chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling tired; nasal drip; being unable to sleep; head congestion; weakness; Flu-like Symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number H7JY4, expiry date 1st July 2021) for prophylaxis.   On 8th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th June 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the patient experienced tiredness, runny nose, sleeplessness, head discomfort and weakness. On an unknown date, the outcome of the influenza-like symptoms was not recovered/not resolved and the outcome of the tiredness, runny nose, sleeplessness, head discomfort and weakness were unknown.   It was unknown if the reporter considered the influenza-like symptoms, tiredness, runny nose, sleeplessness, head discomfort and weakness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and approximately 24 hours following vaccination flu-like symptoms including weakness, feeling tired, nasal drip, and being unable to sleep due to full head congestion. The patient went to his physician's office last Wednesday before the date of reporting and did work ups such as swabs and smears in nose and throat for flu, strep throat, etc. and all was clear.  The patient also reports blood pressure okay, no fever, and having clear lungs.  The patient has another appointment at time of reporting due to symptoms getting worse. The reporter consented to follow up.   Discrepancy regarding to the outcome of the event influenza like illness in document mentioned as recovering and in database given as not recovered/not resolved. so kept as per database.      Lab Comments: lab test were performed on unknown date
Not aware of any adverse reaction that patient may have. Patient receive PEDIARIX in addition to extra dose of Hep B pediatric dose.
C/o not feeling well after flu vaccine. Feeling shaky. Visibly shaky. Blood pressure 138/92 Pulse 80 Respirations 20. Began to feel better after 5 minutes of rest. Stood up and took a few steps. Turned around and took another step. Then fell forward and began seizing.
One hour post inject loose bowels, six hours post inject arm site pain,  ten hours post inject pain radiating to entire body from head to toes causing fingers and toes to be numb, twelve hours post inject migraine headache with dry heaving and some vimitting,  ( no sleep)  twenty hours post inject flu like symptoms of body aches and stomach sickness for 24 hours.   48 hours later another migraine headache.     PCP aware of all these symptoms.
Rash in the form of small red itchy spots/hives intermittently across body. The rash appeared suddenly starting at around 8:00 or 9:00 PM the night after I received the injection. Most severe concentration are on my left forearm, the crooks of both elbows, behind my left knee, and on my chest/abdomen/sides. Rash is continuing to spread in clusters. OTC antihistamines (diphenhydramine, 25 mg, two tablets) are so far ineffective at reducing the spread or the itching of the rash.
passed out; little bit of memory loss; had to stop and think/, it is not like the brain would provide the information like it would normally do.; light-headed; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out), AMNESIA (little bit of memory loss), MEMORY IMPAIRMENT (had to stop and think/, it is not like the brain would provide the information like it would normally do.) and DIZZINESS (light-headed) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS. Concomitant products included MONTELUKAST, HYDROXYZINE HYDROCHLORIDE, DEXLANSOPRAZOLE (DEXILANT) and ATORVASTATIN for an unknown indication.    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 LOSS OF CONSCIOUSNESS (passed out), AMNESIA (little bit of memory loss), MEMORY IMPAIRMENT (had to stop and think/, it is not like the brain would provide the information like it would normally do.) and DIZZINESS (light-headed). At the time of the report, LOSS OF CONSCIOUSNESS (passed out) and DIZZINESS (light-headed) had resolved and AMNESIA (little bit of memory loss) and MEMORY IMPAIRMENT (had to stop and think/, it is not like the brain would provide the information like it would normally do.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) blood pressure dropped.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included drank Gatorade. Patient didn't blacked out, and that eventually patient started to feel better.
