chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to an unspecified number of unknown patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M020926 and expiry date 11-AUG-2018)(dosing regimen unknown). No adverse effects reported. The vaccine was exposed to temperature excursion of 61 F for 39 hours. No previous temperature excursion was reported. No product quality complaint was filed. Additional information has been requested.
5x3cm area of erythema, warmth, edema and tenderness around injection site.
Patient did not have any issues.  They were 17 at the time of administration and current guidelines are for patients 18 years and older.
Initial red spot at injection site disappeared after a day but on February 23rd it reactivated for 2 days. Very red and hot to the touch, spreading to 3 inch diameter.  This seemed unusual since it had been fine for a full week before the flare-up.
"chills, fever, and felt like he was paralyzed, stating he couldn't get up out of bed" Narrative:
localized, inflammatory reaching rt upper area approx 3x4 inches area red, swollen & warm to touch pain & itching; tx DPH, warm moist compresses to area-no sports-APAP PRN;
Initial and follow up information has been received from a nurse practitioner concerning an 18 year old white female patient who on 18-JUL-2007, was vaccinated with a first 0.5ml dose of GARDASIL vaccine (yeast) (Lot# 657737/0522U). On 18-AUG-2007 a month later (4 weeks after her last menstrual period), the patient found out she was pregnant. The date of her last menstrual period was reported to be 17-JUN-2007. Her estimated delivery date was reported as 25-MAR-2008. Her pregnancy was confirmed by lab work and an ultrasound. It was reported that the patient had a total of 4 ultrasounds and al were within normal limits (WNL). Prenatal vitamins were reported to be taken during the pregnancy. The patient has not had any previous pregnancies or previous live births. On approximately 30-DEC-2007, 28 weeks from her last menstrual period, the patient developed gestational diabetes. On 14-MAR-2008, the patient gave birth to a liveborn infant male weighing 7 pounds 15 ounces. The infant was reported to be normal. It was unknown if the infant had any congenital anomalies or if there were any complications. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Janssen COVID-19 Vaccine EUA. Fatigue, hypersomnia, painful white blisters on tongue and in throat, laryngitis, headache, difficulty breathing (more severe than pre-vaccine) Started 5 days after vaccination. Symptoms have not subsided 17 days after vaccination.
Pt developed larg bruising and swelling in both axilla, this lasted several months.  Now has some small patches of purpura in axilla witch itch.
headache immediately, pain in mouth similar to tooth ache, after using mouthwash mouth felt like it was on fire, saturday night feeling of electrical shocks throughout body, small circles appeared on arm , monday a migraine headache developed on left temple
Information has been received from a registered nurse concerning a pediatric male patient who in approximately October 2006 ("about a month ago"), was vaccinated with a dose of Pneumovax 23.  Concomitant vaccine therapy included a dose of influenza virus vaccine (unspecified).  "Shortly after" receiving the vaccine, the patient developed a fever.  Unspecified medical attention was sought.  Subsequently, the nurse believed that the patient recovered with no problems.  No product quality complaint was involved.  Additional information has been requested.
Chills, muscle aches especially neck but most muscles, headache. Lasted about 4 hours overall.  The next day I was very tired (not sleepy) and low energy, but after that I was back to normal.
breakthrough cases of COVID/ COVID symptoms that make sense right, malaise, cough; breakthrough cases of COVID/ COVID symptoms that make sense right, malaise, cough; she is not eating; This is a spontaneous report received from a contactable consumer (the child of the patient) from  group.  A 78 year-old female patient received BNT162b2, administration date 13Apr2021 (Lot number: ER8734, NDC number: 5926-1000-03) at the age of 78 years as dose 2, single and administration date 23Mar2021 (Batch/Lot number: unknown, NDC number: 59267-1000-03) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history (No other medical condition, she is very healthy). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "breakthrough cases of COVID/ COVID symptoms that make sense right, malaise, cough"; FEEDING DISORDER (non-serious), outcome "unknown", described as "she is not eating". The patient underwent SARS-COVID RNA test: positive. Clinical course: The reporting consumer (patient's child) and the patient came to visit from out of state for the holidays. They were fully vaccinated, the patient was vaccinated with Pfizer and the child's was Moderna and they both have breakthrough cases of COVID. The state only reports the breakthrough cases of the people who have died and who are either bedded or on ventilator in the hospital and that is not good enough for the patient and her child. They had no way to report their breakthrough cases, that was why the child was calling Pfizer directly. The child had signed the patient up for 'Monoclonal' anti body therapy (They did not call the patient back and then they called the patient on the seventh day and said too many fax order came on the top of "yours" and the child kept filing for the patient). The child knew there were other treatment, shots and because the patient is of (off) age, she did not get any help. The patient's weight was 120 pounds, probably a little less now, she is not eating. The patient was suffering from COVID symptoms that make sense right, malaise, cough.