chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 60-year-old, adult, male patient. On 16-Oct-2018, temperature excursion of the vaccine occurred. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805010) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received on 13-Nov-2018: The reporter refused to provide the patient's initials. The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative and case comment were amended accordingly.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old patient who received SHINGRIX for prophylaxis. On 20th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown. It was unknown if the reporter considered the headache and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine yesterday from the reporting date and had common side effects such as headache and fever. The patient asked whether to take a fever reducer or cold medicine to counteract these side effects. The patient denied permission to contact their physician and said the patient would call their local pharmacy regarding the same issue. Further the patient told that the patient did not like to give too much information on the internet, and the patient already given more information than the patient was comfortable giving.
Immediate feeling of pain that shot down arm of left arm ("tendonitis-feeling") after receiving vaccine. Developed odd lower back and abdominal cramping 4 days later accompanied with loss of appetite. Provider thinks possible colitis but unsure.
COVID 19 Treatment; COVID 19 Treatment; Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Moderna/ Dose #4: Pfizer/ Dose #5: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2022 as dose 4 (booster), single (Lot number: FR9893) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Lot number: 010M20A), in left arm, on 10May2021 as dose 2, single (Lot number: 040M21A), in left arm, on 25Oct2021 as dose 3 (booster), single (Lot number: 091D21A), in left arm and on 12Sep2022 at 12:00 as dose 5 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative Colitis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "High Triglycerides" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE, start date: Jan2010; LOSARTAN, start date: Mar2020. Past drug history included: Novocaine, reaction(s): "Known allergies: Novocaine"; Codeine sensitive, reaction(s): "Known allergies: codeine sensitive". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20May2022, outcome "unknown", described as "Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Moderna/ Dose #4: Pfizer/ Dose #5: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
She has begun having weakness and neuropathy of all 4 extremities that is worsening, concerning for Guillain Barre.  She has been referred to neurology and instructed not to get the second dose of the vaccine.
NSTEMI; Pulmonary Embolism; left upper arm thrombosis; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 22Mar2021 (at the age of 48-years-old) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other vaccine received in four weeks. On 15Apr21, the patient presented to hospital with complaints of dyspnea, chest pain and arm swelling. The patient was found to have left upper arm thrombosis, pulmonary embolism, and NSTEMI. The adverse events started on 15Apr2021 and resulted in emergency room/department or urgent care visit, hospitalization on 15Apr2021 and life-threatening illness (immediate risk of death from the events). An unspecified treatment was received in response to the events. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Child came in for immunizations on 3/10/04,child was given DTAP#4 IM to Rt. thigh, IPV#3 sq to Lt. upper thigh,Hib#4 IM to Lt. lower thigh and child also received tb (Mantoux).  Pt. returned for ppd reading on 3/12/04 and child also presented with 4x4" area of redness, swelling,and hot to touch, to Right thigh.  Pt was examined by the pediatrician on duty and was discharged on Keflex 250mg/5ml po q6hrs. and hydrocortisone 1% cream.  Follow-up phone call was made on 3/15/04 and mother states Rt. thigh swelling and redness had cleared.  Pt. was also re-examined on 3/22/04.
Patient given 4 go shots (DTAP, IPV, MMR, VZV KINREX) 2 days ago L arm developed redness and induration with elevated warming with mild tenderness. No fever.
Pt woke me up about 11:30 pm and it scared me because I did not recognize his voice. He sounded extremly hoarse, he was very pale, skin was cold and clammy and wheezing. He said he was having much trouble breathing (getting his breath). I called the emergency dept. and spoke with them relayed Pt's symptoms and I asked if this was a reaction to the flu vaccine I was told they did not think so that any symptoms occurred 10 to 12 hours after the shot. We then made the pt as comfortable as possible and it seemed to start to give him some sort of ease. About two this morning he finally dosed off into a fitful sleep this was on and off for the rest of the night, extreme chills, sweats, nausea persisted. This morning he was still having the occasional chill, very weak, lightheaded, and the breathing problem was much better but uneasy feeling was still here. His eyes are very red, his skin is a little pale and his head hurts. He states he still feels nothing like he did last night. The pt is a owner operator and we had to cancel todays load and Friday's load. It is impossible to drive in this condition. I called and was told to fill this form out.
