chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Persistant pain at injection site with pain/cramping/paresthesias in bicep/tricep/forearm medial and lateral/hand and fingers.  Developed tremor of hands/fingers with loss of fine motor control, decreased grip strength, involuntary dropping of objects (that is starting to resolve as of 10/10/2003). Pain and muscle spasms in muscles of entire arm now intermittent but still frequent.
Pt developed redness, mild fever and pain on left breast. Pt was seen by MD who diagnosed mastitis and treated with Cipro. Redness resolved in one week, pain resolved in two weeks. MD would not rule out or rule on caused by flu shot.
Pt. developed chickenpox on 12/5/08. Varicella adm. 11/20/08.
Extreme fatigue on a daily basis.  Struggle to stay awake during the day especially when reading or watching something on a screen.  Muscle soreness in legs and back.
Information has been received from the author of a published article, concerning a 61 year old female patient. The patient's medical history included end-stage liver disease secondary to hepatitis C genotype 1a liver cirrhosis and a deceased donor orthotopic liver transplant. On unspecified dates, the patient was vaccinated with the first, second and third doses of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route and lots # not provided). The patient acquired immunity to hepatitis B in March 2013, but lost her immunity to hepatitis B in February 2015 prior liver transplant. Upon follow up in transplant infectious disease clinic 1 month following her liver transplant, she was doing well. Interestingly enough, hepatitis B serology during that time showed positive HBsAB and HBcAb tests and negative HBsAg and HBV DNA. They continued to monitor recipient hepatitis B serology and found that her HBcAb which was positive became negative 9 months after the transplant and her HBsAB which was positive became negative 9 months following the transplant despite after receiving a hepatitis B booster dose in December 2015. The patient's monitoring laboratories were as follows: HBsAB pretransplant (10-FEB-2015): <10, HBcAb: negative and HBsAg: negative. HBsAB 1 month testing (21-SEP-2015): 237, HBcAb: positive, HBsAg: negative and HBV DNA: negative (9/10). HBcAb 3 month testing (09-NOV-2015): positive and HBsAg: negative. HBcAb 4 month testing (07-DEC-2015): positive and HBsAg: negative. HBcAb 5 month testing (05-JAN-2016): positive and HBsAg: negative. HBsAB 6 month testing (02-FEB-2016): 27, HBcAb: positive and HBsAg: negative. HBcAb 7 month testing (01-MAR-2016): positive and HBsAg: negative. HBsAB 9 month testing (09-MAY-2016): <5, HBcAb: negative and HBsAg: negative. At the time of the report, the patient's outcome regarding acquired immunity but lost it was recovered on an unspecified date and the outcome for HBcAb positive but became negative after 9 months following transplant despite after receiving hepatitis B booster dose was unknown. Additional information has been requested.
Chills, fever, body aches, headache, pain at site of injection. Symptoms managed by using NSAID (Advil)
dose 1: Rabavert given on 6/30/2004. Dose 2: Rabavert given 07/07/2004. Patient stated she had general malaise and dizziness for 24 hours after first dose of vaccine. Dose #3 Rabavert with-held on 7/14/04. Patient stated she had a 20 minute episode of left chest/ breast muscle pain/ spasm on evening of second dose, along with difficulty swallowing. She did not seek medical attention and it abated 20 minutes. She also experienced malaise for 24 hours after second dose of Rabavert.
After receiving Moderna Booster, Pt felt chest pain 4/10 and headache. Per Pt she felt like "something is sitting on her chest".  She felt the same type of chest pain after receiving her 1st dose of Moderna, she was sent to ED but was cleared to get her 2nd dose of Moderna vaccines. She was sent to ED after getting her 2nd dose due to chest pain again, they did stress test and was  monitored then was sent home. Per Pt, she was cleared by her MD to get her booster vaccine. Pt BP 153/75, HR 107, RR 22 O2 Sat 98% RA T 97.8 F. Pt has Hx of Bypass surgery. Per Dr., send Pt to ED for further Eval and Tx. Called emergency immediately. EMS came @ 3:55pm and transported Pt to ED @ 4:01pm.
Pt had myalgia of (R) UE where vaccines have been given. No induration, erythema.
Joint ache (most joints). Right shoulder pain. Limitation in activity. Shooting/dull pain on/off.
