chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After my second dose, within 8 hours I had muscle construction throughout my body, fever, severe migraine, extreme fatigue. Within a few days I could not move my head, lymph nodes in my neck, trouble from pain lifting my head. I was in bed 13 days and over three months I was having chronic fatigue, rashes, muscle pain from my hips to my feet with stiffness, difficulty breathing, pain in my thorax, heart racing, vertigo. Four months later rt upper quadrant pain, crossing over under my ribs. Difficulty swallowing pain in my neck. I spoke with a different doctor office 1 month post second vaccine was told to take Motrin and warm packs and that was all. I?ve never regained my energy and still have body stiffness and arthritis type symptoms and overall unwell.
Improperly stored vaccine administered; No adverse effects; This spontaneous report was received from a nurse referring unspecified patients of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored M-M-R II lot # N013295, expiration date: 28-APR-2019; lot # N025894, expiry date: 19-SEP-2019, therapy type rHA (strength, dose number, dose, unit, route and anatomical location were not reported) for prophylaxis (product storage error). Other suspect therapies which were improperly stored included ROTATEQ lot # N022015, expiry date: 10-MAR-2019, LIQUID PEDVAXHIB lot # M032148, expiry date: unknown for prophylaxis and sterile diluent (was used as reconstitute) (strength, dose number, dose, unit, route and anatomical location were not reported). The administered doses of the vaccines experienced temperature excursion from 47ºF to 9 Degree Celsius (48.2ºF) for 4 hours and there was no previous temperature excursion. The action taken with sterile diluent with respect to all the events was not reported. The call was due to digital data logger. No adverse effects were reported. The outcome of product storage error was unknown. No product quality complaint (PQC) was involved.
Patient called and stated that the 4 hours after receiving the vaccine, she got localized swelling at the site of the injection and mild fever. The swelling area got larger and became little discolored and bluish. She took Acetaminophen 500 mg and went to urgent care next day (Aug 13th). The swelling started to go down on Aug 13th and was resolved the same day. She did not take any medication for swelling.
1:20AM - chills, shakes and a temperature, Felt like the flu. I waited till the morning. 5AM took Tylenol and took Advil 3 hours late. Rotated both meds. It lasted for 2 days. 2nd day was less severe. 2 days - Tylenol and Advil few days, headache, temperature.
Diarrhea, chills, tiredness, fatigue, anxiety, insomnia, aching joints, aching muscles, headache, dizziness.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).  On 06-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) (Therapy type: Digital Data Logger), lot number S003448 and expiration date 04-FEB-2021 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided). The sterile diluent (MERCK STERILE DILUENT) used for reconstitution was properly stored (lot number S025291 had not been valid upon internal validation; expiration date 23-APR-2022).  The vaccine was stored at a temperature from 6 degree Fahrenheit to 14 degree Fahrenheit (7.2 Fahrenheit), for a timeframe of 25 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter; Sender's Comments:  US-009507513-2001USA009007:
This is a spontaneous report from a contactable physician via a Pfizer sales Representative. A female patient of an unspecified age and race/ethnicity received the 2nd single dose of TRUMENBA via an unspecified route of administration, on an unspecified date, for immunisation. Concomitant medication included influenza vaccine on the same unspecified date, for immunisation. The patient medical history was not reported. Since an unspecified date the patient was achy and experienced bronchitis (5 days later), flu nasal congestion, cough, no known fever, difficulty sleeping and crusty eyes. Events outcome was unknown.
Within 2 days of my first covid vaccine, I had an outbreak of a herpes cold sore on mouth (HSV1) and genital area (HSV2).  Lasted about a week. Before this outbreak, I had not had any outbreaks of HSV in 5 years. This outbreak was only the third outbreak I have had in my lifetime. I received my second Covid vaccine on 3/17/21. About 2 or 3 days later, the same reaction occured. I developed an outbreak, just like after my first Covid vaccine.
Narrative:  Patient received four doses COVID 19 vaccine in Jan/Feb/Apr/Oct 2021. The patient tested positive for COVID 19 on 24 Oct 2022. The patient presented to the ED with shortness of breath, cough, and fever. The patient was admitted with aspiration pneumonia, sepsis, and hypoxia. The patient was treated with antibiotics, oxygen, and steroids. The patient was discharged in stable condition on 4 Nov 2022. Reported per EUA.
