chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called back about 4 hours after administration of vaccine to state her arm was very sore, more sore than she had imagined. Pain at injection site and radiating down to about elbow.
Pt reported swelling at injection site immediately which progresed to swollen glands under arm of injection site as well as neck region. Pt seen on 9/18/14 treated with antibiotic (Augmentin).
Information has been received from a certified medical assistant concerning a female patient who on unspecified dates was vaccinated with the GARDASIL series (lot numbers not provided). It was reported that and on an unspecified date, the patient testing positive for HPV. The patient sought unspecified medical attention. No treatment was given for the adverse event. It was unspecified if any lab diagnostic studies were performed. At the time of the report, the patient was not recovered. No further information is available.
The patient experienced 1-3 days progressive eruption without systemic symptoms except a limp left ankle. The patient had generalized distributed blanching with 3-15mm rose colored papules and plaques and swollen neck glands.
Chills; Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headaches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headaches). On 04-Apr-2021, CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headaches) had resolved.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-363240 (Patient Link).
arm soreness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 15:00 (Lot number: EN6206) at the age of 49 years as dose 1, single and administered in arm left, administration date 24Mar2021 12:15 (Lot number: ER8730) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "arm soreness". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient's concomitant medication included unspecified vitamin (daily; as reported). The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was further reported that the patient only had some arm soreness with first shot; and on 24Mar2021, patient experienced a bit more arm soreness with second shot.   No follow-up attempts are possible. No further information is expected.
Oct 1, 2014, received flu shot, left arm at 12 noon. 11 days later, on Oct 12th - symptoms developed in (L) side (facial droop, couldn't hear (L) ear; no taste). 10/9, 10, 11 I had pain extending from (L) ear to top of head - along nerve roots. 10/8 - dizzy. 10/9 - dizzy, headaches, pain in (L) facial area.
discomfort in his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DYSAESTHESIA (discomfort in his arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE and ROSUVASTATIN for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DYSAESTHESIA (discomfort in his arm). At the time of the report, VACCINATION SITE DYSAESTHESIA (discomfort in his arm) 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 treatment information was provided.   This case was linked to MOD21-032046 (Patient Link).
Patient is passenger seat.  Patient recieved vaccine in vaccine tent. On  the way to the observation parking lot, patient diverted to high risk tent which was the nearest medical profession. Patient recieved in the passgenger seat reclined with eyes closed and unrespnisive to the driver, his wife's voice and attempts to arrouse. Vital signs checked while still attempting to arouse by calling his name. BP-150/83, HR-31. Sternal rub performed, no response.  Patients wife  splashed water on patients face while calling his name and rubbing his shoulder. Epinephrine 0.3mg administered  in right lateral thigh by RN. Patient immediately aroused. Patient AOx3. EMS arrived to scene. Care transferred to EMS. Patient not transported.
Left dr office at about 12 noon within few hrs baby developed a temperature of 100.2 gave some Tylenol then by 11pm the temperature was 104.2 with no other symptoms with or following the temperature medicated with Tylenol again and gave bath called Drs office the following morning.
30 minutes after getting vaccine she reported lips tingling, felt hot all over body, became diaphoretic.  Was given Benadryl 25 mg PO at 1126.  By 1137, pt reported her lips stopped tingling and her skin was warm and dry.  Was monitored for another 30 minutes in the lobby, then sent home with Benadryl.
Vial was expired on 13-Aug-2022, initially stored on 05-Sep-2022 and administered to the patient on 06-Sep-2022; No adverse event; Patient administered expired Moderna COVID-19 vaccine (Monovalent); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna COVID-19 vaccine (Monovalent)), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 05-Sep-2022 and administered to the patient on 06-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Unspecified COVID-19 Vaccine Dose 1), COVID-19 Vaccine (Unspecified COVID-19 Vaccine, First Booster Dose) and COVID-19 Vaccine (Unspecified COVID-19 Vaccine Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, COVID-19 Vaccine and COVID-19 Vaccine.    On 06-Sep-2022 at 3:17 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Sep-2022 at 3:17 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna COVID-19 vaccine (Monovalent)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 05-Sep-2022 and administered to the patient on 06-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna COVID-19 vaccine (Monovalent)), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 05-Sep-2022 and administered to the patient on 06-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna COVID-19 vaccine (Monovalent)) and PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 05-Sep-2022 and administered to the patient on 06-Sep-2022).    No concomitant medications were reported.  Vial size was reported as 5.5 ml. The vaccine was delivered and placed into the freezer on 18-Apr-2022 and the vial did not undergo any temperature excursion.  Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 06-Sep-2022 vial was placed into refrigerator on 05-Sep-2022.  NDC of vial was 8077727310.  No treatment information was reported.