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Body rash like hives all over; Body rash like hives all over; itching; booster; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), at the age of 30 years old, via an unspecified route of administration in left arm on 25Oct2021 at 13:00 as dose 3 (booster), single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Patient had no COVID prior vaccination. It was unknown if patient had known allergies. Medical history was acidity. Patient did not receive other vaccine in four weeks. Concomitant medication in two weeks included omeprazole taken for acidity. The patient previously received the first dose of BNT162B2 (lot number: unknown) on 29Mar2021 (at the age of 29 years old) and the second dose of BNT162B2 (lot number: unknown) on 19Apr2021 (at the age of 30 years old), both in left arm at single dose for COVID-19 immunisation. The patient experienced body rash like hives all over and itching on 26Oct2021 at 18:30. Patient had to go to urgent care for help and medication. Events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if COVID had been tested post vaccination. Therapeutic measures were taken as a result of events and included treatment with two injections, diphenhydramine hydrochloride (BENADRYL) and other was dexamethoson. Outcome of events body rash like hives all over and itching was recovering. Outcome of other events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
pt recv vax;devel neck pain,hip pain & flu like sx;stabilized & fully recovered w/in 2 days;
This case was reported by a consumer via call center representative and described the occurrence of pain in a arm in a 73-year-old female patient who received SHINGRIX. Previously administered products included Flu shot with an associated reaction of pain in extremity. On 6th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, feeling unwell, weakness, lethargy, tiredness and body temperature increased. In March 2018, the outcome of the pain in arm, feeling unwell, weakness, lethargy, tiredness and body temperature increased were recovered/resolved. The reporter considered the pain in arm, feeling unwell, weakness, lethargy, tiredness and body temperature increased to be related to SHINGRIX. Additional details were provided as follows: The reporter was husband of the patient. The patient experienced events that occurred within 12 to 24 hours after receiving SHINGRIX. Arm soreness that occurred in left arm was greater than anything experienced with flu shots in the past. Specific name of flu shot was not provided. The events resolved within 36 hours after SHINGRIX dose. This case was linked with US2018049831 and US2018049818, reported by same reporter and with US2018GSK055557 for the same patient.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (welt), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (welt), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swollen). On 25-Jan-2021, VACCINATION SITE ERYTHEMA (redness) had resolved. At the time of the report, VACCINATION SITE URTICARIA (welt) had resolved and VACCINATION SITE SWELLING (swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
About 2 1/2 weeks after my first COVID vaccine I developed a case of shingles, Herpes zoster.
severe local rxn;saw MD 9OCT97;blood & fluid were removed by MD on 20CT97;cont med care;
Pt had Covid vaccine. 5 minutes after vaccine complained of tachycardia. HR initially to palpation was in the 220s. Pt assisted supine. Code Blue called per protocal. Dr. to room. Pts BPs were 160/80, 144/90, 140/84, and 138/80. HR 140, 134, and 123 bpm. O2 sat the whole time was 100% on RA. Pt c/o nausea and dizziness. Assisted to stretcher and brought to ER for evaluation. Pt state she had a previous history of Covid and anxiety but this experience felt different to her then her previous panic attacks. No rash, wheezing, oral swelling, pruitis.
I gave the patient her vaccine and when I went to apply a second bandaid, the patient passed out in the chair.  Her head went back with eyes wide open and she was unresponsive.  Within a minute she came back to and said that she was all tingly.  My technician came out with me and stayed with me till the ambulance arrived.  She kept going in and out of consciousness.  She did leave with the ambulance to go to the hospital
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 04-DEC-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Information has been received from a registered nurse concerning a 15-year-old white male who on 20-AUG-1992 and 24-AUG-2004 was vaccinated with the first and second doses of MMR II. Subsequently, the patient experienced mumps. It was noted that the patient visited the emergency room 2 to 3 times. Blood work done in the ER was not conclusive, and new blood work was pending at the time of the report. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information received from a registered nurse indicated that on 15-APR-2006, the patient developed fatigue and fever with parotid swelling. A mumps IgM Ab was borderline at 1.0. Additional information has been requested.
patient had redness in his arm and some pain. Patient went to MD office and was diagnosed with Cellulitis
erythematous macules/papules 48hr p/vax;from scalp to soles of feet & palms of hands;rash blanches;child fussy no other illness;
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with RECOMBIVAX HB (lot # L039660, exp 02-FEB-2018) for prophylaxis. On 2017 the patient experienced incorrect product storage.  On an unknown date the patient experienced no adverse event. This is one of several reports received from the same source. ; Sender's Comments: US-009507513-1707USA011495: US-009507513-1707USA011496: US-009507513-1707USA011478:
Sense of taste changed; Swollen lymph node (size of a golf ball); Painful lymph node; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Painful lymph node), TASTE DISORDER (Sense of taste changed), LYMPHADENOPATHY (Swollen lymph node (size of a golf ball)) and MYALGIA (Soreness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, QUETIAPINE FUMARATE (SEROQUEL), VALPROATE SEMISODIUM (DEPAKOTE), PRAVASTATIN, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced MYALGIA (Soreness). On 05-May-2021, the patient experienced LYMPH NODE PAIN (Painful lymph node) and LYMPHADENOPATHY (Swollen lymph node (size of a golf ball)). On 08-May-2021, the patient experienced TASTE DISORDER (Sense of taste changed). At the time of the report, LYMPH NODE PAIN (Painful lymph node), TASTE DISORDER (Sense of taste changed), LYMPHADENOPATHY (Swollen lymph node (size of a golf ball)) and MYALGIA (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Tylenol.
