chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6 patients vaccinated from vials stored in freezer no DDL temp monitoring; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer no DDL temp monitoring) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer no DDL temp monitoring). At the time of the report, PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer no DDL temp monitoring) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information were given.  Reporter stated the pharmacy hasn't been using a data digital logger to monitor the freezer temperatures that the Moderna COVID-19 vaccine is stored in.  It was reported that to their knowledge, there has been no temperature excursion and the temperatures of the freezer remained consistently within range. They keep a written temperature log. It was reported that there is no current and previous temperature excursion. The storage condition at the time was frozen storage. The lot numbers supposedly affected were 022J21A, 083J21A, and 059M21A. Maximum or minimum temperatures were not recorded but only morning and evening temperatures were recorded. The excursion in question was from 8 Feb 2022 to 20 May 2022 and affected only 6 patients within that time frame.  The vials were moved to the refrigerator to be thawed for vaccinations on 8 Feb 2022, 21 Feb 2022, 31 Mar 2022, 2 May 2022, and 20 May 2022.  No treatment information were given.
Patient says she had fever, chills, dizziness for 2-3 days and had swelling, redness and pain in the arm of injection.
No additional AE; product expired on 9/13/2022 and was administered; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 23-SEP-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U002528, expiration date: 13-SEP-2022, administered for prophylaxis (dose, strength, site, and route of administration were not provided) (expired product administered). Customer confirms the product was stored appropriately and did not have any temperature excursions prior to administration. No additional adverse events details or product quality complaints were reported (no adverse event).
Subsequent to receiving the third dose of Lymerix the pt experienced a bull's eye rash. As of 09/05/2000 the outcome of the event is unknown.
minor cough, head fog, head ache, nausea, extreme fatigue,  and muscle pain
Tingling in the Left Arm and Left Shoulder (Injected Arm); This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the Left Arm and Left Shoulder (Injected Arm)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced PARAESTHESIA (Tingling in the Left Arm and Left Shoulder (Injected Arm)). At the time of the report, PARAESTHESIA (Tingling in the Left Arm and Left Shoulder (Injected Arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored PNEUMOVAX 23, (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Round, red, painful 1" diameter reaction at injection site.  Lasted for 24 hours, gone at 36 hours.
Received dose 1 of Pfizer/BioNTech vaccination @1100.  At 1130 started to feel itchy and noticed a hive-like rash.  He took 75mg of Benadryl PO and waited a bit, then started to feel  as though he had a "lump in his throat".    Denies SOB, voice changes, lip or tongue swelling, and tolerated secretions in the ED.  Physical exam + for diffuse urticarial rash, predominantly trunk, neck, and scalp.  Medications received - Epi 0.3mg IM @1234, Benadryl 50mg q6hr IV @ 1757, 1/8 0012, 1/8 0558, Famotidine 20mg BID @1223, 2221, Solu-medrol 40mg @ 1757, 1/8 0011, and 1/8 0558.  Discharged on 1/8 from ED  @ 0811 clinically improved.
Develop itchy bumps on forehead and neck 3 hours after vaccination. Took two zyrtec and it settled down. Headache and fatigue the morning of 9/7.
I had sore arm and I was really tired. I tested positive for COVID-19 on July 30th. I was six weeks. I was very tired. I had body aches. I slept a lot for 3 weeks. I went to urgent care about this. They did a chest x-ray to make sure there was nothing going on with my lungs.
TOOK ONLY ONE DOSE; A spontaneous case report was received from a physician on 11-Feb-2019 for four consumers.  Based on the information obtained from the physician, four individual case safety reports PVX201902-000103 (PVX2019-369; physician), PVX201902-000104 (PVX2019-371, male consumer), PVX201902-000105 (PVX2019-372, female 1) and PVX201902-000106 (PVX2019-373, female 2) were created and cross-linked in the database.  The report describes a 25-year-old adult female consumer who "took only one dose". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took the first dose of Vivotif on 02-Feb-2019. She did not take the other doses since then.  The action taken with Vivotif with respect to the event "took only one dose" was not applicable.  The clinical outcome of the event "took only one dose" was unknown.  Company's Comment: The causality of the event "took only one dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only one dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201902-000103:
On 6-7-2022, I started having a cough and sore throat. On 6-8, I noticed fatigue and slept a lot. On 6-9, I starting having a headache and running fever up to 100.5 but felt a little better. I was still having these symptoms on 6-10, so I took a home Covid test which was positive. I called and had a telehealth visit with my PCP office that day. I was prescribed PAXLOVID. I started taking that on 6-10. I have been coughing more today but I am feeling slightly better with no headache. I am reporting a breakthrough case of Covid.