Woke up on day 9 after vaccine with redness and swelling at injection site. Rash is a circle aprox the size of an egg. Arm is itchy and sore
Had a rash; Hives; Iching from Mid waiste to top of head; High Blood pressure; Ponding Heart; Rasing Heart; Vision was effected; Anxious felt like I was in a cloud; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; This is a spontaneous report from a contactable other healthcare professional (Patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727), first dose via an unspecified route of administration, administered in left arm on 29Mar2021 at 10:45 (at the age of 53-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/(privacy) administration facility. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing, menopause from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took propofol and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient also administered with Other Vaccine (lot number=EW0161) on 29Mar2021 in Left arm as dose 2 single. On an unspecified date in Mar2021 at 10:45, had a rash, Hives, Itching from Mid waist to top of head. High blood pressure, Ponding Heart, Raising Heart. Vision was affected, Anxious felt like I was in a cloud. Her tongue lips and throat started to tingle and swell. Told many providers trying to figure out what was going on. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability, or permanent damage.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug bnt162b2 cannot be excluded. The case will be reassessed once new information is available. 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.
Red, swollen face, eyes, fingers next day after vaccination - given BENADRYL EVERY 6 hrs
Patient received moderna vaccine on 1/29/21, 3/1/21, and 11/3/21. Presented to ER on 7/16/22 and found to be COVID positive. Presented to the ed for syncope found to be hypotensive. Patient was walking to her car when she began acting disoriented, confused and unsteady. Patients family was able to catch her before hitting the ground. Unconscious for seconds. Endorsing diarrhea for last couple of days. Family also reports that patient does not eat or drink well and has lost several pounds over last year due to anxiety and depression, which she sees her PCP for. Patient denies headache, chest pain, shortness of breath, abdominal pain, nausea, vomiting, dysuria.  COVID  - patient has diarrhea, but otherwise seems asymptomatic  - no indication for dexamethasone or remdesivir  - airborne and contact precautions  Discharged on 7/18/22
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2017, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, orally (dose, lot# and expiration date were not reported). There were no adverse symptoms reported. The temperature excursion and its time for administered doses of vaccine was unknown by the reporter. It was unknown if data logger was involved. There was an unspecified number of multiple ongoing excursions since April 2017. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA011987: US-009507513-1709USA011849: US-009507513-1709USA011986:
COVID VAccine Breakthrough CAse  Pfizer Dose 1 2/19/21 (EN6200) Pfizer Dose 2 3/12/21 (EN6207) COVID Positive 12/8/21  12/13/21: -Patient is an 81 yo male with medical history of HTN, HLD, DMT2, gout , BPH  -He is presenting with worsening COVID symptoms. He tested positive at an outside facility last week wednesday. Symptoms have been ongoing for about a week. Patient is COVID vaccinated. Symptoms include cough, chills, SOB, anorexia, weakness , diarrhoea.  -In the ER vitals significant for fever 101.1, tachycardia 103 , BP 126/67, 92 % on room air  -CXR showed minimal airspace disease at the lung bases, may represent atelectasis or infiltrate from known COVID-19.  -Lab remarkable for lactic acidosis 4, AKI 1.4, Trop <0.01, normal CBC  -He received IV Zosyn and pending IV Vanc  , as well as total 2.8L fluids in the ER for sepsis  12/15/21: Patient is an 81 yo male with medical history of HTN, HLD, DMT2, gout , BPH from home  He presented  with worsening COVID symptoms. He tested positive at an outside facility last week Wednesday.  In the ER vitals significant for fever 101.1, tachycardia 103 , BP 126/67, 92 % on room air  CXR showed minimal airspace disease at the lung bases, may represent atelectasis or infiltrate from known COVID-19.  Lab remarkable for lactic acidosis 4, AKI 1.4, Trop <0.01, normal CBC  He received IV Zosyn and pending IV Vanc  , as well as total 2.8L fluids in the ER for sepsis in ED  He is saturating 93% on room air today.  He will be discharged to home on oral azithromycin and the plan to follow with a PCP  Patient is complaining of fatigue and he will be discharged on VNA for monitoring oxygen, physical therapy and OT.
