chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician that reported three cases of severe cellulitis for three patients. This is the second of three reports. A 62-years-old female patient received PREVNAR 13 (lot J67645, exp. date 29Feb2016) on 17Dec2014 at 0.5ml single dose, intramuscular on left arm. Medical history included hypertension, chronic gastritis since 2012, coagulopathy, deep vein thrombosis, esophagitis since 2012, hyperlipidemia, obesity all ongoing and finger pain, hand pain, gastric polyps since 2012, thyroid nodule since 2011, unknown if ongoing. Concomitant medication included TOPROL XL 50mg tablet once a day by mouth for hypertension, PRADAXA 150 mg capsule one twice a day by mouth for coagulopathy and deep vein thrombosis, losartan 100mg tablet once daily by mouth for blood pressure, ASTEPRO 205.5 microgram nasal spray 2 puffs twice a day to each nares for allergies and CRESTOR 10mg tablet one daily by mouth for hypercholesterolemia. On 19Dec2014 the patient experienced sore and warm at injection site, it was recommended to ice and call if got worse. On 22Dec2014 the patient came to the office with big site reaction warm cellulitis. Lab data included TSH was little low and has been chronic, T3 and T4 were normal. Full blood count was normal and mean cell volume was a little microcytic. The patient was not recovered from all events.
pt recv vax 2JUN95 & 15JUN97 pt devel breakthrough chickenpox;
I started having a dry cough. I had a low-grade fever the first day with body aches. Then I got a high fever on March 1, 2023, of 101.5 degrees. I was very fatigue at this point and decided to call the nurse line because the Tylenol and Advil weren't working anymore. I tested mostly negative on March 7, 2023. I experienced sinus congestion up until March 12th and am still experiencing fatigue.
About 8 or so hours after injection: sore throat headache and nausea. About 20 hours later injection site extremely red, sore and swollen. Also noted severe rash under breasts; mainly right sided but also left. Asthma symptoms developed within 24 hours. Coughing, wheezing. Symptoms continued through weekend (had vaccine on Thursday; symptoms developed Friday.) Self medication....creams, Pro-air inhaler, OTC Nyquil. Saw doctor on Monday July 10 9:45 a.m.
Brother-in-law got vaccinated with Moderna Covid-19 vaccine & got Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Brother-in-law got vaccinated with Moderna Covid-19 vaccine & got Covid-19) 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 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Brother-in-law got vaccinated with Moderna Covid-19 vaccine & got Covid-19). At the time of the report, COVID-19 (Brother-in-law got vaccinated with Moderna Covid-19 vaccine & got Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided. Reporter reported-  She wants us to disregard her previous report as 1 & she is not sure if her brother-in -law got the Moderna vaccine.  she does not want to skew out records.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Significant follow up received including new Events, & Case related data.; Sender's Comments: This case concerns a male patient with no reported medical history, who experienced the non-serious, unexpected and AESI event of COVID-19. The event occurred approximately on an unknown date after receiving an unknown dose number of the mRNA-1273 Moderna COVID-19 vaccine. The rechallenge was not applicable, as vaccination, event and dose number are not available. The benefit-risk relationship of the mRNA-1273 Moderna COVID-19 vaccine is not affected by this report.
FEVER; bad nausea; back pain for several days; bones were sore and painful; muscles were sore and painful; exposed to COVID after receiving her 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER), NAUSEA (bad nausea), BACK PAIN (back pain for several days), BONE PAIN (bones were sore and painful) and MYALGIA (muscles were sore and painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (FEVER), NAUSEA (bad nausea), BACK PAIN (back pain for several days), BONE PAIN (bones were sore and painful), MYALGIA (muscles were sore and painful) and EXPOSURE TO SARS-COV-2 (exposed to COVID after receiving her 1st dose). At the time of the report, PYREXIA (FEVER), NAUSEA (bad nausea), BACK PAIN (back pain for several days), BONE PAIN (bones were sore and painful), MYALGIA (muscles were sore and painful) and EXPOSURE TO SARS-COV-2 (exposed to COVID after receiving her 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient took Tylenol to treat symptoms.
