chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient reported on 06/12/21 to the pharmacy he started having tinnitis in his right ear 1 week following vaccination. He went to the doctor and was diagnosed with post viral neuralgia of the right ear. The patient stated his doctor believed it was vaccine related. The patient also reported having thought he had been ill with Covid-19 in February 2020 before testing was readily available and at that time he had ear pain in is right ear (same ear) with the illness.
Fever 102 through Thursday night; Responded to APAP; Restless, irritable, vomited, listless;
Back started scratching; Goosebumps frequently; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration on 20Feb2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included chlortalidone (CHLORTHALIDONE) and olmesartan (MANUFACTURER UNKNOWN); for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On an unknown date in 2021, a few weeks after the vaccination, the patient experienced back started scratching uncontrollably every day and goosebumps frequently. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event back started scratching and goosebumps frequently was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report received from a contactable consumer or other non-HCP. A male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of COVID-19 vaccine (manufacturer unknown), for COVID-19 immunization. The patient had malaise (felt ill after 2nd dose), onset 2021, with outcome of unknown. Additional information: Prior to vaccination, unknown whether patient was diagnosed with COVID-19. Since the vaccination, unknown whether patient tested for COVID-19. Unknown whether patient received any other vaccines within four weeks prior to the vaccination. This follow-up submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed and no further information expected.
2/10/21 at 9:30 pm, the night after I received the vaccine, I noticed a red rash on my chest/stomach. The next day I noticed that it had spread a bit to my back. As of right now, 2/12/21, it has lightened to a more pink color. It doesn't hurt, at most it itches but otherwise I don't really notice it.
I have a hearing problem; on and off dizzy/light headed; 2 very bad headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 02:30 (Lot number: EN6206) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart by pass" (unspecified if ongoing); "Known allergies: Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN.  The following information was reported: DIZZINESS (non-serious) with onset 13Mar2021, outcome "not recovered", described as "on and off dizzy/lightheaded"; HEADACHE (non-serious) with onset 13Mar2021, outcome "not recovered", described as "2 very bad headaches"; HYPOACUSIS (non-serious), outcome "unknown", described as "I have a hearing problem". Therapeutic measures were not taken as a result of dizziness, headache.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The other medications the patient received within 2 weeks of vaccination included rosuvastatin. Prior to vaccination was the patient was not diagnosed with COVID-19. Since the vaccination has the patient has not been tested for COVID-19. Allergies to medications, food, or other products: seasonal allergies. Patient stated she received the Pfizer vaccine (Vaccine name not clarified, hence suspect captured as Unspecified Vaccine and is this a Pfizer product tab checked-Yes) on March 12 (not clarified) and she was still getting like on and off dizzy spells and light-headed and a couple of times and had really a bad headache on the left side. The patient further stated she have a hearing problem and she was having a really hard time in understanding what they are saying.   No follow-up attempts are possible. No further information is expected.
Won't stop crying and had trouble breathing. Mom stated child would have irregular breathing and infant would breath shallow then stop, arms flail and then restart breathing. x ray abdomen in the ER showed multiple air fluid filled loops of small and large bowel throughout the abdomen.
Within about 20 hours I spiked a fever of 102.7 and 102.9 for two days and then my temperature dropped to 99.6 for a day.  I had chills, joint achiness, fatigue, foggy headed feeling, a runny nose, sinus pressure, headache, chest tightness and pain, arm pain, stomach pain, lymph nodes in my left armpit are sore (after 10 days), and I now seem to have a worsened allergy to dairy and a new allergy to nuts - I get very phlegmy, cough, and have chest pain and tightness.   These symptoms lasted for 5- 6 days and the allergies with their symptoms and sinus pain and sore lymph nodes have continued.
at 5am this morning i woke up with a severe headache and feeling nauseous.  I sat at the end of my bed and then do not remember anything until my head hit the bathroom floor.  My wife said i stumbled across the bedroom into the bathroom and it looked as if i just passed out and fell to the ground.
