chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx 6 hrs after injection, pt dev itching and redness at injection site. 48 hrs later, increased redness extending down L arm. Pt saw family Dr and was rx steroids orally and an antibiotic.
The patient received both vaccines in the same arm and began experiencing a red band around 3/4 of arm, swollen, painful and warm to the touch. I spoke with her today (9/11/18) and she said the side effects have significantly lessened.
TOOK AN UNREFRIGERATED DOSE; A spontaneous case report was received from a physician on 11-Feb-2019 for four consumers.  Based on the information obtained from the physician, four individual case safety reports PVX201902-000103 (PVX2019-369; physician), PVX201902-000104 (PVX2019-371, male consumer), PVX201902-000105 (PVX2019-372, female 1) and PVX201902-000106 (PVX2019-373, female 2) were created and cross-linked in the database.  The case report describes a 17-year-old adolescent male consumer who "took an unrefrigerated dose". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took the first dose of Vivotif that was not refrigerated.  The action taken with Vivotif with respect to the event "took an unrefrigerated dose" was not applicable.  The clinical outcome of the event "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201902-000103:
Got vaccine and got shingles/Suspected vaccination failure; Got shingles; Pain was so bad; This case was reported by a consumer via interactive digital media and described the suspected occurrence of vaccination failure in a 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), shingles and pain. The patient was treated with analgesic, nos (Pain Medicine (Medication Unknown)). On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter said Shingles vaccine did not work, got vaccine and got shingles.  The reporter said same as COVID vaccine, reporter's son in law had all COVID shots and got it.  The reporter was not against vaccines, had all just saying, sometimes they did not work. The patient got the shot for Shingles and still got it, the pain was so bad, needed pain medicines to help with it. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Information has been received from a nurse practitioner concerning a 23 year old female patient with a history of her first abnormal PAP Low Grade Squamous Intraepithelial Lesion (LGSIL) (18-MAR-2008) and cervical intraepithelial neoplasia (CIN 1) after colposcopy (02-MAY-2008), who on 14-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 660393/0067X) IM and on 21-JUL-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot # 660553/0070X) IM. Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). The nurse practitioner reported that on 14-MAY-2008 and on 21-JUL-2008, the patient experienced itching, redness, swelling on left palm after received the first and second dose of HPV vaccine. On 15-MAY-2008, the patient was seen by her family physician who did not know patient had just received HPV vaccine and diagnosed patient with a cold sore and patient was treated with VALTREX 1gm for 1 dose. On 16-MAY-2008, the patient recovered from her first episode of itching, redness, swelling on left palm and swelling on left palm. On 21-JUL-2008, after the second dose of HPV vaccine, the patient developed itching, redness, and swelling of the left palm that evening. On 23-JUL-2008, antibody titers were done which showed IgM not detected IgG titer for Herpes simplex 1 was positive. On 26-JUL-2008, the patient recovered from her second episode of itching, redness, swelling on  left palm. The NP was unsure if she would give the patient the third dose of HPV vaccine. Additional information has been requested.
Extreme body aches, severe headache, chills, fever of 104, dizziness, blurry vision, perspiration.
blood pressure dropped; oxygen saturation decreased; old site was red and inflamed; old site was red and inflamed; got sick from flu shot; Initial information received Regulatory Authority, on 30-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves a 66-year-old male patient (79 kg) who experienced blood pressure dropped, oxygen saturation decreased, old site was red and inflamed, got sick from flu shot after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included treprostinil sodium (Remodulin); riociguat (Adempas); rivaroxaban (Xarelto); and macitentan (Opsumit).  Patient began therapy with Remodulin (treprostinil sodium concentration 10 mg/ml) on 10-Jan-2018 for primary pulmonary arterial hypertension (ongoing medical history). The current dose was reported as 0.062 ug/kg, continuous via subcutaneous (SQ) route. Patient reported that his subcutaneous Remodulin site fell out (device dislocation). He tried to start a new subcutaneous Remodulin site three times without success (device placement issue). He had been without Remodulin for about 40 minute before he was able to insert a site with registered nurse verbal assistance and restarted the CADD pump infusion. Remodulin was dose temporarily withheld due to the event of device dislocation.   On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer (strength, formulation, dose, frequency: unknown) (lot number and expiry date: not reported) via subcutaneous route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date in Sep-2022, the patient developed non-serious events of, old site was red and inflamed (infusion site erythema), (infusion site inflammation), blood pressure dropped (blood pressure decreased), oxygen saturation decreased, got sick from flu shot (illness) (unknown latency) following the administration of influenza vaccine.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if there were lab data/results available.  Action taken with Influenza Vaccine was not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Unknown for all events.  The reporter's causality for the events of oxygen saturation decreased and blood pressure decreased with influenza vaccine was considered to be possibly related.
