chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soon after getting vaccinated with Anthrax, I began to feel irregularities in my heart beat. This condition got worse up until June 2018 when I started having syncopatic events where I passed out. I was diagnosed with PVCs, PACs, arrythmias, tachycardia, and syncope. Also, I have never had back problems previous, but have started having shoulder pain and tingling that radiates down my arms and legs.
Slight headache and sore arm in the evening, and lower backache the following day.  Pain lessening on the fourth day.
Mother reported noticed her left arm was red and swollen the next morning, child went to the ER October 19th, dx with allergic reaction and cellulitis, was given prednisone and Bactrim.
The patient reported there was a large red area that developed on shoulder after receiving her shot. It was about 5 inches in diameter, and she complained that it ached a little. Denied any other symptoms (ie itch). It started yesterday, and she says it already aches a little less today.
Within 24 hours of Prevnar vaccine, this infant got a fever of 102 - 103 F, and hives all over her body.
A report has been received from a physician concerning a patient of unknown gender, who had been receiving nasal FLUMIST started on 17-JAN-2014. for the patient there was expired FLUMIST which started on 17-JAN-2014. The outcome of the even of expired FLUMIST is unknown. The report was considered to be non-serious.
employee reports painful and swollen lymph nodes in armpit, axillary lymphadenopathy radiating down to arm of injection site 5 days post vaccination administration. employee took tylenol BID, adverse event lasted 2-3 days and resolved.
This case was reported by a healthcare professional via a sales representative and described the occurrence of erythema in a 5-year-old male subject who was vaccinated with INFANRIX, GlaxoSmithKline. Concurrent vaccination included MMR vaccine, Merck and VARIVAX Merck both given on 15 September 2008. Concurrent medications included Allegra. On 15 September 2008 the subject received 5th dose of INFANRIX at 0.5ml in the left thigh. On 16 September 2008, 1 day after vaccination with INFANRIX, the subject experienced erythema, induration, itching and local reaction at injection site. The subject's itching was treated with Westcort cream. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with INFANRIX. Follow-up information was received on 14 October 2008, via nurse, who reported the subject received INFANRIX by intramuscular injection. The subject has a concurrent medical condition of allergic rhinitis.
pt c/o redness to site, site was red & warm to touch, face flushed, lips ruby red color, top half of chest & back pain in color & top of shoulder administrated DPH given; VS stable;BP 104/68, P75, R18, lungs clear;
Developed redness and started to itch on 9/3/09. Continued to get worse want to Dr. on pt had hives down left arm. Plan-CLARITIN x 30 days. PREDNISONE taper 11 days. 3 week physician following.
I do not know the type of flu shot I received, on my paperwork all it states is "Influenza Vaccine (Quad) PF".  The nurse seemed grumpy and in a rush, she grabbed my arm and injected higher up and more anterior than my usual flu shot. Three hours after the injection I could not lift my left arm and was in severe pain, I called my doctors' office and spoke with the nurse and she said it was normal.  She told me to just move my arm around, when I told her that this never happened with any other flu shot I had before, the nurse became very defensive and stated she has "been doing this for over 30 years" and she "knew what she was doing" and basically blew me off. The office did not report an adverse reaction that I know of and never gave me a follow up call. Following the injection I was not able to lift my left arm more than 1" from my side and was in extreme pain. Ice and motrin did not help. It was nearly impossible to put a shirt over my head, wash my hair, or lift anything over 25 lbs.  Over the next 1.5 months I would wake up at 3 am with stabbing pain my left shoulder; during the day I could not lift my arm and was in pain when I tried to move it.  I took 3 over the counter Aleve tablets every 4 hours to reduce the pain. I still now have pain and have limited movement.
Started feeling light-headed in afternoon. Worsened to general malaise with aches and pain. Injection site sore. Difficulty sleeping that night.  Felt miserable the next day.  Injection site becoming hot and swollen and red.  Taking pain killers.  Persistent headache.  Slept better the next night.  Injection site still hot and swollen.
After 30 minutes of monitoring patient reported itching and feeling hot. Eeythema noted to chest. BP elevated to 160/100. Sao2 100%RA. Lungs clear no difficukty breathing. After another 15minutes BP 200/120. Patient coughing and reporting scratchy throat. No airway restriction and lungs remain clear. Facial flushing also noted. Patient left clinic after an hour of monitoring . No epinephrine given.
