chrisvoncsefalvay/vaers-outcomes huggingface dataset:
16 month old male seen on 7/31/02 after two day history of right thigh swelling and induration at the site of his dTaP vaccination on 7/9/02.  The site had two 2 mm papules with some ecchymosis, and a surrounding area of erythema 10.5 x 8 cm involving the entire anterior right thigh.  60 Day follow up states that pt recovered.
pt recv vax & pt devel an allergic rxn, including rash & pruritus;the reporter noted that no rxn was observed before;no further details were provided;
As documented in CPRS: "fever/chills, myalgias, vomiting,head pressure, rhinitis, congestion, cough, sneezing, oral cold sores" Narrative:
Two days after receiving GARDASIL, 8/7/14, shot experienced bilateral thigh pain. Around 2 weeks after shot, experienced nosebleeds at random times. Most recent nosebleed last week. Also have had increased pain and bleeding with menstrual cycles x2. ADVIL for cramps. Used to only get nosebleeds in winter. Has not had them for a long time. Increased pain and bleeding in Sept and October. ADVIL 400 mg did not help. Thigh pain last a few weeks. Not doing any activity this summer. Was not working, no sports. Never both legs at the same time. When it did hurt, would last an hour. Was not limping. Pain usually started when laying down. Could get up and move around when had the pain. Did not wake from sleep. Increased bleeding: Uses pads (regular flow, thins). Usually has to change once a day. Usually only has 2 inch circle of blood. Increased to almost the whole pad and needed to change 2-3 times a day. That same flow lasted for 7 days. August period - had it when had shot. Early Sept and early Oct had cycle. This month was normal cycle. Nosebleeds since shot: Had one last week. At least 3-4 per month since vaccine, until last week.
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients' were vaccinated with improperly stored LIQUID PEDVAXHIB (dose, strength, route, frequency, lot # and indication unknown) (incorrect product storage). The vaccine was exposed to a high of 9.5 degree Celsius temperature for a time frame of 24 hours. No adverse events were reported. Data logger was involved. It was reported that there was no previous temperature excursion. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
eRYTHEMA, SWELLING AND WARMTH AT INJECTION SITE (RIGHT UPPER ARM), EXTENDING FROM SHOULDER TO 2 INCHES ABOVE ELBOW. RIGHT UPPER ARM 4 CM LONGER THAN LEFT UPPER ARM. C/O PAIN IN RIGHT UPPER ARM.
Rapid heart rate, fever, vomiting, chills, kidney pain, chest pain, headache, swelling, warm, redness at injection site, increased liver enzymes
giving the patient  her  second  moderna  vaccination and  the   vaccine came out of the connector  at the site of the    needle and   syringe  ,  they both were  tight   but the  vaccine   ran  down her arm  from coming out of that  site.    patient    then  received the  second   dose   to  complete her  series .  under  direction of the pharmacy director  was notified.  and if  less than  50 %  was   received then  give  another  dose .
herpes zoster; Information has been received from a lawyer concerning a case in litigation and refers to a male patient of an unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On or about 02-SEP-2016, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and zoster-related conditions, at his local pharmacy. Subsequently, on an unknown date, the patient was treated by a provider for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of the event was unknown. The causality was related.
pt recv 2 doses of vax & pt exp failure to seroconvert w/ELISA w/ a cutoff of one;
Diarrhea, NauseaVomiting, swelling and soreness at injection site Narrative:
Started in the first of November 2022, respiratory, flu like symptoms, COVID- 19 test is was negative. The doctor did a battery of tests, COVID-19 result was negative and influenza A and B. Those test results came back that I had influenza B. I had a persistent and quite bad cough that lasted for 2 months. They did not give me medication except for cough medicine. It went all through Christmas and all through January. I got a flu shot in mid-October 2022, but it did not stop me from getting the Influenza B.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX lot # M038350 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX.
Employee states two hours after receiving the influenza vaccine she began to experience burning in her left upper arm, sharp pain in her wrist, extending to her fingers and thumb, weakness sensation and elbow pain.
patients received a lower than authorized dose of bivalent Moderna today( 0.3 ml was administered instead of 0.5ml).  The patient was notified and was able to return to the clinic on the same date to receive the remaining volume dose (0.2 mL), based on guidance from the CDC. Vaccine administration errors and deviations
Erythema & tenderness at injection site. Came to ER for above complaints. On 1-20-10. Treated with Benadryl, Prednisone, Darvocet.
Pt had 1st Pfizer dose 4/27/2021 then 2nd Pfizer dose 5/18/2021 at the Pharmacy , then presented to us on 7/3/2021 requesting the J & J immunization. Pt stated NO to receiving any previous Covid-19 vaccines. We were unable to access medical record at that moment so immunized customer believing they had honestly answered the questions pertaining to previous immunizations. Went to add this immunization into the medical record and found the previous immunizations.
