chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inflamed neck; Light headed; Flash and Tingling in upper body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Light headed), PARAESTHESIA (Flash and Tingling in upper body) and SWELLING (Inflamed neck) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Neck stiffness. Concomitant products included ADENOSINE (TRICOR [ADENOSINE]), VITAMIN 15, LOSARTAN and SIMVASTATIN for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced DIZZINESS (Light headed) and PARAESTHESIA (Flash and Tingling in upper body). On 20-Feb-2021, the patient experienced SWELLING (Inflamed neck). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (Light headed), PARAESTHESIA (Flash and Tingling in upper body) and SWELLING (Inflamed neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
7 days after first shot of Moderna, I started itching in the area where I received my shot. Throughout the day, the area got very red and itchy like a big red spot. When I touch it, it feels very hot and sensitive.
74 y/o male with hx of pneumovax given on 5/19, developed left deltoid swelling, welts over torso and arms. The welts have nearly resolved but still a few on the right side of the body. No fever or chills. He did take keflex for 10 days finishing 4 days before the pneumovax was given for a finger lac. He has no swelling above the neck, no skin changes above the neck and no sob or cp.o; 1.5-2.5 raised areas on right chest that are 2mm in height and erythematous, no drainage. area on left arm at the elbow of erythema 6cm diameter, no open areas.  a/p allergic reaction to pneumovax. discussed option, pt not bothered enough to take medrol dose pack, will use hydroxyzine and call for any concerns.
Patient received the Pfizer-BioNTech COVID-19 Vaccine at 1734. Reported onset of symptoms at 1735 with immediate itching at injection site. Benadryl 25 mg po given and observed for 40 minutes. Felt better after further observation and left the clinic.
When I received vacciane for first and second time, I was trying to conceive, and got miscarried at 6 weeks (after both doses). This was my second attempt to conceive, got successfull and then miscarried. After that I tried many times till November, there was no positive results. I was suggested to take booster dose, took it in november end, and luckily concived again in same cycle, which again ended up in miscarriage on 27 dec. I took booster on day 1 of my period, conceived on the same cycle and miscarried again.
Below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number cm7ck, expiry date 29th July 2023) for prophylaxis.   On 17th July 2021, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The physician reported that a patient was administrated with Boostrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported . The reporter consented to follow up. This case is one of 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 25-FEB-2015, the patient was vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient noticed a rash on her arms at 10:30 PM on the day she received her vaccine. She showed her mother and discovered it also covered the trunk of her body, neck, and face. She woke up the next day and the rash had spread to her full body. The rash did not itch and was not painful. Her mother made an appointment to be seen again that same day. Patient mentioned having had her wisdom teeth removed on 6/15/2020, and she was still taking Amoxicillin 500mg every 8 hours. Her last dose was the evening on the day after the vaccination. The rash may have been related to a reaction from the antibiotic per the provider who examined her (NP), and recommended she did not take the last dose that evening. She was told to call the office if the rash did not subside within three days.
It could be that I?m just sixteen, but I started the worse period of my life today. It is really heavy (more so than normal) and I?ve been having some pretty intense cramps. For the first time in my life I?m considering taking some sort of pain medication for my cramps.  I didn?t have any of the usual signs that it was coming. As in, I normally cramp for maybe 2 days before my actual period starts. My cycles are normally quite long and irregular, but that ?pre-cramping? always happens.  I?m also really tired, but that seems normal as everyone else in my family was super tired and their arm hurt.
Patient called reporting a soreness, fever, muscle and joint pain, nausea, and dry heaving.
Localized inflammation at injection site, arm pain from elbow to shoulder, possible swollen axillary glands (by patient report, not felt on day of exam), fevers (Tmax 101), subjective shoulder joint pain  Treated with NSAIDs, topical steroid cream for local injection site and close monitoring
Localized swelling reaction of the right arm above the elbow = soft swelling with erythematous hive.
Inncorrect vaccination given to patient. Ped/adol Hep A given instead of adult Hep A.
