chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INJECTION SITE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 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 MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site pain was not reported. This report was non-serious.
sore throat; body aches, pain; bruising; cough; fatigued; headaches; diarrhea; sign of congestion; second dose,(subcutaneous) area; This case was reported by a other health professional via call center representative and described the occurrence of sore throat in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of urticaria (1st dose received on 28th January 2022 and experienced a welt, fatigue and tiredness, For tolerance of 1st dose ,refer case US2022AMR073549).   On 29th April 2022, the patient received the 2nd dose of Shingrix (subcutaneous). On 29th April 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced sore throat, general body pain, contusion, cough, fatigue, headache, diarrhea and nasal congestion. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sore throat, general body pain, contusion, cough, fatigue, headache, diarrhea, nasal congestion and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the sore throat, general body pain, contusion, cough, fatigue, headache, diarrhea and nasal congestion to be related to Shingrix.  Linked case(s) involving the same patient: US2022AMR073549   Additional Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comment: The reporter was physicians assistant. The reporter reported that, a patient was inadvertently administered the second dose of Shingrix in the posterior triceps (subcutaneous) area.  The reporter called in to inquire about any efficacy and/or safety information of a Shingrix subcutaneous injection. The patient experienced pain, bruising fatigued, body aches, cough, sore throat, sign of congestion, diarrhea, and headaches.  The reporter was unable to provide full vaccine details. The reporter did not consent to follow-up. Additional Supportive Information: The reporter reported that, a patient was inadvertently administered the second dose of Shingrix in the posterior triceps (subcutaneous) area, which led to intramuscular formulation administered by other route.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR073549:same reporter
SIDS patient presented unresponsive taken to ED by ambulance and pronounced dead. 5/18/06 Received autopsy report which revealed COD as SIDS/ss
Around 6 months ago i had my 4th Pfizer shot in my right hip and now i am having issues with my TI muscle tendon; Around 6 months ago i had my 4th Pfizer shot in my right hip and now i am having issues with my TI muscle tendon; Around 6 months ago i had my 4th Pfizer shot in my right hip and now i am having issues with my TI muscle tendon; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; anatomical location: left shoulder), for COVID-19 immunization, reaction(s): "issues with my left shoulder", "had first Pfizer shot in my left shoulder/Has issues with my left shoulder"; Bnt162b2 (DOSE 2, SINGLE; anatomical location: left shoulder), for COVID-19 immunization, reaction(s): "issues with my left shoulder", "had first Pfizer shot in my left shoulder/Has issues with my left shoulder"; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), TENDON DISORDER (non-serious) all with onset 2022, outcome "unknown" and all described as "Around 6 months ago i had my 4th Pfizer shot in my right hip and now i am having issues with my TI muscle tendon". The events "around 6 months ago i had my 4th pfizer shot in my right hip and now i am having issues with my ti muscle tendon" required physician office visit.  Additional information: It was also reported that around 6 months ago patient had 4th Pfizer shot in right hip and now was having issues with TI muscle tendon Dr said patient need another shot not sure what to do.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
-day after vaccine, experienced headache, temp of 101, body aches/chills, no appetite. -headache lasted for 24hrs after, body aches chills decreased w/tylenol. Still decreased appetite until 3rd day fever was down to 99-100 w/tylenol
pt recv vax 24MAR94 & 27MAR94 exp dizziness, stomach ache & cramps, general flu-like sx & presented to ER; MD was uncertain whether the pt had an actual rxn to the vax or a panic attack d/t receiving vax; also exp dizzy spells & funny feel
Have had diarrhea since the first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Have had diarrhea since the first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Have had diarrhea since the first shot). At the time of the report, DIARRHOEA (Have had diarrhea since the first shot) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications reported.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up appended ON 25-MAY-2021. Agency document attached.
No additional AE.; some of the MMR II dripped out and down the patient's arm.; This spontaneous report was received from a nurse concerning an 18-month-old child (also reported as baby) patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 12-AUG-2022, the patient may have been vaccinated with less than the recommended dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) administered subcutaneously as prophylaxis, lot number U025199 with expiration date 13-AUG-2023 (dosage regimen was not reported). The nurse reported that when the child received the vaccine, some of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) dripped out and down the patient's arm, and the child's parents were concerned the patient did not get the full dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) (Vaccine underdose). No additional adverse events were reported (No adverse event).
The day after my vaccine I started my period. It was close to my usual cycle. It was rather light flow but for a normal duration. 23 days later began another period. It's early. I am now on day 21 of an active flow. On Day's 7-9 I experienced extremely heavy flow, soaking overnight pads in a matter of 2 hours, and experience large blood clots. On day 14 I caught medical attention at my normal primary care clinic through their walk-in services.  I was given birth control and told that at my age this was just to be expected. No lab work was performed.
Red rash and tenderness at injection site. On 5-10 arm very sore, rash spreading, unable to sleep at night and had headache.  5-11 thru 5-13 rash continues to spread.
Approximately 10 hours after receiving the vaccines (11/17), she developed generalized myalgias and fever. Continued to have fever until the following day and presented to the hospital due to immunocompromised state. Had fevers from 11/17-11/19. Treated with very broad spectrum antibiotics but all infectious studies were negative. Developed erythema over the R deltoid (location of pneumovax, but not influenza vaccine) on 11/20.
