chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Prior to my shots, I was very healthy for several years now. Around July 16, 2021 I came down with Shingles. Lasted for weeks, Very, very painful. Ended up on two meds; one that started with gab and the other with a P. Sorry don't remember the actual names but prescribed by my doctor. Later on I had soreness in my gums on the bottom side of a bridge I had put in years ago. Hurt like heck. Then I noticed my one  toe on my left foot the nail turned completely black. Didn't hurt but where did that come from? Eventually as it grew out I was able to rip pieces of it off and now it is almost gone, but under the nail is now a hard scabby area. Also similar on my right foot and the same toe. Most recently I ended up with my right leg hurting as if I sprained it. Couldn't straighten it out all the way. Hurt when I walked and bent it. Pain was on the bottom side of my top part of the leg and in my calf area. Hurt like hell. Eventually my lower right leg began to swell up. Became real concerned that I was having a blood clot. So soaked in hot water with Epson salt, took Tylenol, and some inflamation meds from a friend. Took awhile but eventually the swelling went down. I was out of town for over three months but made a doctor appointment for when I got home on the 12th of October. As stated above had all kinds of blood work done and all came back negative. Today while walking my dog, I noticed some blurred vision in my left eye. I am 67 years old and know my body. This is not normal nor will I accept I am just getting old. I was in good health prior to the vaccine. I swear I had infection in my whole body and it just moved from one area to the other. Plus I truly believe the vaccine lowered my immune system to fight things.
Had flu vax on 10/12. Seven days post vax, on 10/19, cough, strangulation cough, questionable bronchitis, non productive. Every time vaccinee was active or talked, she would experience shortness of breath resulting in cough. She is still seeing physician.
COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220327300 and 20220327382.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
16 hours after receiving 2nd dose. I experienced severe chills and body aches, low grade fever, nausea and headache.  Ibuprofen was taken at 22 hours post vaccine with fever resolve.  Body aches and fatigue continued for additional 36 hours
Was doing well with just some minor joint pain, then a couple of days ago I could not stop itching. Wife looked a day later after my complaints and saw tiny red bump clusters. Some were on my back, shoulder, buttocks and the itching was also spread out; on the head, foot, wrist, and groin region. She found no dots there. I did not contact my primary yet. Cortisone cream and antihistamine pill today are what I took.
80mmX80mm area of redness and slight swelling at the injection site.  Pt reported sore to touch.  Pt reported feeling itching near the injection site.
Patient came to office on 10/06/2015 complaining of rash on right deltoid.
Fully vaccinated. Hospitalized due to COVID-19. PUI tested positive 8/30/2021 with a symptom onset 8/23/2021. PUI has congested heart failure, possible COPD, one kidney, and covid-pneumonia at the moment so extended isolation date end would be 9/12/2021.  Did require mechanical ventilation.
pt recv vax & devel 1 vesicle @ inj site;4/1/98 pt broke out in approx 10 red papules on face & head;pt saw dermatologist & dx w/folliculitis vs atypical varicella;
had issued an expired IPOL vaccine to a child with no adverse event; Initial information received on 17-Aug-2022 regarding an unsolicited valid non-serious case received via Medical assistant. GMI number: 01238850.  This case involves a 1-year-old male patient who had been issued an expired IPV (VERO) [IPOL] vaccine to a child with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), HEPATITIS A VACCINE (HEPATITIS A), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) all for Immunization.  On 15-Aug-2022, the patient received suspect Ipol vaccine at dose 0.5ml once via intramuscular route in the right leg (Lot: T1D482M and exp: 25Jul2022) for prophylactic vaccination (expired product administered).  Medical assistant reported that they had issued an expired ipol vaccine to a child. No adverse event was reported.  Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Not Recovered.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Pt vacc. /w DTP/OPV experienced non-stop crying for 3 hrs also was lethargic & had a loss of appetite.
Patient received one dose of Pfizer in the left arm. Vaccinator incorrectly documented vaccine site as left bicep instead of left deltoid. Medical record on state reporting system was fixed and correct documentation was added stating patient received vaccine in the left deltoid.
