chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dehydrated; Vomiting; Severe diarrhea; Didn't get out of bed; Wasn't feeling good; A spontaneous report was received from consumer, concerning himself, a 78-year-old, male patient, who received Modena's COVID-19 vaccine (mRNA-1273) and experienced a diarrhea, dehydration, vomiting, malaise, feeling abnormal.  The patient's medical history included diabetic (insulin dependent) and rheumatoid arthritis. The concomitant medications included as otilimab and insulin.  On 17 Mar 2021, he got the first of two planned doses of mRNA-1273 (lot 038A21A) in his left arm, intramuscularly for prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient experienced diarrhea, vomiting, malaise, feeling abnormal. On 19 Mar 2021, patient had dehydration.  The patient was hospitalized for vomiting, diarrhea and dehydration.  Treatment included treated for dehydration, monitoring his heart, and giving his insulin,  Action taken with mRNA-1273 in response to events were not provided.  The outcome of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Further information has been requested.
No previous health conditions. Fluarix Quadrivalent was administered in 10/2021 and caused immediate cardiac abnormal palpatations and chest pain once received, which lasted several weeks.  Site of flu injection has caused and is causing severe pain for almost one year now, my arm hurts with dull and sharp pains from the flu shot injection site and has spread to my elbow (has spread approximately 7 inches with constant pain) - this pain is EVERY DAY.
Severe Pain, Migraine, trouble walking,  trouble speaking, Achy/hot, lasted for 2-3 days
administered powder reconstituting it with non-GSK diluent; administered powder reconstituting it with non-GSK diluent; This case was reported by a nurse and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva677a, expiry date 30th April 2023) for prophylaxis.   On 25th August 2022, the patient received the 1st dose of Menveo (intramuscular). On 25th August 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 Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The reporter reported that the patient received Menveo in that administered powder reconstituting it with non-GSK diluent. The patient was still trying to revaccination. All five potential patients were recalled for revaccination. No adverse reactions known. The reporter stated that the system was utilized from 6th September 2022. Diluent would be dispensed with the powder in this machine. RNS to check all vials for vaccines prior to administration. The reporter associated the events to erroneous administration and lack of effect. The reporter did not consider the event wrong solution used in drug reconstitution and inappropriate dose of vaccine administered to be related to Menveo. The reporter did consent to follow up. Additional supportive information: Menveo reconstituted with non-GSK diluent instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was one of 5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022124956:Same reporter/ original report US-GSK-US2022AMR131200:Same reporter US-GSK-US2022AMR131247:Same reporter US-GSK-US2022AMR131240:Same reporter
Client stated that incident occurred 2d after vaccine. Severe abd pain started 10 min after eating lunch on 11/16/06. Client took 25 mg Benadryl, as she has food allergies, and thought it was something she ate. Shortly after, SX progressed to dry heaves, chest pain. BP decreased 60/40, Pulse decreased to 44. TO ER all cardiac tests neg. other cardiac test pending. Strong family HX of cardiac problems.
Information has been received from a physician concerning a female who was vaccinated with GARDASIL vacine (yeast)l.  Subsequently the patient's arm was sore at the injection site.  The patient recovered after one month.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been eceived from a physician concerning a female who on an unspecified date was vaccinated intramuscularly with GARDASIL vaccine (yeast). The reporting physician was told by a family physician that one of his patients who he vaccinated with GARDASIl vaccine (yeast) subsequently deveolped arm swelling and was sore at the injection site for approximately 10 days post vaccination. The patient recovered after one month.No additional information is expected.
Headache, Arthralgia, FATIGUE, PAIN INJ SITE Narrative:
body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches) and PYREXIA (fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced PAIN (body aches) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN (body aches) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 10:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 10:35 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 67.62.  Concomitant products were not provided.  On 28-Apr-2021, the excursion time was at 9 AM, temperature was 33 degree fahrenheit, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 28-Apr-2021. 4 vials were sent to clinic. Vaccine BUD date was 19-May-2021.On 28-Apr-2021 the vial was kept in cooler 1.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Minor chills 36 hours after shot with sever chills 6-8 pm evening of shot.  Fatigue and joint aches 36 hours after shot.  Slept much more then normal 12-36 hours after shot.
developed blood blister on side of tongue; then was like a sore on the side of her tongue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 29Jan2021 (at the age of 67-year-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 05Feb2021, the patient developed blood blister on side of tongue, then was like a sore on the side of her tongue. Blood blister came on right away, it lasted two hours and burst, then was like a sore on the side of her tongue. Patient went to her physician who said it was healing. The patient underwent lab tests and procedures which included blood test: everything looked excellent on an unspecified date in 2021, everything looked excellent, there was nothing abnormal at all. Which is good. The events resulted in physician office visit. the events did not require treatment. The outcome of the event blood blister was recovering and the outcome of then it became sore on the side of tongue was unknown.   Follow-up attempts completed. No further information expected.
About 8 hrs after this "flu shot", my wife began feeling feverish and had myalgia and arthralgia. Symptoms persisted for 2 days more.