Red rash formed up about 4-5 days after the vaccination, the area where the shot was performed had a red circle. Was itching but not a profuse amount.
Hospitalized 11/16/2021; COVID-19 positive 11/09/2021; fully vaccinated  BRIEF OVERVIEW:   Admission Date: 11/16/2021 Discharge Date:  11/21/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Typical atrial flutter Pneumonia due to COVID-19 virus  COVID-19    HOSPITAL COURSE: Patient is a pleasant 44 y/o male who is vaccinated (moderna, last dose in April)and tested positive for COVID on 11/9 with symptom onset 11/8.He was started on decadron and remdesivir on admit and was requiring 2L NC. He had CTA showing COVID pneumonia but no PE. On admit he also was noted to have new onset Afib RVR and was briefly back in the ICU on cardizem drip, He was transition to Metoprolol. He was able to move out of the ICU on 11/17. He had an ECHO showing EF 58%. His procalcitonin was elevated and he was felt to have secondary bacterial pneumonia and he was started on azithromycin and rocephin.  Over the course of the hospital stay his oxygen needs gradually diminished and by the day of discharge he was down to room air at rest and 3 L with activity.  He completed his antibiotic course of Rocephin and azithromycin during his hospital stay and did not require further antibiotics at discharge.  He was discharged on dexamethasone to complete an additional 5 days.  Additionally given his AFib on admission this thought this was possibly related to his acute infectious process.  Consideration could be given to doing a ZIO patch in the future to assess his amount of AFib when not acutely ill.  His chads Vasc score was 1 has recommended that he take aspirin 81 daily.  His lisinopril was discontinued and he was started on metoprolol 25mg 2 times a day.  If he remains in sinus rhythm he could eventually be converted back to his lisinopril.
This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Could not lift arm up), ILLNESS (Illness), PYREXIA (Low grade fever), NAUSEA (Nausea) and MYALGIA (Body aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included ADALIMUMAB (HUMIRA) from 24-Sep-2020 to an unknown date for Rheumatoid arthritis. On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced JOINT RANGE OF MOTION DECREASED (Could not lift arm up), ILLNESS (Illness), PYREXIA (Low grade fever), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, JOINT RANGE OF MOTION DECREASED (Could not lift arm up), ILLNESS (Illness), PYREXIA (Low grade fever), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
no adverse events; Dose of PNEUMOVAX23  had expired on 06/12/2021 and was administered on 06/21/2021; This spontaneous report was received from a medical sassistant, referring to a 68 year old male patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 21-JUN-2021, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5ml, lot# S029916, expiration date 12-JUN-2021, for prophylaxis (strength, dose, route and frequency were not reported). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029916; expirationdate: 12-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Red egg-sized rash; Very itchy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red egg-sized rash), PRURITUS (Very itchy) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (Headache). On 19-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red egg-sized rash) and PRURITUS (Very itchy). On 10-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, RASH ERYTHEMATOUS (Red egg-sized rash) and PRURITUS (Very itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No Treatment Information Provided.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/25/2022 NONISCHEMIC CARDIOMYOPATHY  ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/25/2022 CHF, STAGE C, UNSPECIFIED
Patient reports experiencing pain in the left arm, numbness. tingling, sensation traveling to er fingers, generalized pain in the arm . pain in hand. inability to perform daily functions
On that date my son complained of abdominal pain; then again on 11-7-09. He also developed a mild runny nose/sneezing, cough. On Monday 11-9-09 he awoke at 2:00 AM with a fever of 102 degrees. I contacted his doctor. I have not yet had to schedule a doctor's visit.
Patient developed tooth and (R) sided jaw pain after receiving BEXSERO vaccine. Symptoms have worsened since day 1, not improving.
24 hours after applying the 5 vaccines patient had a red rash all over his body with itching and difficulty breathing. Until now it still presents only the red coloration on the skin. 11 days after the vaccine continues taking antiallergic medication. In his vaccination schedule says that he would be given 4 vaccines, but in the hospital he was given 5.
Tested positive for COVID-19 on June 23, 2022, was treated with Paxlovid, tested positive again for COVID 19 on July 5, 2022.
Day after injection, 4/14/21, experienced arm pain, joint aches, eye pain, fever, chills that lasted 24 hours and a severe headache. that lasted 4 days. Second day after injection, 4/15/21, developed a rash on chest and neck. Rash appeared red, raised and itchy. On 4/26/2021 went to PCP for the rash and was prescribed a topical Cortisone cream. The rash resolved after a few days of treatment. Patient states can tell where rash had been and sun exposure causes itching in that area.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Moderna Vaccine on 01/25/2021 and 02/25/2021. Covid + 1/15/22. Recently admitted for COVID19 PNA w/symptoms starting on 12/30/21, dx on 1/1/22. Tx'd w/Actemra, remdesivir, and steroids. Discharged with dexamethasone w/4L O2.  Presented to ED 1/15/22 w/SOB. Admitted for acute hypoxemic resp failure 2/2 Covid19.  CT scan showed bilateral persistent interstitial lung disease. Chest tube placed 2/2 R pneumothorax. Intubated 1/28, course c/b MRSA pneumonia, bacteremia and septic shock. A-fib tx'd w/amiodarone.  Tx'd w/vanc, zosyn, gent, doxycycline, rocephin, ganciclovir, micafungin, dexamethasone, solumedrol. Resp status cont. to decline, transitioned to DNAR. Expired 02/11/22.
