chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pre-cancerous condition; abnormal pap smear one month after getting both Moderna doses,abnormal PRE-cancerous pap smear now; This spontaneous case was reported by a consumer and describes the occurrence of SMEAR CERVIX ABNORMAL (abnormal pap smear one month after getting both Moderna doses, abnormal PRE-cancerous pap smear now) and PRECANCEROUS CONDITION (Pre-cancerous condition) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 086B21A and O37A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, 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 experienced SMEAR CERVIX ABNORMAL (abnormal pap smear one month after getting both Moderna doses,abnormal PRE-cancerous pap smear now) (seriousness criterion medically significant) and PRECANCEROUS CONDITION (Pre-cancerous condition) (seriousness criterion medically significant). At the time of the report, SMEAR CERVIX ABNORMAL (abnormal pap smear one month after getting both Moderna doses,abnormal PRE-cancerous pap smear now) and PRECANCEROUS CONDITION (Pre-cancerous condition) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Smear cervix: abnormal (abnormal) abnormal PRE-cancerous pap smear now.         No relevant concomitant and treatment medications were reported  Patient has to have a double-mastectomy  Company Comment: Very limited information regarding the events Abnormal PAP smear and Precancerous condition has been provided at this time.  Further information has been requested.  The event Breast cancer seems to have occurred in another patient. Currently, there is no information available about the drug involved. Additional information has been requested.    Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow up received :This report contains no new information; Sender's Comments: Very limited information regarding the events Abnormal PAP smear and Precancerous condition has been provided at this time.  Further information has been requested.  The event Breast cancer seems to have occurred in another patient. Currently, there is no information available about the drug involved. Additional information has been requested.
No adverse reaction however 4 yr old patient given Adacel instead of Dtap vaccine - SP to mfg and since it is Dose 5 & no reaction no re vacciation requirred. Spoke to Sanofi Pasteur re: wrong vaccine of Tdap instead of Dtap given to pt they advised since 5th in series that valid vaccine & no need to reimmunize. Patient mother notified and patient had no adverse reaction from Tdap & patient should have had Dtap.
25OCT94 tc from mom pt recvd vax & began jerking & twitching; seemed perfectly nl-playing, talking, etc. felt warm to touch; did not take temp; cutting teeth as well; mom called MD; pt broke out in rash
Developed itchy facial/neck rash within 2-3 hrs of receiving vaccine. Rash present but no more extensive on 04/24/2002.
Foggy head; Sore arm; This is a spontaneous report from a contactable consumer (reporting on herself). A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0150 and Expiration was not reported) via an unspecified route of administration in Arm Left on 08Apr2021 13:00, as 1st dose, single for COVID-19 immunization. Medical history included seasonal allergy, hypersensitivity, food, food allergy all from an unknown date and unknown if ongoing. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC ALLERGY); mometasone furoate (ASMANEX) both taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. It was reported that after the first dose of the vaccine she had a foggy head, sore arm. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
4 HOURS POST IMMUNIZATION PATIENT EXPERIENCED SHORTNESS OF BREATH AND CHEST PAIN. WENT TO ER DEPARTMENT.   CHEST X-RAY, EKG AND BLOOD WORK PERFORMED.  NEXT DAY VISIT TO PEDIATRICIAN FOR UNRESOLVED CHEST PAIN, GIVEN ANTI-INFLAMMARY RX AND PPI FOR GERD.
first dose was on 11Mar. His second dose was 01Apr. COVID positive 18Aug; first dose was on 11Mar. His second dose was 01Apr. COVID positive 18Aug; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old male patient received bnt162b2 (COMIRNATY), administration date 01Apr2021 (Lot number: EP7534) as dose 2, single and administration date 11Mar2021 (Lot number: EN6204) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Aug2021, outcome "unknown" and all described as "first dose was on 11Mar. His second dose was 01Apr. COVID positive 18Aug". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Aug2021) positive. It was reported that he received his first and second vaccine doses and 3 months later on August 18th, he tested positive for Covid.
