chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12 days after receiving the vaccine, I noticed a red oval/circle mark around the injection site. (otherwise known as "covid arm") I also noticed that my left arm was a little itchy as well. The redness went away after 4-5 days.
Emailed me on 2/8/17, beginning on 3/3/17 "feeling of deafness" in (R) ear, which then changed to (L) ear and then went back to (R) ear. No other symptoms or illness. Still waiting to hear back.
Dizziness; Chills; Fatigue; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity and diabetes. The patient had no known allergies to medications, food or other products. Concomitant medication included metformin (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 11May2021 at 10:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 02Jun2021 at 12:00, the patient experienced dizziness, chills, fatigue and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of dizziness, chills, fatigue and diarrhea was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Initial and follow up information has been received from a registered pharmacist and another reporter concerning a 15 month old healthy white female pt with an unk medical history and no reported allergies who on 11Jul05 at 11:00AM was vaccinated SC with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot649237/0553P). Concomitant vaccinations included fourth dose of poliovirus vaccine inactivated (IPOL), a fourth dose of diphtheria toxoid (+) pertussis acellular 3 component vaccine (+) tetanus toxoid (BOOSTRIX), a third dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar), a fourth dose of Hib conj vaccine (PedvaxHib) and a fourth dose of hep B virus vaccine rHBsAg (yeast) (Engerix B). There was no illness at the time of vaccination. On 18Jul05 at 3:00PM, the pt developed atypical measles. It was reported that the pt had a fever of 102 (axillary) at seven days after vaccine was administered. The fever continued for two days and was controlled with acetaminophen (unspecified) and ibuprofen (unspecified). The pt had a rash over entire body that started 9 days after vaccination. She was seen in the clinic on day 11 and diagnosed with atypical measles. Rash was gone by day 16. It was reported that the pt was recovered on 28Jul05. There was no product quality complaint involved. Additional information is not expected.
The patient received his 2nd dose of the Moderna COVID-19 vaccine 3 days early. The patient came into clinic to receive his 2nd dose of the Moderna COVID-19 vaccine. At check-in he stated that he was supposed to have come for his 2nd dose on 3/29/21. He did not have his vaccine card with him and 1st dose appointment was not verified at check-in. The patient received the 2nd dose of the Moderna vaccine and the date discrepancy was discovered upon check-out. The patient received his 1st dose vaccine on 3/11/21 and was not due to return for his 2nd dose until 4/8/21.
01/30/22 presents to ED for "Pacemaker Problem". PMHx of "CHF s/p ICD placement (8/13/21), bicuspid aortic valve s/p TAVR"
Information has been received from a physician, concerning an 18 year old, non-pregnant female patient with celiac disease and a penicillin allergy, who on 16-Aug-2007 was vaccinated IM with the first dose, 0.5 ml, of Gardasil, and on 19-Oct-2007 with the second dose of Gardasil (lot # not provided).  There was no concomitant medication.  Following the second vaccination, the patient missed her period (date not specified), and was diagnosed with premature ovarian failure.  Diagnostic tests included hormonal studies and thyroid studies (results not reported).  At the time of this report, the patient had not recovered. 02/12/2010 Initial and follow up information has been received from a physician concerning an 18 year old,  non-pregnant female patient with celiac disease and a penicillin allergy, who on 16-AUG-2007 was vaccinated IM with the first dose, 0.5ml, GARDASIL (lot #657868/0523U) and on 19-OCT-2007 with the second dose of GARDASIL (lot # not provided). There was no concomitant medication. The physician reported that the "patient presented with new onset amenorrhea times 2 months starting concurrent with her first vaccine," however the date of onset was also reported as 24-OCT-2007. She had a workup with labs, which determined that she had premature ovarion filure and Hashinotot's thyroiditis. There was no concomitant medication. At the time of this report, the outcome of the events was not specified. The physician questioned a causal relationship of the events to GARDASIL. Additional information has been requested.
Within 2 hours, the pt experienced pain, swelling, redness with rapid extension. Seen in ER and received antibiotics and Benadryl. The symptoms resolved.
Initial information received on 17-Aug-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a four-years old patient (gender not reported) who experienced localized reaction, while he/she received a dose of ADACEL instead of DAPTACEL on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine lot number not reported. On an unknown date, the patient developed non-serious localized reaction (Local reaction), following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. It was also a case of actual medication error due to wrong vaccine administered. Relevant tests were not reported. Final diagnosis was severe localized reaction. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
After receiving the Janssen Covid 19, patient fainted while sitting on a chair approximately 10 minutes after receiving the vaccine. Paramedics were called. BP and EKG were normal. Patient returned to work. Patient informed Pharmacist and Paramedics that he fainted before when donating blood.
