chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shaking about two hours after the injection; Could not control body movements rapid and random fingers would not move in the directions as patient wanted them to; rapid decline of blood or oxygen level to 70; muscle aches; Violent chills; first day temperature rose to 100 second day day fever was 99 and third day temperature was 98; Initial information received on 28-Aug-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional.  This case involves a 69-years-old female patient who experienced shaking about two hours after the injection (tremor), could not control body movements rapid and random fingers would not move in the directions as patient wanted them to which is much like a patient with Parkinson's (dyskinesia), rapid decline of blood or oxygen level to 70 (oxygen saturation decreased), muscle aches (myalgia), violent chills (chills), first day temperature rose to 100 second day day fever was 99 and third day temperature was 98 (pyrexia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 28-Aug-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via an unknown route at unknown administration site for prophylactic vaccination.  On an unknown date patient developed a non-serious shaking about two hours after the injection (tremor), could not control body movements rapid and random fingers would not move in the directions as patient wanted them to which is much like a patient with Parkinson's (dyskinesia), rapid decline of blood or oxygen level to 70 (oxygen saturation decreased), muscle aches (myalgia), violent chills (chills), first day temperature rose to 100 second day day fever was 99 and third day temperature was 98 (pyrexia) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Relevant laboratory test results included: On an unknown date: Body temperature [Temperature rose to 100 next day fever was 99 and then 98] On an unknown date: Oxygen saturation decreased [rapid decline of blood or oxygen level to 70]  The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] (ASPIRIN [ACETYLSALICYLIC ACID]) for Pyrexia.  On an unknown date, the patient recovered from all events.   There will be no information available on the batch number for this case.
2 days, post vax, in left thigh, pt developed 8, 1mm X 1mm bright red blanching papules, surrounded by white halo (1/2cm) 7 scattered over left thigh and 1 on calf.
Pt exp an adverse reaction p/vax was administered; pt became pale & exp extreme drop in BP from 140/80 to 70/40;
The first dose my arm got red and swollen for about three weeks. It has a big  bump in the center that was hot to the touch. I got it checked out by a covid reaction physician who said it was a mild allergic reaction. The second dose my left eye swelled shut and both lips swelled up about 24 hours after administration. My throat started to close and I couldn?t breathe. I ended up having to go to the emergency room where they were able to control the allergic reaction. They said it was an allergic reaction to the vaccine and have recommended not getting any more covid vaccines in the future if there were more produced.
pneumonia; arms swollen; arms hurting; Initial information was received on 06-Nov-2020 regarding an unsolicited valid serious case from a consumer (patient) via social media.  This case involves a patient of unknown demographic who experienced pneumonia, swollen arms (peripheral swelling) and hurting arms (pain in extremity), while patient was treated with INFUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received INFLUENZA VACCINE produced by unknown manufacturer [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown), the patient experienced pneumonia (serious event), arms swollen (peripheral swelling) and arms hurting (pain in extremity) (non-serious events) following administration of INFUENZA VACCINE. The event pneumonia was assessed as medically significant.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the pneumonia was unknown and recovered for peripheral swelling and pain in extremity (duration was reported as two days).  Information on the batch number was requested.; Sender's Comments: Sanofi company comment dated 11-Dec-2020: This case concerns a patient of unknown age who was presented event pneumonia, hand swelling and arm pain after vaccination with company suspect Influenza Vaccine. The time to onset was compatible. However, patient's medical condition, concomitant medication ruling out alternate etiologies, laboratory tests were not reported. One vaccination preceded the events. Based upon the reported information, the role of an individual vaccine cannot be assessed.
4 hemodialysis pts recvd 3 doses of engerix & 2 pts JUN92, 2 pts JUL92 had neg titer; non responder;
Developed cancer; Immunocompromised; This is a spontaneous report from a Pfizer sponsored program from a physician (the patient).     A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and  dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) both as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient stated he became  immunocompromised (medically significant) on 2021 with outcome of unknown , and developed cancer  (medically significant) on an unspecified date with outcome of unknown.   Events description. He is done with the first and second dose of the Pfizer covid vaccine. He is now immunocompromised today and for the past few days. He has also developed cancer.   The lot number for the vaccine  was not provided and will be requested during follow up.; Sender's Comments: There is no reasonable possibility of causal association between the event of Immunodeficiency ,Neoplasm malignant and the drug BNT162b2.The case will be reassessed further upon receipt of additional information. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
mom observed pt's arms, legs, and lips dusky 1.5 hrs /p vax adm. also shivering, and mottled in color. Took pt to ER, T 103.8. tx for high fever, released w/ T102. Mom states pt didn't have prolonged cry, sz activity or somnolence
Rib cage pain; Muscle pain; Joint pain in thumb; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Rib cage pain), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain in thumb) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (Rib cage pain), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain in thumb). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Rib cage pain) and ARTHRALGIA (Joint pain in thumb) had not resolved and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Concomitant product use was not provided by the reporter. Treatment for the event included Naprosyn.; Sender's Comments: Although a temporal association cannot be defined, based on the information provided and the known safety profile of the vaccine a causal association between the product administration and the reported events cannot be excluded.  Arthralgia and myalgia are consistent with the known safety profile of the vaccine.
