chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lump at injection site; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0169), via intramuscular route of administration, administered in left arm on 26Apr2021 at 10:30 (at the age of 55-years) as single dose for COVID-19 immunization. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8732), via intramuscular route of administration, administered in left arm on 03Apr2021 at 10:30 (at the age of 55-years) as single dose for COVID-19 immunization and had experienced shingles, lumps on back of head which was hurting along with her hair. The patient medical history included cholesterol, shingles. The patient had a positive family history for ovarian cancer, colon cancer and heart disease. The patient had known allergies including food allergies to Soy (highly), peanuts, tomato, wheat; and previous allergies to medications including Nickel, Gold, Formaldehyde, Bacitracin, Neomycin, Thimerosal, Dimethylaminopropylamine, Methyl dibromo glutaronitrile, Bronopol. The patient's concomitant medications included ongoing cetirizine hydrochloride taken for allergies and rosuvastatin taken for cholesterol. Following second dose vaccination on 26Apr2021, the patient had experienced lump at injection site. The patient had not received any treatment for the event. The outcome of the event was recovered on an unspecified date in 2021 at the time of report.   Follow-up attempts are completed. No further information is expected.
body aches; fever; chills; emesis; This spontaneous report was received from a health care professional via Food and Drug Administration (FDA) and refers to an 17-year-old female patient. It was reported that the patient had no allergies to medications, food or other products. She also did not have any concurrent conditions. Her concomitant vaccines included third dose of poliovirus vaccine inactivated (vero) (IPOL) and second dose of meningococcal acyw conj vaccine (crm197) (MENVEO). No other information regarding the patient's medical history, concomitant medications was provided.  On 25-APR-2019, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscularly in the left arm, lot # R026716, expiration date 30-MAY-2021 (strength, dose, frequency was not provided) for prophylaxis. On the same day, the patient experienced fever, chills, body aches, emesis. It was reported that the patient recovered from the events on 27-APR-2019 (reported as lasted for 2 days).  The causality assessment between the events and of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Follow-up information was received from the health care professional on 19-MAR-2020. It was specified that the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left deltoid. Additionally details of vaccine administration and patient's demographics were provided.
Redness/swelling at site L/leg, size of quarter. Temp elevation 104. Symptoms subsided after a few days but lump size of golf ball now remains.
The medication that I am on called Latuda does have a side effect of heartburn, but that is why I was taking the Omeprazole to stop the heartburn that the Latuda medication caused. So, the heartburn was controlled and managed, but after getting the vaccine I had severe heart burn. I was struggling to drive when I had drove to the pharmacy to get the medication that my urgent treatment clinic doctor told me to get. I had pain under my ribcages that was just burning. It lasted all day and through the night. It made me stay awake till 1AM because of how uncomfortable it was. I took twice as much of the Famotidine medication than I was supposed to, but it did help relieve the heartburn. The next day it was still uncomfortable but not as bad. Also, 2 weeks later I had a super heavy period and extreme nausea. I still have lingering nausea, but it seems to be getting better.
Pt states that she had minor redness at the site of injection on the day of the vaccination.  Over the next day she describes itching and an increase in redness and warmth greater than the size of a quarter at the injection site.  Today, 08/30/2015, pt still has redness and warmth at the site.  She states that the itching is decreasing, and that she thinks the redness is not getting worse.
Erythema circumferential, distal to injection site.  Advised to take Benadryl or Allegra.
This spontaneous report was received from a Registered Nurse, regarding a 12 months old male patient with no pertinent medical history reported. On 26-MAR-2013 the patient was vaccinated with VARIVAX (Merck) (lot number and expiration date not reported) (dose and route not reported) in the left arm. Other suspect therapies included PROQUAD (Merck) (lot number and expiration date not reported) (dose not reported), subcutaneous, in the right arm. The Registered nurse stated that the child was inadvertently vaccinated with VARIVAX (Merck) and PROQUAD (Merck) the same day. Staff error only. No adverse effects reported at that time. Additional information is not expected.