Patient states that the day after she received the vaccine she felt exhausted, had a sore arm where the vaccine was administered, a headache, neck stiffness, and an asthma exacerbation. Patient states that she also had numbness and tingling along the same path that she experienced when she was diagnosed with shingles a few years ago. Patient states that this path started in her lower left abdomen, traveled into the left side of her face, and down her neck into her left shoulder.
Outbreak on right side, facial rash/pain/burning along with few vesicles about a month after vaccination
That evening I felt my arm painful, warm to touch and felt like a hard ball at the injection site while I was trying to sleep. The next day I looked and saw there was a red circle around the injection size about the size of a quarter, now it?s the size of a silver dollar still red, hot, hard, and painful.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 10Apr2021 as dose 2, single (Lot number: ER8731), in left arm, on 22Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 01Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment Treatment start date- 05Oct2022; (11Oct2022) Negative, notes: Rebound of symptoms and positive test eight days after negative test; (19Oct2022) Positive, notes: Rebound of symptoms and positive test eight days after negative test. Therapeutic measures were taken as a result of vaccination failure, covid-19.The patient was treated with COVID 19 Treatment from 05Oct2022 to 10Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever, headache, body aches, vomit, weakness. Severe flu like symptoms for 36 hours after the shot.  Incident of  Shortness of breath and chest pain 6 months after. Followed up with my doctor.
Bells Palsy, Left side of face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 10:00 (Lot number: FE3594) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. Patient had no other vaccine in four weeks. There were no concomitant medications in two weeks. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8736, Expiration date: 31Jul2021, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 11May2021, when the patient was 28 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 13Apr2021, when the patient was 28 years old, for COVID-19 Immunization. Patient was not diagnosed with COVID-19, prior to vaccination. On 29Dec2021, patient had been tested for COVID-19 via polymerase chain reaction (PCR) test, result was negative.  The following information was reported: BELL'S PALSY (medically significant) with onset 03Jan2022 08:00, outcome "recovering", described as "Bells Palsy, Left side of face". The event "bells palsy, left side of face" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: on 03Jan2022, patient had been for COVID-19 via nasal swab, result was negative and on 05Jan2022, patient had been for COVID-19 via nasal swab, result was negative. Therapeutic measures were taken as a result of bell's palsy and treatment included week of prednisone and anti-viral medication. The investigation results were reported and the investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8737, fill lot EW3426, and the bulk formulated drug product lot EP8586 and lot ER8736, fill lot EP8688, and the bulk formulated drug product lot EP8585. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
On 3/6/2021 I started itching and noticed at the injection site a baseball size area was swollen and very red it was itching and hot to the touch. The initial all over lasted only about 1 hr then just at the injection, this has continued and is still slightly swollen and pink and still itchy.  PCP notified
Pt devel t103 r 2hrs post vax; temp went to 104 8hrs later; Mom administered tempra & bathing; Seen by MD on 11JUL91, t102 @ that time, excessive crying; MD described as shock rxn;
Information has been received from a lawyer regarding a case in litigation, which was reported in a published article, title as stated above, concerning a male who alleged that after receiving RECOMBIVAX HB (manufacturer unknown), he developed a hepatitis B vaccine caused neuropathy. It was reported that the patient did not have the conditions claimed, the special masters ruled in Aug 31 decision, but instead probably suffered nerve damage from injuries incurred in a variety of "extreme" sports. It was reported that the petitioner's treating physician was unpersuasive in demonstrating he had transverse myelitis (TM) or chronic inflammatory demyelinating polyneuropathy (CIDP) and the physician had never treated him for either condition. And a diagnostic impression of small nerve fibers neuropathy in his medical records undercut his assertion of a demyelinating illness because small nerve fibers did not have a myelin sheath. Further, the petitioner had no measurable hepatitis B titers when tested in September 2001, more than 2 years after the vaccination, which showed that, whatever his injury, it was not from a reaction to the vaccine. The petitioner's many serious injuries incurred in motocross, mountain biking, roller blading, hang gliding, parachuting, rafting and mountain climbing. The injuries included fractures in both legs, a fractured hip, fractured hands, facial lacerations, concussions and dental work that petitioner stemming from sports-related accidents. The special master reported "such traumas can lead to entrapment neuropathies by restricting the free movement of nerves in an area when the broken bone calcifies or heals itself. The calcification process occurs over time and the healing patient can subsequently experience pain in the previously injured areas. Upon internal review, fractured hip was determined to be an other important medical event. No further information is available. A copy of the published literature article is attached as further documentation of the patient's experience.
