chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse concerning to a 4 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There was no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Saturday, 10 Apr 2021, 01:00AM MT: Woke up with substantial upper back pain and slight nausea. Took Alieve + hot 30min shower with water directed at upper back. Went to sleep at 04:00AM MT same morning.   Sunday, 11 Apr 2021: Woke up with some degree of conjunctivitis (pink eye) in right eye. Eye was red and experienced pain due to sensitivity to light. No water or other discharge. Additionally, upper back discomfort still experienced. However, such went away with Tylenol.  Monday, 12 Apr 2021: Some form of conjunctivitis continued in right eye. However, light sensitivity lessened greatly; eye minority affected by sunlight and no longer affected by indoor bright house lights. No water or other discharge. No back pain.  Tuesday, 13 Apr 2021: Right eye is getting better. Eye is still somewhat red. No more pain due to light sensitivity. No water or other discharge. No back pain.
Received vaccines on 2/2/11. Came in for PPD reading & (L) shoulder was noticeably swollen from shoulder to mid forearm no redness not hard to touch. Seen by MD & diagnosed as vaccine reaction treatment BENADRYL.
Initial information has been received from a pharmacist concerning a male patient with an unspecified age, pertinent medical history or drug reactions / allergies. Approximately in December 2012, the patient was vaccinated intramuscularly with the second dose of PNEUMOVAX23 (dose was not reported). No other co-suspects were reported. No concomitant medications were reported. On 28-DEC-2012, the patient experienced swelling and redness at the injection site after the administration of PNEUMOVAX23. This was also the patient's second dose of PNEUMOVAX23 within a year to year period. The patient was unaware of his vaccination history prior to receiving the second dose of PNEUMOVAX23: The patient was advised to apply cold compresses and ice. There was not lab diagnostics test performed. On 04-JAN-2013, the patient recovered, within 1 week all swelling and redness had disappeared. Additional information has been requested.
Pt. had nausea and vomiting the following day for 24-48 hours. Since resolved.
I started having diarrhea and what felt like acid reflux two days after. I became so uncomfortable and had a horrible headache, so I went to the emergency room. BP and heart rate were elevated, and had three abnormal EKGs but was sent home following bloodwork and told to follow up with cardiologist. Ended up having to return to the ER five days later due to chest pains and rapid heart rate. BP was 178/120. Was admitted to the hospital for 3 days where they found that I have a left bundle branch block and EF of 35%. Now treating with beta blockers and ARBs until more is known from upcoming cardiac MRI.
This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 29-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 with expiry date: unspecified for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012684 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
On 6-25-07, patient returned to office for additional vaccines. Mother informed us of a knot with bruising at site. Doctor examined the area. Advised mom to watch it and put some ice on it, call in 2 - 3 days if not better.
No symptoms until 15 hours after vaccine, then symptoms began with local injection site pain followed by fatigue and body aches. At 330pm the day after the vaccine, there was abrupt onset of fever that reached 105.2 by 8pm and would not respond to OTC medication, followed by difficultly moving arms and legs, difficulty hearing and seeing, difficulty chewing and eating, sharp pins and needles pain in fingers and toes, extremely cold extremities, twitching and jerking of hands, delay in cognitive and motor process, difficulty with short term memory processing, severe upper neck pain, spacial delusions, profuse eye watering and nasal congestion with runny nose, anxiety and irritation due to cognitive difficulty.  This happened to me at worked and I had to be removed from the facility.  The symptoms subsided over a period of 12 hours and fever went down to 99.2 and cognitive ability and spacial awareness returned completely. Residual neck pain remains and can now be relieved by OTC ibuprofen. I have previously had a serious case of Covid-19 virus.
Patient has a papular rash on UE and trunk that developed 8 hives after HPV vaccine given. Pt does not have any itchiness to the sites. Pt had been referred to allergy and dermatology for further testing. Pt currently still has the rash.