Rash, itching in Rt deltoid where she was given TDAP. Sx started approx 2 days after vaccination. Tx: hydroxyzine, SARNA lotion, cool compresses.
Starting 06/13/2022, I started having coughing, chills and fever. On 06/14/2022, I tested Positive for COVID, and went to urgent care where I was prescribed Paxlovid. I started the Paxlovid on 06/15/2022. My entire body has been aching, my throat was dry and I felt horrid. . 06/15/2022 I started getting dizzy and had to steady myself. So far to this day I have had a day and a half of the Paxlovid, and I am starting to feel slightly better but I am very fatigued and feel the need to nap throughout the day (which I do not like to do).
fever 104 during noc > 12 hrs p/started @ 4PM of immmun; t102 also being uncomfortable, tremor like movement; somewhat lethargic when not sleeping; gave APAP; called MD
About 1-2 hours after vaccination patient experienced trouble breathing and throat closing. She went to ER and received an epi pen and steroids and states she is much better now.
I have not had my period for two months since the vaccine. I NEVER miss periods. I hardly bled at all (only a few drops) and did not have any of my usual symptoms (no cramps). I feel bloated.  I am NOT pregnant.
in evening headache nausea overall sick feeling  weak  had to get in bed  no sleep during night sick all night  unable to get out of bed till noon  felt better  ate drank around 2 pm today
This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were inadvertently vaccinated with oral, ROTATEQ (dose, route and lot# were not reported) that had been improperly stored. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
This is a spontaneous report from a non-contactable consumer (mother). An infant patient (less of 6 months old) of unspecified gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient stopped breast feeding on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about lot number cannot be obtained.
Shingles rash within three days following; full diagnoses and treatment via oral medication the following week (when the rash bubbled and was clearly viral). Presented as small red dots and eventually grew pussy and looked more traditional. Pain presented after rash.
Pt stated her arm started hurting the night after getting her flu shot and experienced intense pain for at least 3 days following. Treatment limited to OTC analgesics. Complained that the pain has been persistent and she experienced weakness in the affected arm.
Cellulitis; Warmth; A lot of redness; Swelling in the arm right at the area where I had it injected; Enlarged lymph noes; Arm soreness; A spontaneous report was received from a physical therapist, who was also a 30-years old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed arm soreness, injection site redness, injection site warmth, injection site swelling, cellulitis, and enlarged lymph nodes.   The patient's medical history and concomitant medications were not reported.   On 26 Dec 2020, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On 26 Dec 2020, the patient experienced arm soreness.    On 01 Jan 2021, she experienced swollen lymph nodes.    On 02 Jan 2021, she experienced redness, warmth, and swelling at the injection site.  She was diagnosed with cellulitis.  Treatment included clindamycin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, arm soreness, swollen lymph nodes, redness, warmth, and swelling at the injection site, were not reported.; Reporter's Comments: This case concerns a 30-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of cellulitis, the non-serious listed events of lymphadenopathy, injection site erythema, injection site swelling, and arm soreness, and the non-serious unlisted event of injection site warmth.  Based on the current available information and the temporal association between the use of the product and the onset of events at the site of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Information has been received from a Licensed Practical Nurse concerning a 64-year-old female with hypertension, hyperlipidaemia, scoliosis, rhinitis allergic, osteoporosis, gastrooesophageal reflux disease, mitral valve prolapse, depression, left carotid bruit, and penicillin, MACROBID and BACTRIM allergies who on 18-MAR-2008 was vaccinated subcutaneously in the right deltoid with a 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot# 659759/1873U). Concomitant therapy included hydrochlorothiazide (manufacturer unknown), atenolol, NEXIUM, LIPITOR, ZYRTEC, OMACOR and NASACORT. On 20-MAR-2008, the patient experienced a shingles like rash on the patient's left shoulder. Medical attention was sought at