Patient called and reported she had a fever and redness, pain, and swelling at the injection site that started the day after the injection and continued for 3-4 days. Sore knot then developed. Instructed to come in for evaluation if symptoms persisted or she had any concerns about the site.
Began with localized soreness.   Began to have some  axillary tenderness with increase in axillary nodes right side.   Began to spread to chest with mild chest wall swelling lateral to right nipple extending about half way down chest.  Non tender.  No rash associated with this.
when she drew titers on the patient, she was not immune; when she drew titers on the patient, she was not immune; when she drew titers on the patient, she was not immune; This spontaneous report as received from a nurse practitioner refers to a 24-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, when the patient was a child, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 0.5 milliliter, subcutaneous (lot # and expiration date were not reported) for routine vaccination.        On an unknown date, the patient had drew titers on her and she was not immune.  The outcome of the event was not reported. Causality assessment was not provided.
This spontaneous report as received from a 68 year old female consumer refers to herself with cancer. She once had a reaction in the back of her neck to meloxicam. On 03-OCT-2013 the patient was vaccinated with ZOSTAVAX  (dose, frequency, route, lot# and expiration date unknown). Approximately on 04-OCT-2013 the patient experienced a big, red, painful spot with radiating heat at the injection site about one day after receiving her ZOSTAVAX. The symptoms lasted approximately three to four days. No lab diagnostics studies were performed. The patient didn't seek medical attention. The events were improved on therapy and the patient was recovered from the events on an unspecified date in October 2013. No product quality complaint (PQC) was reproted. This is one of several reports from the same source. Additional information has been requested.
11 days after vaccination itchy hives appear all over body (arms, legs, abdomen, back, neck, head, forehead, and waist). Flare ups occur on different body parts at different times. Three days after symptom onset hands and feet are slighty swollen. 50mg of Diphenhydramine every 4 hours helps the itching somewhat.
This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant therapies provided. On 03-JUN-2017, the patient was vaccinated with a first dose of GARDASIL 9 (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis. At reporting time, the reporter stated that the patient would like to receive a second dose of GARDASIL 9. No adverse symptoms were reported.
Nine days post vax pt experienced 8-10 lesions and was presented to physician with symptoms. Pt was afebrile.
Non-stop crying for 5 hours, tiredness, paleness, mild fever, loss of apetite, fussiness, heavy breathing, unusual behavior. Tenderness, redness & swelling & cramping at injection site (right leg). I was told to just continue with the baby Tylenol.
Swelling, erythema and tenderness of (L) upper arm 24 hrs after receiving DTaP and HIB vaccines.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ orally (lot#, expiration date, dose were unspecified). Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient experienced low grade fever, weakness, aches, stomach upset from 9-16-10 to 9-20-10. Ibuprofen taken to alleviate symptoms.
PT SEEN VMH ER 5/3/21 BY DR, PARESTHESIA, VACCINE REACTION, INITIAL ENCOUNTER, LEFT SIDED PARESTHESIA, UNCERTAIN ETIOLOGY, NEGATIVE SCANS, NEGATIVE WORK UP, NO OBVIOUS FOCAL NEUROLOGIC DEFICITS BEYOND PARETHESIAS, LIKE IS REACTION ITSELF OR POTENTIALLY MIGRAINE VARIANT TRIGGERED BY VACCINE, RECEIVED SECOND MODERNA VACCINE 4 DAYS AGO, FLU LIKE S/S DAY AFTER, FELT BETTER, LAST NIGHT STARTED DEVELOPING PAESTHESIA ON LEFT SIDE, FACE, ARM AND LEG, DID SPRAIN ANKLE COUPLE WEEKS AGO, NO HEADACHE NOW, NO VISUAL ACUITY CHANGES, NO MIRGAINE HISTORY, NO HEAD TRAUMA, DISCHARGED HOME, RETURN PRN. NO MEDICATIONS HERE, TYLENOL OR IBUPROFEN PRN.