Immediately post vax, the pt experienced "redness - hard and swollen - cellulitis." The pt was seen by a physician. Additional information has been requested.
Shoulder pain with movement and limited range of motion started at approximately 5 pm in the evening on the same day the vaccine was given (11/11/21).  I looked at vaccine site and could see that the site was too high, just under the acromion.  I went to urgent care at 7;30 pm that evening and was prescribed Prednisone 60 mg daily for 5 days.  I took this with some improvement in pain and range of motion. However, upon stopping steroids after 5 days,  the pain and limited range of motion returned. I  have been taking ibuprofen since and went to PT but the symptoms are worsening.
24h after immunizations, he developed redness/warm at injection site. Marked with pen by family. Came to office today (48h after injections) due to spreading redness and warmth and tense/tight feeling at site. No fevers or constitutional symptoms and no pain complaint. Area of redness/warmth 11cm x 14cm. No edema. 2-3 very small pinpoint intact blisters centrally. No edema. I did treat as a cellulitis (with possible minimal extravasation with the blisters centrally) in addition to supportive measures. I asked to return for f/u in 48h if persistent or sooner if acute worsening or new symptoms.
Dose number 3; Sore and swollen armpit; Sore and swollen armpit; This is a spontaneous report from a non-contactable reporter (consumer or other non hcp). The reporter is the patient.  A 38-year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: unknown) at the age of 38 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing) and "bipolar disorder" (unspecified if ongoing). Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Anatomical location: Left arm), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Anatomical location: Left arm), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Dose number 3"; AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 02Jan2022, outcome "not recovered", and all described as "Sore and swollen armpit". Therapeutic measures were not taken as a result of axillary pain and swelling.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Per pt's agent, Pt had arm pain going down her Right arm (vaccine given in Right deltoid) within 15 minutes of receiving vaccine.  Pt left after 15 minutes (pt did not notify us of anything wrong, and went straight to her PCP). Pt's agent said within 1 hour of the vaccine, pt was experiencing arm pain that radiated to neck, shaking, headache, heavy feeling of chest accompanied by shortness of breath, general muscle pain, and worsening of her carpal tunnel. pt agent said PCP gave pt benadryl shot, and prescribed pt hydroxyzine and diazepam (which were promptly picked up by pt agent to be delivered to the pt). Pt relayed all the above information to us as she was on the phone with the pt during this whole conversation.  We will follow up with pt today.
Joint pain; Arm pain; Headache; Swelling of lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 10May2021 at 15:15 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included low thyroid (Hypothyroidism). Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and aripiprazole (ABILIFY) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 19Apr2021 at 15:15 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 at 04:45, the patient experienced headache, swelling of lymph nodes, joint pain and arm pain. The events did not result in doctor or other Healthcare Professional office/clinic visit, and Emergency room/Department or Urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, swelling of lymph nodes, joint pain and arm pain were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Fever; was Shaking; Cold chills; cold; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 20th July 2020, the patient received Shingles vaccine and dTpa vaccine. On 20th July 2020, less than a day after receiving Shingles vaccine and dTpa vaccine, the patient experienced fever, tremor, chills and cold. On an unknown date, the outcome of the fever and cold were unknown and the outcome of the tremor and chills were not recovered/not resolved.   It was unknown if the reporter considered the fever, tremor, chills and cold to be related to Shingles vaccine and dTpa vaccine.  Additional case details were reported as follows: The case was reported by the spouse of the patient. The patient started having symptoms during the evening of 20th July 2020.  The patient experienced high fever, cold chills, and was shaking. The reporter was provided with the names and adverse reactions information for Shingrix and Boostrix brands.  The patient received since they do not know the brand names of these specific formulations. The reporter consent to follow up.
I had shoulder pain in my left shoulder (where the shot was administered) within one day of the shot, and it has continued to this day and has become a very severe, intense pain. My doctor, with whom I had an appointment upon my return, said my continued extreme shoulder pain very likely could have been caused by SIRVA (Shoulder injury related to vaccine administration), because I had no prior issue with my shoulder and had done nothing to injure it, and the pain started within a day of the shot.
