chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant medication was reported.  It was reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults. The HCP had asked if the patients need an additional 0.25ml dose now.  It was reported that CDC had recommended to re-vaccinate the patient with full dose of 0.5mL.  No adverse events were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:same reporter
9 Days after the vaccine I developed edema, heat, rash, itching and pain radiating down the arm I received the injection in.  Rash is painful, spreading.
Within 12 hrs had pain in arm, subsequently had pain, swelling. Pain helped by muscle relaxants. Now had redness, blanching, has probable arthous type III hypersensitivity reaction.
Mom states nurse gave 2 doses of ROTATEQ at 4 months WCC visit.  Mom states nurse told her she gives 2 in case patient spits some out.  Patient has had constipation since I received vaccine.
chest tightness.; headache; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9269), via an unspecified route of administration, administered in arm left on 16Feb2021 08:15 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma and thyroid disease. Concomitant medications included levothyroxine sodium (SYNTHROID); beclometasone dipropionate (QVAR); montelukast sodium (SINGULAIR); iron; and loratadine (CLARITIN [LORATADINE]); all were taken for an unspecified indication, start and stop date were not reported. On 18Feb2021 05:00 AM, the patient experienced chest tightness, bad headache and dizziness. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23Feb2021; and scan with an unknown result on an unspecified date. Therapeutic measures were taken as a result of the events as the patient received new strong inhaler, prednisone for 5 days and scan. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
It was reported that a male pt received an IMOVAX, IM, vaccination on 5/12/01. Reportedly, 10 days after injection, the pt developed swelling in both hands followed by generalized swelling. Ten to twelve hours later, the pt developed angioedema and urticaria. Treated with BENADRYL and is resolving. From additional correspondence received on 5/30/01, it was reported that these symptoms resolved with BENADRYL and forced fluids.
Tingling in extremities (hands and feet); chest tightness/pain.. beginning a couple of hours after vaccination and persisting on and off for several days
This is a spontaneous report received from contactable other HCP/consumer or other non-HCP, for a Pfizer sponsored program (143231). A 58-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 58, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had increased hair loss and peripheral swelling (swollen feet), with outcome of unknown. Additional information: Ibrance on hold while pending PET scan in next two weeks. Last dose Aug 26, 2021 end of cycle. Had 1st COVID-19 vaccine a couple weeks ago. Side effects (after vaccination): increased hair loss and feet swelling. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
This spontaneous report as received from a 71 year old female patient refers to herself. Patient's pertinent medical history included asthma and unspecified reaction (drug reaction or allergy) to miconazole nitrate cream. On 26-JUN-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose number, lot/batch number, expiration date, route and anatomical location were not reported). Concomitant therapies included NASONEX, dexamethasone cream (manufacturer unknown), triamcinolone, FLOVENT and fluticasone nasal spray. On 30-JUN-2014, the patient experienced widespread itching. The patient called her physician's office and was prescribed a 6 day course of prednisone. The patient was seen in the office on 10-JUL-2014, and was diagnosed with pneumonia. She was prescribed a 6 day course of azithromycin. On 19-JUL-2014, the patient was evaluated at an unspecified emergency room and on the same day, the chest X-ray was performed which revealed "water in the lungs" and she was prescribed BIAXIN. The patient's symptoms did not improve, so she was seen in her physician's office again and prescribed AUGMENTIN. On 02-SEP-2014, the patient was prescribed another course of azithromycin. The patient stated that at the time of the report she was feeling dizzy, sweaty and had shortness of breath with exertion, all experienced in 2014. It was reported that the treatment was given for the events. The patient sought medical attention (emergency room visit). The outcome of events was reported as not recovered/not resolved. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Because I didn't report right away, I don't recall the date exactly but I got FLUZONE vaccine in October of 2013. 3 days later, I began experiencing uncoordinated left hand, weak and achy feeling in (L) arm and (L) leg. (I rec'd vaccine in my left deltoid) symptoms went on for months requiring a month leave of absence and many medical test. ER visit.
generalized urticarial and nausea 15 min post administrations. IM solumedrol, IM Benadryl, PO Zofran administered. patient monitored for 1 hr post medications administrations, vss, symptoms resolved, pt sent home.
