chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure/I got shingles/6 months after/ the shingles shot; shingles; some kind of pain; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. The case was reported by patient himself/herself. The patient received Shingles vaccine and after 6 months patient experienced shingles and was in some kind of pain. The patient stated that if vaccine was supposed to make it better he/she would hate to see worse. Follow-up would not be possible as no contact details provided. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.; Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) and PRODUCT STORAGE ERROR (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) in a 47-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) and PRODUCT STORAGE ERROR (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  On 24-Jan-2022, vial was transferred from the Freezer to the refrigerator and initially stored in it. The vial did not undergo temperature excursion.The Pharmacist does not have any other adverse events or side effects to report.  No treatment medication information was provided.
1.  3/31/21 Within 15 min of getting 2ND shot, under tongue was feeling odd and like swollen.  This happened slighty after 1st shot but much more after second shot.  2.  4/1/21 3:00PM  - 4/3/21 Started not feeling well.  A little tired.  Headache and stuffy nose.  Low grade fever (around 99-99.9). Under tongue and under jaw/side on left side of face kept feeling odd and getting more painful.    3.  4/4/21 Incredible sore throat.  Excruciating pain to swallow.  Left side of throat was red.  Right side was fine.  100.3 fever highest during day.  Terrible chills last night (shivering and couldn't stop - not more than an hour).  Just stayed in bed under blankets.  Thought I might bite tongue as couldn't control jaw.)
Chills, Temp. 36.4, Headache, Sore Arm and muscles, Arthritic joints, Low Back Pain, Ringing in ears
I had blister on the bottom of my tongue and my tongue swelled but went down by the next day. Blister lasted a couple days.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
Information has been received from a physician concerning a 7 year old female twin who on 02-Jan-2009 was vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Oka/Merck) (lot# 662455/1329X). There was no concomitant medication. On the same day of vaccination. 02-Jan-2009, the patient experienced dizziness along with pain and swelling at the injection site after vaccination. The patient called the physician for medical attention. Subsequently, the patient recovered on an unspecified date. Follow-up information was received on 13-Jan-2009. The reporter stated that she was not sure if the patient recovered but noted that the patient had not called for a follow-up visit. This is one of several reports received from the same source. The patient's twin also experienced an adverse experience following vaccination (WAES#0901USA01025). Additional information has been requested.
feet got sore, became painful icy hot eased pain but it returned pain worsened felt like needle stabbing feet swollen feet
This spontaneous report as received from a Registered Nurse through a company representative refers to a 14 year old male patient. On 01-MAR-2012, the patient was vaccinated with the first dose of GARDASIL intramuscular in the left arm (dose not provided, lot # reported as: 1524AA, expiry: 23-AUG-2014). On 09-APR-2012, the patient sought medical attention and was admitted to the hospital for two days. During his stay he was diagnosed with diabetes. Apart from that unspecified tests were performed in the hospital and determined he had been probably pre-diabetic for 6 months prior to being diagnosed with diabetes (approximately since October 2011). The outcome of diabetes was unknown. Relatedness between the events and GARDASIL was not specified. Additional information has been requested.
Fatigue; Nausea; Joint pain; This is a spontaneous report from  a contactable consumer (patient). A 26-year-old non pregnant  female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route administration in the left arm on 28Feb2021 at 11:00 at the age of 26-years-old as a single dose for COVID-19 immunisation. Medical history included Crohn's disease and allergic to dairy and shellfish. The patient received unspecified medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. On an unspecified date in 2021, the patient experienced fatigue, nausea and joint pain. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcomes of the events was recovering.  No follow-up attempts are needed. No further information is expected.
The morning of April 3, staff at the Vaccination Clinic discovered a discrepancy in the preparation of Pfizer vaccine doses. It was discovered that several undiluted vaccine doses were administered. Staff accounted for all unused undiluted vaccine doses. Unfortunately, 10 undiluted vaccine doses had been administered to patients and were not able to be retrieved. This patient received one of the undiluted doses.   The medical team contacted the CDC to determine the potential side effects and observation requirements of receiving an undiluted vaccine. The CDC confirmed that the recipients of the undiluted doses may experience stronger side effects and symptoms than someone who received the diluted dose (sore arm, flu-like symptoms, etc.).  The site public health officer spoke with suspected recipients of the undiluted vaccine to explain potential medical side effects.  follow up to monitor their status.
