chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a Pfizer COVID-19 vaccine on 12-23-20 at her place of employment. She missed the second dose opportunity and was told to schedule elsewhere for second dose. She then came to the health dept on 3-19-21 and received a Moderna COVID-19 vaccine without informing the administering nurse that she had already received a previous Pfizer dose. The patient documented on the consent form that the vaccine given on 3-19-21 would be her first COVID-19 dose. The patient was immediately called once this was discovered when putting the vaccine record in  Shots and she stated that she was feeling fine other than her arm was sore at the injection site. Patient was advised to seek medical care if she developed any severe side effects. She was informed that she would be called for the next 2 days for monitoring.
pt recv vax 5AUG98 & 7AUG98 pt devel pain in the trapezius muscle inj site;
April 1, 2022 early in the morning I had terrible pain in my left rhomboid. I went to the ER. They didn't do much. I was prescribed some pain killers. I got physical therapy after that. As I finished up physical therapy my fingers started tingling on my left hand.  I found out that there was a problem with my ulnar nerve. I had surgery for that, and it is better but it is still not good. I still have weakness in my hand. I am working a little bit. In general after getting the omicron on 1/9/2022  I started getting tired easily. I been sleeping a lot more. On the second day of having omicron I felt horrible. I thought I was going to die. My doctor just told me to take Vitamin C, Zinc, and Aspirin so that I don't get a blood clot. After that day I would wake up and feel like I have a cold. If I go out in the cold I feel like my lungs will not allow me to stay out there long.
Day after receiving Td vaccine, site became very red, swollen and tender-pt described some streaking. 2 day following, she called clinic to report. Streaking had disappeared. Still other local sx. swelling was firm, about size of "egg." Advised pt to see physician but she was unable today, tomorrow.
She had no adverse experiences following receipt of the 1st 2 Engerix-B injections. On 2/28/02, the vaccinee received her 3rd injection of Engerix-B. On 2/28/02, immediately after the injection, she experienced tingling. Later that day, she developed a "severe" rash and itching all over her body. As of 3/5/02, the tingling and rash had improved; however, the itching persisted.
Patient came into Public Health Clinic for 1st dose of COVID-19 Vaccine. Patient completed COVID-19 vaccine screening checklist for contraindications. Patient reported that she had a penicillin allergy-hives and had a reaction to an unknown agent that caused eye and lip swelling. Form reviewed by Dr who verbally screened risks for patient. Patient made educated decision to get vaccine knowing risks of allergic response. Patient received Moderna Lot # O11J20A in left deltoid administered by Indigo RN. Patient observed in clinic for 15 minutes after vaccine given. No reactions reported at that time. Patient waited longer due to significant other also receiving the vaccine and having to wait for observation. At 1054 patient reported to pharmacist of her lips feeling tingly and her tongue feeling heavy. She reported to, RN and informed Dr. of patient's status. Upon physical assessment of oral mucosa, no tongue swelling, throat soreness, redness or swelling noted on physical exam, vessels under bottom lip looked slightly dilated. Patients lips also within normal limits, no swelling noted. Vital signs of 98.3F tympanic, O2 sats 100% on room air, heart rate 91, respiratory rate 16. BP R. arm 164/104, L. arm 165/112, manual on R. arm 164/98. Patient states she took hydrochlorothiazide for BP at 12:30, right before coming into clinic. Patient still feeling like her lips are tingly and tongue is heavy, Per Dr. would prefer to assess patient in the ER. Instructed patient to go to Health Center ER with husband for further assessment. Per chart review from ED, Pt monitored in ED for 1 hr. without recurrence or development of symptoms. She states that she feels normal and is ok with going home. Return precautions discussed. No interventions.
Pt developed motor rigidity with clenching of teeth and abdominal cramping. Pt treated with Benadryl.
Very little arm pain. Extreme chills and fatigue after each shot - about 4-6 hrs. - more after second shot. Didn't want to bother doctor. Chills lasted about 1 1/2 days. Just thought someone should know. Read warnings - my choice to proceed with these shots.
Headache, severe injection site pain, body aches, racing heart, "arrhythmia".  mom says child had similar symptoms after receiving first in series but never notified parent.   symptoms continued until today.  still with some minor arm pain but other symptoms seemed to have resolved.
patient had sx 1-27-22, tested + 1-26-22 .  Nursing home resident.   Admitted to hospital 1-15 -2023 and discharged 1-26-2023 to Hospice center and  deceased on 2-2-23
Pain to injection site, muscle mass to left deltoid is diminished compared to right arm, numbness and tingling to arm and site, palpable knot to left shoulder.
