chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within four hours of shot had severe flu symptoms fever, chills, achy all over. Felt like the worse day of having the flu. Lasted a good 8 hours. Took TYLENOL Q4H helped a little. Have been getting shot for many years never had a problem. Came very close to going to ER.
FULL BODY RASH - red and purple, painful, VERY itchy,  now looks bruised symptoms started sunday 5/2/2021 and still continuing and ongoing as of 5/7/2021
Got the vaccine, and a few minutes or so she felt like a funny sensation up around/left side of her head, like something was crawling inside her head, like something bulging.  Throbbing type pressure sensation.  She did not say anything at the time, and went home.  She went home and still felt the feeling on her head.  She did also notice that her hot flashes got a little worse than usual.  Had a sore arm for a couple of days.  When she laid down at night she could feel that sensation/throbbing in her head a little more.  She put a ice compress on it but could feel it a little bit, not as bad as it was as of today 3/16/21.   She called the pharmacy on Wednesday 3/10/21 who advised her to go see her PCP.   She went to the UC last Friday 3/12/21 as she could not see her PCP.   They checked her scalp and did not see any rashes or anything, and advised her to take Motrin intermittently with Ibuprofen.  She also told her to check back if she continued to have problems, but she decided to see her regular PCP.
A third Pfizer Covid vaccine was given unintentionally to May. 30 minutes post injection there are no AE.
Patient stated the day after the immunization his toes started to tingle and his arm was sore. The tingling in his toes lasted on and off for the next week. Then on 10-15-20 he reports his face and toes were puffy.
pt recv vax 10APR98 & T105 12APR98;dx w/LOM & rx w/ATB;16APR98 rash began on trunk, neck, buttocks;
Patient presents reporting arm discomfort and swelling since receiving Tdap on 6/17/11 in right arm. There is a hard slightly raised area that is about baseball sized on right deltoid, some some diffuse pink coloration. Is not hot to the touch. Patient states that it was swollen down to her elbow previously, and more red and sore, but that it has been gradually improving and is much better now. Has been applying ice.
Several breakouts all over his body. From the last vaccination, he had one rash and this time, he had several breakouts all over his body. Doc prescribed same medicine Hydrocortisone 2.5% . He declared its eczema and it had no relation with vaccination. Kindly understand until vaccination, my kid never had any skin problem, and now he is declared to have eczema, which goes and comes back. He scratches. What if he scratches, it might entertain his blood line. Should I wait for a day to come. All this happened because of multiple vaccines which doc totally ignores. Where can I go. I have been to the doc at least six time because of it. Sleepless nights.
Patient was administered vaccine after the 30 day beyond use date; No adverse event; Patient was administered vaccine after the 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after the 30 day beyond use date), PRODUCT STORAGE ERROR (Patient was administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination. No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after the 30 day beyond use date), PRODUCT STORAGE ERROR (Patient was administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Patient was administered vaccine after the 30 day beyond use date). No concomitant medications were reported.  Individual vials or unbroken cartons was opened individual vials. Vial size was 2.5ml. The vial was initially stored in the refrigerator was 20-Sep-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.
10-309 Sz- 1st episode seizure - MRI negative - 10am. 10-12-09 Left hand weakness > given phenytoin - 7pm. 10/23/09 Medical records received for ER visits DOS 10/03 and 10/09. FINAL DIAGNOSES: Seizure disorder, left arm parasthesia. On 10/3 first time seizure w/prolonged postictal period. Witnessed by parents. Hard to awaken. H/O extremity shaking, numbness and tingling, dropping things w/o LOC. Usually in the am. PE wnl, (+) fatigue only. Discharged to home. Planned neuro follow-up.    10/9 patient returned to ER with c/o  L hand, coldness, tingling  and numbness. Subtle pain 1/3 up to elbow. Equal grasp.  Developed weakness bilat legs in ER. Phenytoin tx.  Resolved. Discharged to home.  EEG and Neuro follow-up as planned.