I felt generally unwell, achey, headachey, arm soreness with a little chest pain by 9/5/21  and I was really having chest pain on 9/7/21 with pronounced dyspnea going upstairs. I had had that, though, with the first two shots and it was bad enough with the second I asked my pcp for a pe workup as I have a big family history and the chest pain was so pronounced then. PE work up was negative so when I had pain after the third shot I didn?t say anything until it was so bad by 9/10/21 I went to the ER. ER doc refused a work up saying I was too young for cardiac chest pain. I made a pcp and cardiology appt but they weren?t until October. Cardiology was concerned for hocm and said my heart was enlarged and ekg was extremely abnormal. Pain was already minimal then but still had dyspnea which was concerning as I had a marathon coming up in 2 weeks. He did a stress test and echo which were both normal on 10/5/21 but I hit max heart rate on the stress test really fast and he felt like my heart looked like I did 5ks instead of training for a marathon. When he followed up with another ekg on 10/12/21 he said my heart was almost completely back to normal and I was cleared to run and could follow up as needed. I have since done two half, two whole marathons and a 10 and my pacing is getting better.
My blood pressure spiked and I had to do a phone conference with my doctor to add another blood pressures medicine to bring it down. I now take two blood pressure medicines daily instead of one.
KIDNEY FUNCTION ISSUES; This spontaneous report received from a patient concerned a 34 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on unspecified date of MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date of JUN-2021, the patient discovered that he had kidney function issues (not assuming it was the vaccine but he was researching to see if it might have a link with the vaccine administration). The patient had lab investigations done frequently which showed elevated kidney function rate and it continued through the summer. He tried medication, change of diet but kidney function rate was still high.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from kidney function issues. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210929343-covid-19 vaccine ad26.cov2.s -Kidney function issues. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
9/19/2013, pt observed red patches and blisters on (R) leg and stomach. Pt also experienced tenderness in stomach area. Pt was on camping trip.
very red arm, redness getting progressively worse; cannot life arm, not even one inch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (very red arm, redness getting progressively worse) and LIMB DISCOMFORT (cannot life arm, not even one inch) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced ERYTHEMA (very red arm, redness getting progressively worse) and LIMB DISCOMFORT (cannot life arm, not even one inch). At the time of the report, ERYTHEMA (very red arm, redness getting progressively worse) and LIMB DISCOMFORT (cannot life arm, not even one inch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
came down with chronic diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 06Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset Oct2023, outcome "recovered", described as "came down with chronic diarrhea". Additional information: the patient received the vaccine on 06Oct2023, stating this was about 5 weeks ago. A week later after getting the vaccine, the patient came down with chronic diarrhea and it has persisted for a solid four weeks.         The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and  when received.
This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a female patient who received SHINGRIX for prophylaxis. On 11th February 2019, the patient received SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was experiencing all of the side effects of the vaccine. The patient was asking was there anything she should do or would the side effects wear off soon.
Swelling, redness, & rash at site of admin. of left upper arm. Also, pt says tingling/numbness of fingers of left arm.
pt mom contacted by supervisor; when contacted mom stated pt recv shot & 4 hr later had t104 & profuse vomiting; recv 1 dose of APAP immed p/vax; tx w/APAP in ER & released;
I got my first vaccine dose on March 21. On March 27, i started developing a rash in my armpit. when i went to the urgent care, i was given a steroid cream to apply to my armpit. within 4 days of using the steroids the rash had went down significantly. Around April 1, i started feeling a burning, stinging, uncomfortable, sensation near my vagina. Shortly after i went to an urgent care, again. When i went to the urgent care i prescribed two other creams, one being a medicated steroid i was told to put around my vagina. After two weeks of still being uncomfortable, i made an appointment with my gynecologist. My gynecologist took cultures, to find that i had a minor yeast infection, which i took monistat for, and it cleared up within a day. The pain was still persistent so I made a follow up appointment with my gynecologist, and she says everything seems to be normal. I?ve seen 4 different doctors who cannot tell me what is medically wrong with me, but i have never had any problems like this before receiving the vaccine.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 8:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 8:50 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the fridge on 03-May-2021, moved to clinic on 24-May-2021 and proposed beyond use date was 02-Jun-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On the date of administration, at 08:00 A.M and 09:00 A.M, the temperature recorded was 35 degree Fahrenheit, that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Rash. Patient described inflammation and possible knot or bump under skin and soreness caused by ZOSTAVAX.
