chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bottom of face is still swollen- Feels like there's liquid in it; Had plastic surgery and those scars are redder today; headache; arm was hurting; swollen face/ swelling in face/ bottom of face is still swollen- Feels like there's liquid in it; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) (at the age of 56-years-old) as 1STDOSE, SINGLE for covid-19 immunisation. Medical history included facial surgery/face lift on Nov2020 and plastic surgery from an unknown date and unknown if ongoing. The concomitant medications were not reported. The patient previously took botox on Nov2020. The patient stated that had a face lift in Nov2020 and her face was slow to heal. Patient reported a swollen face after receiving the first dose of the pfizer covid 19 vaccine along with a headache on 30Jan2021. Patient wanted to know was the swollen face because her facial surgery had not healed or was it a reaction to the vaccine. On Sat- 30-40 min later, patient had swelling in face and her arm was hurting yesterday- headache today and bottom of face was still swollen and Feels like there's liquid in it. In Nov caller had plastic surgery and those scars were redder today. Patient wanted to know what she could take for her headache that she thought was related to the pfizer covid 19 vaccine. The patient was enquiring about any information regarding the use of the pfizer-bioNTech covid-19 Vaccine in people who have cosmetic fillers or Botox. Patient stated that she never had anaphylaxis to a vaccine and she had face lift surgery in Nov. Wanted to know if she had an allergic reaction to the vaccine or if it was from the surgery and she was not fully healed. Also stated that her left arm was hurting yesterday but was fine today. Outcome of the events swollen face/swelling in face/ bottom of face is still swollen- Feels like there's liquid in it and headache was not recovered. Outcome of the events arm was hurting, bottom of face is still swollen- Feels like there's liquid in it and had plastic surgery and those scars are redder today was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): 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.
This is what I wrote to my Dr.:  I was able to get a shingles vaccine yesterday. Everything went smoothly except I got a rxn during the night. I got very fatigued (went to sleep 9:30) and around 11p I started to get the shivers. I tried to go back to sleep but around midnight the shivering woke me up again. I couldn't stop. I put on more clothes and returned to bed. I woke several times during the night and by 4a I had pretty much stopped. I took off the clothes that I put on earlier because I was getting warm. This morning I feel only only slight residual shivering. My arm with the injection is much stiffer that yesterday but I don't think it is serious. I am letting you know because I plan to report this to VAERS. I don't think this is enough to prevent me from getting the second vaccine.
they feel unomfortable towards neck; A rash on the arm ,it is blotched and red; SORE ARM; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (SORE ARM), MUSCULOSKELETAL DISCOMFORT (they feel unomfortable towards neck) and RASH (A rash on the arm ,it is blotched and red) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (SORE ARM). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (they feel unomfortable towards neck) and RASH (A rash on the arm ,it is blotched and red). On 22-Jan-2021, PAIN IN EXTREMITY (SORE ARM) had resolved. At the time of the report, MUSCULOSKELETAL DISCOMFORT (they feel unomfortable towards neck) and RASH (A rash on the arm ,it is blotched and 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.
flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included flu shot (gets yearly).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The case was reported by patient's wife. The patient experienced flu-like symptoms for a couple days. The side effects were expected and left after a day or so. The reporter did not specify if side effects occurred after dose 1 or dose 2 or both. The reporter stated that she was certain that her husband does not want GlaxoSmithKline to contact his doctor. The reporter did not consent to follow-up. For 2nd dose, refer case US2021AMR193164, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192908:same reporter US-GLAXOSMITHKLINE-US2021AMR193160:same reporter
Chills, achy, swollen arm where injection was put. Arm sore for about a week.
3/26/2023 I was out of the country and had a funny feeling, a tickle, dry throat and I was feeling congested and tired. I found out several people I was with had been diagnosed with COVID. On 3/28/23 I tested negative with an at home COVID test. I took another at home COVID test this morning and it was negative. This is the worst thing I have had in 10 years. Today I am feeling fatigued, congested, my throat hurts, I am coughing and can feel it in my chest. I spoke with my doctor yesterday and she will not prescribe PAXLOVID unless I have a positive COVID test.
