chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developped occasional pain in chest, under left arm pit moving toward nipple,  1-1.5 min. Although none since hospitalization 2/15-17/2021 dx atypical angina, hypertensive urgency- started on chlorithalidone
This spontaneous report was received from a nurse practitioner refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions and allergies was unknown. Concomitant therapy included sterile diluent. On an unknown date, the patient was inadvertently vaccinated with one dose of PROQUAD intramuscularly (units and frequency were unknown) (lot # M047303 and expiration date 29-MAY-2018) and one dose of VARIVAX (units and frequency were unknown) (lot # N019127 and expiration date 22-JUN-2019) at the same visit. The nurse practitioner reported the PROQUAD was checked by four different people who did not notice the varicella on the label because the writing wraps around the label and she thinks varicella should be printed underneath the measles. No adverse effects were reported. There was no product quality compliant reported. Lot number [M047303] has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live].
Administered vaccine that was stored at temperature between negative 80 degree F to negative 84 degree F; Administered vaccine that was stored at temperature between negative 80 degree F to negative 84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between negative 80 degree F to negative 84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between negative 80 degree F to negative 84 degree F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 5:05 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 5:05 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between negative 80 degree F to negative 84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between negative 80 degree F to negative 84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between negative 80 degree F to negative 84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between negative 80 degree F to negative 84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month.The vial was in frozen state at the time of the excursion and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19 Nov 2021, when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator.The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator.No vaccine state changes were noticed.The vaccine was never refrozen. None of the vials were punctured.No previous temperature excursions were reported.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
This spontaneous report as received from a registered nurse refers to a 1 year old patient. On 31-OCT-2014 the patient was vaccinated a dose of PROQUAD (Merck) (lot # unknown) 0.5 ml, intramuscular and VARIVAX (Merck) (lot # unknown) 0.5 ml, intramuscular. No adverse events were reported. It was unknown if the patient had sought medical attention. Action taken was not provided. The outcome was unknown. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "hashimotos thyroiditis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LISINOPRIL; HCTZ; PRILOSEC; LEXAPRO. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin", notes: Augmentin; Biaxin, reaction(s): "Known allergies: biaxin"; Quinolones, reaction(s): "Known allergies: quinolones". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Suspect drug (Pfizer), Indication is used for treatment of COVID-19, start date: 15Jun2022, Date of last administration: 16Jun2022. Active Drug substance names: COVID 19 Treatment. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient was previously received a COVID-19 Vaccine. Reported Event: Rash on my face and neck, hot to touch, tingling in lips. The treatment received for the adverse event with Benadryl on 16Jun2022 10:00. The outcome of event was Recovering. No Hospitalization Prolonged. The patient was received treatment as yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Began with extreme soreness in vacination shoulder that evening redness in areas of vacination and soon developed into rash over arm and hand. On 7/14/14 he called we called his regular doctor who saw him that day and was told the rash was the result of the shot. He had an appointment with his dermatologist on 7/29 at 9:40 he saw him and his condition was immediately diagnosed and lab work later confirmed was shingles.  He has been weak and unable to use arm and hand.
Suspected vaccination failure; Had 2 shingle shots and still got them; This case was reported by a consumer described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had two shingle shots and still got them and it was not fun. This case was considered as suspected vaccination failure since the details regarding time to onset and lab test confirmation were unknown at the time of reporting.
Freezer temperature excursion- 12.1 degrees F. Vaccine administered. No adverse event for patient reported. Data logger determined to be off on calibration with troubleshooting efforts. Replaced and working properly.