On 06/17/2022, we had taken a trip and I was coughing up a lot of mucus, I fell in the tub and I hurt my back. I was still having pain, so on 06/22/2022, I went to urgent care for my back. I mentioned my chest cold, they tested me for COVID-19 and the test came back positive.
Dizziness now & then; Vertigo; Rash at the opposite arm; Heart palpitation; Chest tighness/occasional left chest tightness; Pressure in her head; Diarrhea; This spontaneous case was reported by a health care professional and describes the occurrence of PALPITATIONS (Heart palpitation), CHEST DISCOMFORT (Chest tighness/occasional left chest tightness), HEAD DISCOMFORT (Pressure in her head), DIARRHOEA (Diarrhea) and DIZZINESS (Dizziness now & then) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included RA and Iron decreased. Concomitant products included IRON for Iron deficiency, MINOCYCLINE for Rheumatoid arthritis.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PALPITATIONS (Heart palpitation), CHEST DISCOMFORT (Chest tighness/occasional left chest tightness), HEAD DISCOMFORT (Pressure in her head), DIARRHOEA (Diarrhea) and RASH (Rash at the opposite arm). On an unknown date, the patient experienced DIZZINESS (Dizziness now & then) and VERTIGO (Vertigo). On 12-Apr-2021, PALPITATIONS (Heart palpitation) and RASH (Rash at the opposite arm) had resolved. At the time of the report, CHEST DISCOMFORT (Chest tighness/occasional left chest tightness), HEAD DISCOMFORT (Pressure in her head), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness now & then) and VERTIGO (Vertigo) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Blood test: high (High) ESR high. On 12-Apr-2021, Electrocardiogram: normal (normal) Normal.     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.   Pills loaded with vitamins are the other concomitant medication reported by reporter  for an unknown indication. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-May-2021, contains non significant information. On 21-Jul-2021: Follow up received on 21-Jul-2021 contains non significant information.
PC from father of child on 8/15/03 stated child's left arm "twice as big between elbow and shoulder", "hot and red". Child complained of "pain" at injection site. Instructed father to apply warm compress for 20 minutes of hour today, offer Tylenol and seek MD help if no improvement.
17 year-old received the Moderna COVID-19 vaccine; A spontaneous report was received from a nurse concerning a 17-year-old, male who received Moderna's COVID-19 vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12-Feb-2021, prior to the onset of the event, the patient received their first of two planned does of mRNA-1273 (Lot number: 012M20A) for prophylaxis of COVID-19 infection.  On 12-Feb-2021, the patient was administered mRNA-1273 vaccine.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, 17-year-old received the Moderna COVID-19 vaccine, was considered resolved on 12 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 012M20A) with no associated AEs reported.
I had congestion, fatigue, nausea, and coughing. I tested positive for COVID-19 test. My doctor suggested to drink lots of fluids and take MUCINEX over the counter. I still phlegm and a cough and it has been 3 weeks since I had it.
Janssen vaccine n 3/25/21 and patient hospitalized for COVID resp failure on 12/31/21
SIRVA; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 68 year-old patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Lot number: EL9267) at the age of 68 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Anatomical site: Deltoid, Lot: EL8982, unit: 0.3ml), administration date: 29Jan2021, when the patient was 68 years old, for COVID-19 Immunization. The following information was reported: SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (non-serious), outcome "unknown", described as "SIRVA". Therapeutic measures were not taken as a result of shoulder injury related to vaccine administration.  Additional information: Anatomical Site of injection: deltoid. Vaccination facility type was Doctors office/ urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any treatment for the event. Specific Relevant Test for Thromboembolic Events with Thrombocytopenia and other relevant tests were unknown. Vaccine dose 3 was due on or after 23Jul2021.  No follow-up attempts are possible. No further information is expected.
