chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; myalgia; headache; This case was reported by a nurse via sales rep and described the occurrence of fatigue in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose, refer case US2019AMR128716).   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced fatigue, myalgia and headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fatigue, myalgia and headache were recovered/resolved.   The reporter considered the fatigue, myalgia and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife who herself was a Nurse. Approximately 8 months before the date of reporting, the patient received a dose of Shingrix at his primary care location. Fatigue, myalgia abd headache were lasted approximately for one day. The reporter said that prior to receiving the vaccine she told the patient that the side effects could be expected from many vaccines, including Shingrix and did attribute the side effects to vaccination. The reporter did not agree for follow-up.
The pt experienced a screaming cry, unconsolable from 10:30 am to 8:00 pm (on and off). Did sleep some. The pt had a fever of 103. Gave Tylenol every 4 hours.
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, those patients were administered doses of improperly stored doses of M-M-R II lot# M035388, expiration date: 02-AUG-2018 (dosage and route were not reported). No adverse events were reported. Vaccines were stored in the temperature of 47 to 77 degrees Fahrenheit for 18 hours. On 16-AUG-2017 a call was placed to the reporter. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005591.
No fever. No visual changes. Within 12 hours of immunization, developed severe constant pressure in back of neck and entire head, had sound sensitivity and nausea. All symptoms resolved by 24 hours after immunization except anorexia which persisted until 48 hours after immunization.
Slight rash at injection site noticed later on in the same day as injection. The rash grew and was tender when noticed on Satuday 4/10 more then 48 hours after injection. Arm is still sore as of 4/13.Headache began on Monday 4/13 and is persistent throughout day.
R thigh on Thursday 9th had redness & swelling 60x40mm No pain - used warm compresses
pt was given vax 1PM & 8PM pt suddendly fell asleep on floor; became rigid & began shaking; all extremties; pt was taken to ER; seen by ER staff;
Patient c/o metallic taste and mild SOB after regular flu shot. Tx with BENADRYL 50 mg PO and solumedrom 125mg IV in ER and discharged after treatment. Symptoms 1 mild SOB and metallic taste. Treatment drugs Used: 1 diphenhydramine, dose 50 units: MG Freq: ONCE Route: PO 2 methylprednisolone: dose: 125 units: MG Freq: once route: IV
10JAN94 sl araised area on trunk & arms; 11JAN94 hives to breasts, hips & rams, progressive, throat swelling treated @ clinic; 15JAN94 hives inc & resp swelling; dx urticarial react/serum sickness;
1 day after my vaccination, My left arm (vaccinated site) was swollen (sized like a half dollar coin) and it was really red and had a hard surface which was not normal and also was very painful. The swelling lasted a week and then turned into a big bruise. As of today 01/28/2022 the bruise is still visible but the hardness in my skin and the pain disappeared.
swelling, redness, pain at injection site; swelling, redness, pain at injection site; swelling, redness, pain at injection site; Lump on upper left collarbone that is causing pain in upper left chest, left side of neck, and left side of head; Lump on upper left collarbone that is causing pain in upper left chest, left side of neck, and left side of head; Lump on upper left collarbone that is causing pain in upper left chest, left side of neck, and left side of head; Lump on upper left collarbone that is causing pain in upper left chest, left side of neck, and left side of head; Start Date/Time: 14Apr2021 10:00 AM; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6205) via an unspecified route of administration in left arm on 14Apr2021 at 10:00 (at the age of 31-year-old) as single dose for COVID-19 immunization at Workplace clinic. Medical history included sleep apnea and shellfish allergy. Patient did not receive other medications in two weeks or any other vaccine in four weeks. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6205) via an unspecified route of administration in left arm on 06Jan2021 at 11:30 (at the age of 31-year-old) as single dose for COVID-19 immunization and experienced COVID-19. On 15Apr2021 at 19:00, patient experienced swelling, redness, pain at injection site. Lump on upper left collarbone that was causing pain in upper left chest, left side of neck, and left side of head. Adverse event resulted in emergency room/department or urgent care. Patient did not receive any treatment in response to the event. Outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