VERY FAINT BRUISE AT THE INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced very faint bruise at the injection site. The action taken with covid-19 vaccine was not applicable. The outcome of very faint bruise at the injection site was not reported. This report was non-serious.
pt recv vax JUL95 & 4AUG96 pt exp herpes zoster w/distribution of the rt femoral cutaneous nerve & had approx 9 vesicles;lesions did not itch but were not painful;pt had scarring, however had recovered by 11SEP96;
The reaction is "COVID arm": a red ring approximately 3-4in in diameter surrounding the injection site.
His kidneys are hurting; A lot of peeing/Was urinating every 20 or 30 minutes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 05Oct2021 (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LASIX [FUROSEMIDE]. Vaccination history included: Bnt162b2 (1st dose), when the patient was 79 years old, for Covid-19 immunization; Bnt162b2 (2nd dose), when the patient was 79 years old, for Covid-19 immunization. The following information was reported: POLLAKIURIA (non-serious) with onset 06Oct2021, outcome "unknown", described as "A lot of peeing/Was urinating every 20 or 30 minutes"; RENAL PAIN (non-serious), outcome "unknown", described as "His kidneys are hurting".  Additional Information: Reports a lot of peeing following booster dose. Complains that his kidneys are hurting then when he pees it is better. Sits in his chair. Thinks it is relevant to the chair. Was urinating every 20 or 30 minutes. Lasix once a day in the morning. Put a pillow behind him. The caller states her husband was experiencing a lot of peeing after receiving the booster dose Pfizer Covid Vaccine. The caller states the patient received the Booster dose Pfizer Covid Vaccine yesterday, 05Oct2021 around 1330 or 1400. Today, 06Oct2021, the patient is peeing about every 30 minutes. Reporter states patient is fine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It felt like a sinus issue. I had swollen lymph nodes on my left side by my ear. This lasted for about a week or two.
Tremors of the right hand, right leg, and right foot.  Cold sensation in bilateral lower extremities.
Began vaginal spotting/bleeding that is outside of my regular menstrual cycle. Bleeding has been going on for over 3 days and is extremely heavy, soaking through a super pad every 1-2 hours. This is very abnormal for me.
Hiberix mixed with saline water rather than diluent; Hiberix mixed with saline water rather than diluent and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-month-old male patient who received Hib (Hiberix) (batch number 595R2, expiry date 09-JAN-2025) for prophylaxis.   On 30-OCT-2023, the patient received the 4th dose of Hiberix. On 30-OCT-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Hiberix mixed with saline water rather than diluent) and inappropriate dose of vaccine administered (Verbatim: Hiberix mixed with saline water rather than diluent and administered to patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-OCT-2023 The nurse reported a patient was administered with Hiberix that was mixed with saline water and not the accompanied diluent, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The reporter consented to follow up.
MOM STATES THAT CHILD DEVELOPED A KNOT AT INJECTION SITE WHICH WAS RED AND SWELLING SPREAD THROUGH LEG.
Patient received the first dose of Moderna vaccine today 4/21/22. After vaccine was administered and patient was moved to post-vaccination waiting area, he fainted, collapsed and began having a seizure. Code white was called, 911 called, seizure lasted about 15-20 seconds and patient came to. Cold compress was applied to back of patients neck, water and orange juice were given to patient. Patient stated having vasovagal reaction to a blood draw many years ago, but never with the vaccines that he has received in the past. Patient stated that he has had a seizure before, but not on any medication to treat seizures. All was discussed prior to vaccine administration and patient left with EMT's shortly after they arrived.
this was new patient to our clinic; Reporting showed that patient was in need of MMR and Varicella;  patient was given combination vaccine of MMRV outside of intended age range.  Patient is 16.  Days after this vaccine was given,  another record was received by the school nurse that showed patient was not in need of MMR or Varicella and was up to date on these vaccines as 2nd dose was given in 2011.  Patient had an additional dose of MMR and Varicella on 6/22/22 and was given a combination vaccine that is not intended for age 16
1. Achy body, fever, headache and loss of appetite lasted for 2 days 2. Swelling and soreness in upper arm persists to this day 2. Swelling and pain spread to my arm pit and persists to this day. 3. Hand is tingling/numb which persists to this day
Blisters in area of vaccine (approx. 2" dia of blisters) plus localized swelling approx. 4" wide and 7" long. All in area of injection on right arm.