This case was reported by a healthcare professional and described the occurrence of rash in a 56-year-old female subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline). On 3 March 2010 the subject received 1st dose of HAVRIX 1440 (unknown). On 3 March 2010, less than one day after vaccination with HAVRIX 1440, the subject experienced rash and shortness of breath. The healthcare professional reported that after receiving HAVRIX 1440, the subject developed a rash on her neck and chest. Then the subject experienced shortness of breath which she sought treatment for in the emergency room (ER). The subject was given prednisone and BENADRYL in the ER. No other information was available at the time of the report. At the time of reporting the outcome of the rash and shortness of breath were unspecified. Follow-up received via the nurse on 02 November 2010 indicated that the subject experienced an unspecified reaction in 2008, but the reporter was not a witness to it. Associated medications taken by the patient were not reported. The reporter only started seeing the patient at her office in 2010. No additional details were provided.
Information has been received from a registered nurse concerning her 4 year old grandson who was previously vaccinated with a dose of varicella virus vaccine live date unknown. There was no concomitant medication. On 6/14/2005 the patient experienced breakthrough varicella. The RN did not know if the patient had sought medical attention. The patient recovered from breakthrough varicella. No product quality complaint was involved. Additional information has been requested.
Patient received vaccination 10/20/11 about 4pm. 10/21/11 525am - nausea, vomiting & headache T-97.9 P 100 BP 144/106. TYLENOL 650 mg PO given - sxs resolved no further complaints.
Patient is a 67 y.o. female patient with history of CHF, diabetes, GERD, hypertension, and stroke who presented to Doctors Hospital with generalized weakness.   Covid-19 Virus Infection Acute respiratory failure with hypoxia Date of onset of symptoms: Patient not sure Symptoms present on admission: Fever, shortness of breath, weakness, cough Date of covid positive test: 11/2/2022 Vaccination status: vaccinated Imaging: Chest x-ray negative, pacemaker in good position Oxygen requirements on admission: 1 L nasal cannula, placed on2 lit ovrnight. Wean as tolerated Continue Decadron, Vitamin C, Vitamin D, Zinc, Pepcid, and Loratadine Albuterol inhaler, Incentive Spirometry, and Continuous Pulse Oximetry   Special Precautions      Generalized weakness Fatigue Likely in the setting of COVID CT head negative, brain atrophy and chronic microvascular ischemic changes stable Pt seen by PT/OT. Recommending 5 days therapy, however doing better this am PT to reevaluate   Elevated troponin Troponin 20 > 21 EKG negative for acute ischemic changes     Essential hypertension Continue home amlodipine and Coreg Uncontrolled, will increase home dose   History of stroke Cerebral venous sinus thrombosis Found in 9/2021 Continue Eliquis and atorvastatin Diabetes mellitus, type II, non-insulin-dependent Hemoglobin A1c 10 Glucose 351 SSI and glucose checks   Hypothyroidism Continue home Synthroid   GERD Continue home PPI   Depression Continue home fluoxetine
from a contactable nurse (patient mother). A 28-year-old male patient (reporter son) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: ER8731, Expiration Date: 31Jul2021), via an unspecified route of administration on 19Apr2021 (at the age of 28-years-old) as dose 1, 0.3ml single for COVID-19 immunisation. The patient medical history included blood cholesterol increased. The reporter stated that she called for her son. She have a concern he had his first shot on 19Apr and that was Monday, last Monday and then Sunday he felt some symptoms and Sunday and Monday but he did not tell her until today. On the second day, on Monday a lot of fatigue, no energy, a little bit of nausea and he just slept it off and yesterday when he told her the symptoms he experienced. Its just because of the vaccine of the, she know its like less more than, less than a week 6 days after he said he felt some numbness on his left leg both legs but most in the left leg. He had some tingling pins and needles like on his mouth like numb on the left side of his body. She don't know if its related to the shot, it was 6 days after but she was concerned. He said, than he did not tell her he just let it go but he was like scared