Headache, Myalgia, Fever, Fatigue, swelled lymph nodes at armpit. Narrative:
Mom says on the night of 10/20/2005 he started gasping a few times breathing, complained of right leg pain, leg looked limp to mother, eyes bloodshot, and around eyes red with swelling, face swollen, she gave one dose of Tylenol, came to health dept the next am to report reaction.
Cold- sore throat; Cold- sore throat; Sick/ She is sick as a dog; This is a spontaneous report from a contactable consumer (patient).  This female patient with unspecified age received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 06Jan2021 (age was unknown at the time of vaccine) as single dose, for immunization. Medical history included she is in between major surgeries (unspecified) and ongoing, and when she took the vaccine she was already coming down with a cold - sore throat.  Concomitant medications were reported.  On Jan2021 patient feels 'more sick/sick as a dog' following vaccination. She knew she probably shouldn't have taken the vaccine given she felt a cold coming on but she took it anyway.  She believes it is only a cold as her husband came down with a cold as well and tested negative for Covid.  She states she doesn't believe the vaccine has anything to do with her cold. She was asking if she took an 'antibx' (if prescribed by her hcp) would it interfere with vaccine at all. The outcome of events Cold was unknown, for sore throat was unknown, and for Sick/ She is sick as a dog was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Cold - sore throat worsened is not related to the vaccine use but represents the progression of the pre-existing medical condition.
VOMITING FOLLOWED BY SYNCOPE DAY 1 AND DAY 5 FOLLOWING VACCINATION.  WBC - 30,000, NEGATIVE WORK UP. NO LASTING SYMPTOMS.
received the booster vaccine in Oct and two days ago developed COVID.; received the booster vaccine in Oct and two days ago developed COVID.; She received a Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team and product quality group for a Pfizer sponsored program (172086). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single, administration date 21Jan2021 (Lot number: EL3247) as dose 2, single and administration date 31Dec2020 (Lot number: EH9899) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: RITONAVIR; AMLODIPINE. The following information was reported: IMMUNISATION (medically significant) with onset Oct2021, outcome "unknown", described as "She received a Pfizer booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "received the booster vaccine in Oct and two days ago developed COVID.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive.  Clinical information: Reporter was a pharmacist and a patient. She developed covid 2 days ago and wants to know how she can obtain the product. She also stated that she received her first Pfizer covid vaccine last New Years Eve (31Dec2020) and her second dose 21 days later. She received a Pfizer booster vaccine in Oct2021. Pharmacist was just trying to find out an additional treatment for this virus that she was very concerned about. She had to get from the health department because the pill, Paxlovid was not available yet. Pharmacist further stated, By the way other two people (further clarifications unknown) were positive and they have got Pfizer shot too but they both are asleep. She became positive from another person who had three shots from Pfizer. She stated, she just knows that yes hopefully she would be okay. She was just worried a lot and she did everything for her mouth and then she got chilled everything (further not clarified).  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Immunisation, Vaccination failure , Covid-19  and suspect drug BNT162B2 cannot be excluded.
This spontaneous report as received from a pharmacist refers to a 67 year old female patient with diabetes and no known drug allergies. On an unspecified date, in October 2012, approximately one year ago, the patient received the first dose of PNEUMOVAX23 (Lot#, dose and route not provided) and on 17-OCT-2013, received a second dose of PNEUMOVAX23 (lot # J006921; exp. date: 09-AUG-2014) (dose and route not provided). Concomitant therapies included metformin, levothyroxine sodium(manufacturer unknown), VICTOZA, WELLBUTRIN, ZOCOR and glimepiride. On 17-OCT-2013, the patient experienced severe swelling and pain in the arm where she received the second dose of PNEUMOVAX23 and mentioned that the arm felt warm to touch and pain in the arm where she received the second dose. The patient sought medical attention by a phone call to the pharmacy. No laboratory tests were performed. As treatment for the events it was given ice, ibuprofen and TYLENOL. The outcome of the events was not recovered. Additional information has been requested.
Weakness in knees & lower extremities; pain in pelvis; stretching anterior thigh nl > lt.
p/vax pt devel rash on legs;rash is getting worse pt told to see MD;
Information has been received from a consumer concerning her 15 year old daughter with no past medical history and no drug reactions or allergies who in August 2008, was vaccinated with the first dose of GARDASIL. In October 2008, the patient received the second dose of GARDASIL. There was no concomitant medication. The consumer reported that the patient developed a low grade fever and felt "sick" the day after receiving her second dose of GARDASIL. During October and November of 2008, the patient experienced intermittent "stomaches", nausea and vomiting. Starting December of 2008 until the time of this report, she had experienced persistent extreme stomach pains and vomiting. The patient had been examined by three gastroenteriologists who were not able to determine the cause of her symptoms. She had missed 60 days of school. Lab diagnostics studies included a stomach empty test, CAT scan and blood tests with no results available. At time of this report, the patient had not recovered. The patient sought medical attention by an office visit. Upon internal review, low grade fever, felt "sick", intermittent "stomaches", nausea, vomiting and persistent extreme stomach pains were considered to be disabling. Additional information has been requested.  3//25/09 MR received from parent which include several GI consults and diagnostic testing.  Per MR pt began having intermittent vomiting in Sept 2008.  Usually at night waking pt, accompanied by abdominal pain, H/A and associated with shaking/shivering/chills.  Occ nausea. 6-7 lb wt loss.  ROS (+) for fatigue and chest pain. PE WNL except for eczematous rash on hip, iliac crest and axilla. Some improvement with Reglan but now c/o dizziness. W/U essentially (-). No final DX. 2nd GI consult seen 1/9/09. PE (+) for tenderness to palpation of the epigastrium, RUQ and RLQ. Has missed 28 school days since Sept 08.   Labs and diagnostics:  Upper GI WNL. CBC WNL. Chem WNL. H. pylori (-). BX of esphagus and stomach WNL.  Some inflammation of lamina propria of duodenum. Upper GI (+) for small ring shadow of distal stomach with SB follow through WNL. Head CT WNL. US abd WNL. HIDA scan WNL. CT abd and pelvis WNL. Gastric emptying study WNL. X-ray abd (+) for increased stool. EGD WNL.
