chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Administered dose of expired vial to patient; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose of expired vial to patient) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-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 31-Mar-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 (Administered dose of expired vial to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered dose of expired vial to patient) 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 (Administered dose of expired vial to patient).    The concomitant medication was not reported by reporter. It was reported that the 2 vials were transferred to another site this morning and vaccines were showing expired. Vaccines expired on 11-Feb-2023. Site administered 3 doses from these expired vials to patients this morning. It was unknown if they experienced symptoms. The treatment medication was not reported by reporter. This case contains information for the 1st of 3 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718085, US-MODERNATX, INC.-MOD-2023-718084 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718085:Patient 3 out of 3 patients
maternal vaccine exposure with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 32 year old female patient patient who was at 31 weeks of pregnancy and was exposed to vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] during third pregnancy trimester.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was reported as 07-Feb-2023. The estimated due date is 14-Nov-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 13-Sep-2023, the pregnant patient received a dose 1 with unknown dose of suspect Influenza Quadrival A-B Vaccine (expiry date, strength and lot number not reported) via intramuscular route in unknown administration site as prophylactic vaccination (maternal exposure during pregnancy) (latency: same day). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the pregnancy is still ongoing.
Vaccine reaction - Received COVID vaccine (2nd dose of Moderna) on 29 Jan 2021 - Symptoms started approx 24 hours later - chills, fever, nausea, body/joint aches, abdominal pain, diarrhea - Symptoms decreased approx 4 hours later and improved over the next 24 hours.  - However 72 hours after receiving vaccine developed left arm swelling, hives. - Took Claritin, Motrin and Tylenol this morning which helped with symptoms - Now has mild hives on left arm, redness, swelling, warmth - + tingling/pressure sensation on left side of face and lips are tingling - Denies shortness of breath, chest tightness
I had a sore throat and head congestion so I took a home rapid test on June 26th and it was positive. I went to an urgent care and they did a rapid test which was negative then a PCR test and it was positive. I was not able to get PAXLOVID because I was not at risk. I was advised to take cough medicine over the counter. I took ibuprofen and decongestant. My symptoms became worse. I had fever and feelings of vertigo from the head congestion. I also developed a cough that is not bad. I got worse for 2 days but have been improving since then.
Patient experienced vasovagal syncope at 12:11 pm. Patient was lowered to the floor, elevated legs, pulse strong. Once lowered to the floor and legs elevated patient alert and oriented to self, date and location. Transferred to the gurney, BP 106/64, pulse 74, O2 99% Provided the patient a snack and after 30 mins of monitoring, ambulated without dizziness.  Recommend to receive the 2nd dose in the gurney.  Note mother reports the paternal father has a history of vasovagal syncope.
Patient called our clinic to report swelling and redness of the left hand.  He said this symptom started several days after receiving the vaccine at an outside location.  Symptoms gradually worsened over the last few days until his hand became so swollen that it became difficult to make a fist and is impairing his activities of daily living.  Reaction seems to be localized to the hand and patient reports no other symptoms.
Red puffy eyes. Red swollen throat. Tight chest. Tx: 4 BENADRYL 25mg over 24 hours.
