chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received 04 June 2009 from a consumer, who is also the patient. A 67-year-old female patient with a history of penicillin, seafood and bee sting allergies, had received a left deltoid injection of DECAVAC, lot number U1923HA during January 2008, and the day after vaccination, she was "covered in hives which lasted for a year". She received various medications as corrective treatment to relieve the hives and at the time of the report, she reported that she continues to have occasional episodes of hives. The patient had no illness at the time of vaccination and she had been taking Synthroid and Crestor concomitantly. She had not received any other vaccines within four weeks of DECAVAC. The patient's recovery status was reported as unknown at the time of the report. According to the reporter, she also had a sister who experienced "the same reaction to Tetanus vaccine". No further information was provided at the time of the report. Documents held by sender: None.
Dizziness Chills General malaise Temperature (when feeling better temp was 99.3, dont know how high it was, didnt feel like I had a temperature)
Feeling Lethargic; Shortness of breath; No strength in leg; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Feeling Lethargic), DYSPNOEA (Shortness of breath), ASTHENIA (No strength in leg), HEADACHE (Headache) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced LETHARGY (Feeling Lethargic), DYSPNOEA (Shortness of breath), ASTHENIA (No strength in leg), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, LETHARGY (Feeling Lethargic), DYSPNOEA (Shortness of breath), ASTHENIA (No strength in leg), HEADACHE (Headache) and NAUSEA (Nausea) was resolving.            No treatment medication were reported.
Client's left thigh became red and swollen, twice the size of her other thigh.  Client had pain and itching of her left thigh.  On 4/5/08 in A.M., she had a fever of 101.  On 4/6/08, leg was worse - mom took to ER - was told it was cellulitis and put on Keflex 250mg TID.  Mom also used cold compresses and Motrin.
18-year-old male received an expired dose of Menactra; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old male patient who received 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]  (lot: U5766AE and expiry date: 02-Dec-2018) via unknown route in the right arm, on 07-Aug-2019.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) in left arm for Immunisation on 07-Aug-2019.  The patients past medical history, concomitant medication and family history were not provided.  It was an actual medication error due to expired vaccine used.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
severe pain in the right side of his chest down to his ribcage; pain with from his right side and his rib cage that goes to his back; having a quite severe, he had pain in his ribs; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A male patient (reporter's fiancée) of an unspecified age received BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced severe pain in the right side of his chest down to his ribcage, pain with from his right side and his rib cage that goes to his back, having a quite severe, he had pain in his ribs. The outcome of event was unknown.  Follow-up attempts are completed. Information about lot/batch number cannot be obtained.
I had a reaction after each of the Covid shot but it was not a bad reaction. In terms of the enlarge lymph node I did not feel anything. They have been surveilling me for a while for breast care and I had enlarged lymph nodes a year ago and they removed one a year ago on October. It was benign. But they have been watching for close to a year. They did an MRI on 03/29/2021 just to check because I have problems and It turned out to be an enlarged lymph node on the right side where is the side where I got the shot. Also, the MRI revealed something going on in my left breast and that turned out to be carcinoma. They confirmed the left side tumor with an ultrasound 2 weeks later. They did a repeat MRI in May to look at the lymph node and it was still enlarged.
immediately felt sore on site of injection and within minutes of leaving clinic, i felt sharp pain in my upper left back (still have that discomfort and I looked at my back this a.m. and i have a red bruise like mark)  I took advil and laid down, fell asleep and when I tried waking up, I couldn't wake up and when I did wake, I was breathing hard and disoriented.  I slept with my mom in fear of having episode again. Around 2:45 am, my mom woke to me shaking like I was having a seizure. it lasted about 30 secs. she called 911 and i was checked out by paramedics, who said my vitals were fine and I should flollow up with medical care. My mom and I agreed that perhaps I needed stress dosing of Cortef. I took stress dosage and have been taking stress dosage all day and so far no more episodes.  Now waiting for Doctor to call me back and advise.
