chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site warm to touch; Injection site redness; Injection site swollen up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site warm to touch), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swollen up) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical history was reported by the reporter.  Concomitant products included APIXABAN (ELIQUIS), FLECAINIDE, KETOROLAC TROMETHAMINE (TORADOL), POTASSIUM CHLORIDE, ATORVASTATIN, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ) and PREGABALIN for an unknown indication.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site warm to touch), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swollen up). At the time of the report, VACCINATION SITE WARMTH (injection site warm to touch), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swollen up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
About 2 weeks after the 2nd Covid shot I started getting flu like simptoms,  A few days later I started getting a painfull, red itchy rash on my face.  It eventually spread to my neck and scalp.  At first my doctor thought it was celulitus and gave my Doxycycline for 7 days.  It helped  reduce inflamation but as soon as I finished the Doxycycline the rash got worse and spread to my neck and scalp..
This case was reported by a nurse via call center representative and described the occurrence of bloating in a 43-year-old female patient who received TWINRIX (batch number 3HG77, expiry date 3rd July 2020) for prophylaxis. Concomitant products included VIVOTIF and hormonal contraceptives for systemic use (Oral Contraceptives). In March 2018, the patient received the 2nd dose of TWINRIX 1 ml. In March 2018, less than a month after receiving TWINRIX, the patient experienced bloating, nausea and gas. On an unknown date, the outcome of the bloating, nausea and gas were recovered/resolved. It was unknown if the reporter considered the bloating, nausea and gas to be related to TWINRIX. Additional details were reported as follows: The age at vaccination was not reported, but it could be 42 or 43 years old. The patient had no drug allergies. In 2018, around same time frame of vaccination with TWINRIX, the patient received VIVOTIF (other manufacturer). The reporting nurse administered TWINRIX to the patient in the left deltoid and she reported that, the patient experienced bloating, gas and slight nausea at the end of March. The patient made some dietary changes and her symptoms were resolved on unknown date in 2018.
Pain at injection site; experienced pain; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix. In FEB-2023, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: experienced pain). On 07-JUN-2023, the patient experienced injection site pain (Verbatim: Pain at injection site). The outcome of the injection site pain and pain were not reported.   It was unknown if the reporter considered the injection site pain and pain to be related to Shingrix.     It was unknown if the company considered the injection site pain and pain to be related to Shingrix.   Additional Information: GSK Receipt Date:07-JUN-2023 The case was reported by patient who was nurse. The reporter stated that after self injecting shingrix in February experienced pain and reported pain at injection site on the day of reporting. The reporter did not consented to follow up.
About 10 hrs p/vax, mom described PT becoming fussy; PT turned yellow, lips purple; PT was limp & staring; brought to ER where exam was normal;
Patient had reaction to COVID-19 vaccine. Patient was monitored after COVID-19 vaccine as recommended per agency guidelines.  The following reaction signs/symptoms were observed: difficulty swallowing, nausea and other : felt "woozy," felt like tongue and throat were swollen. Patient in passenger seat of car with her husband in driver's seat. Symptoms started about 5 minutes after vaccination. Pt reports that she is on BP meds for the last few months, took her BP meds today, lately BP ~120/80. She did eat lunch before coming. Called EMS due to feeling of tongue, throat swelling. EMS arrived, assessed pt, released her to home with her husband.
Cold; This case was reported by a consumer and described the occurrence of cold in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   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 cold. On an unknown date, the outcome of the cold was recovering/resolving.   It was unknown if the reporter considered the cold to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient experiencing a cold since receiving the first dose. The patient asked whether the patient could received 2nd shot if the patient recovering from a cold.
arm is like reddish where they gave me the shot and itchy; arm is like reddish where they gave me the shot and itchy; if she lays down in that side, it is sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (arm is like reddish where they gave me the shot and itchy), INJECTION SITE ERYTHEMA (arm is like reddish where they gave me the shot and itchy) and INJECTION SITE PAIN (if she lays down in that side, it is sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (arm is like reddish where they gave me the shot and itchy), INJECTION SITE ERYTHEMA (arm is like reddish where they gave me the shot and itchy) and INJECTION SITE PAIN (if she lays down in that side, it is sore). At the time of the report, INJECTION SITE PRURITUS (arm is like reddish where they gave me the shot and itchy), INJECTION SITE ERYTHEMA (arm is like reddish where they gave me the shot and itchy) and INJECTION SITE PAIN (if she lays down in that side, it is sore) outcome was unknown.            No concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.
immediate hot burning up shoulder, neck into head and across forhead into an instant migraine,  profuse sweating, sharp stomach pain, nausea, vertigo, fatigue, dizzy, confusion, vision blirry, stiff neck
Extreme fatigue, confusion/"brain fog," and chest tightness which have mostly subsided. Tinnitus: Loud ringing in ears has not stopped.
Fatigue and body aches throughout entire body for the first 20 hours.  Angioedema reaction started 48 hours after the injection including swelling of both hands, left foot, and top lip.