Suspected vaccination failure/got shingles on my head; Shingles on head; PHN bad; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix.     Additional Information: GSK receipt date: 21-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient reported that he/she need to speak to the physician about his/her experience with Shingrix. The patient got the shingles on his/her head and have had post herpetic neuralgia bad. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As post herpetic neuralgia is a sign and symptom of shingles, conservatively outcome was captured as not recovered for both the events.
Patient received two Pfizer-bioNTech vaccinacation on the same day by accident. Received both doses in a time span of 5 minutes apart.  (Received both doses in left arm). Patient kept in observation room for 30 minutes after time of vaccination to monitor for any adverse events.  Patient will contact nursing supervisor if any severe adverse events occur within the week.
Dizziness, blurred vision, flushing, blotchy skin, and feeling a warming sensation starting in my face then moving to my arms and hands then moving to my legs and feet.  These sympoms lasted about an hour and a half.
Red areas to arm of injection site; warm to touch. Reports arm was approximately 1" to 1.5" larger than other arm. Firm and tender to touch. Had 1"x1" bruise to injection site. Below that, there was a 1"x1/2" red mark below that there was a 3/4"x1/8" red mark.
after she has received this shot her blood sugar has increased on Jan2021; it is higher than usual; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 11Jan2021 to 11Jan2021 at a single dose for COVID-19 immunization. Medical history included diabetic. It was reported that the patient got the COVID vaccine and she have diabetes after she has received this shot her blood sugar has increased on Jan2021; it is higher than usual. The outcome of the event was unknown.
Presented wtih cough, congestion, HA, mild hypoxia; CXR: Atypical PNA Dx: Acute respiratory distress due to COVID-19 virus secondary to COVID-19 pneumonia; Labs: D-dimere 0.79; CRP: 34.61;  Tx: oxygen, remdesivir, zinc, vitamin-C, dexamethasone 12/31 still desats with activity on room air; cont remdesivir and low O2; 1/2 normal sats with walking on room air; dc without O2
Moderna COVID-19 Vaccine   About 9 days after receiving the first shot, the injection site started itching in the evening, and by the next morning a large pink circle formed around the site and it was very warm to the touch. As of right now (Sunday afternoon, May 16) it remains the same size and color, itchy, tender, and warm.
Patient with 2 COVID vaccines who admiytted with muscle pain and positive COVID test.  She has history of  long chain acid Acetyl COA dehydrogenase deficiency.  Presented with generalized pain has had similar pains and multiple admissions.  No hypoxia noted during stay.
HOT; UPPER BACK PAIN; STUFFY NOSE; RECURRENT FEVER; NAUSEA; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 110 pounds, and height was 62.4 inches. The patient's past medical history included anaphylactic reaction to penicillin, and anaphylactic reaction to sulfa drug, and concurrent conditions included non alocoholic, and nonsmoker, and other pre-existing medical conditions included the patient had no history of drug abuse or drug illicit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced hot. On 10-MAR-2021, the subject experienced upper back pain. On 10-MAR-2021, the subject experienced stuffy nose. On 10-MAR-2021, the subject experienced recurrent fever. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) LOW TEMPERATURE not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from recurrent fever, nausea, and headache on 13-MAR-2021, and had not recovered from hot, upper back pain, fatigue, and stuffy nose. This report was non-serious.
Patient developed cellulitis, redness, heat and swelling on right thigh secondary to injection.
