chrisvoncsefalvay/vaers-outcomes huggingface dataset:
contracted COVID-19/got vaccinated still tested positive for covid19 afterwards; contracted COVID-19/got vaccinated still tested positive for covid19 afterwards; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 9-year-old female patient received BNT162b2 (BNT162B2), on 04Nov2021 as dose 1, single (Lot number: FK5127), on 23Nov2021 as dose 2, single (Lot number: FK5127, Expiration Date: 03Dec2021) and on 23May2022 as dose 3 (booster), single (Lot number: FL0007) at the age of 9 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "unknown" and all described as "contracted COVID-19/got vaccinated still tested positive for covid19 afterwards". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive, notes: got vaccinated still tested positive for covid19 afterwards. Clinical course: the reporter was a vaccinated and twice boosted mother of 4 and part time HCP. Reporter's husband and four children (Ages 5, 5, 7, and 9) have each had 3 doses of the vaccine designed to lessen severe illness from a COVID-19 infection. They contracted COVID-19, likely 03Jul2022. Only one of the five year olds has remained negative via at home antigen testing.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200021017 Same reporter/vaccine/event, different patient.;
No adverse event was reported when we spoke to patient and informed them that their shot was received shot after the beyond use date.
Initially just a swollen sore injection site.  Then painful to lift or use arm. Flu like symptoms developed through the overnight hours 10/16 to 10/17.
w/in 24 hrs devel generalized urticaria & fever of 100.5; seen by MD 9JUL93; sx resolved 15JUl93;
Some soreness at site of injection immediately but of no concern. About 1 week later itching at the site and red rash around injection site and upper arm descending to and around arm
- I did the first shot in left arm - no side effects from that shot - I did the 2nd shot in the right arm -  * I started having heart palpitations about 4-5 days after the second shot.  The palpitations were causing abnormal/atypical heart beats for about 15-20 atypical beats per minute.  The palpitations were confirmed at the Emergency Room in April.    * two nights later I awoke in the middle of the night will both arms mostly numb.  The numbness subsided the next day but both shoulders were hurting.  The arms got worse that day and the 3rd day.  I've played sports my entire life but never had shoulder problems this bad.  The left shoulder was so frozen that I couldn't move it backward or extend it behind my back because I had lost the flexibility, and it was very painful when I tried to stretch it.  I went to 15 physical therapy sessions that improved it, however, it is still damaged.  The right shoulder had problems too but not nearly as bad.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L70A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information were Ibuprofen, Aspirin.   This case was linked to MOD-2021-085539 (Patient Link).
Wheezing/ shortness of breath/ respiratory distress 1.5 hours after vaccination -  have needed to take rescue inhaler every 4-6 hours since vaccination  Hives & swelling on hands 3 hours after vaccination hives on back three hours after vaccination
Vaccine was retrieved from pharmacy on the morning of 12/9/2021.  It was mistakenly grabbed from the area of the refrigerator that had been partitioned off for recently expired vaccine that is separate from the active vaccine refrigerator area.  Vaccine was brought to clinic in a temperature-controlled cooler that stored the vaccine at refrigerated temperatures (36F to 46F).  Vaccine was reconstituted and drawn up to administer.  Pharmacist gave vaccine and documented for CDC and state data.  It was discovered that vaccine was expired at this time.  Any additional vaccine from expired vials planned to give was postponed and remaining vaccine wasted.  No adverse effects noted post administration. Called pharmacy who ensured expired vaccine was removed completely to prevent any further errors.  Notified facility administration and patient of error.  Followed up again in less than 3 hours with patient who had no adverse effects noted and felt fine.  Patient questioned if additional vaccine would be needed.  Followed CDC guidance to contact manufacturer regarding error and gain additional information.  Will follow-up with facility and patient tomorrow to make sure there have been no adverse effects/events post administration.
A had loss of smell, congested and sneezing . After I tested positive I had severe chest congestions, stomach problems like no appetite, diarrhea , severe fatigue and muscle pain. Body aches, chills. I called her and I was on Paxlovid and I still am having symptoms like tired and digestive issues and today I have a headache and still having cough. Sometime in Aug23 I had the TDAP vaccine.
Body aches, headache and fever 100.5. Developed chills and nausea later that evening. 10/5/2000 still having aches and neck pain, headaches, nausea. Yesterday felt much worse.
3/10/21 - injection area swollen, painful, and feverish, chills, 99.5-99.8 all day, body aches, lethargic, no appetite (day / night). 3/11/21 - injection area swollen, painful and feverish, chills, lethargic, dizziness, 99 - 99.8 fever off /on all day, body aches, some appetite. 3/12/21 - injection area painful; lethargic, 99.5-99.8 fever fluctuated 12:00 am - 10:00 am Took Motrin the entire time.