Immediately I got a red, feverish patch about 3X3 on the area of the injection. I also began to feel achy and feverish. In 3 days I broke out in fever blisters on both sides of my mouth. My arm began to be sore and difficult to raise. At this point, almost 3 months later it is still difficult for me to raise my arm and I am being treated by a PT for a frozen shoulder. I have never had a reaction to any type of injection. I am so concerned that I will not take the second shot.
This spontaneous report as received from a pharmacist (age and gender unknown) refers to himself. The pharmacist reported, that on an unknown date, he accidentally stuck himself with a needle that was on syringe contained reconstituted ZOSTAVAX (lot#, expiration date were not provided). Needle punctured his ring finger. No adverse events were reported. Additional information has been requested.
Extreme rigors, fever, shortness of breath/hypoxemia within hours of receiving vaccine according to staff at the care home. leukopenia, pulmonary edema, death
Pt was given duplicate dose of DTaP. (No adverse reaction reported). Will continue to check on pt. next 48 hours.
Within two days of receiving COVID vaccine, I began to have a very heavy period. I have been on birth control on and off for many years due to irregular and heavy periods. As such, I have not had a period in years. There was significant clotting and heavy flow associated with the period which lasted about 4 days before subsiding. No other adverse effects aside from muscle pain at injection site.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.   This case was linked to MOD-2021-395985 (Patient Link).
PATIENT BECAME DIZZY AND LIGHTHEADED   THEN HAD NAUSEA 20 MINUTES AFTER SHOT.  SHE WAS GIVEN WATER AND SOMETHING TO EAT SINCE I BELIEVE SHE MISSED EATING BREAKFAST. PATIENT SAT FOR 30 MORE MINUTES AND WAS FEELING ALITTLE BETTER AND LEFT TO GO LAY DOWN AT HOME
Development of large welps/hives covering both arms and both legs. They range in size from adult pinkie nail to the size of a quarter. The larger ones appear to be hard and peak in height in the center. Daughter is scratching them; not sure if due to them being there or if they actually itch.  Provided cortisone to all of the welps, put bandaids on to prevent scratching and also gave Benedryl in case they do itch. the welps appeared at daycare today, likely after nap time, but daycare staff not sure of the exact time. They were not there this morning.
On date of vaccination pt's birth control pill was increased from Junel 1.5 to Sprintec due to GYN concerns of dyspareunia/dysmenorrhea/menorrhagia. She was also give the vaccine uncomplicated administration.
Enlargement of left lymph node at side of breast. Nausea, fatigue, lethargy and confusion as well as abdominal pain on right side of body.
Site of injection on right arm raised, red, and painful.  Redness, edema, and pain have intensified over past 2 days.  Cephalexin prescribed to cover for infection.  Tylenol #3 given prn pain.
Tripled the size in my arm; very hot to touch/my arm is super super hot; a little bit red at the site/it was really red; feeling sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (feeling sore arm), SWELLING (Tripled the size in my arm), VACCINATION SITE WARMTH (very hot to touch/my arm is super super hot) and VACCINATION SITE ERYTHEMA (a little bit red at the site/it was really red) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (feeling sore arm), VACCINATION SITE WARMTH (very hot to touch/my arm is super super hot) and VACCINATION SITE ERYTHEMA (a little bit red at the site/it was really red). On 08-Feb-2021, the patient experienced SWELLING (Tripled the size in my arm). At the time of the report, PAIN IN EXTREMITY (feeling sore arm), SWELLING (Tripled the size in my arm), VACCINATION SITE WARMTH (very hot to touch/my arm is super super hot) and VACCINATION SITE ERYTHEMA (a little bit red at the site/it was really red) 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.   No concomitant medications were reported. No treatment related information has been reported.   Reporter did not allow further contact
hives & itching on feet & hands;2 days p/inj of vax swelling of hands p/that sx relieved w/oral DPH;pt pvt MD was contacted by the mom;
Headache, Rash, Itching, gatigue, chills 3-4 days Narrative:  Other Relevant History:
This spontaneous report was received from a 64 years old male consumer refers to himself. The patient was allergic to lisinopril (manufacturer unknown). In June 2013 the patient was vaccinated with ZOSTAVAX (dose and lot # not reported) injection to prevent shingles. Concomitant therapies included ZOCOR. After receiving ZOSTAVAX, in Summer of 2013 approximately in June 2013 the patient developed 3 red dots on his right thumb and right bicep. They were itched but went away in a few months. Approximately 3 to 4 months ago (approximately in January 2014) he developed a red dot on his neck that was still there. It had formed a scab since he irritated it while shaving. The patient showed his pharmacist all these dots. The pharmacist ruled out shingles. Blood work was performed without result. No treatment was given for the events. The patient did not seek medical attention. At the time of the report the patient was recovering from the red dot on his neck and scab. The relationship between the event and ZOSTAVAX was not reported. This case is linked to case 1406USA003356 by same patient link. Additional information has been requested.