and then Monday in the evening, in the afternoon same thing happened like he just went to bed because he was not feeling well and he did not tell her he just said all he was just tired in his head its hurting and laid down and today is when he told her symptoms that he felt like he said mom like mom I read it looks like a TIA(Further not clarified hence not captured in tab). So, Sunday he felt like pain on both legs but most on the left leg. He felt like paralysis on the left side like numb on the left side and then he had some headache too, blurred vision and confusion. He had a shot on Sunday, on Monday it had some proximity. The reporter states that, she don't know if its related we had a shot on the 19, He do not have numbness or anything now. 25th he felt like he was sitting down himself. He said his left leg is paralysed. He said a little bit little for a short time he had blurry vision. He could not focus. He did not tell any of us about any of the symptoms. She guess he just went to sleep, it lasted 15 minutes. He just told her yesterday that his cholesterol was high according to his primary physician. she have not really called to find out exactly what the numbers are but he told her his cholesterol was high but he is not being treated for anything. He is not on any medication except for the vitamins that he takes every morning. That was January. She think its the usual CBC and CMT. she did not get a chance to see his results. She thinks he just did virtual, he just talk to the doctor and they talked about vital signs, she was not sure. She just corelated it because he just have it for almost a week that is why she was like could it be related, that is her concern and he is going to get his second dose in May 10. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Headache, Myalgia, Arthralgia, Fever, chills Narrative: pain to inj site, headache, fatigue, body aches, muscle aches, fever 100.9, joint pain symptoms lasted for 5 days
Protocol to dilute Pfizer 5-11yrs old wasn't followed.  Vial wasn't not diluted.  no s/s noted after 15 minutes of observation period was over.
9:00 pm - onset of severe body aches, fatigue, lethargy, scratchy throat approx 10 pm - onset of low grade fever/chills, headache, lightheaded approx 11pm - took sleep medicaiton (trazodone, hydroxyzine) and drank half a theraflu packet approx 11:30 pm - woke up with nausea, vomitted twice ,  continued severe body aches approx 12:30 am - woke up with worsened headache, continued fever/chills, vomitted  approx 1:30 am - woke up drank some water, took temperature fever at 99.4 degrees (usually I run 97 degrees), applied voltaren topically to shins which hurt at level 6 out of 10, vomitted approx 4:00 am - had very broken sleep, sweating profusely, severe headache, vomitted bile, very lightheaded & lethargic approx 7:30 am - continued broken sleep, sweating, headache, chills, fever, vomitted bile approx 8:30 am - arrived at urgent care for treatment of dehydration, fever/chills, nausea/vomitting.
No adverse effects reported; 2 improperly stored doses of ROTATEQ were administered to unspecified patients on unspecified dates; This non-valid spontaneous report was received from a registered nurse and refers to unspecified patients of unknown demographics. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with 2 improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R012954 with expiration date: 04-DEC-2019 and lot # R033256 with expiration date: 23-JUN-2020, orally (exact doses were not reported) for prophylaxis. The vaccines underwent temperature excursion of the highest temperature above 47 degrees Fahrenheit (48.7 degrees Fahrenheit  for 18 minutes There was no previous temperature excursion. The digital data logger was involved in recording excursion details. No adverse effects were reported.  Follow up information has been received from nurse on 23-JUL-2019.  Upon receipt of follow-up information, it was determined that this case is now valid because the patient identifier was received.   The nurse reported that only two patients were vaccinated. The patient initial and date of birth has been updated. Currently the patient was 8-month-old. On 03-JUL-2019, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot # R012954, expiry date: 04-DEC-2019) that had been involved in a temperature excursion but did not experience any adverse event.  This is one of two reports received from the same reporter (1907USA015441).
