chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 75 year old female with no pertinent medical history and no history of drug reactions/allergies who on 14-AUG-2007 was vaccinated with PNEUMOVAX 23 (lot # 655289/0958F) 0.5 ml IM in the left triceps. There was no concomitant medication. On 14-AUG-2007, the patient experienced an injection site reaction when the patient got home from the vaccination. At an office visit on 17-AUG-2007, the reaction was described as a red, tender, warm area with induration at the injection site that was 16 by 17 mm. The injection site reaction was characterized as possible cellulitis. On an unspecified date, a complete blood count was performed, no results reported. The patient was given a prescription for KEFLEX 500 mg three times a day for 7 days. The patient was contacted by the nurse by phone on 24-AUG-2007. The patient recovered on 27-AUG-2007. The registered nurse considered the events to be disabling. The nurse requested a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released. Additional information has been requested.
Awful illness following second dose. Headache, fever, nausea, soreness, dizziness.
Deltoid muscle soreness, stiffness, achy. not chronic, comes and goes.
As above. by report experienced pulmonary embolism 5 days after pfizer dose 1
Information has been received from a registered nurse concerning a 59 year old Caucasian male with hypertension, hyperlipidemia and diabetes who on 01/28.02 was vaccinated  IM in the left deltoid with a first dose  of pneumococcal vaccine 23 polyvalent (lot # 637263/1448K). The nurse reported that the patient was well at the time of vaccination. On 01/30/02, the patient called his physician's office and reported that the injection site was red and he had a rash and a sore at the site. The physician ordered diphenhydramine hydrochloride (Benadryl) cream to the area and to call back if the symptoms worsened. On 01/31/02, the patient saw his physician and complained of the injection site being red and hard to touch. A diagnosis of cellulitis was made and the patient was treated with amoxicillin (Augmentin) 875 mg BID for 10 days. The patient was seen again in the office on 02/06/02 and the physician noted marked improvement in the cellulitis but still some redness at the site.  The patient was considered to be recovered as of 02/06/02. The reporter also reported thata 26 year old male developed cellulitis after vaccination with pneumococcal vaccine 23 polyvalent (MSD) (lot # 641114/1387L) (WAES0202USA02499). The reporter stated a concern about the particular lot of vaccine. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. No further information is available.
I26.99 ACUTE PULMONARY EMBOLISM 4/9/2021 NEOPLASM, BLADDER I26.99 ACUTE PULMONARY EMBOLISM 4/9/2021 BLADDER CANCER, UNSPECIFIED SITE
Pt presented to pharmacy 11/4/16 c/o of persistant arm discomfort and weakness. Stated it started around the time she received her shot.
I had a very bad couple of days following my Pneumococcal vaccine.  I was not able to lift my arm at all at first and then only with extreme pain.  I barely slept because I typically sleep on my left side and would wake up in pain if I rolled on to my left side.  I would do mild stretches in hopes of improving mobility.  I still cannot close my drivers side door using my left arm.  I went back to Dr. to have her evaluate the injury and she referred me to another Dr.  Prior to seeing Dr. I had an X-ray, which was one of the most painful experiences I can remember.  Dr. agreed that the injury was consistent with SIRVA and prescribed Physical Therapy.  I am still doing PT at home mostly now.  While I have improved, I am still waking up in pain if I rolling my left side and have limited range of motion.  It's impacting my balance and my ability to carry things. Even something as simple as making the bed can result in pain.  I have improved though which gives me hope that this could eventually resolve.
Information has been received from a physician referring to an unspecified number of unspecified patients. No medical history or concurrent conditions were included. Since 06-SEP-2016, the patients had been administered doses of GARDASIL 9 (lot#, expiration date, dose, route unspecified) which were improperly stored. No adverse effects reported. This is one of the reports received from the same reporter. Additional information has been requested.
refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA038467, 2020SA038474, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038351, 2020SA038352, 2020SA038466, 2020SA038468, 2020SA038469, 2020SA038470, 2020SA038471 and 2020SA038472.  This case involves a 10 years old female patient who received 0.5 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ254AC (Expiry date 30-Jun-2020) via unknown route in the right deltoid for Prophylactic vaccination on 17-Jan-2020 which was exposed to refrigerator down to 29.1F.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to Product storage error temperature too low.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever above 99 degrees, extreme fatigue, dizziness, weakness, inflammation at sight, cough, nausea, diarrhea, and chills.