Facial numbness, finger numbness on both hands (numbness developed 3 days after vaccine & has persisted 10 days post-vaccine), fatigue (marked 3 days post-vaccine through 10 days post-vaccine), left armpit pain/tenderness (developed 6 days post- vaccine), mild headache all 10 days post-vaccine
1st 48 hours left arm was really sore. Lymph nodes - severely was painful and swollen - noticed this on January 4th and I went to urgent Care  that same day - and they couldn't do anything. 11 days about before swelling went down and it resolved.
Severe Shoulder pain at injection site (Left Deltoid); Unable to lift arm (left arm); This non-serious case was reported by a physician via call center representative and described the occurrence of injection site pain in a male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9B2Y4, expiry date 20-OCT-2024) for prophylaxis.   On 03-SEP-2023, the patient received Arexvy (intramuscular, left deltoid). On 03-SEP-2023, less than a day after receiving Arexvy, the patient experienced injection site pain (Verbatim: Severe Shoulder pain at injection site (Left Deltoid)) and injected limb mobility decreased (Verbatim: Unable to lift arm (left arm)).  The outcome of the injection site pain and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to Arexvy.     It was unknown if the company considered the injection site pain and injected limb mobility decreased to be related to Arexvy.   Additional Information: GSK receipt date: 03-SEP-2023 The patient and received the RSV vaccine today around 12 noon and within a couple of hours the patient was having shoulder pain and what the patient meant by shoulder pain was could not raise arm on the side of the injection.  The HCP left message on after hours VM box, stated could call phone number provided to obtain additional information.  However, specific details for Safety team follow-up was not provided.
I have had a dull ache in this arm since I got the injection; Over the last few days a knot has developed in the muscle. (At least-- that's what it feels like.) It is causing soreness in my neck and shoulder as well.; Over the last few days a knot has developed in the muscle. (At least-- that's what it feels like.) It is causing soreness in my neck and shoulder as well.; Over the last few days a knot has developed in the muscle. (At least-- that's what it feels like.) It is causing soreness in my neck and shoulder as well.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 30Mar2021 at 16:00 at the age of 48-years-old as a single dose for COVID-19 immunisation. Medical history included asthma, arthritis, blood pressure high (HBP), and known allergies to several food and environmental allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included SINGULAIR, ZOLOFT, PROCARDIA, METFORMIN, and TIZANIDIN, all for unknown indication from unknown date unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received VIOXX for an unknown indication on an unknown date and experienced drug allergy. On 30Mar2021 at 21:00, the patient experienced a dull ache in this arm since she got the injection. On an unknown date in 2021, over the last few days, the patient experienced a knot had developed in the muscle (at least-- that's what it feels like) and it was causing soreness in her neck and shoulder as well. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with antiinflammatories, ice, and rest. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a dull ache in this arm since she got the injection, a knot had developed in the muscle (at least-- that's what it feels like) and it was causing soreness in her neck and shoulder as well was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Started with low fever, 101 degrees, progressed to 103 on 01/18/2013, reached as high as 104.9. Used OTC children's Motrin, fever has not gone below 101. Complains of fever aches and chills and pain in chest, congestion and sore throat. Calls made to office to report effects to both children who received the vaccine, brother age 15 also has same reaction with slightly lower fever.
Patient received an improperly stored vaccine; This spontaneous report was received from a nurse and refers to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-OCT-2020, the patient was vaccinated with the first dose of improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) therapy type rHa, lot# T009929 has been verified to be a valid lot number, expiration date 16-SEP-2021 (exact dose, route and site of administration were not provided) for prophylaxis. The temperature excursion was - 6.6 Celsius degrees (C) for 1 hour and 45 minutes. There were no previous temperature excursion. The digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA010348: US-009507513-2010USA010299:
Hives, red patches in skin, itchy areas, anaphylaxis, still continues to this day
1) fever x 3 days. 2) arm swelling x 3 days. 3) muscle aches.
Report of AFIB on 11/22/2021, went to the Dr and had EKG said shows signs of past Heart Attack
Redness & soreness to elbow lasting 5 days pt did not report until 4/29/04. Inj. date 4/21/04.