chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling tired; pain; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she was administered yesterday 17Feb2021 with the first dose of the vaccine and today on 18Feb2021, the patient started feeling tired and with pain. The outcome of the events was unknown.   Information about Lot/batch number has been requested.
(L) upper arm below injection site - pain at 4 hours with mild redness by 20 hours. About 36 hours marked erythema inner upper aspect of (L) arm (about cm from injection site).
This spontaneous report was received from a registered nurse referring to a patient of currently 4 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursion. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Patient complains that her left arm is now swollen, red, and hard. She has a fever of 101. She took TYLENOL, hydroxyzine and SINGULAIR. No rash noted at 10:13. No swelling to face. No complaint of difficulty of swallowing or difficulty breathing.
At 8.30pm had a fever of 100.6 and at 8am this morning of 104.2; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (At 8.30pm had a fever of 100.6 and at 8am this morning of 104.2) in a 12-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-2022 at 3:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2022 at 8:30 PM, the patient experienced PYREXIA (At 8.30pm had a fever of 100.6 and at 8am this morning of 104.2). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PYREXIA (At 8.30pm had a fever of 100.6 and at 8am this morning of 104.2) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2022, Body temperature: 100.6 100.6. On 22-Jun-2022, Body temperature: 104.2 104.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  It was reported that patient had experienced at 8.30 pm had a fever of 100.6 on 21 Jun 2022 and at 8 am 104.2 on 22 Jun 2022.  The patient had not received any medical care yet.
Chill after injection; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution (COVAES). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 15Feb2021 12:30 (lot number: EL3247; expiry date: unknown) at the age of 36-years-old, as dose 2, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if the patient had known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at 08:00 AM (lot number: EL3247; expiry date: unknown) at the age of 36-years old, as dose 1, single, in left arm for Covid-19 immunisation. The vaccine was administered in a workplace clinic. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient has not been tested for COVID-19 since vaccination. The patient experienced chill after injection on 15Feb2021 at 12:30. The patient did not receive treatment for the event. The patient recovered from the event on unspecified date.    No follow-up attempts are possible. No further information is expected.
Received second dose of vaccine on 1/18/21. Had contact with +COVID family member. Asymptomatic but COVID  tested on 2/13/21 and was negative. 2/16/21 came to ED with fever that had developed. COVID tested again with + result
fever & lesion;pimple lt forearm, temp 6 days, red raised bump, mom not sure if vesicular;
Patient reported severe pain in left arm, left arm pain extending from arm down to left hand, left arm soreness, left arm numbness and difficulty opening left hand.
Body aches, joint pain, chills without fever, headache, nausea, fatigue
Thirsty; Tired; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (Thirsty), FATIGUE (Tired) and PAIN IN EXTREMITY (Pain in the arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm). On an unknown date, the patient experienced THIRST (Thirsty) and FATIGUE (Tired). At the time of the report, THIRST (Thirsty), FATIGUE (Tired) and PAIN IN EXTREMITY (Pain in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I had another allergic reaction, skin sensitivity all over my body. I noticed I had a rash around vaginal area and my tongue was slightly swollen with bumps. Contacted the pharmacy and was told that is normal. The allergy symptoms  did go away after a week.
ACHE; SORE ARM; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On 2021, the subject experienced sore arm. On 2021, the subject experienced tired. On 2021, the subject experienced ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, tired and ache was not reported. This report was non-serious.
Very sore arm at site of injection plus about 7 raised welts. Three days later soreness is a little less but the welts are blending together.
ACUTE PULMONARY EMBOLISM RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Low blood sugar =90 Blood sugar increased to 105. Seen by Paramedic and released Recorded by RN
c/o fever to 104 R x 36 hrs p/DTP/OPV vaxed also c/o listlessness x 48 rhs;
Shortly after the administration of the vaccine, the patient began to feel weak and as though she was going to pass out. The patient fell back and was caught by a family member. She complained of blacking out and having trouble seeing. 911 was called and the patient was ambulatory and examined by medics off site.
1040:  Pt reports not feeling well. Reports has had "passed out in the past"  Pt A&O and slightly diaphoretic noted on forehead.  No color change at present moment.  Pt instructed of breathing techniques.  EMS requested by NP as pt appears to have facial paleness and lips no longer pink in color- "I'm going to pass-out"  Pt remained seated upright in chair and LOC for apprx 4 seconds.  Pt did regain consciousness without assistance or injury.  Pt ambulated to WC without assistance and wheeled to medical evaluation room in rear of the OBS area.  1045:  EMS vitals:  118/66 P-65. while lying on cot. Pt consumed a 16.9 oz water bottle intermittently without difficulty.   1100:  EMS vitals:  126/85 P-63.  pt able to sitting position without complication independently. 1110:  Pt ambulated to OBS general sitting area without assistance-pt stable. 1115:  pt reports doing better-"No problems"   1125:  Pt ambulated independently to exit and instructed in 3 weeks to inform vaccination side to have pt lay down prior to injection. Pt reports someone will drive him home.  Pt instructed if not feeling well-pull over and call 911.  Pt verbalized understanding.