Narrative: .59 y/o female, post menopausal (no hormone replacement therapy). BMI=30. No personal h/o clotting. Her Father had clotting issues with cancer/chemo .She is having Factor V Leiden workup to make sure not predisposed. Patient did reports symptoms started about 3 weeks after vaccination (vaccine 3/24/21, DVT dx was 4/26/21)
Developed hives on day 9-post second Pfizer vaccine dose and then again on day 13-post dose: > 50 hives on legs. Continue to develop new hives each day since, including today (day 19-post dose), about 4 to 5 new hives per day since day 13-post dose.
Information has been received from a health professional concerning a 12 month old white male with no relevant medical history or illness at vaccination who on 03/26/2002 was vaccinated with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) SC in his right thigh (lot # 63937/1476L).  Concommitant suspect therapy included the first dose of varicella virus vaccine live SC in his left thigh (lot # 640090/1147L).  On 04/02/2002 the patient developed a red rash and temperature of 100.2.  No further information is expected.
patients who received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. On 13-Jan-2022, Vaccines placed in refrigerator. No treatment information was provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 35-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 11Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Bipolar 2 disorder" (unspecified if ongoing), notes: Bipolar 2 disorder; "Depression" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Chronic pain" (unspecified if ongoing). The patient's concomitant medications were not reported. It was unknown whether the patient was pregnant at time of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Therapeutic measures included anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment started on 30Jun2022 and stopped on 05Jul2022 via oral route, Indication: Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I got hit with paralysis from the waste down. It lasted about 12Hrs. Started about 6pm that evening. Lost feeling and use of both of my legs. Was bed bound. Next morning, was able to lift and use my legs. I?m already disabled with MS so if made it way worse
ALMOST DIED; This spontaneous report received from a consumer concerned a male of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient almost died, and he was within wheelchair now and disabled now. The patient had visited clinic two times. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from almost died. This report was serious (Disability Or Permanent Damage). This case, from the same reporter is linked to 20210540143.; Sender's Comments: V0: 20221238334- almost died. Follow-up received regarding Clinical Details. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
sore arm; This is a spontaneous report from a Pfizer-sponsored program About Pneumonia Unbranded . A non-contactable consumer (patient) reported for a patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date.The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
R upper arm pain, tenderness, reduced range of motion, reduced strength.  Onset at time of vaccine (3/13/21) to present (4/10/21).  Reduced range of motion and reduced strength noted by occupational therapist on 4/7/21.  Recommended f/u with physician.  Diagnostic ultrasound on 4/9/21 by physician noted inflammation of supraspinatus tendon of the injected arm.    Significant reflux symptoms also began in the days after the vaccine and continue to present (4/10/21).
administration of Boostrix to a 30 week pregnant patient; 30 week pregnant patient 2 weeks apart/1st dose on 23OCT2023 and 2nd dose 08NOV2023; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 31-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 324B2, expiry date 30-JAN-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 54CP2, expiry date 11-JAN-2026) for prophylaxis.   On 08-NOV-2023, the patient received the 2nd dose of Boostrix. On 23-OCT-2023, the patient received the 1st dose of Boostrix. On 08-NOV-2023, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: 30 week pregnant patient 2 weeks apart/1st dose on 23OCT2023 and 2nd dose 08NOV2023). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: administration of Boostrix to a 30 week pregnant patient). The outcome of the vaccine exposure during pregnancy and extra dose administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   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: 09-NOV-2023 The medical assistant requested data on potential effects of administration of 2 doses of Boostrix to a 30 weeks pregnant patient 2 weeks apart, which led to vaccine exposure during pregnancy and extra dose administered. The reporter consented to follow up.
Every night since the 9th i keep having restless leg syndrome from somewhere between12-2am. I have to get up and walk around and get an ice pack to help it go away.  It was my first covid vaccine dose and i thought maybe it was the seroquel but i didn't have any issues with it before and already been taking it for a while. THEN i realized the vaccine was the only thing i did different so that has to be it since it started the very next day. I want it to go away, i can't sleep as it is