Admitted with acute hypoxemic respiratory failure, symptomatic anemia.  Patient was found positive for COVID-19 and positive for influenza B. Treated w/O2 with need for intubation, abx, steroids, remdesivir, thiamine, Vit C, zinc. Post extubation pt failed multiple swallowing trials and Dobhoff placed d/t inability to place PEG. Pt dc'd to LTAC.
first dose: left arm swollen; first dose: left breast swollen; pain under her left arm; This is a spontaneous report from a contactable 62-year-old female consumer (patient).  A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 17Mar2021 (at the age of 62-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 07Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported On an unspecified date, after the vaccination, the patient experienced her left arm and breast were swollen Stated that she is still having pain under her left arm. The outcome of the events peripheral swelling and breast swelling was unknown and pain in extremity was not recovered.  No follow-up attempts possible. No further information expected.  Follow-up: (29Jul2021): This follow-up is being submitted to notify that the new information is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected
I am having headache and it is at the back of my head; I am kind of dizzy; looks like I am confused; I am kind of dizzy; looks like I am confused; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05May2021 05:40 (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: HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "I am having headache and it is at the back of my head"; DIZZINESS (non-serious), CONFUSIONAL STATE (non-serious) all with onset May2021, outcome "unknown" and all described as "I am kind of dizzy; looks like I am confused".  Additional Information: Reason for no lot number: Consumer stated, I think my card is in the car, Sorry. Consumer stated, I got my vaccination done, it was Pfizer vaccine first dose and I have been noticing that my head I am having headache and it is at the back of my head and I am kind of dizzy and looks like I am confused you know, It was my first dose of Vaccine. Consumer stated, further probing could not be done as consumer dont want to share further information. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headaches; Swollen under left arm; Hot and cold feeling; Menstrual cycle came back on after going off just before the injection; Pain/ Throbbing pain under my arm;  fatigued; I couldn't concentrate; I was moving in slow motion, and tripping over my feet; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) in the left arm on 31Mar2021 at 13:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Concomitant medications included unspecified multivitamins for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Apr2021, the patient experienced headaches, swollen under left arm, hot and cold feeling, menstrual cycle came back on after going off just before the injection. Every evening around 02:00, she also experienced pain, such as headache and throbbing pain under arm, gary fatigued and really could not concentrate and seemed like she was moving in slow motion and tripping over her feet. The events resulted in emergency room/department visit 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 event headaches, swollen under left arm, hot and cold feeling, menstrual cycle came back, throbbing pain under arm, gary fatigued, could not concentrate, seemed like she was moving in slow motion and tripping over her feet was resolving at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) in the left arm on 28Apr2021 at 13:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
SORE ARM AND SORE THROAT RESOLVED IN 48 HOURS Narrative:
About 3 months after injection I started to have 2 periods every month. By December 2022, I bled from December 30th 2022 until February 12th 2023 (45 days) and have now started my period again on February 27th 2023. I now have to undergo surgery due to this.
From initial information received on 4/22/04 from a patient regarding an adverse event occurring in the USA, it was reported that a 36 year old female patient received her third pre-exposure IMOVAX RABIES vaccination because she handles raccoons, lot number W1419, administered in the right upper arm on 3/8/04. An unspecified amount of time later she experienced nausea, vomiting, headaches, chills, and worsening back pain. The patient is being followed up by her physician and is scheduled for blood work. The patient continued to experience headaches, swollen glands, chest tightness, and nausea and stated that she has been vomiting approximately two days per week. The patient received some relief with symptomatic treatment, but symptoms have recurred and are continuing. From additional information received on 5/18/04 from a health care professional, it was reported that the patient had three prophylactic rabies vaccine, but evidently the manufacturer had a problem with one lot where there was actually live viruses in the vaccine. The lot administered to the patient was not one of recalled lots but the manufacturer suggested the patient be administered two additional booster shots from a new lot. The patient had stated that she had been sick on and off for the last month and a half. She was seen by two physicians. She had intermittent problems with severe headaches, vomiting, intermittent diarrhea, stomach cramps and general malaise, feeling as if she had the flu. The patient was seen by a dermatologist for her nails. A culture was positive for fungal infection and she is now on Lamisil probably 500mg every day for the past three weeks. The patient also at times feel mentally out of it, fatigued. She was on Wellbutrin 150mg twice a day. The patient is to continue to be followed and treated by dermatologist. A rabies was given on 4/23/04 and a second one will be given on Monday, 4/26/04. Appropriate lab test are to be drawn including a pregnancy test. Depending on the results and how the patient feels, will decide further actions for her recurrent flu viral like symptoms.
