chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Congested ears and Tinnitus.  Pronounced in one ear continues to this day.  Nose not congested at all.  Does come and go, Nasal rinse seems to help some.  Steroidal spray has not helped much.
This spontaneous report as received from a 61 year old female patient with allergy to amoxicillin and BETADINE. The patient's medical history included colitis. On 28-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml (lot#, expiry date, site and route of administration were not reported). On 28-SEP-2015, 4 hours after receiving a PNEUMOVAX 23, the patient experienced extreme pain at the injection site. On the same day, the patient also had a low grade fever, swelling, and patchy red spots at the injection site. The patient was treated with unspecified over the counter pain relievers, ice and heat. No laboratory test was performed. The outcome of the events was unknown. The patient sought medical attention by contacting the pharmacy. The relatedness between the PNEUMOVAX 23 and the events was not reported. Additional information has been requested.
Pt states pain in left arm ever since the injection. Pt rates pain as a 3-4 on the pain scale, he can't lay on his left side. Pain has not improved or regressed in the last 2 months.
Cognitive disfunction; extreme confusion; sleepyness; Dehydration; Pain at the injection site; muscle ache; fever; Headache; extreme exhaustion; A spontaneous report was received from a consumer concerning a 72-year-old, male patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  experienced pain at the injection site, muscle ache, fever, dehydration, headache. Later on he experienced cognitive disfunction, extreme confusion, extreme exhaustion, sleepiness, inability to rise or follow  instructions, he didn´t know where he was, he wasn´t making sense.    The patient's medical history, is not provided by the reporter.  Concomitant medications were reported, levodopa, carbidopa and entacapona, pramipexole, fludrocortisone, rasagiline, omega-3 acid ethyl esters, coenzyme Q10, glucosamine, and chondroitin    The patient received their first of two planned dose of mRNA-1273 on 31 Jan 2021.  Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in(Lot number: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 01 Feb 202, the patient, experienced pain at the injection site, muscle ache, fever, dehydration, headache. Later on he experienced cognitive disfunction, extreme confusion, extreme exhaustion, sleepiness, inability to rise or follow  instructions, he didn´t know where he was, he wasn´t making sense.    Treatment for the events included intravenous fluids.    Action taken with mRNA-1273 in response to the events was unknown.     The outcome of pain at the injection site, muscle ache, fever, dehydration, headache. Later on he experienced cognitive disfunction, extreme confusion, extreme exhaustion, sleepiness, inability to rise or follow  instructions, he didn´t know where he was, he wasn´t making sense were unknown.; Reporter's Comments: This case concerns a 72 year old, male patient, with a history of COVID (April 2020), who experienced an unexpected event of cognitive disorder among others, 2 days after receiving 1st dose of mRNA- 1273 (Lot# 041L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.
16 year old Vaccinated with Moderna COVID-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old Vaccinated with Moderna COVID-19 Vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old Vaccinated with Moderna COVID-19 Vaccine). On 08-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old Vaccinated with Moderna COVID-19 Vaccine) had 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 medications were not provided by the reporter. Treatment information was not provided. Reporter reported that the patient never received a second dose.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Followup received on 21 Jul 2021 contains nonsignificant information.
Patient became dizzy, blurred vision, diaphoretic, hands shaking, red, glossy eyes, Respirations up to 24RPM. Reports SOB.
Patient was given Zostravax instead of Varivax that was ordered.  Patient had no reaction/ no symptoms.
Prior to vaccine administration she did state she had an allergy to the preservative in flu vaccines. Patient came up to staff at 1400 and stated she had a headache. She also felt like her joints were also tight. She then also mentioned that her throat was sore and that had been occurring for about 15 minutes but she was trying to wait and see. Asked if she should just take benadryl. Advised that I could not advise that and would recommend seeing a physician. Walked her to the emergency department at 14:01.
Large reddened area in to inner forearm that is warm to the touch and painful with movement.
No rash, muscle soreness and joint pain in right shoulder. 19 days after injection. Again no rash or redness nothing involving the skin just muscle and joint pain.
