chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ACT-HIB was given to a patient without reconstituting with proper diluent and instead it was reconstituted with sterile water/ no adverse event; Initial information received on 26-Jul-2021 regarding an unsolicited valid non-serious case received from a physician and Other Health Care Professional.  This case involves a 6 month-old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] without reconstituting with proper diluent (reconstituted with sterile water) [product preparation error].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for prophylactic vaccination.  On 26-Jul-2021, the patient received third dose 0.5 mL (once) of suspect HIB (PRP/T) VACCINE (lot UJ405AAB and expiry date 08-Oct-2021) via an intramuscular route at the right thigh for prophylactic vaccination.  It was reported that "Physician assistant student reports that he gave ACT-HIB to a patient without reconstituting with proper diluent. States he did not see diluent packaged with ACT-HIB and instead he reconstituted with sterile water".  It was a case of an actual medication error due to wrong solution used in drug reconstitution (latency was on same day).  At the time of report, no adverse event was reported.  Event outcome was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Arm has remained sore, has trouble lifting above the shoulder, has pain from mid deltoid down to midway on front edge of arm, is trying ADVIL, will let us know.
Tested positive for Covid 13Apr; Tested positive for COVID 13Apr; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 16:00 as dose 1, single (Lot number: EL8982), in left arm, on 03Mar2021 at 15:00 as dose 2, single (Lot number: EN6198), in left arm, on 06Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FE2589), in left arm and on 12Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK4989) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: Name of Drug as Reported : Latex, Reaction : allergy. Concomitant medication(s) included: SYNTHROID, start date: Dec1999; BUPROPION HCL XL, start date: Mar2019; ALENDRONATE SODIUM, start date: Sep2019; VAGIFEM, start date: Jan2015; NAC SR, start date: Mar2019; MOVE FREE ULTRA, start date: Jan2018; FLAXSEED OIL NATURE MADE, start date: Jan2017; FISH OIL, start date: Jan2017; NATURE'S BOUNTY OPTIMAL SOLUTIONS HAIR, SKIN & NAILS, start date: Jan2020. Past drug history included: Percocet, reaction(s): "Allergy", notes: known allergies: Percocet. The following information was reported: COVID-19 (medically significant) with onset 13Apr2022 at 08:00, outcome "unknown", described as "Tested positive for COVID 13Apr"; VACCINATION FAILURE (medically significant) with onset 13Apr2022 at 08:00, outcome "unknown", described as "Tested positive for Covid 13Apr". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Apr2022) Positive; (Apr2022) Negative; (29Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received treatment of Covid-19 with antiviral medication Paxlovid starting on 13Apr2022. The patient was recovered after 5 days and was tested negative. The treatment was stopped on 17Apr2022. Came down with Covid again on 23Apr2022. The patient had milder symptoms. The patient still tested positive as of 29Apr2022. The patient took other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  No follow-up attempts are possible. No further information is expected.
States in the middle of the night he woke up gasping for air, wheezing, cough - non productive, lasted 1-2 hours then improved, propping self up with pillows. This AM better but still feels congested, no more SOB or wheezing.
Moderate swelling and erythema and pain of leg and below site of administration 15 cm in lenth and 2/3 circumference of leg.
Patient contacted our office on 2/20/19 in the afternoon the day after immunization. Reported chills, fever, pain at injection site and swelling. Reports that the swelling and redness had increased and moved down her left upper arm to her elbow. Directed to clinic. Dx with cellulitis and given oral antibiotics. Saw her PCP this morning 2/21/19 who assessed cellulitis and placed pneumoccocal vaccine on her current list of allergies. Redness and swelling is improving but still present.
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. This Pharmacist reported similar events for three patients. This is first of three reports. An elderly female patient (65-75 years) received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist report that the patients complained of fever, sever lethargy, redness and soreness that lasts anywhere from 2 days to 7 days on an unspecified date. The outcome of the events was unknown. Information on lot number, batch number and expiration date has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018480405 same drug/event different patient; US-PFIZER INC-2018480406 same drug, event/different patient.
Information has been received from a physician and a licensed practical nurse (L.P.N.) concerning a 71 year old male with hypertension, diabetes and a history of right cataract extraction and no drug allergies who on 02-JAN-2009 was vaccinated IM into the left deltoid with a 0.5ml dose of PNEUMOVAX 23 (lot # 663012/1163X). Concomitant therapy included "9 (unspecified) medications". It was reported that the patient received PNEUMOVAX 23 in the past with no problems. On 02-JAN-2009 the patient experienced the injection site being red, swollen and painful. The patient sought medical attention at physician's office. The physician believed the patient had cellulitis and had a white blood cell count of 18000. The patient was hospitalized, and still in hospital at the time of reporting. Unspecified lab work was performed in hospital. The adverse events were considered to be immediately life-threatening, the patient was on vancomycin I.V. and clindamycin I.V. 900mg every 8 hours. As of 05-JAN-2009, the patient was recovering. The reporter considered the adverse experiences to be other important medical events. This is one of several reports received from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released.
