chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches overnight; headache; mild nausea; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Mar2021 13:50 (Lot number: EN6203) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FAMOTIDINE taken for reflux gastritis (ongoing). Vaccination history included: Bnt162b2 (1st dose, Time: 13:50, Anatomical location: Left arm, Route of administration: Intramuscular, Lot No. : EL3247), administration date: 24Feb2021, when the patient was 54 years old, for COVID-19 Immunization, reaction(s): "muscle soreness at injection site". The following information was reported: PAIN (non-serious) with onset 17Mar2021 23:00, outcome "recovered" (Mar2021), described as "body aches overnight"; HEADACHE (non-serious) with onset 17Mar2021, outcome "recovered" (Mar2021), described as "headache"; NAUSEA (non-serious) with onset 17Mar2021, outcome "recovered" (Mar2021), described as "mild nausea". Therapeutic measures were taken as a result of pain, headache.  Additional information: Patient's medical history, family medical history and relevant test was reported as none. No other prior vaccinations. Body aches were still present the next day (on 18Mar2021). Headache and body aches responded to acetaminophen (TYLENOL) given as needed.  No follow-up attempts are possible. No further information is expected.
Just assuming this is one adverse event, not multiple Woke up at 2AM thirsty; got up got water felt weak got back to bed. Discovered my oxygen reading on a pulse oximiter was 77 and pulse was 79. My understanding is I shouldn't have been walking with that reading but I was. Was too weak to work the rest of the week. For the next three weeks my pulse was over 100 for walking around the house. oxygen reading was over 94 and thus I didn't note the exact value. I sought some help after the second week and got an answer of I think the vaccine set your covid recovery back.  I seemed to get better, went on my scheduled vacation for middle of September, found I was still much weaker than my normal self, came back, and slowly lost ground. I'm weaker now and am on over the counter sleep aid melatonin. I struggle to get enough sleep, I struggle to get work done. My heart surges at the slightest provocation, and my stress handling is completely shot.  I have actually been afraid to go into the doctor's office because my primary care physician originally thought it was depression, which I can disprove to myself and made multiple attempts to have it treated by mental health. It is probable I have depression, but that's not the primary cause here.
Bloody stools - red blood and mucous noted in stool 4 hours after vaccine given. (+) fussiness, mucousy stools lasted for few days. other symptoms resolved in 1st day.
anaphylaxis; treated with an epipen; extreme swelling of tongue and parts of mouth.
11 days post immunization employee developed pain, swelling over injection site,with 2-3 small raised bumps, not vesicular. Following day noticed maculopapular rash chest,approximately 4-10 lesions, multiple lesions over left antecubital, and scalp. No fever. C/o dry cough, runny nose, afebrile. Sent home, sequestered, verbal instructions to avoid immunosuppresed persons. F/U Monday by phone.
Vaccines was verified and pulled by a CMA and she had to leave office. A new employee wrote vaccines on consent. She went to get assistance from an LPN to give injections. NCIR was printed. Vaccines were verified on consent with immunizations and drawn up. They did not look closely at the Hep B that is typically given at 2 months. This particular child was given 1st dose at birth and 2nd dose at age 1 month. She was not due for 3rd dose until 10/27/2021. Hep B 3 dose that was given is now an invalid dose. Per medical professional at NCIR- this will not harm child and she will be due for 3rd dose on or after 10/27/21.
Patient came in 5 days after her vaccination complaining of slight itching and a small bump at the injection site. Upon examination the injection site had slight induration but did not look red, swollen or warm to the touch. Instructed the patient to follow-up with her PCP for further testing.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Rash (other than injection site)-Mild
Woke up from a nap at 5:30 pm the day of the immunization with chills, fever, shortness of breath and a cough, weakness, achy on left side of body- her arm/shoulder, her hip, the left side of her abdomen. She took some Ibuprofen and went to bed. The morning of 11/19/15 she called into Employee Health stating she had a reaction to the vaccine. She continued to feel chilled, weak, SOB. I informed her she should come into the ER to be seen. She had a temp of 101, positive reflexes and strenght in her extremities. Area of vaccination was pink and warm, with slight swelling noted- very tender to the touch. She has had the influenza vaccine for the past seven years without issues.
