chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Loca site induration (About 8 cm diameter), redness and localized pain associated with low grade fever started about 6 hours post vaccination, continued to worsen (to above size) on Day 2 and started to resolve on D3 post vaccination.
metallic taste in her mouth; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101620646 (Pfizer inc.).  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 14:30 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "immunization" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation. Vaccination history included: Bnt162b2 (Dose Number: 01, Administration Date: 19Mar2021, Administration Time: 08:06 am, Anatomical Site: Left arm), administration date: 19Mar2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 02, Administration Date: 09Apr2021, Administration Time: 09:06 am, Anatomical Site: Left arm), administration date: 09Apr2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021 14:30, outcome "unknown", described as "booster"; TASTE DISORDER (non-serious) with onset 11Nov2021 15:07, outcome "not recovered", described as "metallic taste in her mouth".  Additional information: No Other Products, Patient History, Investigation Assessment has been reported. Caller relays that approximately 37-40 minutes after the booster she was in the car and got a metallic taste in her mouth while she was driving. States she looked online and some people describe it like a mouthful of nickels. States she thought something was wrong, she could taste or feel metal in her whole mouth. Caller states she got her booster around 2:30pm and it happened at 3:07pm. Caller relays it didn't prohibit her from eating but she still had it and hoped it was going away and it came back and it's 5 days later. Caller states she went to her dentist yesterday and asked them and they told her they haven't heard of that, not many people have that. States she kept apologizing at the dentist as her mouth felt like metal and she had gotten ready for the appointment. Caller states it has not gone away yet, when it 1st happened 37 minutes after, it was very pronounced and she was overcome by it it came on suddenly. States she told her husband and he couldn't believe it. States something is wrong with her mouth and maybe she has gotten used to it but it's not as pronounced but it's still there, not every minute. The patient was not visited Emergency Room and Physician Office. Patient's Medical History (including any illness at time of vaccination) and Relevant Tests mentioned as None.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PHARMACIST ADMINISTERED 0.25ML INTRAMUSCULAR TO THE LEFT ARM  MODERNA COVID-19  VACCINE AS SECOND DOSE INSTEAD OF 0.5ML DOSAGE.
"Started to have itch on Thurs 2/4/21, then noticed a red spot, almost a quarter and hard underneath like more firm -slight warm -not draining -no fevers"
5/20/2021 experiencing symptoms: dyspnea 5/24/2021 Admitted to hosp. and treated for COVID-19/ pneumonia 5/30/2021: died
Pronounced lump at the injection site with erythema started day after with pain at axilla 24 HR after onset of pain. (+) swelling at both axilla + (R) deltoid with lump.
Pt. states had reaction of 5 inch x 3 inch redness to injection site. One week after injection started with frequent falls that required an ER visit. Diagnosed with vertigo & a viral infection - required home care x 17 days. Stable now.
First Moderna dose given 3/188/2021 and second dose given 4/15/2021 Positive COVID test on 6/3/2021. symptoms began on 5/28/2021 of cough, body aches, headaches and sore throat. Had known exposure. Was treated with monoclonal Aby therapy.
35 y/o female with a h/o HFrEF develops L sided 6/10 chest pressure radiating to the L arm 15 minutes after COVID-19 vaccine. She was evaluated by EMS and taken to ED.
got shingles they both had the vaccine /suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's son or daughter. The age at vaccination was not reported. The reporter stated that, his or her mother had shingles vaccine shot and got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided. This case was linked with case US2021AMR184399, reported by same reporter for different patient.
Patient reported itching in mouth s/p 5 min vaccination. Patient had a visible rash around mouth w/o swelling of tongue. Pt was given 50mg of liquid Benadryl which resolved the rash after 30min.