she could not use her arm; Headache/My head hurt so bad; Sick; Swelling up; Rash/This rash is spreading/ little spot on the side of her nose, on the side of her face; she came home and she felt her arm was a little swollen up; she could not eat anything; Itch; scratching; This is a spontaneous report from a contactable consumer (patient). A 70-year-old (as reported) female patient received first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration in Oct2019 at single dose for not to get sick.  Medical history included asthma, cholesterol. Concomitant medication included simvastatin (Expiration Date: 04Mar2020) at 20 mg, once daily at night at bed time for cholesterol, montelukast sodium (SINGULAIR, Expiration Date: 03Mar2020) at 10 mg, by mouth at bed time once a day for asthma. The patient previously took unspecified medications (pneumonia shot). Consumer stated, when she got the shot (pneumococcal 13-val conj vac (dipht crm197 protein)) in Oct2019 and this was not her first pneumonia shot (Unspecified medications), at that night she could not use her arm and it was like bad and she had to put it in the front so, she was thinking that and the headaches she had and she had it for like three or four days she was very sick, the headache, the swelling up, it was just horrible but, she felt it was okay but, she noticed she kept scratching this little spot on the side of her nose not on her nose but, on the side of her face and she was looking in the mirror and she did put Vaseline on it again but, it looked like it had got bigger so, she looked at it and it was a rash which she thought it was okay and it would go away. At time of the report,  it had been going on for three weeks and the rash had taken over her face, it was slowly taking over her face. She had been very sick and she was old and when you get that sick it was scary. The patient had an appointment with Primary Care tomorrow and she could call back with more details. The patient was just given pneumococcal 13-val conj vac (dipht crm197 protein) and she came home and she felt her arm was a little swollen up so, she put ice and stuff and by the night time she could not use it and she was sick. Treatment included she took something for her headache because, her head hurt so bad and she could not eat anything. The patient had an appointment that was Friday. She have an appointment on Monday morning at 09 o'clock so, they have already put in for a dermatologist so, they can get a closer look at it because, it had spread and they could see how it had spread since she was there Friday. They just squeezed her in and lady told her did not put anything on it, if it itches or so put cold compress because, it did itched and wait till she come in Monday so they can get a look at it and try to figure out what had happened here or was it something else and not the pneumococcal 13-val conj vac (dipht crm197 protein). The outcome of the events was unknown.
Diarrhea, Nausea, Headache, Bodyache, and pain at the site of the injection. All symptoms are still present 4 days post injection with the exception of the pain at eh injection site.
pt inadvertently recv 2 doses of flu vax 2OCT98;one dose was administered subcutaneous;late that evening, pt devel black & blue mark @ inj site & insomnia;pt felt miserable;
MY daughter had no signs of autism until her 18 month vaccines were given. Soon after, she lost all speech, made no eye contact, withdrew into her own little world. Hair and urine tests have shown mercury toxicity. My daugher has multiple deviant mental delays. She is nonverbal, has many allergies, hyperactive, sensory integration dysfunction and is heavy metal toxic. We are using natural chelatton but progress is slow. Mercury is the last and the hardest metal to get out. I was 100% for vaccinating until I watched the vaccines at 18 months trigger autism. She had no autism symptoms prior to 1/5/01. the IOM can report all they want on how safe thimerosoal is but I know the truth from this unfortunate experiences. Per annual follow up report: my daughter is improving with chelation treatment using DMPS ( a superior mercury chelator). However, she remains non verbal, developmentally delayed and has immune and gastro intestinal problems.
Missed dosing window of second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dosing window of second dose) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dosing window of second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dosing window of second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
Booster dose; Fever; Headache; Nausea; Chills; Sore arm; This is a spontaneous report from a contactable consumer. A 61-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an intramuscular route of administration in the left arm on 19Oct2021 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and was not sure of having known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included ascorbic acid (ESTER C) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an intramuscular route of administration in the left arm on 05Feb2021 (at the age of 60-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an intramuscular route of administration in the left arm on 26Feb2021 (at the age of 60-year-old), both as a single dose for COVID-19 immunisation. On 20Oct2021, the patient experienced fever, headache, nausea, chills and sore arm. 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, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events fever, headache, nausea, chills and sore arm was recovered with sequelae on an unknown date in Oct2021.
