chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shots are painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR117906   Additional Information: GSK Receipt Date: 29-JUL-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient reported that shots were painful but it was a few seconds. The patient stated that after 1st dose he/she had no soreness. Additional Supportive Information: The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR117906:Same reporter.
Severe arm and full body pain, 102 fever, headache, tremors, shaking, fatigue
numbness around the lip; felt thingness around the skin of the lips; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numbness around the lip), FEELING ABNORMAL (felt thingness around the skin of the lips) and PAIN IN EXTREMITY (sore arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Asthma and Thrombosis. Concomitant products included PARACETAMOL (TYLENOL).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (numbness around the lip), FEELING ABNORMAL (felt thingness around the skin of the lips) and PAIN IN EXTREMITY (sore arm). On 26-Jan-2021, HYPOAESTHESIA ORAL (numbness around the lip) and FEELING ABNORMAL (felt thingness around the skin of the lips) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information reported. Patient only took two Tylenol prior taking the vaccine.
Headache beginning Friday (day of vaccine). Increased intensity until Monday. Mild Tuesday. Initial arm pain. Increased arm pain Sunday, Monday, and Tuesday
FLU LIKE SYMPTOMS; ACHEY; CHILLS; NAUSEA; HEADACHE; This spontaneous report received from a parent concerned a 26 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 07-APR-2021, the subject experienced flu like symptoms. On 07-APR-2021, the subject experienced achey. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms, headache, chills, and nausea, and the outcome of achey was not reported. This report was non-serious.
2 days after vaccine I was sitting down for a presentation and slowly started to feel a tightness in my chest that turned into pain and had an ambulance called. There was an xray done at city hospital and the doctor found no cause. Immediately after that I got heavy flu like symptoms(fever phlegm expulsion and bad cough) which lasted 2 to 3 weeks and the pain in my chest persisted off and on along with pain running down my left arm on until August or September of 2022. After the flu like symptoms went away I've also had a case of sinusitis around November of 2021 which was found with an mri of my head. During that time(Nov 2021) I've also gotten a permanent case of tinnitus.
Patient reported 3 weeks after getting his second COVID shot he had immediate fluid retention, shortness of breath and ill feeling.  Felt like he was going to explode.  Did not go to a doctor but managed it on his own.  Patient then received the COVID booster shot on 12/16/21 and reported again after 3 weeks has shortness of breath, weakness and ill feeling.  Patient believes there is a corelation between the shots and his symptoms.  The only medication or medicine he took was a flu shot one month before receiving the booster shot.  No information on the flu shot when/where
Behavior or Conduct change, difficulty breathing, debility, dizziness and beats of heart too fast to 160 per minute.  Treatment: Benadryl with Solumedrol by vein and two serum.
Pt recvd 1 dose of Engerix-B in JAN92 & 2 days post inject, pt exp severe h/a, vertigo, & malaise; tx APAP still persisting as of 13FEB92;
Left deltoid. Area of induration (1.4 x 1.9 cm). Warm/tenderness.
Very sore arm by 3 hours after shot.  Following morning, whole body aches, dizziness, lethargy, chills
This is a serious spontaneous case, initially received from other non-health professional via Novartis on 12-Nov-2018, concerning a 15-year-old, adolescent female patient. On an unspecified date, the patient was administered INN flu vaccine seasonal (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). On an unspecified date after vaccination, the patient developed a huge big swollen welt at the injection site that was sore to the touch. On an unspecified date, the patient developed the flu. At the time of this report, the outcome of the event was not reported.
Shoulder started getting sore; A spontaneous report was received from a physician who is a male that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder getting sore.  The patients' medical history was not provided. No concomitant medications list was provided.  On 23-DEC-2020, prior to the onset of symptoms, patient received the first of two planned doses of mRNA-1273 (BATCH: -unknown) for the prophylaxis of COVID -19 infection.   The patient felt nothing after receiving the vaccine, but 6 hours later he experienced his shoulder started getting sore.   Treatment for the event, shoulder soreness was not provided.    Action taken with planned second dose of mRNA-1273 in response to the event was not provided.  The outcome of the event, shoulder soreness was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaginal bleeding even though post menopausal for over 8 years.  Severe leg cramp.
Pediatric DTap given on 7/11/06, Adult Tdap should have been given and actually was on 8/29/06.
Dizziness, syncope, disorientation.  Seizures and syncope with loss of function on left side started 10/28 with hospitalization, headaches, migraines, nausea, vomitting, rash, acne, fatigue, abnormal blood pressure.
Positive for COVID-19; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Positive for COVID-19) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Feb-2021, the patient experienced COVID-19 (Positive for COVID-19). The patient was treated with BAMLANIVIMAB on 22-Feb-2021 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient received bamlanivimab antibody treatment on 22/Feb/2021.
