chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vomiting; body ache; fatigue; nausea; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: VOMITING (non-serious), outcome "unknown", described as "vomiting"; PAIN (non-serious), outcome "unknown", described as "body ache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10/25  Uncontrolled High Blood Pressure, Vertigo, Dizziness, Nausea  Took off work 10/25 & 10/27 Saw PCP 10/27 She started me on Lisinopril 10 10/30 Started Vomiting, Nausea and vertigo persisted,  uncontrolled high blood pressure, syncope and was taken to ER by Ambulance 10/30 - ER Diagnosed with Sepsis & unknown source of Enteritis, Bloody stool and bloody urine, All labs abnormal 10/31-11/2 - In Hospital, treated for multiple things but never found another source of where this all started. Discharged  still bleeding, nausea, and uncontrolled B/P , Pulse, and Chest Pain, & Shortness of Breath 11/5 - Hospital F/U and still very sick and worsening, Dr sent me to ER for Shortness of Breath, High blood pressure, and tachycardia. 11/6 - Sent home with Holter/Monitor , Changed meds 11/11 - Still sick, seen by Nephrologist for high b/p and shortness of breath. Started me on more new meds Continued to be sick through  11/27 - Prescribed more meds Still having Tachycardia and some SOB to this day 12/1
Patient reported feeling "numbing, tingling, and constriction" in her throat approx. 13 minutes after her vaccination (11:03 am) that was progressively getting worse. Patient was breathing easily, lungs were clear. Resting heart rate 95 bpm. Nursing Services Director contacted and 0.5 mg of 1:1 epinephrine and 50 mg of Benadryl were administered in the room by me in the left deltoid muscle @ 11:08am. Patient tolerated injection well and reported improvement in signs/symptoms  by 11:10 am. FD in room at approx 11:15 am, assessed patient O2 saturation, blood pressure, and heart rate. Found to be within normal limits.  EMS arrived shortly afterwards at approx 11:20 am. Patient was taken to nearby hospital for further evaluation in stable condition.
a temperature excursion due to a malfunction with the refrigerator. The excursion lasted for 69 days 1041 hours and the temperature of the refrigerator was 56.0-63.0 degrees Fahrenheit with no reported AE; t.The vaccine was given post excursion to patient post excursion with on reported AE; Initial information received on 21-Feb-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2023SA061081.  This case involves a 13-year-old female patient and reporter reported temperature excursion due to a malfunction with the refrigerator. the excursion lasted for 69 days 1041 hours and the temperature of the refrigerator was 56.0-63.0 degrees fahrenheit and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was given post excursion to patient with on reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included althaea officinalis root, cinnamomum camphora essential oil, citrus aurantium oil, eucalyptus globulus leaf essential oil, mentha x piperita essential oil (Gardisil).  On 08-Feb-2023, the patient received 0.5 ml (milliliter) (once) of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (lot: U7048AA, expiry date: 28-Feb-2024) (strength: unknown) via intramuscular route in the right arm for immunization.  On an unknown date, reporter reported temperature excursion due to a malfunction with the refrigerator. the excursion lasted for 69 days 1041 hours and the temperature of the refrigerator was 56.0-63.0 degrees fahrenheit with no reported adverse event (product storage error) (unknown latency) and on 08-Feb-2023, vaccine was given post excursion to patient with on reported adverse event (poor quality product administered) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both events.   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 the guidelines. 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.; Sender's Comments:  See related case-01501093:
No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No allergy or disease reported.   On 17-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    No concomitant medications were reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medications were reported.
Itching, raised red rash. Painful and continued to get worse, red, swollen, hive like for three days.
The patient received the Janssen Covid 19 vaccine (lot 1805022) on 3/17/21. Today (4/5/21) the patient called to report several adverse reactions. She stated that she had body aches and chills the day after the vaccine. The aches went away but the patient reports that the chills in her hands, legs, and feet have persisted. The patient also said that she started to have facial paralysis on 4/3/21. Also on 4/3/21 she reported developing multiple skin rashes on different areas of the body. She also said she went to the ER and had multiple tests run, including an MRI to rule out stroke. She did report to her primary care doctor who advised her to see a Neurologist. I offered to reach out to her primary care but she did not provide the information. I advised the patient that she would need to seek care from a provider who could assess and treat her as needed. I called Janssen and they said the facial paralysis is a very rare possibility but did not have any additional information to provide me. They advised me to tell the patient to seek medical care as necessary. I spoke with the patient multiple times this evening and provided her with the information to VAERS and Vsafe. I also let her know that I contacted Janssen and gave her the information they gave me. I expressed to her that I understood that she was concerned and she could reach out to me if needed. I also will follow up with her later in the week.
