chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; alternating feeling hot and cold; vomited; shaking chills; nausea; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration (left arm) on 06Jan2021 09:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 16Dec2020 (09:00 AM) for Covid-19 immunization. Medical history included hypothyroidism; no known allergies. Concomitant medications included levothyroxine, macrogol 3350 (MIRALAX), docusate sodium (COLACE), and ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dihydrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, lycopene, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, xantofyl, zinc oxide (CENTRUM FOR WOMEN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that it was the second dose of her Pfizer COVID vaccine series; 12 hours afterwards she got shaking chills and nausea (06Jan2021) and this continued overnight, no fever. The next morning, she had the worst headache of her life, and nausea and alternating feeling hot and cold, no more shaking chills and no fever. The patient reported that it continued throughout 07Jan2021, and on 07Jan2021 she vomited once. Then 08Jan2021 in the morning, she still had the worst headache of her life, she took Ibuprofen to which the headache became much diminished. But headache continued with less intensity, so she was able to go to work throughout 08Jan2021. She continued with Ibuprofen and added Tylenol. Then at 3 am on 09Jan2021, she woke with the worst headache again so severe and took both Ibuprofen and Tylenol and it got better. By afternoon 09Jan2021, she was back to herself with no more headache and a normal appetite. She did take a sick day on 07Jan2021. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 post vaccination.
0840: After receiving 2nd Covid vaccine, pt c/o rash on chest & itchy throat, chest & back but no SOB.  Also had some rash with 1st vaccine 0851: BP 101/60 HR 74 SpO2 100%  Benadryl 12.5 mg po given 0907: Symptoms 50% improved.   Recommended if any increase in symptoms, go to UC. 0908: Released home at pt's request
angioedema; swelling of lips and chin; Swelling of chin; This case was reported by a physician via call center representative and described the occurrence of angioedema in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 24th October 2019, 3 days after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant), lip swelling and facial swelling. On an unknown date, the outcome of the angioedema, lip swelling and facial swelling were unknown.   It was unknown if the reporter considered the angioedema, lip swelling and facial swelling to be related to Shingrix.  Additional details were provided as follows: The reporter who was a physician and reporting a case for himself. The patient received a dose of Shingrix on the left deltoid. The patient experienced swelling of lips, chin and angioedema. The reporter asked if there was data available regarding how long after the 2nd Shingrix shot did angioedema occur. The reporter consented to follow up.
Insomnia; Felt tired; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia), FATIGUE (Felt tired), HEADACHE (Headache) and CHILLS (Chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INSOMNIA (Insomnia), FATIGUE (Felt tired), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, INSOMNIA (Insomnia), FATIGUE (Felt tired), HEADACHE (Headache) and CHILLS (Chills) 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.
patient didn't have an actual adverse event he just received the vaccine outside of our standing order protocol.  We did reach out to his physician and they did send over a prescription authorizing the receipt of the vaccine
No adverse affects reported; An expired dose of GARDASIL 9 was administered on 7/1/2020; This spontaneous information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.    On 01-JUL-2020, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number N022728 with expiration date reported as 21-MAY-2020 but upon internal validation established as 31-MAY-2020, as prophylaxis (strength, frequency, route of administration and anatomical location were not reported) (expired vaccine used).  No adverse effects reported.
Pt had Varicella vaccine on 1/14/00. He was seen in the clinic on 6/12/01 for a probable chickenpox. Doctor advised Benadryl and Caladryl.
Itching all over (head to feet) Start: 4/23/18 7pm Stop: 4/24/18 8am.
diarrhea; vomiting; nausea; horrible headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VOMITING (vomiting), NAUSEA (nausea) and HEADACHE (horrible headache) 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 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced DIARRHOEA (diarrhea), VOMITING (vomiting), NAUSEA (nausea) and HEADACHE (horrible headache). On 31-Jan-2021, DIARRHOEA (diarrhea), VOMITING (vomiting), NAUSEA (nausea) and HEADACHE (horrible headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
I have had a headache every day since receiving the vaccine.  4 days ago my legs began to feel weak and shaky. At some points it is so bad that I have to sit because they feel like they can?t support me. I have never experienced this before.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial and follow-up information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267227; 2019SA267226; 2019SA267229; 2019SA267228; 2019SA267230; 2019SA267232; 2019SA265193 (same reporter).  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the right deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other concomitant vaccine was given.  It was a case of actual medication error due to incorrect product storage.  At the time of report, no adverse event was reported.  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.
difficulty using arm, where PNEUMOVAX 23 was injected; injection site pain and swelling; injection site pain and swelling; This spontaneous report was received from a medical assistant regarding a 69 year old male patient. The patient's concurrent condition included diabetes. Approximately in 2019, reported as "1 year ago", the patient was vaccinated with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). The patient's concomitant therapies included diclofenac, metformin, triamcinolone acetonide and cetirizine hydrochloride (ZYRTEC). The patient did not have any drug reactions/ allergies. On 17-JAN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S028601, expiration date: 02-JUN-2021 (strength, dose, route of administration and anatomical location unknown) in the arm for prophylaxis. On the same day, the patient had injection site pain and swelling (injection site swelling) and difficulty using the arm where pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was injected (injected limb mobility decreased). On 18-JAN-2020 and on 21-JAN-2020, the patient was seen in the office. The patient did not receive any treatment for the events and no lab diagnostics or studies were performed. The outcome of injected limb mobility decreased, injection site swelling and injection site pain was reported as not recovered. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported. No product quality complaints were involved.