Difficulty swallowing, chest discomfort  severe about 6 hrs day of vaccine lingering difficulties  throught 3 days .continued  . saw dr. march 1st  soft foods for now
injection site hard; nausea; vomiting; injection site red; injection site swollen; severe headache; stiff neck; trouble moving around, her body would hardly move; didn't sleep; chest pain right in the middle of her chest; did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), MOVEMENT DISORDER (trouble moving around, her body would hardly move), INSOMNIA (didn't sleep), CHEST PAIN (chest pain right in the middle of her chest) and VACCINATION COMPLICATION (did not feel well) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), MOVEMENT DISORDER (trouble moving around, her body would hardly move), INSOMNIA (didn't sleep), CHEST PAIN (chest pain right in the middle of her chest), VACCINATION COMPLICATION (did not feel well) and HEADACHE (severe headache). On an unknown date, the patient experienced VACCINATION SITE INDURATION (injection site hard), NAUSEA (nausea), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site swollen). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and NITROGLYCERIN for Adverse event, at an unspecified dose and frequency. On 03-Nov-2021, VACCINATION COMPLICATION (did not feel well) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck), MOVEMENT DISORDER (trouble moving around, her body would hardly move), INSOMNIA (didn't sleep), VACCINATION SITE INDURATION (injection site hard), NAUSEA (nausea), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE SWELLING (injection site swollen) and HEADACHE (severe headache) outcome was unknown and CHEST PAIN (chest pain right in the middle of her chest) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal (normal) There was nothing wrong with her heart. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, she did not have COVID before either.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-375291 (Patient Link).
Shortness of breath; Hemoglobin went from 8.8 to 8.2; oxygen level was at 82 whenever she is standing or walking; Sore arm; A spontaneous report was received from a consumer concerning a 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, sore arm, oxygen level at 82 when walking, and hemoglobin went from 8.8 to 8.2.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273(Lot number:039K20A) for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient experienced soreness in arm immediately after receiving the shot. The soreness resolved few days later.  On 29 Jan 2021, Lab work done due to her being anemic and on perpetual oxygen therapy. Her hemoglobin level went down from 8.8 to 8.2 and her oxygen level was 82 on exertion.   On 31 Jan 2021, the patient started experiencing shortness of breath. Patient stated that her saturation level was at 82 percent whenever she is standing up or walking and she runs out of breath. When she sits down, the level of the oxygen will go up. She said she is not sure if her medical condition is getting worse or if this is vaccine related  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events, shortness of breath, sore arm, oxygen level at 82 percent when walking, and hemoglobin went from 8.8 to 8.2 were unknown.; Reporter's Comments: Based on the information from the source document that the patient is an anemic patient on perpetual oxygen, the events of oxygen saturation decreased, hemoglobin decreased and dyspnea on exertion is assessed as unlikely related to mRNA-1273. The event of pain in extremity is possibly related. Further information has been requested.
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. Patient medical history and drug allergies were not reported. On an unknown date, an unspecified number of patients received improperly stored (Merck) PROQUAD (Incorrect product storage) lot # K020753, exp date: 30-APR-2016 (dose, strength and route were not reported). No concomitant medications were reported. No adverse effects were reported. Lab tests were reported as unspecified. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. No further information was provided. Additional information has been requested.
PHN used diluent with an expiration date of 7/31/12 for the MMR and varicella vaccinations.
Recipient became gray, dizzy, light-headed and fainted after receiving the vaccine. Did not hit head or fall on floor. Lost consciousness for less than 10 seconds and stated he did not eat anything that day. 911 was called but he refused to go to the ED and said he was okay.
PARTIAL DOSE; This spontaneous report received from a pharmacist concerned an adult of multiple patients of unspecified sex. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced partial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose was not reported. This report was non-serious.
pt recv vax 18OCT95 & 15JUL96 pt exp shingles effecting the radial nerve of the lt arm;
Severe and acute eczema for almost 2 years Strabismus Extopia on both eyes needs surgery Food allergies (eggs , dairy, sesame...) Developmental delays Non verbal until 3 yrs of age
Hypersensitivity  reaction at site of injection creating lump and redness under skin that has lasted over a month on left arm, fever (102.2), chills,  body aches, headache fatigue.  Site of injection experienced large swelling and pain to the slightest touch. Also itchiness
pt recv vax 13MAY98 & c/o dizziness, lightheadedness, thirsty, feels warm;has taken sz med & ate breakfast but does not feel any better;advised to consult w/MD;
Fever & fussy 6/20/11. Fever 6/21/11. Found unresponsive after taking a nap.