Prior to receiving the shot the patient said she was extremely nervous to get shots.  Patient initially tolerated the shot well and left smiling and left the office.  Told the patient it is recommended to stay near the location for 15 minutes after the shot so we could monitor for any adverse reactions.  Shortly thereafter the patient was in line picking up a prescription at the consult window and collapsed.  Patient recovered and sat back down in the waiting room.  She said she could not feel her hands and appeared panicked.  We called a service 88 and called 911.  Per other staff reports her eyes rolled to back her head, could not feel her hands but were moving her hands up and down, said she could not talk but was talking coherently.  Assistant managers and others directed EMS to the patient and she was taken away in a stretcher.
I experienced a constant dull pain in my left arm and could not lift my arm for over a week.  When I tried to lift my arm, I experienced excruciating pain.  Ibuprophen and Tylenol gave only minor relief.
Sudden hearing loss and pain left ear. Began mid-October continues to date. Hearing test and appointment in otolaryngology 1/5/2022. Significant neurosensory hearing loss left ear. Treated with burst and taper of prednisone. 1/26/2022 second appointment in otolaryngology with hearing test. No improvement. Treated with inner ear steroid injection. Scheduled for 2 more inner ear steroid injections.
pt recvd vax; eyes swollen almost closed; to er; meds given; had similar rxn to previous vax;
1-2 min after administering the vaccine, patient felt dizzy and faint. The patient laid down for 25 min, drank some water and applied an ice pack to his neck. After he felt better. Vitals were stables. No repeat of symptoms occurred.
Patient awoke at 2 am with fever, cough and body aches.  AT ED visit temp 102.7
Patient fainted shortly after administration while still seated in vaccination chair. Immunizing technician and mother supported patient while I administered an ammonia inhalant to which patient immediately responded. The patient vomited once and began to improve. She was given water, OJ and one glucose tablet to support her recovery. She remained in the vaccination booth the entire time and was completely recovered in 10 mins.
Soft tissue at the site of both knee and right hip replacements. Began w/low grade fever & upper respiratory problem producing large amounts of phlegm for several weeks. After being sick for a while was not able to stand without difficulty. Had severe pain around replacement joints and some spasms. Was anemic and high inflammatory markers along with high potassium levels. Treated with amoxicillin with no change in respiratory condition. Prednisone helped swelling & pain. Now on small dose prednisone, folic acid, & methotrexate.
Gave injection & pt said she felt lightheaded. Said she had not eaten & felt lightheaded & wanted me to call EMS. Her BP dropped but came back up. She laid down on floor & felt better EMS check her out & released her.
Took Vivotif on two consecutive days (did not skip a day in-between); Spontaneous case was received on 26MAR2020.  A nurse reported that a female consumer who "took Vivotif on two consecutive days (did not skip a day in-between)" (PT: Inappropriate schedule of product administration). She was receiving Vivotif for immunization. The consumer did not take Vivotif doses according to the schedule. She took the two doses of took Vivotif on two consecutive days (did not skip a day in-between). The nurse did not know the exact dates the consumer took the Vivotif. Action taken with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif on two consecutive days (Inappropriate schedule of product administration) instead of taking them on every other day. Considering the nature of the event, the causality of Vivotif of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took Vivotif on two consecutive days (Inappropriate schedule of product administration) instead of taking them on every other day. Considering the nature of the event, the causality of Vivotif of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
my body was hurting so bad; This is a spontaneous report received from a contactable consumer (Patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. Medical history included elevated heart beat in the 90's. Concomitant medications were not reported. On an unspecified date (Patient got her first covid vaccine last Thursday and on Saturday through Sunday), her body was hurting so bad but she figured it was from the covid shot. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a healthcare worker (also reported as Healthcare Prof-other) refers to a patient of unknown age and gender. On 13-MAY-2015 the patient was vaccinated with an improperly stored VAQTA 25/0.5, injection (lot 3 K018181, expiry date 04-JUN-2017) (route, dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. There was no product quality complaint reported. The action taken with the therapy with VAQTA. The outcome of the events was unknown. The relatedness of the events to the therapy with VAQTA was unknown. This is one of the many reports from the same source. Additional information has been requested.
Shooting and intermittently intense nerve pain in and around right ear, jaw, head, lumps (large) and lesions on right side of scalp from base of neck to front of forehead hairline (diagnosed as shingles by MD).  Brain fog and lethargy.
consult Infectious Disease in the setting of her immune compromised state, and to see if they have any input on this lower extremity bilateral weakness that has occurred since having COVID.    vaccine given no lot number available
This spontaneous report was received from a pharmacist refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent. On 07-NOV-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (units and frequency were unknown) (Lot # N020943 and expiration date 26-OCT-2018) for prophylaxis. Reporter informed that, there was temperature excursions for the ZOSTAVAX (Lot # N020943 and expiration date 26-OCT-2018) at a temperature of 6°F to 14°F and time frame 10 hours 45 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported.
Patient is 6 years old. An adult hep A shot was administered to him instead of a pediatric dose.
Hives on trunk of body.  Not on extremities or head.  Resolved after 6 days of symptoms (day 9 after vaccination).
Reported to this writer that 20 minutes after flu shot, pt "passed out", felt tightness in throat, was cold and clammy. Given orange juice after which finger stick glucose was 79. O2 sat decreased to 83% at one point. Transferred with EMT via ambulance to hospital. Returned to work next day 11/6/03. The hospital discharge summary received on 1/13/04 states syncope, and rash at inj. site.
16 year old given vaccine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given vaccine). On 14-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The reporter stated that the patient tolerated the second dose vaccine well   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-JUN-2021contains: Second dose details were added. On 13-Jul-2021: Follow up received on 13-JUL-2021 contains added ethnicity and statement of tolerance.
felt like he got the vaccine in his arm again and it was going into his shoulder/ arm felt achy like it was the day he got the shot and the day after; felt like he got the vaccine in his arm again and it was going into his shoulder/ arm felt achy like it was the day he got the shot and the day after; achy arm; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information team a Pfizer-sponsored program, Pfizer First Connect. A 61-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 12Jan2021 at a single dose for COVID-19 immunization administered at the hospital. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, batch/lot number and expiration date unknown) on 22Dec2020. Relevant medical history included high blood pressure and diabetes; both were diagnosed in 2006 and ongoing conditions and were under control. Concomitant medications included metformin, lisinopril for high blood pressure, and semaglutide (OZEMPIC, injection), which was a once a week injection kind of like "Trulicity" that encourages his body to make more insulin. The patient said that when he got the second dose of the vaccine on 12Jan2021, he got an achy arm and it went away. At the time of the report on 18Jan2021, almost a week later, he felt like he got the vaccine in his arm again and it was going into his shoulder. The patient was asking if it was normal. He was driving at the time of the call. The patient had been a scrub technician (tech) and an endoscopy tech for 20 years. During the first surge, when they shut down the outpatient surgeries, he went and worked as an aide in the COVID ward. He was glad to get the shot. He did what his kids would do when they were young and would get a shot. He took ibuprofen. Later that evening for the achy arm, he took more ibuprofen. The achy arm lasted only a day. He thought he wasn't going to have any side effects at all. It felt like a flu shot. The patient clarified that at the time of the report (18Jan2021), his arm felt achy like it was the day he got the shot and the day after. He got the vaccine as he was in the first bunch in the city and he works in healthcare and the fact that he was over 60 years old. The patient stated he could live through it and he was just curious. The reporter assessed the events as non-serious. The events did not require any visit to an emergency room or a physician office. The patient had no relevant tests. Therapeutic measures were taken as a result of achy arm, which included ibuprofen. The patient recovered from the event "achy arm" on 13Jan2021, while the outcome of the event "felt like he got the vaccine in his arm again and it was going into his shoulder/ arm felt achy like it was the day he got the shot and the day after" was unknown.  Information on the batch/lot number has been requested.
Rash suddenly appeared all over body about 24 hours after vaccine administration and child was not acting himself per mom.
2 days later while rinsing my hair, a clump of hairs came out in my hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A 66-year-old female patient 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: BNT162b2 (DOSE 2, SINGLE), administration date: 31Mar2021, for COVID-19 immunization, reaction(s): "hair started to fall out at an alarming rate"; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "2 days later while rinsing my hair, a clump of hairs came out in my hand".  Additional information: Patient got 2nd dose of the Pfizer on 31Mar2021. Starting in Apr2021 patient noticed hair started to fall out at an alarming rate. Patient had since lost 50 % of my hair mass. patient got my 2nd booster on 27May. On Sunday 2 days later while rinsing my hair, a clump of hairs came out in my hand. Was there a treatment to counteract the effects of the vaccine that causes hair loss.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Nausea, vomiting, fever, pain s/p Moderna #2 01/30
Patient was seen in ER on 3/29/23 @ 0749. Reports of mild full body rash , low grade fever overnight and fussy. Parents gave patient ibuprofen. Temp in ER 99.5. Was given 6.25mg of Benadryl in Er and advised to take up to 4 x per day PRN. Patient was sent home and came back again on 3/29/23 @ 11:54am. Parents have concern that patient had a seizure. Temp of 102-102.6, HR 172-190, RR 24-67 and sats 96-100% on RA. Admitted to hospital for observation on 3/29/23 @ 1727.
Night sweats, headaches, intense pain  in wrist and ankle joint going on 3 days now
Site: Bruising at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Mild, Systemic: Headache-Mild, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium, Additional Details: patient completed vacination form at 10:43am. Patient recieved vaccination at 10:45am and by 10:50am patient request informed others she felt light headed. Nurse rushed to the patient with the Epi pen.  They observed patient head tilted backward and unresponsive. Nurse opened the Epi pen but did not remove the blue needle cover and was unable to inject patient. At this time the patient started to be responsive and was confused.  called 911, patient refused to go with them