chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/15/10 - after immunization temp - 101 - injection site painful mild erythema, 12/16 - temp 99 - mild erythema -> 12/17 - area 10cm x 9cm area of erythema indurated area 5cm x 4cm, area warm to touch, mild pain upon palpation - started KEFLEX & will recheck in am.
Acute hypoxemic respiratory failure; COVID-19 viral pneumonia; Superimposed community acquired pneumonia; Acute kidney injury; Leukocytosis
Nausea, headache, lethargy, achy bones, no fever but chills
Mother describes the onset of rash as gradual, over 2 days. Child has also had fevers up to 101F. MD described rash as fine and red, covering face, torso and arms. Fever was treated with Tylenol. Rash was treated with Benadryl.
she had mild soreness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "she had mild soreness at the injection site".  Additional Informtion: Caller asked if multiple Pfizer Coivd-19 vaccines out there? Caller stated when she looks on the internet she saw there was the Pfizer BioNTech Covid-19 vaccine and the Comirnaty Covid-19 vaccine so she was curious if they are all the same? She received the first two Pfizer doses she only had mild soreness at the injection site. potential duplicate AE. Call was warm transferred to agent withheld NTID withheld Reportum# withheld. Patient was a 64-year-old female. Caller disconnected the call during warm transfer to agent. Caller questioned that she would like to know if the Pfizer booster dose she received was the same as the first two Pfizer doses to explain the different reaction she was having to the booster dose?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received first dose of Shingrix, 8:45 AM, January 15, 2020.  Went to bed around 10:00 PM, with minor soreness at the injection site. Awoke around 2:00 AM, Jan. 16, to use the bathroom and was quite dizzy. Awoke again at 7:30 AM and the dizziness continued. This was the first time, I've had such prolonged dizziness.  On January 17, at 11:00 AM, as the dizziness was continuing, I contacted the clinic and spoke with a nurse. She recommended increasing my water intake, called me five hours later (4:00 PM), asked me to take my blood pressure (128/74), and recommended that if symptoms did not improve by the next morning (Saturday, Jan. 18), I should go to an urgent care center for further medical assistance. As of 6:40 PM, January 17, symptoms appear to be improving.
Localized reaction to DTAP/Hib in left thigh with a 3" diameter erythema, surrounding injection site, slight swelling, slight warmth and firm.
Information has been received from a female (age not reported) who on unspecified dates was vaccinated with first and second doses of Gardasil (lot number unknown). The patient is not having any symptoms from the Gardasil who has been diagnosed with another type of human papilloma virus (HPV) infection (type unspecified) since vaccinated. The patient also reports that as of 27-JUN-2007 the patient is 2 weeks late for her third vaccination. No further information is expected. No additional information is expected.
The Vaccine  was expired on 03-oct-21, placed in refrigerator on 22-sep-21 and administered on 03-Nov-21; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (The Vaccine  was expired on 03-oct-21, placed in refrigerator on 22-sep-21 and administered on 03-Nov-21) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The Vaccine  was expired on 03-oct-21, placed in refrigerator on 22-sep-21 and administered on 03-Nov-21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (The Vaccine  was expired on 03-oct-21, placed in refrigerator on 22-sep-21 and administered on 03-Nov-21) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Date place in refrigerator 22 Sep 2021.  Treatment information was not provided by the reporter.
This spontaneous report as received from a physician refers to a 3 month old female patient. The patient had not relevant medical history, concomitant medications and drug history. On 28-JUL-2016, the patient was vaccinated once with a 0.5 ml dose of PEDVAXHIB, which was involved in a temperature excursion (lot # J016188, expiration date 01-OCT-2016) by unknown route. Concomitant medication was not reported. The reporter explained that no adverse events had been relayed to him thus far after the patient received this vaccination. The patient had no relevant laboratory data. This is one of several reports from the same reporter. Additional information has been requested.
