chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Allergic reaction like rash and getting like bumps; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Allergic reaction like rash and getting like bumps) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced RASH (Allergic reaction like rash and getting like bumps). At the time of the report, RASH (Allergic reaction like rash and getting like bumps) outcome was unknown. Not Provided          He was eating shrimp and got allergic reaction on the same day of vaccination. He stated that he was pretty sure that the allergic reaction was from shrimp.  No concomitant medication reported.
I had my vaccination on 11/18/2021. I started to experience COVID-19 symptoms on 11/18/2022 to include a headache. I tested COVID-19 positive on 11/19/2022. I was prescribed PAXLOVID.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (pain in arm hurts) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (pain in arm hurts). At the time of the report, pain in extremity (pain in arm hurts) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Pain in arm around vaccination site that increased over a couple days and then dissipated over a few days. Then about 9-10 days after the date of vaccination the area began to itch and developed a red circle about an inch to an inch and half away from the vaccination site.  Dissipated significantly  over the next 5-6 days (which brings us current to today). The area of my arm at the vaccination site still feels a little off but is almost back to normal.
Information has been received from a nurse concerning a 14 year old female who recently (in approximately December 2010) was vaccinated with the first dose of GARDASIL (lot # not reported). Concomitant therapy included MENACTRA received at the same office visit. Subsequently the patient became flushed, pale, dizzy and could not talk for a moment while leaving the office. The patient did not wait 15 minutes before attempting to leave the office. The patient recovered immediately before leaving the office (time frame unspecified). Therapy with GARDASIL continued as reported. Additional information has been requested.
1/26/2022- Presents to ER from group home for SOB. T-101.2 , HR-105, SPo2 80's placed on 2L o2 via NC increased to 90's. Hypotensive with systolic BP in mid 70's requiring 2L NS bolus. CRP-2.0. Ct scan-patchy airspace disease at the medial aspect of the left lower lobe consistent with atelectasis and pneumonia. Admit acute respiratory failure due to bilateral Covid-19.Start IV ceftrixone, IV doxycycline, IV remdesivir, decadron and baricitinib. Continue aspirin and Eliquis.  1/27/2022- BP dropped to 70/50's requiring pressor support, norepinpehrine and IV vancomycin. Started on BiPAP d/t hypercapnia Pco2 51.3. 1/29/2022- BP 127/80. Started on Cefepime for UTI. Satting at 95-99% on 3-4L via NC.  1/30/2022-Not tolerating Bipap, is satting on RA around high 90's. Transitioned to RA and Supplemental o2 as needed. BP improved 134/70, pressors d/c put on midodrine.  2/4/2022- Continues on supplemental O2 as needed. Afebrile.  2/7/2022- CRP-1.6. Afebrile. BP-104/70. Spo2 low 90's on RA. Discharged to group home.
Moderna 12/29/20, 1/26/21. Positive on 1/30/22
Approx. 7 x 7 cm, red, itchy lesion at site of injection.
Felt dizzy after the shot with resultant spike in blood pressure to 190/80.  Blood pressure receded to 156/76 before7:00 pm to allow drive home. Please provide information with medications taken and results for safety.
Nurse gave pedatric patient Flublok instead of Fluarix. Patient's mother was informed
Fever of about 100 degrees, slight swelling in the arm, tenderness, warmth and red. She is taking ASA for the fever and is doing alright
The morning after receiving the vaccine, around 8 am, I began to feel extremely dizzy and nauseous. These symptoms abated after a couple of hours, but meanwhile, full-body muscle aches began. The pain became so bad I almost left work because I was having trouble moving normally. However, later in the evening- perhaps 6:30 or so- the pain began to lessen. I went to sleep as soon as I got home from work that night, and by morning I felt perfectly fine.
joint pain in her elbow, knees, and ankles; ankles are also now swollen; This is a spontaneous report from a contactable consumer(patient). A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/batch number: unknown), via an unspecified route of administration on 04Jun2021 as a 2ND DOSE, single dose for COVID-19 immunisation. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/batch number: unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date Jun2021, patient experienced joint pain in her elbow, knees, and ankles and stated her ankles are also now swollen. Patient stated that she spoke to someone who took a report including the lot number of the vaccine and then she was told to call Medical Information for more information regarding her side effects. The outcome of the events was reported as unknown.  Information about batch/ lot number has been requested.