Fever, swelling around the injection area, pain.  Came back to us on 8/6.  Advised Zyrtec, Benadryl.  Some improvement.  Returned 8/7, minimal immprovement.  Given Medrol dose pack.
Information has been received from a nurse concerning a female who in January 2007, was vaccinated IM with a first dose of Gardasil.  Subsequently, in January 2007 the patient experienced pain and nausea.  It was reported that the patient did not seek medical attention.  On an unspecified date, the patient recovered from pain and nausea.  On an unspecified date, the patient was vaccinated with a second dose of Gardasil and planned to finish the series.  Additional information has been requested.
Information has been received from a registered nurse (R.N.) concerning a 10-year-old female with insulin-dependent diabetes mellitus (IDDM) and no allergies, who on 13-MAR-2000 was vaccinated subcutaneously in the left arm with a dose of varicella virus vaccine live.  Concomitant therapy included insulin.  On 27-FEB-2006, after being exposed to chickenpox, the patient had a varicella titer drawn.  The titer showed that the patient was not immune to chickenpox.  Unspecified medical attention was sought.  It was reported that at the time of this report the child was well with controlled IDDM.  No product quality complaint was involved.  Additional information has been requested.
experienced sore right arm,; experienced sore right arm, and chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (experienced sore right arm,) and CHILLS (experienced sore right arm, and chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L220A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included HYDROCORTISONE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (experienced sore right arm,) and CHILLS (experienced sore right arm, and chills). The patient was treated with IBUPROFEN on 27-Jan-2021 at an unspecified dose and frequency. On 30-Jan-2021, PAIN IN EXTREMITY (experienced sore right arm,) and CHILLS (experienced sore right arm, and chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were hydrocortisone 5-10mg, Thyroid medication, and supplements for drug use for unknown indication.
WHEN GETTING UNDRESS NOTICED LT UPPER ARM RED, TENDER AND WARM TO TOUCH. NO TREATMENT NEEDED.
3 days after vaccination, notice Rt upper arm at injection site become warm, swollen, burning, tender to touch with discomfort raising up arm. Consulted Dr. at employee health, prescribed with antibiotic and diagnosed with cellulitis.
A report has been received from a pharmacist via Abbvie concerning a 12 year old, male patient, height: 60.0 inches; weight: 80.0 pounds. The patient took no concomitant medications. The concomitant diseases of the patient were not provided. On 19-Oct-2015 the patient received FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, once/single administration (0.1mL per nostril). The patient complained of cold symptoms referred to nasopharyngitis started on 21-Oct-2015. The patient went to his doctor with a fever and had a nasal swab done which was positive for type A influenza on 22-Oct-2015. FLUMIST QUADRIVALENT was continued. The outcome of the events was unknown. The event of type A influenza was considered as serious with the serious criteria of important medical event by company physician. The events of cold symptoms referred to nasopharyngitis and fever were considered as non-serious by company physician.
Pt recvd 3 doses of Engerix-B vax 8NOV90, 30NOV90, 2MAY91 & 27SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B; recvd booster, titer pos;
Five hours after receiving this shot,  my site of injection became swollen, red, raised, hot  and my shoulder and  arm became VERY painful. I was unable to move this arm. Unable to sleep on that side of my body during that night.  The next day I felt unwell. I felt sick to my stomach. then I experienced chills (around 5:00 PM on 4/17/2019) fever of 100. the morning of 4/19/2019 I again well unwell. My blood pressure started to rise (my BP in the doctor's office two days before was 121/92. Now it was 136/98, 146/97, and after icing the back of my neck, 128/93.  Felt sick to my stomach and dizzy.
