chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she felt a little tired after the first dose of the pfizer covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (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: FATIGUE (non-serious), outcome "unknown", described as "she felt a little tired after the first dose of the pfizer covid 19 vaccine".  Additional information: Patient was scheduled to get an eye examination and her optometrist will be putting some solution to both of her eyes next Tuesday. She wanted to know if she should wait longer because she didn't want to mess up the vaccine's efficacy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021412212 PFIZER (Same reporter/patient/product, different dose/event)
Nurse discovered that Pfizer vaccine was not properly removed from the regular freezer on 10/13/2021. The Pfizer vaccine was moved from ultra cold freezer to regular freezer on 9/28/2021 and should have been removed from the regular freezer the end of the day on 10/13/2021 and placed in the refrigerator for 31 days. The vaccine was not removed on this day from the freezer. The vaccine is still in the freezer today 10/25/2021. It was investigated and found that the vaccine was used in clinic Monday 10/18/2021 through 10/23/2021. NP called Pfizer med and spoke with an attendant, walked her through the scenario and she made NP aware that vaccine could not be used past day 17 after being in the regular freezer< voiced that vaccine stability could not be determined and that vaccine should not have been used past the 3rd day grace or day 17 and should have been moved to the refrigerator on day 14 after removal from regular freezer. Patient was notified of the incident.
arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). At the time of the report, PAIN IN EXTREMITY (arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided.
Pt received vax around 11:30 AM, around 6:30 PM, the mom noticed that he couldn't walk normally, leg was swollen with erythema from site of injection to knee. Mom called MD and gave child Tylenol. MD said it wasn't necessary to be seen by MD, but to notify the health department. 2 days later the pt ate, and felt ok (according to mother). on 3/13/00, the pt continues to have slightly edematous leg and knee.
Approximately 15 hours after the vaccination was given at 11:00 PM started to feel ill, body aches, fever, chills, very similar to flu like symptoms only not quite as bad.   This lasted for approximately 5 hours, and by 04:30 AM I started feeling better and by 06:00 I was perfectly fine and felt completely normal.
Pt did not respond to the Engerix-B vax series; 30JAN92 neg HBSAB titer results drawn on 4SEP91 & 5FEB92 were neg;
it felt like I got the flu bad.; could not sleep (kept tossing and turning for hours; had nightmares; felt wobbly when walking; I feel weak; my neck hurts; my back hurts; vaccine may have kicked up my arthritis symptoms; my shoulders hurt; I also felt like I had a fever; feel achy all over her body; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (it felt like I got the flu bad.), INSOMNIA (could not sleep (kept tossing and turning for hours), NIGHTMARE (had nightmares), GAIT DISTURBANCE (felt wobbly when walking) and ASTHENIA (I feel weak) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A and 069H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccine in December 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Arthritis.   On 21-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022 at 6:30 AM, the patient experienced INFLUENZA (it felt like I got the flu bad.), INSOMNIA (could not sleep (kept tossing and turning for hours), NIGHTMARE (had nightmares), GAIT DISTURBANCE (felt wobbly when walking), ASTHENIA (I feel weak), NECK PAIN (my neck hurts), BACK PAIN (my back hurts), ARTHRITIS (vaccine may have kicked up my arthritis symptoms), ARTHRALGIA (my shoulders hurt), PYREXIA (I also felt like I had a fever) and MYALGIA (feel achy all over her body). At the time of the report, INFLUENZA (it felt like I got the flu bad.), INSOMNIA (could not sleep (kept tossing and turning for hours), NIGHTMARE (had nightmares), GAIT DISTURBANCE (felt wobbly when walking), ASTHENIA (I feel weak), NECK PAIN (my neck hurts), BACK PAIN (my back hurts), ARTHRITIS (vaccine may have kicked up my arthritis symptoms), ARTHRALGIA (my shoulders hurt), PYREXIA (I also felt like I had a fever) and MYALGIA (feel achy all over her body) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-455461 (Patient Link).
Urticaria , 1" in diameter and erythema of 2" to 3" at site of injection. Faded after 20 minutes (only a small residual area of erythema).
This case was reported by a consumer via patient support programs and described the occurrence of injection site irritation in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site irritation. On an unknown date, the outcome of the injection site irritation was unknown. It was unknown if the reporter considered the injection site irritation to be related to SHINGRIX. Additional details were provided as follows: This case was received from the consumer via the vaccine patient assistance program. The age at vaccination was not reported. The patient reported that she had irritation at injection site. The patient's healthcare professional (HCP) told her to call her to report. The patient was incorrectly advised that GSK needed her HCP to call and report. The patient did not provide personal information for claim. The reporter had not been informed that they had reported an experience with a GlaxoSmithKline (GSK) product that needs to be shared with GSK. The reporter had not agreed to have GSK's safety team follow up with them via postal mail. This event did not include a product complaint.
