chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with poor quality product), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/ Vaccines stored in the refrigerator underwent several temperature excursions.) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.       Concomitant medications details were not reported by the reporter.  Anatomical location for vaccine administration was reported as deltoid.  The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients.  On 07 Sep 2022 vials moved from freezer to refrigerator.  The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle.  The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle.  No adverse reactions reported to our knowledge for any of these patients.  It was unknown patient had been ever diagnosed with or tested positive for COVID-19.  Treatment details was not reported by the reporter.
mom states pt started crying almost immed p/shots & cried 4 hrs straight; could not be consoled; fever was low grade; onset of vomiting; some fussiness;
Patient with venous sinus thrombosis 19 days after Moderna booster shot.  Presented with headache, N/V, photophobia.
Pains on the right side of body.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date at 14:00 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included diabetic and allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included metformin (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. On 31Mar2021, the patient experienced pains on the right side of body. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event pains on the right side of body and included treatment with ibuprofen 800 mg. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pains on the right side of body was unknown at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The patient then got COVID-19 and never got the 2nd dose; The patient then got COVID-19 and never got the 2nd dose; This is a spontaneous report from a contactable pharmacist.   A female patient of an unspecified age received bnt162b2 (BNT162B2, BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included immunodeficiency from an unknown date and unknown if ongoing did go through immunotherapy. The patient's concomitant medications were not reported. On an unspecified date patient experienced the patient then got covid-19 and never got the 2nd dose with, Caller states that she has a patient who was "involved in home health back in Jan and received the 1st dose of the Pfizer COVID-19 Vaccine. The patient then got COVID-19 and never got the 2nd dose. The caller wants to know if the patient can get her 2nd dose or if they need to restart the series over. Caller would also like to know if there are any contraindications for the patient getting the 2nd dose of the Pfizer COVID-19 Vaccine after having had immunotherapy treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome for all events was unknown.   Follow-up(19Jul2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported for a patient that:  Caller declined to proceed with report stating she doesn't have all of her information and she will let her son know that they can report and requested transfer to regulatory authority. Full report details not obtained.   Information on the lot/batch number has been requested.; Sender's Comments: The reported event Covid 19 after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
so severe she could not get out of bed; pain in her legs; sore arm; She had a headache ever since; pain in hip area; chills; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (so severe she could not get out of bed), PAIN IN EXTREMITY (pain in her legs), PAIN IN EXTREMITY (sore arm), HEADACHE (She had a headache ever since) and ARTHRALGIA (pain in hip area) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-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) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced MOBILITY DECREASED (so severe she could not get out of bed), PAIN IN EXTREMITY (pain in her legs), PAIN IN EXTREMITY (sore arm), HEADACHE (She had a headache ever since), ARTHRALGIA (pain in hip area) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. On 14-Apr-2021, PAIN IN EXTREMITY (sore arm) and CHILLS (chills) had resolved. At the time of the report, MOBILITY DECREASED (so severe she could not get out of bed), PAIN IN EXTREMITY (pain in her legs), HEADACHE (She had a headache ever since) and ARTHRALGIA (pain in hip area) outcome was unknown.            No concomitant medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
On Sat. 01/12/08 patient ran a fever between 99-102 til Tue. 01/15/08 then broke out in a rash all over his body Wed. 01/16/08. The spots were light, he didn't seem to be itchy; they lasted for about three days. I only gave him Tylenol during fever at night, because he was very fussy, not eating, just drinking lots of fluids at least. All in all he was pretty miserable for about a week, then he was back to self.
pt recv vax 14AUG92 & lab eval on 26JAN96 revealed a susceptible titer;
Red splotchy rash on right lower leg noted 15 minutes after injections, lung sounds clear, no distress.  Child give BENADRYL three fourths teaspoon, some pencil eraser size red splotches noticed on left leg at that time, oxygen saturation by pulse oximeter equals 98 percent on room air.  Received child 09:50, oxygen saturation by pulse oximeter equals 98 percent on room air.  Child playing, no distress, foster mother to take child home, repeat dose of BENADRYL in 6 hours, call clinic if any problems, hives seem to be resolving when child leaves.