Seizure on 11/23/21 and seizure on 11/29/21, each lasting approximately 2 minutes.  EEG found abnormal results. MRI, no significant findings. Started medication for seizures on 12/1/21 (prescribed b neurologist)
48 days since she received the first dose of vaccine; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and PRODUCT DOSE OMISSION ISSUE (48 days since she received the first dose of vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (48 days since she received the first dose of vaccine). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 23-Jan-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (48 days since she received the first dose of vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.
Fever every 5 hours for 48 hours with chills, cold sweats, blurred vision. Softball sized covid arm reaction that is hot to the touch and itchy but painful when touched. Random moments of chills occurring 4 days later.
Vomiting, diarrhea (4 hours ) Fever up to 101.6
day 10 after injection , light red swollen patch at vaccine location , approximate size 2" diameter, irregular shape, slightly itchy,  Plan to visit family physician.
Left arm nagging ache from elbow to wrist; weakness to each thigh; This is a spontaneous report from a non-contactable other health care professional. An adult patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E51685), intramuscular in left arm, on 18Dec2020 14:30, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took nitrofurantoin (MACROBID) and experienced allergies. The patient experienced left arm nagging ache from elbow to wrist and weakness to each thigh on 19Dec2020 at 18:00. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-10 since vaccination. The reporter assessed the events as non-serious. The outcome of the events was recovered with sequel (reported as recovered with lasting effects).  No follow-up attempts are possible. No further information is expected.
Patient received vaccine on Monday 7/24/23, experience muscle soreness the next day, then noticed a developed lump under his arm by Wednesday 7/26/23.
Received DTaP and IPV in right deltoid on 05/29/2003.  Developed erythema, swelling, tenderness and warthm of right deltoid measuring 11 x 14cm.  Seen on 05/30/2003: no fever but suspicious cellulitis.  Placed on 7 day course of Augmentin.
Flu like symptoms with meningeal signs. Fever to 102 within a few hours with headaches. Pt seen at office next day with neck soreness, positive Kunig and positive Brudzinski. To ER R/O meningitis. LP WNL. 8/30/07-records received for DOS 7/20-7/21/07-DC DX: Headaches. Acute febrile illness, viral etiology. Positive meningeal signs on exam. Kernig and Brudzinksi signs positive. Temp 100.4. Neck pain.  Follow-up: Patient already had a diagnosis of migraines before the event. Currently beinig eval by Neurologist for further management.
On 3/23/22 teen experienced chest pain and nausea while running during PE class. Symptoms persisted roughly 1-2 hours. Due to his prior history of myocarditis after COVID immunization, family sought medical care for him on 3/23/22.
Body Aches, chills, fatigue, sore arm, fever blister on lip.
Pt recvd immun 28JAN91, 2 hrs later fever 101; The following day temp to 104, vomiting, & diarrhea; Seen in office; On 30JAN pt better & temp was down;
47 YO was administered Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old female patient who received Herpes zoster (Shingrix) (batch number 23E5G, expiry date 11th February 2024) for prophylaxis.   On 20th September 2022, the patient received the 1st dose of Shingrix. On 20th September 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 03-JAN-2022 Reporter's Comments: The pharmacist enquired, on how to proceed and any effectiveness data available for the first dose until patient turned 50 years and any under 50 years guidance. The registered pharmacist (RPH) stated they realized the patient was not immunocompromised and had no underlying conditions and the patient really should not had gotten the Shingrix dose at this age. The RPH mentioned they follow disease control guidelines and based on disease control protocol technically they could not administer the second dose until the patient is 50 years of age. The pharmacist confirmed second dose had not been administered. The reporter did not consent to follow up. Additional Supportive Information: The patient received a dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Pt developed a mild rash on face, hours after shot. He broke out in hives, 24 to 36 hours later. Hives covered 60% of skin area. Went to ER and received treatment. Hives are slowly going away.
