chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Feb2021 (at the age of 72 years old) (Batch/Lot Number: EN6203) as unknown, single for COVID-19 immunization. Medical history included asthma, occasionally. The patient's concomitant medications were not reported. The patient previously took pneumovax and experienced Known allergies: Pneumovax (Pneumovax 23/1 Dose 25 Mcg/0.5ml Injection). On 24Feb2021 20:00, patient experienced tightness on left side of throat, increased blood pressure, 172 normal 117, decreased oxygen, 91, very lightheaded, brain fog, red swollen left cheek. The patient underwent lab tests and procedures which included blood pressure increased on 24 Feb 2021, 172 normal 117, oxygen saturation: decreased on 24Feb2021 decreased oxygen, 91. Events resulted in emergency room. Therapeutic measures were taken as a result of events with Benadryl in hospital 3 hours. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
Left arm red at injection site, swollen all around upper arm , stiff neck left side, arm Hot, not normal.  Swollen left side arm pit ( hard lump, pain) pain radiates toward side chest- breast to opposite direction towards elbow.  Trying massage plus ice to relieve swelling and pain.
Hives / rash started a week or so after the injection (3/28).  I don't really remember what date it started on, as it was minor at first (The start date above is an estimate.) It got progressively worse each day, and was severe by 4/13.  It was doubling in size and severity each day.  I finally went to a dermatologist on 4/14, and began a two week Prednisone taper to stop it.
This spontaneous report as received from a pharmacist refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, drugs allergies and concomitant medications, if any, were not reported. On 07-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 (dose number, dosage, route of administration, anatomical site of vaccination were not reported; lot number 0653AE) for prophylaxis instead of PREVNAR 13. Pharmacist was uncertain how the medication error occurred, and was uncertain whether product confusion was involved. Lot number 0653AE was confirmed a valid lot number for PNEUMOVAX 23 but the expiration date for this lot was reported as 02-OCT-2014. The pharmacist was certain this could not have been the correct lot number for the dose of PNEUMOVAX23, however at the reporting time, the expiration date was not confirmed. Additionally, no adverse event was reported.
Besides being tired after my first 2 shots, I didn't have any side effects. For my booster, I had a swollen lymph node under my right arm that developed the following day, but went away after several days. The tinnitus developed suddenly a couple of weeks later. It's been non-stop for the past 3 weeks with no signs of abating.
Cellulitis in left bicep at 24 hours; extreme redness, swelling at 48 hours. Intravenous antibiotic administered at Hospital 11/3, followed up with 10 days of AUGMENTIN (125 MG 2x daily). Redness lightened w/in 24 hours, swelling and pain persisted through 11/8/2017. Very faint redness and soreness a/o 11/10/2017.
Pronounced cervical lymphadenopathy, neck pain, pharyngitis, headache, low grade fever, abdominal pain. Symptoms improved but persisted for one week. Pharyngitis continued to 10 days. Tx with Amoxicillin pending throat cultures. Saw in office 3-1-2011 with small anterior cervical nodes and mild ly erythematous posterior pharynx. 2+ tonsils. Throat culture was negative.
Aching; Chills; High fever, fever was of 100°F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching), CHILLS (Chills) and PYREXIA (High fever, fever was of 100°F) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Aching), CHILLS (Chills) and PYREXIA (High fever, fever was of 100°F). At the time of the report, PAIN (Aching), CHILLS (Chills) and PYREXIA (High fever, fever was of 100°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 °F (High) 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Foggy headed, sometimes a little dizzy, off balance Fatigue More aches and pains than usual sometimes a feeling of shortness of breath
Heart racing (this happens sometimes when I have a cold, but I usually attribute it to taking Dayquil; in this case I am not taking anything other than ibuprofen)
Patient received a dose of expired Havrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   On 17th October 2022, the patient received the 1st dose of Havrix. On 17th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's comments: A nurse had reported that the patient had received a dose of expired Havrix vaccine, which was expired on 09 August 2022. The reporter had consent to follow up.  Additional supportive information: The patient had received an expired dose of Havrix, which had led to expired vaccine used. This case was linked with US2022168181 which was reported by same reporter.; Sender's Comments:  US-GSK-US2022168181:Same reporter.
Pt. was anxious at the time of administration, "I do not like needles, sometimes I pass out."  She was advised by nurse to look away if that helped.  Patient started feeling dizzy immediately after dose was administered she began feeling faint.  Pt. was given O2 and IV fluids and was transported to hospital with O2 and IV.  Pt. vitals normal at the time of transfer to hospital.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 18-NOV-2014 the patient was vaccinated with the third dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
The patient was given the incorrect dose 0.25mL instead of 0.3 mL
tried to use a cream Dr prescribed for hemrrhoids, had to have them surgically cut, drained of blood clotts, sent home. went back to urgent care 4 day later still in a lot of pain, was given a surgical consult, waiting for a appointment. Rash Dr prescribed prednisone and topical cream 2x daily on rash, still having rash issues spreading.