Dizziness; vertigo; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 02Apr2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and allergies were not reported. The patient did not receive any concomitant medications within two weeks prior to COVID-19 vaccine. 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 vaccination. On 04Apr2021 the patient experienced dizziness, vertigo and nausea. The adverse events had not resulted in a visit to the doctors or other healthcare professional office or clinic visit or emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events dizziness, vertigo and nausea were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swelling; This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 10-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E4T, expiry date 1st October 2021) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, less than 6 months after receiving Boostrix, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to Boostrix.  Additional information received were as follows: The age at vaccination was not reported. The reported batch number 43E47 was updated to 43E4T as per sales data sheet. The healthcare professional reported that the patient had swelling the size of a goose egg at the site of Injection with Boostrix, which led to extensive swelling of vaccinated limb. The reporter consented to follow up. This case is 1 of the 4 linked cases, reported by the same reporter.
Since April 3rd, two days after the shot I have been getting super itchy and then I get  hives on my arms, chest, stomach, and back. It started off as a couple little ones and go away after a couple of hours, now they are happening by mid afternoon and they have been a lot bigger and a lot more are popping up.  They can be as big as a quarter in size.  They last until after I'm asleep.  At first I was putting calming lotion on them, now I'm taking claritin once I start itching and they start appearing.  This stops the itch and most of them go away in an hour or two.  A few linger for longer.  I twice went to a doctor for other things and told them about the hives, but I did not have any showing at the time.  I took lots of pictures since then for proof. They don't appear until mid to late afternoon.  The mornings I'm totally fine.
Uneasiness/discomfort high up on the left side of the chest, slightly below shoulder. Feeling for a few days. On 5/30, it felt more pronounced and I felt I had difficulty to breathing. Hard to take deep breaths and feel as though I was getting enough oxygen.  Was breathing mostly normal by morning. By the time I saw the doctor, only chest uneasiness was still there but not persistent as it once was.
Pins and needles in hands and feet. Burning in feet, legs, hands. Sharp pains/muscle jerks in legs.  Experienced same side effects in May following second dose of Pfizer
Patient received the Pfizer COVID vaccine (lot ER8732, exp 7/2021) at 0935. At 0946, she told EMT that she felt dizzy. PHN and EMT assessed patient who reported feeling dizzy, sweaty, and anxious due to the peer pressure of getting the vaccine when she was not interested. At 0946 vital signs: blood pressure 122/84, pulse 101, O2 99%, respirations 18. Allergies include penicillin and seasonal allergies. Medical conditions include asthma. Medications include albuterol inhaler. Patient stated she did not eat breakfast. PHN offered patient Benadryl, patient declined reporting that she had driven herself and would take some when she returned home. At 1000 vital signs: blood pressure 120/78, pulse 97, O2 99%, respirations 18. Patient stated symptoms of dizziness and feeling sweaty were improving. Patient noted less anxiety. At 1010 patient decided she would leave, PHN encouraged patient to notify provider and symptoms when to call 911. At 1011 patient walked out with steady gait.
Tired unable to concentrate.  Left arm injection site still swollen and painful.  right hand, arm and shoulder swollen and extremely painful in the upper arm and shoulder.  occasional  shortness of breath.
Reports that after his Td shot on Sept 22 the site of the injection still numb and with a knot that bothers him to raise his arm. He also report breaking down in a rash. He reports that he has taken tetanus shots before and had never cause him any problems. He said that the rash has subsided and gone but his (RT) deltoid area is sore. Denies any fever or chills.
covid vaccine breakthrough   dose 1 7/8/21 Pfizer EW0191 dose 2 7/29/21 Pfizer EW00191
tender to touch; achy when I raised my arm; itching; delayed side effect; rash; small swelling; swelling of the arm right below injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender to touch), PAIN IN EXTREMITY (achy when I raised my arm), PRURITUS (itching), VACCINATION SITE REACTION (delayed side effect) and RASH (rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CICLOSPORIN (RESTASIS) for Dry eye.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tender to touch), PAIN IN EXTREMITY (achy when I raised my arm), PRURITUS (itching), VACCINATION SITE REACTION (delayed side effect), RASH (rash), SWELLING (small swelling) and VACCINATION SITE SWELLING (swelling of the arm right below injection site). At the time of the report, TENDERNESS (tender to touch), PAIN IN EXTREMITY (achy when I raised my arm), VACCINATION SITE REACTION (delayed side effect), SWELLING (small swelling) and VACCINATION SITE SWELLING (swelling of the arm right below injection site) outcome was unknown and PRURITUS (itching) and RASH (rash) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.
Pt felt weak, he was sweating, he felt very anxious and he had a fast heart rate.  Also pt  c/o  "If I open my eyes I'm going to die, Get me out of here and the light bothered his eyes".
Injection site swell up to 14mm surround area was red and itching. Also had flu-like symptoms (runny nose, sneezing) for 2 days after injection
Child developed redness around the site of injection on (R) thigh. Seen 1/9/2020 for cellulitis -> Keflex started.