pt recvd vax 19FEB96 & later that day pt reports rt arm painful & enlarged;21FEB96 remains painful rt arm 2.7cm;lt upper arm 22cm;
Feelings of passing out/dizziness; room spinning; nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feelings of passing out/dizziness), VERTIGO (room spinning) and NAUSEA (nausea) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included METFORMIN and ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DIZZINESS (Feelings of passing out/dizziness), VERTIGO (room spinning) and NAUSEA (nausea). The patient was treated with DIMENHYDRINATE (DRAMAMINE) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Feelings of passing out/dizziness), VERTIGO (room spinning) and NAUSEA (nausea) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: normal (normal) Normal. On an unknown date, Blood pressure measurement: normal (normal) Normal.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
vaccination stirred up herpes zoster; I have a breakout; pustules on sacral area; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (vaccination stirred up herpes zoster), ACNE (I have a breakout) and PUSTULE (pustules on sacral area) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. declined) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (vaccination stirred up herpes zoster), ACNE (I have a breakout) and PUSTULE (pustules on sacral area). At the time of the report, HERPES ZOSTER (vaccination stirred up herpes zoster), ACNE (I have a breakout) and PUSTULE (pustules on sacral area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact
Brought the patient back into the room for his first COVID-19 Pfizer vaccination. Verified name/birthdate. Went to inject the vaccine, inserted the tip of the needle into the right deltoid as I realized I had not pulled up the vaccine into the syringe. Quickly removed the tip of the needle and stated, "I am so sorry I got ahead of myself and did not pull up the vaccine into the syringe. I typically do that before the patient comes back, I'm so sorry." Pt stated, "It's okay, its fine no problem." Nothing was administered, there were no air, vaccine or medication in the syringe when the needle was inserted. Pt did not appear upset. Changed needles, pulled up the vaccine into the syringe in front of patient, showed it to him, injected the vaccine into the right deltoid no issues. Pt waited 15 minutes in the lobby with no reaction. Left without questions, complaints or issues. Occurrence report submitted.
Febrile seizure, 10/24/08, 9:00 pm - hospital ER.
3 months p/recvd last of 3 Engerix-B titer showed pt did not seroconvert;
2 days after flu shot was administered patient developed hives on chest, stomach and back. Pt has had flu shots before and also took MUCINEX during this time.
low grade fever; A spontaneous report was received from a consumer concerning a 56-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events low grade fever, fever now at 101 degrees.  The patient's medical history was not provided. Concomitant medications reported were levothyroxine, metformin, insulin for drug use for unknown indication.  On 16 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 042L20A) via unknown route for prophylaxis of COVID-19 infection. On 10 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) low grade fever. On 12 Feb 2021, the patient experienced the event(s) fever now at 101 degrees.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), low grade fever, fever now at 101 degrees was unknown.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired first primary dose after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 7-Nov-2022 which expired on 17-Nov-2022 and was administered on18-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 10-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received an expired first primary dose after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 7-Nov-2022 which expired on 17-Nov-2022 and was administered on18-Nov-2022).    No concomitant medications were reported. The vial size was 2.5 mL. The vial was initially stored in the refrigerator on 7-Nov-2022. Th vial did not  undergo any temperature excursions. No treatment medications were reported.
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves an unknown gender 36 months (reported as more than three years) old patient who was vaccinated with a 0.25ml dose of FLUZONE QUADRIVALENT (Batch number: UT6315TA, expiration date: 30-Jun-2019, and site of administration: left thigh was not reported) on 09-Nov-2018 instead of 0.5 ml. The patients' medical history were not reported. No other vaccines given at that time. It was an actual medication error due to vaccine underdose. It was unknown whether patient experienced any adverse event following vaccination. 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.
Pt has very swollen arm with redness spreading down several inches from injection site. Pt arm is warm to touch. Pt was seen by physician on 03/13/2017 at 8:40 AM and given medication to help with swelling and told to come back if it does not get better in a couple days.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M009786, expiration date: 26-MAY-2017) (dose and route of administration were not reported). No adverse effects were noted in any patients. Administered doses of vaccines experienced the temperature excursion of 0.4 degrees Celsius for 89 hours and 5 minutes. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected, as there was no consent to contact with the reporter.
Extremely sore arm at injection site; Fever; Chills; Nausea; Lethargy; This case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (in approximately 1971). Concurrent medical conditions included hypothyroidism. Concomitant products included levothyroxine.   In September 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, fever, chills, nausea and lethargy. On an unknown date, the outcome of the injection site pain, fever, chills, nausea and lethargy were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever, chills, nausea and lethargy to be related to Shingrix.     Linked case(s) involving the same patient:  US2023001647   Additional Information: GSK receipt date: 06-JAN-2023 Reporter's comment: The patient self-reported this case. The patient had her initial shingles vaccine in September 2022.  She had an extremely sore arm at injection site, fever, chills, nausea and lethargy for 24 hours.  The symptoms were not treated. The reporter consented to follow up. Additional Supportive information: For tolerance of 2nd dose refer case US2023001647, reported by same reporter.; Sender's Comments:  US-GSK-US2023001647:Same reporter
Achy; chills; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), CHILLS (chills) and PYREXIA (Slight fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and PRAVASTATIN for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PAIN (Achy), CHILLS (chills) and PYREXIA (Slight fever). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN (Achy), CHILLS (chills) and PYREXIA (Slight fever) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
CHILLS, FEVER, BODY ACHES, MUSCLE ACHES, HEADACHE, PAIN AT INJECTION SITE, ITCHING AT INJECTION SITE, BRAIN FOG, ALL SYPTOMS DISAPPEARED WITHIN 24 HOURS EXCEPT SOME HEADACHE, BRAIN FOG, PAIN AND ITICHING AT INJECTION SITE, WEIRD DREAMS
Sore arm  first 4 days Chills- first 3 days Rash at injection site - since vaccine & currently Tinnitus- since vaccine & currently Vertigo symptoms- since vaccine & currently
first dose November 14, 2019, has not received second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th September 2019, 0.5 ml).   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 reporter was patient. The age at vaccination was not applicable for this report. The patient stated that she received her first dose of Shingrix and still had not received the second dose, which led to incomplete course of vaccination. No lot or expiration date was known. The reporter did not consent to follow-up.  The reporter declined to provide any demographics, date of birth or health care professional information.