Patient had declining health for the past 6 months, dementia and unable to walk. Patient had decreased appetite starting 1/1/21. After 1st vaccine shot patient appetite decreased further. After 2nd vaccine shot patient fatigue increased to the point where she could not get out of bed and had minimal appetite. Patient passed away 10 days after receiving 2nd shot on 2/22/21. Patient did not go to ED and was not hospitalized.
Patient mentioned that she has a bruise from the Pfizer booster she received on 04/02/2022 and wanted to know if that was normal.  She has not had any reactions to previous 3 doses. She said it is getting better. it is still sore but not as sore as it was before. the bruise appeared to be the size of a quarter and blueish purple with yellow outline. It looked to be healing and she said it was smaller now. I advised her to watch  the bruise and soreness, since she is stating it is getting better, it looks like it will heal but if it gets worse or soreness gets worse or doesn't lighten to have her call her MD and inform us.
Pt recvd vax & devel a react in the throat described as elongation of the uvula accompanied by pain for 2-3 days;
Fever, chills, all over body aches. Began around 10pm on evening of shot, and resolved around 9am the following morning.
This spontaneous report as received from an healthcare worker refers to an unspecified number of patients of unknown age and gender might have received VAQTA (lot # unspecified) dose, frequency and location unspecified, which were stored improperly on an unspecified date. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Received DaPT morning of 03/01/05 in right deltoid.  Around 18:30pm, parents noticed non-painful redness and swelling upper arm area.  He was rechecked and I found him to be in no distress.  He had an area of blanching erythema and mild warmth consistent with urticarial reaction.  He was treated with Benadryl and cold compresses and had no further problems.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 09-APR-2013, the patient was vaccinated with a expired dose of (Merck) VARIVAX (Lot number 669193/0096AE, expiry date was 11-NOV-2012, route and dose were not reported). No adverse event reported. The reporter did not know if the expired dose was the first dose of (Merck) VARIVAX. Additional information has been requested.
This spontaneous report was received from the health worker refers to an unspecified number of patients of unknown age and gender. On an unspecified day, GARDASIL underwent an excursion and the excursion was supported. On unspecified dates, unspecified number of patients were administered with post excursion supported GARDASIL (Strength, dose, route and lot number were not reported) for an unknown indication. No adverse effects had been reported by any patients. This is one of the several reports from the same reporter. Additional information has been requested.
Patient developed urticaria on face after injection and palmar erythema.  Urticaria have occurred in multiple areas on the face since the injection 5 days ago. They are not always present and go away without treatment.  Fever of 101.8 4 days after injection. Cough started 3 days after injection.
Client reports inside of hands and in between fingers are itching. She reports no changes other than got flu shot yesterday. She denies ever having allergies to vaccines or other allergies.
Received 0.5 ml Moderna Booster instead of 0.25 ml.  Muscle aches - more intense from the second dose, headache and tired.  1st and 2nd dose just had a headache.
Patient was fully vaccinated with Pfizer. Doses received 3/18/21 and 4/8/21.   Patient was admitted approximately 1 week ago for acute hypoxic respiratory failure due to COVID-19.  Patient was admitted for COVID at a different facility and discharged , he has declined.  He continued to feel worse each day and  developed a coughing fit.  He called his granddaughter who came to see him and said he was acting confused and appeared to be in distress.  She states that he said he felt like he was dying.  She called the ambulance and they brought him to the hospital.  Patient endorses shortness of breath and productive cough with some specks of blood.  Patient was admitted 11/19/21 and is still in hospital
Erythema, edema mild-mod at the injection site.  No intervention necessary yet.
