chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick for two weeks; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 01-Dec-2020.  This case involves a patient of unknown demographics who was sick for two weeks (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.   On an unknown date in 2017 reported as 3 years ago, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick for two weeks (illness), (non-serious event) (unknown latency) following the next day of administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Became lethargic, no appetite, fever of 103.6. Fever continued for 30 hours. Highest recorded: 104.5.
Notes of the checks/events with resident:  18:36 2/2/21  Resident had no complaint of pain, swelling, redness or warmth to vaccine site.  No signs and symptoms of fever, chills, tiredness or headache. T 97.2 02:50 2/3/2021  Resident received 2nd COVID vaccine.  No complaint of pain, swelling, redness or warmth to vaccine site.  No signs and symptoms of fever, chills, tiredness or headache. T 98.1 07:15 2/3/2021  Resident was observed not breathing.  911 was contacted along with the doctor.  Resident was confirmed having passed away.
I began to experience leg pain in my left leg. I then received care 3 weeks later and have a blood clot in my leg and multiple pulmonary emboli.
Moderna vaccine administered 4/29/23 was incorrect COVID vaccine. Patient should of received Moderna (dark blue top/gray label). T/C with mom and she is aware that the recommendation is to have additional dose administered. Mom wanting to think about giving additional dose and will call back if interested. Per mom no side effects experienced. Vaccination administered by LPN. VAERS form completed by CMA.
L arm at injection site tender eve of injection and progressively became worse. On 3/1/06, an area of induration, redness and warmth at site measured 3"  circ with axillary lymph node involvement and much pain. Was sent to MD and was dx with cellulitis. Tx - 500mg keflex q12h for 12 days and off work for 2 days using ice packs to area prn. On 3/3/06, redness has abated as well as induration and most of the pain, but a residual lump is felt. On 3/6/06, the arm is fine - no additional complications.
one day after receiving the updated COVID booster (SpikeVax, aka Moderna), I experienced fever, change in color on face (red/purplish color) swelling of the face, bad headache, sleepiness, as well as lymph node swelling.  While I had lymph node swelling from ALL Moderna COVID shots (this was my 5th or 6th, I've lost count), I've never had the other reactions, so think this should be reported (fever, swelling/change of color in face).  Took lots of Benadryl for my face, and it is much better today (02Nov20230
12-18 hours after injection-Severe muscle pain in arm followed by fever, extreme chills, all over muscle aches, joint pain.  Right hand was warm to touch.  Fever, chills and muscle aches eased with Tylenol, but returned when Tylenol wore off.  36 hours after injection left with headache and nausea.  Sore muscle at injection site persisting 4 days post but lessening soreness.
He developed in the same area smaller swelling around the time he received the first dose; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0151, Expiration date was not reported), via an unspecified route of administration in arm left on 06Apr2021 (at the age of 56-years-old) as a dose 1, single for COVID-19 immunization. The family medical history relevant to AE(s) was reported as none. The patient's medical history (including any illness at time of vaccination) was reported as none. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. It was reported that, the patient had received the first dose on 06Apr2021 administered in the left arm. Stated that, on an unspecified date in 2021, he developed in the same area smaller swelling around the time he received the first dose. It would come and go. Stated that, he was unsure whether that was corelated or not. The relevant tests were reported as none. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Experienced wide spread rash and sought medical care initially on 4/1/21, : Diagnosed via biopsy on 4/16/21 as pityriasis rosea, possibly drug induced Diagnosed with Bell's Palsy 7/26/21
Patient's husband stopped by the pharmacy to report that patient is having hard time lifting up her arm in which she received the vaccination since vaccination. He further stated that she is being seen by a physiotherapist and it's been almost a month.
initial fever for 4 days, fatigue, malaise, nausea, vomiting, rash (also reports had rash/ hives with 1st dose after 24 hours but failed to report at time of 2nd dose), extreme headaches daily for past 60 days.  Also reports had Bell's palsy (history of Bell's palsy with surgeries:  brain surgery and back surgery).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Aug2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Patient did not have known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 11Feb2023 to 16Feb2023 for Treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe rigors, fever to 100.2, went to ER and required oxygen briefly for desaturation and shortness of breath.
Extremely painful nerve pain.  It may be Guellain-Barre Syndrome.
This spontaneous report as received from a registered nurse refers to a adult male patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB injection (dose, lot#, expiration date and route of administration were not reported). On an unknown date six weeks after the patient was vaccinated with the first dose of RECOMBIVAX HB, he received his second dose. No adverse effects were reported. Additional information has been requested.