About 15 minutes after vaccination, employee started to feel tingling and burning sensation in elbow and wrist.  He stated he felt like he was having a reaction.  No issues with throat, no shortness of breath but did feel dizzy.  Was assisted to the ground and eventually was taken to local ED.
Extreme fatigue and body aches began about 6 hours after the injection.  About 24 hours after injection, he had low grade fever (100.3), severe fatigue, body aches, sore throat, and nausea.  These symptoms lasted until about 36 hours after injection.  Called physician and was instructed to continue with giving Advil and Tylenol on a rotating basis and have him rest and hydrate.  I am a registered nurse and was comfortable caring for him at home with this guidance.
Patient was administered live varicella vaccine on 7/25/14 to her left upper arm. On 8/1/14 patient came in with complaint of a rash on her left side. With presence of dermatome diagnosis is shingles as adverse reaction from varicella vaccine.
Information has been received from a medical assistant concerning a male patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (LOT # 657941/0851U) second dose. The medical assistant reported that the patient developed an injection site reaction after the second dose. The symptoms were described as a "big red rash" at the site, the rash is described as puffy and big circle. The physician has prescribed an unspecified medication for the symptoms. It was reported that the patient was recovering and sought unspecified medical advice. This is one of five reports from the same source. The physician reported that these patients had similar reactions after their second dose due to these experiences. Further information has been received regarding this 6 year old male patient who was vaccinated on 15-AUG-2007 with varicella virus vaccine live (Oka/Merck) (LOT # 657941/0851U) second dose subcutaneously at approximately 10:00 AM. The physician reported that there were no pre-existing conditions not any illness at the time of vaccination. The physician reported that the patient had localized erythema. This is one of five reports from the same source. Additional information has been requested.
This spontaneous report was received from a registered nurse refers to a 22 years old female patient with mild headache, no pertinent medical history and no drug reactions or allergies, who on 15-AUG-2012, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number not reported) and on 09-OCT-2012, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot number 0754AE, Exp. Date: 17-JAN-2015). No other co-suspects were reported. Concomitant medication included unspecified birth control pills. The registered nurse reported that on 09-OCT-2012, the patient was experiencing a mild headache when she had arrived at the office to receive second dose of GARDASIL the headache began prior to receive the second dose. About an hour after receiving the second dose, the patient's headache worsened so she had to go home and lay down. No treatment was given for the experience. No lab diagnostics studies were performed. The patient recovered from the headache on 10-OCT-2012. The patient sought medical attention by calling to the office. The relatedness for the patient's headache worsened after receiving second dose of GARDASIL was unknown for GARDASIL. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Lot number: ???) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: COVID test  x 2 rapid antigen test from 2 different manufacturers; (May2022) Positive, notes: COVID test  x 2 rapid antigen test from 2 different manufacturers. Therapeutic measures were taken as a result of covid-19. The patient did not have ant known allergies.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
HAS HALF AN INCH, CLUSTER OF RED, RAISED RASHES ON THE NECK, STOMACH, AND BACK. ITCHING AND PAIN ON THE INJECTION SITES, LEFT AND RIGHT DELTOID.
pt recv vax APR95 & 11NOV97 pt devel a red papular vesicular lesion on face;;25NOV97 pt devel more lesions mostly on chest;
broken cold chain until two weeks after the shipment arrived with no reported adverse event; after excursion, vaccine was administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient and reporter reported broken cold chain for haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] until two weeks after the shipment arrived with no reported adverse event and after excursion, vaccine was administered with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect haemophilus type B (HIB) (PRP/T) vaccine Powder and solvent for solution for injection (lot number, strength, dosage, expiry date- not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on the batch number was requested  Caller reported broken cold chain for haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] until two weeks after the shipment arrived with no reported adverse event (product storage error) (unknown latency) and after excursion, vaccine was administered with no reported adverse event (poor quality product administered) (latency- same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA124713:Master case
This spontaneous report was received from a registered nurse concerning a currently 4 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# N035177, expiration date: 09-JUN-2019; N028447, expiration date 09-APR-2019 or lot#N025929, expiration date: 18-MAR-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15°F to 46°F (-9°C to 8°C) (19F). The previous temperature excursions were 6°F to 14°F (-14°C to -10°C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of PROQUAD was received by the patient. No adverse effects were reported. This is one of several reports from the same source.; Sender's Comments:  US-009507513-1805USA006682: US-009507513-1805USA007511: US-009507513-1805USA007508: US-009507513-1805USA007509: US-009507513-1805USA007504: US-009507513-1805USA007510: US-009507513-1805USA007505: US-009507513-1805USA007506:
This spontaneous report as received from a nurse refers to a female patient of unknown age. On 03-MAY-2014 the patient was administered a dose of MMR II (HSA; lot # 0183AE; expiry date 18-JAN-2014) subcutaneously that had been properly stored, but expired. The dose (0.5 ml) was the patient's first dose of MMR II. No adverse events were reported. Additional information has been reported.
