chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; 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 52-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid as treatment of COVID-19 from 15Oct2023 to 20Oct2023. Patient had other medications Estradiol patch (0.025) and Progesterone in 2 weeks of Paxlovid treatment. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Tingling in extremities; redness all over face, neck, etc... Client complained of tightness in throat. The symptoms developed over 3 hours. Patient was treated at ER for allergic reaction to flu shot.
5NOV93 pt's skin color turned red & pt stopped breathing for 30 seconds; had been well prior to this; Pt was taken to hosp & hospitalized overnoc  in a croup tent; dx asthma;
Information has been received from a consumer, who read an article concerning a male who in November 2004, was vaccinated with a single dose of MMR II. The consumer reported that in the article it mentioned that in approximately November 2004, "about 10 days after receiving the vaccine", the patient had seizures and at one point the patient's father thought that the patient was life less and was taken to the hospital (name, address and phone number unspecified). At the hospital, the patient had several seizures and had a Computed Tomography Scan done which showed the patient had degenerative brain damage from the seizures. At the time of the report, the patient's outcome was unknown. No further information is available.
Chills, nausea, and fatigue beginning within approximately 12 to 18 hours of vaccination and lasting about 36 to 48 hours after vaccination. Rash appeared on left arm (that was vaccinated) within 4 days of vaccination. Rash subsequently appeared on right arm, abdomen, and legs. Rash has improved with use of hydrocortisone cream.
I received my first dose of the Moderna vaccine on 1/17/21.   I had almost no reaction other than a slight soreness.  Now, today, 8 days later,  I have itching, swelling, redness at the injection sight.    Almost a rash- like redness.
Information has been received from a consumer for the Pregnancy Registry for GARDASIL concerning her 18 year old daughter who on 24-MAR-2008 was vaccinated with her first dose of GARDASIL (lot# not reported) and was pregnant.  The patient's estimated LMP was 09-FEB-2008.  The pregnancy was confirmed with a pregnancy test.  The patient sought unspecified medical attention and the physician's information was not available.  Follow-up information has been received from a Certified Medical Assistant, who reported that their office did not have any records of the patient receiving GARDASIL injections.  In follow-up, the Certified Medical Assistant indicated that on 04-NOV-2008 the patient delivered a normal, healthy male baby weighing 8 pounds, 11 ounces via vaginal delivery.  The patient had no complications in her pregnancy, just some "muscle spasms".  There was no indication that there were any problems with the baby either.  The mother returned for her postpartum exam on 19-DEC-2008 and had a full normal exam and had an intrauterine device (IUD) inserted for contraception.  The Certified Medical Assistant contacted during telephone follow-up could not supply the following information:  lot number, healthcare provider name and contact information.  No further information is available at this time.  No further information is available at this time.
Covid vaccine soreness and muscle ache at injection site; Covid vaccine soreness and muscle ache at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, 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), MYALGIA (non-serious), outcome "unknown" and all described as "Covid vaccine soreness and muscle ache at injection site".  Additional Information: No underlying conditions. No allergies. No previous COVID-19. Events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4/9 vaccination I went to grocery store. While in the store, I was getting nauseous. I got home and went straight to the bathroom; soft stool, very nauseous came in waves. By evening felt like I needed to throw up. Kept having urge to go to bathroom Sat. I stayed most of the day in bathroom. I was drained.  Sun. My legs were cramping from going to bathroom so much. I couldn't eat. I was lightheaded, HR was fast. I decided to go the ER. The blood work was normal, BP was little high but fine, EKG was normal. Potassium was low. Prescribed; Zofran and Bento.  *Still presently nauseous, still soft stool. The nauseous  is overwhelming, I haven't vomited for 2 days.
5 minutes following the shot: had turned pale sweaty and vomited once. Epinephrine 0.22cc given.
Developed a rash typical of zoster over the upper division of the 5th cranial nerve.  The eye was spared.  Patient got immediate relief with first dose of acyclovir.
