chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her husband had a high temperature all night long and was shaking; her husband had a high temperature all night long and was shaking; sick; fever; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced a high temperature all night long and was shaking, sick and fever on an unspecified date. It was reported as, "Caller said she and her husband both had 2 doses of the Pfizer COVID-19 vaccine on the end of February. They were hanging out with two friends who were also completely vaccinated with the Pfizer COVID-19 vaccine the whole day yesterday. This morning, her girlfriend called saying that her husband had a high temperature all night long and was shaking. Her girlfriend's husband's doctor felt that it was highly unlikely that he has COVID-19. Caller wanted to know if it is possible that her girlfriend's husband has COVID-19. Caller said that they are still waiting for the results of her girlfriend's husband's COVID-19 test. She wanted to know what to do in the meantime. Reporter stated she is calling about the two doses of Pfizer COVID vaccine that her husband and she got. Reporter stated they are doing fine but she has a question about being with people that also got two doses of the COVID vaccine. Reporter stated her girlfriend just called her saying her husband was sick all last night and was shaking with a fever. Reporter stated although they are all vaccinated could they still get a mild case of COVID.Reporter confirmed that her husband, herself, and girlfriend is fine. Reporter confirmed that the girlfriend's husband is the one that is shaking with a fever. Reporter declined to complete report at this time wished to be transferred for her question. Reporter stated so she knows her husband and she was them yesterday and she was wanting to know how everything stands with if they could get mild COVID. Reporter confirmed that her girlfriend's husband got the Pfizer COVID vaccine but she is unsure when he got the doses. Reporter confirmed that everyone had the Pfizer COVID dose". The patient underwent lab tests and procedures which included body temperature increased: increased on an unspecified date. Outcome of the events were unknown.  Follow up attempts are needed. Further information has been requested.
pt recv vax in 12/96 & in 12/97 pt devel varicella w/moderate vesicular rash. also devel otitis media. treated w/atb
Case number PHEH2014US006938 is an initial spontaneous report from the consumer received on 07 Apr 2014. This report refers to a female patient of an unknown age. She was vaccinated with FLUVIRIN (batch number: 1309401, expiry date: 30 Apr 2014) on an unknown date. On an unknown date, after vaccination she experienced lip swelling and tearing of eyes. The final outcome, seriousness and causality of the events were not reported.
This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient (not pregnant) received the first dose of bnt162b2 (BNT162B2 also reported as product COVID 19 brand Pfizer, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm on 05Feb2021 08:15 at SINGLE DOSE for Covid-19 immunisation. Medical history included colorectal cancer and thyroid cancer. She had allergies to sulfur. She did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine sodium (LEVOXYL). The patient experienced her lips felt swollen and numb for about one hour after the dose was administered (non-serious) on 05Feb2021. No treatment was given. The outcome of events was recovered on unspecified date in Feb2021.  Information on the lot/batch number has been requested.
Blisters/rash on chin. Went to Dr 4/15 was giving an antibiotic cream, 4/16 went to urgent care and diagnosed Impetigo, went to dermatologist on 4/28 treated fro shingles.
CONFIRMED COVID-19 INFECTION (WHICH WAS DESCRIBED AS MILD COUGH, BODY ACHES, DIARRHOEA, CHILLS AND LOW GRADE FEVER); This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On MAR-2021, the subject experienced confirmed covid-19 infection (which was described as mild cough, body aches, diarrhoea, chills and low grade fever). On 18-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection (which was described as mild cough, body aches, diarrhoea, chills and low grade fever). This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
patient  13yo male received pfizer vaccine, 1st dose. patient was fine with parents after vaccine.  Patient later walked around store and parents stated he started seeing black spots then went limp.  Father carried him back to pharmacy where he was already fully alert and coherent at arrival to pharmacy  Blood pressure was taken.  Patient stated he was fine.  Patient advised to remain seated in pharmacy immunization booth.  patient remained completely coherent.  blood pressure taken a second time with normal results .  patient drank a small amount of water and repeatedly stated ok.  discussion with parents that an ambulance could be called at their choosing but completely conscious and alert.  also advised if they felt it necessary they could seek medical evaluation or if condition changed then would definitely seek medical attention.
knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (knee pain) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date, Cholesterol since an unknown date and Pace maker (Patient has a pacemaker). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (knee pain). The patient was treated with TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) on 22-Jan-2021 for Knee pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications reported were medication for high blood pressure, blood thinner, and medication for cholesterol. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (knee pain) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date, Cholesterol since an unknown date and Pace maker (Patient has a pacemaker). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (knee pain). The patient was treated with TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) on 22-Jan-2021 for Knee pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications reported were medication for high blood pressure, blood thinner, and medication for cholesterol.