left arm was swelling/his arm swelled up all this week; had some shoulder pain/shoulder hurt all week; his arm has a mustard looking color about 3- 4 inches long on his left arm which is where the vaccine was injected; it is making it kind of hard to sleep; This is a spontaneous report from a contactable consumer (patient himself). An 83-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration in the left arm on 18Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that a couple of days after the administration of the first dose of the Pfizer COVID vaccine, on an unspecified date, he noticed his left arm was swelling and he had some shoulder pain. His arm swelled up and his shoulder hurt all that week and it started to go down. According to him, it was also kind of making it hard to sleep on an unspecified date. He also stated that his arm had a mustard looking color about 3- 4 inches long (also reported as across) on his left arm which was where the vaccine was injected and he can see where the injection was. The patient would like to know if this was normal and if he has to worry about it. He was scheduled for the second dose on 12Feb2021 and he will get the second dose on the right arm at that time. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. On an unknown date the patients might were vaccinated with a dose of PROQUAD (Merck) (lot# not reported) stored as high as 9F for about 2 months. No adverse effect reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
12/29 vaccination 1pm. At about 6pm experienced diarrhea, lasted till 10pm. Went to the bathroom and upon exiting, syncope and hit head. Husband call 911; could not wake me. EMT had transported to ER; dehydration, concussion. *intermittent fasting (felt good going into shot) 'barely remember the situation'
Patient received his vaccine and waited the 15 minute observation period before leaving the clinic. At 2:00 he returned to the clinic, stating to the paramedic that he felt like he was having an episode of Bell's Palsy. His vital signs were checked and were as follows: BP 169/96 mmHg, HR 72 bpm, O2 sat 99%. The patient has right sided tingling extending from the eye to the mouth. He had no visual changes. The patient was offered transport to the hospital and further medical treatment. He refused transport or treatment and left the vaccination clinic.
CHILLS; GENERAL MALAISE; FEVER; TIRED; ACHY ALL OVER/YUKINESS; SLEEPING A LOT; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hiv positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced sleeping a lot. Laboratory data included: Body temperature (NR: not provided) 99.6. On 28-MAY-2021, the subject experienced achy all over/yukiness. On 28-MAY-2021, the subject experienced chills. On 28-MAY-2021, the subject experienced general malaise. On 28-MAY-2021, the subject experienced fever. On 28-MAY-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the general malaise, fever, chills, achy all over/yukiness, tired and sleeping a lot was not reported. This report was non-serious.
Temperature ranging from 99.6 to 100.2, headache, low back pain, general unwell feeling, UTI symptoms (pain in bladder, frequency increased of urinating, pain when urinating - felt like a UTI but I was tested by Kaiser and it came back as not a UTI and then symptoms went away on 11/9/21), and swollen gums.
Information has been received from a registered nurse (a school nurse), via a company representative, concerning a 16 year old female patient, who in March 2007, was vaccinated with a dose, 0.5ml, IM, of Gardasil. The nurse reported that on the following day, the patient developed swelling and pain at the injection site, chest tightness, shortness of breath and facial redness, and was transported by ambulance to the emergency room. The nurse stated that treatment included oxygen, and epinephrine injection, and prednisone. Following treatment "the patient's symptoms resolved and the patient completely recovered." The nurse considered the events to be life threatening and disabling. Additional information has been requested.
Headache Narrative:  DOSE 2: HA 10/10 WITHIN 15 MIN OF VACCINE TYLENOL 650 MG GIVEN X 1 - HA 5/10 IN 20 MIN.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL. On 1 October 2008 the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced extreme injection site redness and extreme injection site soreness. At the the time of reporting the outcome of the events was unspecified. The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752835A and A0752837A.
Site: Swelling at Injection Site-Mild, Systemic: Hematoma immediately formed at injection site-Mild, Additional Details: Small amount of bleeding at injection site, but immediate hematoma formation. Correct landmarks were used and vaccine was administered into left deltoid in correct location. Pt denies any use of blood thinners or any bleeding disorders.
Developed Shingles 5 days after taking 2nd shot.  Having recurring shingles about every 2 weeks.  5th breakout since shot. Having shingles on both sides of body.  Have had 5 breakouts and been treated with valaclyclovir.
Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Additional Details: patient fell down and apper to have seizure , we called  emc ,emc take care of the pt, and he was ok,pt refuse to go to er.
Herpes zoster; Information has been received regarding a case in litigation, referring to a currently 89 year old female pt. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. In or about 2009, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the patient was treated by a healthcare provider at a clinic for herpes zoster. The pte, claimed damages as a result of: Injury to themselves and economic losses. At the time of the report, the outcome of herpes zoster was unknown. The lawyer considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-DEC-2015 at 13:21, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 6.8 and 5.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.