patient received an expired dose of TENIVAC with no reported adverse event; Initial information received  on 31-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 40 years old male patient who received an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] with no reported adverse event while receiving vaccine   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 29-Oct-2022, the patient received 0.5ml, once dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (strength, formulation was unknown, lot U6831AA and expiry date: 08-Oct-2022) via intramuscular route in Deltoid NOS for Immunization.  On 29-Oct-2022 the patient developed a non-serious event of patient received an expired dose of tenivac with no reported adverse event (expired product administered)(Latency: same day) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken: not applicable.  Outcome: Unknown  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This patient had Pneumovax in 1993. He was admitted with pneumococcal pneumonia with septic shock and positive blood cultures.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA302269, 2018SA313505 and 2018SA302120. This case involves a child patient who was vaccinated with 0.5 ml IPOL (batch number P1A251M, expiration date 02-May-2020) via intramuscular route in left thigh on 19-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL for Immunisation. It was an actual medication error due to incorrect product storage. It was reported that an open IPOL was administered following 2 excursions. The patient had no adverse event. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
No adverse event. Client did not receive vaccine she thought she received. Powdered vial given with sterile water instead of diluent.
Information has been received from Healthcare Worker concerning to a female patient (age unknown). On unknown date, the patient was exposed to GARDASIL (lot number and expiration date not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient was removing a GARDASIL via from a carton but the vial was cracked, so her hand got wet from exposure to the product from the cracked vial on an unspecified date. No adverse effect reported. Product quality compliance involved. The outcome of her hand got wet from exposure to the product from the cracked vial was unknown. Additional information is not expected.
Rapid heart rate requiring hospitalization and cardioversion (and planned cardiac ablation) six days after administration of first vaccine dose.
Right knee pain and right shoulder pain - patient refused further work up or treatment. Symptoms persist as of 4/23/2020.
This case was reported by a other health professional via call center representative and described the occurrence of rash in a 1-year-old female patient who received DTaP vaccine for prophylaxis. Co-suspect products included DTaP vaccine for prophylaxis and DTaP vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of DTaP vaccine, the 2nd dose of DTaP vaccine and the 3rd dose of DTaP vaccine. On an unknown date, less than a year after receiving DTaP vaccine, DTaP vaccine and DTaP vaccine, the patient experienced rash, hives, condition aggravated and condition aggravated. On an unknown date, the outcome of the rash, hives, condition aggravated and condition aggravated were unknown. It was unknown if the reporter considered the rash and hives to be related to DTaP vaccine, DTaP vaccine and DTaP vaccine. It was unknown if the reporter considered the condition aggravated to be related to DTaP vaccine. It was unknown if the reporter considered the condition aggravated to be related to DTaP vaccine. Additional details were provided as follows: This case was reported by an optometrist who did not administer the vaccines. The healthcare professional called to question whether an 18 year old patient could receive MENVEO despite having had rash and hives to a DTaP vaccine at approximately 1 year of age. The DTaP vaccine was unknown. The healthcare professional stated that the patient, when around 1 year of age, received 3 doses of DTaP and the rash and hives worsened with each dose. No other information was available.