chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Multiple Palpable lymph nodes New onset Headaches Swelling of extremities/fingers; Multiple Palpable lymph nodes; New onset Headaches; Swelling of extremities/fingers; This is a spontaneous report form a contactable Nurse (patient). A 51-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER8737), via an unspecified route of administration in arm left on 15Mar2021 (at the age of 51-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included Hashimoto's from an unknown date and unknown if ongoing. The patient had no known allergies. The concomitant medications of the patient included levothyroxine sodium (SYNTHROID) taken for an unspecified indication start and stop date were not reported. It was reported that patient took first dose of BNT162B2(solution for injection, Batch/Lot number: EN6207), via unspecified route of administration on 15Mar2021 at 14:00. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 01May2021, the patient experienced multiple palpable lymph nodes new onset headaches swelling of extremities/fingers, multiple palpable lymph nodes, new onset headaches, swelling of extremities/fingers. The events resulted in the physician office visit. The outcome of the events was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Inability to sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Inability to sleep) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Sulfa drug) and Allergy to antibiotic (Allergic to Penicillin). Concomitant products included METFORMIN, TRAMADOL, TRAZODONE and LISINOPRIL for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INSOMNIA (Inability to sleep). At the time of the report, INSOMNIA (Inability to sleep) had not resolved.
FOR 24 HOURS POST INJECTION, HAD VIOLENT CHILLS AND SEVERE HEADACHE
On 11/22/21, a Pfizer vaccine vial was reconstituted at 10:45 AM. All doses were kept in the vial. On 11/23/21, patient received the reconstituted vaccine from 11/22/21 at 10:08 AM.
This spontaneous case, initially received on 26-Jan-2017, was reported by a non-health professional and concerns a 62-year-old male patient. Weight: not provided; Height: not provided. Concomitant mediation: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 03-JAN-2017 to 03-JAN-2017. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: 13049221A. No additional suspect drugs. Adverse event description: On 03-Jan-2017, the patient received AFLURIA vaccine following temperature excursion (outcome: unknown). Special circumstances: incorrect product storage without adverse event, drug administration error without adverse event).
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case belongs to 178th out of 190 patient. 190 patients (9 different lot numbers) received a vaccine past the beyond used by date Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Contacted patient 9/30/09 to refund admin charge - she then told me of reaction - generalized "felt bad out of it" Headache. I asked 4-5 dx - recurred but will not get another pneumonia shot had flu shots previously - no problems.
pt recvd vax; w/in hrs of vax pt started exp fever, chills, joints aches, n, rt arm painful at inject site;
This non-serious consumer report (initial receipt 08-Sep-2015) concerns a 62 year old female patient who had no remarkable relevant patient history and no known drug allergies. On the 02-Oct-2014, the patient received AFLURIA (batch number not reported) 0.5 ml via the intramuscular route in the left deltoid. It was a pre-filled syringe and the 2014-2015 formulation. On the 04-Oct-2014, she complained about lumps under her left arm. On the 06-Oct-2014, she saw her MD (Medical Doctor) for swelling and lumps under her left arm that extended all over under the arm. The MD believed it could be due to the flu shot, but wanted her to get additional diagnostic evaluation. The patient had an ultrasound on the 07-Oct-2014 on her left axillary. The image result showed multiple lymph nodes, enlarged, none of pathological appearance, left axillary adenopathy observed consistent with that of reactive lymph nodes, a likely response to the flu shot. On the 07-Oct-2014, the patient went to the MD for follow-up and she explained that the imaging results concluded it was due to the flu shot and there was improvement. The MD recommended ibuprofen and warm compresses for the lumps and the lumps slowly started to be less painful and eventually went away in about three weeks from this medical appointment. The patient could not move the arm during this time and it was very painful. Even though the lumps ended up shrinking, they were painful. This cause impaired mobility. The lumps extended under the arm to the breast area. Outcome was not reported. Reporter comments: The reporter stated that the imaging results concluded it was due to the flu shot.
Same day about two hours following the injection through the entire following day?headache so severe that face and teeth hurt which did not improve with OTC pain reliever, taste of metal in mouth Fatigue?for 48+ hours following injection Next day?swelling of lymph area in armpit spreading into breast area through today and has not resolved. Fever 101.3?starting approximately 40 hours after the injection
TOOK TWO NAPS; FEELING SLOW MOTION; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 2021, the subject experienced took two naps. On 2021, the subject experienced feeling slow motion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling slow motion on 2021, and the outcome of took two naps was not reported. This report was non-serious. This case, from the same reporter is linked to 20210431321.