39 y.o. female with history of asthma but no previous anaphylaxis to vaccines received covid-19 vaccine (Moderna) at 4:15pm today and within a few minutes developed tachycardia, nausea and vomiting  No shortness of breath, no wheezing, speaking in full sentences No chest pain  She has a history of asthma and hives to terbutaline, and anxiety reaction to gabepentin. No history of intubation or serious reaction from asthma  Transferred to the procedure room by RN with my assistance Blood pressure 132/82 pulse of 135, 02 sat 100% on RA, speaking full sentences, stating she had some chills lungs clear, tachycardic, and moving air well, no wheezing. Patient stated said she had to the bathroom right away, was going to have diarrhea.  Said she could walk, and was walked across hall with assistance to bathroom, where I stayed with patient.  I accompanied patient to bathroom, she had one episode of diarrhea, and dry heaving, returned to procedure room, lied supine, IV started, NS bag hung.  RN present, additional ARNP present, staff aware, anaphylaxis kit present.  Patient tachycardic and continued with normal 02 sat and good air movement, EMS with request for ALS activated due to reaction to vaccine.  I made decision to give epinephrine with her tachycardia and continued nausea with diagnosis of anaphylaxis, and as preparing epinephrine, patient stated she started to feel tight in chest, epinephrine given 0.3mg of 1:1000 IM. Lungs notable for reduced air movement lung bases. Patient denied throat tightening, rash, lip swelling, but she continued to have dry heaves, and stated she had a "sore throat". EMS had already been activated before first epinephrine dose. Awaiting medics, patient given Solumedrol 125mg IV, benadryl 50mg IV, and zofran 4mg IV Patient also given four puffs of albuterol MDI with spacer.  Medics arrived, patient still feeling tight in chest, blood pressure 125/70, 02 sat 100%, lungs still tight with reduced air movement  Patient given second dose of epinephrine 0.3mg, 1:1000 IM, approximately 7-8 min after the first dose. EMS transferred patient to gurney with transport to PEMC Patient alert during entire reaction.  PEMC notified.   To ED via ALS PEMC notified   Timeline of anaphylactic reaction: 1615: Covid Moderna 2nd injection given  RN notified of patient feeling rapid heart rate and nausea. Patient pulled back to procedure room.  1631: Vitals: BP 132/82, HR 135, Temp 97.1, O2 sat 100% 1637: IV start in LAC, NS running  1645: 0.3 mg IM Epi - administered by  RN  1648: 4 mg IV Zofran - administered by ARNP 1650: 4 puff Albuterol sulfate 90 mgc given via spacer - administered by  MD 1651: 50 mg IV Benadryl - administered by ARNP 1652: 125 mg IV Solumedrol -  administered by ARNP 1653: 0.3 mg IM Epi - administered by RN
Received vaccine at 3pm on 4/8 and adverse event happened the morning of 4/9. Leg cramps/pains, dizziness, shortness of breath, weakness, and fatigue. I passed out in the morning at a doctors appointment and took a couple minutes to get back consciousness. All color was drained from my face for hours and had to receive 2 bags of fluid. Still getting dizzy/light headed 5 days out from the vaccine.
no adverse effects reported; the patient was inadvertently administered two doses of VARN AX on 9/14/2020 and 10/16/2020, which were expired. Both doses supported.; the patient was inadvertently administered two doses of VARN AX on 9/14/2020 and 10/16/2020, which were expired. Both doses supported.; This spontaneous report as was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medication, drug reactions or allergies was provided.     On 14-SEP-2020, the patient was inadvertently vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection (lot # R021097 with an expiration date in 23-JUL-2020), for prophylaxis (strength, dose, route and frequency were not provided). On 16-OCT-2020,  the patient was inadvertently vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection (lot # R021097 with an expiration date in 23-JUL-2020), for prophylaxis (strength, dose, route and frequency were not provided). No adverse effects reported.
Patient experience some dizziness shortly after getting the vaccine and sat down and waited for a ride. I called the pt about an hour later and he said he was fine and feeling better.
Pt was instructed to wait 30 minutes for observation following vaccination due to history of allergic reaction and anaphylaxis. About 33 minutes following injection, pt began feeling tightness and scratching of the throat and feeling the need to cough/clear throat frequently. Pt refused Epi-pen administration, but accepted Benadryl 50mg orally. EMS was called. Pt refused transport via ambulance but drove self to the ED for eval/monitoring.
Redness and swelling to injection site. Very warm to the touch. Pt was given prednisone and Keflex.