Patient currently hospitalized at (11) days. Patient is a 43 y.o. male with past medical history of obesity and hypertension on no home medications.  Patient was initially seen in the emergency department on 12/31 for cough at which time he was diagnosed with community-acquired pneumonia and discharged on Ceftin and doxycycline which he did not start taking.  His COVID was pending at time of discharge from the ER but did come back positive.  Patient was brought back to the emergency department on 01/01 with reports of weakness and confusion.  Patient had had a fall while trying to get in to a friend's van.  Further history regarding this is unattainable.  At time of admission patient is alert and oriented x4 stating the day as the 1st of the new year.  He reports chronic pain in his legs with some difficulty ambulating.  Reports he had been using a his mom's walker intermittently.  He initially tells me he did not fall but later complains of right sided thoracic pain which he reports he hit on the van when he fell trying to get in.  He has a very difficult historian but does report cough of unknown duration with intermittent sputum production.  He tells me it has been ongoing for ?awhile? but when asked to clarify if he means days, weeks or longer he says I do not know.  He reports he is vaccinated for COVID but does not know when.  Per review of chart it appears he got him in February and March, denies getting a booster.  He denies any recent sick contacts and states his wife does not have any similar symptoms.  He denies feeling short of breath.  He does not have any chest pain.  He denies having any fevers or chills although with febrile in the emergency department.  Denies nausea, vomiting, diarrhea.  Has no other acute complaints.   Emergency department febrile at 39.4, tachycardic with heart rate up to 137 and hypoxic at 85% on room air now requiring 4 L of supplemental oxygen.  Lab significant for procalcitonin 1.22 and lactic acid 1.1.  WBCs within normal limits.  Blood cultures x2 drawn.  COVID was positive on 12/31.  Urinalysis without evidence of infection.  CT head and cervical spine were without acute pathology.  CTA thorax was without PE but notes bilateral pneumonia consistent with COVID.  CT abdomen and pelvis without acute pathology.  No chest x-ray on 12/31 showed left lower lobe consolidation.  Emergency department patient received 1 L IV fluid, Tylenol, albuterol, IV Rocephin and doxycycline.
Patient states he had sore arm after 2nd shingles. He thought it would resolve, but states even weeks later he lost range of motion when putting Left arm behind back. He also stated his arm felt numb multiple times post vaccine. He is starting PT this month. He is not sure if this is all related to vaccine but did state RPH who administered possibly gave the vaccine too high on the arm. He had vaccine in October and emailed my Pharmacy on 2/7/20 about this event. I met with patient and told him I would document his case. He starts PT (possible for rotator cuff damage) next week.
No adverse event; Received a Moderna Covid-19 vaccine for 6 months to 5 year old for her  booster dose  instead of the bivalent vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received a Moderna Covid-19 vaccine for 6 months to 5 year old for her  booster dose  instead of the bivalent vaccine.) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B, 025J20-2A, 024M20A and 032F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE and LOSARTAN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Received a Moderna Covid-19 vaccine for 6 months to 5 year old for her  booster dose  instead of the bivalent vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received a Moderna Covid-19 vaccine for 6 months to 5 year old for her  booster dose  instead of the bivalent vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received a Moderna Covid-19 vaccine for 6 months to 5 year old for her  booster dose  instead of the bivalent vaccine.).    No adverse reactions reported after receiving first, second dose of primary series and first, second booster dose of vaccine. No treatment drug was reported.   This case was linked to MOD-2022-657575 (Patient Link).
