chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a 39 year old female with drug allergies to MORPHINE and DARVOCET and medical history of "pain", splenectomy and pneumonia who on 17-NOV-2010 at 6:30pm was vaccinated intramuscularly with a dose of 0.5 ml expired PNEUMOVAX 23 in the right deltoid (lot # 663889/0632Y, expiration date 12-NOV-2010). Concomitant therapy included FLUZONE in left deltoid on the same day, doxepin hydrochloride 50mg, oxycodone, methadone hydrochloride and occasional generic AMBIEN. At 10pm the patient experienced pain and swelling at the site, migraine, nausea and vomiting. The patient had sought unspecified medical attention. At the time of reporting, the outcome was unknown. Due to the patient's medical history, the pharmacist stated the patient got a PNEUMOVAX 23 every year or had for the last couple of years. Additional information has been requested.
5x7 cm circle of erythema at injection site, with associated warmth, itching beginning 5 days after vaccine was given.
Rhabdomyolisis; Fall; This spontaneous case was reported by a pharmacist and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolisis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolisis) (seriousness criterion medically significant) and FALL (Fall). At the time of the report, RHABDOMYOLYSIS (Rhabdomyolisis) and FALL (Fall) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood creatine phosphokinase: high High.     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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
S: I feel shakey and c/o headache O: AAO x 3, BP 250/140, P=100 regular O2 99 mild diaphoresis; (-) SOB (-) wheezing skin: mild B/L arm flat macular rash  chest - upper chest & neck - red, small raised papules. A/P R/O allergic reaction - called ambulance @ 2:50pm gave benadryl 50 mg PO; EMT & RN present
Around 3 pm felt chills, HA. Took TYLENOL. Few hours later temp was 102 degrees F and at 7 pm was 104. took MOTRIN 400 mg. Called in sick (work night shift). Did not eat much. 10 am temp was 101 degrees F; vomited yellow liquid. C/o ringing in ears body ache. Had to take deep breaths. By noon felt well. No localized reaction.
pt recv vax 23JAN96 & on 30APR97 pt devel two spots on hairline & back that appeared like chickenpox;
I saw the year and went forward as if they were 18, not realizing their birthday had not past yet. So no adverse event reported but did give injection outside of age indicated
hematoma; Pain in arm; Pain has increased since then in my upper arm muscle; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL 9263) via an unspecified route of administration in the arm left on 06Feb2021 at 15:30 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroidectomy, hormone replacement therapy, sulfonamide allergy, seafood allergy (scallops) and fruit allergy (strawberries). The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) from an unknown date and unknown if ongoing for an unknown indication. The patient was allergic to amoxicillin and epinephrine. On 06Feb2021, the patient experienced pain in the arm and pain has increased since then in my upper arm muscle which would make it worse while exercising. On 10Feb2021, 4 days after the vaccination, the patient developed a hematoma. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in the arm, hematoma and upper arm muscle pain were not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
14 days after immunizations, patient developed abd pain, was found to have pancreatitis - lipase > 2000, and was hospitalized for IV fluids.
Information has been received from a licensed practical nurse (LPN) concerning a 3 months old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies or concurrent conditions were not reported. On 12-NOV-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ administered orally for prophylaxis (lot number M004508 with an expiration date of 29-JUN-2017) (dose was not reported). Other suspect and concomitant medications were not provided. There was no adverse effect reported. The temperature excursion reported was 1 degree Celsius (C) for 48 hours. A digital data logger was involved. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA013756.
3 days after vaccination, patient had edema in legs, excessive bruising (9 spots) in legs, knots in forearms (5 total, one 9cm in diameter and one smaller), one knot initiated in wrist and moved upward on forearm; patient consulted with cardiologist who referred her to ER on April 28, 2021.  Patient has not experienced shortness of breath or difficulty breathing.
Heat around injection site; Hard around injection site; Redness around injection site; Swelling around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat around injection site), VACCINATION SITE INDURATION (Hard around injection site), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE SWELLING (Swelling around injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 030C20) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included IBUPROFEN and ACETAMINOPHEN for Arthritis, HYDROCHLOROTHIAZIDE, FAMOTIDINE, GABAPENTIN, MELATONIN, ALPRAZOLAM (ALPRAZOLAN), ROSUVASTATIN, UBIDECARENONE (COENZYME Q-GEL), HYDROXYZINE, CARVEDILOL, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Heat around injection site), VACCINATION SITE INDURATION (Hard around injection site), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE SWELLING (Swelling around injection site). At the time of the report, VACCINATION SITE WARMTH (Heat around injection site), VACCINATION SITE INDURATION (Hard around injection site), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE SWELLING (Swelling around injection site) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable. turmeric unknown strength ibuprofen 400 mg PO BID and acetaminophen 2300 mg PO daily in divided doses (as ongoing concomitant meds for pre-existing arthritis.)   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Event Outcome update
12 hours after vaccine, 100.4 fever, chills, body aches.  Fever broke after about 18 hours. General pain on injection arm, continuing through this day.  General pain/discomfort in upper left arm and shoulder/back area.