I developed a red firm itchy raised rash at the injection site over a week after my vaccine, see dates listed above.
patient who received one extra dose for the schedule of Havrix and Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 10-year-old female patient who received HAV (Havrix) (batch number 4KJ79, expiry date 30th October 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) (batch number LM992, expiry date 13th December 2022) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (received primary vaccination on an unknown date) and Engerix B (received primary vaccination on an unknown date).   On 14th April 2021, the patient received the 3rd dose of Havrix, Havrix Pre-Filled Syringe Device, the 4th dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 14th April 2021, unknown after receiving Havrix, Havrix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was physician's office manager. The reporter stated that the patient received one extra dose for the schedule of Havrix and Engerix-B, which led to extra dose administered. The patient was fully immunized with both the vaccines, but they did not know at the time of vaccination.  The reporter consented to follow up.
Patient described arm as "hot" 1 day after shot. Recommended  ie and OTC analgesic. Proper protocol followed during admin.
2 days inconsolable crying, floppiness, refusal to bear weight, periods of staring, blinking, period of tongue thrusting. Left eye drooping that still continues when tired, decreased appetite, fever 2 days excessive drooling, disorganized suck. As of 6/6/06 pt still has some sequelae. 06/08/06-Spoke with the RN/reporter in Dr's. office, she administered the vaccine. Mother of child is a Clinician. All information submitted on the VAERS report was documented by the mother. In addition, an informal telephonic phone call between mother and neurologist. According to reporter mother stated that currently when the child becomes fatigued, bilateral hand tremors and slight droop of left eye are noticed. Dr. recommended that Pertussis vaccine should be held, next vaccination occurred during month of June 2006 without Pertussis and no adverse events were noted.  06/21/2006-The above conversation with Dr. was supported by submitted 3 page office notes and correspondence with mother and physician.
Towards the evening of the same day as receipt of the vaccine, I began to experience a growing fever, aches, and headache. By the time 11pm came around I was in a full blown fever which lasted until around 5:30 am the next day. The fever was reduced through the taking of two Acetaminophen pills. Throughout the night, I was unable to sleep due to intense headache pain, I felt exhausted and couldn?t move. I had a fever around 102 degrees Fahrenheit at its peak and maintaining usually around 101.4 degrees. I was nauseous and experienced emotional instability. The adverse affects lasted until the morning with some affects such as the headaches and nausea still currently lingering on to present time (10:48am).
reported experiencing pain in shoulders, neck and base of skull and dizziness for more than 2 weeks after injection.  She had been taking ibuprofen but getting little relief.  Patient will contact her primacy care provider.
Pt recvd MMR on 06AUG82 & devel a rash;
04/28/04: Dysuria, culture obtained, subsequently negative. 04/29/04: Fever 102.2, ill-appearing, morbilliform rash, pharyngitis, conjunctivitis, admitted to clinic to rule out Kawasaki Disease. Was seen by Infectious Disease specialist felt to be MMR reaction; symptoms resolved without treatment.  Nurse follow up on 05/17/04 states: "Add: Viral syndrome."
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some times to get the VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 16-SEP-2014, the patient was vaccinated with a dose of VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
High dose flu vaccine given instead of regular flu vaccine or Flu Blok.  Pt denies any problems since receiving vaccine.
death. No known symptoms or complaints. found unresponsive in bed. Released to funeral home as the Medical Examiner will not perform and autopsy. Dr. will sign the DC.
MOD-LRb. AMT. Redness, warm to touch at injection site R upper leg noted 8/8/02. Returned 8/27/02 seen by RN and NP appears with some brownish discoloration. Return visit shed for 10/1/02 for observation.