Vaccine administered around 11:30 am in (L) arm. Pt immediately felt a little unusual gi upset. Once she got to lobby, she broke out in drenching sweat and sat down and passed out for 5-10 sec. Vision and hearing seemed "fuzzy". Symptoms resolved by 3:30 pm
I started getting the sore throat and it started becoming scratchy. It started becoming more congestion then the cough started. The cough and congestion got a lot worse. I ended up getting very dehydrated and I wasn?t drinking much. No appetite. Chills and body aches for a week. Then I started experiencing decreased fetal movement on May 14, 2022. They sent me to labor and delivery, and I was seen by nurse and the triage there. They said the baby was fine and that I was really dehydrated. They gave me IV fluids and the baby perked up. They gave me a z-pack, do tea, Pedialyte, Gatorade. Basically, flush my system and took Sudafed. I was on that for another 4 days then I got flu A that was brought home from my daughter. I got sick again then spent all of May sick. It has not been fun. I was seen a second time at labor and delivery on May 20, 2022 because at this point, I have lost 4 lbs. between the 17th and 20th. I was coughing badly and they did another COVID test, RSV, Flu A & B, and everything came back negative except for the Flu A. They tested me the week prior and I was negative. Even if I didn?t get the test, I would have assumed it was just a continuation of the last 2 weeks. I cough so hard I feel like I have pulled a muscle or have separated muscles in the stomach. I now have to hold my stomach in order to cough otherwise it?s too painful. I had to start using my albuterol inhaler because I couldn?t catch my breath. I was doing the steam from heat, and it helped a bit but as soon as I got out of that, I would get congestion again. Because of this, I have been tachycardic for most of this month because of being sick. It?s been awful.  On May 21, when I got the positive test for the Flu, they prescribed Tamiflu and that's when I began to see improvement.
Redness near area where vaccine given, tenderness around area; By afternoon, the redness began turning puffy and aches began in left upper arm where vaccine given. That night, could not sleep on left arm for pain was severe. By 10/6/16, welt-like puffiness all along upper arm, both front and back, from shoulder to elbow. No itching, but terribly sore. By bedtime, I was able to sleep for short periods on left side.
I had about 24 hours of symptoms, starting on the evening of the vax:  Bad headache, overall fatigue, body aches, weakness in legs and knees, tenderness on the shoulder at the point of injection.  The headache responded to an extra tablet of acetaminophen, beyond my normal 1-a-day dosage.   The symptoms are now totally gone after 48 hours.  No need for further consultation or a physician call or visit, in my judgement.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 18Mar2021 as dose 2, single (Lot number: EN6204), in right arm, on 25Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in right arm and on 03May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient was given anti-viral Paxlovid 17Aug2022 to 22Aug2022 for treatment of COVID-19. Rebound of COVID symptom two day after completing Paxlovid treatment. No known allergies.
This spontaneous report as received from a consumer refers to her currently 19 years old daughter with drug allergy to Amoxicillin. None pertinent medical history was reported. In August 2016, the patient was vaccinated with the first dose of unidentified Merck hpv vaccine  which could not be confirmed whether it was GARDASIL or GARDASIL 9 (lot # and dose unknown, intramuscularly. The reporter reported that that patient passed out and became stiff about 15 minutes after receiving the initial dose of the vaccine. She stated that it took her a good 30 minutes to fully recover. No treatment was given to the event. None lab diagnostics studies was performed. Additional information has been requested.
temperature up to 99.6 F.; Myalgias; fatigue; This is a spontaneous report from a contactable physician (patient). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) intramuscularly at left arm on 30Dec2020 at 07:30 AM at a single dose (dose number: 1) for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events myalgias, fatigue, temperature up to 99.6 F; all with onset date in Dec2020. The events were non-serious. No treatment received for events. The outcome of events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Immediate/short term: swollen arm (sight of injection) swollen lips tightness of throat difficulty swallowing dizziness increase heart rate  Long term (life long) pericardial effusion hyperthyroidism systematic inflammation mimicking Lupus (more than 3 systems, but negative ANA) asthma allergies - everything despite negative blood work or skin prick.
mom states pt devel not in rt calf 1 wk p/vax; seen by on 8FEB95; t98.6; f/u by MD 21FEB95 t98.9-no improvement in size of knot; adm to hosp;
Patient received an adult pfizer vaccine 0.3ml, instead of getting pediatric pfizer vaccine 0.2ml
pt recv vax & devel a zoster like rash behind rt ear;lesions were described as confluent around center & quite painful;pt sought unspecified medical attention;
rash which was red, itchy and was on right side of the arm; rash which was red, itchy and was on right side of the arm; rash which was red, itchy and was on right side of the arm; This is a spontaneous report from a Non-Contactable pharmacist.  A female patient of an unspecified age and ethnicity received pneumococcal 7-val conj vac (dipht crm197 protein) (PREVNAR) , via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced rash like the size of a hand  which was red, itchy and was on right side of the arm on an unspecified date with outcome of unknown.  No follow up attempts are possible. No further information is expected.