headache; nausea; vomiting; extreme fatigue; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Jun2021 14:00 (Batch/Lot number: unknown) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Date: 25May2021, Route of administration: Intramuscular, Batch/Lot number: Not available), administration date: 25May2021, for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 15Jun2021 16:00, outcome "recovering", described as "headache"; NAUSEA (non-serious) with onset 15Jun2021 16:00, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 15Jun2021 16:00, outcome "recovering", described as "vomiting"; FATIGUE (non-serious) with onset 15Jun2021 16:00, outcome "recovering", described as "extreme fatigue"; DIARRHOEA (non-serious) with onset 15Jun2021 16:00, outcome "recovering", described as "diarrhea". Therapeutic measures were not taken as a result of headache, nausea, vomiting, fatigue, diarrhoea.  Additional information: The patient did not taken any prior vaccinations. The patient had Covid prior vaccination. The patient was not tested for Covid post vaccination. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
severe headache,and back of neck(base of skull) pain and tenderness, lower back pain, slight fever,  total joint pain, muscle aches. Unable to sleep
intermittent and repeated lymph node swelling and tenderness in both armpits, lasting now more than 3 months after 3 different diagnoses and courses of treatment.
Pt spiked fevers day after vaccines. Admitted to hospital after 5 days of fever. Bone marrow done. Pt pancytopenic. No source of fever found. Bone marrow eventually recovered. Patient had bone marrow biopsy, EEG (Febrile seizure), brain MRI, abdominal CT scan, CXR. Oncology, rheumatology and infectious disease consults. Multiple viral swabs negative. CRP elevated to 15. Typhus fever neg. Rickettsial serology negative. Epstein-Barr virus AB panel done - suggestive of a past EBV infection. Moderate lymphopenia, she was treated for a tick borne illness - Doxycycline (9/9/18). D/C Dx systemic inflammatory process of indeterminate etiology, suspect autoimmune vs autoinflammatory vs infectious, pancytopenia which was resolved, thrombocytosis (suspect reactive), Hepatitis, lipemia of indeterminate etiology, and paroxysmal spell, non-epileptiform. At arrival to hospital a lab work up was done and was notable for elevated transaminase (AST 210, ALT 144), elevated ESR 144. Positive rhinovirus. Admitted initially for dehydration on 9/6/18. Patient was discharged on 9/14/18. Patient followed up with Cardio for an Echo, indicated Kawasaki's syndrome (9/21/18).
Pt next day had cellulitis on upper arm about 3 inches wide and halfway around arm. Lasted about 3 days.
after a flu shot that had numerous elements in it patient was allergic to; Initial information was received on 05-Jan-2021 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media.  This case involves a patient of unknown age and after a flu shot that had numerous elements in it patient was allergic to (hypersensitivity), while patient received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient had numerous elements in it patient was allergic to (hypersensitivity).  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  Information on lot number was requested for this case.
Fever (102), chills, headache, body aches, itchy, bloody nose (possibly unrelated). Sick in bed for 4 days.
Information had been received on 19-OCT-2016 from a medical assistant who reported that a patient (age and gender not reported), on an unknown date, was accidentally administered a PROQUAD vaccine instead of ZOSTAVAX due to a human error. No adverse effects were reported. No other information was available. Additional information is not expected.
pt onset on 8/17/99 rash lasting 7 days;pt had between 50-500 bumps;unk fever temp for 2 days;took APAP for fever;no complications, no rx meds given;
Reported to ER 3/14 with left facial numbness and left arm weakness, Labs, Chest x--ray and Ct brain completed, transferred to higher level care facility, Echo/MRI brain completed 3/15 with noted small acute infarct Right frontal region, facial numbness resolved, Right arm weakness continues but improving, PT/OT exercises given, Discharged 3/16 to home
4-5 hrs after flu shot, pt started with a headache which progressed over time to a real head-in-a-vice splitting HA. Did not resolve with TYLENOL. 3 hrs of fever and body ache which resolved quickly. HA took about 24 hrs to go away.
The parent of patient came into the pharmacy after reading an article online regarding vaccines and side effects. She stated her son experienced muscle weakness approximately 2 weeks after receiving the vaccine. Parent stated she was concerned that it was caused by the vaccine and requested we report the event.
pt recvd vax 24oct94 at 4pm; at 8pm welts on face itching; red blotches on face, neck & back; lumps in throat; called private MD who advised meds; feeling better  now;
pt recv 1 dose varivax 4/13/98 & 4/20 pt devel rash on bottom & fever.
Information has been received from a physician concerning a child who was vaccinated with a dose of VAQTA this past summer, 2007.  Concomitant vaccinations given at the same time included a dose of DTPA (unspecified) and a dose of HIB (unspecified carrier).  On an unspecified date following vaccinations, in the summer of 2007, the patient experienced fever and difficulty focusing.  No outcomes were reported.  No product quality complaint was involved.  Additional information has been requested.