The pt began with dime sized red rash on both legs on 5/5/01. By 5/6/01 the pt had a rash covering both thighs with a little on her face. The pt was very cranky and tired. The doctor suggested Benadryl. The pt was given Benadryl and symptoms faded gradually.
Immunosuppression; This case was reported by a other health professional via call center representative and described the occurrence of immunosuppression in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included breast cancer (was diagnosed in December 2018). Concomitant products included chemotherapy, nos (Chemotherapy).   In January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced immunosuppression (serious criteria GSK medically significant). On an unknown date, the outcome of the immunosuppression was unknown.   The reporter considered the immunosuppression to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccaination was not reported. At the time of reporting, the patient was completing her chemotherapy and radiation. She stated that, she was having big issues with immunosuppression with the chemotherapy.   The patient really did not see the connection with Shingrix. The reporter consented to follow up.
Information has been received from a pharmacist concerning a 75 year old patient of unknown gender who received two doses of ZOSTAVAX (strength, dose, route, lot# and expiration date were not reported) in error. The first dose of ZOSTAVAX was received on 17-DEC-2011, and the second dose was received on 24-JAN-2015 (extra dose administered). The patient had not reported an adverse experience. It was unspecified if the patient sought medical attention. Additional information has been requested.
Nausea, dizzy, flush followed by cough, throat feeling "funny", pale, sweaty...BENADRYL & EPIPEN given.
This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 54-year-old female patient who received SHINGRIX for prophylaxis.  On 27th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms. On 29th July 2018, the patient experienced localized erythema, pruritus, swelling and feeling hot. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the localized erythema, pruritus, swelling and feeling hot were not recovered/not resolved and the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the localized erythema, influenza-like symptoms, pruritus, swelling and feeling hot to be related to SHINGRIX. Additional details were provided as follows: The patient received her 2nd SHINGRIX vaccination in left arm on Friday night on 27th July 2018 and developed a red spot yesterday on 29th July 2018 which was oval shaped, big, swollen, hot and itching. She stated that the injection was lower on her arm than the previous dose, she had taken Benadryl but it had had no effect on the area. This case has been linked with case US2018136201, US2018136203 and US2018136205 reported by the same reporter.
Fatigue; Body ache; fever (100F )/low grade temperature (99.6/99.8); Slight headache; Dry cough; This is a spontaneous report from a contactable consumer (patient).   A 72-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EP7534, Expiry Date: Not Reported), via an unspecified route of administration, administered in Arm Left on 01Apr2021 at 13:15 (age at vaccination was 72-year-old), as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included Monitoring Thyroid Nodule and penicillin allergy. The patient previously took penicillin b and experienced rash. The concomitant medication included atorvastatin (ATORVASTATIN), and acetylsalicylic acid (ASPIRIN 81) taken for an unspecified indication, start and stop date were not reported. The patient received these medications within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6203, Expiry Date: Not Reported), via an unspecified route of administration in arm left on 11Mar2021 at 13:30 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID-19 since the vaccination. On 02Apr2021, at 19:00 the patient received fatigue, body ache and fever (100F) on the first and second days after the second dose vaccination. Thereafter low-grade temperature (99.6/99.8) in the early evenings accompanied by slight headache for the past week which goes down late evenings. Taking Acetamenphane 500mg before bedtime. Running a temperature every evening for the last 15 days after the 2nd dose vaccination. Highest temp 100.8. Normal temp in the mornings. Dry cough for the last 4 days. The patient underwent lab tests and procedures which included body temperature: 99.6/99.8 Fahrenheit (Low grade temperature (99.6/99.8) in the early evenings) on 02Apr2020, body temperature: 100 Fahrenheit on 02Apr2021, sars-cov-2 test (Nasal Swab): negative on 06Apr2021 and blood test and urine test on an unspecified date. The patient took Acetamenphane 500mg before bedtime as a treatment for the events fever (100f)/low grade temperature (99.6/99.8) and dry cough. The adverse event fever (100F)/low grade temperature (99.6/99.8) and cough led to physician office visit. The patient did not receive any treatment for fatigue and body ache. Outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected
I get severe headaches almost daily. I get nauseated almost daily. I've now begun throwing up weekly from the nauseation. I have sleepless nights almost every other day. I would go to the doctor but I don't know what they could actually do for me. I used to be extremely active, working out 5+ days a week. Now I go to the gym only a few days a week because I get so light headed after a short amount of time from even the littlest workouts. I've thrown up from jogging for 5-10min and have almost passed out in the shower many times.  I have zero health issues. Completely healthy 29 year old. This all started a couple months after getting the vaccine. I don't feel like my normal self anymore.