Narrative: COVID infection following COVID vaccine series 03/11, Pfizer, dose #1 04/01, Pfizer, dose #2 08/11 pt cc: chills, cough, diarrhea, fever, loss of taste or smell, rhinorrhea, exposure: unknown 08/16 COVID swab, result: detected 08/25 SARS-COV-2 LINEAGE AY .25 08/25 SARS-COV-2 CLADE 21A DELTA clinically resolved
Patient called to report COVID arm -rash and redness at the injection site.  Also, reported night sweats
for 72 hours after second vaccine arm became sore; for 72 hours after second vaccine arm became swollen; for 72 hours after second vaccine arm became red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (for 72 hours after second vaccine arm became sore), VACCINATION SITE SWELLING (for 72 hours after second vaccine arm became swollen) and VACCINATION SITE ERYTHEMA (for 72 hours after second vaccine arm became red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE PAIN (for 72 hours after second vaccine arm became sore), VACCINATION SITE SWELLING (for 72 hours after second vaccine arm became swollen) and VACCINATION SITE ERYTHEMA (for 72 hours after second vaccine arm became red). At the time of the report, VACCINATION SITE PAIN (for 72 hours after second vaccine arm became sore), VACCINATION SITE SWELLING (for 72 hours after second vaccine arm became swollen) and VACCINATION SITE ERYTHEMA (for 72 hours after second vaccine arm became red) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
1 patient who received the open IPOL since the temperature excursion occurred (with no reported adverse event); highest temperature it reached was 54.6F for a total duration out of range of 55 minutes with no adverse event; Initial information received on 03-Mar-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15-year-old male patient and reporter reported that patient received the open poliomyelitis vaccine (inactivated) [IPOL] since the temperature excursion occurred with no reported adverse event and highest temperature it reached was 54.6f (Fahrenheit) for a total duration out of range of 55 minutes with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, caller reported that 0.5 ml (milliliter) (once) (1x) of suspect poliomyelitis vaccine (inactivated), suspension for injection, ( lot V1B891M , expiry date: 01-Jun-2024) (With unknown  strength, route and at unknown administration site) for immunization was exposed to highest temperature it reached was 54.6f for a total duration out of range of 55 minutes with no adverse event (product storage error) (unknown latency) and patient received the open ipol since the temperature excursion occurred with no reported adverse event (poor quality product administered) (latency: same day).  It was also reported that extended stability data covers unopened products with the exception of the open IPOL. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data. (IPOL LOT LOT V1B901M EXP 02JUN2024 LOT V1B902M EXP 02JUN2024).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Felt tired; fever of 104 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 104 degrees) and FATIGUE (Felt tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-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 08-Mar-2021, the patient experienced PYREXIA (fever of 104 degrees). On 09-Mar-2021, the patient experienced FATIGUE (Felt tired). The patient was treated with IBUPROFEN at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 1 dosage form. On 09-Mar-2021, PYREXIA (fever of 104 degrees) and FATIGUE (Felt tired) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 104 (High) 104 degree Fahrenheit.         Treatment included cold compressions. No concomitant medication information was provided.   This case was linked to MOD-2021-035199 (Patient Link).
Tightness in right side of my chest; This is a spontaneous report from a contactable consumer (patient). This 48-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1695 or EL1695 and Expiration date 31Mar2021) on 06Jan2021 (at 48 years of age) as single dose for COVID-19 immunisation.  Medical history and concomitant medication were not reported. The patient experienced tightness in right side of chest on an unspecified date. Patient called to see if this was a common event as patient was going to the hospital shortly to be sure nothing was wrong.  Outcome of event tightness in right side of chest was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
allergic reaction to the 1st dose; Hives; This is a spontaneous report from a contactable consumer (parent). A 15-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 10Aug2021 (Lot Number: EW0181) (at the age of 15-years-old) as dose 1, single for covid-19 immunisation. Medical history was none and there were no concomitant medications. The patient had an allergic reaction to the 1st dose of the vaccine and had hives on 10Aug2021, same day of her dose. The patient did not receive the treatment for the events. The reporter was just wondering as their pediatrician said not to get the 2nd dose. The outcome of the events was unknown.
pt came in for immunization and was asked 3 times if this was her first covid shot, she repeatedly said yes.  The shot was administered.  It was not until afterwards that she explained that she wanted a hepatitis  B shot and that she had already had her 2 Pfizer vaccines.
GBS - I could have gotten it from the vaccine. It also could have been a stomach bug. I think it was both mixed together. No one can be sure.
Fever, nausea, vomiting; patient received shot of KETOROLAC 60 mg/2ml today, 2/25/09. Also, patient was prescribed PHENERGAN 25 mg tabs, 1 pill at bed time as needed. Temp 99.3, BP 118/76.
Sept 30, 08 season flu shot, that evening, next day heavy feeling-H1N1 Oct 19 right arm again, next day arm heavy, next day pins and needles few times a day. Progressively more and more numbness and tingling.
sharp pain in arm; soreness in arm about hour or 2 later after injection; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events got soreness in arm about hour or 2 later after injection, i am having sharp pain in arm other arm (right arm), right in the middle of forearm like somebody.  The patient's medical history was not provided. Concomitant medications reported were amiloride, liptor, allopurinol, levothyroxine, quinApril, Norvasc for drug use for unknown indication.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) got soreness in arm about hour or 2 later after injection . On 13 Feb 2021, the patient experienced the event(s) i am having sharp pain in arm other arm (right arm). right in the middle of forearm like somebody.  Treatment details included applied ice and helped.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of event(s), got soreness in arm about hour or 2 later after injection, i am having sharp pain in arm other arm (right arm),right in the middle of forearm like somebody was unknown.