Patient presents with right eye pain after receiving  First Pfizer COVID vaccine dose   Patient stated got first vaccine,  went out into the waiting room for observation,  sat down for a few minutes, then  right eye started to throb.   Patient brought into exam  room for assessment by  on site provider Denies visual disturbance, headache, photophobia, ill contacts, or COVID symptoms    Ate breakfast and plans to eat lunch after appointment today   Review of Systems  Constitutional: Negative for activity change and fatigue.  HENT: Negative for congestion.   Eyes: Positive for pain (right). Negative for photophobia, discharge, redness, itching and visual disturbance.  Respiratory: Negative for cough and shortness of breath.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting.  Skin: Negative for rash.  Psychiatric/Behavioral: The patient is not nervous/anxious.   All other systems reviewed and are negative.   Right eye pain Symptoms resolved while in exam room. Call if symptoms recur. Reviewed symptomatic treatment and patient and/or guardian verbalized understanding
Primarily pruritic rash. Started on the left arm near injection site. Exacerbated by day of onset of rash after spending time in a hot tub. Urticaria rash present prior to exposure to warm water. Urticaria at first even though 4 days after vaccination. Then started on right arm. Later spread to trunk, upper legs (anterior & posteriorly), then neck, scalp line (face spared, as were palms and soles of feet). Rash was distinct maculopapules, no pustules, no vesicles, no petechiae; + blanching. No other systemic symptoms, no other physical exam findings, + dermatographia. Started on medrol dose pack on 1/30/2021. Seen in ED on 2/1/2021 and hospitalized until 2/6. Seen in ED again 2/7/2021. Treatment History: 2/1 - 2/6/2021 Ceftriaxone 1 gm IVP on 2/1 Famotidine 20 mg IVP Q12 hrs Benadryl 50 mg IVP Q6 hrs prn Hydroxyzine oral prn Ativan oral prn Methylprednisolone 40 mg Q6 hrs x 4 doses, then 40 mg Q12 hrs x 3 days Discharged pn Prednisone 40 mg BID x 4 days, 30 mg BID x 4 days, 20 mg BID x 4 days, 10 mg BID x 4 days, 10 mg daily x 4 days  Also given betamethasone dipropionate augmented 0.05% topically BID prn 2/7  Changed to zyrtec from hydroxyzine
63 yr male reporting after event of not taking his RX'd anti anxiety medications, had elevated b/p and dizzyness. Self resolved to tolerated levels after observation, hydration, juice given and ambulation with Stand by assist by EMS. Cleared and declined ER visit.
Pregnanacy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnanacy) in a 38-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth). Concurrent medical conditions included Hypothyroidism since 2016. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 09-Jul-2020 and the estimated date of delivery was 15-Apr-2021. On 28-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnanacy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 28-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnanacy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: positive (Positive) Positive. On an unknown date, Prenatal screening test: normal (normal) normal.     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.   Treatment medication was not reported. Good prenatal checkup was done.  Previous pregnancy included live full-term birth as outcome on 09-Nov-2017.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
p/vax pt c/o SOB, throat swelling, increase resp rate, decrease pulse oximetry to 90% RA;pt treated w/epi, DPH & Solumedrol w/complete resolution of sx;adm to hosp x 3hr for observation & did well;
Patient reported arm discomfort, numbness and tingling the same day as vaccination occurred. Discomfort is ongoing and Pain Clinic provider indicated the following in -e-consult note: Therefore the symptoms are more likely c/w small cutaneous nerve damage from either needle/hydrostatic pressure damage during vaccination despite normal EMG as the symptoms match temporally and anatomically with injection time and site and small fiber damage is often not seen on EMG's. Rule of thumb for small fiber dmg is 90% better in 90 days and 99% better in a year. As long as the condition is slowly improving I would not recommend further modalities such as nerve blocks or even cutaneous infiltration and suggest continued watchful waiting and/ or symptomatic care with reassurance that this condition should slowly improve. If condition worsens, consider neuro econsult/consult and then can consider local infiltration/nerve blocks in addition to pharm and MH related pain control techniques. Please let me know if you have questions.
Pt recv vax on 4/7/99; on 4/8/99 swollen/ red vax site
Left arm has been extremely sore for about 1 week now. Hurts to lift arm/put shirt on Taking advil, iceing, still very sore MD stated to continue treat as is
Patient developed positive covid (confirmed by symptoms: Sore throat, headache, overall weakness); Patient developed positive covid (confirmed by symptoms: Sore throat, headache, overall weakness); booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 61 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 09Nov2021 (Lot number: FH8028) at the age of 61 years as dose 3, (booster) single, intramuscular, administration date 04Feb2021 08:15 (Lot number: EL0140) as dose 1, single and administration date 25Feb2021 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cochlea implant" (unspecified if ongoing). Concomitant medication(s) included: MOTRIN [IBUPROFEN]. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: IMMUNISATION (medically significant) with onset 09Nov2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant) with onset 06Jan2022, outcome "not recovered", COVID-19 (medically significant) with onset 06Jan2022, outcome "not recovered" and all described as "Patient developed positive covid (confirmed by symptoms: Sore throat, headache, overall weakness)". Clinical course details: Patient developed positive Covid-19 (2 home tests confirmed by symptoms. Had a PCR test 07Jan2022. Sore throat, headache, overall weakness for first 2 days. The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (07Jan2022) unknown results, notes: Covid test type post vaccination: Nasal Swab; sars-cov-2 test: (06Jan2022) positive, notes: home tests; (06Jan2022) positive, notes: home tests. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a 17 year old female with no pertinent medical history and no history of drug reactions or allergies who on 30-JUL-2007 was vaccinated with the first dose of GARDISIL (lot#: 657621/0387U) 0.5ml IM into the right arm. There was no concomitant medication. Subsequently the patient experienced severe vomiting, headache and abdominal pain. Subsequently, the patient recovered from severe vomiting, headache and abdominal pain. The patient sought medical attention with a physician office visit. Additional information has been requested.