Information has been received from a physician concerning an approximately 10 year old female who was vaccinated with Varivax, and subsequently experienced a moderate breakthrough of over 40 lesions of a varicella type rash. It is unknown if medical attention was sought. The final outcome was not reported. There was no product quality complaint. Additional information has been requested.
H1N1 inj 1-8-10 - no reaction. H1N1 inj 2-5-10 - onset 2-9-10 - lt deltoid erythematous, pustules, itchy edematous with yellow drainage. Fever 101.2 orally. Dx: Lt arm cellulitis and acute pneumonia. currently on AUGMENTIN
Pain in both eyes; Swelling in both eyes; Redness in both eyes; Blurred vision in both eyes; Pain at injection site; A spontaneous case report was received from a consumer on 20-01-2021 04:01pm which refers to a 75yrs female gender  The patients had a past medical history of Asthma and osteopenia and allergies include shell fish, soy, latex and sulfa .Relevant concominant medications were reported.  On  13-01-2021,  the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination.   On 14-01-2021 the patient developed Vaccination site pain, also developed pain, swelling, Redness and blurred vision in both eyes. Relevant laboratory results were not included .  Ophthalmologist advised the caller to not take second vaccine.   The company believes the following facts are also relevant in this case: vaccination site pain The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship. At this time of Report , the outcome of the event was recovered
INCORRECT PRODUCT STORAGE; ADMINISTRATION OF TEMPERATURE EXCURSION AFFECTED VACCINE; This spontaneous report received from a pharmacist concerned a 20 year old male. Initial information was processed along with the additional information received on 10-SEP-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 21-SEP-2021) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, the patient experienced administration of temperature excursion affected vaccine. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of temperature excursion affected vaccine and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210913164, 20210915731, 20210916129, 20210916520, 20210915852, 20210916228, 20210916498, 20210916415, 20210916455, 20210916401, 20210916811, 20210916768, 20210916849, 20210917226, 20210916312, 20210916465, 20210916584, 20210915661, 20210916910, 20210916300, 20210915719, 20210916959, 20210916808, 20210917160, 20210916965, 20210916697, 20210915646, 20210915623, 20210915748, 20210917074, 20210917500, 20210917515, 20210916907, 20210917163, 20210916553, 20210916658 and 20210918425.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious
Patient had 2 bruises on right arm. States did not fall or get hurt. Believes vaccine related
This report was received from manufacturer and was assigned manufacturer control number (HQ6283021JAN2003. On 3/29/02, a male pt was vaccinated with a dose of MMR II. It was also noted that the pt was vaccinated with a dose of varicella virus vaccine live on 1/11/02. Subsequently, the pt developed symptoms of speech, language, and social delay. Symptoms of speech, language, and social delay were considered to be other important medical events (OMIC). This was originally reported by a physician. Additional info has been requested.  Reported on 03/26/2003: "Follow-up information received from a physician indicated that a 13 month old male received a dose of varicella virus vaccine live (Lot # 639130/0500L) on 01/11/2002.  The child was delivered vaginally at 36.5 weeks gestation following an uncomplicated pregnancy.  The mother of the child had a history of Choroid Plexus Cyst.  The infant weighted 6 lbx. 4 oz., apgars were 7 and 8, he was breast-fed.  The child's past medical history was not significant for many childhood illnesses.  The child had no history of allergies, however testing was currently being conducted.  The child did have an elevated Antigliadin IgG antibody test result.  On 02/08/2002, the child was evaluated which resulted in below normal levels for social development, and the results of speech development in the 16th percentile.  The child was noted to have some "shaking and jerking of the head" on 02/12/2002.  The speech delay and social delay were first noted on 02/15/2002.  Symptoms of speech, language, and social delay were considered to be other important medical events.  Additional information has been requested.  This report was previously sent to PLA V205C.
Red rash on both inner arms. Reddened area noted at injection site with 50 cent size knot. Area warm to touch. Referred to primary care.