she developed a fever; joint pain; muscle pain; diarrhea; nausea; chills; arm hurt for a little bit; No appetite; Headache; stomach pain; she is not feeling that well; tested positive to COVID-19 last Tuesday; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number: not reported) dose 1 via an unspecified route of administration on 18Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant were not reported. It was reported that her arm hurt for a little bit. On 25Mar2021 she developed a fever, joint pain, muscle pain, diarrhoea, nausea, and chills. She wants to know if its normal to get the side effects 7 days later. States that she had knee injections on 22Mar2021, she wants to know if that caused her side. She stated she got her first vaccination on 18Mar and she was fine for 6 days, almost 7 days and then on the 7th day laid me to, she developed a fever 101.68 (not clarified) and she have been running this temperature since Thursday, chills, no appetite, diarrhea, some nausea and very slight headache but its still, all on this temperature every day she put she was better today and then just an hour go and took her temp she was feeling chills and whatever and backup to a 101, so her main concern was are you have anyone having a reaction 7 days into a shot but she know its not being around for a long time, so she just want to know that she should be concerned. On 30March2021, She states that she had a sore arm couple of hours and then she was fine. After a week later she got a fever, chills, headache, diarrhea, and stomach pain. She states everything has been going on since then and she is curious, she has never heard of this happening 7 days later. Is this normal or has this happened to anyone else, it sounds like its all reactions, trying to decide if this is a reaction to the shot or if she should go to the doctor.. She explained she went to the doctors and tested positive to COVID-19 last Tuesday. She added she thought she was better, but her temperature was at 101°F today. She asked what to do about the second dose of the vaccine scheduled on 08Apr2021. Caller asked, Should she get the second dose of the vaccine since she experienced these side effects, If she get tested for Covid and am positive, can she get the second dose and how far beyond the 21-day interval could the second dose of the Pfizer-BioNTech COVID-19 vaccine be administered. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on Mar2021, sars-cov-2 test: positive on Mar2021. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The patient was administered the Covid-19 Moderna vaccine outside of authorized use (was 16 at the time of vaccination).  No Adverse Health events occurred and verified via telephone with father of child.
SKIN REDNESS; Lack of drug effect; COVID POSITIVE; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (SKIN REDNESS), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID POSITIVE) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    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-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 25-Jan-2022, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID POSITIVE). On an unknown date, the patient experienced ERYTHEMA (SKIN REDNESS). At the time of the report, ERYTHEMA (SKIN REDNESS) had not resolved, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and COVID-19 (COVID POSITIVE) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2022, SARS-CoV-2 test: (Positive) Positive.         NO KNOWN ALLERGIES. No concomitant drugs taken. On an unknown date, the patient experienced SKIN REDNESS. On 25 Jan 2022, the patient experienced COVID POSITIVE.. No treatment medication was reported. Primary reporter did not have the lot number information, because the packaging was discarded.   Causality for SKYRIZI(RISANKIZUMAB):  The reporter's causality for the event(s) of COVID POSITIVE was not provided. The reporter's causality for the event(s) of SKIN REDNESS with SKYRIZI(RISANKIZUMAB) was a reasonable possibility.    This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a physician concerning an adult female who on 16-MAR-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). It was reported that the physician was confused because they are both varicella containing vaccines. No symptoms were noted. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
constipation; fatigue/sleepy; fatigue/sleepy; weight gain; nails cracking; elevated blood pressure; change in thyroid lab with Levothyroxine dose adjusted; sore arm after vaccine; This is a spontaneous report from a contactable consumer, based on information received by Pfizer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Mar2021 (at the age of 63-year-old) (Batch/Lot number was not reported) as single dose (dose number unknown) for COVID-19 immunisation and lenvatinib mesilate (LENVIMA) oral from 05Dec2020 and ongoing at 8 mg (frequency unspecified) for endometrial cancer. Medical history included endometrial cancer. Concomitant medication included pembrolizumab (KEYTRUDA) taken for endometrial cancer, start and stop date were not reported. The patient experienced constipation on an unspecified date with outcome of not recovered, fatigue/sleepy on an unspecified date with outcome of not recovered, weight gain on an unspecified date with outcome of not recovered, nails cracking on an unspecified date with outcome of not recovered, elevated blood pressure on an unspecified date with outcome of recovering, change in thyroid lab with levothyroxine dose adjusted on an unspecified date with outcome of recovering, sore arm after vaccine on 17Mar2021 with outcome of recovered on 18Mar2021. All the events were considered as non-serious. The patient reported constipation, fatigue/sleepy, weight gain, nails cracking, elevated blood pressure (lisinopril dose increased again - now at 30mg/QD), change in thyroid lab with levothyroxine dose adjusted, sore arm on 17Mar2021 after 1st Covid vaccine resolved after 1 day, scan last month (e.g. Feb2021) showed decrease in tumor size. The patient will discuss all symptoms with MD at appointment the following week. The action taken with Lenvatinib mesilate in response to the events was dose not changed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My problem is that I am a blood donor. Or I HAVE been a donor. My last donation was destroyed because testing identified a marker for hepatitis. All other tests proved hepatitis was not present, I received a TWINRIX vaccine from my primary care physician to prevent me from getting hepatitis. I am told that I will ALWAYS have the marker they identified because of the vaccine. Ergo, if I donate, my blood will be destroyed after testing until the rules change. I am O+, I can't donate because I am taking the best care of myself to avoid getting hepatitis. Please change the rules/guidelines to allow people with this vaccine to help others. Thank you.
