chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via a company representative refers to a 63 year old female patient who is not pregnant.  On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose not reported, subcutaneously). Concomitant medications were not reported. Pharmacist stated that on an unspecified date the patient developed shingles 7-10 days after the administration of ZOSTAVAX. The patient did not seek medical attention. Outcome of the event was reported as recovering. Additional information has been requested.
Got the vaccine on 1/19/2021  Tested positive for COVID 1/23/2021
Since then I have had difficulty breathing, rapid pulse, can't catch my breath. Had to go to doctor for this on 11/9/00. He put me on Benadryl (that didn't do the job for my numbness and in my body) so had to go to ER on 11/11/00, for oxygen for my breathing and numbness. Heart beating too fast and pulse and BP high from it.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "CHTN" (unspecified if ongoing); "DMII" (unspecified if ongoing); "HLD (hypersensitivity lung disease)" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; METFORMIN; ZOLOFT. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: antigen home test. Therapeutic measures were taken as a result of drug ineffective, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt states she did ok the day of the vax but the next morning when she got up to use the bathroom she became very weak and fell to the floor.  She crawled back towards her bed but she had to lay on the floor for a while.  She became wet from sweat.  She was able to get back into her bed where she stayed until she felt like she could get back up.  Once she was able to get back up she was fine.  She no longer has any symptoms.
I experienced very painful leg cramping in my right leg about two days after my vaccination.  The pain was persistent especially when i sat or laid down. It eased up after about 3-4 days but I am still experiencing pain in my right leg.  I don't usually experience this type of pain which is why i am reporting it.
Swelling on the arm for 2 weeks post vaccination; This is a spontaneous report from a contactable physician received via a sales representative. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)(PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling on the arm for 2 weeks post vaccination on an unspecified date. The patient recovered from the event on an unspecified date.  Information on the batch number has been requested.
Fatigue beginning on Sunday and growing stronger for the next two days. Couldn't get any energy. Slept 12 hours each night. Grew nauseous w/o vomiting on Monday. Had multiple bouts of diarrhea Monday and Tuesday. Slight headache. Lost eight pounds from no hunger and diarrhea. Grew dehydrated and felt more malaise. Symptoms began to resolve by Tuesday night. Slept another twelve hours. Felt much better by Wednesday, enough so to eat a fast food meal that evening. Today, 1 April I feel normal and took the dogs on a three mile hike.
Myalgia, Arthralgia, Fever, Achey, chills, extreme tiredness
tiredness began w/in 1 wk of vax; swollen ankles on 8, 9, 10. 11APR w/no reported sports injury; will be seen by MD on 15APR93;
Chest pain associated with flare up of SLE (lupus)  Hospitalized 9/25/20.  Advised not to get 2nd vaccine shot.
MMR GIVEN 04/04/05.  Pt. found to be pregnant 04/05/05. Pt. instructed on importance of avoiding pregnancy for 1 month.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 at 17:30 as dose 1, single (Lot number: EC9201), in left arm, on 18Feb2021 at 17:15 as dose 2, single (Lot number: EN6201), in left arm, on 30Sep2021 at 13:30 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 22Jun2022 at 11:30 as dose 4 (booster), single (Lot number: FN2908) at the age of 85 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: NSAIDs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Negative, notes: Rebound positive 8 days after negative. Treated with Paxlovid; (07Sep2022) Positive, notes: Rebound positive 8 days after negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was unknown if the patient received other medication in 2weeks. Patient received Paxlovid for treatment of COVID-19 from 24Aug2022 to 29Aug2022. On 07Sep2022, at11:30 AM patient had Rebound positive 8 days after negative. Treated with Paxlovid.
Felt little pain; Arm is swollen; Redness is getting bigger; Itchy around redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt little pain), PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Redness is getting bigger) and PRURITUS (Itchy around redness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included CALCIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (Felt little pain), PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Redness is getting bigger) and PRURITUS (Itchy around redness). At the time of the report, PAIN (Felt little pain), PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Redness is getting bigger) and PRURITUS (Itchy around redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included cold compress.