Headache, Myalgia, Fever, flu-like symptoms Narrative: Had 2nd vaccine 1/25/21 fever, body aches, HA, arm pain, flu-like symptoms for a few days and then better
sore arm after Pfizer covid vaccination; HCP stated like tetanus shot it hurts really bad after getting it due the ingredient in it.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm after Pfizer covid vaccination"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "HCP stated like tetanus shot it hurts really bad after getting it due the ingredient in it.".  Additional information: Health care professional (HCP) reporting for a  patient. HCP wanted to know about the sore arm after Pfizer covid vaccination was it due to anything in the Pfizer covid vaccine or was it due to the way of administration. HCP stated like tetanus shot it hurts really bad after getting it due the ingredient in it. HCP also wanted to know about general side effects and difference in the age group, Pfizer covid vaccine and infertility, used of antipyretic and generals drug interaction with Pfizer covid vaccine, if the formulation for the second dose is still the same and any information about the booster dose, if vaccine can be given with other medications at the same site and sites of administration and arm use.  Follow-up attempts completed. No further information expected.
11 days after vaccination - Hive at injection site,  headaches, hands stiff and swollen, body aches for four days
pt recv vax 15AUG97 & 7 days post vax 22AUG97 pt exp urticaria;f/u 14NOV97 pt past medical history was reported to include asthma 7 allergic rhinitis treated w/asthmacort inhaler;
Side effects began the morning after ? severe headache and body ache (back and abdomen muscle pain), followed in the afternoon by severe fatigue (I slept two hours in the late afternoon before dinner), then by evening mild nausea and chills.  I ended up going to bed at 9pm and slept nearly 10-1/2 hours after, for a total of 12-1/2 hours.
Patient went to get a rapid test on 1/8. Onset of symptoms 1/6:sore throat and headache.  also lower back pain, chills, watery eyes, cough.  Phoned EHS that her results were positive.
COVID vaccination history:  1st dose 1/8/21, 2nd dose 2/8/21, booster 12/2/21. Patient was admitted to local hospital 3/16/22 for intractable vomiting and discharged back to FACILITY 3/20/22.  Workup revealed no clear etiology for vomiting.  After return, tachycardia was noted and resident reported right calf pain - PCP ordered LE venous dopplers for further evaluation of calf pain. PCP's 3/21/22 note states venous Doppler showed DVT on right leg, extending from mid right femoral vein through the posterior tibial and peroneal veins.  Patient admitted to hospital for initiation of warfarin therapy until stable.
Itch; Red; Swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (Itch), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Swollen) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Covid-19 Vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itch), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE PRURITUS (Itch), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided
Shortly after the COVID-19 vaccine being administered, patient experienced and itchy reaction all over her body. Patient took Benadryl and the itchiness went away.
Right deltoid swollen, red, and warm to touch. Treatment - ice pack and NSAIDs.
get sick every time; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 03-Dec-2020.  This case involves a patient of an unknown demographics who got sick every time (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, 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 got sick every times (illness), (unknown latency) following the shot of INFLUENZA VACCINE because of the filler used in making it. Further reported that patient doctor said it was the filler used in making it, even I could hardly take any medicine without being sick for days, sometimes really bad and I hate taking anything.  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.
COVID 19 that lead to hospitalization. Patient was hospitalized for 1 full day. Presented with fever, mildy hypoxic, lower extremity selling and pain.
Patient has c/o injection site pain and pain radiating down (L) arm since vaccine administration.
body and joint aches, fatigue, headache Narrative:  Took OTC Tylenol  Other Relevant History:
cellulitis from the shot in left arm; This is a spontaneous report from a contactable consumer reported for herself. This 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 in her left arm at single dose for covid-19 immunisation. Medical history and concomitant medications were none.  There were no additional vaccines administered on same date of BNT162B2. The patient previously received a pneumococcal vaccine (reported as pneumonia shot) on unspecified date for immunisation where kind of the same thing happened, she had red, bumped up and itchiness at the injection. she didn't remember if she was diagnosed with cellulitis as it was a long time ago and she has no NDC, Lot, or Expiry for the product.  The patient experienced cellulitis from the shot in left arm on 22Jan2021. The event did not require a visit to Emergency Room. She just called the doctor and was given a prescription, the name of the prescription was unknown. The outcome of event was not recovered.    Information about lot/batch number has been requested.
