chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of injection site pain in a 17-year-old female subject who was inadvertently vaccinated with Boostrix for prophylaxis. Concurrent vaccination included Engerix-B, administered on 18 December 2006. This was the subject's 2nd dose of hepatitis B vaccine. On 19 October 2006, the subject received 1st dose of Boostrix. On 18 December 2006 at 15:30 the subject inadvertently received 2nd dose of Boostrix (left arm) rather than the intended administration of Menactra. One day following the 2nd dose of Boostrix, on 19 December 2006, the subject experienced 'mild" injection site pain and injection site swelling at the site of the Boostrix administration. The events resolved on 21 December 2006. The healthcare professional considered the events were probably related to vaccination with Boostrix and could have been associated with the inadvertent administration of a 2nd of Boostrix.
ADMINISTERED 3RD DOSE OF MMR AND A 3RD DOSE OF HEPATITIS B. NURSE PRESENTED WITH ADDITIONAL VACCINE RECORD AFTER IMMUNIZATIONS GIVEN
Pt came in 01/08 @ 5:08 pm to tell us that her MD states we should open report her adverse reaction on her Shingrix.  Pt states that she had redness, swelling, sore glands in arm on right side where shot was given, and a bruise for around 7 days
Starting about 5 days after my vaccine, I noticed soreness in my neck.  It continued into my upper back and now I have long term tingling in my arms.  I went to an orthopedic doctor about it, and he said he has seen such symptoms due to a massive inflammatory response caused by the vaccine.
This spontaneous report as received from a pharmacist refers to a 70 years old female patient. The patient was vaccinated with lot # (669863/0365AA expiration date 09-JUN-2012) of ZOSTAVAX on 07-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 07-JUN-2012, the patient experienced an injection site reaction that was red, itchy and painful after the ZOSTAVAX injection. The patient visited the physician's office. At the time of the report, the patient's outcome was unknown. No further information is available.
It was received from a regulatory authority on 10/29/00, concerning a 76 year old female pt who experienced ischaemic heart disease resulting in death 2 days after receiving the Fluvirin vaccine on 10/13/02. On 10/15/02, two days after vaccination, the pt experienced ischaemic heart disease and died. A post mortem examination was performed and coronary artery disease was reported as the probable cause of death. The reporter has assessed the relationship of the vaccine to the events as having a direct or indirect association.
C/O headache 5 mins after shot, then next day c/o hard warm nodule, swollen, red, sore arm at injection site.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with GARDASIL. No other co-suspects were reported. No concomitant medications were reported. The physician reported that GARDASIL carton was missing a vial upon opening a carton and patient missed the dose due to his quality issue. The office did not have any extra GARDASIL to administer a dose for patient. No adverse effects reported. PQC filed. Patient missed dose due to quality issue is not related to GARDASIL. Additional information has been requested.
This spontaneous report was received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with GARDASIL (lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced severe abdominal pain. Calcium carbonate (TUMS) was given as treatment for the event. It was unspecified if the patient had sought medical attention. The outcome was reported as recovered at an unknown date. This is one of several reports received from the same reporter. Additional information has been requested.
Slight fever; Chills; Headache; Exhaustion; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male received the BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot no: EL3247) second dose via unspecified route of administration in left arm on 12Feb2021 11:00( at the age of 35-years-old) as 2nd dose single for COVID-19 immunization. The first dose via unspecified route of administration in left arm on 21Jan2021 01:45 (batch/Lot no: EL3247) 1st dose as single for COVID-19 immunization. The patient medical history included the allergies to the sulfa drugs were reported. Patient received Sertraline within 2 weeks of vaccination as concomitant medications were reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 13Feb2021 10:00 AM, the patient experienced with slight fever (100F) and chills for 1 day, headache for 2 days and exhaustion for 2 days. Treatment received for the adverse event headache which included Acetaminophen. Outcome of the events slight fever (100F) and chills was recovered for 1 day on 14Feb2021 and headache, exhaustion recovered for 2 days on 15Feb2021.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
plunger rod on prefilled syringe was bent and difficult to depress on 9/4/2019; The patient flinched and complained of pain at the injection site; Information has been received from a pharmacy intern referring to a 21 year old female patient. The patient was allergied to eggs, amoxicillin, acetaminophen(+)hydrocodone bitartrate(LORTAB). The patient's historical condition and concomitant medications were not reported.  On 04-SEP-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (lot # reported as 1602284, expiration date reported as 03-SEP-2020 and auto generated as 26-SEP-2021, dose, frequency were not reported) for vaccination. The plunger rod on hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe was bent and difficult to depress (Syringe issue) and was not injected into the patient. A few minutes later, the patient received another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, frequency,lot # and expiration date were not reported) without any difficulty.The patient flinched and complained of pain at the injection site. The outcome of product quality issue was unknown. The outcome of injection site pain was reported as recovered on the same day (reported as recovery date: today). No treatment given for the event. No lab diagnostics/studies was provided. The patient wasn't sought medical attention. The causality assessment was not provided.