Headache, Fever, Diarrhea, injection arm pain, axillary lymph node swelling Narrative:  Other Relevant History:
Headache; Temperature; aches and pains/soreness; the whole the nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Lot number: EN6200, Expiration Date: 30Jun2021) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Headache"; BODY TEMPERATURE ABNORMAL (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Temperature"; PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "aches and pains/soreness"; NAUSEA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "the whole the nausea". Relevant laboratory tests and procedures are available in the appropriate section. clinical course: patient had a delayed reaction to the first vaccine. most people (further clarification unknown) they going to had reaction it happens in the first day or two, after had the second vaccine, mine happened on day 13th of 14 days to be fully vaccinated. Patient got all of the symptoms, likevheadache, the temperature, the aches and pains, the whole the nausea and it lasted 4 days, then patient go on and patient get, that all happened in Mar2021. The reaction happened like on 05Apr2021 & then in May2021 patient got tested for MAC lung and then in Jul2021 and then in Jul2021 patient got shingles., these are all related to immune system. Now they are asking to take another booster and patient was scared (Further clarification unknown) because patient did not have no idea what was going to happen? and whether or not patient was going to have other reaction, not just the reaction the soreness and the headache and all that but some other thing that may come up and pop up. The MAC lung, patient am asymptomatic on the MAC lung and the test that they did to sputum, it was corrupted and they could not do anything for it. So, Doctor told not going to take the sputum test again unless patient become symptomatic.  Follow-up attempts are completed. No further information is expected.
does not feel well; has had rash on body for 2 days; been throwing up for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (does not feel well), RASH (has had rash on body for 2 days) and VOMITING (been throwing up for 2 days) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (does not feel well), RASH (has had rash on body for 2 days) and VOMITING (been throwing up for 2 days). At the time of the report, MALAISE (does not feel well), RASH (has had rash on body for 2 days) and VOMITING (been throwing up for 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No corrective treatment was provided.   Reporter did not allow further contact
Severe headache, chills, sweats, tired, weakness, every muscle I have hurt.
Bell's palsy; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL9269), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that the patient had an attack of bell's palsy on an unspecified date. Outcome of the event was unknown.
Severe chills. Nausea. Body aches. Weakness. Need to sleep.
Patient experienced dizziness, diaphoresis and syncope following vaccine. Patient regained consiousness within 30 seconds. Placed in supine position with cool packs on neck and forehead. Patient slowly transitioned over 45 minutes from supine to standing and left office under own power. BP 100/60 p 60 in supine position. 80/52 p 88 standing
Tired; some aches; She slept through the night, and was sweating; Chills; Fever/temperature it was 101.0 /99.0 temperature; This is a spontaneous report from a contactable physician reporting for self. This 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 around 7 PM at single dose at left arm for Covid-19 immunisation.  Medical history included high blood pressure and acid reflux. Concomitant medications included lisinopril for high blood pressure, famotidine (PEPCID) for acid reflux. The patient previously received first dose of BNT162B2 (Lot: EL0140) on 23Dec2020 at 630-640pm at single dose for Covid-19 immunisation. And received paracetamol (TYLENOL) on unspecified date. The patient got her second dose of the COVID Vaccine around 7pm on Thursday, 14Jan2021. She was fine until about 12am-1am on 15Jan2021 when she got chills but she was still at work so she didn't take her temperature. When she got home she took her temperature it was 101.0 so she took naproxen sodium (ALEVE) and paracetamol throughout the day. On Saturday, 16Jan2021 she felt better but was still taking the naproxen sodium and paracetamol. On Sunday (17Jan2021) she didn't take anything but by 6PM felt chills, had 99.0 temperature, and some aches.  She said on Sunday around 6pm, which was yesterday, she took 2 paracetamol and 2 naproxen sodium. She slept through the night, and was sweating.  Today (18Jan2021) she is feeling better and has no temperature, she is just tired.  It is reported that she took a couple paracetamol before and after the shot. Events did not require a visit to emergency room or physician office. Patient did not have additional vaccines administered on same date of the Pfizer suspect. The outcome of chills, fever was recovered on 18Jan2021, outcome of tired was not recovered, outcome of other events was unknown.   Information on the lot/batch number has been requested.
dose one 12/31/2020 - developed headache, swollen hands and red palms, puffy eye 24-48 hours after dose. Took Tylenol. dose two 1/25/2021- developed continuous headache 8 hours after dose into day 2. Developed chills, sweats, body aches and burning sensation of eczema site on right foot 17 hours after vaccine administration. Took Tylenol and airborne without relief.
Breakthrough case admission after 3 vaccines Pfizer 1/18/21 Lot# EL1283;  Pfizer 2/8/21 Lot# EL9269;  Pfizer 9/9/21 Lot# 30135BA
Large area of redness and inflammation and swelling left shoulder.  Nausea and vomiting about 24 hours after the vaccination.  Temp 100.5 F with shivering.  Treated with tylenol.  Symptoms from about 48 hours after immunization.