chronic fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Oct2021 15:30 (Lot number: 301358A) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE, administration date 17Oct2021; LISINOPRIL AND HYDROCHLORTIAZIDE; METHYLPREDNISOLONE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 19Mar2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 15Apr2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 19Oct2021 15:30, outcome "recovered" (2021), described as "chronic fatigue". Therapeutic measures were not taken as a result of fatigue.  Additional Information: patient received within 2 weeks of vaccination: Lisinopril hctz 20/12.5mg and Methylprednisolone 4mg and  Patient reported that they experienced chronic fatigue post 48hrs of receiving COVID-19 booster. No covid prior vaccination and No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Varivax and Prevnar given in right ankle and right thigh on 11/11/2003.  Mother states that evening patient developed redness and inflammed on right upper thigh at injection sites.  Patient presented at clinic on 11/14/2003-area on right thigh 3-4cm erythematous as per MD who examined.  Mother told to give Tylenol/Motrin as needed.
Patient was coming in for a Tdap, a flu shot was administered instead.  We did then administer the correct vaccine. No signs or symptoms.
when vax given 3MAY93 pt devel a fever of 105; had to go to ER:
1st of vaccine(July 5th, 2022) results in normal sized swelling but 2nd dose (august 3rd,2022) that was administered on Thursday resulted in considerable swelling, pain, redness, firmness to touch, induration, and very warm/hot to the touch. I have pictures of the progression and marked it as it started to swell just text, call or email me
Swollen axillary lymph on left arm; low grade fever (daily average: 97.3. For 24 hours following injection was 99.8); Significant lethargy; "railroad spike" headaches that correlate with the right parietal and right occipital lasting approx 30 hours; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK4176), via an unspecified route of administration in the left arm on 20Jan2021 at 07:00 at a single dose in the hospital for covid-19 immunization. Medical history included hyperlipidaemia, depressive disorder, chronic anxiety disorder, hypertensive, allergies to PCN (anaphylactic) and sulfa (allergic). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]), escitalopram oxalate (LEXAPRO), losartan, and Mg/Ca supplement. The patient experienced swollen axillary lymph on left arm, "railroad spike" headaches that correlate with the right parietal and right occipital lasting approx 30 hours, low grade fever (daily average: 97.3. For 24 hours following injection was 99.8), and significant lethargy on an unspecified date. The patient did not receive treatment for the events. Outcome of the event headache was recovered and for other events was reported as recovering.
Received a Pfizer Covid-19 covalent vaccination at 3:30 PM. A 9:00 PM I experience a sharp pain in the urethra of my penis. It was gone when I woke up the next morning.
Left arm swelling, redness, warmth and tenderness.  Started on Bactrim for cellulitis treatment.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The patient did not have pertinent medical history. The patient had drug reaction to codeine result in hives. On 11-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K003603, expiration date 20-MAR-2015, dose 0.65 ml) subcutaneous in the left arm for vaccination. None concomitant therapies were reported. On  11-NOV-2014 in the evening, the patient experienced injection site redness, chills and hardened area in left arm from elbow to armpit. As of 14-NOV-2014, patient's adverse effect had resolved somewhat but not completely, so she sought medical attention with pharmacist for recommendation for treatment. Ibuprofen was given for treatment of the adverse event. None lab diagnostics studies were performed. Action taken for ZOSTAVAX was not applicable. The relationship between all event and ZOSTAVAX was not reported. Additional information has been requested.
we got covid; we got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "we got covid". Therapeutic measures were taken as a result of suspected covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a consumer via call center representative and described the occurrence of burning sensation skin in a69-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (10 years ago). Concomitant products included Levothyroxine. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced burning sensation skin. On an unknown date, the outcome of the burning sensation skin was recovered/resolved. It was unknown if the reporter considered the burning sensation skin to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had the dose of SHINGRIX in late March 2018 or early April 2018. The patient reported that she developed a burning sensation, but no rash along the same nerve pathway where had a Shingles infection 10 years ago. The patient reported that this burning sensation ran from her back to left side to under left breast area that lasted for about 3 weeks and resolved on its own.
nauseated; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseated) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced NAUSEA (nauseated). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, NAUSEA (nauseated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to, INC.-MOD-2021-046626 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: INC.-MOD-2021-046626:Crosslinked wife case
This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (103 Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (underwent monoclonal antibodies treatment 30 days prior to the vaccination). Concurrent medical conditions included Asthma.    On 13-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PYREXIA (103 Fever). At the time of the report, PYREXIA (103 Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.  Patient told the pharmacist that she was feeling feverish before, but reporter stated that there is not any way of knowing if the fever was caused by the vaccine.