I started sleeping all day after vaccination and for 2 days after slept more than 16 hours a day. I had severe body aches, chills, fatigue, cough and it exacerbated my asthma symptoms, but no fever. On December 26, I went to the emergency room due to shortness of breath that was not improved by albuterol inhaler or respiratory therapy. Metrol pack was prescribed and I have felt better since.
Severe arm muscle pain, Excruciating shoulder pain, severe swelling, redness, bruising, and hot to the touch at injection site, muscle weakness in arm - can't lift or grasp anything, fatigue...all symptoms remaining still 7 days later.
In for third dose of rabies pre-exposure (occupation risk) reports that after second dose she developed (R) side neck pain and swollen glands about 15 min. after #2 vaccination. About an hour (may have been a little sooner) developed nausea, dizziness and chest tightness that lasted 3-4 hours (reports she didn't feel it was a panic attack). Call to local allergist who recommended she be given (first allergy tested) the vaccine under the supervision of an allergist. Client will be setting up appt to do so.
Soreness, Lethargic, Skin discoloration, sore breasts and under arm soreness.
Is shortness of breath common after second dose of moderna vaccine?; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Is shortness of breath common after second dose of moderna vaccine?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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, the patient experienced DYSPNOEA (Is shortness of breath common after second dose of moderna vaccine?). At the time of the report, DYSPNOEA (Is shortness of breath common after second dose of moderna vaccine?) outcome was unknown. Not Provided          no concomitant medication were reported no treatment information was provided
quarter-sized red lump below DTP site; no tender, no drainage; 1MAR93 sm lump size of dime sm bruise; no other signs;
I ovulated early (day 11) and my menstrual cycle was only 21 days long. I am actively trying to get pregnant so I have 1+ years worth of cycle history to show that this 21 day cycle, 10 day luteal phase and day 11 ovulation was an abnormal event.
Sore left arm for 2 months; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breat cancer treatment", start date: Sep2017 (unspecified if ongoing), notes: Breast cancer treatment starting, September 2017. Concomitant medication(s) included: LETROZOLE; ZINC; QUERCITIN; VITAMIN C [ASCORBIC ACID]. Vaccination history included: pfizer / biontech (Dose 3 (Booster), single, Vaccine lot number: FF8839, vaccine location: Left arm), administration date: 26Sep2021, when the patient was 74-year-old, for COVID-19 Immunization; pfizer / biontech (Dose 2, single, Vaccine administration time: 12:45PM , vaccine lot number: EL9267 , vaccine location=Left arm), administration date: 25Feb2021, when the patient was 73-year-old, for COVID-19 Immunization; pfizer / biontech (Dose1, single, Lot number: EL9269, vaccine location: Left arm), administration date: 04Feb2021, when the patient was 73-year-old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Jun2022 at 08:00, outcome "not recovered", described as "Sore left arm for 2 months". Therapeutic measures were not taken as a result of pain in extremity. Additional information: Patient had no known allergies. patient experienced Sore left arm for 2 months and Recurrence of illness with a positive test after testing negative with a 10 day isolation. No follow-up attempts are possible. No further information expected.
One day after the shot a furuncle swollen on my right axillae, the pain level is 3.
Patient with headache to crown of head since 4/12/21.  No history of thrombosis.  Tylenol resolves the headache for 4 hours, then it comes back.  Patient is treated with IV Tylenol and IV fluids.
Reports hot/cold shivering started 6/25 then started with nausea, vomiting & Diarrhea. Chest pain/pressure started 6/29 and went to hospital. MD reports increasing Troponin so admitted to hospital for ECHO & Cardiac Cath. Discharged on 6/30. Still reports Fatigue