Facility/pharmacy did not monitor after injection. Driving while onset of symptoms occurred within 15 minutes of vaccine administration.  Extreme sweating, claminess, dizzy/light headed, pale face, jittery, pressure in both ears, nausea
196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent; No adverse event; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Dec-2022 and was forwarded to Moderna on 28-Dec-2022.    This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent) 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 (196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent).    No concomitant medication was reported.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up information received: Patient age group and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Master case
Body aches all over started the morning after the vaccine shot. Nausea began second day after vaccine and I threw up clear liquid that day. I?ve had no appetite and have lost about 5 lbs in 2 days from not eating.  I have dizziness as well but it is not severe enough that I cannot walk on my own. I have injection site redness as well. I am reporting these symptoms on the third day after my shot and I have improved but only slightly.
had pneumonia twice after the Prevnar / had Flu and Pneumonia shot on the same day; itching; blemishes; bumps / appear and disappear; sick four to five days; This case was reported by a consumer via other manufacturer and described the occurrence of pneumonia in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2016-2017 season) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) (batch number R12276, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2016-2017 season and PREVNAR 13. On an unknown date, unknown after receiving Fluarix Quadrivalent 2016-2017 season, the patient experienced pneumonia (serious criteria GSK medically significant), pruritus, skin disorder, rash and sickness. On an unknown date, the outcome of the pneumonia and sickness were recovered/resolved and the outcome of the pruritus, skin disorder and rash were not recovered/not resolved.   It was unknown if the reporter considered the pneumonia, pruritus, skin disorder, rash and sickness to be related to Fluarix Quadrivalent 2016-2017 season.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Fluarix and Prevenar 13 vaccine back in early 2017 and had a severe reaction. The patient was still had some of that going on with skin such as itching, blemishes and bumps that appear and disappear. The reporter's doctor said patient should get the COVID 19 vaccine, patient was not sure whether he/she wanted to take it due to the reaction from Prevenar 13. The patient had pneumonia twice after the Prevenar 13, was sick four to five days after the Prevenar 13. Reported it all to VAERS, patient had seen several other doctors with different specialities and nothing seemed to help. No further details were provided. The reporter was wondering how Prevenar 13 and Covid 19 vaccine were compared to one another in regards to ingredients, could he/she be tested for something to find out if he/she should not get the Covid 19 vaccine. The pharmacist advised patient that he/she should be in hospital setting to receive the Covid 19 vaccine in case of a reaction. Main thing to consider was patient would be one of the last ones to get the Covid 19 vaccine because of the reaction to Prevenar 13, patient was wondering what to do. The reporter clarified that patient had not yet received the Covid 19 vaccine. Been on the computer and talked to as many people as he could, had yet to talk to the country health department. The reporter had been trying to speak with a immunologist, but there was not one staff at the local hospital. The reporter believed he previously filed a report in regards to this information and filled out paperwork two or three separate times of Pfizer about patient's reaction to Prevenar 13. Temporary VAERS report number was E115405 and report was done on 3rd January 2017. The reporter consented to follow up.
vaccine given 1/12/2021 by covid clinic team. bells palsy diagnosed on 1/18/2021.
17-year-old patient was given first dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient was given first dose of vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient was given first dose of vaccine). On 01-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient was given first dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications provided by the reporter.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with no current conditions and a history of unspecified reaction to penicillin and aspirin. On 13-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # K020801, expiration date January 2016 (dose and route were not reported) for vaccination. Concomitant therapies included morphine, torsemide, NEXIUM and DEPAKOTE. Subsequently, on an unknown date in April 2015, the patient experienced swelling and redness like the size of a baseball at the injection site. The patient was given BENADRYL as treatment. The patient sought medical attention, she spoke to the pharmacist. No laboratory studies were performed. The outcome of the events was reported as recovering. Relatedness between the therapy and the events was not provided. Additional information has been requested.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 06-MAR-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of VAQTA (lot # L023232 and expiration date: 25-FEB-2017, administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
First injection, no issues.  Second injection led to blood glucose of 368 about an hour post injection.   Beginning the morning of Sunday, 04/18/21, I had a low blood glucose episode early in the morning (meaning blood glucose 30 mg/dL or below). Typical to these I react by sweating profusely, trembling, visual anomalies, anxiety.   Never in my life have I experienced what I did on 04/18/21 concurrent with low blood glucose out of dozens and dozens of such episodes in my lifetime since being diagnosed with type 1 diabetes at age 3. I suffered right side weakness (hand, arm, leg, trouble focusing right eye). My blood glucose at that time was low and I immediately drank some juice and ate something, but even an hour into the episode I was experiencing right side weakness and difficulty keeping my footing and hand action.