Exacerbation of previously controlled hypertension with blood pressure spiking to 200/100; Had skeletal chest pain; doing well until Covid vaccine; This is a spontaneous report from contactable physicians (one of which was the patient).  A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration at the right arm on 22Jan2021 08:30 at single dose for COVID-19 immunization. Vaccination was done in a TN. Medical history included CABG Post op RT CABG (coronary artery bypass; doing well until Covid vaccine) from 11May2020 and hypertension. Concomitant medication included metoprolol succinate (TOPROL), ubidecarenone (COQ10), losartan and Hybrid. There was no other vaccine receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient previously took atorvastatin (LIPITOR) and experienced allergies: Lipitor.  The patient experienced exacerbation of previously controlled hypertension with blood pressure spiking to 200/100 on 26Jan2021, went to local ER, BP 180/100 there on 26Jan2021. He had skeletal chest pain which began 25Jan2021 22:00. He stated post op right cabg from 11may2020, doing well until covid vaccine on 22Jan2021. Treatment IV Hydralazine received. The events were considered non-serious by the reporter. On 26Feb2021, it was reported that the patient provided information to another physician regarding the reported adverse events with the use of BNT162B2. The physician did not consider the Pfizer product had a causal effect to the adverse events. Lab data also included Covid test (rapid nasal swab) on 26Jan2021 was negative. The outcome of the events was not recovered.  Follow-up (26Feb2021): New information received from a contactable physician in response to HCP letter sent includes: reporter details (added a physician as a reporter), causality assessment and clinical course details.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT62B2 to the events hypertension aggravated, skeletal pain and unwell cannot be excluded. The fluctuation of underlying hypertension may be major cofounder.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
VOMITING, WEAKNESS, SHAKINESS, RIGHT SIDE BREAST PAIN, DIZZINESS AFTER SUDDEN MOVEMENT
itch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch) in an 88-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.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itch). At the time of the report, PRURITUS (itch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
vaccine was given on 8/22/07 (MMRV) low grade fever 1 wk after vaccine was given rash started 1 week later with pink/red papules developing on legs, arms, face after few days also small pink papular rash on back few days later
Patient presented to pharmacy on 8/28/17 reporting redness, swelling, and heat at injection site following ZOSTAVAX vaccination. She reported using several doses of BENADRYL and that symptoms have improved but are still present. She was told this is a common side effect and as long as symptoms don't worsen or change, it should completely resolve soon. She was told if symptoms worsen or change to contact provider.
Woke on 4th day after first vaccine with nausea, vomiting, headache, fatigue, lethargy, dizziness, weakness. In the evening, hands, wrists, feet, and ankles began itching and showing large, red welts; took Benadryl. Woke on 5th day, itching and red welts began spreading all over body, including head and ears. Continued taking zyrtec, benadryl, and cortisone, which helped somewhat.  On 6th day, these medications were not controlling the itching and welts/hives. By evening, all was worsening and throat was swollen. Went to ER on night of 3/18/21, where I received IV treatment to stop the reaction. ER also prescribed 4 days of prednisone and recommended that I not take the second Covid-19 vaccine.
Spoke w/MD pt had arthritis sx & rash; No specific tx; Saw MD 2 wks p/shot;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On unknown date, the patients were vaccinated with improperly stored doses of VAQTA injection (exact dose, route of administration, lot number and expiry date were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 32 degrees Fahrenheit to 35 degrees Fahrenheit (33.9 degrees Fahrenheit) on an unspecified date, for a time frame of 40.5 hours. A digital data logger was involved. There were no previous temperature excursions recorded. No adverse experiences were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA012404: US-009507513-1707USA012403: US-009507513-1707USA012405:
Fever/Chills for three days/ Fever 103/ Fourth day fever 99.0/ Fifth day fever and chills no longer present/ Arm   painful for 2 weeks
Information has been received from a nurse concerning a 16 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 19-DEC-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017, dose and route unspecified) for prophylaxis. It was reported as a "13-DEC-2016 temperature incident". The vaccines were stored at 11.6 degree centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree centigrade for 50 minutes. It was reported that the excursion involved a total of three lots of GARDASIL 9. The nurse later confirmed that there were two lot numbers, L024993 and M024261 were actually administered to patients after the "temperature incident". No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008047: US-009507513-1612USA007442: US-009507513-1703USA002792: US-009507513-1703USA002793: US-009507513-1703USA002794: US-009507513-1703USA002795: US-009507513-1703USA002796: US-009507513-1703USA002797: US-009507513-1703USA002798: US-009507513-1703USA002799:
Information has been received from a health professional concerning a patient of unknown age and gender. Information regarding concurrent condition, medical history and concomitant therapy was not reported. It was reported that an expired dose of VARIVAX (dose, route, and lot# not reported, expired date 16-OCT-2015) was inadvertently administered on 17-JUN-2016 instead of ZOSTAVAX. The reporter confirmed that there was no medication confusion involved; however, it was given in error. Also, it was confirmed by the reporter that ZOSTAVAX was not administered to the patient. No adverse effects were reported. Additional information has been requested.
Day after vaccine patient woke up with arm was red, itchy and swollen. Day 2 after vaccine patient developed blisters and was taken to the ED. Patient was placed on antibiotics and since then patient's arm has blisters have been drying up and healing. Patient did not develop fever-per pt father.
