chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ACID REFLUX; ITCHINESS AFTER COVID-19 VACCINE AND FLU SHOT; SORE ARM AFTER COVID-19 VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (ACID REFLUX), VACCINATION SITE PRURITUS (ITCHINESS AFTER COVID-19 VACCINE AND FLU SHOT) and VACCINATION SITE PAIN (SORE ARM AFTER COVID-19 VACCINE) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free and dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (ACID REFLUX), VACCINATION SITE PRURITUS (ITCHINESS AFTER COVID-19 VACCINE AND FLU SHOT) and VACCINATION SITE PAIN (SORE ARM AFTER COVID-19 VACCINE). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (ACID REFLUX), VACCINATION SITE PRURITUS (ITCHINESS AFTER COVID-19 VACCINE AND FLU SHOT) and VACCINATION SITE PAIN (SORE ARM AFTER COVID-19 VACCINE) outcome was unknown.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
due to no enough diulent for complete reconsititution big chunk observered which did not dissolved into diluent/No AE; patient had sent home without receiving vaccine/No AE; Initial information was received on 15-May-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 22-years-old female patient who did not received RABIES (HDC) VACCINE [IMOVAX RABIES] due to no enough diluent used for complete reconstitution and big chunk observed which did not dissolve into diluent (product dose omission and Package quantity incorrect).  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the vaccination was scheduled of suspect RABIES (HDC) VACCINE [vial lot: R1C85, Diluent lot: N1L47, Box lot: R1C854M and expiry date: 14-May-2021] for prophylactic vaccination for the patient.  It was a case of potential medication error due to product dose omission and Package quantity incorrect.   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.
Late. entry. Patient called 3/15/21. She stated she was administered the Moderna vaccine on 3/11/21, and initially had a runny nose, dry throat. She stated the next morning when she got up at 11:00 AM, she noticed a big blotch about 6" under injection site. It was red and itchy. She stated it looks better today, but seems to get red and more itchy, and burning feeling at night. She stated she is not having any pain. She denies any other symptoms at this time.  There was no time of vaccine or lot number available from Color platform.
A physician reported that several pts received TD Toxoids Adsorbed, Purogenated and subsequently, developed cellulitis. The pts recovered. The reporter was unable to specify the number of pts who experienced this event. Additional reports will be generated when identifying information is provided.
SEVERE, SHOOTING, BURNING PAIN UNDER ON RIGT RIB THAT TRAVELS TO BREAST AND TRAVELS TO MID-SPINE.  DOCTOR SAYS IT MAY BE  SHINGLES BUT RASH HAS NOT YET APPEARED.
Tested positive COVID-19; pain at injection (L); Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive COVID-19), VACCINATION SITE PAIN (pain at injection (L)) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at injection (L)) and FATIGUE (Fatigue). On 14-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive COVID-19). The patient was treated with AZITHROMYCIN (Z-PAK) on 14-Jan-2021 for COVID-19, at an unspecified dose and frequency; steroid pack on 14-Jan-2021 for COVID-19, at an unspecified dose and frequency and Cough syrup OTC on 14-Jan-2021 for COVID-19, at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive COVID-19), VACCINATION SITE PAIN (pain at injection (L)) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: positive (Positive) contracted Covid-19.         No relevant concomitant medications were reported.
Adverse Event: Right upper deltoid displayed discoloration, warm, redness and pain. Pain was a 3 or 4. Event occured the month of the 2nd dose of COVID vaccine administration.   Treatment: Went to Urgent Care in July and was prescibed Keflex 500mg 3 times per day.   Outcome:  Currently the pain has decreased and on a pain scale of 0-10(10 being the worst pain I've ever felt), it is a 2. Warmth, redness and discoloration of the skin remains.