Rigors; Hyperhidrosis; Fever of 103.4; General myalgia; Intermittent severe nausea; Sleep interruptions; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 21Apr2021 at 13:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and generalised anxiety disorder. 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.  Concomitant medications included sildenafil citrate (MANUFACTURER UNKNOWN), lorazepam (MANUFACTURER UNKNOWN). The patient previously received BNT162b2  (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 30Mar2021 at 13:30 as a single dose for COVID-19 immunisation. On 22Apr2021 at 02:30, the patient experienced rigors, hyperhidrosis, fever of 103.4, general myalgia, intermittent severe nausea and sleep interruptions. On 22Apr2021 at 02:30, the patient body temperature measured and the result was 103.4 (unspecified unit). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rigors, hyperhidrosis, fever of 103.4, general myalgia, intermittent severe nausea and sleep interruptions was recovered on 24Apr2021, after the duration of 34 hours.   No follow-up attempts are needed. No further information is expected.
Trouble breathing in the afternoon. Chest was very tight and breathing was constricted. Symptoms remained throughout the night but have started to retreat. Slight tightness of breath still remains.
Vaccine breakthrough, asymptomatic. 9/14   Inpatient admit 9/22 to present, non COVID reason
problems with eyes: pressure within the eyes, nervous blinking of eyelids, swellings around the eyes, hanging eyelid (right)
On March 14, I suffered a severe flare-up of an old right shoulder injury (originating in 1993) and had to visit urgent care while traveling to obtain treatment for the pain.  While I had overworked the shoulder at that time, likely explaining the immediate incident, since that time I have developed a series of inflammatory flare-ups at various sites in my body that persist to this day.  Also, in the months surrounding the injury, I have had a serious flare-up of atopic dermatitis. Shortly after the shoulder incident, I had a day of high, unexplained fever (multiple COVID tests were negative). Since then, the inflammation has traveled to my back for a week, to my left knee and leg on and off, and  now suffer severe arthritic pain in both hands almost daily.  I do not seem to be able to fight off this inflammation, which has now persisted for nearly 3 months. It seems to have come on suddenly, not gradually, and I wonder if having had the original series of COVID vaccines and three boosters has just been "too much." I list my flu vaccine in October above, even though it was not "prior" to the bivalent COVID vaccine, sinply becasue it was close in time.
7APR95 vax administered; 15MAY95 3cm induration, pain, distal neuropathy; 17MAY95 1.7cm induration, dec pain w/NSAIDS; 20JUN95 3cm induration, pain into chest & upper back & elbow;
04/25/2021 I went for a run and I couldn't catch my breathe, by 07:00PM ET, I started having pain in my lungs. 04/26/2021 07:00AM I went to urgent care and was diagnosed with pneumonia and pleurisy. I don't remember the medications that was given for the diagnosis. 10/02/2021 I woke with the same experience but it was not that bad but by the evening it had worsen. At about 06:30PM I went to another urgent care in another state and it was indicated that I had blood clots in my lungs and was sent to the emergency room. I was given Eliquis as a blood thinner.
Swollen armpit; Hair loss; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 17:00 (Batch/Lot number: unknown) at the age of 32 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "known_allergies: Penicillin" (unspecified if ongoing), notes: known_allergies: Penicillin. Concomitant medication(s) included: TDAP taken for immunisation, administration date 09Aug2021; HEPLISAV B taken for immunisation, administration date 09Aug2021. The following information was reported: SWELLING (non-serious) with onset 23Aug2021, outcome "not recovered", described as "Swollen armpit"; ALOPECIA (non-serious) with onset 23Aug2021, outcome "not recovered", described as "Hair loss". Therapeutic measures were not taken as a result of swelling, alopecia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No other medications the patient received within 2 weeks of vaccination.  Follow-up (14Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Increased heart rate majority of day, low bld sugar, nausea and headache late evening of vaccine. Hives appeared Rt arm - elbow, neck to eye. Took Benadryl 50mg at 7:30 pm another dose at 10pm. Awoke 12-29-20 all hives gone but feels hot, fluctuating heart rate, stiff neck, short of breath. Called MD, will monitor symptoms next 24 hours.
