chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Moderna Bivalent vaccine was administered Beyond use by date to 6 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients).    No concomitant information was reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697926, US-MODERNATX, INC.-MOD-2023-698131, US-MODERNATX, INC.-MOD-2023-698132, US-MODERNATX, INC.-MOD-2023-698134, US-MODERNATX, INC.-MOD-2023-698307 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697926:Same reporter US-MODERNATX, INC.-MOD-2023-698131:Same reporter US-MODERNATX, INC.-MOD-2023-698132:Same reporter US-MODERNATX, INC.-MOD-2023-698134:Same reporter US-MODERNATX, INC.-MOD-2023-698307:Same reporter
Fatigue started 3-4 hours after injection for~2 days. Starting early the next morning: - Headache for ~3.5 days, less intense after ~2. Treated with ibuprofen. - Fever/chills for ~1.5 days. Treated with ibuprofen. - Altered sense of taste for ~2 days. Treated we're less intense but also shifted somehow. - Nausea after eating/drinking, even if it was just a few swallows of water. Did not actually vomit, just felt like I might each time. - Difficulty sleeping, frequent waking, and intense dreams for the first two nights (and the day in between). I would wake up, change positions, and fall back into the same dream repeatedly.
Patient experienced "pin-point, red dots" on stomach and legs. They appeared within days of immunization (5/21/13) and are still present but are improving (5/27/13). No other symptoms. Condition is improving.
used sterile water to mix it with the powder when they administered pentacel with no adverse event; Initial information was received on 15-May-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 months old male patient who used sterile water to mix it with the powder when they administered pentacel with no adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) for Prophylactic vaccination.  On 15-May-2023, the patient received 0.5 ml, once dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ807AA, expiry date: 01-Oct-2023), (strength: standard) via intramuscular route in unknown administration site for Immunization.  On 15-May-2023, the patient had used sterile water to mix it with the powder when they administered pentacel with no adverse event (product preparation error) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
This spontaneous report as received from a pharmacist refers to a 35 year old female patient. The patient had a complete series of RECOMBIVAX HB at an unspecified time in 2006. On an unknown date in 2007, the patient was vaccinated with a second series RECOMBIVAX HB (Lot number, expiry date, route and dose were not reported). On an unknown date, the patient has had titers drawn at an unspecified time and the results "don't show high enough titers" yet reports no other adverse effects. The reporter stated that the patient may be attempting to attend nursing school and was in need of vaccination. The outcome of don't show high enough titers was unknown. Additional information has been requested.
Inflammation and swelling of site - diameter of an egg. Several days. Applied ice. Couple of days later ended up with bruise same size.
Patient fainted 1 minute post vaccination.  Patient said experienced arm pain and felt off immediately after vaccine.  Patient came to within one minute of fainting.  Blood pressure was checked and  was in range at 119/90.  Patient was slowly given water and started feeling better.  Patient was also given orange juice and crackers.  Blood pressure was taken again at 122/82.  Patient experienced feeling cold and some yellowing of hands as well.  Patient has a history of fainting when giving blood and is afraid of needles.   After 50 minutes patient felt much better and left pharmacy.  Followed up with patient after 2 hours and patient stated felt fine.
The HPV (Third HPV) given at about 12:05 pm 06/25/10, about 10 minutes later, patient felt dizzy, head nodded down, but still responsive, not falling, after resting in bed and O2 2 liters given, patient feels well, alert, VS stable.
Post vaccine 3 days later developed low grade fever x 3 days 37-38 degrees C.
This case was reported by a other health professional via call center representative and described the occurrence of angioedema in a 72-year-old male patient who received SHINGRIX for prophylaxis.  Concomitant products included cetirizine hydrochloride (Zyrtec) and magic mouthwash (nos) (Magic Mouthwash). On 15th February 2019, the patient received SHINGRIX. On 16th February 2019, 1 days after receiving SHINGRIX, the patient experienced angioedema (serious criteria GSK medically significant). On an unknown date, the outcome of the angioedema was not recovered/not resolved.  It was unknown if the reporter considered the angioedema to be related to SHINGRIX. Additional details were provided as follows: The batch number and expiration date was not provided as the vaccine was administered at an outside facility. The angioedema was unresolved with some slight improvement with treatment; the reporter also noted the patient might need corticosteroids if symptoms do not further improve.