NOTE: the lot # is not legible. I'm unable to make out the 4th character in 041"A"Z1A.  I have had a headache off and on for the last 2 weeks. I usually wake up with it, and have to slowly get out of bed. Last night (5/18/21) it was a little more intense, perhaps due to the storms/atmospheric pressure
Hives; some redness; dry skin; BP 94/54; (pulse 66); stable; Benadryl 25 mg given.
w/in 2 wks of flu vax pt devel numbness & progressive weakness of rt arm (inject site); rxn persisted untill mid JAN92; pt was unable to work for an unspecified length of time due to the severity of this weakness;
L arm small amt induration at injection site. Erythema around site of injection. Dose not extend to elbow or shoulder. Tx: Cool compress and ibuprofen.
Patient stood for count in the prison and blacked out.  Fell and lost conciousness for approximately 2 seconds.  Reported since "this am" he had been experiencing weakness, joint aches, hot flashes, and nausea.  Reports he is dizzy.  BP 108/64, HR 84, RR 16, O2 sat 96% room air.  Was given tylenol and advised to rest.
dizziness w/in few seconds lasting a few seconds only; felt dizzy, cold clammy skin;
1st dose Trumenba, 2nd dose Bexsero; This case was reported by a physician via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero, Bexsero Pre-Filled Syringe Device and the 1st dose of TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:24-Mar-2022 Reporter's comment: The patient was administrated with two different vaccines for the schedule of Men b. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The patient received first dose of Trumenba and the second dose with Bexsero, which led to interchange of vaccine products.
Vial was initially stored in refrigerator on 22-Aug-2022 and was administered on 04-Oct-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-Aug-2022 and was administered on 04-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-Aug-2022 and was administered on 04-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-Aug-2022 and was administered on 04-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-Aug-2022 and was administered on 04-Oct-2022).    Concomitant drugs were not reported. It was reported that the monovalent vial of size 5.5ml with the beyond use date as 21-Sep-2022 was initially stored in refrigerator on 22-Aug-2022. The vial did not undergo any temperature excursion. Treatment medications were not provided. The case was reported for patient 1.   This case was linked to US-MODERNATX, INC.-MOD-2022-655876 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-655876:same reporter
received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date 3rd December 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 10th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that the patient received expired dose of Kinrix today (day of reporting), which led to expired vaccine used. No further information reported. The reporter consented to follow-up.
9/6/08 within several hours of receiving IPV + DTP, PT developed confluent rash with raised welts incompletely responsive to Benadryl received Epi & ORAPRED lasted 6-7 days + buttock rash.
some side effects; has a temperature; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (some side effects) and PYREXIA (has a temperature) 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 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (some side effects) and PYREXIA (has a temperature). At the time of the report, ADVERSE DRUG REACTION (some side effects) and PYREXIA (has a temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported.
This spontaneous case initially received on 07-Sep-2016, was reported by a Non-health Professional and concerns a patient of unknown age/gender. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Unknown. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced anaphylactic reaction (medically significant, outcome: not reported).
Day 1: injection site soreness Day 2: Extreme fatigue, muscle soreness, aches, fevers, chills, dizziness, nausea Day 3: Extreme fatigue, muscle and joint soreness, aches, fevers, chills, dizziness, nausea  Day 4: moderate fatigue, chills, fever spikes, dizziness
numbness/tingling in lower legs, fatigue, severe headache, eye pressure pain, nausea, hot/cold chills, low back and leg pain
Pt developed urticaria-1st at right arm-site of both varicella and MMR vaccinations-within 1/s hour urticaria on trunk anterior and posterior-Benadryl 19 mg administered to this 34 pd pt. This is in follow-up to report(s) previously submitted on 5/16/2007. Information has been received from a registered nurse concerning a 4-year-old male with no pre-existing allergies, birth defects or medical conditions who on 01-MAR-2007 at 9:00AM was vaccinated SC in the right arm with a second dose of VARIVAX (Merck) (Lot # 656079/1306F). Suspect therapy that day at 9:00AM included a second dose of MMR vaccine (MSD) (Lot # "0697F"). There was an illness at the time of vaccination. Concomitant therapy that day at 9:00AM included a fifth dose of INFANRIX (Lot # AC14B02BA) administered in the left deltoid and a forth dose of IPOL (Lot # 20306) administered SC in the left arm. On 01-MAR-2007 at 9:00AM the patient experienced urticaria. It was noted that the urticaria was first at the right arm at the site of both the VARIVAX (Merck) and MMR vaccine. However, the event occurred immediately after the VARIVAX (Merck) administration. Within a 1/2 hour, urticaria expanded to the anterior and posterior trunk. Benadryl 19mg was administered, and the patient was abserved in the office for 1 hour. He was discharged from the office to continue Benadryl 1 and 1/2 tsp hours for hives and itching. Subsequently on 07-MAR-2007, the patient recovered. There were no adverse events following prior vaccinations. The event was considered an other important medical event by the reporter. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologies Evaluation and Research and was released. Additional information has been requested.