Pt's mother states pt broke out in hives and had bad GI upset and body aches starting the night after receiving the immunization. Pt took BENADRYL and have improved.
itching / scratchy / head is itchy where her hairline is; some little pimples, kind of like a rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Mar2021, the patient experienced itching / scratchy / head is itchy where her hairline is; and some little pimples, kind of like a rash. It was further reported that she was calling because on the 10th she got her vaccine and a couple days ago she had itching and some little pimples, kind of like a rash. It was reported that it was scratchy like a mosquito bite. She has some on her arms, her stomach, her back, her legs and her head is itchy where her hairline is. The caller wanted to know what to do since tomorrow was her due for her second dose. She asked if she needed to cancel it or get the second vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, could not move arm due to pain, nausea, low temp, cold sweat, rash on face and neck, tiredness and muscle pain
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced shingles, pruritus, skin scaly, injection limb mobility decreased, red face, pain and injection site inflammation. The patient was treated with VALTREX. In April 2018, the outcome of the injected limb mobility decreased and injection site inflammation were recovered/resolved. On an unknown date, the outcome of the shingles, pruritus, skin scaly, red face and pain were unknown. The reporter considered the shingles, pruritus, skin scaly, injected limb mobility decreased, red face, pain and injection site inflammation to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 15:40, the patient received SHINGRIX vaccine on left arm. The patient experienced shingles on the left side of her face, mostly on the left side of her forehead. On 26th April 2018, the patient went into the pharmacy and stated that it was improving. The reporter described the patient's face looked scaly and red. The patient experienced pain and itching that was so bad that she wanted to scratch her whole face off. Less than a month after receiving SHINGRIX, the patient experienced inflammation at the injection site and she was unable to move her arm for two to three days. The patient went to her physician and was prescribed VALTREX.
This solicited case was received from the investigator participating in a trial on 21 November 2014. A 19-year-old female subject, with no reported medical history, had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 06 May 2014. ECG performed on 15 May 2014 showed abnormal results (no details provided). On 02 June 2014, i.e. 27 days post vaccination, she was diagnosed with unspecified disease of pericardium. Electrocardiogram performed on 13 June 2014 showed normal results. MRI (brain, heart, spinal cord), lumbar puncture and troponin I level were not performed. Patient's outcome was not provided. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
broke out into a full body rash ~30 hours after vaccination.; Mild to moderate itching around non-raised groups redness. Mostly upper body, sparse in lower body.; Mild to moderate itching around non-raised groups redness. Mostly upper body, sparse in lower body.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm right on 29Apr2021 at 16:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dexamfetamine sulfate, amfetamine sulfate, dexamfetamine saccharate, amfetamine aspartate (reported as ADDERALL Generic) and bupropion hydrochloride (reported as WELLBUTRIN Generic); both from unknown date for unspecified indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 06Apr2021 at 15:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 20:30, approximately 30 hours after vaccination, the patient broke out into a full body rash, mild to moderate itching around non-raised groups redness mostly upper body, sparse in lower body. The patient was still experiencing, now 4 days after vaccination, but it seemed to be fading in severity. The patient had no other recent changes in food, clothing, medications, or settings. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events full body rash, mild to moderate itching around, non-raised groups redness mostly in upper body and sparse in lower body was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt states her arm was sore after she received the vaccine.  She then experienced chills, joint pain, fever, and vomited when she returned home. On the following 2 days, Tuesday/Wednesday she had a fever between 100-102 F.  By Thursday most symptoms had rectified, however she had a severe headache and abdominal discomfort.  At time of my report (Friday), she states that the symptoms have mostly resolved.
syncope within 5 minutes of immunization. faint, white and sweating. had patient lie down, elevate legs and gave some water.  He rested for 30 minutes and then was released.