This spontaneous report as received from a pharmacy technician concerning a currently 76 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 24-APR-2014, the patient was vaccinated with ZOSTAVAX lot #J007208; expiration date: 20-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with ZOSTAVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Facial fullness, chest tightness, hypertension starting ~45 minutes post administration.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 59-year-old male patient who received BOOSTRIX (batch number 9GM3R, expiry date 20th January 2020) for prophylaxis. On 21st May 2018, the patient received the 1st dose of BOOSTRIX. In May 2018, 2 days after receiving BOOSTRIX, the patient experienced knee pain, walking difficulty, swelling of knees, swelling of legs and redness of legs. On 22nd May 2018, the patient experienced injection site swelling and injection site erythema. The patient was treated with prednisone. On an unknown date, the outcome of the injection site swelling and swelling of knees were recovering/resolving and the outcome of the knee pain, walking difficulty and injection site erythema were not recovered/not resolved and the outcome of the swelling of legs and redness of legs were unknown. It was unknown if the reporter considered the injection site swelling, knee pain, walking difficulty, injection site erythema, swelling of knees, swelling of legs and redness of legs to be related to BOOSTRIX. Additional details were reported as follows: The caller was wife of the patient. The patient received BOOSTRIX on right arm. The day after the patient experienced arm swelling and redness at the site. The day after that the patient had swelling and redness of his right thigh and his knee was painful and swollen. The patient had difficulty walking as well. The patient was seen at urgent care and received prednisone to help reduce the swelling. The patient had since then experienced pain and swelling in his other knee, ankles and wrists. She stated the swelling had reduced but the pain remained. He had been prescribed pain medication from his physician. The wife reported she believed the issues were worse because they were moving around. She added the initial joint pain in his right knee was not as bad, but he was still limping when he walked. She stated at the reporting time it was the other knee and the pain in the wrists comes and goes.
Patient received 0.25ml of Moderna bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) 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 UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine).    No concomitant drug information was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.   It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received narrative updated.
the patient "was administered a dose of Rotarix (lot and expiration unknown, manufacturer unknown) on 12/17/2019 at a different providers office and is in the office today, 02/13/2020, to receive the second dose in the series as ROTATEQ; Information has been received from a medical assistant, referring to a 4 months old patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.      On 17-DEC-2019, the patient was administered with a dose of rotavirus g1 p1 vaccine live (89-12) (ROTARIX) at a different provider office. On 13-FEB-2020, the patient received the second dose in the serious as rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, lot # and expiration date unknown) orally for prophylaxis (interchange of vaccine products).
Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: difficulty walking had to call 911-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: per Nurse,  pt developed severe vertigo and pt had developed weakness and lead to difficulty walking
I felt paralyzed,  unable to move or speak after a nap.  It lasted several hrs. and I thought I might be dehydrated.   A friend had to assist me to sit up and drink water.  I had confusion and difficulty speaking in complete sentences.  No treatment sought.  Pt reported this on 3/25/2021 as her response to her first dose, after already having then had her 2nd dose.
Swelling in Lymph Node by collarbone on Left side next day and still have 5 day later.  4 days after vaccine having flu like symptoms
examined @ 1030PM 20MAY93 had 3 hrs of constant, high pitched scream since DTP inject; exam nl, good color, consoles; dx DTP reaction; no further DTP;
36 week pregnant woman were to mistakenly be vaccinated with Arexvy; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: 36 week pregnant woman were to mistakenly be vaccinated with Arexvy).  The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 36 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 14-OCT-2023 The reporter had a question regarding the new RSV vaccine Arexvy that were there studies conducted on pregnant women. If a 36 week pregnant woman were to mistakenly be vaccinated with Arexvy what would be things to be worried about and should she be vaccinated with the correct RSV vaccine. The reporter consented to follow up. No additional details available due to web form submission. The patient who was pregnant received Arexvy vaccine, which led to vaccine exposure during pregnancy.
This spontaneous report as received from a nurse refers to a male patient. The patient was vaccinated with the first 2 ml dose of ROTATEQ (lot number unspecified) orally on 05-NOV-2012, when he was 31 days old. No adverse effect was reported. Additional information has been requested.
TD Adult and MMH were given same day. By 4P I had hives all over my body. I was visiting my grandmother at the hospital and a nurse confirmed it was hives. I could not get rid of the hives. I had them everyday primarily on my hands, feet and mouth for 7 years! I went to an allergist who decided to give me liquid Atarax and also started me on allergy shots. Every time I got an allergy shot, I broke out in hives.
According to Hospital ED record:  This is a 38 yo male present to ED with complaint of tingling sensation and reaction after receiving COVID-19 vaccination.  Symptoms started approx 30 min after he received the initial shot.  Patient was on his way home when he noted some tingling in his tongue and strange sensation to the mouth.  Pt denieschest painSOB, LOC, AMS, neurological deficits.  No abdominal pain, nausea or emesis.