After the first dose she had mild pain all over body; This is a spontaneous report from a contactable Consumer reported for herself.   A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249, Expiry Date: Not Provided), via unspecified route of administration in left arm as 1st dose, single dose on 06Jan2021 for COVID-19 immunisation. Relevant medical history was none. Concomitant medications included She takes birth control pills regularly. She had Excedrin for migraine pain, she took it after the vaccine. The patient had reported that with the first dose patient had mild pain all over the body. Patient also wanted to know what she should do next and if this is a normal Side effect as patient was frustrated asking how long she would have to wait for the other department, She waited 1 hour just to give all this information and now she is going to be transferred again. Outcome of event was unknown  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Had my first Moderna shot on 2/12/21.  On 2/23/21 - 10 days later, had to go to (PCP) due to difficulty breathing while walking, climbing stairs, drying after shower etc.  Called my Cardiologist and scheduled an appointment.  Had a left heart cath on March 25th.   Stress Test, CAT scan and other blood tests on April 23rd.   Was then sent to Pulmonary specialist on May 10th.  Given Inhaler that did no good.  Still having problems breathing.  Underwent a sleep test followed by a Right Heart Cath on August 18th
Pretty quickly after the shot (that evening) I felt a tingling/prickling in my finger tips and I swore down in my toes. I developed a few sickness symptoms the next day but definitely felt much better about 48 hours later.   What I really want to say now is that I still feel like I notice very minor tingling in my fingers (mainly left arm) but sometimes down in legs or right forearm. Additionally, my upper left arm where the injection was sometimes feels stiff or strange. It isn't pain, but its more like a nuisance.
Heavy menstrual flow. Prior to vaccine had 1-2 day period with very light menstrual flow and no cramping, minimal breast pain prior to period. In the 5 months since vaccination all periods have changed.  I now have significant breast pain in the days leading up to period, along with moderate cramping, and significantly heavier menstrual flow. Flow is now 3-4 days instead of 1-2 prior to vaccination.
Almost exactly 48 hours after the injection, I felt pain behind my left ear, extending down my neck to my jaw and up to the side and back of my head.   The pain was so severe (maybe 3 or 4 on a 10 scale) that I was unable to sleep much for two nights.   It has now been 4 days since the injection, and my jaw area aches.  The paid behind my ear has subsided somewhat and I was able to sleep some during the day today.   My wife received her second injection at the same time as mine.  She experienced pain behind both her ears on the second day but it went away after 24 hours and she now has no symptoms. If this discomfort continues for another day or two, I wonder if I should go to a medical clinic or emergency room.
In the evening about 7 or 7:30 my arm was sore from the injection and a little better in the evening it started to travel up my neck and it was hard to move my arms and shoulders.  The next morning because of the soreness in my neck, I am not sure if it was my neck was sore from the pain radiating from my arm, but my neck was very painful to move it.  My neck felt like it could not freely move it, I wasn't able to move it in normal ranges.   I had x-rays taken of my neck, the provider felt like it was from muscle spasms from after having the vaccine.  I went the physical therapy and they taught me exercises to relieve the pain.  I feel like it has slowly been getting better.
arm discomfort; sleepiness; heaviness; pain in the arm; redness in the arm; swelling in the arm; headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (arm discomfort), SOMNOLENCE (sleepiness), LIMB DISCOMFORT (heaviness), VACCINATION SITE PAIN (pain in the arm) and VACCINATION SITE ERYTHEMA (redness in the arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (arm discomfort), SOMNOLENCE (sleepiness), LIMB DISCOMFORT (heaviness), VACCINATION SITE PAIN (pain in the arm), VACCINATION SITE ERYTHEMA (redness in the arm), VACCINATION SITE SWELLING (swelling in the arm), HEADACHE (headache) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (PANADOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOMFORT (arm discomfort), SOMNOLENCE (sleepiness), LIMB DISCOMFORT (heaviness), VACCINATION SITE PAIN (pain in the arm), VACCINATION SITE ERYTHEMA (redness in the arm), VACCINATION SITE SWELLING (swelling in the arm), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-378001 (Patient Link).
Minor rash chest and back - LS Cl bilat. Pt denies SOB 8 y/o male 55lbs notified med control after admin 25 mg quick desolve strip and 25 mg BENADRYL PO 2.5 mls rash subsided @ 17:32 (shot @ 17:29).
On 12/07/2022, I had a slight sore throat, I thought I was not drinking enough water, so I increased my intake of water. By 12/11/22 I had major head congestion and was starting to feel fatigued, I used a home COVID-19 test that came back positive. I called my doctor and had a telehealth visit. I was prescribed Paxlovid that I started taking on 12/12/22. I started feeling back to my normal self by the end of the end. I did have some loose stools during the week of taking the Paxlovid, and I have weak legs two days. But I am testing negative.