supraclavicular lymph node swelled to about pea size after 1st dose and stayed that size until 2nd dose. Swelled to size of moth ball after 2nd dose; supraclavicular lymph node swelled to about pea size after 1st dose and stayed that size until 2nd dose. Swelled to size of moth ball after 2nd dose; day after 2nd dose all joints felt stiff and extremely sore; day after 2nd dose all joints felt stiff and extremely sore; Incredibly lethargic with headache and brain fog; Incredibly lethargic with headache and brain fog; This is a spontaneous report from a contactable other HCP. This other HCP (Patient) reported for self that the 49-year-old female patient who received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Jan2021 06:00 AM on Left arm at single dose for covid-19 immunisation. She is not pregnant. Medical history included known allergies: Augmentin. The patient previously took first dose of bnt162b2 via an unspecified route of administration on Dec2020 06:00 AM on Left arm at single dose for covid-19 immunisation and experienced Supraclavicular lymph node swelled to about pea size after 1st dose. Concomitant medications included in two weeks Sertraline 50 mg, Vitamin D3 5000 IU. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced supraclavicular lymph node swelled to about pea size after 1st dose and stayed that size until 2nd dose. Swelled to size of moth ball after 2nd dose. day after 2nd dose all joints felt stiff and extremely sore. Incredibly lethargic with headache and brain fog. The events started from 11Jan2021 04:00 PM. The outcome of the events was recovered with lasting effects. No treatment was received. No COVID prior vaccination. No COVID tested post vaccination.   Information about lot/batch number has been requested.
About 1 min after TD injection, pt complained of dizziness, follow by diaphoresis, vomiting, syncope in rapid succession. Pt recovered with in 10 minutes and left under parental supervision.
Information has been received from a nurse concerning a male patient between the age of 11-13 who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot# unknown). It was reported that the patient also received a dose of influenza virus vaccine (unspecified) (Lot# unknown) (manufactured unknown). The nurse reported that the patient experienced a localized reaction after receiving the dose of VARIVAX (Merck). The nurse stated that the patient had called the physician to report the events. On 19-OCT-2010, the patient had recovered. The patient sought unspecified medical attention. The health care professional contacted during telephone follow up could not supply the following information: patient name, date of birth, dates of vaccination, lot number. This is one of several reports from the same source. No further information is available.
Shingrix vaccine was given subq, not IM. patient developed large, red, raised, itchy patch on arm that grew in size over a 3 day span.
Redness, swelling and pain, induration. Symptoms resolved with use of BENADRYL.
About 5 hours after the second dose I started feeling very fatigued, chills, and had a fever.  I had these symptoms and flu-like symptoms for about 36 hours before they subsided.  I then started to get over the hump and feel better.  I also had a very sore, swollen, itchy injection site and arm.   Then, Mon. evening, 3/1/21, 5 days after the second dose I was feeling somewhat dizzy, right before bedtime.  So I just went to sleep.  Today, 3/3/21, I am extremely dizzy and lightheaded and struggling to doing my daily activities.  I'm not sure if this is still related to the 2nd injection or not, but I'm concerned.
pt recvd vax 14NOV95 & by 6PM intense itching all over-still itching on 17NOV;
Mild lower abdominal discomfort. May or may not have been associated with shot. Lasted about a day, then went away. Pain at injection site started later, that day, gone in a day or so. No treatment
Mid April 2021 started having pain on the left side of neck upon swallowing. Sometimes it stretched from bottom of ear to my clavicle. After two weeks called my Dr.  and he put me on Keflex.  After 3 days there was no improvement.  I was then scheduled for a barium swallow which was negative. Then was seen by ENT.  The total time of this event was about 6 weeks. By the time I saw the ENT the issue had resolved.  Now for the last 2 months I am having redness in my left foot and ankle.  A doppler ultrasound was normal. I am scheduled to see a vascular specialist this week.  8/2/2021.