This spontaneous report as received from a certified medical assistant to a 14 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Muscle aches and fever.  Fever was in range of 102 degrees.  Lasted 18 hours.
After taking a hot bath.  Redness at vaccine site and down the left arm on both sides.  Some itchiness at the vaccine site.  Took 1 benadryl and the redness and itchiness disappeared rather quickly.  Some mild redness at the site.
Approximately 1 month following vaccine administration, patient was hospitalized with shingles. Patient reports not ever having shingles before this event. Patient has MS and is not sure if prolonged illness is due to MS or result of vaccine.
Moderna Dose 1 2/19/21 (023M20A) Moderna Dose 2 3/19/21 (026A21A) Moderna Dose 3 12/15/21 (029H21B) COVID Positive 2/5/22  2/5/22: 68-year-old male patient with a history of muscular dystrophy, hypertension, s/p pacemaker placement several years ago  is wheelchair-bound at home.  There is a caretaker who helps him.  Patient has been constipated for more than 2 weeks.  He has had very little flatus.  His abdominal pain has been slowly getting worse.  Patient has had some nausea and only 1 episode of vomiting.  Since the pain was getting worse, patient came to the hospital for further evaluation.  The pain is located in all the quadrants of the abdomen.  Patient has not had any bloody stools.  He denies any fever/chills associated with abdominal pain.  A CT of the abdomen/pelvis shows evidence of significant amount of stool impaction.  Surgeon was called from the emergency room for consultation.  2/9/22: 68-year-old male patient with a history of muscular dystrophy, hypertension, s/p pacemaker placement several years ago  is wheelchair-bound at home.  There is a caretaker who helps him.  Patient has been constipated for more than 2 weeks.  He had very little flatus.  His abdominal pain was slowly getting worse.  Patient has had some nausea and only 1 episode of vomiting.  Since the pain was getting worse, patient came to the hospital for further evaluation.  The pain was located in all the quadrants of the abdomen.  Patient  had no bloody stools.  He denied any fever/chills associated with abdominal pain.  A CT of the abdomen/pelvis shows evidence of significant amount of stool impaction.  Surgeon was called from the emergency room for consultation.   Patient had manual disimpaction of the stool on 02/05 per surgery in the OR.  Patient was also noted to have rectal colitis and started on Levaquin and Flagyl.  Patient subsequently was able to have bowel movements without difficulty.  Patient also had  perirectal fissure, wound nurse was consulted.  Patient was also tested positive for SARS-CoV-2 infection but he was totally asymptomatic and was not placed on any oxygen.  He did not require any treatment with remdesivir or dexamethasone as he did not complain of any shortness of breath.  His electrolyte abnormalities were corrected.  Patient was stable at the time of discharge.  He was discharged home with VNA.  He will complete the course of antibiotics as prescribed for treating rectal colitis.  I did discuss with the patient's caregiver and all questions were answered.  Patient will follow-up with primary care physician in 1 week.  Patient was advised high-fiber diet and stool softeners advised to be continued to prevent is further episodes of severe constipation.
Pt. awoke on 12/1/99 with terrible headache, extremely sleepy, a little disoriented & no appetite. On 12/2, saw his DR, and was still  had headache & tiredness. That night he felt better and went to school the next day.
RED ARE W/ PERIMETER OF 4 1/2" X 3 3/4". RIGHT DELTOID AREA RED AND SWOLLEN. SHARP PAIN, FEVER.
Patient was inadvertently given the  Pfizer Ped (5-11 yr) vaccine.  No adverse reactions to the vaccine
PSA detectable; mild sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (mild sore arm) and PROSTATIC SPECIFIC ANTIGEN (PSA detectable) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Prostatectomy (3 years ago).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (mild sore arm). On 01-Mar-2021, the patient experienced PROSTATIC SPECIFIC ANTIGEN (PSA detectable). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 02-Feb-2021, PAIN IN EXTREMITY (mild sore arm) had resolved. At the time of the report, PROSTATIC SPECIFIC ANTIGEN (PSA detectable) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Prostatic specific antigen: detectable (Positive) detectable.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Shortly after the second shot the patient went to hospital and got blood drawn for PSA, it was detectable.
