chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My left arm has been sore for the last 5 weeks since the shot; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Em 9808) via an unspecified route of administration administered in arm left on 07Feb2021 09:00 AM as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Facility type vaccine was reported as other. The patient was not tested with Covid infection prior to Covid vaccination. The patient was not on any other vaccine four weeks prior to Covid vaccine. The patient was not on any other medications two weeks prior to Covid vaccine. On 07Feb2021 at 10:00 AM, the patient experienced left arm had been sore and was there for the last 5 weeks since the shot. The patient had not received any treatment medication for the resulted events. The patient received Pfizer other vaccine (unspecified) on 26Feb2021 on left arm. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information was expected.
below the injection site / hot /  and warm to touch; below the injection site  pink; This case was reported by a consumer via call center representative and described the occurrence of skin warm in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 4th January 2021, less than a day after receiving Shingrix, the patient experienced skin warm and skin red. On an unknown date, the outcome of the skin warm and skin red were not recovered/not resolved.   It was unknown if the reporter considered the skin warm and skin red to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, after vaccination just below the injection site, the patient had 2 inch circle which was hot, pink and warm to the touch. The reporter did not consent to follow up.
Intermittent throat swelling, lasting 5-10 seconds, resolving spontaneously. Associated chest tightness/pressure/pain. BP 140/85, HR 55, O2 99%. Orange juice/crackers given. Stable and released.
This is a spontaneous report from a contactable physician and from Pfizer Consumer Healthcare for a contactable Pfizer sales representative. This physician reported different events with the same suspect product for four patients. This is the fourth of four reports. A 90-year-old female received PREVNAR 13 (lot J67644, expiry date Mar2016) at 0.5 ml single, intramuscular, in left deltoid, on 15Jan2015 at 13:00. Medical history included allergy to ZOLOFT and ACE inhibitors. Concomitant medications were not provided. On an unspecified date 6 days after vaccination, the patient experienced a large local reaction. The patient was treated with antihistamines and antibiotic. Event outcome was unknown at time of report. The Pfizer sales representative mentioned that the doctor believed that the reactions were experienced by the patient because of the PREVNAR 13. Follow up (23Jan2015): New information from Pfizer Consumer Healthcare for a contactable Pfizer sales representative includes causality assessment. Follow up (18Feb2015): New information from a contactable Nurse on behalf of Physician includes: patient age and gender, past drug history, vaccination date, route and anatomical location of administration, event onset latency, treatments received. Follow-up attempts completed. No further information expected.
have not gotten my period; heart palpitate; my tongue went numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Aug2021 (Lot number: FF8839) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "anemia" (unspecified if ongoing); "mitral valve prolapse" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]. Past drug history included: Aspirin, reaction(s): "known allergies: aspirin". The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "have not gotten my period"; PALPITATIONS (non-serious), outcome "recovered", described as "heart palpitate"; HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "my tongue went numb". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Facility type vaccine: Pharmacy or Drug Store, Other medications in two weeks: only vitamins: D, Multi, After the first dose, she felt her heart palpitate but it went away quickly. Then her tongue went numb. She was checked out by an RN who said she was ok. She also had not gotten her period since the vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101372458 same patient and drug, different AE and dose
Admitted to hospital with breakthrough COVID infection. Symptomatic starting 1/8/22. Admitted to hospital 1/17/22.
Information has been received via a company representative, from a pharmacist who stated that a registered nurse informed him of a 78 year old male patient, who on 19-MAR-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 658200/0804U). On approximately 19-MAR-2008 or 20-MAR-2008, the patient developed an injection site reaction, with redness and swelling from the elbow to the shoulder. The patient called the nurse's office, and was instructed to treat the symptoms with ice and acetaminophen (TYLENOL). On 24-MAR-2008, the patient informed the nurse that the symptoms had subsided. Additional information has been requested.
no immediate side effects, Onset of side effects was the next day with sudden dizziness, nausea, headache, fatigue, myalgias, fever tmax 102, and left axillary lyphadenopathy. All symptoms except left axillary lymph nodes lasted x 6-7 hours and resolved quickly. The lymph nodes fet like golf balls and extender across left side of chest. This pain lasted about 4 days.
