chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experiencing headache; Feels like he is tired/ He is feeling tired; This is a spontaneous report from a contactable consumer or other non hcp (mother) reporting for a patient (son).  A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on 09Oct2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccination included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on unknown date as dose 1, single for covid-19 immunization. On an unspecified date in 2021, the patient reported experiencing headache, feels like he is tired/ he is feeling tired. Reporter stated her son had the second dose of vaccine yesterday but he was complaining he had a headache and he felt like he was tired. Reporter asked what kind of medicine that she needed to give. Her concern was could she give him a medicine just like over the counter medicine like Tylenol or Advil or Motrin or pain reliever. Reporter further stated she was going to ask somebody and she was not going to go to the doctor because that's only the side effect, it was not the fever, feeling right now. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day 1 Nausea  Dehydrated Headache Fatigue Felt heavy, freeze/stabbing pitch fork headache all day  Day 2 Headache Fatigue Arm pit itch Teeth pain and clinching (neurological uncontrollable) vertigo/dizzy  Stiff neck sore muscles and joints   Day 3 Fatigue Headache  Day 4 Fatigue Ankles got really swollen Out of breath on just a walk Headache Shooting Pain in legs and feet Pain at past mohs surgery site  Day 6 Agitated  Nauseous  Dizzy Headache Bells palsy like symptoms right side of my face
Nausea, body and joint aches (all over), chills, sweating, felt feverish, most symptoms subsided within 48 hours. Does continue to have slight body aches.
Freezing cold, could not get warm. Turned heat up to 70, multiple sweatshirts, blankets & electric blanket on high. Lasted through next day late afternoon (2:00 pm) when I started to warm up. No fever, no sickness, just frigid cold.  Temp taken in ear was 95.7 right, 96.3 in left.
Patient developed symptoms of optic neuritis and acute disseminated encephalomyelitis within a few days of immunizations. Her neurologist at the clinic expects a complete recovery may be possible. Discharge summary states neck pain. msv
This spontaneous report has been received from a nurse practitioner concerning a 25 year old female patient. The patient did not have pertinent medical history and any drug reactions / allergies. Concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with GARDASIL, intramuscular (lot# and expiration date unknown) for prevent against human papillomavirus (HPV). The patient had been received three doses of GARDASIL (each dose on a separate unspecified date). In approximately 2017 (reported as "recently"), the patient developed abnormal menstrual periods and weight gain. She had been trying to get pregnant for the "past year" but was unsuccessful. On 02-AUG-2017, the patient was seen in nurse practitioner's office due to the symptoms reported above and a Papanicolaou (Pap) smear was performed. The Pap smear result showed negative however was positive for 13 human papilloma virus (HPV) types. No treatment was given for the events. Outcome of the events was not recovered. This is one of two reports received from the same source. Sender's Comments: US-009507513-1708USA012191.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extremely dizzy similar or worse than Vertigo, dizziness is worsening by the hour) and CONDITION AGGRAVATED (Extremely dizzy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for an unknown indication. Concurrent medical conditions included Diabetes. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced DIZZINESS (extremely dizzy similar or worse than Vertigo, dizziness is worsening by the hour) and CONDITION AGGRAVATED (Extremely dizzy). On 22-Feb-2021, DIZZINESS (extremely dizzy similar or worse than Vertigo, dizziness is worsening by the hour) and CONDITION AGGRAVATED (Extremely dizzy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications was reported. No treatment details was specified. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26 Apr 2021 included: reporter contact details, updated the outcome of the event (dizziness) and patient's medical history.
No additional AE; One patient was inadvertently administered a expired dose of MMR II; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On 20-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella virus vaccine, live (M-M-R II) 1 time dose, for prophylaxis (lot number S022754 has been determined a valid lot number for measles, mumps, and rubella virus vaccine, live; expiration date reported and establish as 22-JUL-2021) (strength, route of administration and anatomical location were not provided).         No adverse event reported.
soreness at injection site; has not yet received dose 2; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cancer. Previously administered products included Shingrix (1st dose received a year before reporting). Concurrent medical conditions included diabetes.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. Consumer did not have vaccine information for this adverse event.   Follow up information received from physician on 24th July 2020: The patient's demographic details were updated. The patient experienced soreness at injection site in less than 2 months after receiving 2nd dose of vaccine. The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. This case was linked with US2020AMR145722, reported for same patient for 1st dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR145722:same reporter
crying unless held for several days following inject; 6 days p/inject had a sx; neuro consult pending;
Patient report that she had a rash and sharp pain in her left arm... injection site is warm to the touch and red...
