chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of administration of expired product to a four-year-old male was received from a clinic administrator concerning a four-year-old male subsequent to the administration of FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient's medical history and concomitant medications were not reported.  On 22-Feb-2010, the patient was administered FLUMIST.  There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Follow up - No late occuring adverse events were reported. Additional information was received on 13-May-2010 and incorporated into narrative: information on late occurring adverse events.
Patient came into our pharmacy and requested a vaccine for Shingrix.  At the time other vaccinations were going on including Covid vaccines. The patient was inadvertently given a dose of Pfizer covid19.  The patient stated that they had already received a series (two shots) of Moderna Covid19.  The patient had no immediate signs and symptoms and was told to look out for the normal adverse events seen with Pfizer Covid19 vaccine.
9/29 Mom noticed pink area on (R) upper arm in am. States area aprox. 6" x 4" area not hot to touch (=) raised area. By afternoon area red warm to touch but did not get larger.
Lacrosse ball sized swollen injection site; Redness at injection site; Pain at injection site; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 29Oct2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included desogestrel, ethinylestradiol (KARIVA), lysine (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and ascorbic acid (VITAMIN C), all for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH9899) via unspecified route of administration in the left arm on 29Dec2020 (at the age of 26-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 19Jan2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 30Oct2021, the patient experienced lacrosse ball sized swollen injection site, redness and pain at injection site. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lacrosse ball sized swollen injection site, redness and pain at injection site were resolved on an unknown date in 2021.
Rash is not always visIble, it comes and goes, it's like a hives, little hive types under the skin; Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Rash is not always visIble, it comes and goes, it's like a hives, little hive types under the skin) and RASH PRURITIC (Itchy rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 URTICARIA (Rash is not always visIble, it comes and goes, it's like a hives, little hive types under the skin) and RASH PRURITIC (Itchy rash). The patient was treated with TRIAMCINOLONE ACETONIDE for Itchy rash and Urticarial rash, at a dose of 0.1 percent and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Rash is not always visIble, it comes and goes, it's like a hives, little hive types under the skin) and RASH PRURITIC (Itchy rash) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information not provided by reporter.   This case was linked to MOD-2021-029805 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Reporter's email info corrected
This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 09-OCT-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N009802, expiry date: 19-DEC-2019) and ROTATEQ (dosing details not reported) (lot # N009948, expiry date: 12-OCT-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA007011:
patient stated that 20 minutes after receiving vaccine she had muscle cramps. Started in legs, went through behind and back and went up to the shoulders. By 11 that same night, she had fever, and chills, and fatigue.  Patient is still suffering from AE, and is being treated by doctors for muscle cramps
I have had continuous ear pressurization problems since the first Covid Vaccine administered on March 30, 2021.  I have also had two additional Covid vaccines  on 4/20/21 and 9/13/22. All three are Pfizer vaccines administered at pharmacy. The ear pressurization was on and off at first but lately it has been constant.
Phoned wilth c/o general malaise, h/a, joint aches fever, up to 102 F.  States s&s initiated approx 2 hours after injections. Diarrhea, nausea; no vomiting.
Nerve sensitivity in the upper torso. Affected area is painful to the touch, a light piece of clothing rubbing the skin is painful. Hot or cold does not seem to have an effect on the pain level, it is more pain with direct contact rather than temperature fluctuations. Almost feels like a severe sunburn, but no visible skin reactions. Primary care phys. and dermatologist both ruled out shingles.
2 hours after vaccine on 02/26/2020 noted pain in arm, later that evening noted that her left deltoid region to elbow was itchy oval shaped raised an inch area surrounded by deep red oval shaped area. Applied ice with relief.  On 02/27/2020 noticed that redness was a dull red that was progressing down the arm. Complaints of nausea, headache and fatigue.  Called health department and was advised to observe for further reactions. On 02/28/2020 noted that back was itchy and hot, noted red rash to chest and abdomen that was itchy and hot. Came into family care clinic for check up. Prescribed claritin 10mg one po daily x 5 days. Denies any shortness of breath or swelling in mouth, lips or tongue.