Heart palpitation and coming and going feeling of hear pumping really fast. Im getting tired easly during exercise which was not the case prior to vaccination and experiencing migraines also did not have them prior vaccination.  Also I have reported previously that I have experienced periods every 2 weeks since my vaccination and it has been now 3 months and my menstruation cycle has not came back to normal.
patient administered the vaccine and syringe failure.  Squirted out the side of the syringe, dripped down the patient's arm, onto her pants and the chair.  After discussion with the patient, she opted to receive another dose as a significant amount of the previous dose was no injected.
Fever and sweats overnight, headache, tired, nose bleeding and bruises  in legs.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021 at 4:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 4:19 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 61.96 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 37 degree Fahrenheit at 10:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a  traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report as received from two registered pharmacists refers to a 70 years old female patient with fibromyalgia, asthma and allergic reaction to quinolones. The patient's medical history included hypertension. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # reported as 0709AE) IM on 03-OCT-2012. No other co-suspects were reported. Concomitant medications included: MOBIC. On the same date, the patient developed chills, fever, myalgia and pain after receiving PNEUMOVAX 23. The reporter mentioned the patient said she had so much pain she could not lift her arm. No treatment was given for the events. The pharmacist reported that the patient's fever and chills were gone but she still had arm pain. The outcome of myalgia was reported as not recovered/not resolved. The relationship between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Initial report received from a consumer who is also patient mother, on 01 May 2012.
Pruritic 5 cm raised pink wheal that appears like one large hives lesion. Low grade fever between 99-100.
I have been having heart fluttering as well as the feeling that my heart is pounding or suffocated. A few weeks after the shot, I was driving and my heartbeat was 115 BPM when I was completely calm, and is typically around 60 BPM at rest and around 105 BPM when walking.
This was a Covid Booster and Flu shot at the same time. I had the J & J vaccine on 19 March 2021  (Janssen Lot # 1805022). I was fine for about 12 hours, but for injection site pain. At approximately noon the next day, 3 November 21, I began feeling weak, flushed, and disoriented. I was struggling to focus and started coughing. I teach computer science and could not perform programming tasks that I do all the time. I canceled class and went home. I guess I was hallucinating a bit on the way home. I was at a traffic light near my house and felt I was lost. I was looking for my old house I moved out of in 2013 and my ex-wife! Not my current wife! I made it home and went to bed. - Fever spiked at 103 - Was coughing up massive amounts of thick yellow fluid - Was sweating yet was very cold.  - More hallucinations for a few minutes. Called out for my ex-wife again ( that's really weird) - Got up to use the bathroom and fell - Slept for about 12 hours My current wife is a nurse and got me through it.  Today I'm fine other than my chest hurts from coughing.
Pt c/o mild fever, chills, pain and swelling at the site of injection, also pt reported mild urinary retention. Pt had improvement in pain and fever after 24 hours.
Vaccine given on 2/15/18 and no unexpected adverse effects until the evening of 2/17/18 when arm began to ache at about 11:00 pm. Discomfort disturbed sleep on 2/17 and 2/18 but I took MOTRIN although it really did not help. The on 2/19 the ache seemed to dissipate. The evening of 2/22, I remember my legs starting to itch but I just ignored it. I woke on 2/23 covered in hives: legs completely covered, arms and back just starting, my legs were obviously swelling. I was seen at our Health Care facility that afternoon by Physician Assistant who diagnosed condition as Serum Sickness. I was put on Prednisone: 20 mg x2 for 5 days. This was a Friday and the rash had cleared by Monday. But over weekend I started having trouble breathing and doctor prescribed an inhaler on Monday. I went in and saw doctor on Wednesday and received a breathing treatment, five more days of Prednisone and a chest X-ray.
Case had symptom onset 7/30/21 which included subjective fever, chills, muscle aches, runny nose, sore throat, fatigue, cough, wheezing and shortness of breath. He was still symptomatic at time of case investigation on 8/2/2021. He was seen in the ER department and tested for Covid 19.
This spontaneous report concerning a patient of unknown age and gender was received from a pharmacist via Pfizer Inc. No medical history or concurrent conditions were reported. On unknown dates, the patient was vaccinated with a PNEUMOVAX 23 and a PREVNAR 13 (dose, dosage number, route of administration, anatomical location, lot # and expiration date for both the suspect vaccines were unknown). No concomitant medications were reported. On an unknown date, following the administration of PNEUMOVAX 23, the patient reported having a bright red arm. At the time of reporting, the outcome of the event was unknown. The reporter also failed to provide a causal relationship between the event and the vaccination with the suspect vaccines. Additional information has been requested.