Mom reports increased heart rate of 124, profuse sweating, chest tightness, dizziness, coughing. Mom gave albuterol inhaler after callling MD. The pt was also given a nebulizer treatment. Later that day pt feeling much better.
fever 103, then 101 X 4 days; L arm swelling 6-7 inches X 3-4 inches, warmth, tenderness X 3 days; diarrhea X 2 days; resolved spontaneously
This spontaneous report as received from a certified medical assistant refers to 48 patients of unknown age and gender. On an unknown date, and unknown number of doses of VARIVAX were inadvertently administered between January 2014 and June 2014 that had been improperly stored (-14C to -10C for about 5 months) was administered. No adverse effect reported. The reported was unable to clarify how many of the 48 patients were administered VARIVAX and how many were administered PROQUAD (1406USA012539). At the time of the report the action taken was unknown. This is one of two reports from the same source. Additional information has been requested.
Sore arm for 24 hours; This is a spontaneous report from a contactable Consumer (patient, reported for herself)  A 43-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date: UNKNOWN) via an unspecified route of administration in Arm Left on 25Feb2021 17:15 as SINGLE DOSE for covid-19 immunization at pharmacy or drug store. Lot unknown reason other, not given info by pharmacist. Patient Medical history, known allergies included Drug allergy to Codeine and morphine. Other medical history included congenital heart Defect from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (Other medications in two weeks) included: digoxin (LANOXIN), lisinopril, furosemide (LASIX [FUROSEMIDE]), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and multivitamin all taken for unspecified indications, doses, unspecified dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since the vaccination.   On 25Feb2021 at 22:30 patient experienced sore arm for 24 hours. Patient did not received treatment for the adverse events. The patient was not tested for COVID post vaccination. Event Sore arm for 24 hours was non-serious. Outcome of the event was reported as recovered on an unspecified date.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Severe neck pain and stiffness, constant. Bilateral ear pain, intermittent. Taking high doses of motrin daily and using heat packs to deal with this.
Information has been received from a male physician who on approximately 18-Oct-2006 was vaccinated with a dose varicella-zoster virus vaccine live. On 22-Nov-2006 the physician reported that he has thoracic zoster on his left side which hurts. He rated his pain a 5 on a scale of 0 thorugh 10 being the most. No speciment was collected for PCR analysis or DFA as he was traveling in another country. At the time of the report, he still had pain. No further information was provided. Additional information has been requested.
Dry rash around injection site; This is a spontaneous report from a contactable Other Health Professional (patient). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at 15:00 at single dose for COVID-19 immunisation. Medical history included known allergies: lavender and trees. Concomitant medications included magnesium, birth control, elder berry. Nasal swab on unknown date was negative. It was unknown if treatment received or not. Outcome of the event was unknown.  Information on the lot/ batch number has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 27-SEP-2013 the patient was vaccinated with VARIVAX (Merck) (subcutaneous, 0.5 ml; dose number unknown; lot # G007461 exp 02-AUG-2013). The patient was administered an expired dose of VARIVAX (Merck). No adverse effect was reported. Additional information is not expected.
This is a spontaneous report from a non clinical study program from a contactable nurse who reported for two patients. This is the second report for different patient, same vaccine (same lot number) and different adverse reactions. A 79-year-old female patient received PREVNAR 13 (lot J04196), via an unspecified route of administration on 09Apr2015 at 0.5 ml single. The patient medical history was not reported. The patient was taking other unspecified medications. On an unspecified date the patient got cellulitis of the arm, due to which she was hospitalized from 11Apr2015. The event was still ongoing and the patient was still in the hospital.
Liquid portion only; Liquid portion only; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA768A, expiry date 31-DEC-2023) for prophylaxis.   On 03-JUL-2023, the patient received the 2nd dose of Menveo. On 03-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Liquid portion only) and inappropriate dose of vaccine administered (Verbatim: Liquid portion only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-JUL-2023 The reporter reported that a patient accidentally received an incomplete dose of Menveo, receiving only the adjuvant and wished to know how to proceed.  The information about the vaccine, patient and event collected. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The patient accidentally received an incomplete dose of Menveo, receiving only the adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Severe dysuria, loss of swallowing control, tongue fasciculation, generalized weakness Onset 1-2 weeks after second dose of covid vaccine.