bell's palsy; This is a spontaneous report from a contactable physician.  A female patient of an unspecified age  (age: 37 unit: unknown), received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced bell's palsy on 30Dec2020.  The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bell's palsy might not be excluded, considering the plausible temporal relationship.  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.
Within 5 mins after administering the shot patient had itching around the injection site and after few minutes she had dizziness and her lips started swelling. She went to the ER right away where she got prednisone shot and she is fine after that.
3/29/2021 5:32 PM:Searched for moderna, added Moderna COVID-19 Vaccine (SARS-COV-2 (COVID-19) Vaccine, mRNA (Moderna) 100 MCG/0.5 ML) Intramuscular Suspension Received call from 64 yo female wt 165 lbs who had received 2nd Moderna vaccine yesterday around 1045. Today about an hour ago, she developed chest pain which continues. I recommended that she needs to call 911 or ED eval. COVID staff will follow-up for more details.  3/30-Spoke to patient, she is feeling much better after taking 2 benadryls and ibuprofen last night.
This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a adult patient who received SHINGRIX for prophylaxis. On 4th April 2019, the patient received the 2nd dose of SHINGRIX. In April 2019, less than a week after receiving SHINGRIX, the patient experienced upset stomach, stomach pain, pain in arm and diarrhea. On an unknown date, the outcome of the upset stomach was not recovered/not resolved and the outcome of the stomach pain, pain in arm and diarrhea were not reported. It was unknown if the reporter considered the upset stomach, stomach pain, pain in arm and diarrhea to be related to SHINGRIX. Additional information were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient got the shingle next shot on Thursday. In April 2019, the patient experienced very bad upset stomach, actual stomach pain, soreness of arm and diarrhea. The patient was curious and wanted to know how long would this last. The patient consented to follow up.
after the initial vaccine like, woke me up at night; This is a spontaneous report from a contactable Nurse. A 49-year-old female patient received first dose of BNT162B2 (solution for injection; Batch/lot number: El1284) via intramuscular in left arm on 05Jan2021 at 11:30 as single dose for COVID-19 immunisation. The patient's medical history and concomitant were not reported. The patient was not pregnant at the time of vaccination, Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 05Jan2021, the patient received the first vaccine, 16 hours after the initial vaccine, the patient reported that, she woke me up at night at 12:30 am. The outcome of the event was unknown.
Right facial droop, unable to swallow, steroids given and eyes drops instilled. Patient became better over time.
Child started itching when she go to the care after injection. 8:15 PM patient was itching more, mother noticed hives on side of left rib cage(about 10 of them) and 2-3 hives in axilla area.  Mother treated patient with Benadryl 8:15 PM and 0615 AM. No problems with breathing.  Mother is ER nurse.
Muscle pain and severe bruising. Bruising is resolving and patient is managing pain with APAP.
10/15/03- received smallpox- primary 10/25/03- noticed rapidly progressive and symmetrical rash all over body- mild pruritus- no burning sensation, f/c or malaise- went to ER- was told he had a "generalized vaccinia"- no labs, cx, or skin biopsy done- given Benadryl 10/27/03- walk in clinic - rash "gone down"- no pruritus- lesions symmetrically distributed on skin covering face, arms, chest, back, and legs- no lesions on mucus membranes- no bullae- allegro and steroid cream prescribed 10/29/03- rash resolving- Raji cell analysis, CRP, and C1Q binding studies done 11/20/03- all lesions "are now gone"- no complaints   A copy of the patient's clinical summary sent to VAERS via FedEx on 11/24/03
Patient got an ear infection 1 week after receiving second SHINGRIX dose and felt it was due to the shot.
