chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had COVID-19; had COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 day, as dose 2, single (Batch/Lot number: unknown) for 1 day, as dose 3 (booster), single (Batch/Lot number: unknown) for 1 day and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "had COVID-19".  Clinical course: It was reported that caller and the patient (husband) both had COVID-19 at the end Jun2022. Caller stated they have both had the Pfizer-BioNTech COVID-19 Vaccine, (monovalent) vaccines, have had the primary series and the booster doses twice. The caller and patient (husband) both received their last booster dose in May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received  from a consumer and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (manufacturer unknown), (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On an unknown date, the reported inquired if they could give the second dose of hepatitis A vaccine, inactivated (manufacturer unknown) before 6 months, 2-3 weeks early, or if they had to revaccinated (inappropriate schedule of drug administration). Additional information has been requested.
This case was reported by a consumer and described the occurrence of hepatitis B in a 47-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). This report has not been medically confirmed by a healthcare professional. Concurrent medical conditions included anemia and cystic acne. Concurrent medications included Iron salt and Spironolactone. On 26 September 2011 at 12:00 the subject received 1st dose of TWINRIX in the left arm. On 29 September 20111, 3 days after vaccination with TWINRIX, the subject tested positive for hepatitis B after giving blood. At the time of reporting the event was unresolved.
Fluarix was exposed to 31 Fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 554NM, expiry date 30-JUN-2024) for prophylaxis.   On 21-OCT-2023, the patient received Fluarix Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced incorrect product storage (Verbatim: Fluarix was exposed to 31 Fahrenheit). The outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-OCT-2023 The reporter stated that Fluarix was exposed to 31 Fahrenheit and administered to at least 60 patients as they had a flu vaccine clinic which led to incorrect product storage. The reporter consented to follow up via postal. The vaccine administration facility was the same as primary reporter. The reporter did not have any patient demographics at the time of reporting.
Pt developed swelling at the injection site which she attributed to a thimerosol allergy.
fever of 100.5; was crying; This case was reported by a consumer via call center representative and described the occurrence of fever in a 6-week-old female patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, less than 2 months after receiving DTPa vaccine, the patient experienced fever and crying. On an unknown date, the outcome of the fever and crying were recovered/resolved.   The reporter considered the fever and crying to be related to DTPa vaccine.  Additional information was provided as follows: The reporter wanted to remain anonymous.  The patient received Diptheria Pertussis Tetanus and went into the hospital because she had a fever of 100.5 and was crying.   She did not complete the series.  The reporter anonymous and provided limited information. She also mentioned something about an outbreak of whooping cough at a school no further details and assume it was something she saw online or saw on the news. She was just using that as an example of why she was anti-vaccine.      Lab Comments: Lab test performed on unknown date.
Mild fever 100.4, body aches, slight chills , slight headache. Tiredness. I drank plenty of fluids, Tylenol, bed rest
Headache, Myalgia, Fever & NauseaVomiting Narrative:  Other Relevant History:
20 days between 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION had resolved.            No concomitant product was provided by the reporter. On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular). No treatment medication was provided.
Swelling in the armpit and breast on the same side as the injection; Pain in the breast on the same side as the injection; Pain in the armpit on the same side as the injection; Body aches; Low grade fever; Fatigue; Light, red and non raised rash at the injection site; Non raised rash at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 27Apr2021 at 13:45 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and food allergy. Concomitant medications were not reported. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 06Apr2021 at 14:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 15:30, the patient experienced pain and swelling in the armpit and breast on the same side as the injection, body aches, low grade fever, fatigue, light red non raised rash at the injection site. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with BENADRYL. The clinical outcome of the event swelling in the armpit and breast on the same side as the injection, pain in the armpit and breast on the same side as the injection, body aches, low grade fever, fatigue and light red non raised rash at the injection site were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Felt like my body was fighting something off.  Extremely tired, upset stomach.  That evening had a fever and diarrhea, nausea, Sat morning still had those symptoms but sore throat and burning congested chest.  Today is the seventh day since being vaccinated and hopefully will be better.
TINGLING OF FINGER TIPS OF LEFT HAND; HEADACHE; TIRED; ARM PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cat allergy, alcohol user, and smoker, and other pre-existing medical conditions included the patient had no any drug abuse or illicit drug usage and other pre-existing medical conditions included nothing significant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included minerals nos/vitamins nos.  On 07-APR-2021, the subject experienced arm pain. Treatment medications included: Tylenol (paracetamol). On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced tingling of finger tips of left hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling of finger tips of left hand on 09-APR-2021, arm pain on 08-APR-2021, headache on 10-APR-2021, and tired on 11-APR-2021. This report was non-serious.