Severe swelling, hard, itching, red circle around, and warm injection site lasted 2 weeks. Purple/bluish appearance around injection site afterwards.
26MAY92 t104 R, mom treated w/APAP; 27MAY92 t103.6, pt became irritable, devel anorexia, faint red rash on trunk, posterior cervical lymphadenopathy, sore throat; 28MAY92 visit to MD, performed throat strep screen, neg; sx resolved by 29MAY
Patient received a 3rd dose of Moderna. 1st dose on 1/20/21, 2nd dose on 2/17/21, and 3rd dose on 5/13/21.
I had normal couple of days feeling feverish, tired, headache and body aches immediately after vaccine.  Then I felt great, better than for over a week. Then 2 weeks after vaccine, had numbness and tingle in feet hands and arms. Followed by severe migrating nerve pains. First in right forearm, moving to hand within 2 days. Then i had headaches and nerve pains in my face, that was worse when i laid down. Then a couple of days later, severe nerve pains in left upper arm migrating over 3 days down arm to wrist then hand. Then a day or 2 later, severe awful nerve pain in groin, that stayed 2days, then moved down the back of left leg (sciatica like pain) traveling over several days to back of knee,  lower leg, ankle  and then outer toes. Was so painful, I could hardly walk for a week. I was also exhausted for 3 weeks. About a month after the pains started, the vanished as quickly as the came.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and unknown gender. No medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L020015 and expiry date 16-AUG-2017, and lot # L028083 and expiry date 03-SEP-2017) (dosage, frequency and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
The injection was painful and my arm was sore all night. That evening I was super sleepy. The next morning my arm was only a little sore and not red or swollen as for warned. Instead I continued to experience fatigue and a sort of out of body feeling. Then came the waves of nausea which were followed by more fatigue and a head ache. Tylenol and sleep help.
On October 30, 2023, a 64 y/o female came in for covid vaccine.   RN pulled vial of 5-11 y/o Pfizer vaccine instead of the intended Spikevax 12+ vaccine. 0.5 mL of the 5-11 y/o Pfizer was administered to patient. Error was not caught until vaccine was already administered.  Patient was notified of the error and was observed for 30 minutes in clinic.   The patient voiced that she was feeling fine, and no adverse reactions were noted upon patient leaving. RN notified  RN, CDNS and she notified PCM, Regional Director, and Immunization Program Nurse. Per Dr, Patient will need to be revaccinated 3 weeks from vaccination date (10/30/23) with age appropriate COVID vaccine of patient's choice.
Received 2nd dose 2 years after the 1st; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th July 2020, batch number:NB9D3, expiry date: 16 April 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 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 Information: GSK Receipt Date: 25-APR-2022 Reporter's Comments: The patient was not immunocompromised. The patient had second shingrix dose 2 years after the first dose. The reporter a asked if there was any data on efficacy if he received 2nd dose late.  The reporter consented to follow up. Additional Supportive Information: As the patient received 2nd dose 2 years after 1st dose which led to lengthening of vaccination schedule.
Suspected vaccination failure; have Shingles on the back of my head; very painful headaches; very painful headaches; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and headache. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and headache to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows The patient had reported this case. The age at vaccination was not reported. The patient received both the doses of Shingles vaccine last year from the date of reporting. The patient went to see the doctor on 26th August 2021 and had shingles on the back of head and very painful headache. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation were not provided.
102 degree fever started.  Fever continued on 7/13/2012 along with nausea, lethargy, and vomiting.  Fever peaked at 103 degrees.  Diarrhea on 7/14/2012 in evening.  Contacted doctor on 7/13/2012 and told to continue administering Tylenol.
numbness; headache; dizziness; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date: was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced numbness, headache and dizziness on an unspecified date. It was reported that, The caller was a pharmacist who reported an adverse event regarding her sister. The pharmacist stated that her sister received the Pfizer COVID-19 vaccine and then developed symptoms similar to that of the pharmacist when she received the Moderna COVID-19 vaccine. The pharmacist stated that she personally developed numbness in her body, a headache, and dizziness following the Moderna COVID-19 vaccine and that her sister had developed the same symptoms following the Pfizer COVID-19 vaccine. Adverse Event regarding pharmacist's Moderna COVID-19 side effects already reported. Consent obtained for Safety Team follow up. The outcome of the events were unknown.  Information on lot/batch number has been requested.
Patient's left arm swelled 10 days after the Moderna injection. There was a delayed skin reaction, which included a large red painful lesion around the injection site and some itching,
Patient became immediately constipated, and has been constipated since. She had a bowel movement every feeding since she is exclusively breast fed, and right after the vaccine her bowel movements stopped.
ErythemaMultiform, Swelling, heat, induration Narrative: Swelling, heat, induration 8 days later at injection site