Presents to clinic with left upper arm swelling and redness noted. Area hard and warm to touch. Received DTaP in Left upper arm on 6/28/04. Dx: Imm reaction. Tx: Ice and Benadryl
Every night have weird nightmares; Am water tortured where I wake feeling as though a gallon of water has been dumped on me; Head has an awful manufactured feeling; Phantom fevers/ high fever; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 08Apr2021 at 13:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 29Apr2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included laryngopharyngeal reflux (LPR) and intolerance for Silicone contacts. The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Minocycline (MANUFACTURER UNKNOWN), Dicloxacillin (MANUFACTURER UNKNOWN), Levaquin (MANUFACTURER UNKNOWN) for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was very active, healthy female, after shot 1 it took her until 25Apr2021 before she felt 100 percent (%) better.  The patient's symptoms post 1 & 2 were in alignment, but more intense for the 2nd. On 30Apr2021 at 07:00, after second dose, the patient experienced every night she had weird nightmares and feeling like water tortured (a gallon of water had been dumped on her), as phantom fevers break. They broke through the day as well but not as often. The patient had been taking her temperature around the clock as her biggest complaint was her head. The patient felt like she had a high fever but actually haven't had a fever even once. The patient experienced an awful manufactured feeling. The patient had 2 thoughts: She had a sensitivity to one of the ingredients in the vaccine. Although her symptoms were ever present, they subside slightly as the day went on and she was convinced to herself because she was taking so many fluids during the days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events of every night have weird nightmares, heavy sweating, phantom fevers/high fever and head has an awful manufactured feeling were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Parent was notified by phone - waited in the office for 20 minutes. Pt was in for a  well child visit and father asked for flu shot. Nurse gave flu vaccine to the 2 months old patient. Pt waited in office for 20 minutes no noted reaction. Went back to notify patient, and they need left office.
pt recv vax;devel T of 104 R;apap given;T dec to 101; hx of ear infect;will see MD for eval;to MD;no ear infect;apap given; no oth sz;
Onset of tinnitus  7/10 on scale.  Remains steady and has not decreased.
Loss of range of motion.  Constant pain in shoulder radiating to elbow.  Treatment of Physical therapy and ibuprofen.  Outcome:  Still having symptoms and treatment.
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-046661 (Patient Link).
COVID-19; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000217341. This case, from the same reporter is linked to 20220235393. The suspected product quality complaint has been confirmed that the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Version created to amend previously reported information on 28-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
PATIENT STATED DIZZINESS EYES GLAZED OVER PALE AND PASSED OUT FOR 2 SECONDS DID STERNAL RUB DIAPHORETIC  BP:83/40 HR:93 (2ND) BP:97/59 HR:71
Pt complained of feeling bad and her blood pressure was high. She thought it may have been because she started a new blood pressure medication. She was also broken out with a rash.
Bruising on all arms and legs, approximately 6 per limb. Resolved in 1 week without treatment.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received bnt162b2 (BNT162B2 NOS), on 02Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neomycin, reaction(s): "Allergy". On an unspecified date, the patient experienced of COVID-19. Covid symptoms went away on the medicine but came back 12 hours after I stopped the medicine. Sore throat then runny nose. Then cough four days later. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After 5 days patient came down with Chills and aches and pains all over his body. By 5pm on 4/10/21 Patient reported feeling better
This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's husband. The age at vaccination was not reported. The reporter stated that, the patient took the shingles shot then he came down with the shingles and had to visit the emergency room. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
PAIN AT THE INJECTION LOCATION; FATIGUE; MILD 3 SECOND  HEADACHE; MILD 3 SECOND ABDOMINAL PAIN; 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 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced mild 3 second abdominal pain. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced mild 3 second headache. On 02-APR-2021, the subject experienced pain at the injection location. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild 3 second abdominal pain, and mild 3 second headache on APR-2021, and pain at the injection location on 02-APR-2021, and the outcome of fatigue was not reported. This report was non-serious.
Information has been received from a physician concerning a patient's friend (age not reported) who was vaccinated with Gardasil vaccine (lot# unknown) injection. Subsequently, the patient experienced a "nervous system problem", after receiving the Gardasil vaccine. No further adverse event information was given. Additional information has been requested.
BREAKTHROUGH COVID INFECTION. PATIENT TESTED POSITIVE ON 09/03/2021. PATIENT FULLY VACCINATED ON 02/27/2021
SEVERE LEFT HAND PAIN Narrative:  PATIENT DESCRIBES HAND AS THOSE SOMEONE HIT IT WITH A HAMMER IN SAME SIDE AS VACCINE WAS GIVEN.
The patient was administered an adult dose of the COVID-19 Pfizer vaccination for his second dose instead of the pediatric dose