9 days p/vax pt devel a rash started on face & neck progressed to extremities; trunk generally clear; no elevated temp, swollen glands or cold sx
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2016, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient. On an unknown date in 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earning capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Johnson & Johnson Janssen COVID-19 EUA Community Vaccine Clinic c/o dizziness, became obtunded, eased to floor, progressed to sitting then to standing  escorted to post-vax for further monitoring
16 years old received the 1st dose of Moderna COVID19 vaccine on 03/10/2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received the 1st dose of Moderna COVID19 vaccine on 03/10/2021) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received the 1st dose of Moderna COVID19 vaccine on 03/10/2021). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received the 1st dose of Moderna COVID19 vaccine on 03/10/2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information was provided.  This report refers to a case of Inappropriate age at vaccine administration  for mRNA-1273, lot # 032M20A with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Non-Significant Follow-up appended on 15-JUN-2021; Sender's Comments: This report refers to a case of Inappropriate age at vaccine administration  for mRNA-1273, lot # 032M20A with no associated AEs.
Swollen arm at injection site, warm to touch, slight itching and redness. Doctor told her she probably had an infection and told her to use cool compresses and watch for increase in redness. No antibiotics were given. Customer decided to take BENADRYL to relieve itching.
pt screamed from midafternoon of day of vax through the noc & most of next day; APAP would give temp relief (about 1-2 hrs);
Severe pain in left arm. Severe headaches. Nausea. Flushed face and hot. Still experiencing nausea.
Pt husband describes that the pt had difficulty breathing, but no signs of BP change. She stated it was familiar and they went to the ER on Friday night where they confirmed she once again had pulmonary embolisms.
Site: Swelling at Injection Site-Medium, Systemic: LYMPH NODE SWELLING IN THE UNDERARM AND NECK-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: PATIENT HAD ALREADY EXPERIENCED THE SAME SIDE EFFECTS ON HER 2ND DOSE OF PFIZER COVID VACCINE. IT HAPPENED AGAIN ON THE 3RD DOSE. RPH ADVISED HER TO TAKE IBUPROFEN FOR THE LYMPH NODE SWELLIGN AND CLARITIN AS WELL.
Covid Arm. Large swollen rash at injection site. Appeared one day after the injection. Grew larger for the next four days. Hot to the touch, swollen and itchy.
3cm x 3cm redness at injection site with 5 1/2 cm x 5 1/2 cm lump underneath redness - observe - F/U if worsening. May give BENADRYL.
Lymph nodes began swelling 3 days after shot on left side of neck. The same side that shot was given. The swelling began in my neck along the collar bone. At first it felt like little knots, but  by the end of the day the swelling had increased encompassing the entire area between my neck and shoulder as well as along the collarbone.  I called my doctor who recommended warm compresses and tylenol as needed. I used warm compresses and essential oils to reduce the swelling. There was some immediate relief with the compresses and oils. Within 24 hours the larger area was no longer significantly swollen and continued to reduce over the next few days. However there are still knots and swelling present in my lymph nodes running along  the collarbone on day 18 since the shot..
weakness, chills, severe headache, low grade temp to 100.5, nausea, fatigue, severe joint pain, muscle aches lasting acutely x 48hrs and sub-acutely to present day.
First phase: dizziness lightheaded difficulty breathing diaphoresis, duration 30-40 minutes  Second phase: severe abdominal pain, cramps, nausea vomiting; headaches; tinnitus; severe generalized muscle pain, LBP, pelvic pain; low grade fever, chills, shivering, diaphoresis, profuse sweating; lightheaded, dizziness, fatigue, weakness, exhaustion; severe depression, somnolence, difficulty concentrating
she's shaking, her hands are shaking; she's having a hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (she's shaking, her hands are shaking) and DYSPNOEA (she's having a hard time breathing) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (she's shaking, her hands are shaking) and DYSPNOEA (she's having a hard time breathing). At the time of the report, TREMOR (she's shaking, her hands are shaking) and DYSPNOEA (she's having a hard time breathing) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
RED RASH ON LEFT ARM, AT SHOULDER AND BELOW TO ELBOW, ITCHY & BURNS. BEGAN A WEEK AFTER SHOT 1/23/21 & IS SLOWLY FADING. NO TREATMENT WAS GIVEN.
Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Shoulder pain). At the time of the report, ARTHRALGIA (Shoulder pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. Concomitant information was not provided.
Patient did not have an adverse reaction to the immunization.  Patient was due to Hib vaccine and polio vaccine was administered. Called Health department and mother notified.