This spontaneous report was received from a doctor of pharmacy concerning an approximately 76 year old female patient with hypothyroidism and with no drug reactions or allergies. On 04-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. Approximately on an unknown date in July 2013, the patient experienced pain in her whole arm after receiving ZOSTAVAX and she was having difficulty in raising her arm in the air. She was waking up earlier than usual because she was having difficulty sleeping due to the pain. The patient sought medical attention (contacted pharmacist). She was treated with ibuprofen. It was unspecified if any lab tests were performed. The patient was not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Around 7pm the day after my daughter received her second shot (received shot on 12/6 around 3:45pm), we noticed a red slightly bumpy rash on her chest and on her stomach near her waist line. She said it was itchy. She did not have a fever or any other symptoms. We put some cortizone cream on the rash.  I don't believe it will require any follow up but I did notify our pediatrician's office.
This spontaneous report as received from a other licensed practical nurse refers to a patient of unknown age. On 13-SEP-2013 the patient was in the office for vaccination with GARDASIL dose 2 (dose and route not provided). It was reported that the first dose of GARDASIL was administered over a year ago, on an unspecified date. No adverse effects reported. Additional information has been requested.
Pt c/o itching and mild swelling to back of arm (site of Var vaccine). Applied ice. Symptoms worsened and by day 2 the area was red and swollen. Came into office and was measured 60mm X 65mm in diameter. Referred to her physician.
Patient received the Moderna Covid-19 vaccine monovalent instead of the bivalent vaccine for the booster dose; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine monovalent instead of the bivalent vaccine for the booster dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine monovalent instead of the bivalent vaccine for the booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine monovalent instead of the bivalent vaccine for the booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine monovalent instead of the bivalent vaccine for the booster dose).    No concomitant medications were reported.  The reporter stated that this medication error had happened because the monovalent vaccine with the purple border was labeled as booster doses.  No treatment information was provided.
Pt. reports that baseball-sized swelling occurred from injection site, urgent care diagnosed as cellulitis. Pt has been given antibiotic and BENADRYL to treat.
Sore throat, fever, cough. Got worse as day went on. Today is Saturday 12/05/2009 symptoms getting better, throat not sore, still have nasty cough and fever.  Called doctor's office on Wednesday because fever kept going up and just not feeling good at all. Was told it was a reaction, and that it could take several days to be well again.   Then someone told me I should come to this site and infor you of reaction.
Around the 20-22nd of November, the patient began feeling ill and weak. These symptoms progressed to the point that she needed to use a walker to ambulate. She sought medical attention in the emergency department on the 24th of November.
Patient got spikevax on 10-14-23 IM in the left arm. Two days later the patient started having intermittent sharp pain lasting up to 30 seconds at and around the injection site. She did not take anything to treat the pain. She did not check for any redness, heat or swelling. She still had the bandaid on from the vaccine administraion. We went to the vaccine room and she removed the bandaid. No redness, swelling or heat was found. I encouraged the patient to continue to moniter her arm and seek medical attention if the pain worsened or if it started showing signs of infection. She agreed.
I contracted COVID-19 on 06/12/2022 with symptoms scratchy throat, laryngitis, cough, and fatigue. I was prescribed PAXLOVID on 06/15/2022, but I did not take it. I was prescribed a cough pill that I did take. I was ill for 8 days before my symptoms began to resolve. I am fully recovered with no lingering symptoms.
Information has been received from a pharmacist concerning a 68 year old male patient with lymphoma in October 2004 (reported as "six years ago") and no drug reactions or allergies, who on 18-OCT-2010 was vaccinated SQ in the left arm with a dose of ZOSTAVAX (Merck) (lot # not reported). There was no concomitant medication. On 19-OCT-2010 the patient developed redness, induration, warmth and itching at the injection site of the left upper arm. The patient stopped by the pharmacy and the pharmacy reported the size of the reaction area to be 2 inches by 3 inches. No therapy was prescribed. No lab diagnostics studies were performed. At the time of reporting, the patient's outcome was unknown. Follow-up information was received from a pharmacist who stated that the patient had truly recovered. No further information is available.
Pt called indicating symptoms started developing on 8/15/2010. A hard lump, redness w/ swelling at injection site and quite sore. She will keep me abreast as symptoms continue or subside.
patient called 07/16 - had vaccine on 07/13 - has redness, swelling, tenderness, itching at the vaccine site for 3 days - has not improved with advil or tylenol,
Patient received H1N1 inj. vaccination 11/18/09. 24 hrs. later. according to mother, he had sensation of being "unable to feel his legs," nausea, dizziness. Remained able to walk normally. Taken to physician who recommended mother call HD to report adverse effect. Weakness, numbness in legs, fatigue persisted x 24 hrs then resolved completely. (RN called Dr, spoke with nurse: All symptoms resolved when seen by Dr.)