stomach pain; very concerned, worried, scared/ crying and scared; had more diarrhea; IBS flare up; symptoms that seem to be flaring, auto immune system stuff; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 22Jul2021 as dose 1, single for COVID-19 immunization. Medical history included IBS. The patient's concomitant medications were not reported. Patient got her first dose of the Pfizer BioNTech Covid-19 vaccine on 22Jul2021 and was scheduled for her second dose on 12Aug2021. Since the first dose, she has had stomach pain, and was very concerned, worried, scared. She was asking if others have experienced it and how long it lasted for them. Stated she has heard of Covid doing this to people, and knows everyone is different and that she is sensitive to things. She was calling regarding the Pfizer Covid vaccine. She just wanted to get a little bit of comfort. She was late at getting it because she does have some auto immune issues and some significant gastrointestinal things. She was originally on the side of not getting the vaccine but recently decided that she should just go and do it. She was one of those people who were really on the fence because of her underlying stuff. She had the first shot 22Jul2021 and it wasn't even 2 weeks out. Thursday, it will be 2 weeks. Her biggest concern was that she got some symptoms that seem to be flaring, auto immune system stuff. The biggest was stomach pain. She had more diarrhea and she has IBS but has the other kind of IBS. Everything she keeps reading says that it is going away in 3 days. For her, she was usually the exception, hers was usually 5 to 7 days. The severity kind of comes and goes. She didn't need to go to the ER or anything, not to be alarming but, it did feel a lot like an IBS flare up. She was concerned because her next shot is 12Aug2021 and she does not want to not get it and not be protected. She has other side effects and then would not be protected from that either. She has so much going on in her whole life. She was just worried, and has been crying and scared. Her stomach hurts a lot, since 22Jul2021. She thought things would be a little better by now. There were some other things but, this was the biggest. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe seizure disorder. Residual neurological damage. The 60 day follow-up states that the pt has a severe seizure disorder, developmental delays, and immune problems. Seizures started three days after the shot. 1st one for approx. 5 mins. 2nd seizure during the night 07/12/97 was an hour and a half long. General-irritable.
pt recvd vax 17AUG94 & seen by ER 20AUG94 for lt arm numbness;
hot; swelling like an orange; red; tender to the touch; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (hot), SWELLING (swelling like an orange), ERYTHEMA (red) and PAIN IN EXTREMITY (tender to the touch) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced SKIN WARM (hot), SWELLING (swelling like an orange), ERYTHEMA (red) and PAIN IN EXTREMITY (tender to the touch). At the time of the report, SKIN WARM (hot), SWELLING (swelling like an orange), ERYTHEMA (red) and PAIN IN EXTREMITY (tender to the touch) 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.   Treatment medication included Benadryl.  No concomitant medications were provided by reporter.   This case was linked to MOD-2021-028011 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Report form received on 14 JUL 2021: No new information provided.; 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.
Note from provider at appointment on 5/5/17: pt complains of pain in RT shoulder where Tdap was given 2 weeks ago. Pt states injection was very painful when given. Pt states she has had some decreased ROM in the last 2 weeks, now improving. Recommended ice and tylenol x 1 week, if not resolved pt to call clinic for further evaluation.
On day 4 from day of the vaccine, I woke up with a headache.  I soon became extremely nauseated, runny nose, diarrhea, frequent urination, dry heaves.  Some of this was expected, but actually none of this was said to be a side affect.  None of this was advertised.  I had heard that the vaccine makes you sick (thru the grapevine).  Didn't think it would be as bad as it was and that the Pfizer vaccine was not as reactive.  I live alone and am 67 years old .  My chest began to hurt.  After 4 hours of being sick I called 911.
Little Mild Asthma  when I exhale, have feeling I need to cough. when I breathe deep get sharp pain in back. Arm sore for a day.