Symptoms started around 9:15pm on 4/8 ??Mild Arm Soreness initially ??Fever of 100.0 at 10pm. 101.4 at 11:30pm, 99.6 at 4am ??Chills/Tremors: Stop and Start after a couple minutes. Did not stop until 2am ??Hot Breath; Felt like fire after cold water ??Extra Discomfort on lower back/sides ??Jaw Pain after chills stopped around 11:50pm. Took Advil to help  Symptoms for 4/9 ??Sharp pain in chest when breathe in too hard at 4:50pm ??Fatigue all day. Only got out of bed to pick up mail and use the bathroom ??Diarrhea at 6pm. Couldn't keep anything solid down except oranges and bone broth ??Chest Pain after 8:30pm: Put ice pack on chest and it relieved pressure. It feels like something is stuck down my esophagus, even though I have not been able to eat anything solid.
Pt 1 of 9 from total of 191 pts who completed series of 3 hep B vax, failed to achieve immunity.Pt did not seroconvert.
Afternoon of 11/18/08 patient developed fatigue, all-over body aches, diarrhea and rash that covered arms, hands and back.  By 11/21/08 when patient notified health dept., patient reports rash going away and no other symptoms.  Patient reports having taken Benedryl. Patient did not contact doctor.  Advised patient to notify doctor of symptoms, and to seek medical treatment if symptoms worsen or if patient develops wheezing, facial swelling or difficulty breathing.
Since Wednesday 01/06/21, have had on and off unusual taste, almost metallic taste in the mouth intermittently.  Today, 01/22/21, lost my sense of taste. Went to take the Rapid Covid test and was negative,
Per mother child received vaccines Monday March 17 and yesterday was concerned because noticed left arm (deltoid) with redness and swelling. Per mother had never seen this happen to any of the other children so she was concerned. Per mother applied warm compress to child's  arm for comfort. Denies numbness or tingling to left arm or extremities.
TOOK FIRST THREE DOSES WITH FOOD; TOOK FOURTH DOSE A DAY LATE; This spontaneous case (PVX2019-1289) was received from a pharmacist on 22-May-2019. It describes a female consumer who "took first three doses with food" and also "took fourth dose a day late". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took the first three doses of Vivotif 30 min to 1 hour after eating, on every other day. Also, she took the fourth dose on 22-May-2019, which was supposed to be taken on 21-May-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took first three doses with food" and also "took fourth dose a day late" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took first three doses with food" and also "took fourth dose a day late" was considered as not applicable.
Fatigue, joint pain, stiffness, muscular pain and stiffness, lack of strength, stamina, spasms in muscles occurred after 3rd vaccine. After 1st and 2nd vaccine, developed muscular pain, stiffness and spasms only in legs. Been treated for Lyme's for three years; now gone from labs, symptoms remain. 60 day follow up on 11/18/2003: "Vaccine recipient did not recover from the adverse events.  Joint and muscular pain stiffness and inflammation, fatigue, lack of mental clarity.  All the symptoms which were listed on the original report I sent you."
I had the vaccine on 1/20/2021 and  24 hours after I was really tired, I was able to function but I was tired, I could have slept the whole day, I felt this way for about 7-10 days, I felt pressure on my back, I was coughing a little bit, I did nicoplasma which is the lab work you do for bacterial pneumonia, it was positive. I also had 2 other positive tests in summer and November without any symptoms.
Cellulitis left arm. Admitted to hospital after one day. Given IV oxocillin as precautionary measure.
After approximately 5 minutes of the vaccines was administered to the patient, she starts developing short of breath, facial flushing, and a generalized rash with some hives. Immediately Benadryl 25 mg IM and Kenalog-40 - 20 mg was administered to the patient in right and left tight. Furthermore, oxygen was administered via cannula to the patient. 20 minutes later patient resolved all issues, she is breathing perfectly, with no rash, oriented in time and space.
I received the Moderna Covid-19 vaccine at 3:45pm. Approximately 5-10 minutes later I felt flushed (warm chest/face), ear congestion and anxious. After another 5 minutes, I felt an asthma attack start. I could still breath through my nose but it was difficult to swallow.  I used my albuterol inhaler and took Benadryl (2 tablets) and felt much better after 15-20 minutes. I am taking daily antihistimes and still feel congested but no further asthma attacks have occurred. I developed hot flashes and chills the night of taking the vaccine but that has resolved. I also have upper abdominal pain that has not resolved.
Patient received Pfizer COVID vaccine on 9/23/21 and 10/14/21. On 10/19/21, patient was admitted to our facility's med surg unit for acute on chronic hypoxemic respiratory failure secondary to pulmonary hypertension, HF with preserved EF, and COVID-19 pneumonia. On 10/21/21, patient was transferred to CCU for about 18 hours, then transferred back out to the med/surg unit. As of today (10/22/21), patient is still admitted in the med/surg unit.