fainted; sleep apnea; vertigo; dizziness; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 37-year-old female patient who received HAB (Twinrix) for prophylaxis.   On 16th May 2019, the patient received Twinrix 1 ml. In May 2019, less than a day after receiving Twinrix, the patient experienced fainting (serious criteria GSK medically significant), dizziness, sleep apnea and vertigo. On an unknown date, the outcome of the fainting, dizziness, sleep apnea and vertigo were recovered/resolved.   It was unknown if the reporter considered the fainting, dizziness, sleep apnea and vertigo to be related to Twinrix.  Additional details were provided as follows: Within 24 hours after vaccination the patient fainted and then experienced dizziness, sleep apnea and vertigo.  The dizzines and vertigo went away after 2 weeks. The sleep apnea went away after a couple of days. The reporter gave consented to follow up.
felt fatigued; achy legs; had no appetite; felt weak; muscle aches; headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2021, the patient received the 1st dose of Shingrix (intramuscular). On 16th December 2021, several hours after receiving Shingrix, the patient experienced fatigue, leg pain, appetite absent, feelings of weakness, muscle pain and headache. On an unknown date, the outcome of the fatigue, leg pain, appetite absent, feelings of weakness, muscle pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, leg pain, appetite absent, feelings of weakness, muscle pain and headache to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient received Shingrix vaccine in left arm. The patient states that hours later she felt fatigued and achy legs.  At dinner time she had no appetite and felt weak.  At bedtime she reported muscle aches and a headache.  The reporter spoke per content, referred her to health care professional (HCP). The reporter consented to follow up.
The day following the second dose of the vaccine, I felt sick. Chills, sweats, aches, but no fever.  Then the following day I felt better but had a annoying, constant headache all day. Then when showering I found a tender lump in my right armpit (same side as my vaccine). I?m pretty sure this is a swollen lymph node, and thought I should report it since I don?t have a spleen and I developed it pretty soon after the vaccine.
Patient became dizzy and in and out of consciousness. Patient was then taken to a private room where he had a 10 second seizure with no reported hx of epilepsy or other medical conditions (according to the patient)  Needed EMS transport off site. This occurred at a mass vaccination site and patient was transported off facility grounds. Resolved at clinic level, not monetary reimbursement.
Fever 101.9, chills, nausea, body aches, for a day  (Thursday), felt better on Friday and ok on Saturday.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: pt during 15min wait time after booster vaccine, becomes dizzy, falls 6-8 mins after adminsitration. sweating profusely, complained could not breath, administered epinphrine at this point. blacking out, seeing stars. remained conscious throught. called 911 when pt blacking out. girlfriend recieved 30min before pt, says pt might have psyched self out. recieved moderna 1/2 dose no issues.
Arm became very heavy; Became lethargic; Became drowsy; My hands were shaking (could not hold glass); Fever: within 24 hours fever shot to 103.2; Extreme pain in my joints like my entire bone structure was about to collapse; unable to sleep due to pain; Headaches; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 65-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN4199, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 17Mar2021 at 09:00 (at the age of 65 years) as dose 2, single for covid-19 immunization in hospital. Medical history included osteoporosis, osteoarthritis, Hashimoto thyroiditis and known allergies all from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications received within 2 weeks of vaccination included alendronate sodium (ALENDRONATE SODIUM) tablet and levothyroxine sodium (SYNTHROID) both were taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6201, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 23Feb2021 at 09:00 (at the age of 65 years) as dose 1, single for covid-19 immunization and experienced Pain and swelling for about 3days at injection location. After exactly one week she took Alendronate Sodium within the hour the injection location swelled up into a hard ball with intense itching. This lasted several days. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021, the patient experienced arm became very, became lethargic, became drowsy, my hands were shaking (could not hold glass), and on an unspecified date in Mar2021, the patient experienced fever, within 24 hours fever shot to 103.2, unable to sleep due to pain, headaches, extreme pain in my joints like my entire bone structure was about to collapse. It was reported that, after 3 hours of vaccination arm became very heavy, became lethargic and drowsy. By the evening my hands were shaking (could not hold glass), fever: within 24 hours fever shot to 103.2 - responded well to Tylenol. For 48 hours experienced extreme pain in my joints like her entire bone structure was about to collapse- unable to sleep due to pain, severe headaches etc. Patient was asking had anyone else reported interaction with Alendronate sodium (unspecified if she experienced). Having had this reaction when could I restart taking it safely? No treatment was received for the event. Clinical outcome of the events was reported as unknown.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable consumer (Patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in Arm Left on 14Apr2021 (at the age of 58 years old) as dose1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She got the shot on Wednesday the Pfizer when she was very nauseous the next day too typically her arm was so spasmed last night she wakes up with really bad pain in and around her shoulder and under her armpit, it has been there so bad and she gets really nauseous whenever she move her arm and all day she had been like she want to throw up. The pain under her arm, is it that part of shot. The patient reported that very nauseous, she want to throw up and pain was reported as worsened. No treatment provided for the events. The outcome of the events was not resolved and for pain worsened, nausea and vomiting aggravated outcome was unknown .  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A physician reported that a pt received an injection of Flu Shield '00-'01 and subsequently developed hypoglycemia. The reporter indicated that he did not believe that the pt's experience of hypoglycemia was caused by Flu Shield. Follow up states patient recovered.