At 1611 client's Mother alerted EMT daughter had headache and nausea. PHN responded. At 1611 client sitting upright in chair, alert and oriented x4. Client reports that she has been feeling headache since she sat down in observation 20 mins ago and did not inform anyone. At arrival to observation room client stated headache pain 5/10. EMT took vitals at 1614: blood pressure 122/78, pulse 90, oxygen sat 97%. Client denies blurred vision, dizziness, shortness of breath, no rash visible or swelling. Client reports medical history of migraines and high cholesterol, no medications and no known allergies. Per client tolerated 1st Pfizer Covid-19 vaccine well. At 1616 client reports headache resolved and nausea is improving. Vitals at 1620: blood pressure 116/84, pulse 83, oxygen sat 100%. Client reports new onset of "feeling head heavy". Client denies headache at this time or nausea. Per client this "heavy" feeling has happened in the past. PHN  advises client to follow up with provider and client states she does not have insurance or provider at this time. PHN gave client healthcare resources: list of community clinics and Medi-cal resources. PHN  gave ER precautions. Vitals at 1625: blood pressure 110/84, pulse 82, oxygen sat 99%. Client reports all previous symptoms have resolved. Last vitals at 1635: blood pressure 110/78, pulse 82, oxygen sat 99%. Client reports "feeling fine". Client left facility with steady gait at 1640.
Next day post vax, the pt developed swelling, pain, and hyperemia. Swelling measures 6 cm in diameter, indurated and slightly tender.
At night my heart started racing, I felt like coughing, I felt extreme fatigue, no chills or fever, body aches. Muscle  aches. I felt like I had covid all over again. Had COVID in June 2020 and never really stopped coughing. Since I had the vaccination it seems that the cough got a little better.  I also developed Shingles after about a week or so after the vaccine.
Itching limited to immunized arm, swelling limited to area 3 to 4 inches above inject site and down to elbow. Flu like symptoms. Headache.
Individual reported symptoms of cough, congestion, HA, sore throat, and fever since 12/13/21.  Tested positive on 12/14/21. Isolation continued until 12/23/21. She will get antibody testing done after isolation period is completed.
Patient had hives ever since the day after the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnoea syndrome" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM; FLEXERIL [CEFIXIME]. The following information was reported: URTICARIA (non-serious) with onset 09Oct2023 at 08:00, outcome "not recovered", described as "Patient had hives ever since the day after the shot". The event "patient had hives ever since the day after the shot" required physician office visit. Therapeutic measures were not taken as a result of urticaria.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
1. Right lymph glands swelled immediately.  Was given oral dose of steroids.  Swelling went down within a week.   2. Red welps formed in right eye brown and eventually blistered and left scar.  Lasted about a month. 3.  Tinitis started right away but has progressively gotten worse and now have loss of hearing in right ear.
Right side of tongue swelled, sore throat, ear pain then when those symptoms began to subside there were oral lesions, lips swelled, mouth sores and corners of the mouth felt raw
"Moderna Covid 19 Vaccine EUA" Patient received his second dose of the moderna vaccine at approximately 4:00pm on 6/7/21. He reports to me that at approximately 11pm to 12 am after the shot he developed multiple blotches/speckles in his vision.  He also states he is experiencing some balance issues/vertigo but feels it could be due to vision issue.  Patient called me at 2:25pm on 6/8/21 and was still experiencing the vision issues.  He was waiting on a call back from his physician for advisement.  He also states that he was experiencing injection site pain, diarrhea, and stomach pain but experienced these same adverse effects with this first moderna vaccine.
Pt reported he fell and was found unconscious at home by family members after going to bed the night of receiving vaccine. Pt reports was unaware of incident.
Swelling, inflamation, pain at shot site...about 2 1/2 X 3 1/2 inches, lasted over 1 week.  Now, 2 weeks later, site is visibly pink; swelling, inflation and pain gone. I believe the injection was administered into the muscle and not subcutaneous.  My husband and I had the same adverse effect.  We reported the effect to the pharmacist and he said that 4 others had reported the same effects.
Red Arm; Hot Arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Red Arm) and VACCINATION SITE WARMTH (Hot Arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red Arm) and VACCINATION SITE WARMTH (Hot Arm). At the time of the report, VACCINATION SITE ERYTHEMA (Red Arm) and VACCINATION SITE WARMTH (Hot Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient states she has a headache different from her normal chronic headaches.  She states it starts at the base of the back of her head and moves to above her left eye.
