chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to 6 patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On unknown dates the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot# L044529, expiration date 09-FEB-2017, route not reported). Concomitant therapies were not reported. The vaccine was improperly stored at 36 degrees Fahrenheit for 8 hours. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. Additional information has been requested.
a few months after vaccines (series of 2) my right eye had unusual sensations - what felt like numbness. My vision started started to become distorted after several weeks. I went to my family practice doctor in October who referred me to Opthamologist, who referred me to retinology specialist, who diagnosed AMD
Client noticed a rash on both shins and both forearms the AM of 04/11/12. By PM, rash had spread above knees. Rash did not spread above forearms but became more noticeable. Appeared dry, red, raised, irritated with small red bumps. Slight itching but mainly irritated feeling. It "seemed like a razor burn but I hadn't shaved or used any new soap." Client remembered she had gotten a rash with dose #1. Rash confined to upper back, arms, not legs. Rash more diffuse, "almost like little pimples but didn't have a head on them". Denies use of new soap, lotion or wearing new clothing. As of 04/18, client still has rash on lower shins. She has not seen primary care doctor due to lack of insurance at this time. Client received dose #1 Hep B, ENGERIX B, same lot number on 02/15/12. Received dose #1 Tdap, BOOSTRIX, at same time. Lot #AC52B066AA.
23APR92 tc from mom states crying since DTP, leg hurting, vomiting, t102-103 & onset difficult breathing @ 330PM; advised ER exam;  fainted
The infant had a temperature of 103.2 for two nights, 101.3 on 01/05/01.
This spontaneous report as received from a registered nurse refers to an adult female patient, of unknown age. Medical  history and concurrent conditions were not reported. Nurse reported that patient got in December 2013 her first dose of RECOMBIVAX HB (dose, strength, route and lot number were not reported) and came to get her second dose of RECOMBIVAX  HB on 25-AUG-2014 (reported as today). No adverse effects reported. Additional information has been requested.
Tinnitus so severe I had a hard time hearing and falling asleep. Very loud ringing in my ears. It felt like the ringing was screaming in my ears. It came and went over the course of the past two months. It is now much quieter but I am now not hearing as well as I was before the vaccine.
Fever Chills, Fatigue Narrative: Unknown date of adverse event  Other Relevant History:
"NO significant PMH. NO Allergies. S/p COVID Infection Oct 2020 - not hospitalized. NO Current medications. After reaction to first dose of Pfizer, pt was advised to receive Janssen to complete the series. 22min post vaccination, pt c/o chest itching & left arm, throat scratchy, dry mouth, HA, Mild Cough, nausea. Vitals: @9:30 BP 156/90, HR 80, RR 18, O2 Sat 98% -- > @09:43 BP 114/75, 74, 18, 96% -- >@9:55 127/83, 71, 18, 98% At 9:43 pts symptoms remained unchanged.  No visible rash, skin dry, no resp distress.  Pt denies Rx/OTC medications.  No hx of vasovagal w/ needles/shots. At 9:45, pt was given benadryl 25mg PO x1 Pt was given apple juice.  Pt improved with time. At 10:15 pt reported feeling much better.  Nausea and itching resolved; headache and dizziness 1-2/10. Pt ok'd to go home @ 10:20.  Pt escorted out of site. NAD. Ambulates fine."
Information has been received from a female registered nurse who on an unspecified date gave a patient Zostavax. Subsequently, one week later, she developed a rash on her left thigh which was painful. She believed that the rash was shingles. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Near the injection area on upper left arm it swollen to size of my whole hand after one week. It was a big bump and it was warm. It lasted for few days and it disappeared.
Cerebral infarction. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Pain in shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Pain in shoulder".  Additional Context: Report 2 of 2, Caller reports on his sister.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Was exposed to COVID on 10/28/2021. When it started, I thought I was really carsick. I was a little bit dizzy and nauseated. About 04:30 on Sunday, it came on really sudden. I couldn't hand out Halloween candy. The nausea lasted for about 6 days. I had a really bad headache. I took Tylenol for the headache helped enough to fall asleep. Woke up and headache was a little better but was still nauseated. I was dizzy. On the second day, I had chills - cold to the bone. Headache would come and go. The initial night was the worst time for the headache. The next day, the fatigue started. I had significant reactions to the COVID vaccines, and this fatigue was just like that. It came on pretty sudden. My eyelids felt so heavy. I couldn't keep them open. It wasn't because I was tired at the time just heavy. I had a little bit of muscle ache, but it wasn't really bad. The fatigue lasted until this past Saturday from day 3 to day 7. I feel fine today. I normally run a very low temperature, but I was running a 98.7 for me that was a temperature. I had the temperature day 2, 3, and 4 and then I noticed it anymore. No treatment used Tylenol. I had a little bit of a runny nose, but I normally take 2 allergy meds a day, so I didn't take anything else for. The nausea and the fatigue were the most pronounced things for me. Had flu vaccine two weeks after I had the 3rd booster, I think I had it on the 10th of October. It was at another Pharmacy
Patient developed 7mm 2 erythematous macular lesion at the inject site 24 hours after injection.  Non pruritic.  Treatment: cool compresses as needed.  Advil or Tylenol pm per label.  Benadryl 25-50mgs pm per label.