On 11/28/01, mother noticed more than 20 spots on the pt's face and trunk, some of which were vesicular and others that were maculopapular. The pt presents to our office and I examined the pt and some lesions did appear varicelliform and I have documented it. The pt is asymptomatic.
The day after the vaccination I wake up with pain and redness in my arm, headache, nausea, muscle pain and fever.
COVID vaccine breakthrough case. Moderna 2/27/21 010A21A, 3/27/21 018B21A and boosted 12/6/21 058H21A.
Caller reports there have been no additional adverse experiences reported.; an improperly stored vaccine was administered to a patient.; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On 09-JAN-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (lot #W023866 had been verified to be a valid number; expiration date 24-JAN-2024, and upon internal validation established as the same date) (dosage, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported). The administered dose of the vaccine was stored at a temperature of 10 degrees Celsius (C), for a time frame of 1 hour and 28 minutes, as recorded by a digital data logger. There was no previous temperature excursion reported. There was no adverse effect reported.
Moderna COVID-19 vaccine, 0.5ml, was administered using state-supplied Monojet needles. During IM injection, the vaccine leaked from the hub where the syringe and the needle connect.  A large drip was seen on patient's arm. Patient also felt the leakage. Moderna was contacted, and we were given the information that no data exists on what to do in this situation and to use professional judgement. It was decided to administer a second injection, in the same arm (left arm) on the same day, 10 minutes following the first, erroneous administration. We plan to  give the second dose in the series as planned, four weeks later.
patient received the second dose of the vaccine on 06Jan2021 and tested positive for the COVID virus 09Jan2021; patient received the second dose of the vaccine on 06Jan2021 and tested positive for the COVID virus 09Jan2021; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age ((Age: 50; Unit: Unknown; as reported) received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received the second dose of the vaccine on 06Jan2021 and tested positive for the COVID virus 09Jan2021 (medically significant). The clinical course was reported as follows: The patient received the second dose of the vaccine on 06Jan2021 and tested positive for the COVID virus on 09Jan2021. The patient stated that she had signs and symptoms and had exposure to the COVID virus. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 09Jan2021.  The clinical outcome of the events: drug ineffective and COVID-19 virus test positive, was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Patient did not feel well and reports general malaise day 2 and day 3 post vaccination.  She noticed itching of Right Breast  on Day 3 and later that evening, noticed a rash with blisters.
URGE TO GO TO THE BATHROOM (BOWEL MOVEMENT); PRESSURE ACROSS THE CHEST; PRESSURE ACROSS THE BACK; THOUGHT I WAS GOING TO PASS OUT; HEART BEATING QUICKLY; URGE TO VOMIT; VOMITED; CHILLS; COLD SWEAT; FEELING SLEEPY; NOSE STUFFY; PAIN UPON INJECTION; DID NOT FEEL LIQUID FROM INJECTION; ANGLE OF THE NEEDLE FROM THE POINT COMING BACKWARDS FROM THE CYLEINDER WAS VERY ANGULAR; This spontaneous report received from a patient concerned a white not hispanic or latino female of unspecified age. 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, batch number: 1802068) dose and route of administration not reported, administered on 04-MAR-2021 14:00 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced  feeling sleepy, nose stuffy. The patient also complained that she knows several other people 3 other people who felt pain and she also felt pain when receiving the shot that was more painful than having other shots, also she did not feel the liquid come out of the needle when receiving the injection, the angle of the needle from the point coming backwards from the cylinder was very angular and sharp, noticed 3 other people say 'ooo' from pain when receiving injection.  On 06-MAR-2021, the patient's heart was beating quickly, chills and cold sweat, urge to vomit and also vomited.  On an unspecified date, the patient experienced urge to go to the bathroom (bowel movement), pressure across the chest, pressure across the back, and thought i was going to pass out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling sleepy, nose stuffy, chills, cold sweat, urge to go to the bathroom (bowel movement), urge to vomit, vomited, pressure across the chest, pressure across the back, and thought i was going to pass out, and the outcome of pain upon injection, did not feel liquid from injection, angle of the needle from the point coming backwards from the cylinder was very angular and heart beating quickly was not reported. This report was non-serious. This case is linked as same reporter to 20210317609, 20210317681, 20210317682.
