chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Henoch Schonlein Purpura 287.0. Abd pain around 11/10/2008. Purpura started around 11/10/2008. Seen 11/17/2008 and diagnosis made. Labs normal u/a normal 11/20/2008 rash fading.
Second day after receiving Moderna, vaccine developed measles like rash on my left bicep and around injection site.  By the next day rash had effected chest, stomach and back as well as the right arm.  Also developed a low grade fever (under 100) .  Rash is exacerbated by heat of the shower.  Rash migrated to the legs and is especially severe around socks.  rash seems to become more prevalent late in the day and in the mornings.  Mild dizziness when looking up or down.  Low energy and feeling very tired after mild activity.  Symptoms persist 9 days after injection
Red pimples. Mostly over the back and sides. Some on abdomen and upper thighs. Raised centers, which turned yellow. At home treatment with cortisone cream. Slightly itchy. Presently fading.
Moderna COVID-19 Vaccine EUA  First vaccine 2/5/21 second cancelled by phar.  3/5/21 reschd to 3/12/21. FIVE WEEKS. Noon injection. Chills within  ten hours.  (Fri 12th) Soon fevered.  Exhausted. Forty eight hours of average 102° fever.  NO appetite.  Ibuprofen three times.  First food (Sun 14th 6:00pm). Back ache now...pain kept me up during night.   Fever down.  Monday noon back to normal.
weak; could not lift my arm up; blacked out and fell to the floor/ Unconscious; lost hearing; started to lose balance and couldn't stand and couldn't walk; started to lose balance and couldn't stand and couldn't walk; started to lose balance and couldn't stand and couldn't walk; very, very pale; zapped of energy; drenched in sweat; neck was burning, like it was on fire; complete loss of body function; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in left arm on 16Jun2021 12:15 (at the age of 32-year-old), as single dose for COVID-19 immunisation in pharmacy. The patient had no medical history present and no family medical history relevant to AE. The patient had no other products taken. The patient did not receive any other vaccines within four weeks prior to the vaccination. After received the first dose around 16:30 on 16Jun2021, the patient waited there 15 minutes after and was fine. Four hours later, the patient blacked out and fell to the floor. The patient stated he was unconscious for 30 seconds and then snapped back to life, drenched in sweat, started to lose balance, couldn't stand, and couldn't walk. The patient stated he did not have a phobia of getting a needle or anything like that. The patient stated he was not doing anything but eating dinner when it happened. For a minute or two while all this was happening, he states he lost his hearing. Then the patient was able to walk about 25 feet and tried to lean against the wall and then fell to the floor. Patient stated his buddy was there and tried to wake him up. The patient was still thinking in his mind but he didn't know where he was. He had complete loss of body function for about 20 minutes. The patient stated he was then able to lay down, drenched from sweat from head to toe, the cold air outside seemed to help, He stated his neck was burning, like it was on fire. The patient said that  everything came out of left field. He seemed fine from 00:15 until 16:30 (on 16Jun2021). He felt zapped from energy, so he went to sleep from 16:45 until 23:00, which he seemed to help. The patient stated he has had nothing like that today, he was just weak and could not lift his arm. His face did get very, very pale when these events happened. He stated everything happened yesterday between 16:15 to16:45. The patient states for 20 minutes he had to lay down and get fresh air and during that time there was a moment he couldn't hear, he thought he had lost his hearing. Patient stated it was very scary and he considers himself a healthy male and tried to do all the right things. He states he did not have a fear of getting the vaccine, then everything hit him really hard. The patient underwent lab tests and procedures which included blood test: excellent. Outcome of the all events was resolved on 16Jun2021while outcome of the event zapped of energy was resolving and  weak and could not lift my arm up was unknown.
rebound Covid; rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "rebound Covid". Clinical information: Description of Event Outcome: Forwarded as an Adverse Event by the Escalation team on 14Jul2022. Reporter provided verification of contact address on 14Jul2022 You need to update your records on rebound Covid after taking your antiviral medication. In my small circle I know 7 people that have gotten Covid again . I am wai Too see if I do My husband has it again and I am still testing positive. I never would have taken it if I knew that percentage of peoples that get it again . It should only be given to very high risk people. Event Awareness Date 14Jul2022,CEP Number CEP 005570, Date Sent to DSU 14Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200023743 same drug /event, different patient.;
he started with left arm pain; it hurts to raise his arm; He has not yet gotten his second Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26-SEP-2022, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm (Verbatim: he started with left arm pain), pain upon movement (Verbatim: it hurts to raise his arm) and incomplete course of vaccination (Verbatim: He has not yet gotten his second Shingrix vaccine). The outcome of the pain in arm and pain upon movement were not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm and pain upon movement to be related to Shingrix.     It was unknown if the company considered the pain in arm and pain upon movement to be related to Shingrix.   Additional Information: GSK receipt date: 11-MAY-2023 The patient self-reported this case. The patient reported that after his injection, he started with left arm pain where it hurts to raise his arm.  The patient stated that the pain was still there and getting worse.   The patient had not yet gotten his second Shingrix vaccine.   The patient did not had any further information about the vaccine itself. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Mother reported: child was chipper until shortly after getting shot.  He became lethargic, dragging his book bag on the ground.  That night he ran a 102 degree temperature that last one week.  He then started vomiting which lasted 4-5 days.  He was sick for 2 weeks and was in and out the ER during that time.