No side effects were reported. No additional AE; HCP calling to report GARDASIL 9 was administered subcutaneously rather than intramuscularly.; This spontaneous report was received from a Medical Assistant, concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 22-AUG-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 ml, administered subcutaneously rather than intramuscularly for prophylaxis (lot #, expiry date, and anatomical location were not provided) (incorrect route of product administration).  The health care professional (HCP) requested information on revaccination.  No further information was provided and no additional adverse event was reported.
Information has been received form a certified medical assistant concerning a female patient who was vaccinated as a child and then in 1995 received a booster of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) . Subsequently, her rubella titer was negative. It is unknown if medical attention was sought. Additional information has been requested.
Pt received DTAP, HIB, IPV, HEP-B and PREVNAR vaccinations on 9/12/01. Upon returning home, the baby cried inconsolably for approx. 6 hours. Instructed mom to bring him into the office for a re-check. At that time, the baby was fine and had recovered completely.
I think the vaccine was destroyed by my body, so I'm not vaccinated; I had pain in my kidney two or three weeks after being vaccinated; Dizzy; He was really sick for about three weeks; He was throwing up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION ERROR (I think the vaccine was destroyed by my body, so I'm not vaccinated), RENAL PAIN (I had pain in my kidney two or three weeks after being vaccinated), DIZZINESS (Dizzy), ILLNESS (He was really sick for about three weeks) and VOMITING (He was throwing up) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Accident (In 1995 he was in an accident.) in 1995, Cancer (Cancer for 6 years and has been cured of it 2 years ago.), Broken bones (Fingers were broken.), Fracture of pelvis (Pelvis was broken.), Skull fracture (Head was split open.), Dialysis (He was getting dialysis for four years.) since an unknown date, Spinal fusion (Five spinal fusions and can still walk.) and Kidney transplant. Concurrent medical conditions included Blood pressure management. Concomitant products included TACROLIMUS for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 experienced VACCINATION ERROR (I think the vaccine was destroyed by my body, so I'm not vaccinated), RENAL PAIN (I had pain in my kidney two or three weeks after being vaccinated), DIZZINESS (Dizzy), ILLNESS (He was really sick for about three weeks) and VOMITING (He was throwing up). At the time of the report, VACCINATION ERROR (I think the vaccine was destroyed by my body, so I'm not vaccinated), RENAL PAIN (I had pain in my kidney two or three weeks after being vaccinated), DIZZINESS (Dizzy), ILLNESS (He was really sick for about three weeks) and VOMITING (He was throwing up) outcome was unknown.            Patient received first dose of vaccine on January 2021 and second dose on February 2021.  Treatment medications were not reported.   This case was linked to MOD-2021-010275 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received on 02-JUL-2021, contains reporters demographic details, new events added. On 02-Jul-2021: Follow-up information received  contains non-significant information
0.25 mL dose received; no adverse or untoward events associated with this administration.
From initial information received on 10/21/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that two patients (no individual identification provided) received TD ADS ADULT, lot number U0840AA, administered ID in error on 10/19/04 or 10/20/04 instead of TUBERCULIN PPD. An unspecified amount of time later, the patients developed redness and pain at the site of administration. The recovery status of the patients was reported to be unknown. The reporter of this case is the same as for cases 200403439 and 200403441.
I had a breakthrough case of Covid-19 sore throat weakness cough fever cold like symptoms.
Fever 102-103, fussiness. No other sign. Went to ECC on 8/2 - no labs done - treated symptoms only and sent home.
broke out wit hives in about a week. Have been to the doctor, prescribed steroid 2 times, last was a shot of  triamcinolone  and prescribed Montelukast 10mg Tab (which am still taking and not helping)
Fluish like symptoms, fatigue, achy which escalated into extreme fatigue and continuous doctor appt starting in May.  Was suffering from VD deficiency and anemia which continued to escalate.  It took a long time and four different doctors to finally get a hematology referral, and she was put on high dosage of iron.  Iron has just stabilized but still suffering from chronic fatigue and now finding another doctor to address this.