Vaccinee had "no response" p/receiving three doses of Engerix-B vaccine on  11AUG89, 23SEP89, & 24MAR90.
Double vision. Right eye pain. Numbness right temple. Slight double vision for one week, then double vision worsened and not resolving itself.
Vaccine was administered via Intramuscular when it should have been Subcutaneous resulting in an administration error.
shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received 1st dos of Shingrix and then 4 months later had shingles. No further details were provided. The reporter states that  shingles were diagnosed by a different provider, and she did not have any further information available at the time of chat. Consent to follow up was denied.
pt fainted immed post vax-approx 30 seconds revived w/smelling salts;
Pain in arm pit. Extremely swollen lymphnodes under arm. Painful and sensitive to the touch. I have pictures of the swelling and tender area. Lymphnodes were about the size of a base ball.
Woke up with no movement of left hand/wrist. one week later numbness and tingling of left foot with inability to toe walk. Unable to do simple daily life activities (ie. unable to tie my own shoes) EMG done on 12/5/2016 followed by immediate admit to the hospital for GBS. MRI of brain and neck followed by LP.  IVIG was given over the next 5 days. as of today 4/19/2017 I am still having residual weakness and pain in left wrist.  I am unable to resume working due to weakness.
Acute chest pain diagnosed as Myocarditis, 24 hours after the second dose of the vaccine.
gotten covid 2; gotten covid 2; sore arm were they poked him; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (Pfizer covid 19 vaccine), administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot, for immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "gotten covid 2"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm were they poked him". The clinical course was reported as follows: He got covid 19 vaccine . The way a lot of people made it seem he was scared but his work said he needed it. He got the shots and no side effects sore arm were they poked him but nothing bad didn't feel any different . He have gotten covid 2 and if this helped you not get it he will take a shot every year like the flu shot .  The lot number for bnt162b2 was not provided and will be requested during follow up.
7:48 am hot, difficulty swallowing, numbness/tingling lips, raspy/hoarse, 50mg benadryl given-symptoms did not resolve so sent to ER, Initial Blood pressure 166/117  Given 50mg IV benadryl, IV dexa methasone, and IV pepcid   Difficulty swallowing resolved in about 1 1/2 hours, numbness and tingling lips resolved approximately 8 pm 12/28/2020 continued raspy/hoarse and day 2
Always had vaccination with Maderna injections since 2021 without incident.    I lost count o how many but it would be at least 4.
Mother phoned approx 24 hours after child received vaccine states evening of vaccine, (R) upper arm was reddened, itchy and painful. At time of call, mother stated arm was reddened, swollen and hard from about elbow and up. No SOB, no fever, no nausea or vomiting. Recommended BENADRYL, TYLENOL or ibuprofen and cold packs. Patient's symptoms got worse the next day but then better, now fully recovered.
Pt began experiencing abdominal cramping and discomfort.  It progressed to severe diarrhea and a low grade fever.  He stated he felt awful for about 24 hours then all symptoms resolved.
Patient stated that 2 to 3 days after receiving flu vaccine her left arm started swelling. Then she started developing patches down whole left arm and palm. At time of PCP visit on 10/02/2018, patient's left arm was red and swollen and she had sporadic dry patches down arm and palm. Provider tending to patient also stated that patient had vesicles in hard pallet of mouth. Patient also stated that she had pain of left arm when moving. Provider does not think symptoms are associated with shingles but patient patient will be treated with acyclovir. Patient has also been referred to dermatologist.
Upper gastric abdominal pain. Pain intensity 9/10. Time course: 5 minutes.
After getting Johnson & Johnson Covid Vaccine Patient Within 10 minutes exhibited SX of seizures (jerking) & Vomiting. Breathing - NormaL Called 911 & Pt. was taken by ambulance
Extreme pain around torso  about 12 hours after vaccination. Described as "nerve" pain.
After the covid vaccine and 10 minutes of monitoring the patient began to feel dizzy, shaky, and was experiencing palpitations. The nurse gave Benadryl 25 mg by mouth and put an ice pack on the next. Around 03:08 pm the patient states she is ready to go and leaves.