Very red, very painful, its been at least 2 days after injection and still symptoms persist but has gotten better.
Swollen left lymph node on the bottom of her neck, right above the clavicle; Runny nose; Left ear felt a little blocked; Pain higher above her heart; Arm discomfort; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Feb-2021 and was forwarded to Moderna on 01-Feb-2021.    This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Arm discomfort), CHEST PAIN (Pain higher above her heart), LYMPHADENOPATHY (Swollen left lymph node on the bottom of her neck, right above the clavicle), RHINORRHOEA (Runny nose) and EAR DISCOMFORT (Left ear felt a little blocked) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm discomfort). On 13-Jan-2021, the patient experienced CHEST PAIN (Pain higher above her heart). On 17-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen left lymph node on the bottom of her neck, right above the clavicle), RHINORRHOEA (Runny nose) and EAR DISCOMFORT (Left ear felt a little blocked). The patient was treated with NAPROXEN at an unspecified dose and frequency and MULTIVITAMINS [VITAMINS NOS] at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Arm discomfort), CHEST PAIN (Pain higher above her heart), RHINORRHOEA (Runny nose) and EAR DISCOMFORT (Left ear felt a little blocked) outcome was unknown and LYMPHADENOPATHY (Swollen left lymph node on the bottom of her neck, right above the clavicle) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, SARS-CoV-2 test: negative Negative.     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.   Treatment details included Multivitamins and Prilazac or Naproxen.
Pericarditis, anti inflammatory every 8 hrs. Symptoms started with shortness of breath then proceeded to cause chest pain, throat to feel swollen, lead up to vision blurring
Body aches; Night sweats; Swollen lymph nodes on the left sideof body; Chills; Fever; Headache; Arm soreness; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 20Apr2021 at 09:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies to shrimp and nickel. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 01Apr2021 at 17:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 05:00, the patient experienced body aches, night sweats, swollen lymph nodes on the left side of body, chills, fever, headache, arm soreness, nausea and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, night sweats, swollen lymph nodes on the left side of body, chills, fever, headache, arm soreness, nausea and fatigue were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
I waited 20 minutes after my injection and left facility. While I was driving home around 1:00 pm my left arm started to tingle, I got really hot and a wave of lightheaded/dizziness washed over me and I couldn?t swallow. I pulled over to wait it out and my throat swelling got worse.
21 hours after 2nd shot developed tenderness, swelling and pain left armpit area possible interpectional nodes.  Also experiencing nausea.
Has a spot under her breastbone on her ribcage that is "very" sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 10:30 (Lot number: EW0175) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR taken for blood cholesterol; LORATADINE taken for hypersensitivity; CENTRUM SILVER +50 taken for supplementation therapy. Vaccination history included: Bnt162b2 (First dose , Lot :  ER8729, Expiration date: unknown), administration date: 16Apr2021, for COVID-19 immunisation. The following information was reported: MUSCULOSKELETAL CHEST PAIN (non-serious) with onset 10May2021, outcome "not recovered", described as "Has a spot under her breastbone on her ribcage that is "very" sore".  Additional information: Event happened after the second dose of the vaccine. There is constant pain in that area, sometimes worse and sometimes not as bad. When the caller gets up in the morning, she doesn't feel it but when she's up moving around it starts hurting. AE didn't require a visit to emergency room or physician's office. No family medical history relevant to ae. Prior Vaccinations (within 4 weeks) was none.  No follow-up attempts are possible. No further information is expected.
She broke out in spots, which cleared up within a day, then came back worse and more pronounced a week later.
2 weeks and 5 days after injection, patient developed a red patchy rash above the inside of the elbow of his right arm. it is slightly swollen and is warm to the touch. according the patient it is not painful
2 hrs of high pitched inconsolable crying starting 2 hrs post vax & lasting 2 hrs;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Additional Details: Patient had a vasovagal reaction.  He was \"not a big fan of shots\".  Hadn't eaten well the day before nor breakfast.  Didn't sleep well.  Called 911.  They did EKG and it was fine.  Spoke with patient the next morning and he was good.