mark is hot and warm to the touch; mark is now spreading into a round red spot  / got the mark again after it cleared; Covid-arm; hard round lump in her arm; red dot at or near injection site; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Covid-arm), INJECTION SITE MASS (hard round lump in her arm), INJECTION SITE DISCOLOURATION (red dot at or near injection site), INJECTION SITE WARMTH (mark is hot and warm to the touch) and INJECTION SITE ERYTHEMA (mark is now spreading into a round red spot  / got the mark again after it cleared) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Covid-arm) and INJECTION SITE DISCOLOURATION (red dot at or near injection site). 20-Mar-2021, the patient experienced INJECTION SITE MASS (hard round lump in her arm). On an unknown date, the patient experienced INJECTION SITE WARMTH (mark is hot and warm to the touch) and INJECTION SITE ERYTHEMA (mark is now spreading into a round red spot  / got the mark again after it cleared). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Covid-arm), INJECTION SITE WARMTH (mark is hot and warm to the touch) and INJECTION SITE ERYTHEMA (mark is now spreading into a round red spot  / got the mark again after it cleared) outcome was unknown and INJECTION SITE MASS (hard round lump in her arm) and INJECTION SITE DISCOLOURATION (red dot at or near injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Sore Arm; Received the Pfizer Covid-19 vaccine as the first dose and Moderna as the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and WRONG PRODUCT ADMINISTERED (Received the Pfizer Covid-19 vaccine as the first dose and Moderna as the second dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. CO11321A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE MRNA (BNT162B2) for COVID-19 vaccination.    Concomitant products included TAMSULOSIN, LISINOPRIL, METOPROLOL, RIVAROXABAN (XARELTO), PRAVASTATIN and ACETAMINOPHEN for an unknown indication.   On 16-Feb-2021, the patient started COVID-19 VACCINE MRNA (BNT162B2) (unknown route) 1 dosage form. On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Received the Pfizer Covid-19 vaccine as the first dose and Moderna as the second dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 16-Mar-2021, WRONG PRODUCT ADMINISTERED (Received the Pfizer Covid-19 vaccine as the first dose and Moderna as the second dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.            No treatment information was provided.  Pfizer vaccine was given in left arm.  Upon internal review on 30 Jun 2021, event coding was updated.  Based on the current available information and temporal association between the use of the product and the start date of the event of pain in extremity, a causal relationship cannot be excluded.   The causality for the event of wrong product administered remains as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up information received on 28-JUNE-2021, included no new information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of pain in extremity, a causal relationship cannot be excluded.   The causality for the event of wrong product administered remains as not applicable.
Information was received from a physician via a company representative concerning an adolescent male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The physician reported that at an unspecified time, the anonymous male was vaccinated with an unspecified dose of GARDASIL 9 (lot number and dosage not provided), intramuscularly for prevention of HPV. On an unknown date (reported as "a time thereafter"), the patient experienced hair loss on his head. The outcome of the hair loss was reported as "hair grew back." Additional information has been requested.
Vaccine was given in error on 4/13/23, not appropriate for her age. Symptoms unknown, still waiting for a response from the health department in how to proceed.
Pt reports shortly after receiving vaccines, she began having pain in toes, currently 7/10. Pt reports pain is bilaterally lower extremities, up to upper thigh. Pt reports she doesn't feel she can hold her own weigh and when she tries to walk, she feels like she is going to fall. PT reports numbness and tingling, tickling. Pt reports she has also been shaking in lower extremities. Pt denies any weakness in arms or face, Denies any difficult breathing. Pt reports she has been able to urinate following vaccine. Pt denies any changes in voice or hearing.
Brought in by family due to confusion and ataxic gait; incidental finding of COVID-19 but asymptomatic
Recurring migraine headaches the week following each injection; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Feb2021 at 10:00 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included High blood pressure and cholesterol. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Feb2021 at 07:00, the patient experienced recurring migraine headaches the week following each vaccination. Typical frequency is 3-4 per year, the patient had 4 after week after the first shot, 2 the week after the second shot. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event recurring migraine headaches the week following each vaccination was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient Country and contact information added. Relevant Med History Cholesterol was updated to Cholesterol high. Treatment Received was selected as No. Information "if treatment ae: No" and "known allergies: No" provided. Narrative "Medical history included blood pressure high and cholesterol" was updated to "Medical history included High blood pressure and cholesterol".
13year old male received #1 dose of Jansen Covid 19 vaccine on 05/22/2021.   Mother reports no adverse reactions at this time (05/24/2021).
Woke up 130 after injection with painful R shoulder + swelling + rash in this area. Fever, chills, myalgia down throughout R side of body, down to hip. Temp to 103, swelling in axillary area, reddened area, nausea, mild headache.
Seen in our office 08/30/2019 for nausea and hot flashes. fainted while having orthostatic vital signs taken. reffered to cardiology dx POTS 09/03/2019
Pt was given tetanus booster and meningococcal vaccine in the right thigh and polio vaccine in the left thigh. Mom reports pt had severe pain in the right thigh shortly afterwards. Pt had severe malaise and fatigue for 2-3 days. Pt was unable to walk and stayed in bed for several days missing school. Leg pain developed into full body aches. Over the weekend pt developed severe headache and swelling in left eye. Pt started on prednisone 20 mg for 3 days and BENADRYL as well.
Left arm, left hand swollen 2x1.  Left upper arm swollen red 3x5.  Vaccine reaction with distant reaction too, itchy.  Rx Zyrtec.
throat pain; back pain; Headache; right eye pain; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), EYE PAIN (right eye pain), OROPHARYNGEAL PAIN (throat pain), BACK PAIN (back pain) and HEADACHE (Headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain). On 12-Apr-2021, the patient experienced EYE PAIN (right eye pain). On 14-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (throat pain), BACK PAIN (back pain) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Apr-2021, EYE PAIN (right eye pain) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm Pain), OROPHARYNGEAL PAIN (throat pain), BACK PAIN (back pain) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-101123 (Patient Link).