I had a fever, fatigue and a headache. I became lightheaded and I became tachycardic with a heart rate of 140. I spoke with my PCP.  I rested and she prescribed for me a beta blocker to lower my heart rate. Which was effective.
Left arm swollen and has yellow discharge at/near injection site.  Patient diagnosed with cellulitis.  Borders of erythema were marked with ink and patient was instructed to seek additional treatment if erythema went beyond the borders.  Patient was prescribed Augmentin to treat cellulitis.
5/5/11 Pt. given HPV vaccine (#2) & either did not know or did not suspect/state that she was pregnant - subsequent appt. 6/6/11 reveals positive pregnancy.
Awoke from nap 3 hours after vaccination with headache, fever, bloodshot eyes, diarrhea x  once, chest tightness, swollen tongue, throat tightness, slurred speech, expressive aphasia. Admitted for TIA workup. All tests normal. Neurology workup inconclusive. Symptoms completely resolved. Fetus unaffected. Fever 99.8F 12/12/07-records received for DOS 11/1-/07-Admitted with mental status changes and episode of slurred speech, headache. Resolved by arrival at hospital.   PE WNL. Denied numbness and weakness. Felt tired that morning. Neuro consult felt speech difficulty due to swollen tongue. C/O throat tightness.
This spontaneous report as received from a pharmacist refers to 82 years old female patient with none pertinent medical history and none drug reactions. The patient was vaccinated with 0 .65 ml live ZOSTAVAX ( lot # H019999, exp 02-FEB-2014) on 18-JAN-2013. Concomitant medications included Unspecified "sleep aid". On an unknown date the patient experienced a "quarter (coin) size lump on her left arm at the injection site. The patient called the pharmacist for help and no treatment was given for the adverse events. Non lab diagnostics were performed. The outcome of quarter (coin) size lump on her left arm at the injection site was reported as not recovered/not resolved. Additional information is not expected.
Shingles on forehead and scalp, which resulted in inflammation to the 6th nerve and double vision. I also developed viral encephalitis from zoster in my spinal fluid. I was treated with oral Valtrex when I was first diagnosed. After I developed viral encephalisit, I was admitted to the hospital and treated with IV acyclovir.
Beginning the day after the first dose, I began having menstrual spotting. This had continued every day since.
This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 28-year-old female patient who received FLUARIX QUADRIVALENT (batch number 5255R, expiry date 11th May 2017). On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced swelling arm, nasal congestion, fatigue, cough, erythema, nausea, influenza-like symptoms, cold mass and pain. On an unknown date, the outcome of the swelling arm, nasal congestion, fatigue, cough, nausea, influenza-like symptoms and cold were unknown and the outcome of the erythema, mass and pain were recovered/resolved. It was unknown if the reporter considered the swelling arm, nasal congestion, fatigue, cough, erythema, nausea, influenza-like symptoms, cold mass and pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received FLUARIX QUADRIVALENT in the back of her arm. The patient experienced swelling in the arm, red knot that was tender and that took a long time to dissipate as well as cold or flu like symptoms since being administered the vaccine. The symptoms experienced were nausea, fatigue, coughing and congestion.
This case was reported by a pharmacist via sales rep and described the occurrence of generalized urticaria in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 4 days after receiving SHINGRIX, the patient experienced generalized urticarial (serious criteria other: serious per reporter). On an unknown date, the outcome of the generalized urticaria was unknown. It was unknown if the reporter considered the generalized urticaria to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced serious generalized hives. This case has been linked with case US2018GSK064066, reported by the same reporter.