Patient was given Flublok vaccine which is intended for patients 18 years of age and older.  Patient left clinic in stable condition. No known adverse reaction at time of administration.
fever 102.5 X2 days, chills, mild dizziness, 2 day after left arm edema and tenderness,
Information has been received from a physician concerning a male who on 02-NOV-2005 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy that day in the sane arm included influenza virus vaccine (unspecified).  The first vaccination was given three months ago and second was given by mistake. On 02-NOV-2005 the patient experienced pain at the injection site.  Follow up reported that the patient "did not have reaction"  Additional information has been requested.
reconstituted with sterile water; reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva689a, expiry date 20th October 2022) for prophylaxis.   On 18th January 2022, the patient received Menveo. On 18th January 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient administered Menveo vaccine which was inadvertently reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Symptom 1 - joint aches including all of the finger and wrist joints as the worst, but also knees and neck and other joints.  Vaccine was Tuesday at noonish, this symptom was apparent by 6 am on Wednesday when I woke up. Stayed bad all day Wednesday and Thursday.  Still noticeable on Friday as I submit this report, but improving.  Best treatment was electric heat pad, and rest.  Symptom 2 - fatigue.  Began on Wednesday sometime, and I definitely wasn't productive at work on Wednesday.  Slept all day Thursday, still slept without over-sleeping issues on Thursday night.  Still fatigued on Friday as I submit this report, but improving.  Wednesday my body was not where I expect it to be when I moved, I tried to brush a stick out of my path with my foot 3 times and never connected, I also almost fell down when trying to stand up from the toilet once on Thursday.  Thursday I had nausea for the first 2/3 of the day, couldn't eat at first and then only "sick food" easy things to digest.  Thursday during the same period of nausea, I also had hot flashes/chills.  I missed work all day on Thursday, and was definitely at reduced capacity for Wednesday and Friday (so far).  Treatments of choice were lots of sleep on Thursday, plus an electronic heat pad for the joints and especially the fingers on Wednesday evening and night, Thursday and Thursday night, and Friday so far.
I had constipation and lower back pain. I went to urgent care, and they diagnosed me with kidney stones. They did blood tests, urine tests, CT scan. They gave me an anti-inflammatory and pain killer while I was there, but they did not prescribe any.
Pneumonia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 75 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 02Mar2021 (Lot number: En6203) at the age of 74 years as dose 2, single and intramuscular, administered in arm, administration date 09Feb2021 (Lot number: En6201) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies to Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Allergy". The following information was reported: PNEUMONIA (hospitalization, medically significant) with onset 03Nov2021, outcome "recovered" (13Nov2021), described as "Pneumonia". Therapeutic measures taken as a result of pneumonia included IV antibiotics during hospital stay.   No follow-up attempts are possible. No further information is expected.
Welts started to develop on opposite arm (Left) that turned into raised blisters then spread to right arm and upper torso. They are not painful but they are itchy. Patient went to doctor three times. Md took sample for testing on 05/27/2014.
His sister received all 3 doses of the Pfizer COVID vaccine and then contracted the COVID virus; His sister received all 3 doses of the Pfizer COVID vaccine and then contracted the COVID virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single, administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single 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), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "His sister received all 3 doses of the Pfizer COVID vaccine and then contracted the COVID virus". Reporter stated his sister received all 3 doses of the Pfizer COVID vaccine and then contracted the COVID virus. He did not have any other information for her and said she was a very private person. Reporter did now know his sister's height, weight, and Primary care provider. She got two shots and the booster and she got COVID within the last 2 months. She was pro-vaccine and then bingo she got the vaccine. She said she was ok now. She got the booster and she got the disease. She had the booster 4 months ago, unknown date and unknown date of first two doses. Then 5 months ago, she would have had her 2nd shot and 6 months ago, the 1st shot. Lot and expiration are all unknown.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Patient complained of numbness from starting from left side of face to right side from neck to mouth along with headache and fatigue. She is still experiencing some numbness in her chin and mouth. I advised her to follow up with her PCP. BP was 134/93.
Some aching in left upper arm soon after injection.  It became subtally worse over the next several weeks.  No redness, warmth or lumps at injection site.
Got the shot years ago now got shingles/ suspected vaccination failure; Shingles on back; Very painful; Itchy; My back is all scarred; Awful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot years ago now got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on back), pain (Verbatim: Very painful), pruritus (Verbatim: Itchy), scar (Verbatim: My back is all scarred) and feels awful (Verbatim: Awful). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not reported and the outcome of the scar and feels awful were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus, scar and feels awful to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain, pruritus, scar and feels awful to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine years ago and now experienced shingles. The patient stated that it was very painful, itchy and now shingles on his or her back and it was now all scarred which was never had prior to having shingles and it was awful. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.