Did not feel good; Dizzy; Weak; Fatigue; Muscle ache; Heart rate was 144; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel good), DIZZINESS (Dizzy), ASTHENIA (Weak), FATIGUE (Fatigue) and MYALGIA (Muscle ache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concurrent medical conditions included Prediabetes. Concomitant products included METFORMIN for Prediabetes, VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced MALAISE (Did not feel good), DIZZINESS (Dizzy), ASTHENIA (Weak), FATIGUE (Fatigue), MYALGIA (Muscle ache), HEART RATE INCREASED (Heart rate was 144) and HEADACHE (headache). At the time of the report, MALAISE (Did not feel good), DIZZINESS (Dizzy), ASTHENIA (Weak), FATIGUE (Fatigue), MYALGIA (Muscle ache), HEART RATE INCREASED (Heart rate was 144) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No additional AE/PQC; dose of VARIVAX was administered today after the temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 03-NOV-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number T012552, expiration date 10-APR-2022 (route of administration was not provided) for prophylaxis.  The vaccine had a temperature excursion of 7 degrees Celsius (°C) for 14 hours. There was no previous temperature excursion.
That night I developed a sore throat and cough that got worse the following days. Couldn't sleep due to cough and congestion. Forehead sweat but no fever. Sore arm lasted 3 weeks.
pain in both shoulders that is ongoing, the pain is  worse in the right shoulder versus left; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in both shoulders that is ongoing, the pain is  worse in the right shoulder versus left) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and ASA for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced ARTHRALGIA (pain in both shoulders that is ongoing, the pain is  worse in the right shoulder versus left). At the time of the report, ARTHRALGIA (pain in both shoulders that is ongoing, the pain is  worse in the right shoulder versus left) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
December 1, 2021 Moderna vile transferred from Freezer to Fridge  January 3, 2022 Moderna dose administered.
Fever (101F), chills, body aches, headache, weakness, fatigue. Significant soreness at injection site. Started 5-6 hours after injection. No other symptoms. Some improvement after 400mg ibuprofen approximately 24h after symptom start. All symptoms besides injection site soreness resolved within 36 hours. Soreness resolved within 72 hours.
1. Patient had onset of arm pain/swelling that same day.  She tried to self-treat, but ended up  going to emergency room 3/12/2020. Due to extended wait, she left without being seen. On 3/13/2020, she returned to clinic from which she received vaccination. Cannot move her left arm today. From nursing documentation "She states that she has been having severe pain in the left arm for the last two days. No redness or swelling noted to the deltoid area where injection was given. There is also no lump or abnormality noted at injection site. Denies pain at the injection site. She describes the pain to be under her arm, around the inside of the underarm, and up at the top of the shoulder.  States that she has been using heat, ice, and ibuprofen 600mg.  She reports that the ibuprofen has helped with her pain. She rates the pain an 8/10. Provider requested patient to lift arm, and when she couldnt do so with AROM, provider passively moved patient arm which was very painful." Pt education regarding the recent vaccination and expected sensation of this discomfort. Normal motor and neuro function. There was no awareness on behalf of provider/RN that reaction was c/w SIRVA and abnormal reportable event. ON 3/15, seen in ER with persistent pain- "TTP left AC joint,  no obvious bruising or defomorities, unable to do hawking or empty can test, decreased ROM". Patient was psychologically traumatized by this experience and did not trust returning to hospital. Continued with MH treatment, but has reluctantly engaged with medical care.
Vision blurriness and shimmering. Usually a precursor to migraine headaches. Issue is not constant, it comes in waves. Sometimes triggered by bright flashes of light. These symptoms have not occurred before the vaccine.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 01-MAR-2010, the patient was inoculated at a clinic (by an unspecified health care professional) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the female patient was treated (by unspecified health care professional) at a clinic for a persistent and severe rash, which was diagnosed as Herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
A couple of small hives, 5ml dose of children's Benadryl given after.
headache; achy; got pretty sick after getting the vaccine; did not feel good; This is a spontaneous report from a contactable consumer (patient spouse). A 68-year-old male patient (reporter's husband) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history included covid-19 in November for 2 weeks but did not have to go to the hospital and recovered (from Nov2020 to unspecified date in 2020). The patient's concomitant medications were not reported. Other products not provided. The reporter reported that patient got pretty sick after getting the vaccine and he did not feel good. Her husband had a headache and was achy for 2 days after the shot. She mentioned her husband's symptoms lasted a couple of days. She wanted to know if they should get their second scheduled dose of the vaccine. The outcome of events were resolved.  Follow-up activities were closed. No follow up attempt was made .