MMR given on 8/28/12. Redness began at injection site and spread over left thigh. Area of redness was outlined 8/30/12. Patient given a dose of oral steroids and asked to return on 8/31/12 for evaluation.
Right arm pain and swelling developed in middle of night after getting injection. Arm is sore with sharp pain and throbbing in the deltoid area & also throughout upper arm, radiating to forearm & shoulder. Hurts to move the shoulder. No fever.
Woke up with 101.6 fever; took Tylenol and fever only dropped to 99.9. Later in day went back up to 101.6. Next day fever gone, but left me very tired.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: patient was initially feeling nauseous and vomited. She did not lose consciousness or forget memory. She was unresponsive to questions, but were able to move her body and hands to touch. Her breathing did not stop -- but seemed like it was slowing down. She received one dose of epipen. After few minutes, she was responsive and was able to reply in short words and was aware of the situation and where she was.
Graves' orbitopathy post SARS-CoV-2; This is a literature report.  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (ongoing); "struma ovarii" (unspecified if ongoing); "Multinodular goiter" (unspecified if ongoing), notes: Past thyroid diseas. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: ENDOCRINE OPHTHALMOPATHY (medically significant), outcome "unknown", described as "Graves' orbitopathy post SARS-CoV-2". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: Less than 0.02; Thyroid stimulating immunoglobulin: Yes; Thyroxine: 92.67 pmol/L. Therapeutic measures were taken as a result of endocrine ophthalmopathy.  Clinical course: Patient's family history were reported as NA. It was reported that for historical conditions no treatment was given. History of Graves' orbitopathy (GO): new. Severity of Graves' orbitopathy: Moderate to severe GO 10 weeks after treatment of Graves' disease. Onset latency was reported as greater than 70 days. Treatment received with Methimazole.; Sender's Comments: Based on the available information in the case, the causal association between the events ENDOCRINE OPHTHALMOPATHY and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
chronic illness; psoriasis; eczema; Initial information received from on 31-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult male patient who experienced psoriasis, eczema and chronic illness while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number , strength, formulation and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  In 2016 the patient developed a non-serious psoriasis (unknown latency) following the administration of INFLUENZA VACCINE.  In 2016 the patient developed a non-serious eczema (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious chronic illness (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"As if you didn't have enough autoimmune diseases.. my dad got psoriasis and eczema with his in 2016. Cha Ching for them.. for you chronic illness es and lots of tests and pills and potions procedures and doctor visits It is unknown if the patient experienced any additional symptoms/events".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (psoriasis, eczema, chronic illness).  At time of reporting, the outcome was Unknown for the event psoriasis, was Unknown for the event eczema and was Unknown for the event chronic illness.
Tinnitus?I have had this for 30 years,  but was mild. Since I had Covid in December, 2020 the buzzing is louder. Since I got the vaccine in March, 2021, the noise is even louder. Almost unbearable. I will not be getting the second shot.
Sleepy; neck pain; flu like symptoms; Coughing; green phlegm; lethargy; dizziness; disorientation; After getting this shot in my arm my arm felt like it was going to fall off like a hole was scooped out; freezing cold; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), NECK PAIN (neck pain), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (Coughing) and SPUTUM DISCOLOURED (green phlegm) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 045821A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA), MESALAZINE (LIALDA), PREDNISONE, AZATHIOPRINE, CHOLESTYRAMINE, TAMSULOSIN, ALPRAZOLAM, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy), NECK PAIN (neck pain), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (Coughing), SPUTUM DISCOLOURED (green phlegm), LETHARGY (lethargy), DIZZINESS (dizziness), DISORIENTATION (disorientation), LIMB DISCOMFORT (After getting this shot in my arm my arm felt like it was going to fall off like a hole was scooped out), NASOPHARYNGITIS (freezing cold) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Sleepy), NECK PAIN (neck pain), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (Coughing), SPUTUM DISCOLOURED (green phlegm), LETHARGY (lethargy), DIZZINESS (dizziness), DISORIENTATION (disorientation), LIMB DISCOMFORT (After getting this shot in my arm my arm felt like it was going to fall off like a hole was scooped out), NASOPHARYNGITIS (freezing cold) and PYREXIA (Fever) was resolving. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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.
