chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever off and on/ temperature was 100.4; Chills; severe body aches; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 16Dec2020 at 0.3 mL, single; then the second dose on the left arm (reported as 'left shoulder') to 05Jan2021 at 0.3 mL, single for COVID-19 immunization. Medical history included Raynaud's disease probably diagnosed like 7 years ago, but she was not taking anything for it. There were no concomitant medications. The patient reported that she was a dietician. She works in the ICU at the hospital, but was not a healthcare professional. She just got the second dose on Tuesday (05Jan2021), and had severe body aches, fever on and off, and chills with the body aches. Severe body aches started Tuesday evening, but were not really bad, she was just achy, then around midnight on Tuesday, they became severe and she had a fever. They resolved kind of this morning, right now she is a little achy, not like before, where her full body was hurting, it hurt to lay down or do anything, she had to lay in bed for 24 hours. Fever started at midnight, so she guess on 06Jan2020, now she doesn't feel feverish, but she didn't check, she thinks it broke again last night, she was taking Advil. She took acetaminophen (TYLENOL) the first night, at midnight, when she got the fever, she took acetaminophen, and tried to go back to sleep, and woke up at 6AM, with severe body aches still, and her temperature was 100.4 so she took ibuprofen (ADVIL). Acetaminophen for some reason bothers her stomach, so she took ibuprofen. She felt like the acetaminophen didn't do anything. She came to work today. After that, she was taking ibuprofen yesterday through the day. The chills were along with the fever and body aches and are not ongoing right now. She had symptoms after the first round of the Pfizer COVID vaccine too, but they were not as bad. The outcome of the event severe body aches was recovering, of chills was recovered on an unspecified date, and of fever was unknown.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 001J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to (Patient Link).
1 week after large red welt hard and dark red at injection site, 2 day side of face ached and neck started itching and the welt spread on the arm, 3rd day it was itchy scalp and hot flashes then welt spread more, 4th day ears were ringing and anxiety started. It took about 2 weeks for it to go away.
Headache, Fever, chills Narrative: Per nursing report: "took first dose vaccine on 7-28-21. States missed work due to states symptoms of headaches and chills. She reports having had a slight fever between 99.8 & 100 on Sunday [7/31]. Employee states took Tylenoll for two days about every 6-8 hours until she felt well enough not to take anymore. She states was scheduled to work Saturday [7/30] and Sunday 7:30-4. She received the vaccine on Tuesday [sic: Wed. 7/28], started felling sick on Friday [7/30]."
pt recvd vax & had dec in appetite & was very tired & almost lethargic; lab tests revealed elevation in direct serum bilirubin;
He got his vaccine, noticed around 9:00 PM just that his heart was beating fast, it wasn't nothing that he freaked out about but he noticed it.  His blood pressure was OK, and he took his BP medicine and was OK.  His arm was sore pretty bad, and hurt pretty bad on Tuesday and Wednesday, and yesterday it finally eased out.  He still does feel it now but minimal about a 1-2/10 in intensity.  He did not take anything for his symptoms.    A month ago on 8/5/23 he got the flu and pneumonia vaccines, but did not have any reactions.
getting sick; 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 (getting sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 (getting sick). At the time of the report, ILLNESS (getting sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she talked to a couple people of her age that had Covid and the vaccine and had terrible  experience of getting sick again.
Patient about 12 min into observation began with signs of a mild itch, and noted red blotchy spots on inner arm. Patient with a significant allergy report which was properly flagged by clinical nurse for 30 minute observation. During initial assessment, patient denied any SOB, no chest pain, slight pruritus on upper arms and neck. No difficulty swallowing, no wheeze, pulses present and good capillary refill.  Placed on Cardiac monitor - Normal Sinus 89, Pulse Ox 98% room air, 164/88. EMS present as support, patient refusing medical transport, EMS documented refusal.  Patient will obtain Benadryl from the CVS up the road. Patient with no additonal extension of rash, no SOB, no additonal itch from rask on arms and back of the neck.