Pain in neck; Pain in skull; mild vertigo; Prolonged Headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (mild vertigo), NECK PAIN (Pain in neck), HEADACHE (Prolonged Headaches) and HEADACHE (Pain in skull) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced VERTIGO (mild vertigo) and HEADACHE (Prolonged Headaches). On an unknown date, the patient experienced NECK PAIN (Pain in neck) and HEADACHE (Pain in skull). At the time of the report, VERTIGO (mild vertigo), NECK PAIN (Pain in neck), HEADACHE (Prolonged Headaches) and HEADACHE (Pain in skull) outcome was unknown.            No concomitant medications reported. The patient took Aspirin, also had taken up to 6400 mg taking Ibuprofen over a series of days. Patient stated that he took 800 mg of Ibuprofen every 12 hours, also took pain killers .   This case was linked to MOD-2021-083632 (Patient Link).
arm swollen; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demographics who experienced arm swollen (peripheral swelling), while he/she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious arm swollen (peripheral swelling) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other lab data was not reported.  Final diagnosis was arm swollen (peripheral swelling).   It was not reported if the patient received a corrective treatment.  Outcome of event was unknown.
Child tested for Pertussis on 6/24/2010 and State Lab reported as PCR positive.  Culture is still pending.
Information was received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. It was reported that improperly stored (Oka/Merck) VARIVAX (dose, frequency, route, lot# and expiry were not reported) doses had been administered to unspecified patients for prophylaxis on unspecified dates. Number of doses administered were unspecified. This is one of 2 reports received from the same reporter. Additional information has been requested.
C/o nausea and vomiting (2x), soreness at injection site, and arthralgia.
local reaction: redness and possible warmth at injection site immunization administration +1 day: monitoring for spread of redness and will follow-up with pharmacy/PCP accordingly
swelling @ inj site 10 min p/vax;seen by md;no other problems at home all evening;
Achy; Tired; Cough; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/Batch number: not reported), via intramuscularly on the left arm on 29Mar2021 04:15 pm at single dose for COVID-19 immunization. Medical history included diverticulitis. The patient was allergic to scopolamine. The patient received other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. There was no COVID prior vaccination. Previously on an unknown date, patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). Since the vaccination, patient had not been tested for COVID-19. On 29Mar2021, patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and on 30Mar2021 at 12 am, the patient reported that she was achy, tired and coughing. The patient did not receive any treatment for the events. The outcome of the events was resolving.  No follow-up attempts are needed. No further information is expected.
Patches of red raised areas with small papules and early vesicles on Lt anterior thigh at site of KINRINX and MMR-V vaccines.
Headache, low grade fever, chills, vomiting, diarrhea.  Started headache 3 hours after shot fever and chills 10 hours after shot then other issues started at 8pm-midnight.
I fell and must have passed out; I fell and must have passed out; painful, large red swollen arm at injection site (size of half a baseball in height and about 6 inches down my arm); painful, large red swollen arm at injection site (size of half a baseball in height and about 6 inches down my arm); Body pain; severe headache; fever (100/sweating); chills (shaking with temp drop- 97.2; normal 97.6); vomiting; loose stools; Lost 6 lbs; abrasion on her right side forehead; dizzy; weak; fever (100/sweating); nausea; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation, at 68 years old. Medical history included Metastatic breast cancer, thyroid, glaucoma, osteo  arthritis, neuropathy, sulfa allergy, Fish/shellfish allergy, penicillin allergy, MS (Multiple sclerosis), and Phenothiazines allergy. No other vaccines in four weeks were received. The patient is not pregnant at the time of vaccination. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included amlodipine, levothyroxine sodium (SYNTHROID), gabapentin, timolol, and cyanocobalamin (B12), therapy dates and indications unspecified, in two weeks. The patient previously took Cytoxan, cipro, Demerol and experienced allergies. On 28Jan2021 20:00 (also reported as about 8 hours), the patient experienced body pain; severe headache; fever (100/sweating); chills (shaking with temp drop- 97.2; normal 97.6); Nausea; vomiting; loose stools; painful, large red swollen arm at injection site (investigation: size of half a baseball in height and about 6 inches down her arm); dizzy; weak; and she fell and must have passed out. Woke up on floor with abrasion on her right-side forehead. The patient also reported she lost 6 lbs. The events lasted from Thursday evening to Sunday morning. Treatment for the adverse events included BENARDRYL. Outcome of the events was recovered on 29Jan2021. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9267) via an unspecified route of administration (right arm) on 18Feb2021 09:30 for COVID-19 immunisation.  Information on the lot/batch number has been requested.