Swelling, redness & pain in entire upper arm (L) side starting one hour after deltoid injection.
experienced a bad headache as she stated it feels like a concussion; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "experienced a bad headache as she stated it feels like a concussion".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
left side chest pain arising 2 days following vaccination. Ongoing for about 3 months.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old female patient received BNT162b2 (BNT162B2), on 25Nov2022 as dose 1, single (Batch/Lot number: unknown) at the age of 20 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 27Nov2022 at 20:00, outcome "not recovered", described as "left side chest pain arising 2 days following vaccination. Ongoing for about 3 months.". The event "left side chest pain arising 2 days following vaccination. ongoing for about 3 months." required physician office visit and emergency room visit.  Additional information: Left side chest pain arising 2 days following vaccination. Ongoing for about 3 months. Patient had no history of health issues. Patient did not have covid prior vaccination and covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
From initial information received on 9/14/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four year old male patient received a dose of DAPTACEL, lot number C1698AA, administered in the left thigh on 9/9/04. The next day, on 9/10/04, the patient's mother called the doctor's office to report that her son's left thigh was red and swollen. The nurse referred the mother to the emergency room. The patient was admitted to the hospital on 9/10/04, with a diagnosis of cellulitis. He was treated with antibiotics and was discharged on 9/11/04. The patient's recovery status was not reported. From additional information received on 28Oct04 from a health care professional, it was reported that the pt has recovered from this event. No other information was provided at this time. The reporter of this case is the same as for case 200403029. Medical assessment: Even though, injection site cellulitis is not expected after Daptacel, the signs that were reported redness and swelling of the left thigh may be related to the administation of DTAP-containing vaccine.
Rash. On the back of my neck first. Then scattered about on arms and legs. By April 5th the rash was supposed severe. Both knees and elbows were solid red whelps. Both calves and underneath of forearms had multiple red whelps. Some whelps were scattered about. On my arms and legs. The areas were very uncomfortable. VERY itchy and some burning sensation. I saw my dermatologist on  April 7th.
Redness, warmth, itchiness at injection site, 2 inch diameter redness. Facial flushing bilateral. Shoulder lymph and neck lymph on left side.
Refridgeration excursions identified; No adverse event; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022 at 4:51 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 15-Sep-2022 at 4:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant medications were reported.  Anatomical location for vaccine administration was reported as deltoid. It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion. No adverse reactions reported for the patient.  No treatment products were reported.
The pt experienced a fever of 104, 12 hours post vax that has currently persisted to the 3rd day post vax.
The site was itching, it hurt, it was bright red, swollen, 4 inches up and down the arm; it was bright red; sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (The site was itching, it hurt, it was bright red, swollen, 4 inches up and down the arm), VACCINATION SITE ERYTHEMA (it was bright red) and VACCINATION SITE PAIN (sore) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included centrum vitamins, METFORMIN, LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (The site was itching, it hurt, it was bright red, swollen, 4 inches up and down the arm), VACCINATION SITE ERYTHEMA (it was bright red) and VACCINATION SITE PAIN (sore). At the time of the report, VACCINATION SITE PRURITUS (The site was itching, it hurt, it was bright red, swollen, 4 inches up and down the arm), VACCINATION SITE ERYTHEMA (it was bright red) and VACCINATION SITE PAIN (sore) outcome was unknown. Not Provided      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.   Treatment included Benadryl and cortisone cream.
Developed Cellulitis to upper are after injection. Area 11-13cm and second area measures 3-5cm. Both areas have swelling , redness and heat
sick for a month; Initial information was received on 11-Feb-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional. (reference number: US-SA-SAC20210217000572).  This case involves an adult patient who was sick for a month (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication 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 and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick for a month (illness) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome is unknown.  There will be no information of batch number for this case.
Severe heavy menstrual bleeding that lasted 3 weeks. Iron deficient anemia which I didn?t have previously. Headaches, blurry vision at times and dizziness. Changes in frequency of menstrual bleeding , heavy bleeding and large blood clots.
Patient's husband called 9 hours after receiving flu shot stating she developed a fever & fast pulse advised to go to emergency room for evaluation.
This nurse removed opened vial of Moderna from storage, 2-8 C. Placed in cooler with ice packs along with two other unopened vials of Moderna. This nurse then transported and gave the three vials to the agency nurse. Agency nurse administered open vial of Moderna to persons who had signed up for the Booster vaccination of the Moderna Vaccination 0.25ml. Once completed updated Manager that the bottle given to her was open and was going to open another vial. This nurse confirmed with the manager that the bottle had been opened previously, 1/19/2022. This nurse had mis read the storage information regarding Moderna to be stored unopened and unused for 30 days. This nurse made telephone call to each person affected by this opened vial. Per Medical Director Dr. , offered everyone a dose of 0.25ml out of the new unopened vial.  RN
Next day after vaccination I felt like I was getting a skipped heartbeat. So I went to see a cardiologist and they specialize in monitoring regular heartbeats 11/17/2021. They put me on a medication to slow down my heart rate.