Sedation, Myalgia, Arthralgia,  chills, fatigue,poor concentration, site pain  Narrative: Last night cold chills, cold chills today, severe fatigue (difficult to stay awake), difficult to concentrate (I do not feel like myself), generalized muscle pain and pain at the injection site
Patient developed erythematous rash at the site with oozing vesicular rash in the center - at site of injection.
Sore back, muscles and headache Chills and shaking chills Fever of 101.8
Case number PHEH2014US21282 is an initial spontaneous report received from a pharmacist on 22 Oct 2014. This report refers to a 65 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated twice with FLUVIRIN (batch number: 1414101) from mutil-dose vial (MDV); once subcutaneously and then intramuscularly in the deltoid on 22 Oct 2014. No adverse events were reported following the inadvertent administration.
Muscular and joint paint in left arm, back, and chest last more then 12 days
Felt hot, local rxn @ inject site (thigh), cried over 3 hrs; f/u done on 12AUg91; mom said pt was fine by 2nd day;
Tested positive for secondary immune deficiencies after completing the series of 3 Pfizer COVID vaccines; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization; Bnt162b2 (Dose: 02), for COVID-19 Immunization. The following information was reported: SECONDARY IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "Tested positive for secondary immune deficiencies after completing the series of 3 Pfizer COVID vaccines". The patient underwent the following laboratory tests and procedures: Secondary immune deficiencies: Positive, notes: 3 patients have tested positive for secondary immune deficiencies. Therapeutic measures were taken as a result of secondary immunodeficiency. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Clinical course: It was reported 3 patients have tested positive for secondary immune deficiencies after completing the series of 3 Pfizer COVID vaccines. All have been diagnosed and started on IVIG. patients were not treated with any biologics prior to testing positive for secondary immune deficiency.; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162B2 vaccine cannot be excluded for the reported event of secondary immune deficiencies due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including serum immunoglobulin levels at baseline and post vaccination, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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,Linked Report(s) : US-PFIZER INC-202300141697 same reporter/drug/event, diff patients;US-PFIZER INC-PV202300061072 same reporter/drug/event, diff patients;
Tenderness around injection site, slight fatigue, slight chills, slight fever. No treatment other than sleep and rest.  Symptoms disappear by Wednesday, 1/5/2021, a.m.
Narrative:  On 9/23/21 patient self-presented to community emergency facility. Chief complaint: Endocarditis, Stroke agency then informed pt died on 9/27/2021. Pt had received covid vaccines on 1/12/2021 and 8/23/2021- not local - not agency. Death not related to vaccines.
devel rash 3MAY94 w/temp (felt warm) didn't have thermometer progressed to raised-nickel sized papules forehead-hand sought med care 5MAY94; DPH:
At time of vaccine, patient was 17 years and 6 months of age.  Must be 18 years of age and older to receive the Moderna vaccine.
Flat,red, splotchy,pruritic rash developed at hour 48 post-injection and lasted 24 hours Rash included:Neck,right and left arm,back,torso and groin
very high temperature of 108F; This is a spontaneous report from a contactable consumer (patient). This consumer reported same events for 2 patients. This is one of the 2 reports.   A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization.  Medical history and concomitant medications were not reported. It was stated that the vaccine made her sick as she had a very high temperature of 108F.  Outcome of the event was unknown. . No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021272645 same drug and event, different patient
Pt complained of mild-mod symptoms of tingling in neck, back, some tingling from left thigh to foot after first dose. Pt told to continue work/ daily living activities. Following dose 2: pt complained of tingling going down to lower back/ charley horse in legs, tingling in both legs and feet. Resting at home.
Client received his Pfizer vaccines on 1/14/2021 and 2/4/2021.   On 5/13/21, client had a Watchman device placed in his heart, spending one night in the hospital.  From 5/13 through 5/27, client complained of a sore throat, fatigue and had a cough.  These symptoms escalated and became much worse on 5/25, according to his wife.  On 5/26, client fell at home, was taken by fire rescue to the hospital, admitted early AM on 5/27, and diagnosed w/ COVID-19 pneumonia (and possibly a fractured back).