Post vaccination I had severe joint pain and swelling. This is still occurring and it is now 2/10/21.   3 days after vaccination I also developed UTI symptoms. Those symptoms increased for 2 days and I sought medical attention. There is no other reason for me to have developed a UTI. Another co-worker that had the vaccination the day prior had the same symptoms.
Redness and itching along entire arm. Recommended taking Benadryl or other antihistamine. Outcome unknown.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 15-OCT-2018, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N029888 with expiration date in 28-AUG-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001810: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Day after injection patient noticed body aches & fever of 101 to 103.  Patient was seen 6-11-08 and diagnosed with cellulitis at injection site.  Had redness & swelling also at injection site.  Assessment was a 10cm area of induration & erythema that overlies the injection site but majority of the induration is distal to the site.
The next day after the vaccination I started with pain in my shoulder for 3 days in a row. I went to the doctor that it could be a normal reaction and that it could last for weeks and that he would take only Tylenol. The annoyance comes and goes and I've been like this for months.
I experience muscle pain and fever; I experience muscle pain and fever; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (I experience muscle pain and fever) and PYREXIA (I experience muscle pain and fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical information was provided.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jul-2021, the patient experienced MYALGIA (I experience muscle pain and fever) and PYREXIA (I experience muscle pain and fever). At the time of the report, MYALGIA (I experience muscle pain and fever) and PYREXIA (I experience muscle pain and fever) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient enquired Will taking acetaminophen (Tylenol) affect the effectiveness of the vaccine
SWELLING ON EYES ,HOT FLASHES AND INCHING. WENT TO EMERGENCY ROOM SOLOMEDROL 125MGS IV,BENADRYL 50 MGS IV AND PEPCID 20 IV.  NEXT DAY WITH LESS SINTOMES.
Little bit of tingling in both arms; Little bit of soreness in arm; Warm; Slight headache; Fever; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Little bit of tingling in both arms), PAIN IN EXTREMITY (Little bit of soreness in arm), INJECTION SITE WARMTH (Warm), HEADACHE (Slight headache) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, ROSUVASTATIN and OXYBUTYNIN for an unknown indication.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Little bit of tingling in both arms), PAIN IN EXTREMITY (Little bit of soreness in arm), INJECTION SITE WARMTH (Warm), HEADACHE (Slight headache) and PYREXIA (Fever). At the time of the report, PARAESTHESIA (Little bit of tingling in both arms), PAIN IN EXTREMITY (Little bit of soreness in arm), INJECTION SITE WARMTH (Warm), HEADACHE (Slight headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Since the second dose have had repeated inflammation on entire right side of body. Have also developed trigger finger in ring finger on right hand.
Pain, swelling, inc warmth; pt is hemophiliac; pt seen by Hlth care provider once;
I had foggy brain the next morning For a day, they it went away on its own. The second shot it started when I was asleep and woke up with foggy brain. This also last a day and went away while is was asleep. Woke up the next morning and the foggy brain was gone. I didn't like this adverse reaction.
Within 30 sec of vac pt felt dizzy, nauseated, vomitted  x1,  greying of vision, became diaphoretic and pale.  no LOC .  Past hx of vaso-vagel episodes with vac.  Moved to recovery area in wheelchair. Improved rapidly once supine. Recovery Nurse placed ice pack to back of neck, VS 112/72, HR 73 reg strong, Resps 12 reg, non labored, SpO2 100%. Left Deltoid site benign,  monitored 30 min.  pt stated felt much better, color came back to face diaphoresis ceased.  sat up edge of cot. no N/V, no dizziness.  Encouraged fluids, continued to monitor,  walked back to vehicle. no further complications. encouraged to be driven 2nd dose. provided reassurance.   ok'd to exit.   (Name), RN
Received a subcutaneous injection; A spontaneous report was received from a healthcare professional concerning a patient who was who received Moderna's COVID-19 vaccine and received a subcutaneous injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unreported date in Dec 2020, the patient received their first of two planned doses of mRNA-1273 subcutaneously for prophylaxis of COVID-19 infection.  On an unreported date in Dec 02020, the patient received a subcutaneous injection. No treatment information was provided.  Action taken with mRNA-1273 in response to the event, received a subcutaneous injection, was not reported.  The event, received a subcutaneous injection, was considered resolved on an unreported date in Dec 2020.  The reporter did not provide an assessment for the event, received a subcutaneous injection.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date not provided), who experienced an unexpected event of wrong route of administration. The patient details and time to onset for the events was unknown. The reporter did not provide the causality assessment for the events. However, wrong route of administration is more of a human error and it was unlikely related to Moderna COVID-19 Vaccine.