Coronavirus Concern      "can't taste or smell, coughing, sneezing, runny nose, body aches
Gained 8 lbs. beginning within days of 1st vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot Number: EL1283k), via an unspecified route of administration in the left arm on 21Jan2021 at 08:15 (at the age of 69-years-old), as single dose for COVID-19 immunisation. Medical history included diabetes from an unknown date. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), quinapril (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), VICTOZA for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 25Jan2021, the patient reported that had not gained weight in last years, however post first dose of  vaccination within days gained 8 lbs. No therapeutic measures were taken for the event. The clinical outcome of the event weight gain was unknown.   No follow-up attempts are needed. No further information is expected.
Swelling of tonsils; Swelling of eyelids; Sore throat; Tiny sores on tongue; Unbearable pain on neck; Swelling of fingers, knees and ankles; Facial swelling; Tiny sores on lips; Unbearable pain on elbows, wrists; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR HYPERTROPHY (swelling of tonsils), SWELLING OF EYELID (swelling of eyelids), OROPHARYNGEAL PAIN (sore throat), GLOSSODYNIA (tiny sores on tongue) and NECK PAIN (unbearable pain on neck) in a  patient of an unknown age and gender 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 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TONSILLAR HYPERTROPHY (swelling of tonsils), SWELLING OF EYELID (swelling of eyelids), OROPHARYNGEAL PAIN (sore throat), GLOSSODYNIA (tiny sores on tongue), NECK PAIN (unbearable pain on neck), JOINT SWELLING (swelling of fingers, knees and ankles), SWELLING FACE (facial swelling), CHEILITIS (tiny sores on lips) and ARTHRALGIA (unbearable pain on elbows, wrists). At the time of the report, TONSILLAR HYPERTROPHY (swelling of tonsils), SWELLING OF EYELID (swelling of eyelids), OROPHARYNGEAL PAIN (sore throat), GLOSSODYNIA (tiny sores on tongue), NECK PAIN (unbearable pain on neck), JOINT SWELLING (swelling of fingers, knees and ankles), SWELLING FACE (facial swelling), CHEILITIS (tiny sores on lips) and ARTHRALGIA (unbearable pain on elbows, wrists) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.
Headache (similar symptoms); Body aches (similar symptoms); This case was reported by a consumer via patient support programs and described the occurrence of headache in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th September 2022, the patient received the 1st dose of Shingles vaccine. On 20th September 2022, less than a day after receiving Shingles vaccine, the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were unknown.   The reporter considered the headache and general body pain to be possibly related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR136373   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comments: The reporter stated that the patient had similar symptoms in 2019 with her dose. Reporter stated patient had headache and body aches. The reporter considered the events might had been to be related to shingles vaccine. The reporter did not consent to follow up. Additional supportive information: For tolerance of 2nd dose refer case US2022AMR136373.; Sender's Comments:  US-GSK-US2022AMR136373:Same reporter/ 2nd dose
Red macular rash on trunk, neck, face and extremities, non itchy. Seen in out-patient office visit. Reassured.
I became Covid positive on 12/21/2022 - sore throat, achy, cough, congestion, sinus pain, headache - got paxlovid - symptoms lasted about 5 days. Then got rebound covid positive on 1/10/2023- symptoms were sore throuat, hedache, archy, cough, congestion, sinus pian, lethargy, headache - lasted about 3.5 days then just had cough and somewhat tired.
This spontaneous report was received from a nurse concerning to a 27 year old female patient. Patient's concurrent condition, medical history and concomitant medication were not provided. On 12-FEB-2019 the patient was vaccinated with PROQUAD, subcutaneously, for prophylaxis (strength, dose number, lot # and expiration date were not reported) instead of VARIVAX due to human error. No adverse effects were reported.