This spontaneous report was received from a pharmacist referring to a 72 year old female patient. The patient's medical history included hypertension. Concurrent condition was not provided. On 09-DEC-2015, the patient was vaccinated with ZOSTAVAX (lot # L002422, expiration date 23-APR-2016) subcutaneous (dose was not provided). Concomitant medications were not reported. In December 2015, the patient experienced injection site erythema, injection site swelling and injection site warmth. On 14-DEC-2015, the patient went back to the pharmacy for medical attention because the symptoms were still present. The pharmacist also stated that there was no rash present. The patient did not receive any treatment for the adverse events. The outcome of injection site erythema, injection site swelling and injection site warmth was reported as not recovered. The primary reporter did not provide the causality between ZOSTAVAX and injection site erythema, injection site swelling and injection site warmth. Additional information has been requested.
reconstituted the dry lyophilized component of the Hib vaccine with a sterile diluent and not the diluent provided in the packaging, no AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown demographic patient who was vaccinated with a dose of DIPHTHERIA/TETANUS/2 AC PERTUSSIS/IPV (VERO)/HIB (PRP/T) VACCINE [PENTAXIM] reconstituted with a sterile diluent instead of diluent provided, lot number not reported via unknown route in an unknown administration site on an unknown date.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to inappropriate reconstitution technique. It was reported that the they reconstituted the dry lyophilized component of the Hib vaccine vial in the Pentacel packaging with a sterile diluent and not the diluent provided in the packaging.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Swelling soreness at upper arm injection site. 6-9 am swelling from shoulder to elbow with decrease use of RUE. Ice, MOTRIN. Appt 6-9 localized reaction for warmth & redness. 6-10- worse swelling, redness, hot ER Dx cellulitis given KEFLEX.
Seizure-like movement and syncope with 1 minute of injection. Disorientation x 5 minutes.
This spontaneous report has been received from a registered nurse concerning a 1 year old patient of unknown gender. The patient's concurrent conditions and pertinent medical history were not reported. On 29-JUN-2015, the patient was vaccinated in error with a dose of GARDASI vial wet sd 120, intramuscular injection, (lot #, exp. date, strength and dose not provided). There was no known adverse effects. Additional information has been requested.
Pt. lost consciousness within seconds of vaccine administration. Pt experienced blurry vision then went unresponsive for 5 seconds. Post sternum stimulation patient regained consciousness. Pt expressed feelings of anxiety post vasovagal syncope but heart rate and blood pressure resumed to normal rage within 30 minutes of vaccination.
Bloody nose; Blood in urine (slight tinged); This is a spontaneous report from a contactable pharmacist. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, first dose via intramuscular in left arm on 17Dec2020 10:30 at single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medication included atorvastatin (LIPITOR) and estradiol (ESTROGEN). On 18Dec2020 07:00 AM, the patient experienced bloody nose and blood in urine this morning (slight tinge) and has not exhibited any other side effects at the time of this report. Noted in afternoon on 18Dec2020, the patient urinated and no blood present. It was unknown if patient received treatment for the events. It was unknown if patient had COVID and tested COVID prior vaccination. The patient had no known allergies. The case was reported as non serious as it did not resulted in death, not life threatening, no prolonged hospitalization, not disabling/Incapacitating and no congenital anomaly/birth defect. The outcome of the events was unknown.
Child's temperature went up to 105.8, outside of cheeks on face, blistered, child given alcohol bath, Tylenol/Motrin combined, fever dropped to 102. After fever went down, child slept. He awoke with vomiting and diarrhea. Temp stayed at 102 at this time. Next AM at 05:00, child taken to hospital per ambulance. Given IV tx. DX: Shot allergy. Also, R leg turned red at site and was hard. Clear pus lesion on R leg.