"Pt stated pt got 1st covid vaccine Pfizer 4/26/2021. Pt said pt has tiredness, headache,chills, night sweats, cough, sore throat, sleeping pattern change after covid vaccine. Pt already contacted with PCP(outside) and prescribed melatonin for sleeping pattern change. Noted pt is allergic to Iodine, Acne cream. Pt concerned that daily activities are still affected by the symptoms of covid vaccine side effects. Pt intends to make appt with MD before 2nd covid vaccine. Pt scheduled urgent care provider 5/21/2021 for consultations d/t pt said pt is not able to communicate with PCP during the weekends. Pt made aware. Pt is educated covid vaccine side effects. Pt agreed and verbalized understanding.
First day after short sore arm at shot site , headache low grade fever.  6 -7days after shot arm has a knot at injection site is light red almost pink color around and is warm to the touch and tender to the touch.
Initial report received from a health care professional on 27 December 2013. A 65-year-old female patient whose medical history, concomitant medications and allergies and illness at the time of vaccination were unknown, had received FLUZONE ID intradermal in right forearm (batch number, dose, dose number were unknown) on 23 September 2013. On unspecified date, during a visit for another reason i.e. on 18 December 2013, 2 weeks after the ID vaccine patient developed redness, warmth, itchy feeling and pain at injection site. Patient has a "scar" at the injection site. Corrective treatment and laboratory investigations were not reported. The outcome of the event was unknown. Documents held by sender: none. Follow-up information received from the healthcare professional on 07-Feb-2014. The patient had hypertension and diabetes mellitus. The patient does not have any acute illness at the time of vaccination and had not received any other vaccine. The patient does not have any laboratory details. The patient had not gone to emergency room. At the time of this report the patient was recovered but still sores is seen.
first dose administered in 17Apr2021, second dose not administered yet.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose administered in 17Apr2021, second dose not administered yet.) 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 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose administered in 17Apr2021, second dose not administered yet.). On 17-Apr-2021, PRODUCT DOSE OMISSION ISSUE (first dose administered in 17Apr2021, second dose not administered yet.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not reported.  Treatment details was not reported .
Pt  recvd 2 doses of Hep B vax in mid-FEB91 & end of MAR91; There were no noted rxn following 1st dose; On approx 4APR91, 6 to 10 days following 2nd dose pt devel erythematous pruritic rash; lymphadenopathy devel in groin area; tx meds;
Headache, fever (101 orally), general fatigue, body aches, neck stiffness, diarrhea.  Took Tylenol
Fatigue, Chills, Headache, Lymphadenopathy, Thrombocytopenia, Anemia
On Saturday I got a runny nose and on Sunday I had brain fog, chills, muscle aches. My symptoms stayed the same for days and the next day on Monday I went to the clinic and was started on Paxlovid. I have been sick a total of 4 days so far.
Loss Sense of Taste; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss Sense of Taste) and MYALGIA (Body Aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No significant historical event reported.).   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 14-Mar-2021, the patient experienced AGEUSIA (Loss Sense of Taste) and MYALGIA (Body Aches). At the time of the report, AGEUSIA (Loss Sense of Taste) and MYALGIA (Body Aches) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
My baby was drooling excessively, he was lethargic and lifeless. He was seizing and he could barely breathe and his lips were turning blue. The doctors said that it was more than likely a febrile seizure brought on by the chicken pox vaccine that he received 5 days earlier. This was by far the scariest day of my life and I will be discouraging this vaccine to everyone I know.