Second Dose:  Fatigue and weakness, headache, muscle pain in thighs and lower back, chills alternating with hot flashes for 36 hours; pain and tenderness at left arm injection site for 36 hours.  Tylenol tablets during 36 hours. First Dose:  Pain and tenderness at right arm injection site for 36 hours.  Tylenol tablets during 36 hours.
About 2.5 months after my 2nd vaccine, I developed problems with my heart including chest pain similar to a heart attack. I had no history of heart problems. I had to have an ablation on my heart, due to diagnosis of an electrical problem. I have since had to take blood pressure medication. I am not sure this is related to the vaccine, but I have no family nor personal history of electrical problems with the heart.
Soreness at injection site; Body aches; Tightness/pain in chest along sternum (vertical)
Initial information received on 07-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 61 years old female patient who experienced frozen arm and arm pain an stiffness, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Sep-2010, the patient received a dose of suspect FLUZONE QUADRIVALENT lot UI982AB via intramuscular route. The patient developed a non-serious frozen arm (Periarthritis) following the administration of FLUZONE QUADRIVALENT. The patient developed a non-serious arm pain an stiffness (musculoskeletal stiffness) following the administration of FLUZONE QUADRIVALENT. (Other relevant tests included No lab test.) Final diagnosis was arm pain an stiffness and frozen arm. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for frozen arm and as Unknown for arm pain an stiffness.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose number unknown, single (Lot number: EL9264) at the age of 78 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Known allergies: Adhesive" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN, start date: Sep2010, stop date: 23Oct2022. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: 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: (unspecified date) Positive, notes: COVID 19 Treatment; (Oct2022) Positive, notes: Tested positive again one week later. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Injection site was very red and itchy for 10 days following vaccine.  There was also a hot hard lump at the site of injection for 7 days. Site is occasionally still itchy presently, 20 days later.   Physically I felt fine, symptoms only at injection site.
Left eye swelling and feels like sand in it. Symptoms X 2 days. Eye consult given.
Patient reported that 24 hours post injection she developed a rash at the site of injection. The rash was described as being red without itch. The rash spontaneously resolved after 4 additional days.
Administration Error: Patient received a dose of Moderna on April 1, 2021. He received a dose of Janssen on 6/22. This was due to not preregistering and there was an incentive at this event.
Body aches, headaches, nausea lasting 30-40 hours.  Fatigue, weakness, feeling run down ongoing since time of initial dose of vaccine
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 13Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Hazelnuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment included Paxlovid from 28Mar2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a registered nurse (RN) concerning a phone call from the mother of a 6-year-old white male with no known drug allergy who on 09-MAY-2001 was vaccinated subcutaneously in the left thigh with a first dose of Varivax (lot# 637957/1882K). Concomitant therapy included a first dose of MMR II (lot# 638373/0164L) given subcutaneously in the right thigh. There was no illness at the time of vaccination. On 12-MAY-2006 the patient developed a rash described as small, pinpoint and red with blisters in some areas. The rash was in small clusters on his chest, back and neck and was itchy. No fever was reported. No medical attention was sought; no laboratory or diagnostic tests were performed. Additional information has been requested.
Extensive erythema and swelling of most of the arm inferior to the injection site developing < 24 hrs after injection.
Enlarged lymph node in R axilla (x 2 weeks), fever, chills, body aches w/i 12hrs after injection.
Fatigue, body aches, and chills that got worse into the afternoon the day after my vaccine, got up to a fever of 100.4 degrees. Went away with Tylenol but still felt fatigue. Still felt fatigue and some aches the next day. My arm stayed very sore for about 3-4 days after the vaccine and was very swollen, hot, and red in a large circle around the injection spot.
Severe rash, he was red from head to toe with no white spots on his body; Had surgery on his finger; Severe rash, he was red from head to toe with no white spots on his body; This spontaneous case was reported by a consumer and describes the occurrence of LIMB OPERATION (Had surgery on his finger), ERYTHEMA (Severe rash, he was red from head to toe with no white spots on his body) and RASH (Severe rash, he was red from head to toe with no white spots on his body) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced LIMB OPERATION (Had surgery on his finger). On 10-Mar-2021, the patient experienced RASH (Severe rash, he was red from head to toe with no white spots on his body). In March 2021, the patient experienced ERYTHEMA (Severe rash, he was red from head to toe with no white spots on his body). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) for Finger operation, at an unspecified dose and frequency and PREDNISONE for Rash generalised, at an unspecified dose and frequency. On 03-Mar-2021, LIMB OPERATION (Had surgery on his finger) had resolved. At the time of the report, ERYTHEMA (Severe rash, he was red from head to toe with no white spots on his body) and RASH (Severe rash, he was red from head to toe with no white spots on his body) had resolved.            On 03-Mar-2021, the patient had surgery on his finger and put sulfamethaxazole trimethoprim on it and due to the sulfas, it caused him a severe rash, he was red from head to toe with no white spots on his body. Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Outcome of the events updated.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient experienced injection site pain.