I was tired for a week in my bed sleeping felt terrible got better then had cluster headaches daily which now I have a prescription for cluster headaches that I had to take the medicine for the cluster headaches at least every other day.   I normally wake up with a cluster headaches now.  This is all new and started after the first Covid Vaccine injection.  My head will burn and the cluster headaches will last off and on through out the day.
PATIENT RECEIVED VACCINATION SERIES ON 5/21/21 AND 6/11/21. BOOSTER DOSE WAS GIVEN IN ERROR 1 WEEK EARLY ON 12/4/21.
Admitted to hospital 1/14/21 with Fever; Hypoxia; Pneumonia due to COVID-19 virus;  COVID+1/14/21. Discharged home 1/18/21
Information has been received from a certified medical assistant concerning two patients (age and sex not reported) who were vaccinated with Gardasil.  Subsequently, the patients experienced dizziness and fatigue.  The outcome of the events was not reported.  Additional information has been requested.
headache, productive cough, sore throat, chills, shortness of breath, body aches, sinus congestion, nasal congestion, chest congestion, chest tightness. starting 1/8/22
Left deltoid area erthematous, raised, warm to touch.  Complained of itching at site.  Parent treated with Motrin for pain, topical corticosteroid to site to relieve complaint of itching.
arm hurts; couldn't sleep last night; felt pretty bad; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts), INSOMNIA (couldn't sleep last night), MALAISE (felt pretty bad), MYALGIA (body aches) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PAIN IN EXTREMITY (arm hurts), INSOMNIA (couldn't sleep last night), MALAISE (felt pretty bad), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (arm hurts), INSOMNIA (couldn't sleep last night), MALAISE (felt pretty bad), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication was provided.    This case was linked to MOD-2021-132284 (Patient Link).
Localized redness and swelling upper left arm, low grade fever. Questionable early cellulitis. Will prescribed with Zithromax Tri-pack.
Caller was prescribed antibiotics for sinus infection after the 1st dose; This is a spontaneous report from contactable consumer (Patient) via Pfizer Sponsored Program COVAX US Support. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot: number: unknown) via an unspecified route of administration on 30Jan2021 as DOSE 1 SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sinus infection. She stated that she was prescribed antibiotics for sinus infection after the 1st dose. 1st dose received last 30Jan and scheduled to receive the 2nd dose on 20Feb. Asking if she could still receive the 2nd dose? Therapeutic measures were taken as a result of sinus infection and included treatment with antibiotics. The outcome of event was unknown.   Follow-up attempts were completed. No further information was expected.
The patient had a delayed reaction to the vaccination one-week later which results in a hard bump like rash that was itchy. It resolved after 1 week.
sore injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site) and HEADACHE (headache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore injection site) and HEADACHE (headache). On 15-Jan-2021, VACCINATION SITE PAIN (sore injection site) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided. Consent to follow-up obtained.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Inflamed, swollen right underarm (onset day 7, not improving) Inflamed, pruritic 2? rash at injection site (onset day 8, not improving)
headache has consistently increased recently to a 4/10 than previously; Fatigue; Left ventricular hypertrophy; This spontaneous case was reported by a pharmacist and describes the occurrence of LEFT VENTRICULAR HYPERTROPHY (Left ventricular hypertrophy), FATIGUE (Fatigue) and HEADACHE (headache has consistently increased recently to a 4/10 than previously) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product AGALSIDASE BETA (FABRAZYME) powder for concentrate for solution for injection/infusion for Fabry's disease.    No medical history reported.  Concomitant products included MACROGOL 3350 (MIRALAX), NORMAL SALINE, WATER FOR INJECTION (STERILE WATER FOR INJ.), CALCIUM, TADALAFIL (CIALIS), MULTIVITAMIN [VITAMINS NOS], LOSARTAN, METOPROLOL, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), FINASTERIDE and AMITRIPTYLINE for Adverse event.   On 02-Feb-2017, the patient started AGALSIDASE BETA (FABRAZYME) (Intravenous) 80. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced LEFT VENTRICULAR HYPERTROPHY (Left ventricular hypertrophy). On 20-Apr-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced HEADACHE (headache has consistently increased recently to a 4/10 than previously). At the time of the report, LEFT VENTRICULAR HYPERTROPHY (Left ventricular hypertrophy), FATIGUE (Fatigue) and HEADACHE (headache has consistently increased recently to a 4/10 than previously) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Echocardiogram: left ventricle hypertrophy (Inconclusive) Left ventricle hypertrophy.     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 medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up received on 08-JUN-2021 contains NNI.