COVID 19 Treatment; COVID 19 Treatment; Dose 1, dose 2, dose 4: Pfizer / Dose 3: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 49 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0158), in left arm and on 06May2021 as dose 2, single (Lot number: EW0171), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Dec2021 as dose 3 (booster), single (Lot number: 030H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Livedo reticularis" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing). Known allergies: Yes. Concomitant medication(s) included: FLONASE SENSIMIST ALLERGY RELIEF; VIT D [VITAMIN D NOS]; ZINC. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2022, outcome "unknown", described as "Dose 1, dose 2, dose 4: Pfizer / Dose 3: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Apr2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Apr2023) Negative; (07Apr2023) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical information: First Covid symptoms on 05Apr2023 and tested negative. Tested positive for Covid on 07Apr2023. Anti-viral details included COVID 19 Treatment was started Paxlovid (300mg; 100 mg Dose pack, lot number= GG1442) on 08Apr2023 and Finished last dose of Paxlovid (stop date) on 13Apr2023.
Diarrhoea; Chills; Pyrexia; Exposure during breastfeeding; This case was received  (Reference number: 0936865) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREASTFEEDING (Exposure during breastfeeding), DIARRHOEA (Diarrhoea), CHILLS (Chills) and PYREXIA (Pyrexia) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Peanut allergy, Allergy to nuts (Allergic to pecan), Allergy to nuts (Allergic to nuts) and Stomach flu. Concomitant products included SERTRALINE for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING BREASTFEEDING (Exposure during breastfeeding). On 09-Jan-2021, the patient experienced DIARRHOEA (Diarrhoea), CHILLS (Chills) and PYREXIA (Pyrexia). At the time of the report, MATERNAL EXPOSURE DURING BREASTFEEDING (Exposure during breastfeeding) outcome was unknown and DIARRHOEA (Diarrhoea), CHILLS (Chills) and PYREXIA (Pyrexia) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she experienced symptoms of chills, pyrexia, diarrhea and exposure during breastfeeding.  No treatment information was provided.   This case was linked to MOD-2021-249287 (Parent-Child Link).   See case MOD-2021-249287 for details regarding the child case.
NO ADVERSE EVENT; IMPROPERLY STORED proquad; This spontaneous report was received from a medical assistant regarding a 4 year old patient. The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent. On 19-SEP-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (product storage error) therapy type rha and lot # S013715 and expiry date 01-NOV-2020, (strength, dose, route, were not reported) for prophylaxis. The medical assistant described that diluent that was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was properly stored. No adverse events reported. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was stored at temperature of 5 degree foreign heat to 46 degree foreign heat for 6 hours and 15 minutes, there was no previous temperature excursion and no data logger.
First dose I had mild fatigue and chest pain for about 1 hour.  Second shot I felt a little confused, abdominal pain, chest pain, fatigue and headache.    Chest pain lasted 2 days on and off.  Abdominal pain has lasted over a week.  It has gotten better, but Im still bloated from it.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299815, 2018SA299809, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299814, 2018SA299805, 2018SA299794, 2018SA268354 and 2018SA299808 (cluster). This case involves 71 years old female patient (height: 67 and weight: 204) who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, 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 holders 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.
My period has become full of clots. It was incredibly humiliating as I was standing at a gas pump when I felt a pop and clumps of blood started pouring down my legs. I have always had a very healthy period but after the first vaccine dose, I had clumps of blood and major cramping. After the second dose, I again experienced major cramp and incredible bloating. But the extreme clumping and clots of blood pouring down my legs at a gas pump in front of other patrons was aweful, humiliating, and it is a disgrace to think we can promote this to people!
Started to not feel well 10 hours after injection.  About 12 hours after the injection I had nausea, vomiting, fever, headache.  Symptoms ended about 24 hours after injection.
Patient did not experience an adverse event. The vaccine had undergone one freeze thaw excursion. Upon speaking to Pfizer and reviewing information provided by them, it was determined that the safety and efficacy of the vaccine had not been compromised.
received YF-VAX via intramuscular route instead of subcutaneous route with no reported Adverse event; Initial information was received on 06-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 22 years old female patient who experienced received yellow fever vaccine -[YF-VAX] via intramuscular route instead of subcutaneous route with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included typhoid vaccine (Typhim) for Immunisation.  On 06-Feb-2023, the patient received once a dose of suspect yellow fever vaccine - (strength: standard, lot number: UJ654AB, formulation: Unknown) via intramuscular route in the left deltoid instead of subcutaneous route with no reported adverse event (incorrect route of product administration) (latency: same day).  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event received yf-vax via intramuscular route instead of subcutaneous route with no reported 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 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.; Sender's Comments:  01479362: