chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Licensed Practical Nurse refers to a 6 month old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided. On 29-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293:
I was a little lightheaded right after the shot; Within an hour, I was having significant muscle weakness; It was difficult to walk; My heart rate was around 100 according to the finger monitor I have at home; my skin is itchy; I have a lot of congestion in my throat; I can´t project my voice normally; arm pain; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 19:15 (Lot number: fc3180) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "MCS" (unspecified if ongoing); "Latex" (unspecified if ongoing); "pseudocholinesterase" (unspecified if ongoing), notes: I also have pseudocholinesterase deficiency. Concomitant medication(s) included: AMOXICILLIN. Past drug history included: Chlorine, reaction(s): "allergy". The following information was reported: DIZZINESS (non-serious) with onset 10Aug2021 20:00, outcome "not recovered", described as "I was a little lightheaded right after the shot"; MUSCULAR WEAKNESS (non-serious) with onset 10Aug2021 20:00, outcome "not recovered", described as "Within an hour, I was having significant muscle weakness"; GAIT DISTURBANCE (non-serious) with onset 10Aug2021 20:00, outcome "not recovered", described as "It was difficult to walk"; HEART RATE INCREASED (non-serious) with onset 10Aug2021 20:00, outcome "not recovered", described as "My heart rate was around 100 according to the finger monitor I have at home"; PRURITUS (non-serious) with onset 10Aug2021 20:00, outcome "not recovered", described as "my skin is itchy"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 10Aug2021 20:00, outcome "not recovered", described as "I have a lot of congestion in my throat"; DYSPHONIA (non-serious) with onset 10Aug2021 20:00, outcome "not recovered", described as "I can´t project my voice normally"; PAIN IN EXTREMITY (non-serious) with onset 10Aug2021 20:00, outcome "not recovered", described as "arm pain"; FATIGUE (non-serious) with onset 10Aug2021 20:00, outcome "not recovered", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, muscular weakness, gait disturbance, heart rate increased, pruritus, respiratory tract congestion, dysphonia, pain in extremity, fatigue.  Additional Information: The events onset latency was 45 min after vaccination. Facility type vaccine: Pharmacy or Drug Store. The patient did not received other vaccine in four weeks. Patient had took Benedryl. I did not have insurance, and I can't afford to see a doctor. It is my understanding that vaccine manufacturers have no liability, so that pretty much excludes the possibility of medical care for me.  No follow-up attempts are possible. No further information is expected.
Breakthrough COVID-19 case with  Subjective fever (felt feverish),  Muscle or body aches,  New loss of taste or smell,  Runny nose/Congestion,  Sore throat,  Cough (new onset or worsening of chronic cough),  Shortness of breath or difficulty breathing,  Fatigue or tiredness,  Nausea or vomiting, Headache,  Diarrhea (>/=3 loose/looser stools in 24 hr period). Hospitalized 8/27/2021
DOSE WITHDRAWAL AT 1.5 HOURS OUTSIDE OF THE 6 HOUR WINDOW PERIOD; EXPIRED VACCINE WAS GIVEN TO A PATIENT; This spontaneous report received from a health care professional concerned a 58 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 05-AUG-2021) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced dose withdrawal at 1.5 hours outside of the 6 hour window period, and expired vaccine was given to a subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine was given to a patient and dose withdrawal at 1.5 hours outside of the 6 hour window period was not reported. This report was non-serious.
Patient alert and oriented stated feeling lightheaded soon after arriving to the observation vaccination area. The patient denied chest pain, headache, difficulty breathing or any skin sensitivities such as itching. The patient stated takes a variety of medications including multiple blood pressure medications. BP 82/48 HR 68 RR 18 O2sat 98%  and EMS called immediately to assume patient care. As per EMS patient refused medical care at a hospital facility and was discharged.
Significant swelling, tenderness, erythema, and ecchymosis over injection site. Treated with Motrin and supportive care.
pt recv vax 3PM 4JAN96 & broke out w/rash;wouldn't walk on leg that noc of shot;rash-redness @ site;6JAN had hives down leg;wouldn't walk on leg;seen in hosp ER dx cellulitis @ site prescribed ATB & motrin;
Patient is 16 YO female,  arrived to clinic with mother for third dose Pfizer on 10/09/2021 at 11:00 am. Patient's second dose Pfizer was not reviewed and verified by staff.  Patient was administered the Pfizer third dose today. Per staff, patient and mother left Clinic with no adverse events. Writer reviewed patient's prevaccination Checklist for COVID-19 Vaccines and noticed that patient's age group is not eligible for the booster COVID-19 vaccine at this time. Mother contacted and confirmed that patient's second dose was administered on 06/12/2021. Mother stated that patient is not experiences any adverse events at this time; however, it appears that patient may be catching a cold. Patient was scheduled with Healthcare Provider for a post vaccination follow up to address any concerns and questions. Per patient's visit with Healthcare Provider, mother stated that patient is having nasal congestion. Writer follow up today and mother stated that patient is doing better and that nasal congestion has improved. Mother instructed to monitor symptoms and follow-up with PCP as needed.
Severe headache lasted all evening until I went to bed. About 8 hrs. Woke up with no headache. Through the day seemed more fatigued then mormal
While administering Moderna Covid vaccine boosters, the vile was punctured 22 times, and 22 doses were drawn up and administered.
headache; chills; body aches; Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of HEADACHE (headache), CHILLS (chills), MYALGIA (body aches) and EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced HEADACHE (headache), CHILLS (chills), MYALGIA (body aches) and EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved. At the time of the report, HEADACHE (headache), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. Patient received the 1st dose of Pfizer vaccine 10-Mar-2021, the lot number was a EN6206.  The expiration was JUN-2021. Patient received the 2nd dose of Pfizer 07-APR-2021, the lot number was a EW0150.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: followup received on 2-Nov-2021 and non-serious events are added.
Extreme fatigue, confusion, dizziness, huge swelling and redness at injection site, labored breathing (SOB); Rest, plenty of fluids, self(home) treatment of OTC Benadryl, utilized an inhaler (Pro-air); also doctor's visit with NP (on 03/28/16) to ensure no vitamin B12 deficiency & even requested injection due to the fatigue, SOB, and confusion but NP suggested labs initially. Labs displayed no B12 deficiency. Received vaccination due to WC injury (lacerated digit).
COAGULOPATHY, UNSPECIFIED TYPE MULTIPLE SUBSEGMENTAL PULMONARY EMBOLI WITHOUT ACUTE COR PULMONALE ACUTE PULMONARY EMBOLISM
No adverse effects reported; a improperly stored dose of VARIVAX was administered on 12-JUL-2019; This spontaneous report was received from a healthcare worker, who was also the office manager, and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 12-JUL-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R018143, expiration date on 25-JUN-2020 (strength, dose, route, and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature of 18.9 fahrenheit, during 18 hours and 4 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. No adverse effects were reported.
At 11:32 patient noted to faint in chair and fall to the flood and begin seizing about 1 to 2 min post vaccine. Seizure lasted about 15 seconds. RN supported patients head at time of seizure. Patient was aware of where they were and noted that they were feeling nauseous and dizzy. Patient was eventually helped to a seated position where EMS transported patient.
Pain radiated down to left hand with severe sharp left upper arm pain at left arm injection site.  Pain improved but still have left shoulder movement difficulty. Left side over shoulder movement such as take off clothes is challenging.
1000: After receiving COVID vaccine, pt c/o tingling in lips, cheeks & chin 1009: BP 125/82 HR 98 SpO2 98% 1022: Benadryl 25 mg po given 1037: Not sleepy; no SOB; resolving chin/lips & up to forehead 1045: Benadryl 25 mg po repeated 1051: Not dizzy, no SOB, no throat swelling; tingling almost all gone 1106: Sl numbness cheeks only; "feels like novacaine shot almost worn off" 1116: Left w/husband driving pt; numbness in cheek in presses only
had a severe reaction to 1st dose of the Moderna Covid-19 vaccine; She was in severe pain; She had a case of severe arthritis afterward; She had to stay in the bed.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (She had a case of severe arthritis afterward), BEDRIDDEN (She had to stay in the bed.), VACCINATION COMPLICATION (had a severe reaction to 1st dose of the Moderna Covid-19 vaccine) and MYALGIA (She was in severe pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (significant).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced ARTHRITIS (She had a case of severe arthritis afterward), BEDRIDDEN (She had to stay in the bed.) and MYALGIA (She was in severe pain). On an unknown date, the patient experienced VACCINATION COMPLICATION (had a severe reaction to 1st dose of the Moderna Covid-19 vaccine). At the time of the report, ARTHRITIS (She had a case of severe arthritis afterward), BEDRIDDEN (She had to stay in the bed.), VACCINATION COMPLICATION (had a severe reaction to 1st dose of the Moderna Covid-19 vaccine) and MYALGIA (She was in severe pain) outcome was unknown.            No concomitant and treatment drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-162230 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162230:Crosslink
Upper back pain, worse over the scapula, right scapula hurts too.  Pain worse in the evenings, Pain is so severe that she will not allow her Mom to touch it. She is going to school and participates in PE .  Pain is barely there in the mornings. She denies any injury,   she does not play sports, no dance or gymnastics.  Pain developed 6 days ago and is worsening since then.  Recommended treatment Ibuprofen 300 mg twice a day for 5 days.  heating pad, gentle massage with muscle relaxing ointments such as Ben Gay.
20 month old female in for immunization update, was given DTaP, HIB, PREVNAR and H1N1, on 2/18/10, on 2/19/10 came to clinic with urticaria. Presumed due to H1N1, other vaccines were boosters.
2nd dose of shingrix late.1st dose of shingrix was on 09/05/2019 and  2nd dose on 4/28/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number NP33H, expiry date 8th April 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 5th September 2019).   On 28th April 2021, the patient received the 2nd dose of Shingrix. On 28th April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccination schedule. The reporter enquired about revaccination. The reporter consented to follow up.
lt arm sore, swollen red area approx 100mm x 110mm area feel warm to touch;c/o pain under lt rib cage, was seen by PMD 25OCT95;
-swelling and redness to injection site -exaggerated L arm pain -paresthesias to L side of body next day -ongoing fatigue
Pt called and said she had a rash on face, chest and shoulder, Thursday morning that lasted until Sunday. She went to ER on Monday because she felt sick and couldn't breath. Said she was told by ER Dr not to take another one.
Three hours post vaccination the pt developed swollen left thigh and non-stop screaming for 4-5 hrs. Also had Tachypnea in ER.
PATIENT FAINTED IN THE OBSERVATION CHAIR ABOUT 10 MINUTES  AFTER RECEIVING THE J & J COVID -19 VACCINE. HE FELL OUT OF THE CHAIR BUT WAS NOT SERIOUSLY INJURED, HE MAY HAVE BUMPED HIS MOUTH. THE PHARMACY TECHNICIAN IMMEDIATELY HELPED HIM UP BACK TO HIS CHAIR AND GAVE HIM A BOTTLE OF WATER.  SHE ALSO CHECKED HIS BLOOD PRESSURE (NOW AT 136/94). I CALLED 911 BUT HE DECLINED ANY ADDITIONAL ASSISTANCE SO I TOLD THEM TO CANCEL. WE ASKED HIM TO WAIT AN ADDITIONAL 5-10 MINUTES AND HE WAS FINE. HE LEFT ON HIM OWN ACCORD. I TOLD HIM THAT HE MAY RECEIVE A CALL FROM US AS A FOLLOW UP TO THE EVENT.