Dizziness, pale @12:35  B.P. 83/46    Pulse:48    B.P. 107/70   Pulse: 62 Pt. left in stable condition @12:55
appendicitis/ appendix removed; This spontaneous case was reported by a pharmacist and describes the occurrence of APPENDICITIS (appendicitis/ appendix removed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 03-Aug-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced APPENDICITIS (appendicitis/ appendix removed) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (appendix removed) for Appendicitis. At the time of the report, APPENDICITIS (appendicitis/ appendix removed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Shortly after getting the vaccine  patient starting itching , feeling hot, and coughing. No visible rash seen but patient skin looks pink.  He said his throat started to itch.  He was given liquid benadryl.   Patient was coughing and he used his albuterol inhaler that he had with him.  It helped with the coughing.   Patient started to feel better but had to repeat benadryl and albuterol 2 more times.  Patient was monitor for about 50 minutes and all reaction went away.  Patient was advised if he develops any other reactions to seek medical  help.
ACHING JOINTS; RESTLESSNESS; SOLUTION DRIPPING DOWN ARM DURING ADMINISTRATION OF VACCINE; LOCALISED SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unkown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced aching joints. On 09-MAR-2021, the subject experienced restlessness. On 09-MAR-2021, the subject experienced solution dripping down arm during administration of vaccine. On 09-MAR-2021, the subject experienced localised soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the aching joints, restlessness, solution dripping down arm during administration of vaccine and localised soreness at injection site was not reported. This report was non-serious.
Patient stated that he has been experiencing dizziness since the first dose of the COVID-19 Moderna shot.
Fussy, low grade fever for 2 nights 100-101? Slept almost constantly, voiding, stooling and nursing okay.
Patient had feeling of neck pain during post injection surveillance. She returned to clinic for help. C/O weak legs, tight chest. Patient led to bed for care. Face, arms very warm and flushed. VS @ 11:54: 147/97, 18, 118. VS stayed the same x 6 checks.  12:05pm: Zyrtec 10mg PO x 1 given. Redness reduced on face, arms. Some flushing remained on cheeks, eyes appear slightly swollen, though patient states she takes Prednisone 4 mg po Q day, also took her Flonase. 12:55pm: Ordered Diphenhydramine 25mgs po x 1.  1:10pm: Diphenhydramine po given. Continue to monitor. 1:30pm: Patient resting, feeling much improved. Denies any s&s. VS: remains hypertensive, tachycardic, although Mom states this is baseline, but will be addressed @ next f/u with Cardio. 1:55pm: Eyes improved- no more swelling, patient overall returned to baseline. Discharged home in stable condition with mother. If s7s return or worsen patient was instructed to go to nearest emergency department.
Has come down with Corona virus; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Has come down with Corona virus) in a 50-year-old patient of an unknown gender 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 COVID-19 (Has come down with Corona virus). At the time of the report, COVID-19 (Has come down with Corona virus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.  It was unknown  if the patient received the Moderna vaccine prior to infection.
shortness of breath, heart palpitations, numbing in hands in and feet, unable to move muscles, heat flashes, nausea, passing out.
Sore arm  Headache Palpitations  All lasted 24 hours and then completely resolved
rash; Redness; Swelling; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash), VACCINATION SITE PAIN (Soreness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash), VACCINATION SITE PAIN (Soreness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE RASH (rash), VACCINATION SITE PAIN (Soreness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) was resolving.            Action taken with mRNA-1273 in response to the events was not Applicable.  No medical history was reported No concomitant medications were provided. No treatment drugs were reported.
This spontaneous report was received from a nurse and refers to a 3 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 07-SEP-2017, the patient was vaccinated with improperly stored RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) for prophylaxis. No adverse effects were reported. The administered vaccine underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
After having by Dose 3 vaccination Pfizer-BioNTech Dose 3, 10/30/2021, FF2593. On January 01/20/2021, I began to feel unwell, in the morning I lost my voice and by that evening my symptoms included the lose voice then that night shakes, chills, and fever 104; which my normal temperature runs with a 97.5. I awoke with out a voice and I could not get to the doctor office due to weather alert. Positive COVID on 01/21/2022. Was having issue with heart and leg issues which resulted in seeing a cardiologist 03/03/2022. I was feeling like someone sitting on my chest and I was having an irregular heart beat. My leg was aching inside the muscle and worried about having a DVT and I still have issues with my muscles.
Mother states child had to go to ER due to puffy eyes and redness around her nose.