pain at injection site; redness at the injection site; arm is warm to touch /huge patch which is sore and warm to the touch; feels like she is getting a headache; huge patch not too painful but swollen; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 8th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 8th January 2020, immediately after receiving Shingrix, the patient experienced injection site pain. In January 2020, the patient experienced injection site erythema, skin warm, headache and swelling arm. On an unknown date, the outcome of the injection site pain, injection site erythema, skin warm, headache and swelling arm were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, skin warm, headache and swelling arm to be related to Shingrix.  Additional details were received as follows: The patient did not experience any problems after the first dose of Shingrix. The patient had received the second dose of Shingrix and after that she experienced swelling, pain at the injection site, redness and the arm  was warm to touch. The patient felt pain during the injection.
Osteoarthritis knees; Legs itchy; Fever/running a temp; General body pain/body ache; This is a solicited report from a non-interventional study (FACILITATED COLLECT) based on information received by Pfizer (Manufacturer control number: 21K-163-3977066-00). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscular on 15Mar2021 as dose 1, single, for COVID-19 immunization; and adalimumab (HUMIRA), subcutaneous, with therapy dates, dose and frequency unspecified, for psoriatic arthritis. Medical history included being a non-alcoholic; non-tobacco user; and inflammation. Concomitant medication included meloxicam. On an unspecified date in 2021, the patient had osteoarthritis knees; legs were itchy; fever/running a temp; and general body pain/body ache. In Jun2021, the patient underwent knee surgery and was doing her physical therapy due to the osteoarthritis in the knees. She agreed to have physician contacted. In 2021, patient had second knee surgery; she was doing great but her knees were tight. The patient was using a cane. She had knee surgery and there might have been some arthritis left in her knees, because they were stiff, her healthcare professional was monitoring this. The patient had received paracetamol (TYLENOL) as treatment for fever and body ache; and unspecified treatment for itchy legs. The outcome of the events was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the  event Osteoarthritis and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient received dose and had no immediate problems. While patient was waiting she complained of shortness of breath. I had the patient sit down and drink some water. The symptoms continued to get worse over the course of 5 minutes. At 10 minutes after the dose was given I retrieved the patient's spouse. At 10 minutes I administered 1 dose of 0.3mg epinephrine into the left outer thigh. I gave the other dose pen to the patient's spouse and sent them to the nearest emergency department. As they left I notified the ED that they would be arriving shortly.  Later about 1 hour later I called the patient to follow up at which point the patient informed me the ED personnel had taken chest x-rays and found a blood clot in her lungs. She was currently being treated for the blood clot and could breath easily. She explained to me that the doctors supposed she may have had an active COVID 19 infection recently and was asymptomatic until she came in today. It is my opinion that the vaccine did not cause the clot and that it happened to show up by chance.
Patient completed her second dose on 3/9/21.  Pt presents to ER on 5/9/21 with CC of urinary frequency, urgency, and vaginal discharge.  Patient tested positive on 5/9 and admitted to the inpatient ward for dysuria.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 6-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-DEC-2022, the patient was vaccinated with the third dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #W012143, expiration date: 09-NOV-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933:
On 6/15/17 Pt have a PREVNAR shot, the day after at noon time. By the time she got shower notice swelling on Right shoulder, redness, a little fever got to doctor and prescribe clindamycin and Levocetirizine.
Red blotchiness; COVID arm; A mild temperature; Mild chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotchiness), VACCINATION SITE REACTION (COVID arm), PYREXIA (A mild temperature) and CHILLS (Mild chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PYREXIA (A mild temperature) and CHILLS (Mild chills). On 16-Feb-2021, the patient experienced RASH MACULAR (Red blotchiness) and VACCINATION SITE REACTION (COVID arm). At the time of the report, RASH MACULAR (Red blotchiness), VACCINATION SITE REACTION (COVID arm), PYREXIA (A mild temperature) and CHILLS (Mild chills) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
This spontaneous report as received from a pharmacist refers to a 64 year old female patient. Pertinent medical history, drug reactions or allergies were not reported. On 27-OCT-2013, the patient was vaccinated with ZOSTAVAX lot # J004310, expiry date: 12-JUL-2014 in the inner aspect of her left forearm (route was not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced bruising at the injection site. On an unknown date, the bruising at the injection site resolved with no further difficulties. The patient did not seek medical attention regarding this experience until 30-SEP-2014, when she asked the pharmacist if she should receive another dose of ZOSTAVAX. A second dose of ZOSTAVAX had not been administered to the patient. Causality between ZOSTAVAX and bruising at the injection site was not reported. Additional information has been requested.