Myalgia body aches and fatigue for 48 hrs Narrative:  Other Relevant History:
No additional AE reported; Nurse prescriber is reporting administration of an expired PNEUMOVAX 23; This non-valid spontaneous report was received from a nurse prescriber and refers to an unknown patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-MAY-2022, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #T028093 and expiration date: 24-APR-2022, (strength, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). Caller confirmed vaccine was stored within the recommended storage range until administration. No additional adverse event reported (no adverse event).  This is non-valid report due to lack of the patient's identifiers.  Follow-up information has been received from a nurse on 05-JUL-2022, refers to 54-year-old female patient. Details regarding vaccination was updated. Usage of vaccine was reported as single use of vaccine/vaccine device. Operator of vaccine/vaccine device was reported as  healthcare professional.  The initial report was missing the patient's identifier. Upon follow-up information received on 05-JUL-2022, the case contained all elements to make the case valid
After receiving Covid-19 product Moderna NDC 80777-0275-99 RX team and RPh were under the impression that this product was to be used for booster doses. After due diligence and checking, it was found to be that this patient may have received 0.25ml of that product (rather than the recommended 0.5ml dose for boosters).  I will then contact the patients physician to see if they would like us to repeat the dose.
Post vax, the pt had redness and swelling around Prevnar injection site approximately 3 inches in diameter.
Severe swelling and redness of (L) upper arm at site of injection of "PREVNAR 13" vaccine for 48 hrs, since vaccine was administered on 4-13-11.
Rash on arm near injection site.   Started out as small lump, thought it was a bug bite.  Woke up next morning to a slightly raised rash about 2 inches in diameter.  Mildly itchy, and warm.  Mild tenderness to touch.  Put Benadryl cream on it and itch subsided.  Lasted 3 days.
2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vomiting 3:00-extreme headache (took aspirin for pain) -lower back hurt -pain in right shoulder, elbow, wrist -couldn?t lay on right side (bruising at site but no swell -couldn?t move without vomiting -woke up at midnight completely wet with sweat and sweating continuing even today Tuesday -weakness all over (felt like I had had the FLU) ? I knew there was potential for side effects before taking the vaccine...I was totally unprepared for so many symptoms and how intense they were and what little I could do to relieve any of them. Never had fever that I am aware of. Today I?m weak and sweating is unreal.  ?? Should I prepare/expect my second dose around Feb. 14 to have the same effect on me.? Not looking forward to that. I was almost ready to go to the ER I was getting so dehydrated and weak.
p/vax pt exp chickenpox that consisted of a light rash located in trunk, vaginal area, & mouth;pt seen by MD;
received dose from vial refrigerated more than 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (received dose from vial refrigerated more than 30 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received dose from vial refrigerated more than 30 days). At the time of the report, PRODUCT STORAGE ERROR (received dose from vial refrigerated more than 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Significant Follow up, patient details added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-381057:
Sudden intense light-headedness and nausea.  Felt very much like I was going to faint. Extremely weak.  Returned to bed and symptoms greatly diminished.  Felt very fatigued over next four days.
Chills, fever, soreness all over body, heart palpitations, lightheadedness, weakness, fatigue, pain at injection site, pain under left arm (opposite injection site), nausea
Felt sick and weak for 3 days right after shot. Frequent heartburn (acid reflux), chest pains, heart palpitations, insomnia, pains in head, and pains in left arm and left shoulder where shot was administered that lasted for approximately 3 months. 1 20 mg tablet of Prilosec (1-2 times a day) for 2 months Ketoconazole 2% shampoo applied to scalp 2-3 times per week Clobetasol topical solution applied to scalp once a day
Patient came back about thirty to forty minutes after vaccination stating severe itching.  Upon visual inspection there was redness (about size of fifty cent piece). Gave patient an ice pack to place on area and recommended Benadryl.  He held ice pack for 15 minutes and took Benadryl patient said symptoms improved.  Felt fine to go home.  Educated patient on signs and symptoms of anaphylaxis.  Called patient at 7:00PM (6 hours after) and he said he was just fine.