Ct. c/o tingling in the left arm 10 minutes after receiving vaccine.  Client denies any other symptom and was seen by EMT.  Vital assessments are BP 188/115, HR 72, O2 99.  Ct. appears calm.  Client  verbalized that she was just given a  new prescription for HTN med but had not started and had been monitoring her BP for a week.  Ct. advised to notify MD of finding and cleared to go home by EMT.
Patient reports waking up with "pins and needles" sensation in left leg and foot four days after receiving the vaccine.  Sensation progressed to aching and numbness that has not resolved.  She also reports dizziness and balance issue.  On 8/24/21, patient's prescriber sent prescriptions for nortriptyline, tramadol and baclofen for symptoms.  As of 9/2/21 the patient reports these medications are not relieving symptoms.
On 8/22/01, mother called stating that child had started running a fever of 103F and vomiting on the evening after vaccines. She denies redness or soreness at injection sites. On 8/24/01, the child recovered, per mother.
Moderna COVID-19 Vaccine EUA Pt reported pain and pressure in both hands 4/10 pain and described it similar to arthritis pain. Once Pt removed jacket the symptoms subsided. Pts eyes were also swollen and at the discretion of Doctor. 10ML of Liquid Diphenhydramine (Benadryl) was given. Approximately 10 minutes after that Pt reported feeling better. Pt was advised to follow up with PCP  1109 by phone pt. reported Dull Pain in the knees at 3/10 and stated eyes were still "puffy"  Pt was advised to follow up with PCP and would be receiving a follow up call later
Patient stated that he was feeling faint, and his body went limp and he became unresponsive. It lasted approximately 15-20 minutes.
This spontaneous report received from a patient via social media through a company representative concerned a patient of unspecified age, sex, race and ethnicity. 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 (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number: Unknown and expiry: unknown) dose, 1 total administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received additional covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of administration, batch number: Unknown and expiry: unknown) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced Covid twice (Dose number in series 2). As per the reporter, "I have had Covid twice. I am fully vaccinated and boosted. Somebody is making big money off of this. Around election time there will be another variant to cause another pandemic. Wait and see". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had Covid twice was not reported. This report was non-serious. This report was associated with product quality complaint: 90000216452.
SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient through other manufacturer (Pfizer Inc.) concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies, and other pre-existing medical conditions included: The patient stated he was not taking any other medication or products within 2 weeks of starting covid-19 treatment (Paxlovid). The patient received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: unknown) dose was not reported, 1 total was administered on 09-APR-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 51 years old. No concomitant medications were reported.  It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient also received second dose of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin and route of admin were not reported, batch number: 011F21A, expiry: unknown) dose was not reported, administered on 23-OCT-2021 to left arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following Moderna covid-19 vaccine (elasomeran) (Dose number in series 2). The patient also received third dose of non-company suspect vaccine Pfizer biontech covid-19 vaccine (tozinameran) (Dose number in series 3) (form of admin and route of admin were not reported, batch number: GH9694, expiry: unknown) dose was not reported, administered on 10-SEP-2022 13:00 to left arm for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 3). On an unspecified date, patient experienced covid-19 infection (suspected covid-19 infection) (Dose number in series 3). The patient started taking treatment with non-company suspect drug Paxlovid, (nirmatrelvir/ritonavir) (form of admin and route of admin were not reported, batch number: GF9998 expiry: unknown) dose and frequency were not reported from 10-FEB-2023 to 15-FEB-2023 for treatment of covid-19.  On 21-FEB-2023 at 17.00, six days after non company suspect drug paxlovid treatment, the patient experienced covid-19 rebound infection.  The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable, and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Patient received 1st dose of Moderna Covid vaccine, went to sit down for just a few minutes- got up to ask pharmacy staff for water at pharmacy counter.  As staff was getting water, patient proceeded to pass out in front of pharmacy window and fell to the ground. Technician called 911 immediately and pharmacist and tech went out to patient on ground who by then was awake. Pharmacist helped her up and to a chair to sit down. She was given some water and paramedics arrived within several minutes after and took over patient's care.
Chronic uticaria that appear/dissappear at random intervals throughout the day globally across the body. Very itchy and if left untreated extremely uncomfortable. Mostly disappear 30 minutes after 10-20mg of Zyrtec administered orally.
I had insomnia and a racing heart that evening.  It lasted from when I went to bed until late morning. All is well now. I slept well the next evening. It was strange. Felt like anxiety.
chills, fever, joint and muscle aches, headache, fatigue, painful swollen lymph node under right arm.   I began feeling tired and warm at approximately 6PM the day I received the vaccine 4/7 (received vaccine at 10:30AM). Sweating fever and chills began that evening. I had muscle aches, joint pain, headache, and swollen lymph node under right arm the following morning. Symptoms lasted through the morning and were mostly gone except for remaining lymph node tenderness on 4/9.