14 year old female received the GARDASIL/FLUMIST vaccine on 6 Nov 13. She states that 48 hours later she developed a ring lesion over her left arm surrounding the vaccine. She states her arm was swollen and sore feeling initially. The rash was very itchy at the site only. She went to her PCM and they gave her a steroid cream. It did not help much. She then developed a generalized rash that started on 25 Nov 13. The rash began on her chest and spread to her arms/legs. The rash is described as little itchy bumps everywhere. She denies any other systemic symptoms. She is being followed by dermatology for this condition as well.
Pt was given KINRIX on 3/3/2010. Mother noticed erythema, swelling, warm to touch on 3/4/10. Pt came on to clinic 3/5/10 pt has 2in erythema, warm to touch. Mother states getting smaller. Advice BENADRYL cold compress & TYLENOL. Advice to return to clinic if sign & symptoms get worse.
Injection site is red, swollen, very itchy.   Redness has spread a bit swelling is getting better.  This occurred 7 days post vaccine. Currently just monitoring.
pt was given 2nd booster at age 49 instead of 50.  she did not meet booster requirements (immunocompromised) but dr had told her to get booster.  rph did not catch age discrepency until after boost was given 0.25ml
A report was received from a health care professional concerning a 3 year old male vaccinee who was inadvertently administered Fluvirin on 12/8/03. On 12/8/03, the vaccinee was inadvertently administered Fluvirin. No adverse events have occurred as a result at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1/27/04: A follow up report from a health care professional confirmed that the vaccinee did not experience any adverse events. No follow up pending. All information received.
I broke out into severe hives all over the body around 24 hours after the 2nd dose of the vaccine. No adverse reaction to the 1st does. Extremely itchy, large blotches even on the face. prednisolone prescribed. The hives lasted 7 days.
Petite mal seizures starting sometime shortly after 1st COVID; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on [29Aug2023], this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EM9809), in left arm for covid-19 immunization in morning. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PETIT MAL EPILEPSY (medically significant), outcome "recovered", described as "Petite mal seizures starting sometime shortly after 1st COVID". Therapeutic measures were taken as a result of petit mal epilepsy. His doctor finally got them under control with Xcopri. Since then each time he has gotten a booster he has had 1 or 2 seizures within a week. He never had seizures before the shots. The event was fine now but on meds XCOPRI. The reason reporter believe it was the vaccine is because each time he has gotten a booster, he would have at least 1 episode even though he has been takin XCOPRI 200s daily.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288375 same patient/drug/AE, different dose number;US-PFIZER INC-202300288377 same patient/drug/AE, different dose number;US-PFIZER INC-202300288376 same patient/drug/AE, different dose number;
Patient had a very high temperature for 2 days (Fri-Sat).  Then on Sunday none.  On Monday, she had a runny nose and cough and lost her voice.  By Wednesday, we went to the doctor and asked for medicine for croup.  The cough lasted and then she started shivering really bad.  She had never done this before and has talked for a year with at least 1000 words by age 14 months.  She still stutters a bit but for those 4 days it was bad.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. On 29th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, swelling arm, injection site erythema, extremities hot feeling of and muscle pain. On 30th March 2019, the patient experienced general body pain, fever, headache and injected limb mobility decreased. On an unknown date, the patient experienced chills and injection site induration. The patient was treated with ADVIL. On an unknown date, the outcome of the injection site pain, swelling arm, injection site erythema, general body pain, extremities hot feeling of and muscle pain were not recovered/not resolved and the outcome of the fever, headache, chills and injection site induration were unknown and the outcome of the injected limb mobility decreased was