Patient arrived stable and afebrile; received first dose of Pfizer/BioNTech COVID19 vaccine, administered by pharmacist. During 15 minute monitoring period, patient and accompanying family reported to pharmacy team that she was feeling unwell and noticed some difficulty breathing. Temperature check revealed patient to still be afebrile. Pharmacist performed pulse check on left wrist - heart rate appeared even and steady; grip strength present. Patient denied any vision changes, but felt dizzy; difficulty in breathing remained stable and constant, not worsening nor improving. Pharmacist administered oral diphenhydramine 50 mg to patient, and technician dialed 911 to reach emergency services. Patient brought to front store with other pharmacist, where vitals taken and additional care provided.
Pain in left arm, 3 inch circle of swelling and redness, diarrhea, tiredness
blood pressure high; Felt like couldn´t breathe sometimes; arm sore for 3 days; Fever 107; headaches; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure high), DYSPNOEA (Felt like couldn´t breathe sometimes), PAIN IN EXTREMITY (arm sore for 3 days), PYREXIA (Fever 107) and HEADACHE (headaches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021 and Asthma.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (blood pressure high), DYSPNOEA (Felt like couldn´t breathe sometimes), PAIN IN EXTREMITY (arm sore for 3 days), PYREXIA (Fever 107), HEADACHE (headaches) and FATIGUE (felt tired). At the time of the report, HYPERTENSION (blood pressure high), DYSPNOEA (Felt like couldn´t breathe sometimes), PAIN IN EXTREMITY (arm sore for 3 days), PYREXIA (Fever 107), HEADACHE (headaches) and FATIGUE (felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 107 (High) Fever of 107. On an unknown date, Platelet count: low (Low) Low platelet.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.                   No treatment medication was reported.  The patient was afraid of blood clots from what she had heard.
Pt (R) thigh got urticarial lesion with pink surrounding skin quarter size w/i 5 min of vaccine.
Fever; chills; body pains; headache; diarrhea; nausea; vomiting; weakness; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142, expiration date not reported) via an unspecified route of administration on the left arm on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin, shellfish, seafood. The patient's concomitant medications were not reported. The patient experienced fever, chills, body pains, headache followed by diarrhea, nausea, vomiting and weakness on 07Jan2021 10:00 pm. Treatment was received for the events (unspecified). The events resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included Nasal Swab on 09Jan2021: Negative. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Allergic reaction: Left shoulder affected, significantly improved today. Deltoid area became hot to the touch and very pruritic, which Patient attributes to her first dose of the COVID-19 vaccine (1/30/21). Denies fever.
Patient presented to the ED and was subsequently hospitalized for hypoxia, dyspnea, and pneumonia due to covid-19 within 6 weeks of receiving covid vaccination.
Anxiety episode : duration 10-15 minutes tachycardia tachypnea
Intense Headache; Mild Nausea; Pain in Arm; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6204), via an unspecified route of administration in the left arm on 09Mar2021 at 10:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to guaifenesin (MANUFACTURER UNKNOWN) and BENEDRYL. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included lansoprazole (PREVACID 30 mg), cetirizine hydrochloride (ZYRTEC) 10 mg and fluticasone propionate (FOLNASE) spray received on unspecified dates for an unknown indication. On 09Mar2021 at 17:45, the patient experienced, mild nausea, pain in arm and intense headache while driving home from office. The headache on left side to left temple was painful, different type of pain which was consistent, pain emitted from the inside out and lasted for more than six hours. The patient did not receive any treatment for the events. The clinical outcome of the events intense headache was resolved on 09Mar2021, however mild nausea and pain in arm were resolved on unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
This is report # 2 from me for reactivation zoster after COVID vaccination  This patient got COVID-19 vaccination (Pfizer) (March 9, 2021) Diagnosed with  dermatomal zoster left V1 distribution, complicated by herpes zoster ophthalmicus left eye, and VZV meningitis