CHILLS, SWEATS, TEMPERATURE, FEVER RANGING FROM 99.5 TO  102.5, SHAKES, GENERAL MALAISE, TIREDNESS, NAUSEA, SWOLLEN LEFT ARM LYMPH NODES WITH PAIN, FEVER LASTED 2 AND A HALF DAYS
Uterine cramping and premature menstruales bleeding. Patient does not typically experience cramping during regular menstrual cycle. Bleeding is light. Scheduled cycle was not expected to start for 10 more days following first day of bleeding (5/5/21).
Pt developed redness, swelling and pain at the site of injection (arm). Pt seen at urgent care and felt to have a vaccine reaction. Parents insisted on antibiotics. Pt seen for F/U 2 wks after vaccine given-minimal discoloration remained (redness/purple).
Bell's palsy/Face was turning side ways; This is a spontaneous report from a contactable nurse.  A female patient of unspecified age received BNT162B2 (reported as "Covid-19 Vaccine, manufacturer: Unspecified", Batch/lot number: not provided) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. A woman received a Covid vaccine. She did not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning sideways. Outcome of the event was unknown.  Pfizer is a marketing authorization holder of Covid-19 Vaccine in the country of incident 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.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between reported event Bell's Palsy and BNT162B2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
SLIGHT BODY ACHES; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced slight body aches, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight body aches, headache and fatigue was not reported. This report was non-serious.
tested positive for COVID on 12Apr2021 after coming down with symptoms; tested positive for COVID on 12Apr2021 after coming down with symptoms; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported); dose 2 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) both as single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported receiving both doses of Pfizer COVID-19 vaccine in Jan2021 and the patient tested positive for COVID on 12Apr2021 after coming down with symptoms. The outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for COVID  based on the known safety profile.
On Thursday evening I had a scratchy throat, sinus drainage and I was slightly achy. The next morning the symptoms had increased, and I had a slight headache. I had a doctor tele visit and was prescribed PAXLOVID. I took the course of PAXLOVID. I felt better but then my symptoms came back, and I had a rebound case. My symptoms persisted another 8 days. I continue to have a dry cough.
Woke up in the A.M. and all joints were aching. The aching progressed to difficulty walking. Patient currently prescribed medication, which he started taking in June.
Approximately after 15-20 minutes of injection of covid vaccine, my daughter lost her vision.  All she could see is a bright white light for approximately 2-3 minutes. In addition, her lips became white in color.
Severe diarrhea accompanied with abdominal pain for several hours (began about 10:30 pm lasting 4-5hrs).  Took an over the counter remedy for diarrhea...had to take repeated doses, and still had diarrhea.  Also experienced chills for the same time period. Went to bed about 3am...woke up later in the morning and those symptoms were gone. Over next couple days experience fatigue, slept more often and for longer periods of time. Today is the first day I felt returned to normal.
mom brought to our attention a lump approx 1 /2 cm size deep in lt thigh muscle; on exam the pt did not limp, lump was not tender nor discolored;
Several Herpes Flair ups;  Nerve endings feel uncomfortable in legs and upper body.  Worse with fatigue.  No new treatment.  Just taking prescribe meds for virus  Looking for validation that this could be connected and suggestion for treatment of discomfort
This spontaneous report was received from a registered nurse refers to a 29 years old male patient with none pertinent medical history, none drug reactions/allergies and with pain. On 23-JUL-2012 the patient was vaccinated SQ in right arm with a 0.5 ml dose of PNEUMOVAX23 (lot# 1947AA, exp date 20-OCT-2013). Concomitant medications included: clotrimazole cream, hydrocortisone cream and oxcarbazepine twice a day for pain. On 24-JUL-2012 the patient's right arm was swollen past the elbow with stiff fingers to the right hand, red and hot to touch. The patient was taken to the emergency room but not admitted (he sought medical attention to nurse in the prison yard). None lab diagnostic tests were performed. The patient received ROCEPHIN (1mg) for adverse event treatment. At the time of the report patient's state was recovering. This is one of several reports from the same source. Additional information has been requested.