Extreme fatigue, body pain, chills and fever, sweating, headache, swollen lymph nodes in armpits, elbow, and groin that are worse on left side where injection was given
sometimes the fever would get worse/Feeling weak was reported as worsened; does not feel well; Feeling nauseated; Feeling weak/ Feeling weak was reported as worsened.; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101333008 (Pfizer).  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 15:30 (Lot number: FF8839) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Drug(s) Information 1, Characterization of drug role:Suspect, Proprietary medicinal product name: Pfizer BioNTech Covid-19 Vaccine, Batch/lot number: EW0185, dosage text: Unknown Dose. Injected in left arm., ), administration date: 13Sep2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 05Oct2021, outcome "not recovered", described as "Fever"; NAUSEA (non-serious) with onset 07Oct2021, outcome "recovering", described as "Feeling nauseated"; ASTHENIA (non-serious) with onset 05Oct2021, outcome "not recovered", described as "Feeling weak/ Feeling weak was reported as worsened."; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "sometimes the fever would get worse/Feeling weak was reported as worsened"; MALAISE (non-serious), outcome "unknown", described as "does not feel well".  Additional information: The child reports the mother got second dose of Pfizer COVID 19 vaccine this past Monday and a day and half later, she had side effects as follows: Fever, feeling nauseated and feeling weak. Regarding the fever, he said it is the same overall, but sometimes the fever would get worse. Prior Vaccinations (within 4 weeks) none. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. Provide other relevant medical history including but not limited to these conditions included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: diabetes. Family Medical History Relevant to AE(s) was none. The other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebro-spinal fluid culture, pleural fluid culture, urine culture, diagnostic imaging, (e.g., chest X-ray, MRI) was none. She does not feel well. She has a fever, feels nauseated and weak. It started about a day and a half after getting the vaccine. Vaccine not Administered at a Facility.  No follow-up attempts are possible. No further information is expected.
I started developing walloping palpitations around 3 hours after vaccine was given.  They have continued now for 18 hours post vaccination and I have never had these before in my life.  I have numerous per hour but can be symptom free from time to time.  No significant cardiac history before.
WEATHER WAS BAD, PAIN/PAIN ALL OVER; Headaches; Chills; RHEUMATOID ARTHRITIS HAD BEEN PAINFUL DUE TO WEATHER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (WEATHER WAS BAD, PAIN/PAIN ALL OVER), HEADACHE (Headaches), CHILLS (Chills) and ARTHRALGIA (RHEUMATOID ARTHRITIS HAD BEEN PAINFUL DUE TO WEATHER) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 25-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN (WEATHER WAS BAD, PAIN/PAIN ALL OVER), HEADACHE (Headaches), CHILLS (Chills) and ARTHRALGIA (RHEUMATOID ARTHRITIS HAD BEEN PAINFUL DUE TO WEATHER). At the time of the report, PAIN (WEATHER WAS BAD, PAIN/PAIN ALL OVER), HEADACHE (Headaches), CHILLS (Chills) and ARTHRALGIA (RHEUMATOID ARTHRITIS HAD BEEN PAINFUL DUE TO WEATHER) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  The reporter did not provide any causality assessment for the events of headache and chills with Humira. The reporter did not provide any causality assessment for the events of general body pain, headaches and chills with Moderna vaccine.  The reporter assessed the event of general body pain and arthritic pains to be reasonably possible to Humira. The reporter assessed the event of arthritic pains as not related to Moderna vaccine.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.