This spontaneous report as received from a physician refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (dosing details were not reported) (lot # L043622 with expiry date 03-NOV-2017 and (lot # L048462 with expiry date of 02-DEC-2017, which was exposed to a temperature of -0.7 degree centigrade for a time frame of cumulative total of 36 hours and 40 minutes. There was no previous temperature excursion reported. The call was because of a data logger (therapy type: digital data logger) (Incorrect product stored). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
I got my shots and my arm hurt so much; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was captured as adult as per vaccine indication. The age at vaccination was not reported. The patient 1st dose of Shingles vaccine and his/her arm hurt so much for days. For tolerance of 2nd dose refer case US2021AMR106809, reported with same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR106809:same reporter
sick stomach, headache, sudden severe drop in blood pressure, ashen skin color. BP went to 70/50. took 40 minutes to regain strength and pressure
WITHIN 5 MINUTES OF SHOTS PATIENT FELT DIZZY. LIED PATIENT ON EXAM TABLE. BP 113/72. PATIENT STATED FEELING BETTER. SAT UP BP 103/57. PATIENT SAT FOR A FEW MINUTES AND THEN STOOD TO FEET. BP 76/59. AFTER 3 MINUTES BP 101/59. WALKED PATIENT TO CAR.
Headache, Myalgia, Arthralgia, Fever,  fatigue,  Narrative:
Migraine ...2.5 days...beginning 12 hours after vaccination Chills...16 hours...beginning 15 hours after vaccination  Fever...9 hours...beginning  22 hours after vaccination
On the 16th I was a little bit tired from being out of town. I slept an hour or so. I noticed I had a little stuffy nose. The next day I tested positive. I had a runny nose, cough, and fatigue but nothing severe. On Monday I was feeling a tad bit better but still tired. I called the doctor the next day and he prescribed the antiviral medication in case I started to feel worse. I never took it.
Dizziness, Headache, fatigue, sore arm, brain fog, chills, lower back pain Narrative:  Other Relevant History:
Cronic tiredness persisting for several weeks after the one seiries shot led to sleep study and ultimate diagnosis of Narcolepsy type 2
Very  swallwn kneees and tngling sensation in toes, joint pain and tiredness
This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. On 02-MAR-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Widespread urticaria and bilateral numbness to arms. Advised vaccine staff of reaction. Observed and monitored by staff for 30 mins.  Reaction resolved with self-administration of 50mg Diphenhydramine.
Patient crying and breathing after Pentacel and HBV given in left thigh, after PCV13 given in right thigh patient refused to breathe and began turning red. I advised mom to blow in her face. Pt then took a breathe and mom sat her up. Patient then held her breathe her whole body stiffened and became red and in a daze like state. She then vomited her Rotateq. Patient then started breathing. I grabbed the nearest  provider to me who evaluated the patient and found her to be fine. The patients PCP who she was seeing that day was then notified and checked on patient. She also felt she was fine. Mother left and came back with patient because she did not feel comfortable after her episode so EMT was called and patient was transported to the ER.
He develop redness at injection site and the area is increasing around 4 cm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (He develop redness at injection site and the area is increasing around 4 cm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (He develop redness at injection site and the area is increasing around 4 cm). At the time of the report, VACCINATION SITE ERYTHEMA (He develop redness at injection site and the area is increasing around 4 cm) had not resolved.        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 product use was not provided by the reporter.  Treatment information was not provided.
Arm soreness at injection site, body aches, fatigue, headache, and dehydration.  Symptoms lasted for about 27 hours.
Extremely intense, progressing headache x2  - (11/17 & 11/23) creating nausea and the feeling to vomit (not normal for me).
Patient had his first shot on 7/26/22 when he was 4 years old.  He had his second shot on 8/16/22 when he was 4 years old.  He turned 5 years old, therefore he was supposed to get a monovalent 5 year old dose as his 3rd shot to complete his primary series.  This is what I ordered for his appointment.  When I arrived at pharmacy, I immediately told them when I checked in that he was under the special transition rules.  I had researched on the CDC website and consulted with my pediatrician.  But they did not believe this was true and they gave him a bivalent booster instead.  I even asked what they were giving each of us because there were 4 of us getting shots and they still did not disclose to me that they were giving patient something different than what I asked for.  Right after the shot they asked me to sign a form consenting that they changed the monovalent shot I ordered to a bivalent booster and I was shocked and did not sign because I did not consent to this.  They told me that nobody gets a third shot unless they are immunocompromised.  They did not believe me even when I showed them the CDC guidance.  They were totally unaware that 6 month to 4 year olds have a 3 shot primary series for Pfizer vaccines and they were unaware of the transition rules.  They had no right to give my son a shot that I did not order and did not consent to.
Pain/soreness in right upper arm that woke patient up in the middle of the night after receiving flu vaccine that afternoon. It has been 2 weeks since flu vaccine and she continues to c/o pain that is now focused to her right shoulder and it is interfering with daily activities. She feels the pain when moving her arm in all directions. No redness, warmth or other signs of infection. Ibuprofen is helping the pain. She reports that when she removed the bandaid at injection site she thought it was higher up on her arm than anticipated.
pt had tachycardia as high as 180s went to ED where had labs (i don't have) and ECG (i don't have), reported normal. received 2u IVF and sent home with improvement in symptoms