chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pain moved more towards the back to the hip area; Pain in the pubic bone, and had to hold her pubic bone to walk/ was in excruciating pain; Every step was an agony; Lost of strength on her left arm/Has no energy; Headache; Completely crashed, was exhausted, like really tired; Taste of metal stronger; Arm was killing her/ was a little sore; This spontaneous case was reported by a physician and describes the occurrence of DYSGEUSIA (Taste of metal stronger), ASTHENIA (Lost of strength on her left arm/Has no energy), PUBIC PAIN (Pain in the pubic bone, and had to hold her pubic bone to walk/ was in excruciating pain), MOVEMENT DISORDER (Every step was an agony) and INJECTION SITE PAIN (Arm was killing her/ was a little sore) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from March 2020 to 2020 and Back surgery. Previously administered products included for Back pain: Meloxicam. Past adverse reactions to the above products included No adverse event with Meloxicam. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced DYSGEUSIA (Taste of metal stronger) and INJECTION SITE PAIN (Arm was killing her/ was a little sore). On 09-Apr-2021, the patient experienced FATIGUE (Completely crashed, was exhausted, like really tired). On 10-Apr-2021, the patient experienced ASTHENIA (Lost of strength on her left arm/Has no energy) and HEADACHE (Headache). On 11-Apr-2021, the patient experienced PUBIC PAIN (Pain in the pubic bone, and had to hold her pubic bone to walk/ was in excruciating pain) and MOVEMENT DISORDER (Every step was an agony). On 12-Apr-2021, the patient experienced ARTHRALGIA (The pain moved more towards the back to the hip area). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. On 10-Apr-2021, DYSGEUSIA (Taste of metal stronger) had resolved. At the time of the report, ASTHENIA (Lost of strength on her left arm/Has no energy) and FATIGUE (Completely crashed, was exhausted, like really tired) had not resolved, PUBIC PAIN (Pain in the pubic bone, and had to hold her pubic bone to walk/ was in excruciating pain), MOVEMENT DISORDER (Every step was an agony) and ARTHRALGIA (The pain moved more towards the back to the hip area) was resolving and INJECTION SITE PAIN (Arm was killing her/ was a little sore) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-074894 (Patient Link).
that night congestion in chest croup style cough, fever. taken to doctor next morning, given antibiotics, cough suppressant, steroids, albuterol breathing treatments every 6 hours vomited most of the week choked on phlegm. is still on breathing treatments today after second doctors visit.
My second Moderna vaccine dose  was 2/11/21. Two days after receiving my second dose of Modern a I got COVID arm .It lasted for about 9 days.  On 5/29/21 I had an ischemic stroke.
High fever , seizure lasting 40 min: 10 days after MMR no. 1. Medical records received on 1/20/2005 states cough and congestion.
improvement in her shoulder which was painful and troubling; soreness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), SWELLING (swelling) and THERAPEUTIC RESPONSE UNEXPECTED (improvement in her shoulder which was painful and troubling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (soreness) and SWELLING (swelling). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (improvement in her shoulder which was painful and troubling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, PAIN (soreness) and SWELLING (swelling) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (improvement in her shoulder which was painful and troubling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Immediate rash in chest and face.  20 minutes later entered ER with swollen eye and throat.  14 hours later re-entered ER with rash on chest and face, swollen tongue and throat
Menstrual Spotting after not having had period for 6 months.  I thought I was in menopause.  Note my age is just a few days off 54.  This is not a normal period - never had this before.
Pt c/o dizziness and chest tightness approximately 20 minutes post vaccination.  Observation revealed no visible sign of hypersensitivity.   No injection site reaction was noted.  No swelling of tongue, lips, or throat.  Pt was able to carry on regular conversation without dyspnea, wheezing, or coughing.  Pt was not diaphoretic.  Pt was hypertensive and tachycardic as noted below.  Pt reported taking her daily BP meds already today.  Pt denied chest/back pain, nausea, or left-arm pain.  Impression was that this was anxiety-induced, but could not rule out cardiovascular origin.  Instructed pt to continue monitor BP once home and contact PCP if remained elevated.  Instructed pt to contact 911 if symptoms progressed or developed consistent with cardiac event.  Attempt to contact pt by phone later in the day was not answered.  Voicemail was left, but no reply by patient.