had complaints of dizziness, diaphoresis after shot while sitting in chair, was about to notify someone and had witnessed fall to ground, head first out of chair, fell to ground and had 15 sec syncopal episode, with thready pulse noted, barely palpable, pale, and clammy. feet put up on chair, ammonia tx, regained consciousness, and rolled onto backboard and transported to obs via stretcher, answering appropriately at this time. left forehead abrasions noted. 1105: bp 137/85 hr 76 rr 18 sats 99% on ra. PERRL. 1115: bp 136/86 hr 88 rr 16 sats 100% on ra, feeling better per patient. advised to go via ems for further eval for possible imaging by md and nurses, refusing, as has syncopal episodes in past similar to this with falls. 1124: bp 144/90 hr 81 lying, bp 135/88 hr 82 sitting, bp 126/89 hr 81 standing; asymptomatic. patient states feeling back to baseline. instructed on ss to monitor for and to go to ed. escorted to private vehicle with no further issues.
Chills, fever, exhaustion, itching, golf-ball size lump at injection, arm red & itchy the circumference, down to the elbow. R. Alcohol & Cortisone cream, ADVIL.
Pt recv vax on 7/24/98 and on 8/2/98 pt exp temp-103.8, localized and generalized rash, mildly lethargic, and poor appetite.
THE PATIENT BECAME SEVERLY HOARSEAND HIS VOICE WAS VERY UNCLEAR.    HE ALSO WAS UNABLE TO SLEEP SINCE HE WAS VACCINATED.  HE WAS NOT MANIC OR AGITATED. HE HAD NO PANIC ATTACKS AND HE HAD NO ANXIETY..
This is a spontaneous report from a contactable consumer. A 72-year-old female patient of unspecified ethnicity received PREVNAR 13, via an unspecified route of administration in the left arm, on 24Dec2014, at single dose. Relevant medical history and concomitant medications were not reported. Two days after vaccination the patient experienced redness in the same arm at the site of injection (without itching or pain) for 2-3 days. Four days after vaccination (2 days after redness happened) she experienced neck pain on the same side of the neck where the injection have been (left side) for about 2 weeks and she had trouble, like she could not turn her head all the way to the left. The patient mentioned that she routinely goes to an acupuncturist so she went. The patient recovered from the events.
Night of injection temp 102 and arm where injection was given very sore. Next day temp 101. 3rd day temp 96 and arm less painful.
SHORTNESS OF BREATH, TACHYCARDIA, FEELING HOT, PALENESS, WEAKNESS, PAIN AT INJECTION SITE, BLURRED VISION, VERTIGO, DRY MOUTH (APPROXIMATELY 15 MINUTES AFTER INJECTION)TIREDNESS, CONGESTION, AND LOW FEVER (LASTING ABOUT 2 DAYS)
For three days in a row, I had nose bleeds.  First day about two hours after, 2nd day and 3rd day in the morning. The nose bleeds were about 20-30 minutes in time on Day 1 and Day  2.  Day 3 was manageable. Day 1 and DAY 2 it was shortly after I took a Tylenol the nose bleeds began.
No symptoms or adverse effects reported; Nurse reports 8 patients received unspecified dose of PROQUAD that was improperly stored; This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.  On 10-FEB-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number S012530 and expiration date 20-OCT-2020) as prophylaxis. The sterile diluent (manufacturer unknown) used was properly stored.  According to the reporter, the temperature excursion was -12.8 degrees Celsius for a time frame of two hours and 38 minutes on an unspecified date (product storage error), with multiple previous temperature excursion of, the worst temperature/ was -9.8 degrees Celsius for about 112 minutes; which was detected by a digital data logger.  This is one of eight reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000425: US-009507513-2006USA000426: US-009507513-2006USA000427: US-009507513-2006USA000424: US-009507513-2006USA000428: US-009507513-2006USA000422: US-009507513-2006USA000423:
Hospitalized for evaluation post fall and ongoing/increased confusion in the setting of metastatic cancer, no respiratory symptoms.   Booster 10/26/2021 Pfizer Lot # FH8020
no additional AE; Adult patient was administered a pediatric dose; This spontaneous report as received from a registered nurse referring to a 21-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.    On 08-JUN-2021, the patient was inadvertently vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) at a dose of 0.5 milliliter for prophylaxis (lot# T022333 has been verified to be valid, expiration date reported and validated as 11-DEC-2021) (dose number, route of administration, anatomical location site, and vaccination scheme were not provided) (incorrect dose administered). No additional adverse event (AE) reported.