Patient received flu shot and after about an hour started feeling warm. He got a rash all over body (red) and bumpy. Went to doctor and was prescribed MEDROL Dose Pak. Pt is fine.
patient was nervous upon injection of vaccine. patient came to waiting room to wait for 15 minutes following injection. after 6 minutes, nurse observed patient. Was sitting in chair, appeared to be feeling fine. 7 minutes after receiving vaccine, nurse and receptionist heard a 'thud'. patient had fallen on floor. patient was aroused immediately. he had hit his head on the floor. he was oriented x3 to person, place and time/date. he states that he "fell asleep". He states he got dizzy, sick to his stomach and next thing he remembers was "people all around him". Patient was clammy and pale. patient's vitals were stable and he was assessed by healthcare provider. patient's grandmother accompanied patient to appt, she stated that patient had not eaten or drank anything this morning and that he was very nervous about his vaccine.
Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 24-Oct-2021. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant follow up received on 8 Jun 2022.
Patient received a second dose of Moderna Bivalent today and after inquiring with data it was noted she received a dose on 10/17/22 at a pharmacy per family member. No adverse reaction noted.
He seemed very tired and sluggish immediately after the MMR vaccine. The vaccinations he received that day were Measles, Mumps, Rubela (MMR), Hepatitis A & Varicella. His entire body seemed red and puffy. Before those shots, strangers commented on what a good baby he was. He was so happy, alert, well behaved and active. He started saying words at 11 months. After the shots, he cried more, he stopped making eye contact, he slept more. It was as if his development suddenly halted. I went back to work once he was 8 months old. When he was two the director of the day care center told me that there was something wrong. I asked therapists to evaluate him. They immediately recommended that I take him to the Developmental Center for a specialist. They said that he is very behind and he will need early intervention services. Center had a very long wait list. He was diagnosed at 2 years and 10 months with autism by Dr. Pt had early intervention services, OT, Speech therapy, General Education therapy without much improvement to his behaviors and cognitive development. He became aggressive, biting, kicking, scratching. All my discretionary income goes to find therapies, tutoring and treatments for my son so that he can become an independent adult. He is now in 6th grade and he continues to become so frustrated and anxious that he repeatedly elopes from the classroom. He is taking numerous anti psychotic medications and he was also reevaluated by Dr and pt is now diagnosed with Severe ADHD and autism.
Local swelling and erythema, and pain and general malaise.  Took 400mg Advil.  Later took Tyco #3 and more NSAID.  On 11/19/2010 could not get out of bed secondary to fevers, malaise.  Spiking fevers thoughout the day.  Also confusion and weakness, sweat, decreased appetite.  Diarrhea. Cont to take NSAIDs, and 6:00pm 11/19/10 started prednisone 15mg daily. 15mg prednisone on 11/20, then 10mg 11/21 and 11/22, and then 5mg 11/23.  Symptoms improved with initiation of prednisone, Sunday 11/22 was last day of fevers.
After receiving Hep B #2: She developed HTN/ringing in ears started 1/10 with visual distortions symptoms. Continue to increase. Visiting clinic and many physician. No answer or resolution. TC to us with info as noted - thinks its the Hep B vaccine. On7/14/10 waited 6 months to call.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned an 18 year old male. 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, intramuscular, batch number: 201A21A expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211038507,20211002617, 20211034734, 20211038269, 20211038411,20211039749, 20211038614, 20211039732, 20211038269, 20211038442 and 20211040433.
I woke up with a fever that night. It ran very high for 4 days. My arm was in extreme pain where I got the shots. I went to the emergency room, and they had to give me fluids because I have not been able to eat or drink. I finally drank some broth on Sunday and ate a few saltines, but that upset my stomach, so I just stuck with broth. My head feels like I am in a fog all the time.
This spontaneous report as received from a medical assistant refers to 5 patients of unknown age and gender. The patient's medical history was not reported. On unknown dates, the patient were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX lot # reported as L007216, expiration date reported as 03-MAR-2017 (dose, route and site of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 6.8 degrees Celsius for 5 hours 43 minutes. Data logger was involved. There were no previous excursion reported. Additional information has been requested.