Severe migraine for 3 days after second vaccine (Pfizer)  4 days after second vaccine- lethargy, fatigue, swollen lymph nodes, sore throat
Patient was seated when she received flu shot in left arm and within 30 seconds fainted and then shortly twitched/convulsed upper body for less than 5 seconds. She came back to consciousness slowly within another 30 seconds. EMS was called and arrived at the scene within 5-7 minutes of the adverse event. EMS checked blood pressure which was low and then rechecked in 10 minutes which was still low. EMS filled out report and discussed with mom stating they could admit patient to hospital for more observation/care, but mom was comfortable enough and declined admitting patient to hospital.
swollen lymph node; Swelling; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling), HEADACHE (Headache) and LYMPHADENOPATHY (swollen lymph node) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling) and HEADACHE (Headache). On 28-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node). At the time of the report, VACCINATION SITE SWELLING (Swelling), HEADACHE (Headache) and LYMPHADENOPATHY (swollen lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: NNI
Our Electronic Record system was down on 9/26/08.  Dr. ordered 2 month vaccines for this 2 month old that morning.  I administered them.  Later when the electronic system came back up, I noticed that the patient received the same vaccines on September 12, 2008 at around 6 weeks old by another nurse.            The provider had not written a note in the record for that day 9/12/08.   The patient was scheduled for that day and per mother was here on 9/12/08 and was vaccinated.  I asked our operations manager to pull the encounter form, which she did.  The encounter form was filled out by Dr. with orders for pentacel, hep b, hib and rototeg.       Called the mother again on 10/1/08 to see how the baby was doing.  The mother said the baby was fine.
I had really bad joint pain that is intermittently continuing.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 39 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Phenobarbital, reaction(s): "known allergies Phenobarbital"; Dilantin, reaction(s): "known allergies: Dilantin". The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "I had really bad joint pain that is intermittently continuing.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 but the result was unknown. Device date was reported as 11Dec2021. The case was reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, body aches, at about 10:30am on 12/19/20. Improved with 1g of Tylenol
Fever of 103.6F, shallow breathing, wheezing, fast heart beat and paleness.
Patient was seen in office 4/13/22 for complaints of itchy rash that was present on patient's upper and lower extremities, back, neck, feet, and hands.  Patient reported receiving the COVID Moderna Booster vaccine 3 weeks prior and rash had developed 3 days after receiving the vaccine.  The rash had continued to spread since beginning.  Per Immunization System the patient received the Moderna COVID booster on 3/30/22 at pharmacy.  Patient was started on Vistaril and Prednisone for treatment of rash.
Patient had an injection site reaction developing 2 days after injection.  It is a red, raised area about 1 inch in diameter surrounded by a lighter pink, non-inflamed area covering a larger portion of her arm. Patient also reports the area being tender.
According to the patient she experienced  left facial droop a day after getting her Shingrix 2nd dose and Hepatitis B 3rd dose and  went to the Emergency department. She was treated with  oral steroids , antivirals ,eye drops , physical therapy and is followed up with the neurologist.
Itchiness and redness to site. Seeing "spots in front of eyes". Diarrhea
Intermittent facial flushing, feeling warm and over heated for 3 days, 4th day L sided headache.
drop in temperature; Headache; Stomach pain; she felt like vomiting; She couldn't eat for one day, didn't feel like eating; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2021 (Lot number: EL1283) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose Lot number is EL1284), for Covid-19 immunisation. The following information was reported: BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "drop in temperature"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach pain"; VOMITING (non-serious), outcome "unknown", described as "she felt like vomiting"; APPETITE DISORDER (non-serious), outcome "unknown", described as "She couldn't eat for one day, didn't feel like eating". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information:  Did any AEs require a visit to:   Emergency room: no Physician office: no Prior vaccinations (within 4 weeks): none AE(S) following prior vaccinations: none Patient's Medical History (including any illness at time of vaccination): None  Family Medical History Relevant to AE(s): none Relevant tests:  None Patient said hers was very mild, it was something she expected would be normal No follow-up attempts are possible. No further information is expected.
Covid-19; Covid-19; 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 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 13:30 as dose 5 (booster), single (Lot number: GJ2524) at the age of 70 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19May2022 at 13:30 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6198), in left arm, on 23Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 05Oct2021 at 13:30 as dose 3 (booster), single (Lot number: FF8841), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6198), in left arm and on 23Mar2021 as dose 2, single (Lot number: EP6955), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid (Lot number 281523) from 17Nov2022 to 19Nov2022 for COVID 19 Treatment.
Pt received 2 influenza shots 5 days apart. No adverse symptoms, signs. 1st shot received 11/8/06 during home care visit. 2nd flu shot given 11/13/06 instead of Pneumonia shot, as had been planned. Vaccine was prepared by this writer and administered by home care RN. Error noted 11/14/06. Pt received Pneumonia shot next visit.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA002453: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.