gall bladder infection; tooth infection; This is a spontaneous report received from a contactable consumer (patient's friend). A 60-year-old female patient (no pregnant) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter was calling for her friend who took BNT162b2 and the day after the report was the last day for her to get the second dose of vaccine. The patient had tooth and gallbladder infection and wanted to know if she could still go ahead and get the second shot. The reporter heard many friends had problems with the vaccine and stated she had two also. The reporter wanted to know what organ processed the vaccine, if it was spleen and pancreases. The patient  got one vaccine and she was really nervous about getting her 2nd vaccine because she had a tooth infection and she believed she had a gall bladder infection and she was due to get her 2nd vaccine no later than the day of the report; the reporter asked if she could go ahead and get that 2nd vaccine even though she had a tooth infection and possibly a gall bladder infection. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tingling Right Arm; Numbness Right Arm; Stiff Right Hand; Swollen Entire Right Arm/swelling of entire right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (Tingling Right Arm), VACCINATION SITE ANAESTHESIA (Numbness Right Arm), MUSCULOSKELETAL STIFFNESS (Stiff Right Hand) and PERIPHERAL SWELLING (Swollen Entire Right Arm/swelling of entire right arm) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PARAESTHESIA (Tingling Right Arm), VACCINATION SITE ANAESTHESIA (Numbness Right Arm), MUSCULOSKELETAL STIFFNESS (Stiff Right Hand) and PERIPHERAL SWELLING (Swollen Entire Right Arm/swelling of entire right arm). On 08-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiff Right Hand) had resolved. At the time of the report, VACCINATION SITE PARAESTHESIA (Tingling Right Arm) and PERIPHERAL SWELLING (Swollen Entire Right Arm/swelling of entire right arm) had not resolved and VACCINATION SITE ANAESTHESIA (Numbness Right Arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: NNI- non significant
Information has been received from a nurse concerning a patient who on 06-JUL-2009 was vaccinated with the second 0.5 ml dose of VARIVAX (Merck) (subcutaneous injection) (lot # 663541/0335Y) and a dose of MMR II (MSD) (lot#, dose, route not reported).  On 06-JUL-2009 the patient experienced swelling and redness at the injection site as well as hives later that day.  The patient was seen in the office on 08-JUL-2009 but it was unknown if therapy was prescribed.  The patient called the office on 09-JUL-2009 and stated the symptoms were getting worse.  No lab diagnostics studies were performed.  At the time of reporting, the patient had not recovered.  The nurse mentioned that 6 other patients, who all received VARIVAX (Merck) as a second dose, had reported similar symptoms.  The nurse was requesting a lot check.  Follow up information has been received from the same nurse concerning a 12-13 year old female patient who on 06-JUL-2009 was vaccinated with a second 0.5 ml dose of VARIVAX (Merck) (subcutaneous injection) (lot # 663541/0335Y).  The nurse reported the patient had not had any ore since vaccination, and all that reacted had recovered.  A lot check has been initiated.  A standard lot check investigation was performed for VARIVAX (Merck) (lot # 663541/0335Y).  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the Center of Biologics Evaluation and Research and was released.  This is one of several reports received from the same source.  Additional information has been requested.
After 5 hours when I got my moderna second dose shot. It feels like I?m getting cold for having a fever. My whole body feels like getting heavier because of body pain  and headache. My right arm was hurting when I touched it. It feels like I?m always cold sometime I?m shaking and make me sweat sometimes. It feels like I?m thirsty most likely, so I drink a lot of water.
Patient presented to the ED and was subsequently hospitalized for severe sepsis with lactic acidosis within 6 weeks of receiving COVID vaccination.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 30May2022 as dose 5 (booster), single (Lot number: FH8027) at the age of 60 years, in right arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "severe gastroparesis" (unspecified if ongoing); "Known allergies Erythromycin" (unspecified if ongoing); "Known allergies reglan" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Weak positive, notes: previous test on Day 8 was weak positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment from 24Sep2023 to 28Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320767 same patient, different event/ drug (Paxlovid case);
During the night I woke up with chills. Around 3:30, my fever for 102.5 and I took some Tylenol. I woke up again around 7 and my fever was down, but I still didn't feel well. So, I took my BP and it was 92/70 and I called my doctor. He told me not to take my BP meds and to skip it the following day. I continued to rest for the majority of the day, along with taking Tylenol. I was fine by that night.
Tingling /numb hands and feet, tired, no energy, night sweats, abdominal pain, burning on bottom of feet, muscle weakness,  dry mouth, joint pain, headache,...