Palpitations; Feeling weak; Headache; This case was reported by a consumer and described the occurrence of palpitation in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced palpitation, feelings of weakness and headache. On an unknown date, the outcome of the palpitation, feelings of weakness and headache were unknown.   It was unknown if the reporter considered the palpitation, feelings of weakness and headache to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced palpitations, headache and was feeling weak. The patient asked whether the palpations and headache and feeling weak a reaction from the shot.
Breakthrough case admission after 3 vaccines Moderna 1/22/21 Lot# 027L20A;  MOderna 2/19/21 Lot# 010M20A;  Moderna 10/1/22 Lot# 027E22A
Information has been received from a medical assistant concerning a 21 year old patient who on 29-NOV-2010 was vaccinated with a dose of the pediatric formulation of VAQTA (lot number not provided). No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
This spontaneous report was received from a nurse referring to a currently 68 year old female patient with hypertension and hyperlipidemia. The patient had no known allergies. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (lot # N010109, expiry date: 20-NOV-2018). Concomitant therapies included losartan potassium (manufacturer unknown), potassium, simvastatin (manufacturer unknown), omeprazole, enalapril (manufacturer unknown) and aspirin (manufacturer unknown). On an unknown date, the patient sought medical attention by office visit since she experienced redness, swelling, heat, and red blotches. Therapy for the adverse events was administered (details unspecified). The nurse verified the vaccine was stored properly. No laboratory diagnostics were performed. The outcome of swelling, rash macular, feeling hot and erythema was reported as recovering. The causality assessment between suspect therapy and the aforementioned adverse events was unknown. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA010408.
This spontaneous report as received from a physician refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored with LIQUID PEDVAXHIB (therapy type: Digital data logger) (lot # L012838 with expiry date of 10-MAR-2018), at a temperature of 33 F for a time frame of 8 hrs 20 min cumulatively. The physician reported there was a previous temperature excursions, which was cumulative total since unspecified time in March 2016. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Shortness of breath; Weakness; Fatigue; palpitations; Myalgias at injection site; This is a spontaneous report from a contactable Other healthcare professional, the patient. A 26-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EL1283), via an unspecified route of administration on 20Jan2021 at left arm as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9231) on 30Dec2020 11:13 pm and experienced myalgias, diffuse, causal relationship was reported as related; on 31Dec2020 16:33 experienced fatigue and causal Relationship was reported as unknown; On 31Dec2020 16:33 experienced weakness and causal Relationship was reported as unknown; and on 31Dec2020 16:33 experienced sore throat and causal Relationship was reported as unknown. The patient was not admitted to hospital. One second dose the patient experienced weakness, fatigue, palpitations, and shortness of breath on 22Jan2021 and myalgias at injection site on an unknown date in Jan2021. The outcome of the events was unknown.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/7/22 at approximately 10:50am. When error discovered facility contacted CDC for course of action. At direction of the CDC, patient contacted regarding occurrence to offer re-vaccination of dose. Patient accepted revaccination on 1/28/22. No adverse side effects or event as result of dose.
I woke up with lots of sneezing, severe sore throat that felt like strep throat, coughing, and nasal congestion/draining. I decided to take an at-home COVID-19 test on 01/16/2023. I called my doctor to schedule an appointment; in the office, they took a rapid antigen test to confirm I had COVID-19. He then prescribed me PAXLOVID for treatment. I went home and began the prescription. After taking the prescription, I feel like I've recovered with still slight fatigue and slight sore throat. My senses of taste and smell are still making their way back to normal.
pt recvd vax & exp crying @ 1000PM, curled up into a ball & c/o stomach cramps, t103, leg was sore;
After receiving FLUZONE HIGH DOSE vaccine, the patient became very dizzy & complained of severe nausea. She was checked at nearby PCP office for BP, temp, & blood sugar, then sent home on fluids & bland diet.
Severe muscle pain and weakness all day 10/27. Night of 10/29/2011 fever and chills.
Varicella vaccine breakthrough. Developed fever, cough, nasal congestion on 6/9/06. Temp 100. Rash started 6/14/06. Had about 20 scattered pustules on trunk. Diagnosed with varicella in our office by doctor on 6/14/06.