Pt developed diabetes over time. Dx'd 11/20/99 with Diabetes Type I. The follow up received on 6/19/01 states, "Thank you for referring pt to our clinic for consultation regarding diabetes management. As you know, pt was diagnosed with diabetes on October 20th. She was initially hospitalized, having large ketonuria and a blood sugar over 480. The parents state that things have been going reasonably well, although they find it very difficult to manage pt's diabtes. They feel that her blood sugars fluctuate drastically. She has not had any siezures. She has had a blood sugar as low as 25, at which time she wsa very groggy. She had another hypoglycemic event, with a blood sugar of 35, at which time she could not walk. She has had some blood sugar swings up into the 400's and 500's. However, in reviewing her blood sugars for the past few weeks, most of the blood sugars have been between 100 and 300. The parents have been talking with you for insulin adjustments, and numerous appropriate insulin adjustments have been made over the past six weeks or so. She is currently taking 4 1/2 units of NP and 1/2 unit of regular in the morning and no insulin in the evening. Upon awakening, her blood sugars have generally been in the 100 to 300 range. Pt is eating fairly well. She has three meals and three to four snacks per day. If her blood sugar is high, her snack is generaly withheld. Occasionally she will refuse to eat, and then the parents feel in a panic that hse is going to have a hypoglycemic event soon afterward. Pt has been back to her normal energy level and routine. She is still nursing occasionally, although the mother has been trying to limit the amount that pt is breast feeding. The mother had been fairly close to weaning pt at the time of the birth of pt's 6 month old sibling, but between that and then the diagnosis of diabetes a few months later, pt has continued to breast feed. The parents come in with several questions today. They are wondering whether the fluctuations in pt's blood sugars are typical. They also wonder whether pt's younger sister should receive immunizations, as they have read that immunizations may be the cause of the increased prevalence of diabetes in young children. They do note that pt's blood sugar tends to fall rahter quickly after Humalog insulin, and it also falls in the mid-afternon, between 1 and 2pm. They find it difficult to give pt extra Humalog insulin, asthey are unsure if her blood sugar is going to fall from previous insulin dosages. In looking at pt's blood sugars at bedtime, of late she frequently has been going to bed with relatively high blood sugars, i.e. over 200."  Follow up: "Actual date is unknown.  Onset was very gradual.  Destruction of Islet cells which produce insulin can be immediate or take several years."
Myalgia, Arthralgia, Fever, ErythemaMultiform, NauseaVomiting, chills Narrative:  Nausea, vomiting, chills, mayalgia, arthralgia, fever 100, arm soreness, redness, swelling
Has increased the number and intensity of my menopausal hot flashes. I had been getting hot flashes due to menopause, but since the vaccine, 2 weeks ago tomorrow, they have been out of control.  They are occurring more frequently, more intense and lasting longer. I'm not getting any sleep because of them, it has been miserable.
Patient's wife states that approximately 2 hours after her husband received the Pfizer (bivalent) vaccine his feet, legs, arms, hands, feet, chest (essentially entire body) became red and itchy with a burning sensation. Patient received medical treatment.
Left arm was sore at shot site. Then entire arm went numb. Woke up next morning entire left side and face including head were numb. Two days later entire right and left legs arms and head numb.