Fever 103.5 1 day after PCV 13. No redness at site. MOTRIN advised call if no improvement.
At 1343, RRT was initiated for a 33 y/o F with c/o dizziness, blurry vision, and was diaphoretic. Vitals: BP ? 98/62, HR ? 52, RR ? 19. Vaccinated on the R arm at 1340. No PMH, has multiple allergies (PCN, wheat, pineapple, dairy products, eggs, quinoa, cranberries, barley, and rye), and did not take any medications today. Head-to-toe assessment completed. During monitoring period, client?s condition improved. By the end of monitoring period, client was in stable condition. She was not dizzy anymore, had normal and clear vision, and she was no longer diaphoretic. Client left vaccination clinic at 1425 in stable condition, ambulatory, breathing even and unlabored, accompanied by her husband. Husband drove client home.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated intramuscularly with an expired dose of lot # (669579/0595AA: exp date 30-AUG-2012) of PNEUMOVAX 23 (dose not reported) on 18-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
About 13 days after vaccine, I began having sore leg muscles. It was very difficult to get up from sitting position, walk up steps, bend legs. I went to doctor on march 1 who sent me for blood work. My labs showed messed up level and a kidney function of 6 or 7. I was sent to er. I was diagnosed with rhabdo
2nd dose was administered on 01-Mar-2021, and 3rd dose was administered on 23-Aug-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered on 01-Mar-2021, and 3rd dose was administered on 23-Aug-2021) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included ETANERCEPT (ENBREL), ATENOLOL and TAMSULOSIN for an unknown indication.    On 23-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered on 01-Mar-2021, and 3rd dose was administered on 23-Aug-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered on 01-Mar-2021, and 3rd dose was administered on 23-Aug-2021) outcome was unknown.            Patient never had COVID Positive or diagnosis. No treatment information was provided by the reporter.   This case was linked to MOD-2022-558774, MOD-2022-558245 (Patient Link).
I was given a shot for shingles (Zoster Vaccine (Recombinant) suffered side effects, feeling tired, weak, headache, low grade fever, chills (I put on heavy sweats, long sleeve shirt and sock and still felt chilled.), body ache, rash on arm and face, inisde of mouth felt scaulded.
Pt recvd vax & began having point tenderness base of rt thumb; 2 wks later began to have identical sx in lt thumb; no wrist joint involvement, no other joint c/o, no fever chills; pt was seen by MD & dx as having bilateral tendonitis;
Within 10 minutes of vaccine administration, resident began seeing visual spots and was hypotensive 71/35. BP returned to normal within 30 minutes to 131/68
Delayed local reaction 7 days after 1st injection. Pruritis, erythema, induration, discomfort. No systemic effects. Treated with Prednisone. Resolved in 4 days.  Had 2nd dose of Moderna vaccine on March 10th. Had Nausea and muscle aching and tiredness for about 24 hrs on the day after the 2nd dose. No local reaction.
Caller got first dose of Covid vaccine and got the virus; Caller got first dose of Covid vaccine and got the virus; Patient was late for his 2nd dose; This is a spontaneous report from a Pfizer sponsored program.  A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced caller got 1st dose of Covid vaccine and then tested positive / he got the virus.  The patient underwent lab tests and procedures which included Sars-cov-2 test: positive an unspecified date. The outcome of events was unknown. Patient was also late for his 2nd dose and was wondering if he should still go get his 2nd dose.   Information on lot/batch number has been requested.
Left arm swelling, extending from site to shoulder and elbows 24 hours after vaccination. Hives within 48 hours after
Information has been received from a nurse referring to multiple unspecified patients. Information about concurrent condition, medical history and drug reactions/allergies was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route of administration were unknown, lot # L038503 with expiration date 18-DEC-2017, lot # M017983 with expiration date 30-MAY-2018, lot # M007764 with expiration date 30-JAN-2018, lot # L036301 with expiration date 20-DEC-2017). These vaccines were exposed to 0.4 degree Centigrade for 6 hours 30 min (incorrect product storage). A data logger was used to log temperatures and there were no prior excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.