This case was considered medically important (OMIC). Follow up information stated that on 7/1/04, the peds doc indicated that this case did not meet the criteria for vaccine failure. Information regarding Prevnar was received from a healthcare professional regarding a patient who experienced invasive pneumococcal pneumonia. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. The patient experienced invasive pneumococcal pneumonia. The reporter indicated that 3 children experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is received.
Sore arm after receiving a Shingrix shot; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   The reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter was friend.  The age at vaccination was not reported. The patient was in her 60's and had complained about having a sore arm (at injection site) after receiving a Shingrix shot. No further information was gathered such as the patient's initials or whether it was dose 1 or dose 2(or both).  The reporter also stated that patient did not experience a fever after receiving the Shingrix shot. This is 1 of 5 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021013457:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014254:Same reporter. US-GLAXOSMITHKLINE-US2021013450:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014110:Same reporter.
He had his routine 6 month.m vaccines that lead to seizure and concerning behaviors along with fevers   Prior every other time his vaccines left him with a fever. And issue sleeping, not wanting to eat and clingy.,  Every time I?ve brought this up I?ve been told vaccines can?t cause anything from my doctor at this point though it doesn?t add up and I?m here reporting the seizure for the safety of my child. We are still awaiting to see more specialists including neurology.
After adminstaration of medication, patient had palpitations, shortness of breath, and tingling in the fingers. Paramedic came and took vitals signs and ekg.  Patient symptoms subsided and she spoke to a behavioral health.  As her smptoms dessipate she was release by the nurse.
Sore arm; Chills; sore muscles all over; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and MYALGIA (sore muscles all over) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer on 21-Mar-2021, Pfizer on 22-Apr-2021, Pfizer on 22-Apr-2021 and Pfizer on 22-Apr-2021. Past adverse reactions to the above products included Chills with Pfizer; Muscle pain with Pfizer; and Pain in extremity with Pfizer and Pfizer.   On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and MYALGIA (sore muscles all over). At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and MYALGIA (sore muscles all over) outcome was unknown.            No concomitant medication was reported. Suspect product dosage text was reported as unknown. Patient received Moderna 5th vaccine bivalent Moderna 03-Oct-2022. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-741945 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741945:Same patient, 6th dose moderna vaccine
Pt was exposed to chickenpox 1 week prior to report. Pt experienced several vesicles on erythematous bases. Itchy.
Patient was in usual healthy state - received 1st dose of Pfizer vaccine 3/3, 1-2 days later developed expected reaction (low grade fever, sore arm) - then shortly after developed severe burning in bilateral lower extremities, followed by subsequent development of a necrotic ulcerations. Also then occurred on bilateral arms. Biopsy proven pyoderma gangrenosum - currently being treated with steroids
Rash with welts that "looked like when her son had chicken pox" 7/5/08 until today.  Patient self treated with antihistamine and calamine lotion.
I had injection site pain (soreness) the evening of the injection that was much better by the morning. By the third day it was completely gone. Yesterday (one week after the initial injection) the area around my injection site became itchy and felt bruised. By evening it was becoming quite sore and persisted through the night. I took an ibuprofen in the early morning and the pain is manageable. The site feels tight, warm to the touch, and looks slightly pink compared to the opposite arm (though not prominently swollen or red).
Migraine headache completely disappeared; Warm fairly short lived rush; A Spontaneous  report was received from a consumer concerning an unknown year-old, (unknown gender) patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced therapeutic response unexpected and feeling hot/sensation of warmth.  The patient's medical history was not provided .The concomitant medications were reported as multiple other prescribed medications.  On 15 Jan  2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route in an unknown location for prophylaxis of COVID-19 infection.   It was reported that the patient had on and off  migraine for about a week .On 15 Jan 2021, after seven minutes of vaccine administration patient developed a short lived rush of warmth. The patient was concerned that if it was a negative side effect from the vaccine. About 40 minutes later patient's headache completely disappeared. The patient took no other medications for treatment even though was consuming  some other prescribed medications daily.Patient reported feeling better now with no side effects.  No treatment medication was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events short lived warmth rush and migraine disappeared  were considered as recovered.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
12 cm x 7 cm area of induration/erythema surrounding injection site Rt thigh.