PT WAS ADMINISTERED A JANSSEN VACCINE OUTSIDE THE 6 HOUR WINDOW HELD AT 36-46 DEGREES FAHRENHEIT. THE 6 HOUR TIME FRAME WAS MISCALCULATED AND ADMINISTERED AT EXACTLY 7 HOURS. PT WAS MONITORED FOR 30 MINUTES AND PT NEVER EXHIBITED SYMPTOMS OF ANAPHYLAXIS OR DISTRESS. THE ERROR WAS CAUGHT BY MYSELF 30 MINUTES AFTER THE PT HAD LEFT. I CONTACTED JANSSEN AND THEY HAD NO GUIDANCE AND STATED TO MAKE MY BEST CLINICAL JUDGEMENT. THE CDC GUIDANCE ON COVID-19 VACCINE ADMIN ERRORS AND DEVIATIONS STATES THAT IF THE MANUFACTURER DOES NOT HAVE DATE TO SUPPORT THE STABILITY OF THE VACCINE TO REPEAT  THE DOSE. I CONTACTED THE PT AND SHE STATED " I WILL NOT GET REVACCINATED, DUE TO ME ONLY GETTING IT BECAUSE MY WORK WANTS ME TO." THE PT THEN TOLD ME THAT SHE STARTED EXPERIENCING TINGLING OF THE TONGUE, LIPS, AND GUMS. PT DENIED SOB, DIFFICULTY BREATHING, AND SWELLING OF THE MOUTH/THROAT/FACE. ADVISED PT TO TAKE BENADRYL AND TO GO TO THE ER IMMEDIATELY BECAUSE IT SOUNDED LIKE SHE COULD POSSIBLY BE HAVING A REACTION. PT REFUSED. REEDUCATED THE IMPORTANCE OF GOING TO THE ER TO PT AND SHE REFUSED A SECOND TIME. PT STATES " MY DAUGHTER IS AND RN AND WILL MONITOR ME."
Day 1,2 localized red injection site. Day 3 whole right thigh red, swollen, hard and inflamed. Tender to touch. Warm to touch. Child did not walk for 4 days. Child continues to favor R leg. Ibuprofen given every 6-8 hours. Fever 102.
inoculation site is swollen; inoculation site is red; inoculation site is itchy; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2019, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site itching to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the husband who reported for her wife. The reporter reported that her wife's Shingrix inoculation site was red, itchy and swollen. The reporter asked how long would this last.  The reporter thought hopefully the event would subside in 3 to 5 days.
Large (egg sized) lump at site of injection on shoulder.  Lump was red and quite hot to the touch.
I had a flu shot and right away and since then I have had intense shoulder pain in the shoulder they gave me the shot. It wakes me up and makes dressing and other activities difficult. The pain is not getting better.
Tinnitus both ears.  Ongoing headache occur w movement at times or just pressure.
PT received her vaccine on 3/27/21, 4/17/21 and 10/15/21 and requested the bivalent booster on 10/18/22 Due to mix up of the Pfizer monovalent and bivalent vaccine- she may have gotten either the monovalent or bivalent Pfizer vaccine.
GOT A POSITIVE RESULT ON HER PREGNANCY TEST; TOOK DOSES IN AN INAPPROPRIATE SCHEDULE; This spontaneous case report (PVX2019-2881) was received from a pharmacist on 20-Nov-2019. It described a 40-year-old female consumer who "got a positive result on her pregnancy test" (PT: Exposure during pregnancy) and "took doses in an inappropriate schedule" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever.  Case report: The consumer took Vivotif in an inappropriate schedule. She started the course on 06-Nov-2019 and completed on 14-Nov-2019. She reported that she was four days late on her period, therefore she did a pregnancy test at home on Monday and the result was positive. She did not confirm her pregnancy by her healthcare professional yet. She had an appointment with healthcare professional to confirm her pregnancy.   Action taken with Vivotif with respect to the reported events was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: The causality of the events "got a positive result on her pregnancy test" and "took doses in an inappropriate schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "got a positive result on her pregnancy test" and "took doses in an inappropriate schedule" was considered as not applicable.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided. On 05-NOV-2021, Hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion with temperature excursion of 47.1 Fahrenheit degrees for 36 minutes. No previous temperature excursion On 20-NOV-2021, the patient was vaccinated with the improperly stored Hepatitis A vaccine, inactivated (VAQTA) (1 time dose, lot # T031202, expiration date 14-JUN-2022; strength and route not reported) for prophylaxis (product storage error). No other adverse event (AE) or product quality complaint (PQC) was reported. This is one of several reports received from the same reporter; Sender's Comments: US-009507513-2111USA005243: US-009507513-2112USA000879: US-009507513-2112USA000882: US-009507513-2112USA000883:
Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses.  The vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2022-581986.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received included non significant information of secondary reporter was added.