It was reported that a 48-year-old female received vax on 10/27/1998. One day post administration, the pt complained of rash on upper extremities, uncontrollable crying, and difficulty moving legs, 20 minute intervals. Reports states that on 11/2 pt saw physician and reports rash due to chemicals at work.  Physician ordered cream for rash. On 02/12/99, pt went to ER complaining of toxic reaction to lacquer, uncontrollable crying, red blotches on skin. ER stated she was not having a toxic reaction. 03/01, pt again went to ER complaining of rash and crying, and ER report stated "she's intent on finding a way out of work." Allegra 60mg, twice a day and Medrol Dose Pak was ordered. 03/03 Pt went to ER complaining of pruritic rash on arm. Allegra continued, dose pack stopped. 05/05/99 this was reviewed and no further information is known at this time.
As I was going to bed, my legs, back, torso, and arms started convulsing involuntarily. I was having trouble controlling my breathing because of my abdomen constricting. I could sort of control my body to move into a laying position then a seated position, but the trembling continued throughout that movement. I remained conscious and the event lasted about 5 minutes.
PATIENT STATES WITHIN ABOUT 4 HOURS AFTER RECEIVING THE VACCINE HE HAD FLU LIKE SYMPTOMS FOR THE ENTIRE NIGHT WITH PAIN UP THE BACK OF HIS NECK. ONLY TODAY, 12-26-2019, HAS THE PAIN RELIEVED SOME ON THE RIGHT SIDE BUT STILL HAVING SYMPTOMS ON THE LEFT.
Pt reports deep red area at injection site that measured 3-4" in length.  Now smaller and down to 2" in length. Has lighter red area around deep red section. Feels warm to touch and with hard lump at site. Pt noted that the pink area has small little bumps (like "goosebumps). Area itches intensely despite taking daily antihistamine. Pt noted low grade temp of 99.2 on Saturday with some muscle aches and pains as well. Pt noted that the pink area is almost her entire upper arm. She will begin using Benadryl topical on the site to help with the itch. Advised pt to follow-up with MD if not better or resolving in 2 more days.
I tested positive for Covid-19 on April 01, 2023 I experienced sore throat, & cough. I was taking Day quil and was prescribed Paxlovid had side effects with Paxlovid nausea.
severe tendonitis (arms, wrists, shoulders, ankles) w/joint immobility & pain-inability to close/use hands/wrists;closing of containers/doors/drawers painful;viral infect;
RIGHT ARM SORENESS FROM SHOULDER TO ELBOW TO HAND SWELLING AND PAIN. SEVERE ENOUGH TO REDUCE SLEEP.
Worsening chest pain and difficulty breathing occurred two days after receiving second dose of Pfizer vaccine. Went to ER around 11pm (pain began 6pm) when no longer tolerable. Was given IV toradol, and had blood work done. Blood showed increased troponin levels after two tests but declined upon a third. Discharged hospital around 3-4am Sunday morning with prescription for po voltaren tablets.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2016,the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX, "1 vial given intramuscularly" (Incorrect route of drug administration), which had lot # M005973, expiry date: 02-FEB-2018, dose: unknown. The vaccine had temperature excursion ranging form 5 degree Fahrenheit to 7 degree Fahrenheit through 08-JUN-2016 to 29-JUL-2016 on various random unspecified times. The vaccine had no previous temperature excursion. The call was because of data logger. No adverse effects and no product quality complaint (PQC) reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Tendency to glaucoma; She had an episode were her eyes swelled up really bad; Eyes were red and wet; Blurry vision; Eyes were red and wet; This is a spontaneous report from a contactable consumer (patient herself). A 25-year-old female patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot/Batch number: not reported) via an unknown route of administration on 10Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. In 2021, the patient experienced tendency to glaucoma, she had an episode were her eyes swelled up really bad, eyes were red and wet, blurry vision. The outcome of the events was unknown. It was reported that the patient was supposed to receive the second dose yesterday and she had to reschedule because of events. The patient questioned if there are reports of deaths after getting the vaccine.  Information on the lot/batch number has been requested.
This is a spontaneous report from a contactable other HCP via a Pfizer sales Representative. A male patient (16, unit was not provided) of an unspecified race received TRUMENBA and MENACTRA both on unknown date, via unspecified route of administration, at single dose for immunization. Patient was feeling light headed, turned pale and clammy after receiving the vaccines. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.