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medications were reported.   No treatment details were reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  This case contains information for 113th out of 190 patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact, Sender's Comments:  MODERNATX, INC.-MOD-2023-704335: Master case
Passing out five minutes after dose, extreme dizziness for 24 hrs and randomly passing out. Numbness, which after about 10 hrs turned into extreme tingling sensation in feet, legs, hands, arms, face and neck. Tingling sensation is still present to this day 2 months after first vaccination however it comes and goes, especially present under periods of stress which never happened before until I received the vaccine. I haven?t not received the second dose because I?m too scared I will completely lose feeling in my body and it will never returner I will develop Guillian-Barre syndrome as a result.
patient reports mild facial itching and rash; limited to face only; no rash on trunk or extremities. no other complicaitons.
-reported adverse event on 10/21. when he is felling better. - symptoms start w/ abdominal pain (close to chest). Follow w/ nausea 10/16 feeling that developed to full blown N/V on 10/17 and diarrhea - symptoms slowly subsided, i.e: ability to leave food down. - also experiencing back pain: stomach pain due to constant heaving. - feel better by 10/20 ("normal/patient) this might be unrelated to vaccination since some of  8590 better/patient- lethargic *his coworker experienced similar symptoms.
Body aches; tired; headaches; Just overall a not feeling well arm sore at injection site; Just overall a not feeling well arm sore at injection site; Some chest pain very minor; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: was not reported), via an unspecified route of administration, administered in Arm Left on 23Jul2021 17:30 as 2nddose, single for covid-19 immunisation (age at vaccination was 52 years). Historical vaccine was A 52-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: was not reported), via an unspecified route of administration, administered in Arm Left on 02Jul2021, 04:30 PM as 1st dose, single for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications were not reported.  The patient experienced body aches, tired, headaches, just overall a not feeling well arm sore at injection site, just overall a not feeling well arm sore at injection site, some chest pain very minor on 24Jul2021 10:00. No treatment was received. No, covid prior vaccination. If covid tested post vaccination was no. The clinical outcome of the events was recovering.    Follow-up attempts are completed. No further information is expected.
Patient originally enrolled in COVID19 vaccine trial but tested COVID19 Positive 1/7/2021 and loss smell and taste. She has since been tested 1/21, 1/29, 2/17 & 5/19. Four of these tests were done during and with the Pfizer study for adolescents.  She then came in 5/19 for her 1st Covid vaccine and came also came back positive and experienced a fever and chills after the injection, which mom associated it with her previously having Covid until that test came back positive too. Symptoms since after her vaccine include decreased appetite due to nausea, severe abdominal cramps and when she has a BM it is liquid. Patient reports when she touches cold metal her hands feel as if they are being shocked or burned.  Having Headaches and very fatigued will sleep 12 hours+.
9/23/13-Pt. states as soon as she left her R shoulder became painful and is increasing in pain. 9/28/13 Pt called with complaint but told they are unable to assist. Went to hospital. B/P today 110/70. Still complaining of R shoulder pain.
significantly high fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (significantly high fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024MZOA) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy. Concomitant products included VITAMINS NOS for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (significantly high fever). On 15-Mar-2021, PYREXIA (significantly high fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment was reported. Concomitant medication included allergy pills (unspecified) over the counter   This case was linked to MOD-2021-237395 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up information received on 09-Jul-2021 contains no new information
HYPOTENSION 2/20/2022 ADENOCARCINOMA, RIGHT LUNG MIDDLE LOBE ACUTE RESPIRATORY FAILURE 2/25/2022 ADENOCARCINOMA, RIGHT LUNG MIDDLE LOBE ACUTE ON CHRONIC RESPIRATORY FAILURE 2/20/2022 ADENOCARCINOMA, RIGHT LUNG MIDDLE LOBE HYPOTENSION 2/20/2022 ADENOCARCINOMA, RIGHT LUNG MIDDLE LOBE ACUTE RESPIRATORY FAILURE 2/25/2022 ADENOCARCINOMA, RIGHT LUNG MIDDLE LOBE ACUTE ON CHRONIC RESPIRATORY FAILURE 2/20/2022 ADENOCARCINOMA, RIGHT LUNG MIDDLE LOBE
This spontaneous report was received from a pharmacist (who is also the female patient of unknown age) referring to herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The pharmacist reported that while she was drawing up ZOSTAVAX into a syringe, a few drops leaked out of the syringe onto her hand on 20-JUL-2017. No adverse effects were reported. It was also reported that the dose of ZOSTAVAX was not administered to a patient.
None--medication error. Dose 2 was given 15 days after Dose 1. Pt reported he forgot date of #1 and misreported on VAR. Pt reported only a sore arm x 24 hrs
Within 20 min or so of injection I turned bright ruddy, red in the face, almost purplish.  I did not feel allergenic or odd yet, but looked prety striking. By the time I arrived home 45 minutes after the shot my eyes were puffed almost closed and I had some minor wheezing. I immediately took four 25 mg Benadryl and used my rescue inhaler (albuterol).  By about 1 hour later the reaction was abating and I still felt odd/allergenic plus drowsy from the Benadryl. By  3 hours later my eyes were less puffy, breathing was fine, and no further adverse reaction occurred.  After such a reaction eyes were weird and crusty in the morning but it was just leftover.
Hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurt) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Hurt). At the time of the report, PAIN (Hurt) 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 provided. Treatment medications were nor provided