No additional AE/PQC.; Caller reported AE on behalf of a patient who was administered improperly stored PROQUAD.; This spontaneous report was received from a nurse referring to male patient. The patient's pertinent medical history, concomitant therapies or known drug allergies or reactions were not reported.  On 19-SEP-2023, the patient was vaccinated with an improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rHA)) (PROQUAD) injection 0.2 mL (lot number: X014622 was verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), expiration date was provided and upon internal validation was confirmed to be 18-NOV-2024) administered as prophylaxis (strength, route of administration, and frequency were not reported) (product storage error).  The administered doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) experienced a temperature excursion of -14 degrees Celsius up to -10 degrees Celsius for 4 hours 15 minutes and -8.33 degrees Celsius or -10 degrees Celsius up to 8 degrees Celsius for 7 hours and 45 minutes; with a total duration of 12 hours. No adverse events were reported.
a lot of that (injection) arm is red; vaccination site pain; headache; redness at injection site; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ERYTHEMA (a lot of that (injection) arm is red), VACCINATION SITE PAIN (vaccination site pain), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006m20a or 066m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE PAIN (vaccination site pain), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness at injection site). On 24-Feb-2021, the patient experienced ERYTHEMA (a lot of that (injection) arm is red). On 14-Feb-2021, OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE PAIN (vaccination site pain), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness at injection site) had resolved. At the time of the report, ERYTHEMA (a lot of that (injection) arm is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Rapidly increasing erythema at vaccination site without pain or itching.  I saw him on 5/24/2010, and nearly the entire upper arm was involved, circumferentially, with erythema and warmth, without any area of fluctuance, although there was evidence of deeper redness with a few petechiae around the immediate vaccination site.
This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (He had Covid) and DRUG INEFFECTIVE (Lack of drug effect) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced COVID-19 (He had Covid) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (He had Covid) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had mild symptoms also. No concomitant medication were provided. No treatment details were provided. Company comment: This case of drug ineffective concerns a 63-year-old male patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19 that occurred approximately 5 months after the 2nd dose of the mRNA-1273. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case of drug ineffective concerns a 63-year-old male patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19 that occurred approximately 5 months after the 2nd dose of the mRNA-1273. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient notified me beginning of April 2012 and stated she had had a "sore" at the injection site ever since receiving injection. Upon showing me it appears to be a scaly scab.  Patient says it gets crusty then gets caught on clothing and will fall off --but then keeps coming back.  She reports it is sore when touched.  She says it never gets any better but not any worse either.  She has not sought any medical attention.  I advised her to have her primary physician take a look at it.  As of yet she has not been in to see MD and reported any other updates to me.
Mother reports child developed redness and swelling and itching, "arm is hard" to left deltoid approximately 12 hours after vaccination. Applied cold compress, treated with oral Motrin and Benadryl. No fever; Symptoms resolved by 8/18/08
Not sure if exact time, but hives developed all over upper left arm where injection occurred. Administered Benadryl, and hives continued to get worse.  Is now Sunday night, still has hives after multiple Benadryl doses, and NP suggested we submit report.  We are supposed to follow up with his ped and possibly a derm tomorrow or Tuesday.I have photos of his arm on Sat and Sun.
No additional AE/PQC; PROQUAD administered post temperature excursion; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions and allergies were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number: S031881, expiration date: 07-APR-2021, route of administration was not provided) 0.5 ml diluted in properly stored sterile diluent. The vaccine was stored in temperatures between -9 and 8 degrees Celsius (-2.8 degree Celsius) for 5 hours and 2 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported.
I just felt rally tired and flu like symptoms i did not take my temperature so I do not know if I had  a fever.  Store gave me a COVID-19 test and I took it and it was positive. My doctor gave me the Covid medicine and I felt better three days later I tested negative.
Patient got the vaccine and went out with her mother. After about 5-10 min, a person standing by knocked on the door. When i went out, mother said she is feeling dizzy. We make her sit on a 2 seater chair adjacent to her mother, and lifted her leg up and placed on a nearby chair.  Made her smell the alcohol from the alcohol swab with the hope that she will feel better. She was responding and breathing normally.  Mother gave us permission to call 911 and EMS arrived around 3.15pm. They checked her out and all her vitals were fine. Patient decided to NOT go to the hospital as mother thought she was back to normal.