Pt had fever to 101.9, vomiting several times and bulging fontanelle. She was seen in ER with normal CSF results, WBC 22K.
2 hours after receiving vaccine, patient started experiencing weakness, swelling and tingling to right knee radiating to lower leg
Received the vaccine and about 5-7 minutes she felt like somebody put there thumb on the right side of her throat and pushed really hard.  This got worse and worse for about 10 minutes and stayed that way for about an hour.  She was kept for 45 minutes.  Later on it got less and less and by that evening the sensation was gone.  On day 29 2/20/21 of the vaccine she started having really crazy dizzy spells, off balance, blood pressure was going up and having the shakes.  She went to the ER 02/21/21, which they did a lot of testing, and everything was fine.  They did not know if it was due to the virus.  She saw her PCP today 2/24/21 and she said that it could be from the vaccine, but again not sure.  She called the health dept and told them that she was canceling her appointment and advised that she call us to report the incident.   She has also had pressure in her chest, generally overall not feeling well over the last 3 days.
pt recv vax 22JAN97 swelling @ site of vax;next day rash (sandy) spread to leg-same kind of rash to same side arm rt;rash spread to trunk;devel t103;3 days p/vax cheeks beet red-devel bronchitis 2 wk later;
Redness and warmth at injection site. Advised to monitor his symptoms and report to his local ER if he experiences any shortness of breath, fever, redness extending down/up arm or chills. Joint pain reported RN 5/16/13.
Ocular migraine 6 days after first dose, followed by vertigo and fatigue lasting for a week and a half thus far.
Plaintiff alleges that pt recvd 1st immun afternoon of 28OC88, & displayed fussiness, inconsolable crying, & altered sleep & feeding patterns; pt was discovered pale about noon 29OCT, & died shortly thereafter;
Arm where shot was given  was very sore for 4 days. 14 hours after shot, I felt faint and passed out briefly.
Patient was administered original monovalent Pfizer Covid-19 vaccine instead of bivalent Pfizer Covid-19 vaccine
Patient received pneumococcal vaccine on 6/17/2010. Patient was seen the next day and reported that he was experiencing pain, edema, and redness at the injection site. Patient took oral BENADRYL and TYLENOL. Patient had a low grade fever of 100. Reaction was localized. There were no signs of anaphylaxis. Patient was prescribed oral BENADRYL. Treatment Drugs Used: 1 - Diphenhydramine Dose: 50 Units: MG Freq: QID Route: PO.
I personally have no way to know if the Prevnar was the cause, so I thought you should know that this report is on behalf of my mother. I'm not sure what time on the tenth she actually got the vaccine, but at approximately 4:30pm the same day, she had a massive stroke and passed away. If possible, I would like to have someone contact me. Thank you.