person didn't get the second shot, got sick and died; person didn't get the second shot, got sick and died; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (batch/lot number and expiration date was not reported) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The consumer stated that they had a case where a person didn't get the second shot, got sick and died (pending confirmation). The patient died on an unspecified date. It was unknown if an autopsy was performed.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: person didn't got the second shot got sick and died
It started slowly with feeling extra tired and light arm soreness. Then rapidly became extreme shivering, a fever, headache and full body muscle aches. In the early morning I also got stomachache cramps and felt hungry, but food didn?t help. It actually made me feel nauseous. By 6am the next day I had a serious migraine too - sensitivity to light. My eyes hurt. It actually was so bad I caved and took 2 liquid Advil?s to help with the pain. From there I slowly got better over the day but still had the above mentioned symptoms, just less intense. Around 8pm the fever came back and I called it a night.  Next morning I felt better, but still tired. Still had a headache but not a migraine. And occasional stomach aches. It?s now 2 days later and the head aches, arm soreness and occasional stomach aches have not gone away.
Bunch of people got sick after getting Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Bunch of people got sick after getting Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Bunch of people got sick after getting Moderna vaccine). At the time of the report, ILLNESS (Bunch of people got sick after getting Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
I was diagnosed with Covid; I was diagnosed with Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booter), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "scleroderma" (unspecified if ongoing), notes: I have limited scleroderma. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I was diagnosed with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: . I was diagnosed with Covid and on second day of Covid symptoms started Paxlovid which helped to reduce my symptoms within two days.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Information has been received in a newspaper article concerning a female who in late May 2007, was vaccinated with her first dose of Gardasil whilst at school. The patient stated that instantly after the shot she began crying "because the shot itself hurt so much". An hour later, at 10:30 am, the patient felt nauseated, very dizzy and weak. She laid down on a bed in the sick bay. Subsequently, she experienced hallucinations, described by the patient as "The kookaburras were flying out of the picture at one point and attacking me, and I couldn't see most of the rainforest animals and the ones I could see were also coming at me ...". After a few hours had passed, the patient stated that her entire right side had become paralyzed, her hand was clenched in a fist that she couldn't open, she couldn't lift her right leg off the bed and the right side of her face was weak. at 3:30 pm the patient's mother took her to see a physician, who sent her home to rest. Subsequently, the patient's symptoms resolved. After the patient's second and third doses of Gardasil (Date not reported) the patient stated that her "reactions were less serious", with prolonged weakness and dizziness after the second dose and mild weakness and very slight dizziness, after the third dose. Subsequently, the patient's symptoms resolved. The reporter considered that her symptoms were related to administration of Gardasil. Upon internal review, paralysis was considered to be an other important medical event. Additional information is not expected.
a patient received a dose of PROQUAD and a dose of VARIVAX. No known adverse effects.; a patient received a dose of PROQUAD and a dose of VARIVAX. No known adverse effects.; a patient received a dose of PROQUAD and a dose of VARIVAX. No known adverse effects.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Concomitant therapies included sterile diluent (DILUENT MRK). No information about the patient's pertinent medical history, and drug reactions or allergies was provided.   On 23-AUG-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003085 with expiration date of 29-JUL-2019 (route and frequency were not reported) and, on the same date, the patient also received a dose of varicella virus vaccine live (oka/merck) (VARIVAX)  lot # S005084 with expiration date of 19-FEB-2021 (route and frequency were not reported). No further information provided.
Pt. said she knotted up right after the shot. Said it was never red or hot, just a knot. She said she still has a small knot, less than a nickel size. Said it feels a little achy.
Pt. was in for catch up on immunizations, given the 4 month series and then in 30 days, he will be given the 6 month series.  Pt. was given Kinrix as he needed DTaP and IPV, when entering this into the CIIS system this was not under the recommended vaccines, and alerted me that this vaccine should have not been given to this age of pt.  When reviewing the package insert it was noted that this should have only been given to pts. >4 years of age.  Emailed the CDC NIPINFO helpdesk and asked what should be done, should the dose be invalidated?  Got an email back stating "the Kinrix dose is off-label, and care should be take to ensure that it doesn't happen again, but both the DTaP and IPV components may be counted as valid doses.  No additional action is needed."