Pain in left bicep initially. :Pain and stiffness gradually spread to both shoulders, both hips, and both wrists. Increasing pain and stiffness. Diagnosed with :PMR (polymyalgia rheumatica) Began treatment with :Prednisone
7 cm. round raised erythematous eruption around injection site & 2 cm. rash at site.
Severe, persistent diarrhea (as many as 7 episodes in a 10-hour period, as well as during the night, associated with abdominal cramping and pain). The diarrhea still persists as of this date, despite anti-motility agents. Patient has lost 7 lbs. There has been no nausea, vomiting, fever, or blood in stools, and no recent foreign travel.
Patient state that "her arm got quite swollen and red. The swelling and redness are going down now and there is no sign of infection."
PATIENT HAD PFIZER VACCINE ON 01/21/2021 and 02/11/2021, AND TESTED POSITIVE TO COVID.
Increasing frequency and severity of bradycardia and desaturation events. Eventually progressing to apnea and requiring vigorous tactile stimulation and place back on nasal cannula 0.5LPM up to 35% FiO2. Was previously on room air.
pt recv vax 14AUG96;inconsolable x 4hr on that day;
Could not get comfortable due to arm pain; Did not sleep well; Pain at the injection site; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Could not get comfortable due to arm pain), SLEEP DEFICIT (Did not sleep well), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Fatigue) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Could not get comfortable due to arm pain), SLEEP DEFICIT (Did not sleep well), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Could not get comfortable due to arm pain), SLEEP DEFICIT (Did not sleep well), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided.Treatment information was not provided. Action taken with the drug in response to the events is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up received. Added new AE
Fever 10/10/02 of 102 degrees F. Soreness at site of injection. Chest sore when breathes in; continues today.
Soreness of face and scalp,  extreme tiredness. Symptoms ended  the following day.
Two weeks after receiving the Moderna vaccine a large red oval area appeared on my left arm at the site of the injection.  The area was hot to the touch but was not painful or swollen.  The redness and heat went away after 4 days.  No other side affects experienced.  I did not report this to my primary physician.
The pediatric dose of Pfizer was given to a 15 year old patient. There are no adverse outcomes
26JUN96 2 1/2-3" circle around inj site;arm @ area tender to touch;gen didn't feel well; As day progressed redness dec & arm was less painful;27JUN sl tender dime size spot dull, red color feel much better;
This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced welt associated with ZOSTAVAX administration site. The outcome of welt associated with the ZOSTAVAX administration site was unknown. This is one of several reports received from the same source. Additional information has been requested.
Lightheaded daily, near syncope daily, migraines,  aura sensation and vision changes, facial numbness and tingly occasionally, bradycardic and tachycardia, chest tightness for 2 months, short of breath daily, low activity tolerance
The day after receiving the vaccine, I started vaginal bleeding for 13 days.  This vaginal bleeding looked like menstruation, however I'm 20 years post-menopausal.
For a week in a half before COVID-19 I had sniffles, it felt like a minor head cold or even allergies. I had a COVID-19 test on February 11, February 14, February 15 which were all negative. My partner teaches and she was overly exposed to children and COVID-19. On Feb 16, my symptoms were 100.5 fever and I felt different, congestion, nasal secretions. These symptoms were very different from the week before. I did another at home COVID-19 test on Feb 16 and was positive. I then took another test on the same day to make sure that the results were accurate. I reached out to my doctor, the first NP said she wouldn't give Paxlovid because it was too late if I was having the sniffles a week prior. I then called my doctor office and asked to speak with someone else and they did ask more detailed questions and decided to prescribe Paxlovid. It was renal dose not as strong as the other or so they say I don't understand the difference.  My first dose of Paxlovid was taken Feb 17, and my last dose was taken Feb 22.  I was basically tired and fatigued and slept throughout the day and very low energy, lots of mucus, congestion, almost normal temp, loss of appetite, and the main symptom for me was fatigue through the entire sickness.     I have had the flu two times prior to this, and the COVID-19 illness was nowhere near as bad as the flu.
