chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stronger pain throughout my body; Cold voice; Loose stools; It's like I'm going to catch the flu; My head hurts too much; General discomfort in the body; Headache; Dizziness; Dry mouth; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DRY MOUTH (Dry mouth), DISCOMFORT (General discomfort in the body), PAIN (Stronger pain throughout my body) and DYSPHONIA (Cold voice) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (Dizziness) and DRY MOUTH (Dry mouth). On 27-Mar-2021, the patient experienced DISCOMFORT (General discomfort in the body) and HEADACHE (Headache). On 28-Mar-2021, the patient experienced PAIN (Stronger pain throughout my body), DYSPHONIA (Cold voice), DIARRHOEA (Loose stools), INFLUENZA LIKE ILLNESS (It's like I'm going to catch the flu) and HEADACHE (My head hurts too much). The patient was treated with ACETAMINOPHEN on 26-Mar-2021 at a dose of UNK dosage form. On 26-Mar-2021, DIZZINESS (Dizziness) had resolved. At the time of the report, DRY MOUTH (Dry mouth), DISCOMFORT (General discomfort in the body), PAIN (Stronger pain throughout my body), DYSPHONIA (Cold voice), DIARRHOEA (Loose stools), INFLUENZA LIKE ILLNESS (It's like I'm going to catch the flu), HEADACHE (Headache) and HEADACHE (My head hurts too much) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Bloody nose emanating from left nostril.   Patient treated with standard first aid for this situation.  There was no blow to the nose or face that preceded this event.
On January 21, 2021 at the Prospect COVID 19 Vaccine Clinic, an orthopedic PA was administering vaccinations during the morning for a four-hour shift, 8 AM to noon. At the end of her shift, she handed off her vaccines to another vaccinator (a RN). The PA had three doses of vaccine drawn up at that time, in syringes, on her desk. When the RN inspected the syringes, she found 0.4mL of vaccine had been drawn into those syringes rather than the required 0.3mL. The RN then alerted the lead APRN, who escalated the situation to the operations manager. The operations manager then contacted the Chief Quality Officer.  The concern was that the PA had been vaccinating patients all morning with an inappropriate dose of vaccine, 0.4mL.  After thorough internal investigation, we found that the PA drew up 38 vaccine doses and administered 35 of them.  Additionally, based on vial usage for the day and total number of vaccines administered, we have concluded that it is highly unlikely that excess vaccine was administered. This was a ?near miss? event and is being reported out of an abundance of caution
I took Benadryl 5 minutes before  getting my vaccination since I had had a moderate allergic reaction to the first dose (itching at vaccine site, puffy lips, elevated heart rate, nausea, coughing). Within 15 minutes of receiving the vaccine, I presented with a rash on my face, chest, elbows, and knees. After 30 minutes, I began feeling unwell and the nurse on site suggested I go to Urgent Care or an ER. My husband drove me to an Urgent Care nearby. As I was filling out the paperwork, I felt a rapid pulse, extreme nausea, confusion, trouble with motor skills like filling on intake paperwork. After completing the  paperwork at the Urgent Care, they informed us that they didn't want anything to do with the covid vaccine. My husband found an ER nearby and we went there. The ER offered me a wheel chair to wheel me back because I was feeling unsteady on my feet. They gave me intravenous fluids, steroids, and pepcid, and monitored me for about an hour until my rash dissipated  and my heart rate returned to normal. The doctor then gave me a prescription for 4 days worth of oral prednisone and  7 days of famotidine.  If I had had an epi-pen at the time (I now have one for my wheat allergy), I would have epi-penned myself while I was at the Urgent Care.  Additional effects post-vaccine:  the rash  and racing heart rate reappeared several times throughout the following week, increased cough and shortness of breath for 2 weeks, my following menstrual cycle began 5 days early (my menstrual cycle is typically very regular at 28 days).   After a 2-week recovery period from the vaccine, I saw some improvement in some of my long covid symptoms such as  cough and shortness of breath.  Likely related to long covid, I continue to have symptoms of chest pain, racing heart rate/palpitations, nausea, dizziness. Due to these symptoms, I am undergoing continued testing by my doctors and I had two ER visits during the month of June on 6/16/2021 and 6/18/2021. So far, we have no diagnosis or treatment plan.