Blood Clot; left knee had red marks above it; pain in thigh; swelling from the knee up to the thigh; left knee was in pain tremendously; difficulaty walking; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood Clot) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 GAIT DISTURBANCE (difficulaty walking) and ARTHRALGIA (left knee was in pain tremendously). On 16-Jan-2021, the patient experienced ERYTHEMA (left knee had red marks above it), PAIN IN EXTREMITY (pain in thigh) and JOINT SWELLING (swelling from the knee up to the thigh). On an unknown date, the patient experienced THROMBOSIS (Blood Clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood Clot), GAIT DISTURBANCE (difficulaty walking), ERYTHEMA (left knee had red marks above it), PAIN IN EXTREMITY (pain in thigh), JOINT SWELLING (swelling from the knee up to the thigh) and ARTHRALGIA (left knee was in pain tremendously) 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.   Concomitant medications like high blood pressure medication, cholesterol medication and medication for irregular heartbeat were reported.  On 15 Jan2021, the patient said that his left knee was in pain tremendously and had difficulty walking. On 16 JAN 2021, the left knee had Red marks above it. He also had swelling from the knee up to the thigh. He also experienced pain in the thigh and knee. He went to the doctor on 20 JAN 2021 and was sent for an ultrasound. The doctor thought it could be related blood clot. No laboratory details were provided.  On 20-Jan-2021, the patient was sent for an ultra sound, results unknown.  Treatment included ibuprofen and paracetamol.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Initially: Parathesia in right leg. Other altered sensations progressed to right and left legs, some in arms/back.
Manufacture's package: Measles+Mumps+Rubella+Varicella (ProQuad) is for children 12 months to  12yrs of age. Vaccine administered to child older than 12yrs.
Rheumatoid arthritis flare up; This is a solicited report based on information received by Pfizer from Regulatory Authority (Manufacturer Control Number: 21K-163-4107859-00). A contactable 56-year-old female consumer (Patient) reported that:  Solicited report from the Regulatory Authority by a consumer of an adult female with an event of non-serious rheumatoid arthritis flare up with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced rheumatoid arthritis flare up. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received 1st and 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech.   Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of rheumatoid arthritis flare up unknown onset was not provided. Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) The reporter's causality for the event(s) of rheumatoid arthritis flare up unknown onset was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of event rheumatoid arthritis flare up cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included neuropathy peripheral (peripheral neuropathy on the suboccipital neuralgia), pneumonia and shingles. Previously administered products included antidepressant, opioids and calcium channel drugs. Concurrent medical conditions included pain. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown. It was unknown if the reporter considered the unexpected therapeutic effect to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's father. The age at vaccination was not reported. The patient had pneumonia and all the sudden she started having Peripheral Neuropathy on the suboccipital neuralgia (PHN). Investigating physician was suspecting that it was PHN related to the shingles. Even though the patient did not get a rash, physician believes she had symptoms that were related to PHN due to shingles. At the time of this report, the physician was investigating the cause. The patient had been on opioids, antidepressant, calcium channel drugs and all sort of drugs to treat her pain and the reporter had been struggling with that for 5 years. The reporter stated that, his daughter then had the first SHINGRIX injection and all the pain went away for 3 to 4 days. Then it would come back. The reporter wanted to let the company know, that it could be worth investigating using SHINGRIX vaccine for other indications. This case has been linked to the US2018GSK138666, reported by the same reporter.
BURNING IMMEDIATELY DURING VACCINE ADMINISTRATION; PAIN IMMEDIATELY DURING VACCINE ADMINISTRATION; This spontaneous report received from a pharmacist concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced burning immediately during vaccine administration, and pain immediately during vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning immediately during vaccine administration and pain immediately during vaccine administration was not reported. This report was non-serious.
Moderate pain at the injection site for 36 hours, fatigue 24-48 hours post-vaccination.
Patient complained of dizziness, feeling faint,  racing pulse and  flush of heat all over after 15 minutes in waiting room.  Patient taken to exam room at 5 pm and lied back on exam table with head elevated 45 degrees.  B/P taken at 5 pm 118/88 in left arm sitting,  apical pulse 76 and O2 Sat 100% on room air.  Patient denied chest pain or shortness of breath.  Patient states she has anxiety and fear of needle.  Patient drank a cup of water,  instructed on slow deep breathed.  after being observed for 15 minutes,  patient stated she was feeling better.  Spouse at bedside as well.  Patient observed another five minutes and BP retaken at 520 pm was 116/88 left arm sitting.  Patient states she feel well enough to go home.  Spouse states that she will drive patient.  Instructed patient on slowly sitting up,  then slowly standing.  patient denied dizziness upon leaving at 520pm approx.  patient mood laughing a joking upon leaving.  Patient left in stable condition.  Instructed patient to seek medical attention with any chest pain or SOB.
Pain in left arm deltoid travels to neck w/ mild headache 2/10 pain - pain (sharp) in elbow to wrist. Numb in forearm - slight tingling of fingers. Reaction began at time of injection (8:00 AM) and continued to worsen with soreness beginning in deltoid, and traveling to neck, head, shoulder, and forearm. Muscle spasm left side of neck followed by (mild) dizziness.