Headaches, fever, loss of appetite, diarrhea, fatigue for 24 hours then daily headaches x?s 4 weeks. Taking Aleve for headaches, discussed symptoms with the provider
pt recv vax & 8 days post vax pt exp diarrhea;pt treated self w/usual med;sx resolved w/in 1-2 days;
A female patient received bnt162b2 (reported as Covid-19 Vaccine), dose 2 via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Non-vaccine suspect product included etanercept (ENBREL), via an unspecified route of administration from an unspecified date (Batch/Lot Number: 1123166; Expiration Date: 31Aug2023) to an unspecified date, at unspecified dose for ankylosing spondylitis. Medical history included ongoing ankylosing spondylitis and ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. Historical vaccine included receiving the first dose of Covid-19 Vaccine for COVID-19 immunisation on unknown date. With the first COVID vaccine she stated she was very tired and fatigued, her arm hurt, and she had a headache. The patient stated the second day after the vaccine, she felt even worse. On 12Apr2021, the patient received her second vaccine and stated her arm never got sore but she had a bad headache, felt a little achy and fatigued but she was not sure if that was from the vaccine or not taking her Enbrel. The patient Enbrel was due days ago. The patient was informed by one of her physicians that the COVID vaccine would not be as effective due to her immune disorder. The patient asked if there was any information pertaining to when she should take her next Enbrel dose following her vaccination. The action taken in response to the events for etanercept was post-therapy. The outcome of events was unknown.  Pfizer is a marketing authorization holder of Covid-19 Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Covid-19 Vaccine has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe body aches, cramping, muscle weakness, nauseous and fever. Extreme flu like symptoms. Extensive injection site swelling and large area of redness. Lymph node swelling in armpit near injection site.
Patient tested positive for COVID-19 in May 2021 -- not even 4 months after the 2nd dose of Moderna vaccine was completed. Patient began experiencing symptoms on 5/5/2021 -- dry cough, loss of taste and smell, SOB with exertion, chest heaviness and tightness, body aches, headaches, fatigue, heartburn, nausea and decreased appetite. Patient had to go to Hospital ED on 5/9/2021 due to worsening chest pain -- CT pulm arteries was negative for PE. Primary care office is following patient closely - her symptoms have not resolved yet - will continue monitoring symptoms.
EAR INFECTION; EAR PAIN; This spontaneous case report was received from a pharmacist (PVX2019-020) on 03-Jan-2019. The report describes a 19-year-old adult female consumer who experienced ear pain and ear infection following the intake of Vivotif for an unknown indication.  The consumer did not have any medical history and not taking any concomitant medication.  It was reported that the consumer felt ear pain on 28-Dec-2018. She took the last dose of Vivotif on 29-Dec-2018. She also had an ear infection which started on an unknown date.   The action taken with Vivotif with respect to the event ear pain was dosage maintained, while with respect to the event ear infection was unknown.  The clinical outcome of the events ear pain and ear infection was unknown.  Company's Comment: In this case, a female consumer developed an ear pain and ear infection after receiving Vivotif vaccine.The consumer stated that she did not know specifically which day the ear infection started. Hence temporal association of event with Vivotif cannot be established. Also ear infection is an infectious condition so the causality of the events with Vivotif was assessed as not related.; Sender's Comments: Company's Comment: In this case, a female consumer developed an ear pain and ear infection after receiving Vivotif vaccine. The consumer stated that she did not know specifically which day the ear infection started. Hence temporal association of event with Vivotif cannot be established. Also ear infection is an infectious condition so the causality of the events with Vivotif was assessed as not related.
4 hours after flu vaccine administered started with chills, fever of 102 degrees, nausea, body aches lasting 24 hours.
Patient experienced vagal response after receiving vaccine. She was unresponsive, non verbal, eyes rolled back. Rapid response paged and EMS services called. Patient was lowered to the ground with legs elevated. She regained consciousness, was alert and speaking. Patient was given 6L oxygen via facemask. EMS arrived and assessed patient.
Pneumonia shot soreness at inj. site after given, extremely painful right arm had some dizziness, weakness and nausea, red raised noticed it yesterday.
Thank you. I can't even say it's discomfort. I'm at the point of excruciating pain depending on how I move it, lay on it, or even what I do. I planned on going to my doctor but unfortunately I' in the middle of a two day radioactive thing for my thyroid and my time is limited and I'm not allowed to take certain medicines or have tests done until this is finished. Ugh! Anything you can find out would be greatly appreciated. I would add for me that I started to have some slight improvement but then ever since Saturday things have been the worst the have been for me ever since I got the shot. So much so that certain movements bring such intense pain that I feel as if my shoulder may be broken and the pain can bring me to both screams and tears. I actually have an appt. with my doctor later today and I am going to take __________ as well who is still having discomfort but not always to the same degree as mine. I too greatly appreciate this investigation because something is just not right. I have gotten this shot every year I have been there and never had a problem. After this reaction, I will never get another flu shot.