Positive COVID Disease after vaccination/just finished having COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Positive COVID Disease after vaccination/just finished having COVID) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive COVID Disease after vaccination/just finished having COVID). At the time of the report, COVID-19 (Positive COVID Disease after vaccination/just finished having COVID) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   Reportedly, patient was going to be 65 years old in September.  CC:This spontaneous case concerns a 64-year-old patient of unknown gender with no medical history experienced the Unexpected AESI event Covid-19 in association with mRNA-1273. The event occurred on an unknown date after the second dose of mRNA-1273.  Details of treatment, outcome were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 64-year-old patient of unknown gender with no medical history experienced the Unexpected AESI event Covid-19 in association with mRNA-1273. The event occurred on an unknown date after the second dose of mRNA-1273.  Details of treatment, outcome were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error, on 5/7/2021 by contractor. Note indicated he received his first vaccine on 3/27/2021(he was 16 at initial vaccine)  Troubleshooting: Original vaccinator did not validate age; second vaccinator did not report immediately but left notes in the data system. Unreported as error, found in data mining. He is eligible for the second vaccine per standing orders.
High fever up to 103.7 on 11/2/11. Treated with 400 mg ROCEPHIN IM and TYLENOL/MOTRIN.
6 months after vaccine, at a routine physical, patient was found to have new low levels of TSH.
Case number PHEH2013US026019 is an initial spontaneous report received from a pharmacist on 13 Dec 2013. This report refers to a 65-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml dose of FLUVIRIN (batch number: 13464P) intramuscularly on 13 Dec 2013. This FLUVIRIN prefilled syringe reached 48 F on 03 Dec 2013 at 6 pm, at 08:55 on 04 Dec 2013 it was at 46 F. This first excursion duration was 15 hours. Same vaccine then reached 47 F on 04 Dec 2013 at 5 pm. This second excursion duration was 16 hours. Reporter stated that the vaccine has been in range since that excursion. Vaccine was administered to patient after excursions. No adverse reactions were reported. Seriousness, outcome and causality of the event were unknown.
Large, hard, rashy welts came up on my left leg. For 5 days they continued to appear up and down the left leg only. They were very itchy. After a week they stopped appearing.  Today (day 13) I only have slight scars left from the "hives"?
Shoulder/upper arm pain distal to the vaccination site: itching/aching pain (8/10 at worst, 2/10 baseline, radiating, worse with movement/agitation)
PMH Unknown, Medications Unknown, Allergies: NKA 30 min post 1st dose vaccination and after leaving the vaccination site, pt had flushing/sweating, vomiting, dizziness.  Pt reported reaction post vaccination and reaction to 2nd dose vaccination.
R thigh cellulitis with grouped vesicles. Cellulitis from injection to area to knee and was almost completely circumferential. Transferred to the ER for further treatment.
lethargic for a couple days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57 year-old male patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing). The patient's concomitant medications were not reported. The following information was reported: LETHARGY (non-serious), outcome "recovered", described as "lethargic for a couple days".  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 5 minutes after receiving MMR #2, Dtap #5 in right arm and Varicella #2 and IPV #4 in left arm patient developed hives with erythema on right deltoid.  Negative respiratory difficulties.  Patient given 8mL of Benadryl and Drapred 1 tsp PO BID x 3 days.  Patient was also referred to allergist.
Left side lower jaw/chin burning, tingling pain Left side injection site soreness, redness extending 2" around injection site, boggy swelling Left side axilla large, swollen, painful lump that does not move with skin Right side maxilla between nose and cheek twitching, burning pain Right upper eyelid twitching, feels heavy Fever 102?F, chills Diaphoresis, night sweats Nausea Neck bilateral stabbing, shooting pain into ear Muscle aches Joint pain in thoracic spine, cervical spine, hands and fingers, feet and toes Headache Midline chest pain radiating up into neck/throat Rebound tenderness in spleen area LUQ of abdomen
This case was reported by a physician via sales representative and described the occurrence of injection site infection in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On 15 September 2010 the subject received a dose of FLUARIX (.5 ml, unknown, unknown arm). On 16 September 2010, 1 day after vaccination with FLUARIX, the subject experienced injection site infection. The subject received FLUARIX on 15 September 2010 and returned to the office the next day due to an infection in their arm at injection. The subject may have required medical treatment. At the time of the report no further information was available. At the time of reporting the outcome of the injection site infection was unspecified. The physician reported two subjects were given FLUARIX and returned to the office the next day due to an infection in their arm at injection. Please see case A0882998 for the second subject. Follow-up information was received on 05 November 2010 via physician. The injection site infection with onset date of 16 September 2010 was described as red, hard and hot; the subject was given Doxy 100 mg twice daily. On 17 September 2010 the subject was diagnosed with cellulitis and abscess. On 21 September 2010 the event were noted to be resolving. At the time of this report the injection site infection, cellulitis and abscess resolved. No biopsy was performed. The patient had not experienced any adverse events following previous vaccinations.