Woke up, felt strange, went to get a drink of water, lost consciousness and hit head on tile kitchen floor. Still dealing with vertigo and persistent dizziness due to sustained concussion.
first dose 8 to 10 months ago and had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received, 8 to 10 months ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter claimed that, the patient had first dose of Shingrix 8 to 10 months ago and had not yet received the second dose, which led to incomplete course of vaccination. The reporter had no information regarding the age or gender of the patient involved nor the exact date of the administration of the first dose. There was no information regarding either the expiration or lot number of the administrated first dose. No further events were reported. The reporter agreed to be contacted for follow-up. This is one of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR163653:Same reporter US-GLAXOSMITHKLINE-US2021AMR163652:Same reporter US-GLAXOSMITHKLINE-US2021AMR163653:Same reporter
Broke in zoster like rash; This case was reported by a other health professional via call center representative and described the occurrence of vesicular rash 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, 1 day after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The reporter stated that patient broke in zoster like rash day after Shingrix vaccine. The reporter also asked does this mean she should not get second shot. The reporter did not consent to follow-up.
20-30 min after DTaP#5 administration, pt developed mid facial edema including upper lips, pinta patch face, ant neck and shoulder to scapula and chest to umbilicus pink patch. First complaint HA& itchy. No oropharyingial  edema nor respiratory difficulty. Resolved with oral Benadryl.
Information has been received from a physician concerning a 14 year old female with diabetes who in November 2006, was vaccinated with the first dose of Gardasil vaccine (yeast). The physician's office called the patient to remind her to come in for second dose as she was late for the dose and the patient reported that the pain from the injection was so severe that she refused to come in for the other doses. The patient reported that is was the worst pain she ever had with an injection. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a physician and a registered nurse concerning a 14 year old female with diabetes (patient gives herself injections daily) and cystic fibrosis who on 06-NOV-2006, was vaccinated with the first dose of GARDASIL (lot number 653735/0688F). The physician's office called the patient to remind her to come in for second dose as she was late for the dose and the patient reported that the pain from the injection was so severe that she refused to come in for the other doses. The nurse reported that the patient does not want another injection because it was extremely painful. The patient reported that it was the worst pain she ever had with an injection and the needle was "absurdly long". Subsequently, the patient recovered from the injection site pain. Additional information is not expected.
after the patients got their shot, their immune system was off track; get sick all the time; the patients got off track and get sick all the time.; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown, solution for injection) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "after the patients got their shot, their immune system was off track; get sick all the time"; ILLNESS (non-serious), outcome "unknown", described as "the patients got off track and get sick all the time.". Additional information: The doctor mentioned the COVID vaccine and said she had three patients who had a bad immune system, she finally got the patients on track and states after the patients got their shot, their immune system was off track. The caller asked the doctor if she reported this in VAERS or with Pfizer if it's Pfizer's vaccine, and the doctor didn't respond. The caller asked the doctor which of the three manufacturers she was referring to and the doctor didn't clarify between the three manufacturers. The doctor only said the patients got off track and get sick all the time. Caller confirmed the reporter was a physician. Details of the patient: Unknown. The caller mentions the patients did have comorbidities, but the caller did not ask for any patient details. She believes that was a violation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200402607 Same product and event, different patient;US-PFIZER INC-202200402705 Same product and event, different patient
Red swollen bump with itching, tightness feeling. Right Upper Arm: There is a 10 by 10 cm area of erythema and induration with well demarcated borders that blanch to touch. There is no streaking. The area is warm. There are no vesicles appreciated. Patient advised to apply cold pack, which was provided. She is to take NSAID of choice for inflammation.
Cried for 3-4 hrs p/vax administered on 16OCT91 w/o being able to be consoled; Reported @ vist of 9DEC91; Pt did well w/vax administered 5AUG91;
Suspected vaccination faliure/ was vaccinated but still got the shingles; was vaccinated but still got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 67-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination faliure/ was vaccinated but still got the shingles) (serious criteria GSK medically significant) and shingles (Verbatim: was vaccinated but still got the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-Jul-2023 The case was received from the patient via interactive digital media. The patient was vaccinated but still got the shingles. The patient stated that it seems like a lighter case. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Red Rash, itchiness, soreness on left arm at sight of 2nd COVID vaccine shot
9 hrs after injection, woke up with stomach upset and pain,  12 hr after injection, woke up with severe chills, moderate pain at injection site, moderate stomach pain and cramping, headache, all over body aches, some swollen glands, that prevented sleeping comfortably. At 16 hrs after injection, I woke up for the day and still felt   Some mild chills, registered a 99.8 degree fever, body aches.  Currently lying down and unable to resume normal duties.   Took 1 ibuprofen at 5pm for arm pain, 1 ibuprofen at 3am for body aches, headache.  Both doses provided some relief.
Bitemporal headache unrelieved by ibuprofen and fever up to 101F lasting less than 24 hours.