Herpes Zoster.  I cannot identify any ?drop in defenses? or special stress, usually associated with Herpes Z. That is why I think it could have been  precipitated by the booster or by COVID (in February ), a very mild case.  Although it was intense, the pain was tolerable. I took one week of aciclovir (every 5 hours)  pills and cream. And pregabalina for pain.
MISSED THE LAST DOSE; This spontaneous case (PVX2019-942) was received from a consumer on 22-Apr-2019. It describes a 24-year-old female consumer who was "missed the last dose". The consumer was receiving Vivotif (lot no: 3003242) for an unknown indication. 3  Case report: The consumer took three doses of Vivotif and then went out of town. She missed the last dose, which was due on 21-Apr-2019.   Action taken with Vivotif was not applicable.   The clinical outcome of the event "missed the last dose" was unknown.  Company's Comment: The causality of the event "missed the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the last dose" was considered as not applicable.
61 year old male patient administered FLUZONE HIGH DOSE, no AE; 61 year old male patient administered 0.7 ml dose of FLUZONE HIGH DOSE, no AE; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 61 year old male patient who received 0.7 ml INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 01-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ515AA and expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of overdose and actual medication error due to inappropriate age at vaccine administration (latency on same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
PATIENT FELT LIKE HER HEART WAS RACING. SHE HAD A MINOR LOCAL REACTION TO NEOMYCIN IN THE PAST. BASCIALLY, WE CALMED HER, TOOK HER PULSE (56BPM) AND OBSERVED RESPIRATION. HER BREATHING WAS FINE. WE CHECKED THE INJECTION SITE. IT WAS SLIGHTLY RED AND NO SWELLING. IT WAS A TYPICAL FLARE REACTION. TO ERR ON THE SIDE OF CAUTION, WE OBSERVED HER FOR A TOTAL OF 45 MINUTES. SHE WAS RELAXED AND HER PULSE RETURNED TO NORMAL. THREEFORE, WE SENT HER HOME AND ADVISED HER TO TAKE SOME BENADRYL JUST TO BE ON THE SAFE SIDE.
The first time got the shot the patient was in bed for 3 weeks; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 08-Dec-2020.  This case involved a patient of unknown demographics who reported that the first time got the shot the patient was in bed for 3 weeks (Illness), after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route on an unknown administration site.    On an unknown date in 1958, the patient reported that the first time got the shot the patient was in bed for 3 weeks (Illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
A spontaneous non-serious report of scabies was received form a nurse concerning a six year old female patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 18-Nov-2008 the patient received FLUMIST. On 27-Nov-2008, nine days after receiving FLUMIST, the mother took the patient and her brother, who also received FLUMIST, to the emergency room (ER) with rash on their arms and body that started on or shortly after the day the patient received FLUMIST. Treatment included BENADRYL, and acyclovir. The attending physician in the ER  diagnosed the patient with scabies and not an allergic reaction. At the time of the report, the event of scabies was ongoing and may be worsening.
The patient stopped crying, froze and had a staring spell for one second and then became responsive again and started crying. The patient was observed closely and was back to normal immediately after vaccination. Patient was well when she left the rooms. Her parents confirmed 24 hours later, with a follow up phone call, that she was doing well and showed no signs of adverse effect.
Patient stated that she began to break out in hives yesterday on her legs, stomach, and arms. Patient was told per Dr. to take Benadryl liquid by mouth or apply Benadryl cream to the affected areas.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 42-year-old male patient received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Lot number: FH8027) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 25Apr2021 as dose 2, single (Lot number: 045B12A) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Symptom onset 20May2022. Treated with Paxlovid 23May-27. No symptoms on completion of treatment with negative antigen test 29May. Symptoms returned 02Jun with negative test daily until 06Jun. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Negative; (02Jun2022) Negative, notes: Symptoms returned 02Jun with negative test daily until 06Jun; (03Jun2022) Negative, notes: Symptoms returned 02Jun with negative test daily until 06Jun; (04Jun2022) Negative, notes: Symptoms returned 02Jun with negative test daily until 06Jun; (05Jun2022) Negative, notes: Symptoms returned 02Jun with negative test daily until 06Jun; (06Jun2022) Negative, notes: Symptoms returned 02Jun with negative test daily until 06Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with Paxlovid for treatment of COVID-19. Treatment start date: 23May2022. Treatment stop date: 27May2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Flush, hot. Nauseated, light headed, itching. Symptoms subsided about 20 minutes later. Pt took 50mg Benadryl on her own.