Presented with 27 YO male, seated in a chair S/P receiving Johnson and Johnson COVID-19 vaccine. PT started to feel dizzy and started to become diaphoretic. PT does not speak English, upon translator?s arrival they advised this writer that PT was feeling dizzy, and short of breath. PT visibly diaphoretic and his skin color changing from normal to pale. PT pulse weak and thready, and PT hypotensive at 76/P. PT administered 50mg of Benadryl IM in his right deltoid, successful. PT pulse no longer palpable in the radial so PT placed in a supine position on the floor and PT legs elevated to a Trendelenburg position for his hypotension. PT administered 1mg Epinephrine 1:1,000 IM in the left deltoid, successful. Ambulance called for transport of the PT to the nearest hospital. PT blood pressure slowly starting to stabilize at 90/56. PT SPO2 reading 98% on room air with respirations 18 and regular with clear lung sounds. PT no longer having Shortness of breath or dizziness. PT no longer sweating and he is beginning to stabilize. Radial pulse palpable again and strong and regular at a rate of 76 bpm. PT blood pressure reading 110/76. Upon fire department arrival determined that the PT was stable enough to sit upright in the chair again. PT was assisted off the floor and to a seated position in a chair. PT vitals after seated position for 5-7 min, BP 120/82, pulse 86 strong and regular, RR 20 and clear equal bilateral lung sounds. PT has no other complaints at this time. PT has no allergies to medication, PT has a pollen allergy that he takes over the counter allergy medicines for. PT has no past medical history. Upon arrival of ambulance PT care relinquished to EMS with full report, PT care relinquished without incident or injury.
He may have had a stroke; His left hand, he had no control over it; Slurred speech; This is a spontaneous report from a contactable consumer. A male patient (Father) of an unspecified age received BNT162B2 (BNT162B2, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications was not reported. Reporter was calling on behalf of his/her father, patient took the Pfizer vaccine on Monday, his first shot and sounds like he may have had a stroke (event captured as per verbatim) the next day. He won't go to the doctor, he woke up 'next' morning and his left hand, he had no control over it on an unspecified date. On an unspecified date, he had slurred speech, reporter didn't notice, reporter just found this out today and reporter didn't even know that he has got the shot. The symptoms have gone better, and he didn't go to the doctor. So, one, he never goes to the doctor hardly ever and two, he was researching it online and said that, he thought that maybe those were symptoms like the side effects of getting the vaccine but reporter was concerned that maybe it was a stroke. Reporter have been trying to get him go to the hospital but since the symptoms have got better, he was not going. When asked for LOT of first shot reporter stated, that reporter don't know what that was he/she don't have that reporter can get that from him but he/she was not at his house right now. The outcome of the events was unknown.  Follow-up activities are closed. Batch/lot number is not available
Patient stated she felt fine the day of injection. When she awoke the next morning, she noticed stiff/achy muscles all over her body. She continued her morning routine of going downstairs and taking her levothyroxine and drinking a glass of water. A little while later her stomach started to hurt and she thought she may be hungry. She said the next thing she remembers is waking up in the floor. She has a concrete floor so she had a "goose egg" on her head. She states she did nothing else that day except sit around with an ice pack on her head.
Pain; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pain) and PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN (Pain) outcome was unknown and PAIN IN EXTREMITY (sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.  The patient had pain, sore arm for two days after Moderna booster in November 2021. She got the shingle shot and flu shot in Dec 2021.  Treatment medication not reported.
High fever, wheezing, dark blue and red around leg, swollen, knot (lumps under skin (5) increase heart rate).
Oblong red swollen area approx 4 1/2 x 3" (wide x tall). Treat with Keflex 500mg.
Headache, Myalgia, Fever, chills, pain at injection site Narrative:
Wheezing, shortness of breath, throat tightness, running nose, sneezing.  Symptoms required use of Albuterol rescue inhaler and Benadryl.  Symptoms resolved in approximately 2 hours.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received DTP (A or W not known). On an unknown date, the patient received DTP vaccine at an unknown dose. On an unknown date, unknown after receiving DTP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown. The reporter considered the vaccination failure and whooping cough to be possibly related to DTP vaccine. Additional details were reported as follows: The children experienced whooping cough when they were older in spite of being vaccinated against DTP. The reporter stated that, vaccines are garbage and do more harm than good. This case was considered as suspected vaccination failure since time to onset for the event was unknown. The reporter did not consent to follow up. This case was linked to case US2017GSK139593, reported by the same reporter.
Immediately /p vax was given a 4 cm diameter red area around vax inject site appeared, /P 15 min red area decreased to area under bandaid./P 30 min child had 2 approx 5mm red macules on lower back. No pruritis noted or other skin sx.
Headache and body ache and tiredness started 8 hrs after.  48 hrs later swelling and severe pain in armpit.  Alternating Tylenol and ibuprofen and still feel pain.