the physician's office. There were no laboratory or diagnostic tests performed. The outcome was reported as not recovered. No product quality complaint was involved. Follow-up has been received from the L.P.N. concerning a patient with a history of chickenpox at the age of 7 who was vaccinated with a 0.6 mL (previously reported as 0.65 mL) dose of zoster vaccine live (Oka/Merck). It was reported that a rash had not occur at the site of injection or elsewhere within 42 days of the vaccination. Date of Herpes Zoster was reported as 20-Mar-2008. The patient rated the pain a 5-6 on a scale of 0-10 (10 being the most). Other symptoms included itching. There was no recent exposure to chickenpox. A direct fluorescent antibody was not done. Follow-up has been received from the L.P.N. and physician who indicated that additional concomitant therapy included cyclobenzaprine hydrochloride (MSD). On 20-Mar-2008, the patient developed a rash on the chest area above the left breast and shoulder. The patient's maximum temperature was 98 degrees. There was no recent history of exposure to chickenpox or shingles. On an unspecified date the patient recovered. The patient was enrolled in the Varicella Zoster Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The samples of the lesion were collected on 26-Mar-2008. The sample of #1 and #2 were taken from fluid from a vesicle (swab of vesicle). The PCR results for the specimen from the vesicle identified the presence of WT VZV. Additional information is not expected. This is in follow-up to report (s) previously submitted on 6/24/2008. A lot check has been iniciated. A standard lot check investigation was performed. All in-process quality checks for the lot# 659759/1873U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release not all specifications. The lot met the requirements of the Center and was released. No further information is available.
Presented on 9/29/06 with c/o HA, sweats, bodyaches. Reported receiving smallpox vaccine approximately 1 week prior. Physical exam noted + Tender lymphadenopathy to the L axilla. Smallpox vaccination site within normal limits. Diagnosed as "spv flu". Orders given for quarters times 48 hours (may go to FOB, if able but continue quarters if necessary), f/u on Monday at TMC, Toradol 60mg IM given for HA, 1L normal saline given IV, Mobic 7.5mg 1-2 at supper, Tylenol #3 prn.
Patient received 1st dose of Pfizer Covid vaccine on 4/21, and on 4/22 had 2 generalized tonic clonic seizures.  No previous seizure history prior to this event.  Workup for etiology of Seizure was unremarkable (MRI Brain, CSF studies, UA/CXR)
This is an initial spontaneous report from a contactable reporter.  This female consumer reported that her son received the third injection of PREVNAR 13 on 09MAR2011.  His concomitant medications were not provided.  His medical history includes the first dose PREVNAR 13 at the age of 35 months and a second dose at age 38 months.  The patient experienced an acute reaction, clarified as his eyes were fluttering and jerking after the second dose but it resolved within approximately 3 days.  Within hours after his third dose, he experienced eye jerking, fluttering and rolling into the back of his head.  These events continue.  He has had several tests including an EEG and a CT.  They have not provided a diagnosis yet but they are considering seizures or epilepsy.  The reporter states the physicians do not feel the events are related to PREVNAR 13.  Physician's Contact: refused.  Follow-up (21Mar2011): This is a follow-up spontaneous report from a contactable consumer included product details and event details.  No follow-up attempts needed.  No further information expected.
About a week after the shot, I started getting redness, tenderness, discoloration, and swelling of my right arm. The discoloration began to spread and I went to the doctor on the 21st. The doctor said there was inflammation and because it was warm to the touch, was concerned about blood clots. I was sent for an ultrasound and prescribed an anti-inflammatory medication and advised to take aspirin. Everything cleared up about a week later.
Left fingers and toes started to tingle about 10 minutes after vaccine. This included left pointer, middle, and ring fingers and all toes except big toe left foot. Also started to have discomfort and tingling, numbness in left knee. "Like these areas went to sleep" per patient.  Had him lay down in office for an additional 15 minutes (30 minutes total monitoring), gave him water, and lollipop for sugar.  He continued to have the sensations but nothing worsened 30 minutes after vaccine, so allowed him to go home.