Patient presented in office 8/22/2007 with lt upper arm red, swollen and warm to the touch. Size of redness 70mm. Mother reports that it first showed up this am. Patient denies any pain or discomfort. Inst mother to give advil for discomfort and benerdyl for the swelling. Instr to apply cool compress to area.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-364365 (Patient Link).
no second dose; reaction on my right arm; not feeling well; itch; sore all over; still experiencing joint pain; the rash is itchy; there is hardness; rash on her hand; redness; she is very tired; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (no second dose), VACCINATION SITE REACTION (reaction on my right arm), MALAISE (not feeling well), PRURITUS (itch) and PAIN (sore all over) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder and Hypertension (Hypertension).    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced RASH PRURITIC (the rash is itchy), VACCINATION SITE INDURATION (there is hardness), RASH (rash on her hand), VACCINATION SITE ERYTHEMA (redness) and FATIGUE (she is very tired). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (no second dose), VACCINATION SITE REACTION (reaction on my right arm), MALAISE (not feeling well), PRURITUS (itch), PAIN (sore all over) and ARTHRALGIA (still experiencing joint pain). At the time of the report, PRODUCT DOSE OMISSION ISSUE (no second dose) had resolved, VACCINATION SITE REACTION (reaction on my right arm), MALAISE (not feeling well), PRURITUS (itch), PAIN (sore all over), RASH PRURITIC (the rash is itchy), VACCINATION SITE INDURATION (there is hardness), RASH (rash on her hand), VACCINATION SITE ERYTHEMA (redness) and FATIGUE (she is very tired) outcome was unknown and ARTHRALGIA (still experiencing joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant medications included Thyroid medication and Blood pressure medication (both unspecified). Reportedly, the doctor recommended a cold pack. Patient was also prescribed an unspecified medication for itch.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Suspect product start date and Outcome of event Arthralgia were added. On 16-Jul-2021: Updated activities tab.
This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. On an unspecified dates since 05-MAY-2014, an unspecified number of patients received PROQUAD (lot # K006219 and expiry date: 29-OCT-2015) which was improperly exposed to 22F for 2000 hours. No known adverse effects. No product complaint was reported for PROQUAD. This case is linked to 1411USA001655, 1411USA004432, 1411USA004433, 1411USA004434, 1411USA004435, 1411USA004436, 1411USA004438, 1411USA004439, 1411USA004440, 1411USA004441 and 14411USA004442 (same reporter link). Additional information has been requested.
Narrative: Hospitalization: Fully vaccinated, admitted with encephalopathy and COVID infection
Information has been received from a physician concerning a 4 year old female with asthma who in June 2010, was vaccinated with the second dose of VARIVAX (Merck) (lot number 665885/1589Y). Concomitant therapy included FLOVENT, VENTOLIN and ZYRTEC. The patient went to the physician's office on 04-MAR-2011 with chickenpox. At the time of reporting, the patient was recovering from chickenpox. Additional information has been requested.
Patient reported back to the clinic saying her neck felt thick and off 40 minutes post-vaccination.  Then patient was administered 50mg Benadryl PO. She felt fine after 15 minutes. Patient was informed to call primary care doctor  or 911 if she experienced any problems later.
Patient in clinic with mom and brothers to get the second dose of the Pfizer COVID 19 vaccine. Patient received the vaccine in right arm and a small amount of blood came out of the injection site. Patient looked at the blood and got pale. She loss consciousness for 10 seconds in the chair with her mom on her left side. We attempted to put patient on the floor to elevate her feet but she resumed consciousness right away. An ice pack was placed on the back of patient's neck. Patient did shake a bit and didn't know what happened. Patient then loss consciousness again and myself as well as another nurse  helped her to the floor. Her feet were then elevated and patient regained consciousness again. Vitals were done, see vital flow sheet. No other signs of symptoms of an allergic reaction. Patient as well as parent was given signs and symptoms of allergic reaction and directed to go to ER or call 911. Patient was able to sit up after 5 minutes, then eventually stand and was able to leave clinic after 15 minutes in stable condition with parent.   RN/BSN on 6/10/2021 at 1:18 PM