This spontaneous report as received from a health care worker refers to unspecified patients of unknown age. The unspecified patient's medical history was not reported. On an unknown date, the unspecified patients were vaccinated with 7 doses of VAQTA (dose, frequency and route were not reported) which were improperly stored. No adverse events were reported. No product quality complaint was reported for VAQTA. This case is linked to 1409USA014917 and 1409USA014918 (same reporter link). Additional information has been requested.
patient is pregnant; no adverse event; inadvertently administered a dose of GARDASIL 9 instead of a dose of Tdap; This spontaneous prospective pregnancy report was received from a nurse referring to a 29 year old female patient. Information about patient's concurrent condition, concomitant medication, medical history, drug allergy/reaction was not reported.   The nurse reported that the patient was 28 weeks and 6 days of gestation at the time of vaccination with last menstrual period of 14-JUN-2019. On 02-JAN-2020, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R005341, expiry date 06-DEC-2020 (strength, dose number, route, anatomical location was not reported) for prophylaxis, instead of a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (exposure during pregnancy, wrong product administered). No adverse symptoms were reported (no adverse event). The estimated date of delivery of the patient was 20-MAR-2020. The pregnancy outcome was outcome pending. No product quality complaint was involved.
Rash on her left breast; Bull's eye sized rash on her left armpit and its itchy; metallic taste in her mouth; body ache; low grade fever; Chills; very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Bull's eye sized rash on her left armpit and its itchy), DYSGEUSIA (metallic taste in her mouth), RASH (Rash on her left breast), PAIN (body ache) and PYREXIA (low grade fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL and LEVOTHYROXINE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced DYSGEUSIA (metallic taste in her mouth), PAIN (body ache), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (very bad headache). On 24-Apr-2021, the patient experienced RASH PRURITIC (Bull's eye sized rash on her left armpit and its itchy). On 25-Apr-2021, the patient experienced RASH (Rash on her left breast). At the time of the report, RASH PRURITIC (Bull's eye sized rash on her left armpit and its itchy), DYSGEUSIA (metallic taste in her mouth), RASH (Rash on her left breast), PAIN (body ache), PYREXIA (low grade fever), CHILLS (Chills) and HEADACHE (very bad headache) outcome was unknown.            Treatment details include, Cortisone and Zink oxide ointment.   This case was linked to MOD-2021-090178 (Patient Link).
02/11/2023 I had a bad cough and sinus congestions. After testing positive for a sinus infection I was prescribed Amoxicillin and Prednisone. Symptoms lasted 3 weeks with lingering cough.
51 yo male with hx of hypothyroidism who took his firs shot of covid 19 pfizer vaccine and presented for evaluation of sudden eruption of rash, itching and lip swelling  with facial numbness which started at approxmately 48 post injection. Pt reported pain at the injection site but did not get any fever and wasa doing fine until this afternoon. he had  difficulty breathing but is saturating well on room air. he has redness urticarial lesions on face bl arms abdomen chest  groin and knees. he has swelling of the mucous membranes. no reported allergies to vaccines before. no new meds or changes in diet recently. remote localized bug bite allergy and vioxx allergy.
Child has complained about pain, starting approximately five minutes after the shot was given, and still complaining two days later. Injection site has redness and swelling approximately 4-5 inches in diameter. Site is warm to touch.
PER PATIENT RIGHT EYE SWELLED UP CAUSING BLURRY VISION. PATIENT SAW ophthalmologist. OPTHALMOLOGIST NOTED THE WORSENING IN VISION OF RIGHT EYE ONLY  AS COMPARED TO THE RESULTS OF A VISIT 2 MONTHS PRIOR. PER PATIENT SWELLING RESOLVED ON IT'S OWN IN ABOUT A WEEK
Gave an additional dose of Menquadfi secondary to a medication transcription error. No adverse reaction noted.
left arm aching 3-4 inches from site of inyection; left arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm sore) and MYALGIA (left arm aching 3-4 inches from site of inyection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029LZ0A) for COVID-19 vaccination.     Concomitant products included VALSARTAN, OMEPRAZOLE, MELOXICAM, METOPROLOL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ) and DICLOFENAC SODIUM for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm sore). On 20-Jan-2021, the patient experienced MYALGIA (left arm aching 3-4 inches from site of inyection). At the time of the report, PAIN IN EXTREMITY (left arm sore) and MYALGIA (left arm aching 3-4 inches from site of inyection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she suspended the meloxicam.
injection site swelling, redness, pain and itching. no treatment. duration of 3 days
3 days after 1st dose on 12/23/2020 I developed multiple swollen lymph nodes in armpits, right and left. 2 of which grew to the size of large jelly beans and developed cellulitis and a "head" - infected lymph nodes drained pus and blood
Extreme pain in left shoulder and upper arm for approx. 4 weeks, followed by moderate pain continuing; treated with ice, heat, aspirin, ibuprofen, massage.