This spontaneous report as received from a physician refers to a male patient of unknown age, whose mother was a Hepatitis B carrier. On an unknown date, the patient was vaccinated with a series of RECOMBIVAX HB (dose, frequency and route of administration were not reported). No concomitants were reported. The titers came back negative. As treatment, a second series of RECOMBIVAX HB was again administered to the patient on unspecified dates and titers came back negative again. Unspecified lab diagnostics studies performed were performed. Action taken with respect to RECOMBIVAX HB was not applicable. The outcome of titers came back negative was unknown. Causality was not provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Pt presents to ER with increased weakness, hypoxia,  history of COPD, but not oxygen dependent., hypotension.  Acute Kidney failure  noted in labs,  not previously  diagnosed , new hyperkalemia.  BP 73/39, HR 67. dopamine  initiated, and switched to Levophed.  Oxygen Sat  86%, requiring 10 L  O2.  Transferred from this critical access hospital to another Hospital.  Expires later 2-13-2021
Pt called stating he had been having chest pain, I informed him that he needed to seek medical help ASAP.  He called again on 6/23/21 (bc he forgot to call me back) and said that he did go to the ER and the physician informed him that the chest pain was due to the COVID shot and that we would be ok, however, he was dx with ring worm he is being tx for that.  He will be calling me back today to give me some more information.  I will informing him that he needs to get some testing.
Chilling/fever, weak legs, great fatigue, naseau, feel faint at times, very sore arm.
Patient was given Moderna despite not being eligible for it due to his age. Patient and family report no side effects other than sore arm
No adverse effects were reported.; Patient was administered improperly stored VARIVAX; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 07-JUN-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number R035222 with expiration date in 04-DEC-2020 (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008695: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008723: US-009507513-1906USA008722: US-009507513-1906USA008662: US-009507513-1906USA008721: US-009507513-1906USA008725:
Case number PHEH2015US012028, is an initial spontaneous report from a medical assistant received on 22 Jun 2015. This report refers to a 17 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with BEXSERO (batch number: 146101A) at a dose of 0.5 ml intramuscularly on 15 Jun 2015. It was reported that the patient received BEXSERO that reached up to 49F for 4 hours on 10 Jun 2015. No adverse event was reported.
Patient underage for this vaccine according to EUA.  No adverse outcomes/reactions noted.  No extra monitoring required. Moderna (manufacturer) was contacted.  We were given the advice that the patient may receive a 2nd dose of Moderna vaccine after 28 days if the provider chooses, although such use is still technically off-label and we need to acknowledge that fact.
Patient was very nervous upon receiving vaccine and told immunizing tech that she had previously fainted upon donating blood. Immediately after receiving the  shot, she said she felt like fainting. Her mother walked her to the observation chair for monitoring. She fainted and her mother along with two grocery associates went to hold her from falling off the chair. Two paramedics who happened to be a few feet away came to assist and took her vitals. Other medics arrived and took her to the hospital.
THE FACILITY  ASKED RPH TO GIVE COVID AND FLU SHOT TO THE PATIENT.  FACILITY DIDN'T INFORM RPH ABOUT GETTING FLU SHOT FROM HOSPITAL. RPH DISCOVERED ON HER OWN WHEN ENTERING INFORMATION TO SYSTEM.   RPH CALLED CAREGIVER AND MD.
patient was given a Johnson & johnson vaccine on 2/1/22. Vaccine was opened on 1/28/22 and therefore should of been wasted 6 hours after opening. Medication expiration date was not checked by Medical Assistant prior to administration. Patient was assessed for 15 minutes after injection, per policy, and assessed during the rest of the encounter. No reaction was noted. However, error was not recognized until 2/2/2022.
September 1 - runny nose, lethargic September 2 - see above, plus unhappy Sept 3 - see above, plus fever and crying, no smiles Sept 4 - see above, plus pain at injection site, low muscle tone, moaning day and night Sept 5 - fever gone, but very clingy and crabby, no smiles Sept 6 - crying a lot, covered in a rash Sept 7 0 rash spread beyond chest and back, now on legs, arms, face and feel as well.  Was barely happy, maybe for 1/2 hour of all awake time Sept 8 - slightly happier, still has rash, very clingy Sept 9 - much happier, mostly back to himself.
temperature of 101. Arm achy, mild general malaise. Lasted 5 hours.
fatigue; aches; fever; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first shot of the COVID-19 vaccine. She experienced mild symptoms-fatigue, aches, fever that subsided. This patient said that whoever administered the vaccine told her if she had this type of reaction to the first shot, that she already had antibodies and didn't need the second shot. The outcome of the events was resolving.    information on the lot/batch number has been requested.