Arm soreness and presyncope immediate reaction.  Severe Chills, Fever, Body aches, Nausea, headaches, dry mouth, mild cough nightmares onset delayed  12 hours and lasted 24 hours.  Persisted with mild symptoms of aches, headache and vivid dreams x 3 days. I had Covid December 9, 2020 and it felt like that.
on 9/19/21, patient had aphasia, right arm numbness and weakness, headache, enlarged and numb lips that lasted approximately 30 minutes and was observed by her mother before taking her to the ER.  Once at the ER, her symptoms were gone and she had a negative workup with CT and labs.
accidentally gave a Fluzone 0.5 ml pre-filled syringe to a patient yesterday with the expiration date of 2018; Initial information received on 04-Apr-2019 regarding an unsolicited valid non-serious case received from an- other healthcare professional by phone.  This case involves adult patient of unknown demographics who was accidentally vaccinated with 0.5 ml expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Batch number: UT5911KA and expiry date: 30-Jun-2018, dose in series, route and site of administration were not reported) on an unspecified date for the 2017-2018 season.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Documents held by the sender: none.
13 x 11.5cm erythematous, warm, tender area right upper arm after vaccinated with MMR and VZV.
14 days after taking flu vaccine I got sore throat, lung congestion. Seen at ER on 11/9/03 w/ all symptoms of flu. Am still having breathing problems as of 3/4/04 w/ wheezing, SOB. I was in perfect health before taking vaccines. Given Prednisone, Albuterol inhaler, Cedal, Mavaquin, Keflex, Singulair. Respiratory tract infection, sore throat, cough, chest congestion-no strep throat hosp. does not have flu test but ER Dr states was flu. Information from Annual Follow-up report states I now have adult onset asthma following the flu/pneumonia I got a week after I got the vaccines. I just found out I have 3 blockages in my heart; this is probably due to being put on steroids for flu/pneumonia against my wishes and I have gained 20 pounds. My blood pressure is also elevated. Since I had the shots, my health has deteriorated! I was in perfect health before taking these vaccines. I have had loss of income, health, normal activites and energy. I intend to sue. These vaccines gave me the flu/pneumonia, and I have not been healthy or felt right since. I'll never take them again.
Contracted Covid 3 days after the vaccine. I got slight leg pains which was tolerable but I was getting tightness of the chest and I had energy. Like I could not find it. I didn't feel like moving. I didn't have palpitations and I was attributing to just not getting enough blood flow.
Mother of client mentioned that client was nervous.  Mother talked about friends telling them about adverse event after vaccination.  Discussed possibility of fainting and need to have Mother hold client on way to car.  Client stood in hall while nurse conversed with Mother.  Client was interacting and then stopped responding and stared and then fainted with nurse holding him gently down into squatting position.  Client regained consciousness quickly.
Woke up in middle of night and Still not sleeping well; Not eating well; Felt unwell; Muscle pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Woke up in middle of night and Still not sleeping well), DECREASED APPETITE (Not eating well), MALAISE (Felt unwell), MYALGIA (Muscle pain) and FATIGUE (Fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A, 029A21A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Woke up in middle of night and Still not sleeping well), DECREASED APPETITE (Not eating well), MALAISE (Felt unwell), MYALGIA (Muscle pain) and FATIGUE (Fatigue). The patient was treated with AZELASTINE at an unspecified dose and frequency. At the time of the report, INSOMNIA (Woke up in middle of night and Still not sleeping well), DECREASED APPETITE (Not eating well), MALAISE (Felt unwell), MYALGIA (Muscle pain) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-342370 (Patient Link).
pt adm to ICU w/acute onset of leg weakness; 9 days p/vax pt c/o h/a that resolved,irritability & back pain;10 days p/vax refused to walk;To ER unable to move legs;had not urinated since early morning;dx:transverse myelitis, r/o tumor infil
pt vomiting x2 since 5AM;pt mom informed to provide w/clear liquids x24hr;