Fatigue, shoulder and  neck pain worsening over last 4 days, diarrhea, nausea
Given the varicella vaccine in left upper arm, subcutaneous. I had recieved one dose of this vaccine as a baby, as well as had the chicken pox at age 3. My varicella titer was negative, so I required a new vaccine series for work. The first shot in the series was 02/2017 with no adverse events. The second shot was 04/31. The day following the vaccine, I developed a small rash on my arm and was told it was a "site reaction." two days later, the site became extremely red, swollen, hard to the touch, and warm. I returned to employee health and was told to go to urgent care immediately. Urgent care diagnosed cellulitis  and  prescribed Keflex antibiotics. I was told to return to Urgent care within 24 hours, and then again within 48 hours. I was switched from Keflex to Amoxicillin and given intramuscular Ceftriaxone. Over the course of 10 days the cellulitis resolved with antibiotic treatment.
Peripheral neuropathy requiring ongoing medication in fingers, mouth, tongue and feet. Sensitivity to cold, tinnitus, fatigue, blurred vision, elevated liver enzymes. Non-response to vaccine. Dates of HepB Vaccinations: 8/08/07, 9/11/07, 2/5/08. 7/14/08-records received-Hepatitis received interferon October through December 2007. Developed intermittent tingling of fingers, feet and tongue, loss of pain sensation in extremities. Neurological exam WNL. Symptoms are greatly exacerbated by hyperventilation. 01/25/2010 Ongoing perpheral neuropathy enormous- corpal tunnel ulnar nerve entrapment. tarsal tunnel syndrome documented, in addition the vaccine did not work.
rash on arms, legs, lips and sides, it was itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash on arms, legs, lips and sides, it was itchy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced RASH PRURITIC (rash on arms, legs, lips and sides, it was itchy). The patient was treated with METHYLPREDNISOLONE for Itchy rash, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rash on arms, legs, lips and sides, it was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer reported no concomitant products were used.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non significant follow up
Janssen COVID-19 Vaccine EUA. 6 hours after injection (6pm April 1) I had full body muscle aches, major chills with low grade fever, loss of appetite, a little nausea, major fatigue, headache, prickly sensation on skin. Symptoms subsiding by 1pm on  April 2, 2021.
Case received from a healthcare professional through MIS/VIS on 22/Aug/2006 under the local reference number 06-381.  A 60-year-old female patient with medical history of asthma and GERD and who had fatigue at time of vaccination, had received an intramuscular dose of ADACEL, batch number C2556AA, in the left arm on 16/Aug/2006.  5 days later, i.e on 21/Aug/2006, she experienced 6 cm redness and swelling at injection site leading to doctor visit.  The diagnosis was "cellulitis" however no cultures were done.  She received KEFLEX.  It was worth noting that she had concomitant treatments with NASONEX, LEVOXYL, "PRIEDCID" and SINGULAIR.  The patient was not recovered at the time of the report.  Follow-up information received on 18/Sep/2006.  Per the reporter, the patient had the flu at the time of the vaccination, and laboratory work was performed.  The results of the laboratory work were not reported.  The ADACEL was administered on 16/Aug/2006, not 26/Aug/2006 as previously reported.  The ADACEL was a booster dose for the patient.  The patient's recovery status was not reported.  Follow-up information received on 29/Sep/2006 from a health care provider.  The patient recovered completely by 31/Aug/2006.
1)  No swelling but Grade 3 adverse reaction at injection site, including severe pain for 2 days, then moderate pain for 2 days, then limited use of range of left arm (injected arm) for another 2 days; 2)  Sever systemic Grade 3 adverse reaction including fatigue, malaise, extreme chills and teeth chattering for hours, even under electric blanket, nausea, night sweats, headache, difficulty sleeping due to pain.
Severe body aches began at 11pm on 4/8. Then, a high fever - the worst fever I?ve ever had in my life. That lasted until 8am on 4/9. Now, I have chills and nausea - still ongoing.