Swelling at injection site with red rash-slightly raised. 1.5cm x 1.5cm.
A rash all over their body that was itchy; Muscles in their leg got really really tight; Could not walk for 3 days; This spontaneous case was reported by a nurse and describes the occurrence of RASH PRURITIC (A rash all over their body that was itchy), MUSCLE TIGHTNESS (Muscles in their leg got really really tight) and GAIT DISTURBANCE (Could not walk for 3 days) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 007M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced MUSCLE TIGHTNESS (Muscles in their leg got really really tight) and GAIT DISTURBANCE (Could not walk for 3 days). On 07-Dec-2021, the patient experienced RASH PRURITIC (A rash all over their body that was itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (A rash all over their body that was itchy) outcome was unknown and MUSCLE TIGHTNESS (Muscles in their leg got really really tight) and GAIT DISTURBANCE (Could not walk for 3 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Other treatment information includes resting, drinking plenty of fluids and topical cream.  Reporter stated that patient had no other symptoms and had no new products or no new medication added to their routine.
During the summer of 2021, he started having issues with auditory hallucinations that are being evaluated.  It is unclear if the symptoms actually started before the vaccine was given.
Fever (103°F); Extremely tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever (103°F)), FATIGUE (Extremely tired) and HEADACHE (Headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PYREXIA (Fever (103°F)), FATIGUE (Extremely tired) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever (103°F)), FATIGUE (Extremely tired) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Body temperature: 103 (High) 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Extreme flu-like symptoms. Never felt that sick in my life. I was in the bathroom. It instantly hit me like a brick wall. I almost fell over. I hobbled over to my bed, and shivered under the covers on a hot day unlike I ever have before. It was a few hours before I fell asleep. I woke up the next day still feeling sick, albeit far less so. Took until the next morning to feel fully recovered.
pt recv vax & approx 2wk post vax pt devel a rash;
Headache, nausea, fever, arm pain, soreness, joint pain, muscle ache, burning sensation on soles of feet with blister developing next day
Immediate dizziness, then about 8 hours later fatigue, brain fog, body aches which have lasted 36 hours so far
pt recv vax 8FEB95 & devel severe hay fever sx of excessive sneezing,rhinorrhea & lightheadedness & was treated w/Claritin;sx resolved the following day;
had 2 MENACTRA doses. The first was in 10Dec2016 and the second was in 25Jul2019 with no reported adverse event; Initial information received on 29-Aug-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 16 years old and unknown gender patient who had 2 MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] doses. the first was in 10dec2016 and the second was in 25jul2019 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Dec-2016, the patient received a Primary dose of 0.5 ml suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and On 25-Jul-2019 the patient also received another dose of the same vaccine  (with an unknown batch number, route, administration site, expiry date, strength) as immunization. (inappropriate schedule of product administration) (unknown latency)  It was reported "There is literature saying there's only 2 doses needed but he wants to follow up with us since the patient's Pediatrician and school is asking for another dose. Is another dose required or suggested? System was unavailable for transfer. A Pharmacist reporting a possible medication error with MENACTRA described as receiving a booster dose too early. The Pharmacist reported that the consumer received 2 doses of Menactra on the following dates: 10Dec2016 and 25Jul2019; that the reason for the dose in Jul2019 is unknown to the caller; that the dose was done at the prescribing office; and that the caller is needing to follow up with the prescriber. A possible medication error due to the consumer was booking on the pharmacy online site to receive Bexsero but was prescribed Menactra. The Pharmacist reported that he is not sure if the consumer was to get Bexsero, after speaking with the consumer; that the prescriber needs to be reached to verify if the consumer is to get MENACTRA and Bexsero."  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
This spontaneous report as received from a medical assistant refers to a 5-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 29-APR-2016, the patient was vaccinated with an incorrectly stored PROQUAD (lot # L050909, an expiration date 14-JUN-2017 (reported as 20107), dose, dose number, anatomical location and route of administration were not provided). It was reported that the refrigerator was out of range. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
On 6/21/21, patient came into clinic for a nurse only appointment to receiver her Men B vaccine.  Her father is a physician in the clinic and he approached his nurse about her coming in.  The nurse thought she heard him say, she was coming in for her Covid vaccine too in addition to the Men B vaccine.  The nurse prepared both the Men B and Pfizer Covid vaccines and administered.  Patient was inadvertently given a 3rd Covid vaccine.  She has already received 2 Moderna Covid vaccines on  01/16/2021 and 02/14/2021.   On 06/21/21 she developed chills and body aches, on 06/22/21 the chills and body aches continued, on 06/23/2021 the chills and body aches resolved but she has a small localized reddened area at injection site with mild pain.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 25-AUG-2014 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects were reported. Additional information has been requested.