Injection given SC instead of IM resulted in patient reporting fever, heart palpitations, chills, and weakness approximately 24 hours after administration. At 36 to 38 hours post administration, the patient reported that the back of her left arm had a very large red area. All symptoms began improving on day 3.
Allergy; Initial information received on 19-Aug-2022 regarding an unsolicited valid  non-serious courtesy case received from a consumer/non-hcp via Pfizer.   This case involves a 62 years old female patient who experienced allergy after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (with an unknown strength, formulation, batch number and expiry date) via unknown route in unknown administration site for Immunisation.  On an unknown date the patient developed allergy (hypersensitivity) (unknown latency).  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (Allergy).  At time of reporting, the outcome was Unknown for the event allergy.
Extreme pain in arm after second vaccine. The pain started in the area where vaccine was administered but it has traveled down to above my elbow on left arm. It feels like it's deep within the arm, and I feel the pain when I move it in certain direction. It's slowly getting better. My doctor advised me to report it to this website.
acute hemorrhagic leukoencephalitis; vasogenic edema including involvement of the pons; significant areas of hemorrhage; Initial information was received on 20-Jul-2021 regarding an unsolicited valid serious case from other healthcare professional issued from a literature article.   This case involves an adult patient (gender unknown) who had acute hemorrhagic leukoencephalitis (acute haemorrhagic leukoencephalitis) with the symptom vasogenic edema including involvement of the pons (vasogenic cerebral oedema) and significant areas of hemorrhage (Cerebral hemorrhage ) after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), and family history were not provided.  Information on concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious acute hemorrhagic leukoencephalitis (acute haemorrhagic leukoencephalitis) with the symptoms vasogenic edema including involvement of the pons (vasogenic cerebral oedema) and significant areas of hemorrhage (Cerebral hemorrhage ) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  Relevant laboratory test results included: Magnetic resonance imaging - On an unknown date: showed significant areas of hemorrhage with vasogenic edema including involvement of the pons.  The patient was aggressively treated with plasma exchange and corticosteroids (unspecified) for the events and had a favorable outcome.  At, the time of reporting the final outcome of the events was unknown.; Sender's Comments: This case concerns a an adult patient (unknown gender) who had acute haemorrhagic leukoencephalitis with the symptom vasogenic cerebral oedema and cerebral hemorrhage  after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. The patient's laboratory test included Magnetic resonance imaging (MRI) (brain) that showed significant areas of hemorrhage with vasogenic edema including involvement of the pons. Additional information regarding medical history, condition at the time of vaccination and other lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Pt began to experience fever 100.2, chills within a 24 hour period after injection.
He did not have an adverse reaction to the vaccine. About three weeks after receiving the vaccine is when the trouble started. At first, he had behavioral issues. He went from very happy to very aggressive. About a week later he started throwing up everything he ate. He went through several test and it was determined that he has Celiac disease. He and his sister are first generation Celiac disease in our family.
HEADACHE; This spontaneous report received from a patient via an unspecified company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no information.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The unspecified Company is unable to perform  follow-up to request batch/lot numbers. No concomitant medications were reported.  On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
SORE THROAT, COUGH, NASAL CONGESTION, LEG SWELLING, BURNING FEELING TO BOTTOM OF BILATERAL SOLE OF FEET
Patient sitting in observation. c/o lightheadedness. Taken to EMS room. After lying on cot, states feels much better.
After 1st and 2nd doses of Pfizer COVID vaccine I experienced ringing in ears, joint pain, headache, fatigue, swollen joints, and nausea that never went away. After Booster shot I experienced all of the above plus additional symptoms that have slowly added over time.  My symptoms are constantly changing and now include but are not limited to: Widespread debilitating burning and aching pain in my arms, legs, neck and chest. Weight Loss, Cognitive issues, brain fog and confusion. Abdominal pain, pain in jaw and all teeth. Left side face paralysis of eye and mouth causing a sneering look.  In June 2022 I began stuttering when I talk and starting having seizure like myoclonic jerking of both arms, legs and neck.  New symptoms since include: Tremors, falling, intermittent paralysis of arms. Tingling, numbness, electric shocks throughout body. muscle twitching and spasms.
Arm swelling with pain extending up my neck and culminating with a headache. More than a month after 1st shot I still have neck pain.