Admitted to hospital on 9/14/2021 with SOB, cough, hypoxia. Had been recommended monoclonal antibiotic therapy, but had not been initiated. DX: acute hypoxic respiratory failure, c-19 pneumonia. on 15 L O2, Decadron, declined intubation. 9/16/2021 awaiting transfer to hospice. Died 9/18/2021.  Immunized with Moderna 1/22/2021 and 2/19/2021 - only 2/19 dose available. Copy of vaccination card received where client resided showing both doses.
Developed a reddish bruise on injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Developed a reddish bruise on injection site) and VACCINATION SITE PAIN (Sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 037B21A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], CALCIUM, VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) and LORATADINE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Developed a reddish bruise on injection site) and VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE BRUISING (Developed a reddish bruise on injection site) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-062141 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up document received on 12-May-2021 contains Contact information of patient.
Dizziness. At 941am, BP 157/80, HR 111. Water and orange juice given. At 1002am, BP 138/93, HR 90. Stable and released.
2ND DAY AFTER RECEIVING 2ND VACCINATION. FEVER, BODY ACHE ALL OVER, CHILLS, VERY SORE ARM BELOW THE INJECTION SITE TO THE ELBOW.  LASTED APPROXIMATELY 9 HOURS. SORENESS IN ARM WAS ALMOST GONE BY 3RD DAY. FEEL FINE WITH ONLY A LITTLE FATIGUE ON 3RD DAY. 1ST VACCINATION - ONLY SORE MUSCLES THE ENTIRE ARM FOR 2 DAYS.
Arm soreness; swelling (minor); This is a spontaneous report from a non-contactable consumer. A 32-year-old male consumer (Patient).  A 32-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in right arm on 08Mar2021 (at the age of 32-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 08Mar2021, after the vaccination, the patient experienced Arm soreness and swelling. No other vaccines administered in four weeks, patient was not diagnosed with covid prior vaccination and not tested positive post vaccination. No known allergies reported. The outcome of the events are not recovered.  No follow-up attempts possible. No further information expected.
Fatigue; Achy; Nausea; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Achy), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (Fever). On 25-Feb-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, PAIN (Achy), PYREXIA (Fever) and FATIGUE (Fatigue) had not resolved and NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
On the morning of 5/1/2021, I noticed the smell of coffee brewing did not smell like coffee brewing.  It was a bitter/rancid smell like I have never smelled before.  I also noticed within the next several days that other things such as human feces and cat feces had that same strange smell that coffee had.   I keep thinking it will get better, but it's been 4 months now and it has not gotten better, so I decided to report it.  My taste has also been altered.  I cannot taste garlic and certain other things taste "off" or bitter.
Twenty minutes after receiving Varicella vaccine, patient returned to clinic with swollen right eyelid and had vomited x 1. Gave patient 35mg Benadryl and held in office for 40-45 minutes. Swelling had decreased by the time patient left. No signs of respiratory distress.
Large rash around injection sight about 2" diameter.  101.9 fever.  Tired.
late for 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: late for 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-MAR-2023 The reporter had a lot of patients who comes for the second dose years after the first one. 4 to 5 patients asked reporter this winter, it comes to reporter as a question, and he/she referred them to their provider, but he/she would like to know how to approach them as well and administer if appropriate. The vaccine administration facility for 1st dose was the same as primary reporter. Details was reported for 1st dose. The reporter consented to follow up. Till the time of reporting, the patients did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot # 669692/0615AA expiration date 02-JUL-2012) that was expired on 06-JUL-2012. No adverse event reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. The report was received from the same reporter with the 3 other cases, and their MARRS# are 1207USA002230, 1207USA003758, 1207USA003759, respectively. Additional information is not expected.
This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9ZUZ, Expiration date: UNKNOWN), an unspecified route of administration in arm left on 05Feb2021 at 20:30 as a single dose for COVID-19 immunization. Medical history included chronic kidney disease, borderline high cholesterol, osteoporosis from an unknown date and unknown if ongoing. The patient had no allergies. The patient's concomitant medications were not reported. The patient did not received any other vaccine within 4 weeks and not received any other medication within 2 weeks. The patient was not tested prior to COVID-19 vaccination and not tested for COVID-19 after vaccination. The patient experienced neck started to feel tight on 05Feb2021 at 20:30. The patient has said that that about 25 minutes after shot left side of my neck started to feel tight. I could talk and swallow and after about 10-15 minutes feeling went away. The patient did not receive treatment for the event. The outcome of the event was recovered on an unspecified date 2021. No follow-up attempts are possible. No further information is expected.