COVID vaccine vial was opened 3/9/23. Vial was not discarded at the end of the day and a second dose was drawn up and administered 3/13/23.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever, burning sensation and swelling arm. On an unknown date, the outcome of the fever, burning sensation and swelling arm were recovered/resolved. It was unknown if the reporter considered the fever, burning sensation and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, swollen arm, and felt like her arm was on fire the night after receiving the SHINGRIX vaccine. The reporter did not have vaccine information, patient date of birth, initials or if the adverse events were resolved.
Vaccine administered by nurse to myself in office pending foreign travel. No immediate or local reaction. Several days later, onset chest pain, pericarditis, pleuritis (mimicking inferior MI). Recovery in progress. Medical records state myocarditis, pericarditis. msv
Vaccine administered 07:15, patient reported syncope approx 11:00.  Patient was reclined on floor for 20-30 minutes until episode passed.
Pt recvd vax & exp periorbital swelling, flu like sx; pt seen by pvt MD who dx Bell's Palsy; no meds prescribed; 15AUG93 exp facial swelling & discomfort & flu-like sx; pt severely anemic;
No additional AEs; Caller reported VARIVAX administered after temperature excursion; This spontaneous report has been received from a medical assistant concerning to patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for varicella virus vaccine live (oka/merck) (VARIVAX) in which the maximum temperature reached was 10.9 degrees Fahrenheit for a time frame of 5 hours and 30 minutes. No previous temperature excursions were reported.  On 29-AUG-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, administered subcutaneous (SQ), lot W012166, expiration date 12-APR-2024, (anatomical location was not provided) as prophylaxis (product storage error). No additional events were reported.
Information was received from physician's office via a company employee on 17-NOV-2016. A nurse from the physician's office reported that she hear from an unknown source that another patient (demographic unknown) developed shingles after receiving the ZOSTAVAX (Lot unknown). No other information was provided. Additional information has been requested. This is one of two reports from the same reporter (1611USA009264).
Vaccination failure; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 7 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 8 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 9 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset Oct2023, outcome "unknown", described as "Treatment of COVID-19"; VACCINATION FAILURE (medically significant) with onset Oct2023, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19, patient treated with Paxlovid from 10Oct2023 to 14Oct2023. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Patient felt flushed, heart racing.  Had irregular rhythm.  Transported to Emergency Department.  Treated with epinephrine.  EKG performed, having pre-ventricular contractions.  Checked in to ED for further evaluation.
h/a, discharge of eyes R/L (a few wk) dizziness episodes, aching, hip discomfort;
Mid-cycle menstrual spotting  began 3/31/2021 and continues through present time and date.
Two mornings after injection patient woke and the area was red, raised, swollen & itching. Area was approx 1 1/2" x 4" patient used ice & used hydrocortisone cream & ibuprofen. The swelling stopped but remained itchy.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:01/12/21pfizer,Lot#EL3248 2nd dose:02/02/21 Pfizer,Lot# EN5318 Diagnosed covid positive:04/19/21 Exposure:Home Symptoms:Asymptomatic
This case was reported by a nurse via sales rep and described the occurrence of welts in an unspecified number of patients who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced welts. On an unknown date, the outcome of the welts was unknown. It was unknown if the reporter considered the welts to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The case was reported by a Registered Nurse. The age at vaccination of the patients was not reported. The reporter reported that they were seeing a lot of cases for the patients with welts after receiving FLULAVAL, but she did not had the specific numbers or information for other patients at the time of the call. This case had been linked with the cases US2017GSK165322 and US2017GSK165323, reported by the same reporter.
This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face is swollen) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Face is swollen). At the time of the report, SWELLING FACE (Face is swollen) outcome was unknown. No concomitant product use was provided by the reporter. No treatment medication was provided.
loss of consciousness w/stiffness of whole 10 mins; fever up to 102; rash on trunk;
This spontaneous report as received from a other health professional refers to unspecified number of patients of unknown age. It was reported that the ROTATEQ of unknown dose, have undergone a second temperature excursion dated 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients. ROTATEQ have been administered since date of last excursion of 27-JAN-2014 is with Lot number reported as J006562 and expiry date reported as 29-JAN-2015. This is one of the several reports from the same source: different patients same reporter. Additional information has been requested.