10 mins p/vax given pt lt arm began shaking & cont approx 5 sec; approx 15 mins later rt arm & head also were reported as shaking for approx 5 sec; pt did not respond to mom's voice; pt went to sleep p/awaking;
Shortly after receiving the Covid vaccine on 3/18/21, She experienced some tingling and numbness on her  left arm but went away within 15 mins. Later that night she started feeling some numbness in her left upper  lip. On 3/19/21 and 3/20/21 she noticed her left eye started twitching. On 3/21/21 she felt a tingling  sensation and numbness on the left side of her face.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 18 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Dec2021 (Lot number: Fd0809) at the age of 18 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0172, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 05May2021, when the patient was 17 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0158, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 11Apr2021, when the patient was 17 years old, for Covid-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021, outcome "unknown", described as "Dose Number 3"; PAIN IN EXTREMITY (non-serious) with onset 23Dec2021 09:00, outcome "recovering", described as "Left arm pain"; LYMPHADENOPATHY (non-serious) with onset 23Dec2021 09:00, outcome "recovering", described as "swollen lymph nodes left under arm"; PYREXIA (non-serious) with onset 23Dec2021 09:00, outcome "recovering", described as "fever"; MALAISE (non-serious) with onset 23Dec2021 09:00, outcome "recovering", described as "general malaise". Therapeutic measures were taken as a result of pain in extremity, lymphadenopathy, pyrexia, malaise.No follow-up attempts are possible. No further information is expected.
first dose gave me hot flashes night sweats, put me back into meno pause hasn't stopped,  yet second dose gave me frequent urination going on the 6th day, blood in urine
Information has been received from a physician concerning a 24 month old male patient with no pertinent medical history prior to VAQTA vaccination and no drug reactions/allergies who in November 2009, at the age of 15 months, was vaccinated IM in the right thigh with a dose of VAQTA (lot number 663913/0206Y, exp date unspecified). On 22-JUL-2010 the child was diagnosed with acute Hepatitis. Child had been hospitalized twice. Child had Liver transplantation on 29-AUG-2010, and was still hospitalized at this time. Physician would like a lot check for VAQTA lot #663913/0206Y and wanted to know if there had been any other reports of this occurring. In addition, physician would like to know if this specific lot number was tested in efficacy trials. Physician requested VAQTA specialist call back. Acute Hepatitis was considered to be an other important medical event, disabling and immediately life-threatening by the physician. A lot check has been initiated. Follow up information has been received from the health professional concerning the 24 month old male patient who vaccinated with only one dose of VAQTA and presented less than one year later with symptoms suggestive of acute hepatitis A. Serology on all hepatitis viruses (including hepatitis A) were initially negative. Health professional did not believe the Hepatitis A result and asked the lab to dilute the sample for a follow up Hepatitis A IgM test. The results of this test came back positive. They were not concerned about safety, but rather if this was a case of vaccine failure. Additional information has been requested.
This spontaneous report as received from an 87 year old consumer with allergy to penicillin who refers to herself. On an unknown date, approximately in 2010 (reported as "four years ago") the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, dose, lot# and expiration date were not reported). The patient was taking unspecified concomitant medication. On 01-JUN-2014 the patient had a fever and went to the hospital (went to the Emergency Room but was not admitted to the hospital). The patient had laboratory test performed in the hospital. The doctor told the patient that it was shingles. When the patient left the hospital, the doctor instructed her to see her intern the next day (on 02-JUN-2014). The patient did not explain who her intern was. The patient reported that at the time of the report she experienced a burning sensation in her arm, "between the elbow and up about 6 inches or so". The patient was taking unspecified prescription medication for the treatment (date unspecified, in 2014). The patient said that she had recovered from having shingles but she still was experiencing symptoms (date unspecified, in 2014) (the outcome of the event was recovered with sequelae). The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected, because there was no consent for further contact.