Nose is somewhat bloody and full of mucous; Nose full of mucous; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose is somewhat bloody and full of mucous) and NASAL CONGESTION (Nose full of mucous) 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 EPISTAXIS (Nose is somewhat bloody and full of mucous) and NASAL CONGESTION (Nose full of mucous). At the time of the report, EPISTAXIS (Nose is somewhat bloody and full of mucous) and NASAL CONGESTION (Nose full of mucous) outcome was unknown.            Treatment medication was  not reported. Concomitant medications were not provided by the reporter.
Within 24 hours after administration pt had developed fever up to 103, seizures secondary to fever. Pt was taken to ER per ambulance and was admitted for observation. Pt was diagnosed with an urinary tract infection.
Patient with localized red, itchy rash at injections site starting two days after injection given.
slight metallic taste; energetic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 13:30 (Lot number: PAA156051) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Some SVT in Heart" (unspecified if ongoing), notes: note : Some SVT in heart = supra ventricular tachycardia. There were no concomitant medications. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "slight metallic taste"; ENERGY INCREASED (non-serious), outcome "unknown", described as "energetic".  Additional information: Following his first dose he only had light metallic taste, but then became energetic over the next two days, similar to that of a steroid shot. No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and not tested covid post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Got the vaccine and had soreness in the arm and felt great, and on Saturday 3/6/21 late afternoon his head hurt to touch his hair.  He knew what it was from previous experience.  Was on the top of his head to the right rear predominantly, probably 4" or so.  It was painful and tied into his right eye as he was photophobic with this as well and sunlight would affect that and would get a spasm of pain/2 second or so in the top of his head.  These events continued intermittently until Tuesday 3/9/21 when it was gone, but on his right tricep has a scraping sore feeling on it, which still continues as of today 3/16/21, but only faintly.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient with no pertinent medical history and no drug reactions/allergies. On 23-FEB-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose and lot # not reported). Concomitant medication included an unspecified antiviral medication (for an unspecified amount of time, on unspecified dates) at the time that the injection of ZOSTAVAX occurred. The patient developed a rash on 24-FEB-2013 that was larger than normal around the injection site of ZOSTAVAX. The pharmacist reported that the rash went away three days after it appeared. The outcome of rash around the injection site was reported as recovered. The patient sought unspecified medical attention. No treatment was given for the event. No lab diagnostics studies were performed. Additional information is not expected.
With the patient ahead of her, she observed the pharmacist repeatedly thumping the syringe, and she is assuming that he did the same thing for her; With the patient ahead of her, she observed the pharmacist repeatedly thumping the syringe, and she is assuming that he did the same thing for her; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports.   A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 22Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter got her first shot today. Another healthcare professional told the reporter that when drawing down the drug into the syringe, to be effective, one thing not to be done is thumping the syringe because it makes it less effective or ineffective. With the patient ahead of her (reporter), she observed the pharmacist repeatedly thumping the syringe (22Mar2021), and she is assuming that he did the same thing for her. So now, the reporter assumes that hers is not effective and she has to go back there and get her second dose and it probably won't be effective. Now that the reporter has had one of Pfizer's shots, she asked if she should get another shot of something else.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021315916 Same reporter, drug, and events; different patient
I began (and continue to feel) tingles stemming from my elbow to my ring finger and pinky finger on my left hand. The feeling is similar to when you bump your funny bone, but more muted. The sensation began about 10-15 minutes after the injection. It is relieved with Aleve, but returns once the effects of the medication subside.
11/4/1547 Employee came to site After getting influenza vaccine in (L) arm @ about 1330 from Employee working off of flu cart. (L) Deltoid is warm to touch, has a hardened area at puncture site. Employee C/O soreness & achy which happened immediately happened after vaccination. The warmth & swelling started around 1530
Began with fever, headache, later with lower limb pain, fatigue, chills and sore throat.
overall not feeling well idk if its from covid but after the vaccine i have been hospitalized a few times for heart issues. Constant heart racing, fatigue, passing out, etc