had 2 knots that came up in my arm at injection site; It's red all the way around, up under my arm and then it is too big on the inside of my arm and it's causing fever; did not have redness at the injection site but it turned purple-blueish, like it was a bruise; I 'got up' in the middle of the night; nauseated; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN6201; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as DOSE 1, SINGLE for COVID-19 immunisation. No medical history and concomitant medications were not reported. The patient experienced It's red all the way around, up under my arm and then it is too big on the inside of my arm and it's causing fever. Reporter stated, I have a consumer on the other line reporting an adverse event with the COVID-19 Vaccine, she is 51 years old and all she said was that she received the first dose of the Pfizer COVID-19 Vaccine on Friday and she has experienced an adverse reaction, but she did not tell me what it was. Consumer stated, when they gave me the shot, 2:50 when they gave me the shot at and I 'got up' in the middle of the night, it's red all the way around, up under my arm and then it is too big on the inside of my arm and it's causing fever. Consumer stated, I took some Tylenol, and I went to the emergency room last night and they gave me some Benadryl and they gave me pain medicine (Clarification unknown) for it. When probed if taking any other medications, consumer stated, No, I have been taking Benadryl and 2 Tylenol. Consumer stated, do I need to take the second shot. Consumer stated after my 1st dose on Friday 26Feb2021, I did not have redness at the injection site, but it turned purple-blueish, like it was a bruise, I was nauseated all day from Saturday (27feb) until Monday (1Mar). I also had 2 knots that came up in my arm at injection site. The outcome of the event nauseated was recovered and outcome for other events was not recovered.  No follow-up attempts are possible. No further information is expected.
SYNCOPAL EPISODE, SEIZURE ACTIVITY. Evaluated by EMS-Refusal to transport.
Systemic: Developed spots on hand of vaccine arm. No itch. Getting better-Mild
Patient was given an adult dose of Hep A instead of a Peds dose. Family was notified.
Underneath area of shot, it was red hard and painful.  Lasted 3 days. Then in turned pink and has been pink for two more days.
Itchiness at the injection site; Redness at the injection site; Soreness at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). On 25-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 19-Jan-2021, VACCINATION SITE PAIN (Soreness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the itchiness has diminished and the redness has lightened up. No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Follow-up received on 04-JUL-2021 and contains no new information
patient called pharmacy on 9/27/21 and reported that she was having symptoms of kidney infection;  told patient to go straight to the doctor so it won't get worse; patient in quired about side effects of covid 19, but told patient that kidney infection was not a common side effect of after receiving covid 19 vaccine.  patient stated she will go to the dr so won't get any worse.
Day following immun, mom reported that pt was "acting drunk", irritable, difficult to awaken, & flatulent; No fever; Following day pt was back to normal;
This spontaneous report as received from a registered nurse refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 02-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M031802 with expiry date: 09-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA014706:
Her arm was super sore after the first dose; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported The patient stated that her arm was super sore after 1st dose of Shingrix. For tolerance of 2nd dose refer case US2021AMR064854 and for Flu Shot refer US2021AMR064858. The reporter and healthcare professional consents to follow up was reported as not applicable.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR064854:Same reporter. US-GLAXOSMITHKLINE-US2021AMR064858:Same reporter.
right arm is still sore from the first dose; A spontaneous report  was received from a Healthcare Professional concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right arm is still sore from the first dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31 Dec 2020, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 039K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient experienced the events right arm is sore.  Treatment details included paracetamol or ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events right arm is still sore from the first dose was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL1263), in left arm, on 16Feb2021 as dose 2, single (Lot number: EI9267), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 01Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteopenia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (25Jul2022) Negative; (30Jul2022) Positive; (unspecified date) Unknown results; (28Jul2022) Negative; (30Jul2022) Positive. From 18Jul2022 to 23Jul2022, Paxlovid (Lot number: 2692127) as therapeutic measures were taken as a result of vaccination failure, covid-19.
Mar 29 my first Pfizer dose, Apr 19 my 2nd dose, Sept 29 my booster.  May 13 I had a rash on my forehead and June 3 I had hives.  I've gone through the normal allergy panels and nothing showed up except one rare mold.  I haven't had a day completely hive free since June 3. They were getting better at the end of Sept, but I got the booster and they are back to being a hot mess.  Dr. has had me take 2 Allegra and 2 Pfizer a day along with a prescription antihistamine.  At the end of Sept, I was down to 1/2 of Allegra and Zyrtec a day and no prescription.  Now I'm back to taking all the meds since getting the booster.
Severe widespread urticaria 10 days post vaccination. Took OTC anti-histamines but it would come back within approx. 24 hrs. Now taking prednisone 60mg along with Zyrtec anti-histamine
Widespread body rash with hives, itching, red streaks, spontaneously appearing and disappearing on my neck,torso, stomach, arms, and feet.
PATIENT STATED THAT HE STARTED FEELING SICK AFTER LEAVING THE PHARMACY ON HIS WAY HOME WHICH IS 5 MINUTES AWAY. HE REPORTED BEING NAUSEATED AND BODY ACHES. HE REPORTED NOT BEING ABLE TO GET OUT OF BED THE NEXT 24 HOURS.
an expired menactra was administered to a patient, with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old female patient who had an expired menactra was administered to a patient, with no reported adverse event after receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-May-2023, the patient received 0.5 ml of suspect meningococcal a-c-y-w135 (d conj) vaccine lot U7273BA , Expiration Date: 24-Apr-2023 via intramuscular route in unknown administration site, strength for Immunization.  On 01-May-2023 the patient developed a non-serious event an expired menactra was administered to a patient, with no reported adverse event (expired product administered) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  Outcome:  Unknown for the event an expired menactra was administered to a patient, with no reported 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 the 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.