HOT, BURNING UP; HIGH PULSE; BACK WAS HURTING; BREATHING WAS LITTLE DEEPER LAST NIGHT; APPEARED DEHYDRATED; SKIN SENSITIVITY; CHILLS; HEADACHE; FELT NAUSEOUS, BUT NEVER GOT SICK; RUNNING FEVER, FEVER WITH TEMPERATURE OF 101.9 TO 100.9 DEGREES CELCIUS, FEVER AROUND 100.6, TEMPERATURE WAS 103.2 AND HAD TEMPERATURE 100.9 WHEN WOKE UP; DIZZINESS WHEN STOOD TO WALK; CHEST FELT HOT; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 21-APR-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-APR-2022, the patient experienced dizziness when stood to walk, chest felt hot, breathing was little deeper last night, appeared dehydrated, skin sensitivity, chills, headache, felt nauseous, but never got sick, and running fever, fever with temperature of 101.9 to 100.9 degrees celcius, fever around 100.6, temperature was 103.2 and had temperature 100.9 when woke up. Laboratory data included: Body temperature (NR: not provided) around 100.6, 101.9-100.9 C. On 22-APR-2022, the patient experienced hot, burning up, high pulse, and back was hurting. Laboratory data included: Body temperature (NR: not provided) 103.2, 100.9, and Pulse rate (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from running fever, fever with temperature of 101.9 to 100.9 degrees celcius, fever around 100.6, temperature was 103.2 and had temperature 100.9 when woke up, had not recovered from dizziness when stood to walk, and the outcome of headache, chills, chest felt hot, felt nauseous, but never got sick, hot, burning up, high pulse, back was hurting, breathing was little deeper last night, appeared dehydrated and skin sensitivity was not reported. This report was non-serious.
Initial report received from a healthcare professional on 23 January 2013. A female patient (age was not reported) had received an intradermal dose 1 of FLUZONE ID, lot number UT4471AA on 21 January 2013. The patient was pregnant. The patient's last menstrual period date was unknown. The estimated date of delivery was not reported. On an unspecified date, the patient had experienced redness and swelling at the injection site. The patient's health during pregnancy and risk factors were unknown. Concomitant medications and medical history were not reported. At the time of this report, the outcome of events was not reported. Documents held by sender: none.
Pt recvd MMR vax 23JUL91 & recvd a 2nd dose of MMR 29AUG91 & 3rd inject 18NOV91 pt did not seroconvert following the 3 vax; no further details were provided;
Your vaccine & 2 boosters made me very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Your vaccine & 2 boosters made me very sick". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
cardiac side effects; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A non-contactable consumer reported for a patient (friend of friend). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced cardiac side effects. The reporter stated I have several medication allergies and trying to determine if those anaphylactic reaction to those medication; predispose me to have a reaction with the Pfizer covid vaccine. My pharmacist told me to call you and give you medications I'm allergic to and to check on any cross reaction. What if I have an anaphylactic reaction after the first does. I know someone who had a bad reaction after the first dose. Immediately after the Pfizer covid vaccine the person had cardiac side effects (it was a friend of a friend). I had a side effect after the first dose of the vaccine. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The clinical outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100951798 same reporter/ drug, different AE/ patient
arm is still swollen and red; arm is still swollen and red; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL9267), dose 1 via an unspecified route of administration, administered in right arm on 10Feb2021 (at the age of 69-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included diabetes mellitus from 1999 to an unknown date. Concomitant medication, not had any other recent vaccinations or started any new medications. Patient said it has been years since patient had any other vaccinations. Patient got first dose on 10Feb and patient was supposed to go back 03Mar. Additional information for other conditions: patient diabetes was under control, it was under 7, it was diagnosed when she got sick because patient son went into the military and they couldn't find him and patient was emotional, patient diabetes was emotional. Investigation assessment: no. The patient experienced arm still swollen and red. Patient would like to know, should patient put ice on it. The outcome of the events were unknown.  Follow-up attempts completed. No further information expected
pt recvd vax 1030AM mom returned w/pt stating pt was getting hives all over; upon exam pt was not experiencing any resp difficulties but did have hives like swellings;