I developed lumps in my left breast.; I have had sore to painful breasts since that 1 month mark.; My nipples are also sore to painful at times.; I had a mammogram which showed abnormal tissue in the right breast.; It is very uncomfortable and distracting. It affects my sleep as well.; It affects my sleep as well.; This is a spontaneous report received from contactable consumer (patient).  A 38-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 19Jun2021 (Lot number: EW0168) at the age of 38 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Lot number: EW0168, Left Arm), administration date: 29May2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: BREAST MASS (disability) with onset 01Jul2021, outcome "not recovered", described as "I developed lumps in my left breast."; BREAST PAIN (disability) with onset 01Jul2021, outcome "not recovered", described as "I have had sore to painful breasts since that 1 month mark."; NIPPLE PAIN (disability) with onset 01Jul2021, outcome "not recovered", described as "My nipples are also sore to painful at times."; MAMMOGRAM ABNORMAL (disability) with onset 01Jul2021, outcome "not recovered", described as "I had a mammogram which showed abnormal tissue in the right breast."; DISCOMFORT (disability) with onset 01Jul2021, outcome "not recovered", described as "It is very uncomfortable and distracting. It affects my sleep as well."; INSOMNIA (disability) with onset 01Jul2021, outcome "not recovered", described as "It affects my sleep as well.". The events "i developed lumps in my left breast.", "i have had sore to painful breasts since that 1 month mark.", "my nipples are also sore to painful at times.", "i had a mammogram which showed abnormal tissue in the right breast.", "it is very uncomfortable and distracting. it affects my sleep as well." and "it affects my sleep as well." were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: mammogram: (01Jul2021) abnormal tissue in the right breast; sars-cov-2 test: (26Nov2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of breast mass, breast pain, nipple pain, mammogram abnormal, discomfort, insomnia  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable consumer reporting for herself. This 36-year-old female patient received first single dose of PREVNAR 13 (could have been administered, but unsure) and flu vaccine on an unknown date in 2018 (reported as recently) both for immunization. Medical history and concomitant medications were not reported. On 14Nov2018, she felt her throat was closing, had a reddening from neck to head and for 1 minute felt like I was dying. At the time of the report, patient felt better but her throat still hurt. Final outcome of the event throat was closing and reddening from neck to head was unknown, throat pain was not recovered. Patient wanted to know if this situation could be caused by the vaccines. Information on the batch number has been requested. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of reporter. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
much more than usual nausea, vomiting, fever, & arm swelling, but principally paresthesias of lt arm, neck & face, & diff breathing & swallowing for 12hrs;
43 y/o female reports "throat closing up" 10-12 minutes after receiving Janssen vaccine at 12:43pm. Patient with intractable, non-productive cough and dry heaving. Elevated blood pressure however oxygen saturation and pulse remained within normal limits throughout assessment period; 12:53-1:23pm. Medical doctors with verbal order for Epi Pen administration. 1:23pm Epi-Pen administered. Paramedics were already on site and took over patient care at 1:24pm. Patient transferred by ambulance to hospital for emergency care at 1;33pm.
Chronic prolonged pain and decreased motion; Onset time of vaccine Oct. 9th to present date. Currently under physical therapy.
Starting day after vaccination, left arm became swollen, red, and very sore. Swelling in arm grew to two times regular size and went from top of shoulder down to elbow. A lot of soreness, especially in shoulder area more so than at injection site; unable to lift arm enough to lift trays at work. Lasted about 10 days.
Pt Rcv'd menveo on -2-1-21 - arm started swelling from elbow to shoulder on -2-1-21 - seen in office on 2-3-21. Per provider L arm Swollen, Red, itchy, null fever. -- Pt treated with cefdinir BIX x10days due to cellulitis & induration.
After receiving the first vaccine, my menstrual cycle started 4 days early and was lighter than normal.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 15:00 (Lot number: FC3181) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 28Aug2021 07:00, outcome "unknown", described as "After receiving the first vaccine, my menstrual cycle started 4 days early and was lighter than normal.". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Patient knew her body was reacting to this vaccine based off her cycle history and the symptoms she was experiencing. She was regular with a 28 day cycle. Never early. Never late. Patient did not have covid prior vaccination. Post vaccination patient was not tested for COVID. Patient had no known allergies. Device Date: 30Oct2021.  No follow-up attempts are possible. No further information is expected.
I got the vaccine at around 13:52. I was fine at first, just a bit of soreness at the injection site. Then, I began to itch in my hands, then my feet. Then, I began to notice my hands get puffy and my chest begin to hurt a bit. My coworker looked at me and told me I had hives all over my face and in my scalp. They also began to appear on my hands. This was around 14:45. So, I took benadryl to offset the affects, but then I began to feel hot all over. So, I informed the individual that administered the shot and I ended up receiving Epinephrine via EpiPen.   Question 23: I have had full body hives and occasional sore throat from various flu vaccines prior and do get hives from TB skin tests.
Moderna COVID-19 Vaccine EUA: Patient hospitalized with acute hypoxemic respiratory insufficiency and sepsis. Received steroids, antimicrobials, and remdesivir. Discharged to home medically stable.
shingles; vaccine did not prevent shinges as intended; Information was received from a lawyer regarding a case in litigation concerning a female, age and medical history not provided.  On 01-MAY-2017 the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and the prevention of shingles.  The vaccine did not prevent shingles but rather caused the patient to contract a persistent strain of herpes zoster accompanied by severe pain and permanent disfigurement and scarring.  Shortly after receiving the vaccine the patient developed shingles.  In response to the symptoms, the patient presented to a physician and remains under their care. As a result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.    Herpes zoster/shingles was considered to be disabling.
DRY COUGH; CHILLS; HEADACHE; TIRED; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced tired. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced dry cough. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, tired, chills, and dry cough. This report was non-serious.