1 minute after vaccine administration, patient fell back on exam table eyes open and fixed, unresponsive, hands twitching with decorticate posturing.  Event lasted approximately 20-30 seconds postictal for 3-5 minutes.
Swelling, hot to touch, pain and redness, tried benadryl and clartin, and ice; no help.
Gastro problems, diaherra , muscle aches, my whole body hurts, nausea, headache, very very tired...I have taken a tums and just slept since 1/5/2021 at 4:00p.  I have no appetite.
weakness;dysphagia,dyspnea, weight loss Narrative: Around the time of the first vaccination she developed several progressive symptoms of weakness, dysphagia and weight loss (but it is unclear whether she had mild symptoms before the vaccine). Patient was seen March 11,2021 and then referred to neurology 3/16/21/where ALS is suspected. It is unclear if it is directly related to the vaccine but timing coincides with vaccination.
12OCT95 vax given;13OCT95 temp inc (beginning inc temp);16OCT95 temp to 104 (approx 2PM);17OCT95 temp to 104 (APAP w/o relief)
Mother signed consent for child to receive Gardasil during school physical. Vaccine given, next day mother sent note to school stating child had received vaccines already at MD office. Records requested from doctor's office, child received Gardasil series starting 8-15-07- ending series 7-15-08.
This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sore throat, and mild fever after 72 hours of getting the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat and mild fever after 72 hours of getting the shot was not reported. This report was non-serious.
Temperature excursion at unknown temperature for 5 hours due to human error with no reported adverse event; Vaccine administered post temperature excursion with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patients who were administered vaccine post temperature excursion at unknown temperature for 5 hours due to human error with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the suspect INFLUENZA QUADRIVAL A-B VACCINE was exposed to a temperature excursion at unknown temperature for 5 hours due to human error with no reported adverse event (product storage error).  On an unknown date, the patients received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7682LA and expiry date: 30-Jun-2023; formulation, strength, dose, route and administration site not reported) for prophylactic vaccination.  On an unknown date, the patients were administered vaccine post temperature excursion with no reported adverse event (poor quality product administered) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, "Home health service were training someone new, they took 2 vaccines out of the refrigerator drove it to 2 patients houses and administered them but didn't take the typical transport device for storage".   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.
High pitched unusual screaming & cried x 2 days intermittently assoc w/crankiness;
Body aches, fatigue, headache, feverish; lasted about 40 hours; felt like I had COVID again
After receiving her vaccine client stated that she has stiffness and redness in the right arm in which she had her vaccine was given.   Vital signs obtained by EMS  BP 115/73, HR=74, o@ sat 96%. Client states she feels better.  Client declined to be transported to the ER.  Discharged home by EMS.
dizziness and nausea sat for 5 minutes with head between knees, laid for 15 minutes and sat for 45 minutes symptoms resolved within 1 hour
chest pain and felt heart racing for about a week after booster with pfizer no medical treatment or evaluation during side effects
Started about 3pm with soreness in left arm on 1/11/2021.  By midnight, the left arm was very sore and heaviness/numbness down to fingers.  On 1/12/2021 (today), I could hardly raise my left arm over my head.  I took 2 Ibuprofen and plan to ensure I do range of motion stretches and basically just use the left arm.  I do not have a fever, and plan to drink plenty of water today.
This spontaneous report was received from a medical assistant and refers to a 47 year old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 11-NOV-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # N013521 with an expiration date in 23-JAN-2019 or lot # N029303 with an expiration date in 21-APR-2019), for prophylaxis, that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product Quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA001565: US-009507513-1801USA001567: US-009507513-1801USA001568: US-009507513-1801USA001569: US-009507513-1801USA001570: US-009507513-1801USA001571: US-009507513-1801USA001572: US-009507513-1712USA003377.