On September 27th I went for annual exam and gave a urine sample which showed sugar in my urine.  On September 29th fasting blood work was done and  my HGBA1C was 12.1.  I have been diagnosed with type 2 diabetes and have started medication orally for it.
BODY PAIN; FEELING TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  Concomitant medications included dienogest/estradiol valerate for contraceptive method.  On an unspecified date, the subject experienced body pain, and feeling tired.  Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling tired and body pain was not reported. This report was non-serious.
p/vax pt reported tingling sensation in lt arm/hand since 8/16/99;pt denied any color change in extremity or swelling;per MD w/vaccine MFR sx should subside in days to weeks;pt to call if sx persist;
During the administration, per the patient, a large amount of blood squirted from the administration site. Pressure was applied to the site as well as below the site.  Patient used cold compresses three times a day for about 2 weeks. He returned to the pharmacy and he had some swelling in the area were the shot was administered as well as below, closer to just above the elbow bend, with some noticeable warmth to the touch. Patient was advised to be evaluated by his physician or urgent care.  A follow up call was made on 9/19/21 where he reported that he did go to an urgent care and was told to apply heat and see his primary care physician if there were no improvements in the next 2 days. Was told it could have been due to hitting a nerve or a vein.
Vaccines administered 7-15-08.  Mother noticed redness on left arm 7-16-08. On 7-17-08, Mother noticed redness, swelling, and yellow discoloration from the vaccine site to 1 or 2 inches above elbow of left arm.  It is very warm to touch.  Child c/o itching but is not in pain according to mother.  She called to report symptoms 7-17-08.
01/12/22 presents to ED for "shortness of breath and chest pain". PMHx of "COPD, hypertension"
This spontaneous report was received from a nurse practitioner refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unknown date of March 2015 the patient was vaccinated with first dose of GARDASIL (lot, expiration date, dosage regimen were unknown). It was reported that, the patient was vaccinated her second dose with GARDASIL 9 (lot, expiration date, dosage regiment were unknown). The reporter stated that, this time (exact date not reported), the patient is going to take her third dose in series with GARDASIL 9. No adverse effects reported. No product quality complaint (PQC) was filed. Additional information has been requested.
when I stand up and begin walking, I have hold on to whatever is available and consciously control my body from stumbling; could not get out of bed on her own and felt like some one was pushing her back; weakness; light headedness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (light headedness), BALANCE DISORDER (when I stand up and begin walking, I have hold on to whatever is available and consciously control my body from stumbling) and FATIGUE (could not get out of bed on her own and felt like some one was pushing her back) 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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced ASTHENIA (weakness), DIZZINESS (light headedness) and FATIGUE (could not get out of bed on her own and felt like some one was pushing her back). On 08-Apr-2021, the patient experienced BALANCE DISORDER (when I stand up and begin walking, I have hold on to whatever is available and consciously control my body from stumbling). At the time of the report, ASTHENIA (weakness), DIZZINESS (light headedness), BALANCE DISORDER (when I stand up and begin walking, I have hold on to whatever is available and consciously control my body from stumbling) and FATIGUE (could not get out of bed on her own and felt like some one was pushing her back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no Concomitant products were provided. no treatment medications were provided.  Patient could not get out of bed on her own and felt like some one was pushing her back. She has been to emergency room by emergency services. It lasted for three days. She also has weakness and light headedness. This is still happening from 7th or 8th day after the vaccine but not as severe as it was. Caller would like to know if she can get the second shot and also would like to know how long the symptoms last for.    Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Patient mentioned still have symptoms but not as strong and uncontrollable. Patient have to hold on to whatever available to control from stumbling.
approx 1 wk p/vax pt exp swollen glands in neck, cheek & under jaw;MD dx strep or throat infect;rx ATB could not eat or drink w/o pain;another MD dx mononucleosis could not sleep or rest;pt loss 7lbs;