One patient may have received IPOL post-excursion at minus 0.7 degree Celsius with no A/E; Initial information was received on 01-Sep-2021 regarding an unsolicited valid non-serious case received from an other health care professional via consumer (under Inquiry Number: 00751004) .  This case is linked to case Id: 2021SA292867(CLUSTER).  This case involves a patient of (unknown demographics) who had received IPOL post-excursion at minus 0.7 degree Celsius with no adverse event (Product storage error) IPV (VERO) [IPOL].  On an unknown date, the patient received a dose of suspect IPV(VERO) lot number: U1A452M and expiry date: 02-Feb-2023 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to Product storage error temperature too low (latency: same day).  It was reported "Caller stated that a temperature excursion of unknown origin occurred on 25-Aug-2021. The low temperature was Negative 0.7C and the excursion lasted for 5 minutes before the products were transferred to a different refrigerator. The products involved were a punctured MDV of IPOL as well as unopened ACTHIB and MENACTRA. Caller also stated that 16 patients received the ACTHIB post-excursion, 9 patients received the MENACTRA post-excursion and 1 patient may have received the IPOL post-excursion. Caller stated that she did not had any patient information available at that time, but she can be contacted in the future if it is needed. Caller had asked for stability information for these products."  At the time of reporting, no adverse event reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Fatigue for two days; feverish; stuffy nose and sinses; headache; pain in right underarm (near lymph nodes)
pt recv vax 16OCT98 & 17OCT98 pt had to be taken to ER for Bells Palsy facial paralysis;
I was awakened from sleeping, I broke out in a sweat, fever, nausea, headache, and between 6-7 am I felt weak. Manufacturer: GSK FLUARIX QUADRIVALENT 2016/2017 Formula Exp Date: 6/6/17 Lot number: ZG3S5.
Tendons in my arms hurts since the vaccination. I have no strength and they are in pain
It is all red underneath his armpit, below his armpit, under his arm; Underneath his armpit, is like a ball, it''s like swollen underneath; His is still swollen and he is still like; he cannot really move his arm all the way to the top; I just knew that, he said my arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Feb2022 19:15 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for hypertension. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 04Apr2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: May2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: ERYTHEMA (non-serious), outcome "not recovered", described as "It is all red underneath his armpit, below his armpit, under his arm"; AXILLARY MASS (non-serious), outcome "unknown", described as "Underneath his armpit, is like a ball, it''s like swollen underneath"; SWELLING (non-serious), outcome "not recovered", described as "His is still swollen and he is still like"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "not recovered", described as "he cannot really move his arm all the way to the top"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I just knew that, he said my arm was sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior vaccinations (within 4 weeks): Reporter stated, "No, not before 4 weeks but he has taken his other shots. He took around 04Apr and the other was taken in May of this year and they were both Pfizer(further not clarified)."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Increasing arm soreness, fever of 102, chills, headache, starting in the morning, lasting until that evening. After 11.5 hours of sleep, symptoms resolved the next morning (around 9 a.m.) other than some lingering arm soreness and tiredness.
Moderna Booster administered 11/5/2021 and on 11/15/2021 I went into a sustained arrhythmia at rates of 200 bpm for 3 hours before it terminated.  December 30th 2021 I had a cardiac ablation to isolate arrhythmia.
1. Joint pain start 02112021 end 02222021 2. Skin rash and itchy start 02182021 and faded overtime.  3. Pregnant 02172021?miscarriage 03072021
Itchy injection site; Swollen Injection site; Inject site hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen Injection site) and VACCINATION SITE PAIN (Inject site hurts) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen Injection site) and VACCINATION SITE PAIN (Inject site hurts). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE SWELLING (Swollen Injection site) had not resolved and VACCINATION SITE PAIN (Inject site hurts) outcome was unknown.            No concomitant product use was provided by the reporter.
Went to ER with possible seizure. Felt to be an Vasovagal syncopal episode with possible seizure ave to hypoxia.
09/20/2021- Tongue, neck and face swelling and I could feel it in my throat as well. Vocal cord swelling. I was already in the hospital at the time.
This spontaneous report as received from a physician via a company representative, refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 01-OCT-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. On an unspecified date in October 2015 (reported as 24 hours of the vaccination), the patient experienced "redness and warmth at the injection site", and on an unknown date in October 2015 (reported as "within another 24 hours"), a vesicle appeared at the injection site and it crusted over. The reporter stated that the patient called her unspecified primary care physician to notify the reaction and was advised to go to the emergency room. The patient went to the emergency room of an unspecified medical center, but was informed "the reaction was fine" and was sent home without being admitted. No treatment was given to the patient. On an unknown date in October 2015, the outcome of the injection site erythema, injection site vesicles and injection site warmth was reported as recovered. The relatedness between injection site erythema, injection site vesicles and injection site warmth and VARIVAX (Merck) was not provided. No product quality complaint was involved. Additional information has been requested.