I received my first dose of the Moderna COVID19 vaccine in my upper left arm on March 21. I had the normal muscle soreness, which went away after two days, but no other side effects. On March 29 I noticed that a large, red, roundish lesion about 3-4 inches across in diameter had appeared on my upper left arm where the injection had been given. That area of my arm is warm to the touch.  It is not itchy but is sore/tender in the muscle.  I do not have a fever or feel nauseous or have other side effects.
Patient states that with vomiting the day after vaccines, as well with a fever, feeling lethargic. 10/23/18 02:53PM Patient presents with dad with complaint of "low grade fever, fatigue, HAs, and vomiting" x 6 hours. Patient states he was at school this morning when he started feeling bad. Patient states he went to the school nurse who said he had a "low grade temp" and administered a dose of TYLENOL. Patient states he also vomited once this morning- no blood in emesis. No emesis in the last 3 hours. Patient states he feels tired and had a HA earlier. Patient states his head hurt "on his forehead," but it seems to be better now with the TYLENOL administration. Patient was seen in office yesterday for his WCC where he received the flu, MenB, and MCV4 vaccines. Patient states his arms are a little sore, but he denies any redness or swelling to the administration sites. Patient denies congestion, cough, ear pain, sore throat, ABD pain, diarrhea, or rash. Patient is eating and drinking well. No sick contacts.
admitted for COVID infection. Patient reported that she was diagnosed with COVID on 10/15/2021. The associated symptom include nausea, vomiting, diarrhea, abdominal pain, fever, chills and reduced appetite. Patient started having worsening of neuropathy and generalized weakness, which is gradually getting worse. Patient was treated with zinc, magnesium, Protonix and Lovenox. CXR clear, did not test for Covid this admission,
Blurred vision changed to loss vision within 1 hour of vaccine, arm heavy, face puffy, eyes red and sore x 1 day, cough, difficulty breathing x 12 hr, headache x 4 days - no treatment.
Increased heart rate, dizziness, weakness, paleness and increase BP. Lasted approx 1 hour. Subsequent MD visit was made with dx of mitral valve prolapse.
Case previously recorded as MA2009-5505. Received the following information from a consumer via Novartis Pharma on the 20 NOV 2009. This 2-year-old child gender unknown was inadvertently administered FLUVIRIN (batch number unknown) dosage unknown on 19 NOV 2009. The consumer refused to provide any other information, citing HIPAA violation even when she was told that it would not. The patient outcome is unknown.
A non-serious spontaneous report of portion of vaccine spritz into eye was received from a non health professional concerning a male child. Neither relevant medical history nor concomitant medications were reported. On 01-Dec-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Around 3 am I woke up feeling very hot and nauseous followed by chills. I was so cold and shaky. The chills was the most bothersome part. It lasted about one hour and I feel fine now.
Information has been received from a 61 year old female consumer concerning herself who on 25-SEPT-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported) in the back of her left arm for shingles prevention. Her relevant medical history and concomitant medications include neuropathy for which she took NEURONTIN and diabetes for which she took glimepiride; irregular heartbeat for which she took atenolol; high triglycerides for which she took an unknown medication; high cholesterol for which she took simvastatin. Her relevant past drug history was unknown. On 26-SEPT-2010, she woke up in the morning with a rash on the right side of her chest. In 2010, sometime after developing the rash, she developed sores which turned to hives, itching, and stinging pain on her buttocks and she had been awake most of the night. She had had no laboratory testing performed. As of 09-OCT-2010, the rash had resolved, but continued to have hives, itching, sores, and stinging pain on her buttocks and she was still awake most of the night due to the pain. Additional information has been requested.