Headache within 8 hours, rash all over back, chest, arms, neck, and stomach within 24 hours and worsening over the next 48 hours, sore throat and stuffy nose within 24 hours
Information has been received from a doctor of pharmacy concerning a female patient who on approximately 04-NOV-2008 was vaccinated intramuscularly with a dose of PNEUMOVAX (lot # 662662/0979X). It was not known if the patient had been previously vaccinated with PNEUMOVAX. The pharmacist reported that the patient had injection site reactions of swelling, redness, pain and a hard knot under the skin. The patient gone to the emergency room a couple times and not recovered. Additional information has been requested. This is one of three reports received from the same source.
sore and  swollen neck area; sore and  swollen neck area; feel the lymph nodes swollen in their neck and they are warm to the touch; is red where she got the injection warm  to the touch; feel the lymph nodes swollen in their neck and they are warm to the touch; is red where she got the injection warm  to the touch; left shoulder is sore; their arm was sore; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (sore and  swollen neck area), SWELLING (sore and  swollen neck area), FEELING HOT (feel the lymph nodes swollen in their neck and they are warm to the touch), VACCINATION SITE WARMTH (is red where she got the injection warm  to the touch) and LYMPHADENOPATHY (feel the lymph nodes swollen in their neck and they are warm to the touch) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug hypersensitivity. Concomitant products included METOPROLOL, ALPRAZOLAM (XANAX) and PEPSIN for an unknown indication.    On 22-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2022, the patient experienced VACCINATION SITE PAIN (their arm was sore). On 23-Jun-2022, the patient experienced NECK PAIN (sore and  swollen neck area), SWELLING (sore and  swollen neck area), FEELING HOT (feel the lymph nodes swollen in their neck and they are warm to the touch), VACCINATION SITE WARMTH (is red where she got the injection warm  to the touch), LYMPHADENOPATHY (feel the lymph nodes swollen in their neck and they are warm to the touch), VACCINATION SITE ERYTHEMA (is red where she got the injection warm  to the touch) and ARTHRALGIA (left shoulder is sore). At the time of the report, NECK PAIN (sore and  swollen neck area), SWELLING (sore and  swollen neck area), FEELING HOT (feel the lymph nodes swollen in their neck and they are warm to the touch), VACCINATION SITE WARMTH (is red where she got the injection warm  to the touch), LYMPHADENOPATHY (feel the lymph nodes swollen in their neck and they are warm to the touch), VACCINATION SITE PAIN (their arm was sore), VACCINATION SITE ERYTHEMA (is red where she got the injection warm  to the touch) and ARTHRALGIA (left shoulder is sore) had not resolved.            The patient never tested COVID-19 Positive, neither experienced similar event in the past. No other vaccine were given within 1 month prior to Moderna COVID-19 vaccine. The AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). No treatment medications were reported.
Pt reports moderate edema, erythema and warmth at site below where IZ was given.  Tender but no painful.  States less edema, erythema and warmth 10/22/14. Improved from 10/21/14.
pt said about 3 days after getting arexvy/flu hd pt felt bad, achy, pain in upper part of body. pt said up to this morning he still feels bad, pt said he called dr and his dr said to take a covid test so he will.