recovered/resolved. It was unknown if the reporter considered the injection site pain, swelling arm, injection site erythema, general body pain, fever, headache, extremities hot feeling of, injected limb mobility decreased, muscle pain, chills and injection site induration to be related to SHINGRIX. Additional case details were reported as follows: This case was reported by the patient as well as physician separately. The patient received first dose of SHINGRIX on Friday in right arm at pharmacy and she experienced what she described as quite a reaction to the vaccine. The lot number or expiration date was not available. Less than a weeks after receiving SHINGRIX, the patient chills and induration at injection site. She reported that her right arm was sore and swelled up and was red and the area on her right arm that was red was the size of an orange. These symptoms started as the evening progressed and her arm became more and more sore. On 30th March 2019, 1 day after receiving SHINGRIX, the patient arm was beet red and she had body aches and by Saturday night she had a 101.8 fever with terrible body aches and a headache and she couldn't move her right arm. She used ice on her arm and she took ADVIL and went to bed at 7:00 PM. On 31st March 2019, her arm was painful and red but better. On 1st April 2019, her arm was better but the redness was still obviously there and the size of the redness was all the way across her arm and down her arm this morning and was still painful to the touch. On 1st April 2019, she could raise her arm above her head and her muscle in her arm was still hurting. Her arm was still hot which started the night she received the vaccine.
Patient stated the administration was given in the upper shoulder, not deltoid. Stated the day after experienced pain and eventually shoulder "locked up" and said was having trouble moving.  Stated this required physical therapy for 7 months.  States the issue is now resolved.
Days 2-4 following vaccination patient experienced muscle aching and tenderness at injection site. Pt states there was a small red/swollen circle at injection site, about the size of a quarter.  Day 8 following vaccination pt felt severe fatigue, discomfort, and chills (no temperature was recorded) Day 9-10 following vaccination pt's injection site redness enlarged to size of an orange, become swollen, warm and tender to touch. The injection site was itchy and painful.  Pt reported to clinic on day 10 after vaccination, was diagnosed with cellulitis and prescribed antibiotic for treatment.
pt recv vax 31MAY95 & pt exp h/a, lightheadedness, dizziness, fatigue, overall body pain, flushing & a warm feeling all over body;pt reported for 5 days could not do anything;MD recommended that pt not receive any additional vax
48 hours after vaccination, developed mild (non-painful) case of shingles on right breast.  Consulted family (retired nurse) and friend (active physician) and texted picture.  Saw Dr. physician assistant on 2/1/2021.  Received second Moderna dose on 2/25/21 at same location.  No major adverse effects following injection (other than normal soreness at injection site). Some (temporary?) scarring still remains.
Myalgia & Fever Narrative: Pfizer covid 19 mRNA given 1/4/2021 left arm vaccination site (IM) at 1:17 pm complained of muscle soreness Left arm 09:00 pm 1/4/2021. The next day - morning felt tired, muscle soreness, Headache esp bifrontal and retrobulbar. T 99.7 taken this morning and took Ibuprofen 600mg one tablet this morning. She still reported for work today but complained about these symptoms to Supervisor who consulted EOH providers Denied cough nor colds nor any upper respiratory symptoms A/P: Vaccine related side effects within 24 hours after vaccination Reported to facility admin Can return to work if she feels better tomorrow but without taking analgesics (ibuprofen) nor antipyretics (Tylenol) Informed Supervisor
Pt c/o redness, induration, swelling, pain, inability to elevate right arm over horizontal, acute fatigue, Temp 99.0.
Suspected Vaccination Failure; I still got the shingles; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a male 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 patient had reported for himself. The age at vaccination was not reported. The patient received Shingles vaccine from his doctor. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.