Well my arm was bothering me. It started hurting and I started feeling really achy and hot. So I checked to see if I had a fever but I did not, but I got a rash ( local rash on the injected site). It's gotten bigger and a little redder. I've been putting some cold compress to help with the pain. and I have been a little nauseas. I didn't feel well so I laid sown and put the cold compress on my and that seemed to help to take the heat away and the itchy away. I also kepted it elevated because to swell a little bit.  And I took tylenol.
Body aches, HA, nausea; 5.5 x 3 cm raised erythematous patch at injection site.
Information has been received from a physician concerning an approximately 32 year old female who on 17-SEP-2008 was vaccinated intradermally into the right forearm with a dose of PNEUMOVAX. On 18-SEP-2008, the patient experienced a baseball size reaction at the injection site. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality control complaint was involved. Additional information has been requested.
Nausea and body aches 48 hr large local reaction greater than 10 cm
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Patient had no adverse reaction. Mistakenly, given Pfizer as third vaccine though had received Moderna
I started getting facial swelling especially in the cheeks and lips. I am being treated by my Dermatologist. I am on Prednisone, Antibiotics, and allergy medications. They said it was most likely due to the fact that I got fillers in August 2021 and sometimes people have delayed reactions to fillers and maybe mine was delayed. It has not improved even though I have been on medication since 12/17/2021. Even today I still have swelling in my lips.
This spontaneous report was received from a registered nurse and refers to a patient of unknown demographics. No information regarding the patient's medical history, concomitant medications, concurrent conditions, drug reactions or allergies was provided. On 12-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneous injection, lot # M030138, expiration date 15-JUN-2018 (dose was not reported). The vaccine was stored improperly for 47.5 hours in the temperature between 14 and 46 degrees Fahrenheit. The temperature excursion was registered by the digital data logger. No adverse events were reported. This is one of the several cases reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA014165.
Expired dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2244CG, expiry date 15-MAY-2023) for prophylaxis.   On 07-MAY-2023, the patient received Boostrix. On 07-MAY-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 16-May-2023  The patient was accidentally given an expired dose of Boostrix and wished to know how to proceed.  They stated that they did not know the exact status of the patient's previous vaccinations. Information about patient, vaccine and vaccination was provided.  The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
A few pox on arm and ribs. At first itchy, then painful to the touch.
COVID_test_result=Positive/15Apr2023; COVID_test_result=Positive/15Apr2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Dec2022 as dose 4 (booster), single (Lot number: GL0446) at the age of 45 years intramuscular, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FH8020) intramuscular, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Mar2021 as dose 1, single (Lot number: 031A21A), in left arm and on 23Apr2021 as dose 2, single (Lot number: 039B21A), in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Apr2023, outcome "unknown" and all described as "COVID_test_result=Positive/15Apr2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Apr2023) Positive, notes: Nasal Swab.  Clinical information: No other vaccine in four weeks. No other medications in two weeks. The patient experienced sore throat and body aches on 15Apr2023 12:30 am. AE resulted in emergency room/department or urgent care. Outcome of the events was recovering. No treatment received. COVID prior vaccination: No. COVID tested post vaccination: yes.
Red, hot swelling on arm that extended down to elbow. Started the day after vaccination and continued for 5 days afterward. Worsened for the first 3 days of symptoms and resolved over the last 2 per patient.
Pt report back to clinic site almost an hour later with red blotches on both arms, itching to face and neck, and feeling hot and shaky.  Pt monitored by staff, reported no hives or trouble breathing.  Pt took 1 Benadryl from personal stock, and reported relief of itching and red blotches.  After 15mins She felt well enough to go back to work.
Five weeks after the second dose of the vaccine I noticed my heart was fluttering. I was having palpitations. I visited my doctor and the EKG did not show any problems. I then wore a heart monitor for 48 Monitor and it showed that I was having PVCs. I have never had any heart rhythm problems before. I am a Marathon Athlete and in good health normally. I still have the PVCs which seem to be OK when I am running but get worse with stress.