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (first shot actually helped lessen his/her outbreak and was back to normal in a month). Previously administered products included Shingrix with an associated reaction of blister (had got the shot in 2012 and in 2020 had got blisters on the upper right side of his/her face around the eyes/eyelid and forehead).   In DEC-2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was not reported if the reporter considered the shingles to be related to Shingles vaccine.     It was not reported if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's comments: This case was reported by the patient via interactive digital media. The reporter stated that he/she had got the blister on his/her eyelid and had got treatment/checked out, his /her eyes was ok. He/She had no pain, but quite a few blisters.  He/She had got a new shot in December 2022 and was getting ready to get his/her second shot next month.  Shingles suck. Follow-up would not possible as no contact details were available.
develop 4 nodules with distinctive borders; swelling; redness under both eyes; lymphadenopathy bilateral jaw; This is a spontaneous report based on the information received by Pfizer from Facility (Reference Number: GL-082521-20503). This is a spontaneous report from a contactable physician. A 44-year-old female patient received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported), dose 2 via an unspecified route of administration on 05May2021 (at 44-years age) as dose 2, single for covid-19 immunisation and hyaluronic acid (RESTYLANE), via an unspecified route of administration from 09Jun2020 (Batch/Lot Number: 17327; Expiration Date: 31May2022) to an unspecified date, at 0.5 mL, via an unspecified route of administration from 31Jul2020 (Batch/Lot Number: 17327; Expiration Date: 31May2022) to an unspecified date, at 0.5 mL, via an unspecified route of administration from 02Mar2021 (Batch/Lot Number: 18439; Expiration Date: 31Mar2023) to an unspecified date, at 0.5 mL for an unspecified indication. Medical history included, had Versa to lips on 16Feb2021 with no issues. The patient's concomitant medications were not reported. Patient has not had any other vaccinations, illnesses, or dental procedures in the last 6-12 months. Patient previously received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration on 14Apr2021 (at 44-years age) as dose 1, single for covid-19 immunisation. In Jun2021, patient reported that she started to develop 4 nodules with distinctive borders, swelling, redness under both eves, she lymphadenopathy bilateral jaw. HCP reported patient was seen in Urgent Care in the second week of August and prescribed 6 days prednisone taper. HCP reported the patient then presented to her on 17Aug2021 reporting no improvement with prednisone. HCP reported that she treated the patient with 900U hyaluronidase and Doxycycline. Nodules are 90% improved, still some swelling, redness and lymphadenopathy bilateral jaw but improving. She treated with another 600U hyaluronidase and another week of Doxycycline. Action taken for hyaluronic acid (RESTYLANE) was unknown. The outcome of the events was resolving.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient stated she felt light headed and dizzy.  She put her head down on the table and was sweating.  She did not lose consciousness.  She was able to respond to questions.  She refused the offer of an epi pen or call to 911.  She did not want to have someone called to pick her up.  I gave her a bottle of water and M&M's.  when the dizziness passed, she ate the M&M's, had some water.  She started to fell better after about 6 minutes.  I stayed with her until she able to leave on her own.
Information has been received from a LPN concerning a 5 year old female with egg allergy who was vaccinated with a second dose of MMR II (lot# 647299/1040N), in the right thigh, SC. There was no illness at the time of vaccination. Subsequently on 08-JUL-2004, at 6:15 PM, also reported as "about one hour post vaccination, " the pt developed hives on her arm, chest and back. The pt was treated with Benadryl. The hives resolved within 24 hours. Additional information is not expected.
he got vaccinated and he got sick; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "he got vaccinated and he got sick".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient had received PCV13 (PREVNAR) the year before on 10/20/2015. The PPSV23 was given 10/11/2016, 9 days early according to recommendations to space these vaccines by 12 months. CDC was contacted when this was reviewed and advised that no further doses need to be given, but recommended a VAERS report to be filed to document the error in spacing. Staff were reminded of spacing to be reviewed when scheduling appointments, and move them further out to allow for recommended intervals.
Bladder infection; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (Bladder infection) and NAUSEA (Nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced CYSTITIS (Bladder infection) and NAUSEA (Nausea). At the time of the report, CYSTITIS (Bladder infection) and NAUSEA (Nausea) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment details included Bladder Infection Medication since 18 Feb 2021.
INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; PATIENT RECEIVED 0.15ML DOSE OF VACCINE (INCOMPLETE DOSE); OFF LABEL USE; This spontaneous report received from a physician concerned a 14 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) .15 ml, administered on 28-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUN-2021, the subject experienced inappropriate age at vaccine administration. On 28-JUN-2021, the subject experienced subject received 0.15ml dose of vaccine (incomplete dose). On 28-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration, off label use and patient received 0.15ml dose of vaccine (incomplete dose) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210663915 and 20210735425.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 12:00 as dose 3 (booster), single (Lot number: GJ2524 Giant 348) at the age of 43 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Oct2021 as dose 2 (booster), single (Lot number: 012F21A CVS#1517), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 06Mar2021 at 09:00 as dose 1, single (Lot number: 1805022), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADVIL 12 HORAS, start date: 04Oct2022, stop date: 11Oct2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022 at 12:00, outcome "unknown"; DRUG INEFFECTIVE (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, notes: COVID 19 Treatment, Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient had no known allergies. Anti-viral details: Paxlovid Product=COVID 19 Treatment, Treatment start date=07Oct2022, Treatment stop date=11Oct2022, Indication=Treatment of COVID-19.