surgical repair of ASD in 1 week.  Impression:  Healthy. ASD. Returned 6/23/09 to have throat checked. Impression: Pharyngitis.  In for surgury ~6/27/09 with "catastrophic event" intraoperatively with subsequent encephalopathy. ? Mitochondrial defect. Pt currently with L hemiparesis, R dystonia, non-verbal with receptive language intact. S/P pancreatitis with G-tube feeds. Transferred to higher level of care.
This patient had abdominal pain, decreased appetite, diarrhea, elevated liver function tests, and elevated bilirubin, eyes slightly yellow, rash after injection. Seen 13 days after injection, had lab work.
On 1/25, I got the vaccine with what I thought, were no side effects. I did have some soreness on the side of my breast/underarm area, but I put it off as muscle soreness from working out. On 2/2 I noticed a rash on my arm, which wasn't there before. The rash was warm, hurt when touched, and raised. Seeing that made me realize, the soreness in my underarm area wasn't muscle soreness but my lymph nodes, which I read was a side effect. I compared the right and left, and the right lymph nodes were obviously swollen. On 2/3, the rash was still there but within it, was a small spot (nickel's size) that is darker, looked like a bruise. On 2/4, the rash was still there and still warm to...continued on "Continuation Page"
Chest pain on left side- felt like my heart hurt; Very fast heart rate; Increased blood pressure; Body aches; Chills in the morning; Fever; hot flashes; headache; swollen lymph node in the left armpit; This is a spontaneous report from a contactable consumer(Patient). A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7484, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 13Aug2021 15:00 (age at vaccination 46 years) as dose 2, single for covid-19 immunisation. Medical history included arthritis, fibromyalgia, pcos, hypothyroidism, allergies: Penicillin. The patient previously took BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0196, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jul2021 04:00 (age at vaccination 46 years) as dose 1, single for covid-19 immunisation. Concomitant medication(s) included lisinopril (LISINOPRIL). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Aug2021 08:30 the patient experienced chest pain on left side- felt like my heart hurt, very fast heart rate, increased blood pressure, body aches, chills in the morning, fever in the afternoon , hot flashes in the afternoon , headache , swollen lymph node in the left armpit. The patient underwent lab tests and procedures which included blood pressure measurement was increased on 14Aug2021, heart rate was very fast on 14Aug2021. The patient did not receive any treatment for reported events. The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
Received flu shot on 10/12/11. Soreness at injection site next day. Continues to have soreness to touch and with movement. No relief with Ibuprofen. ? nerve irritation. To reevaluate if symptoms continue.
Information has been received from a physician concerning a 18 year old male who on 18-AUG-1992 and 14-OCT-1995 was vaccinated with the first and second dose of MMR II.  On 30-NOV-2009 the patient experienced mumps.  The patient had a fever of 101.2 F and had a parotitis on the left side.  On 07-DEC-2009 the patient was diagnosed with mumps.  On 07-DEC-2009 the blood work was done and the results indicated IgM<1:10, IgG 7.3, and serum amylase 316.  The outcome of mumps was unknown.  Follow-up information has been received from a physician concerning a 18 year old male who on 18-AUG-1992 and 14-OCT-1995 was vaccinated with the first and second dose of MMR II.  On 04-DEC-2009 the patient experienced mumps and on 09-DEC-2009 was diagnosed.  The patient was febrile and right side parotitis.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Red, swollen very itchy hives on thighs, buttocks, torso for 5 days continuously.
Once the young man was inoculated, he made the movement to get up from the chair, he fell from it, presenting dizziness and paleness. He was aware at all times. He was assisted by the clinical staff of the Vaccination Center and he was taken to the Emergency Room of our hospital, where he was evaluated and discharged. From the symptoms, the ER doctor indicates that he had a low blood sugar.
Client was vaccinated with the Moderna vaccine at 1600, around 1605 while waiting in the observation area, the client vomited once and experienced some dizziness. EMS attended to client, and an ambulance was called. Vital signs were all WNL. After laying down for 15 minutes the client felt well and denied EMS transport to the hospital. Client left with family member in no apparent distress.
PATIENT WAS FAINT 4 MINUTES AFTER THE VACCINE. HER HEAD HIT THE WALL WHILE SHE FELL ON THE FLOOR. SHE WAS CONSCIOUS AT THE TIME. HER BREATH & PULSE WAS NORMAL. PARADMEDIC TEAM CAME IN RIGHT AFTER TO CHECK ON HER. SHE WAS FINE. HER DAD WILL TAKE HER TO DOCTOR TO CHECK ON HER HEAD.
Information has been received on 11-DEC-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In November 2017, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In February 2018, the patient was treated by a healthcare provider at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Subsequent to receiving one dose of varicella virus vax live the pt developed chickenpox. She sought unspecified medical attention.