Pt complains of severe pain in his right arm. Pt claims pain caused by immunization received on 10/3/03.
Primary Care Physician at Discharge: Medical doctor. Admission Date: 8/23/2022 Discharge Date: 8/23/22  PRESENTING PROBLEM: Elevated troponin   HOSPITAL COURSE: The patient is a 15 y.o. who presented to hospital with sharp chest pain exacerbated with breathing a few hours after sport practice and found to have mildly elevated troponin levels.  Subsequently found to be COVID positive. He was transferred to other hospital for further evaluation. Chest pain on further evaluation aligned with musculoskeletal etiology. His EKG obtained here showed no changes and he had a normal echocardiogram. Troponins have returned to normal from elevation at outside hospital. He had no elevation in his inflammatory markers to support inflammation from myocarditis. Overall, it is unlikely this patient currently has myocarditis. He currently presents with an asymptomatic COVID infection. Based on our evaluation we determined that patient did not require any further hospitalization. Will be discharge home to follow up with his PCP should COVID symptoms progress.     Labs reviewed from last 24 hours
Received immunization at Pharmacy, was treated at the Hospital. Developed Glomerulonephritic, self resolving after 49 hours. Initial gross hematuria and proteinurea.
11/2: 5:20pm - Tinnitus, loud and metallic 6:10pm - Tinnitus continued, loud and metallic 7:00pm - Red spot started, very hot shoulder, itchy shoulder, spot measured 2"  11/3: 9:00am high heart rate (135), continued through 3:45pm 9:00 am shoulder hotter than night before, very swollen, red spot now measuring 3" across and still itchy 101 Fever, body aches, dizziness, extreme body fatigue 11:00am Rash across chest measuring 6" Symptoms continued throughout the day, fever broke at 11pm Chest pain Tinnitus still present  11/4: Red hot arm continued. Still painful, still swollen, red spot has increased to 4", still itchy.  Tinnitus still present Rash across chest gone  11/5: Swelling of arm slightly decreased, still hot and painful, red spot increased to 4.5" Tinnitus still present   11/6: Swelling greatly decreased, not as hot, less painful, red spot decreased to 3.5" Tinnitus still present  11/7: Some lingering swelling of left shoulder, some lingering heat, somewhat itchy, red spot decreased to about half an inch.  Tinnitus still present
Soreness at the site of injection; 'Her' right hand feeling colder than 'her' left hand; Chills; Malaise; Headache; This is a spontaneous report from a non-contactable pharmacist, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via intramuscular route of administration in the right arm on 27Aug2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluocinonide (MANUFACTURER UNKNOWN), ergocalciferol (VITAMIN D), fish oil (MANUFACTURER UNKNOWN), acetyl cysteine (N-ACETYLCYSTEINE) and prenatal vitamins (MANUFACTURER UNKNOWN) all  for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via intramuscular route of administration in the left arm on 06Aug2021 at 15:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 28Aug2021 at 08:00, the following day of vaccination the patient experienced soreness at the site of injection, patient right hand felt colder than left hand, chills, malaise and a headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness at the site of injection, patient right hand felt colder than left hand, chills, malaise and a headache were recovered on 29Aug2021.  No follow-up attempts are possible. No further information is expected.
Case completed her Pfizer Covid series on 2/6/21, and tested positive for Covid upon admission to Hospital on 8/4/21.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of an unknown age and gender. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot number: L043703, expiration date: 30-NOV-2017; dose and route of administration were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient called pharmacy 9/13/19 around 8:30am stating her arm was red around the site of injection of Shingrix 2nd dose. Described the size as "bigger than a half dollar" with some swelling.  Redness appeared the morning of 9/13/19. Patient had no other symptoms except redness and swelling around injection site. Informed patient this was a common reaction to the vaccine and was not a concern, should subside in the next couple days. If it got worse, she should seek medical attention or call her doctor. Patient then came in 9/13/19 at 9am to show me the reaction, which looked exactly as she described. Followed up with patient 9/14/19 at 1:00pm, patient stated there was no more swelling. Redness was lighter/fainter than previous day. No new symptoms were noted by the patient.
Itchy solid red rash on left breast started in the evening two days after receiving vaccine. The rash was hot to the touch, approximately 4 inches in diameter, and slowly went away. Once it went away, which was one week after getting the vaccine, I got a similar itchy red rash, approximately 2.5 inches in diameter, at the injection site on my left arm. This rash was extremely itchy for about 10 minutes. It felt hot, swollen, and hard, and seems to be slowly subsiding.