Patient received a flu shot on oct 4, and came back today to get Fluzone high dose, no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 70 years old female patient who received a dose of INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site on 04-Oct-2019 and another dose of flu shot (INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE) (Fluzone High Dose) lot UJ251AB via intramuscular route in the right arm on 15-Oct-2019.   The patient's past vaccination(s) included a dose of PNEUMOCOCCAL VACCINE. The patient's past medical history, medical treatment(s) and family history were not provided.   It was a case of actual medication error due to the extra dose administered.   At the time of reporting, the patient had no adverse 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 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.
Received Zostavax vaccine 11/15/06 within 24 hours noted painful, swollen arm. Seen in office 11/17/06 left arm 4x4 cm erythematous, painful swollen area.
headache; really hot chills; body aches; This is a spontaneous report received from a Non-contactable consumer (patient). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date as first dose single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that after the administration, the patient experienced severe headache, really hot chills, and body aches. patient took 2 Advils which helped relieve the symptoms. The next day, she had the same symptoms, and for that she did the same took 2 Advils again, and then felt fine afterwards. After two weeks patient still had headaches hurt so bad, she finds it difficult to open her eyes. she also said she went back to the facility from where she received the vaccine and was told to go to the emergency room. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient had swelling about the size of a tennis ball, red, hot, and painful area later the evening after vaccination. Patient reported the area was painful upon moving the arm and hurt to touch on 10/26/2020. Patient showed me the area to report the adverse event on 10/28/2020, area still red and a bit swollen. said it did not hurt upon moving her arm but still sore when pressing on area, area was not hot to the touch. Patient did not follow up with primary care provider due to issue getting better. I informed her to follow up and to keep monitoring it, and if it gets work or signs of infection to follow up with medical care.
swetted down; Diarrhoea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (swetted down), DIARRHOEA (Diarrhoea), VOMITING (Vomiting) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 14-Feb-2021, the patient experienced HYPERHIDROSIS (swetted down), DIARRHOEA (Diarrhoea), VOMITING (Vomiting) and PYREXIA (Fever). At the time of the report, HYPERHIDROSIS (swetted down), DIARRHOEA (Diarrhoea), VOMITING (Vomiting) and PYREXIA (Fever) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: 2nd dose details provided and action take with drug updated accordingly. New events details added associated with 2nd dose. Patient's contact information updated.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 9-year-old female patient who received FLUARIX. Concurrent medical conditions included allergy (unspecified allergies). On 12th November 2015, the patient received the 1st dose of Flu vaccine. On 12th November 2015, 12 hrs after receiving Flu vaccine, the patient experienced fever. The patient was treated with ADVIL and TYLENOL. On 12th November 2015, the outcome of the fever was recovered/resolved. The reporter considered the fever to be possibly related to Flu vaccine. Additional details provided were as follows: This case was reported by the patient's father. The patient had allergies on the day of her vaccination. The patient did not have a fever at the time of vaccination. On 12th November, within 12 hours after vaccination, the patient experienced fever, which then spiked to 102.2 degree F. The patient was treated with ADVIL and TYLENOL. The fever went away overnight. The patient's energy level was normal.
Metallic taste right after injection. Two days later I had joint pain, headache with congestion and more use of my asthma inhaler. These are still on-going as well as tightness through the chest and shoulders. Some coughing.
No additional adverse event reported; a patient who is 30 weeks pregnant was administered a GARDASIL 9; administered a GARDASIL 9 vaccine instead of a TD APP vaccine; This spontaneous prospective pregnancy report as received from a nurse practitioner referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 26-FEB-2020 the patient who was 30 weeks pregnant was administered a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602283, expiration date was reported as 16-AUG-2021, but upon internal validation established as 18-AUG-2021; dose and indication were not reported) for prophylaxis instead of a diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (TDAP) vaccine (exposure during pregnancy and wrong product administered). Verified this was not product confusion because the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was a syringe and the diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (TDAP) vaccine was a vial. The provider who administered the vaccine did not read the carton. No additional adverse event was reported. Last menstrual period (LMP) was assumed as 31-JUL-2019, date of conception was assumed as 14-AUG-2019 and the estimated due date (EDD) was 06-MAY-2020.
leaking syringe during second administration; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (leaking syringe during second administration) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 031A21A) for COVID-19 vaccination.     The patient's past medical history included Liver transplant. Concomitant products included TACROLIMUS, LISINOPRIL and VITAMIN D NOS for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced UNDERDOSE (leaking syringe during second administration). On 21-Apr-2021, UNDERDOSE (leaking syringe during second administration) had resolved.            The Action taken in response to m-RNA 1273 was considered to be not applicable.
Patient describes very painful range of motion movement. Patient states right arm is very painful to move since October.
(R) arm upper side hot and red. (L) arm upper & lower side hot and red. Cool compress, TYLENOL.
Patient presented with some redness and warmth in the left arm approximately 3-4 inches below injection site.