This unsolicited case was received on 16-May-2017 from patient under reference number AE 17-0135. This case involves a 34-year-old male patient who was vaccinated with a dose of ACAM2000 (Batch number, expiry date, dose and dose in series were not reported) via percutaneous route in left arm and a dose of ANTHRAX VACCINE (Batch number, expiry date, dose, dose in series and route of administration were not reported) in right arm on 06-May-2017. Illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as seasonal allergies. Concomitant medications were not reported. On 14-May-2017, eight days following the vaccination, the patient had experienced headache, fever of greater than 100 F on and off, chills, fatigue, swollen left arm from the injection site to neck, swollen lymph nodes in the neck, had a buildup of mucous and some difficulty in swallowing. It was also reported that since receiving the vaccines, the patient had been experiencing increasing symptoms. Laboratory investigations were none. Corrective treatments were not reported. Patient was not recovered from the events. List of documents held by sender: none.
pt recvd vax 5MAY95 & 6MAY95 pt had a swollen,hot arm;there was a swollen area 2 inches in size surrounding the inj site;addl pt had a sl sore throat;pt was seen in ER 6MAY95 & was treated w/Motrin & ceclor for sore throat;
Positive pregnancy test on 4/24/07; HPV4 #2 given 04/02/07.
On 11/03/2000 the patient presented with chickenpox. Additional information has been requested.
This is a spontaneous case reported by other non-health professional (consumer) and initially received on 12-Apr-2019, concerning a 28-year-old adult female pregnant patient. The patient had one previous pregnancy. The patient had no history of offspring with major congenital malformation neither had still birth or miscarriage. Also, the patient had no maternal or paternal history with major congenital malformations. The patient had no medical history. The patient did not receive any concomitant medications. The patient's last menstrual period (LMP) date was 19-May-2018. On an unspecified date, ultrasound was performed, and the baby's lungs were clear. On 04-Sep-2018, 15 weeks gestation period, the patient was administered AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for active immunization against influenza. On an unspecified date in Sep-2018, 2 weeks after vaccination, the foetus was diagnosed with chylothorax (fluid around the lungs). It stayed consistent for many weeks but when the patient was at 29 weeks of the pregnancy, the volume increased so they decided to drain it by thoracentesis. The week before the patient delivered the infant, there was a little bit of fluid (explicitly coded as foetal disorder). 37 weeks and 4 days gestational period, the patient delivered a male infant. The delivery method was caesarean. Infant head circumference was 33 cm, infant body length was 19.5-inch, infant body weight was 7 lb 6 oz and the appearance, pulse, grimace, activity, and respiration (Apgar) score: 8 at minute 1 and 10 at minute 5. It was reported that, chylothorax (foetal disorder) resolved and baby was born with no other complications other than hypospadias (tip of the urethra is lower than it is supposed to be). At the moment it was minor, they would re-evaluate at 6 months to see if he need surgery to resolve it. The patient's estimated date of delivery (EDD) was reported as 23-Feb-2019. The reporter assessed the case as serious (medically significant). The patient was willing to enroll in pregnancy registry for AFLURIA QUAD and FLUCELVAX QUAD. This case was linked to case: 201903041 (baby case).; Reporter's Comments: A 28-year-old pregnant patient was administered AFLURIA QUADRIVALENT vaccine (considered as vaccine exposure during pregnancy) at 15 weeks of gestation. The foetus was diagnosed with chylothorax (foetal disorder) in-utero, 2 weeks post vaccination which required thoracentesis. Despite the plausible temporal relationship between vaccination and reported event, considering the lack of biological evidence with vaccination, the event chylothorax (foetal disorder) assessed as not related to suspect vaccine. The event vaccine exposure during pregnancy assessed as not related considering the intended use of the vaccine.
Information has been received from a consumer concerning her child who on 03-AUG-2010 was vaccinated with a dose of ROTATEQ Lot# unknown). The reporter stated that on 03-AUG-2010, she took her child to her pediatrician's office for a check up. She stated that a nurse came in and gave her child a dose of ROTATEQ, however this shot was intended for the patient next door and not her child. She also reported that her child had already received the full course of ROTATEQ and this would had been an extra dose. No further information is available.