This spontaneous report as received from a healthcare worker refers to a 17 month old patient. On 22-AUG-2013 the patient was vaccinated intramuscularly with 0.5 ml GARDASIL (lot # H020002, expiry date 08-AUG-2015) when they were supposed to have received liquid PEDVAXHIB. The scheduled dose of liquid PEDVAXHIB was not administered. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient) and Medical Information Team. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL8982, Expiration date: Unknown) on 21Jan2021 (at the age of 75-years-old) as 1st dose, single on left arm for COVID-19 immunization. The concomitant medications were not reported. The patient stated that years ago, she took a flu vaccine, and after she did not have the flu but had flu-like symptoms, that is probably the only thing that she had a reaction. The patient was not tested positive for Covid-19 prior to the first dose of vaccine.   On 24Jan2021, (after 3 days of  vaccination the patient experienced stomach cramps and diarrhea (till 26th Jan 2021), achiness and headache (till 27th Jan 2021) and also a little bit of chills. The patient receive treatment with Imodium 24-hour period it ended and stomach cramps has been resolved in 2 days. The patient also received treatment with Tylenol for achiness and headache and was resolved in 3 days. The patient askes could the presented events be a side effect from vaccine. The patient is concerned about the second dose of vaccine which was scheduled on 12Feb2021. The patient asked about her second dose if she should not get since, she experienced side effects. Action taken was not applicable. The outcome of the events stomach cramps and diarrhea was resolved on 26Jan2021 while outcome of the events achiness and headache was resolved on 27Jan2021. Outcome of the event also a little bit of chills was resolved on an unspecified date in   No follow-up attempts possible. No further information expected
Information has been received from a licensed practical nurse concerning a 7 month old patient and twin sibling (WAES# 0802USA00297) who on 14-JAN-2008 was vaccinated with the third dose of ROTATEQ (lot# 657516/00512). The patient did not seek medical attention. No symptoms were noted. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
1. SM reports progressively worsening back pain, bilateral knee and ankle pain; onset 25 MAY 2021.  2. SM reports intermittent dizziness upon getting up and out of bed in mornings, upset stomach, gas cramps, belching, and diarrhea; onset MAY-JUN 2021.  3.  SM reports nasal congestion, post nasal drip, sinus pressure, and constant need to clear throat. 4.  SM reports forgetful /foggy brain and frequent trouble sleeping. 5.  SM reports NEW ONSET decreased penile erection; noticed in AUG 2021 per SM. SM states that erection "isn't full" and states that he didn't have this issue prior to deployment. Today, SM denies pain with erection or painful urination; denies abnormal penile discharge. SM given permission to report these finding into VAERS.
Information has been received from a pharmacist concerning his 17 year old daughter who on 21-JUN-2007 was vaccinated with her first dose of Gardasil.  On 31-AUG-2007 the patient was vaccinated with her second dose of Gardasil.  On approximately 09-OCT-2007 the patient experienced lingering headaches.  The headaches were described as painful enough to cause absence from school and with some light sensitivity.  The patient saw her pediatrician twice for the headaches.  No treatment or diagnostic workup specified.  Additionally the patient had syncopal episodes after both Gardasil injections.  The patient's lingering headaches and syncopal episodes persisted.  Additional information has been requested. Follow-up information was received from the physician's office. On an unspecified date the patient had a urinary tract infection with dysuria for 1 and 1/2 days at the time of vaccination. There was no discharge, fever, nausea or vomiting. Concomitant therapy included BACTRIM for UTI. On 21-JUN-2007 the patient's was vaccinated with a first dose of GARDASIL (lot# 0197U) at 8:58 PM IM in the left deltoid. On 21-JUN-2007 8:58 PM the patient walked out of clinic to the waiting room and leaned on her dad's shoulder and had one short episode of dizziness. On 21-JAN-2007 a physicial examination was performed. The patient's general appearance, abdomen, gentalia and neurology was within normal limits. On 22-JUN-2007 the patient had 4 to 5 mild short episodes of dizziness each just lasting a few seconds when rising from lying position. The patient's body temperature measurement was 97.8 degrees F, the blood pressure measurement was 115/55 and the pulse rate was 69. The patient's chest, abdomen, skin, neurology, back and extremities was within normal limits. The patient was alert and active. The patient had no injection site erythema or induration. On 22-JUN-2007 orthostatic blood pressure measurement was 112/65 sitting, 117/74, 71 standing, 111/74 and 76. Recommendations included reasurance, supportive care, increase fluids and to return/call office if dizziness persists. All episodes were resolved by 22-JUN-2007 (office visit at 4:40PM). Additional information is not expected.
pt recvd vax & started sneezing; coughing & vomiting; to er tx w/ meds; ERMD said vax caused sxs; pt cont to have wheezing & shortness of breath; thru 8sep94, had another episode of sxs; went to er;
Rash started 11/30/19over arms. neck & chest worse 12/2 with swelling, rash & itching did have slight heaviness in chest. & face felt flushed  12/3 with less rash & itching, swelling is almost gone - never any wheezing