Inflammed left armpit lymph node after shot, persisted 5 months. Vaginal bleeding episode in which lymph node shrunk. Then on month 5 post vaccine, developed significant severe joint pain, fatigue. Being referred to autoimmune clinic as inflammatory markers were abnormal. Upcoming appt 7/6/21
Three to four days after exposure to varicella the pt received one dose of varicella virus vaccine live. Fourteen days post vax the pt experienced diffuse varicella rash characterized by joint pain, headache and fever of 102F. The pt had greater than 100 lesions. The pt was diagnosed with typical exanthem of chickenpox. The swab specimen from the varicellaform  rash confirmed positive result for VZV and found to be wild type virus.
First day tired and slight headache 2 day arm hurt badly and headache more intense very tired 3 day arm hurts more headache bad and very very tired 4 day woke up at 3:45 am and I couldn?t walk straight and my left side of body was very heavy and my speech was off and my head hurt really really bad and seemed to be on my left side of my head and my neck hurt extremely bad I went to hospital
Initial information received on 23-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves an adult female patient who experienced cant sleep due to the discomfort and can't sleep on that side, fatigue, redness is spreading and arm pain, site is darker, local itching, not able to lift her arm up far as she usually can, hard as a rock about the and size of an olive, while she received vaccine ADACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On 17-Aug-2018, the patient received a dose of suspect Diphtheria-2, Tetanus, 5 AC Pertussis Vaccine (batch no U5879AB) (expiration date 13-MAR-2020) via unknown route in the right arm. On an unknown date, following vaccination, the patient arm developed pain to the point she is not able to lift her arm up far as she usually can. States she can't sleep due to the discomfort and can't sleep on that side, has fatigue, the site is darker and "hard as a rock" about the and size of an olive with local itching. States the redness is spreading and she has contacted the doctor who told her they would get back with her. This is also an actual medication error case due to caller feels injection was given a little lower than it should have been and she thinks definitely not in the deltoid (Vaccine administered at inappropriate site). Other relevant tests included no lab data. Final diagnosis was local itching, skin discoloration, redness and arm pain, fatigue and sleep disorder. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for all reported events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Documents held by sender: none.
Over the counter THERAFLU, NIGHT QUIL & TYLENOL. Chills, fever, chronic cough, sneezing, body pain, pain chest, cold sweats.
1 days after injection, redness, cellulitis around the injection. Discharge summary states reddness, warm. msv
itthat phlebitis is an infection; her arm started swelling and turned red; her arm started swelling and turned red/arm is not as red, but it is the size of a half a dollar; This is a spontaneous report from a contactable consumer. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 19Mar2021 10:45 (age at the time of vaccination was 73-year-old) (Batch/Lot Number: ER2613) as Dose 2, Single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccination includedThe patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in Arm Right on 26Feb2021 10:45 (age at the time of vaccination was 73-year-old) (Batch/Lot Number: EN6202) as for covid-19 immunization and experienced arm was sore. History of all previous immunization with the Pfizer vaccine considered as suspect reported as none. Additional administered vaccines was reported as none. The patient did not visit emergency room and physician Office for AEs. Prior Vaccinations (within 4 weeks) reported none. AEs following prior vaccinations reported as none. On 25Mar2021, the patient noticed that after the second dose her arm started swelling and turned red. Further stated it looked infected. The patient wanted to know is it normal for her arm to be red and swollen. Also reported that it is not quite as red this morning but after the patient arm is not as red, but it is the size of a half a dollar. The patient stated that the arm looks like she has phlebitis. Further clarified that phlebitis is an infection. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected
Approx 3 hours after vaccination pt. reports headache & muscle aches. Approx 8 hours after vax reports fever (99.7) pt. reports "doing nothing but drinking & sleeping" x 3 days. Pt. reports 4" x 4", red, sore area above (R) elbow and 2 lumps close together (one with blister) on back of arm near axilla.
Received Imm 11-28-16. Mom noticed red itchy rash at injection site last evening, it was firm to touch. This morning she had arm pain while putting on her shirt. Left deltoid with 4 x 4 inch area of redness some induration, mildly warm. ROM normal.
Started with nodal swelling within 10minutes of injection. Worsening fatigue as day progressed, developed runny nose and watery eyes, pain in my arm at injection site then spreading to the rest of my body.  Took Sudafed for the cold like symptoms that evening and then in the morning. Went to sleep woke in the morning with severe fatigue, nausea, headache. At 11:00 noted that a bitter taste in my mouth that lead to loosing my sense of taste for 6 hours.  I started getting a fever, which got up to 102 degrees, took Tylenol for this. At the same time my lips started swelling, then my hands, and approximately around 1900 my buccal lining of my mouth.  Took 50mg of Benadryl which helped with swelling and went sleep.  Woke up 6 to 7 hours later and took 50mg of Benadryl for good effect. Continue to have mild fatigue, headache and nausea this morning.