Injection site turned from red to pink; Painful; Inflamed shoulder; Limited range of motion; A spontaneous report (United States) was received from a consumer concerning a 86-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events inflamed shoulder/arthritis, painful/arthralgia, limited range of motion/mobility decreased, injection site turned from red to pink/injection site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 02 FEB 2021 patient experienced inflamed shoulder that is painful, limited range of motion on same day of injection. Site of injection turned red to pink.   Treatment for the event included aspirin and iced it.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), inflamed shoulder/arthritis, painful/arthralgia, limited range of motion/mobility decreased, injection site turned from red to pink/injection site erythema was unknown.
Pts recv vax on unspecified date &subsequently pts exp severe redness at the injection site.
pt devel intense pain down to hand for 48 hrs.  pain in arm and hand 4-5 days, redness around inject site and fever.
Sore throuh neck; Extremely tired; Sore through shoulder; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Sore throuh neck), FATIGUE (Extremely tired) and ARTHRALGIA (Sore through shoulder) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 842L28A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 NECK PAIN (Sore throuh neck), FATIGUE (Extremely tired) and ARTHRALGIA (Sore through shoulder). At the time of the report, NECK PAIN (Sore throuh neck), FATIGUE (Extremely tired) and ARTHRALGIA (Sore through shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment details were provided   This case was linked to MOD-2021-065997 (Patient Link).; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Arthralgia and fatigue are consistent with the product known safety profile.
4 days after vaccine. Body covered in hives every morning.  No relief from any combination of medications.
Pulmonary embolisms in both lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: JUICE PLUS (ongoing). The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "Pulmonary embolisms in both lungs". Clinical course: Patient had been on Juice Plus 20 years that's how patient found out that had a heart, lungs and blood pressure of a kid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt recvd vax & pt either fainted or felt lightheaded; No further details were provided;
(Rt) thigh pt has a knot 1 mm diameter no local tenderness or redness this was the place - where PEDVAX was given.
Noted pain in left axillary region the morning of 12/29/20 with adduction of arm. Self-examination revealed tender lymphadenopathy with size between 1-2cm. Mild itching around the injection site was noted the evening of 12/30/20. A small, irregularly shaped erythematous rash was noted around the injection site the morning of 12/31/20 - over about 24 hours this darkened to be tan/brown as compared to surrounding skin. There was gradual resolution of pain/tenderness, lymphadenopathy, and rash by approximately 1/1/21.
The patient received Varicella vaccine, Hib, and MMR on 11/04/00 and on 11/26/00. The mother noticed some rash on his body , face, and behind the ear. The next day it was filled with fluid, and slightly itchy. Three days later developed a high temperature, vomited 2 times. Today the infant is playful and active. Some lesions have dried up, he has few more lesions in the diaper area.
Body aches; Immediately on injection arm burned from shoulder to elbow; Headache; Dizzy started late that night; Foggy started late that night; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8735) via an unspecified route of administration in the right arm on 15May2021 at 14:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 in Feb2021, the patient reported that due to COVID-19 she experienced loss of taste, loss of smell and long-term fatigue. Prior to the vaccination, the patient was 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 COVID-19 vaccination.  Concomitant medications included an intrauterine device- levonorgestrel (MIRENA) for an unknown indication form an unknown date. On 15May2021 at 14:00, the patient reported that her arm burned from shoulder to elbow immediately on injection. On 15May2021, the patient experienced headache and dizzy/foggy which started late that night. On 16May2021 at 07:15, the patient woke up from body aches and had to keep "stretching" like she had a fever but none was present. The patient reported that these events experienced after the vaccination felt similar to the events, she previously experienced when she had COVID-19. The patient hoped that after she got the vaccine, it would bring back her taste and smell and help with the long-term fatigue. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of events headache and body aches and included treatment with ibuprofen which the patient took around midnight on 15Apr2021. The patient reported that she took ibuprofen and TYLENOL every 3 hours alternating. The clinical outcome of the events immediately on injection arm burned from shoulder to elbow, headache, dizzy/foggy and body aches was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Migraine headache for 11-13 days following vaccine - started within 8 hours of receiving vaccine OTC medication ineffective - Advil Aleve, Aspirins, Sudafed, Excedrin migraine
Approximately 3-4 hours post vaccine adm, had pain at injection site sharp pain through chest on and off which has subsided, later that night began with pain lower left beck and frontal headache on and off. Also feels "feverish." Client was very apprehensive about getting vaccine. Treating h/a with Aspirin.