Skin rash on arms, hands, and fingers that has not yet completely faded.  Rash is below elbow. No itching or burning noted. Rash does not respond to hydrocortisone.
Information has been received from a physician, concerning an 18 year old female patient with no pertinent medical history and no known allergies, who on 22-JUN-2007 was vaccinated IM with the first dose, on 15-AUG-2007 with the second dose, and on 27-SEP-2007 ("43 days later") with the third dose of Gardasil (lot # not provided). There was no concomitant medication. Following the third dose on 27-SEP-2007 the patient experienced arm pain and reported not feeling well. On approximately 14-OCT-2007 ("three weeks after" and on "Sunday night") the patient developed a urinary tract infection and was hospitalized on an observation basis. Treatment included trimethoprim/ sulfamethoxazole (BACTRIM). Diagnostic labs included a blood culture, complete blood cell count, urinalysis (results not provided), and a thyroid function test that indicated an elevated thyroid stimulating hormone (TSH) (value not provided). The following day ("Monday"), she was discharged. At the time of this report, the patient had recovered from the urinary tract infection; the outcome of arm pain, not feeling well, and elevated TSH was unknown. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-APR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M043308 expiration date 24-APR-2018 (dose was not reported), for prophylaxis. The ZOSTAVAX was reconstituted with properly stored diluent (lot# M024781 and expiration date 21-FEB-2019). No symptoms were reported. Administered dose of vaccine was improperly stored for 1 hour and 38 minutes in a temperature range between 6 degrees Fahrenheit and 14 degrees Fahrenheit and for 7 minutes in a temperature range between 15 degrees Fahrenheit to 46 degrees Fahrenheit. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA008354: US-009507513-1704USA006447.
TOOK FIRST DOSE ON A FULL STOMACH; This spontaneous case report (PVX2019-2636) was received from a consumer on 21-Oct-2019. It described a male consumer who "took first dose on a full stomach" (PT: Product administration error), while being on Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on a full stomach.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took first dose on a full stomach" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first dose on a full stomach" was considered as not applicable.
Within two hours after injection, all sun-exposed areas began to itch severely (face, neck, ears, upper chest, arms, hands  and ankles.)  A few small fluid filled pimples also appeared in some of these areas, they have since disappeared. (This was not sunburn.) Three weeks later and the itching continues, at times it is unbareable. It is quite bothersome on a daily basis even if I'm not in the sun, however, if any of these areas or new areas are exposed to the sun, the itching becomes much worse. I have never experienced any issues with photosensitivity or phototoxicity prior having this injection.
This case was reported by a health professional and described the occurrence of expired vaccine used in a adult female patient who received FLUARIX (batch number XE294, expiry date 30th June 2014). On 30th September 2014, the patient received FLUARIX. On an unkonwn date, an unknown time after receiving FLUARIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to bee related to FLUARIX. Additional information received: Nurse reported she gave 4 female adult patients an expired dose of flu vaccine. Additional information was either unavailable or not provided at time of report.
Face got flushed; Warm face; Outline of lips started tingling; Outline of her lips felt irritated; Flank pain on her right side; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face got flushed), FEELING HOT (Warm face), PARAESTHESIA ORAL (Outline of lips started tingling), ORAL DISCOMFORT (Outline of her lips felt irritated) and FLANK PAIN (Flank pain on her right side) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMIN D 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 11-Mar-2021, the patient experienced FLUSHING (Face got flushed), FEELING HOT (Warm face), PARAESTHESIA ORAL (Outline of lips started tingling), ORAL DISCOMFORT (Outline of her lips felt irritated), FLANK PAIN (Flank pain on her right side) and HEADACHE (Headache). On 11-Mar-2021, FLUSHING (Face got flushed), FEELING HOT (Warm face), PARAESTHESIA ORAL (Outline of lips started tingling) and ORAL DISCOMFORT (Outline of her lips felt irritated) had resolved. At the time of the report, FLANK PAIN (Flank pain on her right side) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment includes :seasick drug and Claritin