955 AM - After vaccines administered, client left room to sit down in lobby. Then proceeded to bathroom & threw up. Appeared pale. Put clean damp washcloth on forehead. Administered O2 at 1 L/via face mask at 10:00 am after VS were addressed, B/P 82/60, wheezes heard to upper lobes (B) upon auscultation. 1015 am - T 97.8, HR - 92, B/P - 90/60, Respirations - 24. Lungs CTA (B). A/O x 3. Upon dismissal gait normal. Client voices no dizzy, nausea, difficulty breathing.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching), FATIGUE (Fatigue) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  The patient's past medical history included Pregnancy (On 14-Jul-2019 the baby was born.) on 14-Jul-2019. Previously administered products included for Psoriatic arthritis: Humira (Solution for injection in pre-filled pen. Route- Subcutaneous. The fetus was exposed to Maternal use of Humira in utero during unknown trimester. No maternal medical problems or complications during delivery or the postpartum period were reported. The reporter's causality for the event of maternal exposure during pregnancy was not provided.) from 10-Oct-2018 to 27-Nov-2018, Humira (Solution for injection in pre-filled pen. Route- Subcutaneous. On 14-Jul-2019 the baby was born. (Live birth) with no neonatal complications and congenital anomalies or birth defects. The reporter's causality for the event of live birth was not provided.) from 10-Oct-2018 to 27-Nov-2018. Past adverse reactions to the above products included Live birth with Humira; and Maternal exposure during pregnancy with Humira. Concurrent medical conditions included Psoriatic arthritis. On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Generalized aching), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PAIN (Generalized aching), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown. No concomitant medications were provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of FATIGUE, HEADACHES and BODY ACHES with HUMIRA (ADALIMUMAB) was no reasonable possibility. No treatment medications were provided by the reporter.
Rash started on left arm the next day, then spread to full body including face, bilateral extremities (upper and lower) and trunk. Very itchy and confluent. Appears like a drug rash. No angioedema or anaphylactic symptoms.
The patient was admitted to hospice because she stopped eating and deteriorated. He was being given food through the tube and then he has no vital signs.
Slight dizziness; Feeling like "my" head was three feet thick; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Feb2021 at 10:00 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included osteoporosis, penicillin allergy and lactose allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Feb2021 at 10:00 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. On 27Feb2021 at 21:00, the patient experienced slight dizziness and felt like head was three feet thick. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events slight dizziness and feeling like head was three feet thick was recovered on an unknown date in 2021.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt was about 5 wks pregnant p/having recvd vax; consulted OB/GYN & was advised to not take the measles booster until p/delivery; had elevated BP of 162/96 @ time of hire; had spontaneous miscarriage 20OCT93;
Day 1 headache progressing to migraine and nausea, injection site pain  Day 2 - 3 continued migraine with aura, nausea worsening, runny nose Day 4 abdominal cramping , migraine subsided to dull headache   Day 5 abdominal cramping  worsening and muscle soreness (abdomen and lower back)  hurt to urinate. Day 6 - 7  abdominal cramping subsided general soreness lessened  Day 8 recovered
Patient returned about 1 hour after getting vaccine complaining of itching and trouble breathing, 25mg diphenhydramine was given and cold compress but on her neck.  15 minutes later a 2nd dose of  25mg diphenhydramine was given and 911 was called. Parmedics checked her vitals and spoke with her, She refused to go with them for medical care, Patient called family member to come pick her up. Paramedics and Pharmacist asked her to seek medical care if breathing issue continued, Continue diphenhydramine for itching.
Fever for 2 days; Red spot on arm with hard lump in center; Red spot on arm with hard lump in center; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, patient. A 60-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the right arm on 04Nov2021 at 07:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN); via an unspecified route of administration on an unknown date and second dose of COVID-19 vaccine (MANUFACTURER UNKNOWN); via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 05Nov2021, the patient experienced fever for 2 days, red spot-on arm with hard lump in the centre. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever was resolved on 07Nov2021, while that of the events red spot-on arm with hard lump in centre were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient came in our pharmacy w/ Rx for 3 shots: Tdap; PNEUMOVAX & ZOSTAVAX. I gave him 3 shots approximately 12:30 pm today. Around 12:45 pm he reported some sneezing & congestion then itching all body approximately 12: 55 pm. Then at that time, I gave him 1 IM of BENADRYL (50 mg) at 1 pm.