Information has been received from a nurse concerning a 20 year old female with drug hypersensitivity to sulfamethoxazole and trimethoprim (BACTRIM), sulfamethoxazole (+) trimethoprim (SEPTRA), and Amoxicillin Clavulanate (AUGMENTIN) with costochondritis (for past year), who on 07-APR-2008, was vaccinated with her first dose of GARDASIL (lot# 659964/1978U), 0.5 ml, intramuscularly. On 09-JUN-2008, the patient received her second dose of GARDASIL (lot#60553/0070X). Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). Subsequently, in 2008, days or weeks, after receiving the second dose, the patient experienced intermittent dizziness. There is an orthostatic component to the dizziness, but not always. She was seen by her doctor and a complete blood count, her blood pressure and her ears were all within normal limits. The patient's doctor cleared her for receiving the third dose. The third dose may possibly be given on 03-OCT-2008. The patient's intermittent dizziness persisted. Additional information has been requested.
Received the vaccine in January / Booster in April / Shingles/ suspected vaccination failure; I seem to have gotten shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. In April 2020, the patient received the 2nd dose of Shingrix. On 9th October 2020, between 8 and 10 months after receiving Shingrix and between 5 and 7 months after receiving Shingrix, 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 Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient received the vaccine in January and the booster in April and now seem  to had gotten shingles. The patient was at dermatologist office. The patient wanted to know what was the incidence of shingles after getting the vaccine. The reporter consented to follow up.
A physician reported that an infant female received her third injection of Prevnar. On 12/09/2001, at 11 months of age, the infant was hospitalized for fever "without a source." A blood culture was positive for Streptococcus pneumoniae. Serotype results are pending. The infant was treated with amoxicillin. As of the date of this report, the infant is "clinically improved." Follow-up info received on  01/18/2002 indicated that the blood culture isolate was identified as serotype 19A.
This morning I was dizzy. I fainted. Witness said my head and hands were jerking and shaking. This was less than 10 seconds. I awoke disoriented.
This spontaneous report was received from a nurse refers to a female patient of unknown age. No relevant medical history of the patient was reported. On an unknown date the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscularly (lot number and expiration dates were not reported). No concomitant medications were reported. It was reported that the patient received her third dose of GARDASIL 9 weeks after the second dose of GARDASIL. There were no adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. Additional information has been requested.
I had swelling of the injection spot about 4 in circle red and itchy.  I also had a fever,  fatigue, vomiting, and burping. Joint pain on the side of the injection
nausea fever headache body ache  vomiting chills fatigue joint pain    all lasted until the 9th
I felt like I was going to faint. High fever, bad chills, diarrhea, weakness.
I couldn't breathe; My heart was racing; This case was reported by a consumer via interactive digital media and described the occurrence of difficulty breathing in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced difficulty breathing and heart racing. On an unknown date, the outcome of the difficulty breathing and heart racing were unknown.   It was unknown if the reporter considered the difficulty breathing and heart racing to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient received first shingles vaccine during a check up with doctor later in the day the patient ended up in the emergency room with a reaction to the vaccine. The patient experienced felt like patient was dying, patient couldn't breathe and patient's heart was racing. The patient needless to said he/she was not getting another one. No further information reported.
Large local reaction to Pneumococcal 23 treated with BENADRYL and ibuprofen and ice pack. No sign of anaphylaxis.
Three pustules on her back. She woke on 6/23/2016  with multiple pustules on her back.
No adverse effects at all. Patient reports no serious side effects from vaccine. This is to report medication administration error. Patient was 17 years old, below minimum age for receiving  Moderna vaccine. Error was discovered when patient returned for 2nd dose.
Doctor presented with redness and swelling to right upper extremity, in area of Pneumovax vaccination SQ area. Stated occurred within 12 hours of receiving vaccine. Area remains slightly reddened.
Case number PHEH2014US006396 is an initial spontaneous report received from a pharmacist on 28 Mar 2014. This report refers to a 12 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M13017 and expiry date: 30 Sep 2014) intramuscularly on 25 Mar 2014. The MENVEO reached 32 to34 F for up to 25 hours within 8 day period and was subsequently administered to patient. No adverse event reported following this administration error.
Received vaccine at 930 AM - followed by gradually increasing moderate local reaction at 530 AM next AM had brief shortness of breath but no angioedema - resolved prior to ER presentation at 1045 AM.
Very strong headache, body aches and weakness.  Not strong enough to to leave the bed.