I just have a tiny bruise; This is a spontaneous report from a contactable consumer (patient) reporting for herself.  A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on 24Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, patient reported that When they got it they did not have any soreness in our arm. She just had a tiny bruise on an unspecified date in 2021, but her husband got the bunch of side effects and that was a day later. Patient enquired do they need to continue that shot as her husband didn't want to take that shot. They cancelled the shot as they do not want to continue because we do not want that to happen again. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
10/6/11 came into ED with extreme weakness unable to get out of bed. Admitted with possible Guillain Barre. Receiving plasmapheresis -> Flu vaccine about 2 week prior.
Case number PHEH2016US029284, is an initial spontaneous report received from a nurse on 03 Nov 2016. This report refers to a 13 years old female patient. Past medical history and concomitant medications were not reported. This 13 years old breast feeding patient was vaccinated with single dose of FLUCELVAX (batch number: 187276) at a dose of 0.5 ml, intramuscularly on 03 Nov 2016. No adverse event was reported following exposure during breast feeding. The case was assessed as non-serious by the nurse. Consent to contact was not provided.
About 10 hours after the vaccine I passed out in my kitchen. Was gently stretching, felt dizzy and went unconscious for about 30 seconds. My girlfriend was there to help me up.
Patient states he experienced swollen lymph nodes, dizziness (which has improved), and a runny nose about 2 days after vaccine was given.  No respiratory distress or issues.
Patient received first dose COVID Pfizer vaccine (LOT#: EW0175). Patient alerted EMT at 2015. Patient stated that she felt dizzy and had a headache. Patient was asked to stay an extra 30 minutes for further observation. Patient agreed. EMT took patients vital signs at 2016. BP: 118/76, HR: 61 O2: 99%. At 2016 patient stated that her dizziness started improving and stated "I feel fine." EMT retook patients vital signs and reassessed patient. BP: 110/71, HR: 65, O2: 98%. Patient stated that her headache was a 1/10 on the pain scale. At 2024 patient stated " I feel better" and she no longer felt dizzy or had a headache. At 2035 EMT retook vital signs and reassessed patient. BP:113/72, HR: 81, O2: 97%. Patient stated "I'm good" and no longer felt dizzy or had a headache. Patient did not want to stay the extra time she had for observation. Patient stated she wanted to leave. Patient was educated by EMT on worsening signs and symptoms of covid vaccine and when to seek EMS and stated that she was leaving AMA. Patient verbalized understanding of education and consented to leaving AMA. Patient walked out of vaccination site at 2038 with a steady gait.
8/10/07 pm-site, red, hot, started to swell 8/11/07 am-site-swollen, hard, red, hot to touch, painful 8/11/07 pm-site same-pain in rt shoulder, neck, down rt arm into hand 8/12/07 am-site-same-pain-now also in rt upper arm-shoulder blade-rt  8/13/07-site still red,hot,swollen,hot to touch, pain reduce, not in rt hand and arm 8/14/07-site area 1-1 1/2" circular-still hard, red, hot to touch, slightly swollen pain in the neck/shoulder area and down to the elbow.
joint pain; muscle and joint pain; pain; This case was reported by a consumer and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced joint pain, muscle pain and pain. On an unknown date, the outcome of the joint pain, muscle pain and pain were unknown.   It was unknown if the reporter considered the joint pain, muscle pain and pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vacccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The reporter asked if could symptoms of Shingrix vaccine show up 3 weeks after injection and could there be pain, muscle and joint pain associated with vaccine. The reporter asked if shingrix made from same MRNA as Covid vaccine. The follow-up would not possible as no contact details were provided.
Super tired and lethargic; Super tired and lethargic; This is a spontaneous report from a Pfizer sponsored program  from a non-contactable consumer. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date for covid-19 immunisation. The patient vaccine # 2 and she is experiencing every single side effect. She thought that she'd have felt better by now but super tired and lethargic. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.