Before the vaccine, I had complete normal monthly periods. 28 days clockwork. I have not had a period since the vaccine. My FSH level have gone from normal, to 46.2mIU/ml. My prolactin is also elevated to 46.670 ng/ml CRP is elevated as well. I have hot flashes and night sweats and racing heartbeats.   My doctor is going to re-run labs but has also ordered an MRI pituitary study
Patient's entire upper arm was markedly swollen from the should down to elbow and hot to the touch. She reported an extremely limited range of movement and pain associated with the swelling.
Death from Reyes synd on 24FEB91 & presented to ER in full arrest & was not resuscitative;
On March 3rd 2009 my son recieved the Varicella vaccine along with the Hepatitis A and MMR vaccine. Seven days later he had a slight fever around 100 degrees which I was expecting around 7 - 12 days after being vaccinated.About 30 minutes later I noticed that he had a rash on one side of his body, front and back. The fever and rash was gone by the next day. However that day I noticed a small red bump/blister. I thought it was a bug bite and monitored it to see if it was a spider bite. Over the next few days it progressively grew larger until it reached the size of a thumb print.About a week later as this blister crusted and finally went away another spot appeared and went through the same cycle but is still present to this day March 27th along with two other small formations that I dont believe will continue the entire blistering process. With my concerns on these symptoms I looked on the internet for a list of side effects for the Varicella vaccine that I believe was the cause.It stated that 1% of patients can get chicken pox from the vaccine (this was not on the paper I recieved for vaccine). It also said it can cause shingles(again not stated on info given to me). Many other serious side-effects were seizures, pneumonia, mood changes, brain damage. In conclusion I believe that my son developed a mild case of shingles and possibly chickenpox. This had a major affect on his mood. He cried randomly as if in pain (shingles causes alot of pain). I know it may have been a worse case if he had developed it naturally and it is great if the vaccine prevented him from more severe symptoms. However I feel as if I was not properly informed on all the possible side effects from the vaccine. If I had been informed on all the possible side effects of the vaccine my reaction would not have been as critical. I hope the FDA and CDC will consider these parental concerns and decide to further inform parents of everything to expect from these vaccines instead of telling them that basically nothing bad can happen.
Swelling, erythema to injection site (L) thigh fever to 102.3 degrees, Rx'd TYLENOL tenderness all beginning day of admin & gradually improved.
Approx. 1 1/2-2 hours, post vax, infant began to cry, then scream inconsolably and broke into cold, profuse sweat. She was given Tylenol 0.8 ml. Temperature not assessed at that point. Was taken to ER at 20:50 and temperature 97.9; R-40; P-160; wt-17lbs. Dx'd candida dermatitis and viral URI.
little red pimple; itching on her right shoulder (opposite to where she received the injection); This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 12Mar2021 as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced itching on her right shoulder (opposite to where she received the injection) on 16Mar2021 and little red pimple on 17Mar2021. It was reported that the patient received the first dose of the Pfizer COVID 19 vaccine on Friday 12Mar2021 and last night she felt an itching on her right shoulder (opposite to where she received the injection), this morning she noticed like a little red pimple and it is red, but it didn't look like the one she noticed last night. The patient was asking if this has been reported before. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse concerning a 79 year old male with a history of shingles (twice in the past) and no drug reactions/allergies, who on 28-SEP-2007 was vaccinated in the left upper with first dose of ZOSTAVAX (lot number: 657766/0620U).  Concomitant therapy included aspirin (manufacturer unknown), LISINOPRIL COMP and TEVETEN.  On 22-OCT-2007 the patient went into the office with what looked like a typical chicken pox rash that had a blister-like appearance.  The physician's notes stated that the patient had edematous, pink plaques.  No description of location of plaques.  The patient was prescribed six days post vaccination, VALTREX, hydroxyzine hcl and triamcinolone cream.  The patient was also told to sit in a tub of water for 20 minutes, not dry off and then put on the triamcinolone cream.  Lab diagnostics studies performed included: viral culture (negative) and skin biopsy pathology report (negative for chicken pox, but revealed blisters).  Unspecified medical attention was sought.  The patient was seen in the office.  It was noted that the patient (about 90% of the rash) significantly improved within 72 hours of treatment with VALTREX "and may have already recovered".  No other details.  There was no product quality complaint.  Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of fever in a 15-month-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Previous and/or concurrent vaccination included PEDVAXHIB; Merck; unknown given on 4 November 2008; HAVRIX; GlaxoSmithKline; unknown; unknown given on 4 November 2008. On 4 November 2008 the subject received a dose of FLULAVAL (.5 unknown, unknown, right thigh) and the subject experienced drug use for unapproved indication. At an unspecified time after vaccination with FLULAVAL, the subject experienced fever. The healthcare professional reported that a 15-month-old subject was administered FLULAVAL vaccine on 04 November 2008 in addition to HAVRIX and PEDVAXHIB. She reported that the mother told her the subject had some fever up to 100.3  "off and on" that was treated with over the count TYLENOL. The subject was treated with TYLENOL. At the time of reporting the outcome of the events were unspecified. Follow-up information was received on 17 December 2008, via healthcare professional who reported the events resolved on an unknown date.