I was in on January the 8th and was given albuterol because I wasn't able to breathe. My eyes had gotten infected as well and needed drops for that during the same time. They gave me a couple antibiotics because they couldn't clear up the coughing, wheezing, and congestion. It was more like flu symptoms. It felt different and didn't feel like allergies, or the normal flu, or pneumonia. I took the medication and I felt better for a couple days after and once I was done, the symptoms would come back and wouldn't go away. I went through that from late December to the early February. This just continued with doctors' visits until I got better. My husband went through the same thing, and we got the shot the same day as well.
This child had redness and swelling 15 cm diameter at injection site (left thigh). The swelling was mild, thigh was warm at the injection site, circulation was good. The patient was told to continue with Tylenol, and moist cloths as directed.
As reaching for binoculars, experienced extreme pain in right shoulder area.  After having X-rays and MRI, was diagnosed with "frozen shoulder".  Received 3 cortisone injections, multiple physical therapy visits, and pain medication.  After receiving no relief, I changed orthopedic surgeons.  I am now scheduled for "manipulation under anesthesia" with arthroscopic release from Dr. on 11/5/13.
My right should joint was sore immediately. It's been two weeks now, and the pain is worse than at the time of the injection. My range of motion is severely limited with my right arm due to the pain in the shoulder joint which radiates down the arm. Doing simple tasks like getting dressed cause pain. Sleeping has also been affected. I plan to make an appointment with an orthopedic doctor today since the pain has not subsided.
Redness, warmth, tenderness and firmness at injection site of influenza vaccine present one day after injection which continued to day three.  Diarrhea on day 2.
Approx 2-3 hours after receiving injection for deployment, pt experienced nausea, chills, headache, abdominal pain and was transported to local hospital.
pt reported seasonal allergies and an allergy to the shingles vaccine causing a rash, no other info. pt reported new medications dorzolamide, timolol maleate, latanoprost.
Dimpling and sligt discoloration of skin on left lateral thigh at injection site. Seems to be getting progressively larger, also with 1/2cm palpatable SC nodule.
Information has been received from a health professional concerning a 20 year old Hispanic female with a history of being positive for papilloma viral infection, who on 03-Nov-2007 was vaccinated with a 0.5mL dose of Gardasil.  Subsequently, the patient was pregnant.  The patient's last menstrual period was 21-Sep-2007 and her estimated delivery date was 27-Jun-2008.  The patient had one previous pregnancy and one full term delivery.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Constant severe pain, stiffness, immobility. Prescribed Diclofenac.
On Wed 4/18/07 Patient received imms on 4/19/07. Patient had tactile fever, which continued on 4/20/07 patient had episode of decreased tone, shakin and asymmetry of jaw movement tactile fever persists afebrile in clinic otherwise doing well. Residual asymmetry of lower legs.
It was reported that an 11 year old female received Fluzone SV '2002-'2003 (lot number U0958AA), administered on 11/13/02. The next day on (11/14/02), the pt developed redness, swelling, and pain at the injection site. She presented to the ER on 11/15/02 and was admitted hospital. She was discharged from the hospital on 11/16/02 with the diagnosis of cellulitis. It was not reported whether the pt recovered from the event.   Reported on 03/04/2003: "From follow-up #1 correspondence received at Aventis Pasteur Inc. On 02/24/2003, it was reported that the 10-year-old patient was hospitalized for one day.  No other vaccines were given within 4 weeks.  Patient has a history of asthma and seasonal allergies.  Concomitant medications include albuterol nebulizer, advair, zyrtec and singulair.  Patient had no illnesses at the time of vaccination. A 15-day follow up report received 12/16/2003 adds: On 12/08/2003, the hospital discharge summary and office notes were received. The lot # of the product was reported as U0969AA, not U0958AA, as initially reported. The discharge diagnosis was cellulitis vs. allergic reaction. She was prescribed Augmentin 5cc 3 times daily for 10 days and was advised to follow-up with her family physician. No other info was provided. No further info is anticipated, this case is considered closed.
Narrative: COVID infection following COVID vaccine series 03/10 , Pfizer, dose #1 04/02 Pfizer, dose #2 08/04 pt cc: cough, headache exposure: unknown 08/22 COVID swab, result: detected