Client at ACHD for immunizations for foreign travel.  History of fainting. Lay down for injections for 20 minutes past vaccine then sat in chair for 10 minutes. Became pale and  diaphoretic. Reclined 30 min then ambulatory with BP 104/64 pulse 68 versus 82/54 pulse 64. Discharged to home accompanied by mother.
Tachycardia, palpitations, warmness throughout body. HR up to 146/92.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional information: Caller calling about the Pfizer COVID-19 vaccine. Caller states that he first of all he wants to thank Pfizer. He states that he and his wife got the first shot on Tuesday. He states that he has had no problem just a sore arm like normally would have which was gone away three days later.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning a 44 year old female with a history of asthma, muscle contractions, headache and fibromyalgia who on 25-SEP-2006 was vaccinated in the left deltoid with a 0.5 mL dose of PNEUMOVAX 23 (lot # 651357/0391F). Concomitant therapy included CELEXA, WELLBUTRIN XL, MIDRIN, ADVAIR, and influenza vaccine (unspecified and also administered in the left deltoid). Within 24 hours post-vaccination the patient experienced tenderness in lymph, swelling of left axillary region, aching, syncope, chills, nausea, dizziness, fever of 101.7 degrees Fahrenheit, severe headache. Reportedly with unknown treatment. On 27-SEP-2006 the patient had a complete blood count (CBC) drawn at the office and elevated "20,700" and was sent to the hospital. At the hospital the patient was given IV antibiotics, ultrasound of upper left arm. The patient was hospitalized until 01-OCT-2006 with the diagnosis of fever secondary to vaccination, and "glucocytosis secondary to vaccination." At the time of the report, it was not reported if the patient recovered. The reporter considered tenderness in lymph, swelling of left axillary region, aching, syncope, chills, nausea, dizziness, fever secondary to vaccination, severe headache and glucocytosis secondary to vaccination and CBC elevated 20,700 were considered to be immediately life-threatening, disabling and other important medical events (OMIC). A lot check of concern has been requested. Additional information has been requested.
Infant was admitted to the hospital for rule out sepsis after presenting to the E.D. with a temperature of 101F.
approx 4yrs p/vax pt exp a mild case of chickenpox following exposure to an unvaccinated sibling who devel chickenpox
This spontaneous report was received from a medical assistant, concerning an unknown number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored GARDASIL 9 (lot #, expiration date, strength, dose, route of administration and anatomical location were not reported), for prophylaxis. The storage temperature excursion was reported as 1.2 degrees Celsius (°C) for a time frame of 4 hours and 3 min. There was no previous temperature excursion. No adverse effects were reported in any patients. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA008764: US-009507513-1705USA001817.
pt recv 2 doses of vax FEB97 & MAY97 & lab eval revealed low levels of varicella antibody;
Dad brings child to clinic 11/7/11 , one month after immunizations were given. Describes whelps ? redness, warmth, swelling on child trunk and extremities after 10/6/11 immunizations were given. Treated child with OTC TYLENOL, was much improved the next morning.
a little bit tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Lot number: EN6201) at the age of 77 years as dose 2, single and administered in arm left, administration date 04Feb2021 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "a little bit tired". Additional information: she responds that she is 78 and she already had her first 2 shots back in February, so she went to her local drug store and both her and her husband got their booster shots. She is calling because she figured Pfizer needed to know the side effects people get. She figured that's how Pfizer gets their data. She states it's not a real serious situation, she had no effect on the first and second one, but the booster dose kind of affected her. The caller states the first two shots her and her husband got were back in February. The only effect she had was that she was a little bit tired, but it was for a day. No additional Vaccines Administered on Same Date of the Pfizer. No prior vaccination within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Diarrhea; Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) 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 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medication was reported.  Treatment information was not provided.
Tested for COVID on Feb 2 and again on the 12th. Had congestion and shortness of breath. Symptoms didn't resolve so went to urgent care and they saw artifacts on x-ray so prescribed antibiotics. Antibiotics have been taken but still experiencing shortness of breath and cough.