admitted with COVID and respiratory failure on 1/5/22 .  Had Moderna Vaccine 1- 8/10/21  and 2- 9/10/21
Patient received dose from a vial kept more than 12hrs at room temperature post first puncture; Patient received dose from a vial kept more than 12hrs at room temperature post first puncture; second dose was adminstered after 4 month; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture), EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was adminstered after 4 month) in a 39-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was adminstered after 4 month). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture). At the time of the report, PRODUCT STORAGE ERROR (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture), EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial kept more than 12hrs at room temperature post first puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was adminstered after 4 month) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. It was reported that, the vial was initially stored in the refrigerator on 14-Apr-2022. On 06-May-2022 at around 09.30 am, the vial was first punctured. Pots punctured the vial was stored at room temperature for 29 hours in temperature range (8 to 25 Degree Celsius 46 to 77 Degree Fahrenheit). Later on, 07-May-2022, 4 doses were administered to the patient at 11:20 AM, 11:49 AM, 12:05 PM and 12:30 PM. The vial was exposed to room temperature range from 8 degree to 25 degree Celsius that 46 to 77 Fahrenheit for 29 hours. The vial did not undergo the temperature excursion. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Follow-up received: patient demographics and dosage information was added.
Guest walked up stairs to get to his seat in the post vaccination area. Once he sat down he began to report feeling dizzy and a heaviness in his chest. EMS were called to attend to the guest. Vital signs were taken, all within normal limits. Drank some water. Once guest was sitting for a bit, he stated that he felt better. EMS did clear guest to leave  on his own once his observation time was up.  Guest was going to drive himself home.
administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   No treatment was given to the patient.   The vaccines were stored in freezer, were taken out one to two vials and placed in fridge each day as needed.
3 days, post vax, pt had stiff neck, aching joints, generalized weakness and a sore throat. Pt saw MD and was prescribed Cipro and Toradol.
Started with the chills, then started having severe muscles pain and headaches. She had no mental clarity, balance became off and caused her to fall. Occasional vomiting and diarrhea. Muscle weakness and back pain due to falling. Contacted dr and was told it will take time to overcome the symptoms.
This spontaneous report as received from a pharmacist refers to a 19 year old patient (gender not specified). The patient's concurrent conditions, medical history and concomitant medication use was not provided. The pharmacist reported that when this patient was a child he or she was vaccinated with two doses of VARIVAX, (dates of vaccinations, dose administered, lot#s and expiration dates were not provided). On an unspecified date the patient had serologic testing done and was found to have low titers to varicella. The outcome of the event was unknown. Additional information has been requested.
Swelling of lymph node, and warm, swelling going down midway between site and elbow.  Did not start until Sunday, 06/13/21 around 6:30 p.m.
Given MMRV in left arm on 08/28/2019. On 08/29/2019 a 7-8 cm area on left arm that is hot, swollen, and  tender to touch was noted by grandmother. Seen office on 08/30/2019 and treated for cellulitis by PA-C
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old patient who received Hib (Hiberix) (batch number 242A7) for prophylaxis.   On 21-FEB-2023, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Vaccine administration error. The patient has NOT experienced an adverse event as of 24 hours post-administration.
This spontaneous report as received from a registered pharmacist refers to a 61 years old female patient. The patient was vaccinated subcutaneously with lot # (672429/1606AA), 0.65 ml dose of ZOSTAVAX on 04-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient called the pharmacy on 06-OCT-2012 and said she had "an infection". The patient was calling it "cellulitis". On an unspecified date the patient went to see her primary care physician. The pharmacist did reach out to the primary care physician and was waiting to hear back from him. No treatment information was reported. The outcome of infection and cellulitis was unknown. The relatedness for cellulitis and infection was not provided for ZOSTAVAX. Additional information has been requested.
I started getting fatigued and achy around 5 pm. By 6 pm I started to feel chilled and a fever began to form. By 6:30 or so I was shaking intensely and my fever was climbing quickly. By 8 pm I had a fever of 102.7 F. I took two Advil around 7 pm. My fever stayed that high for less than an hour, but it stayed at around 101.5 throughout the night. When I wok up at 6:30 it was still over 101. It took until early afternoon to go all the way back down to my normal temperature of 97.6 (that has been my normal temperature throughout the pandemic). I had a pounding headache throughout the night (with a fever) and for most of the next day. Today, on the 3/8, I will have some joint and muscle achiness. The most intense aching was in my hips and low back. FYI, I am marking that I have recovered from my adverse reaction in the field below because I am considering the high fever and intense headache and bod aches to have been the adverse reaction. My mild aching right now would not have been worth reporting.