40 minutes after injection: 10 seconds of flutter sensation in chest 1 day after injection: weak and light headed; 2 days after injection:weak and light headed 3 days after injection: extremely weak and lightheaded; heart rate under 55 bpm and pulse oximeter indicated  short interval pulses. Emergency room tests indicated HS Tropinin I at 104.8 over 20 hours. Stress test negative Episodes of pulse irregularities continued for 5 more days and tapered off as measured by 7-day holter monitor Unknown if heart enzyme Tropinin l level are currently in normal range
vial was initially stored in the refrigerator on 22-Aug-2022 and administered on 23-Sep-2022; No adverse event; Received expired  Monovalent vaccine after 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 22-Aug-2022 and administered on 23-Sep-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 22-Aug-2022 and administered on 23-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 22-Aug-2022 and administered on 23-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 22-Aug-2022 and administered on 23-Sep-2022).    Concomitant medication information was not provided by the reporter.  The vial was initially stored in the refrigerator on 22-Aug-2022. Patient received expired Moderna COVID-19 vaccine after 30 day. Beyond use date was reported as 22-Sep-2022.  There was unbroken cartons on vial. The vial size of adult was 5.5 ml. The vial did not undergo any temperature excursions.  Treatment information was not provided by the reporter.
Pt briefly lost consciousness approximately 1 minute after vaccine administered. He began to slowly slide out of chair, eyes were open, limbs began twitching. Revived when arms was grabbed, name shouted. Remained slightly green for approximately 5 minutes. Lay down vitals monitored. HR 92 initially after 1 minute BP 104/64  P 71. Ice pack applied to back of neck. O.J. given P.O. Left feeling "fine"
Deltoid muscle swelling and pain within 24 hours.  Treated with motrin and ice
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received contains age group added and narrative updated.
A 6 month old received Prevnar, Acel-Imune, Hib-Titer and Engerix on 3/24/00 and the next day, developed urticaria. The pt was treated with Benadryl. The pt recovered. This is 1 of 2 patients from this facility who experienced an adverse event following receipt of Prevnar. A copy of this report has been forwarded to SKB, manufacturer of Engerix.
ADMINISTRATION ERROR (15MINS PAST THE 2HR INDICATED ROOM TEMPERATURE HOLDING TIME); This spontaneous report received from a consumer 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  (suspension for injection, route of admin not reported, batch number: Unknown expiry date: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-MAY-2021, the subject experienced administration error (15mins past the 2hr indicated room temperature holding time). The action taken with covid-19 vaccine  was not applicable. The outcome of administration error (15mins past the 2hr indicated room temperature holding time) was not reported. This report was non-serious.
Pt reported pain, redness and blister to left deltoid at injection site. Pt reported itching all over body. Pt advised to take BENADRYL for symptoms.
Unable to regulate body temperature (sweats/chills), headache, nausea, fatigue. These symptoms have lasted from 8pm to 2pm the following day.
Developed swelling of hands, face and lips 2-3 hrs. after receiving second dose of hepatitis B vaccine.  Seen by personal physician who adminstered IM Benadryl with resolution of problem +/- 8 hrs after treatment
Pt began to run fever at midnight, temperature of 103. rolled eyes back, began to tremble, seizure lasted 1 minute. Child unconscious, very purple lips, and difficulty breathing. Mom breathed in his mouth. Called 911, taken to hospital, given Tylenol and released after 2 hours.
Client noticed red area-the following summer small indention on arm below injection site currently <1/4 cm deep under x approx 4.5 long.  Denies any symptoms.
Employee health nurse administering flu vaccine.  Had multiple complaints of burning soreness/swelling/ heat from site.
Approximately immediately after my 2nd dose vaccination I experienced the following symptoms: Dizziness and  Nausea. I was at the vaccination site for about 30 minutes - the health care workers made me lay down. I had to take off at work because I did not feel so good for 3 days. I took Dramamine for treatment and it did help improve my symptoms.
Local reaction at immunization site - 6cm diameter area of erythema, induration, tenderness, & heat.
This spontaneous report was received from a pharmacist of unknown age and gender reporting on themselves. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II injection, in an unspecified arm (exact dose, lot# and expiration date were not reported). The administrating nurse pulled the patient's arm fat down and administered vaccine. The reporter believed that the route of administration was incorrect, however could not confirm if it was subcutaneous or not. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1901USA011995.
None; Patient was supposed to receive Pfizer BioNtech Bivalent but instead was given the monovalent version
Warm flush from the injection site up the neck and across the chest.  Elevated heart rate. Sharp pain in back just above  the waist. Dizziness.  Labored breathing.  Lasted about 10 minutes.  Fatigue  came after an hour.  Not as bad now. Still fatigued 7 days later.