Red spot on right arm; mottled red spots on left arm; hard area at inj. site that started around 4/19/21; dizziness
Patient had syncopal episode immediately following administration: felt faint, BP dropped, clammy. Felt better within minutes and at 15-20 minutes following administration felt that she had returned to baseline (with BP return to normal). Left with spouse.
passed away; cough; This is a spontaneous report from a contactable consumer, the patient's daughter.  A 92-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 13Jan2021 at 11:00 (at the age of 92-years-old) as a single dose for COVID-19 immunization.   Ongoing medical history included nursing home resident, admitted to hospice on 13Jan2021 (prior to vaccination), and oxygen supplementation (due to low oxygen levels) from a few days prior to the vaccine (Jan2021). Other relevant medical history included congestive heart failure from Dec2020 and sulfa allergy. Prior to the vaccination, the patient was tested numerous times (as reported) for COVID-19 and was negative.  There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. A few days before the vaccination, her oxygen level had gone down, and she had been placed on oxygen. Prior to receiving the vaccine, the patient was reported as being 'fine'. On 13Jan2021, the patient received the vaccine at 11:00. The patient coughed maybe 5 or 6 times and then dropped her head. Resuscitation was not performed as patient had a do not resuscitate (DNR) order. The patient passed away on 13Jan2021 at 13:05. The cause of death was not reported. An autopsy was not performed. The clinical outcome of the cough was unknown at the time of death.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away
Inadvertent administration of 4th dose Pfizer vaccine to a child under 5 years. No signs or symptoms reported. Child left clinic with parent.
Information has been received from a 73 year old female patient with hypertension and no allergies who on 24-DEC-2007 was vaccinated with Zostavax (Oka/Merck) 0.65 mL (single dose series).  Concomitant therapy included ZETIA, MIRAPEX, nortriptyline, sulindac, NORVASC and vitamins (unspecified).  On 25-DEC-2007 the patient became drowsy and experienced diarrhea.  The patient sought medical attention via telephone.  Subsequently, the patient recovered from the drowsiness and diarrhea.  There was no product quality complaint. Followup information has been received the physician concerning the patient with hypertension and neuropathy peripheral, vitamin b12 deficiency and gastric ulcer and with no illness at time of vaccination who on 24-DEC-2007 (also reported as "24-DEC-2008) was vaccinated with a first dose of ZOSTAVAX (lot # 658306/0967U). The CBC (complete blood cell count). Stool culture were performed but the results was not reported. on 25-DEC-2007 the patient experienced body aches, diarrhea, chilling without rigorn and no fever, abdominal pain, emesis or rash. The on 03-JAN-2008 the patient recovered.No further information was available.
The next morning I started feeling tingling and aching on my right ribs gradually every day got worse on the 7 day I got sores in my mouth on the 10 day I had a rash on my right neck and half way around my right ribs with burning itching I was nauseated felt hot but the highest temperature I had was 99.7 this lasted for over 30 days
vaccination site erythema; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (vaccination site erythema) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Concurrent medical conditions included Crohn's disease (moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) injection. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (vaccination site erythema). At the time of the report, VACCINATION SITE ERYTHEMA (vaccination site erythema) 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.   No relevant concomitant medications were reported.  Treatment information was not provided.
Patient was vaccinated on 5/19/2023 with vaccine that expired on 5/17/2023.  Patient reported redness, heat, pain, swelling (about a hand sized area) at injection site.  Also reported nausea
Big itchy rash lump at injection site, arm feels heavy, very slight fever, dry throat
Pt went school feeling under the weather (nauseated). At school around lunch time patient reports she got really hot and felt faint. She began dry-heaving. Father came to pick her up and she was having diarrhea. Took PHENERGAN and laid down. Slept most of that day. Felt better next day.
Nausea, vomiting and diarrhea starting around 2am and lasting until around 6am. Later that same day (Tuesday) I had fever, some nausea, and fatigue. My arm was sore and swollen starting Monday night. By Wednesday morning I developed a red rash that is itchy. As of today (Friday early am), the rash has grown larger and more itchy, but the swelling has gone down. All other symptoms disappeared by Wednesday morning.
Pt says she has welts on each side of her belly button similar area to where she had shingles rash last year.