Pt came back to clinic after leaving with husband. States that she received vaccine and left and noticed edema to left arm, visible edema from left elbow to fingertips.  Positive for brisk cap refill Positive distal pulses Denies numbness and tingling, denies pain. Edema or erythema to injection site Spontaneous improvement and continuous improvement at the clinic
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 28-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
I got the shot and that afternoon I had a really bad headache , it continued until that sunday and I could get out of bed. My husband asked me to check my blood pressure and it was really high. I saw a PP at work and she put me on med and the dose kept jumping until I was taking it 4 times a day. When I went to the doctor they switch the med for my blood pressure it seems to be helping but every once in a while it dose spike. I have had no change in my diet so the only thing that we can think is that it had something to do with the vaccine. I was recommend to not get the 2nd dose.
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received PREVNAR 13 via an unspecified route of administration at 0.5ml single in deltoid (unknown in which arm) on an unspecified date. Reporting Pharmacist administered the suspect vaccine. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced cellulitis. The patient was claiming the pharmacist used a dirty needle to administer the suspect vaccine. The outcome was unknown.
very sensitive skin; lower ext weakness; tingling in my feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: SENSITIVE SKIN (non-serious), outcome "unknown", described as "very sensitive skin"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "lower ext weakness"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling in my feet".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 11/5/21 around 8 pm I went to bed and had severe abdominal cramping. I tried to defecate, and after 10 minutes of trying I felt too warm, nauseous and dizzy so I layed on the bathroom floor. After vomiting twice the pain was bearable so I went to bed. In the morning (11/6/21) I took a home pregnancy test (positive result) and scheduled a visit with my PCP's office. He felt my abdomen and recommended that I go to an emergency room. The emergency department did an ultrasound and consulted with OBGYN. The abdomen had free fluid (internal bleeding) and the ovary had a mass that could have been an ectopic pregnancy or a cyst. OBGYN did a diagnostic laparoscopy and removed the mass, excess blood, and stopped the internal bleeding. Over the next few days they monitored my hCG levels. A day after the hCG level doubled, they did an ultrasounds and detected a yolk sac. A week later they detected a fetal pole and heartbeat. My estimated due date is July 10 2022. On 11/5 I was approximately 4 weeks and 5 days pregnant.
On 7-29-15 pt had a small local reaction to (R) deltoid. Nickle size. Denied any other symptoms. Pt. advised to take BENADRYL and RTC if reactions worsened or spread of SOB occurred. Pt. was notified to go to local ER on 7-30-15. Pt RTC with reaction that had significantly increased in size approx 38 mm by 48 mm area very red and warm to touch, given BENADRYL. All vitals normal. No other symptoms. On 7-31-15 pt. was called to check on symptoms. Pt stated site reaction was going away and getting better.
Nose bleed 2 hrs after vaccine.  Occured on 4/18,4/23, 5/6 and 5/7.  No history of nose bleeds prior.
PATIENT WAS GIVEN PROQUAD AND WAS OLDER THAN RECOMMENDATIONS FOR THE VACCINE. NO ADVERSE EVENTS NOTED.
Initial unsolicited report received from a Nurse (LPN) on 04-Jun-2018. This case involves a child patient (age and gender was not reported) who was vaccinated with a dose of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to inappropriate reconstitution technique because only the dtap and ipv was given without hib from the suspect vaccine. 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 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. Documents held by sender: none