Pancytopenia; This is a spontaneous report from a contactable Physician.   A 78-year-old female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly at Left arm on 24Feb2021 (at the age of 78-year-old) for COVID-19 immunization at the Hospital. The patient medical history included Non-Hodgkin's lymphoma. Concomitant medications were none. The patient had received the first dose of vaccine on unknown date. The patient had not known allergies. The patient was not pregnant. Patient has not tested positive for COVID-19 since having the vaccine. Patient had not a COVID-19 prior vaccination. On 01Mar2021 the patient experienced pancytopenia. The outcome was reported as not recovered.  No treatment received. The event was assessed as serious Life threatening  Information on Lot/Batch has been requested.; Sender's Comments: Reported life threatening pancytopenia is considered unrelated to BNT162b2 but more likely associated with patient's medical history of Non-Hodgkin's lymphoma.  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.
11/11/21 presents to EC ED for "confusion has been progressing over the past few weeks" PMHx "lung, and brain cancer"
within one week patient had server abdomen pain. Patient has been bleeding for the past 8weeks.
Information has been received from a physician concerning a 13 month old female who on 12-JUN-2007 was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). She was vaccinated with measles-mumps-rubella vaccine (M-M-R II) at the same time at a different injection site. On 28-JUN-2007 the patient experienced localized rash at the injection site of varicella virus vaccine live (Oka/Merck). On 29-JUN-2007 the patient developed a rash all over her body. Additional information has been requested.
Intense soreness/pain in the shoulder (site of injection) that lasted greater than 2 weeks.
Pt mother reported that pt woke up during night of vaccine given (08/31/2010) with fever.  Not recorded by parent.  Pt had urticara all over various areas of body the next morning, (09/01/2010).  Mother brought pt to clinic the next day and was examined by physician and given diphenhyramine 12.5 mg/5 ml 1/2 gsp every 6 hours PRN for itching x 10 days.
Patient developed right upper arm redness/swelling/itching after Dtap & IPV immunizations given 3/4/13. Afebrile. Dx cellulitis - Rx Clindamycin 150 mg P.O. TID x 10d. Cool compresses 2-3xday until swelling decreases. ZYRTEC 10 mg P.O. qd prn. Borders drawn at reaction site to reveal 24-48 hours if reaction worsens or fever. Follow up appointment scheduled 3/11/13.
Immediate ear to throat throbbing,  arms tingling, chest heaviness, extreme fatigue within 25 minutes of injection, lasted approximately 30 minutes
Worsening tinnitus; This is a spontaneous report from a non-contactable consumer (patient). A 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EW0176), via an unspecified route of administration on Feb2021 (at the age of 53-years-old) at dose 1, single in the left arm for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. The patient has no other vaccines received within four weeks and no other medications received within two weeks. The patient had no COVID-19 infection prior to vaccination. The patient has no known allergies. The patient was tested for COVID-19 post-vaccination. On Apr2021, the patient experienced worsening tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit (physician office visit). The event is serious due to disability or permanent damage. No treatment was given for the event. On Sep2021, the patient underwent COVID-19 Nasal Swab Test with negative result. Outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Urticarial lesion noted on Right lower eyelid, behind Right ear, on right shoulder and right upper back. Mild swelling of eyelid in area where urticarial lesion present. No respiratory symptoms, no facial edema, no swallowing difficulty. Advised to take Benadryl and be seen if respiratory symptoms, edema, other concerns.
Sudden onset of nausea, congestion in chest, and generalized weakness less than 24 hours after vaccine administration.  Tylenol given.
Typhoid given on 4/21/2015 via (L) deltoid. Symptoms of fatigue, sweating, light headed, lethargy, headache.
"Jenssen COVID-19 Vaccine EUA"12:08 Patient felt lips burning and chest tightness with minutes of receiving the vaccine. Individual returned to nurses stating the symptoms started at 12:15 pm. 12:25 pm 153/82,82,94 % RA. She stated that she has asthma and utilized her albuterol inhaler. Individual reported she felt as if she were about to have an Asthma attack. Benadryl 50 mg (Lot # 070101 exp. 7/2022) was given IM at 12:27 pm. Her skin appears to be blotchy and lips still tingling. 12:31 The lip burning is resolving, chest fells normal, breathing easily. Client is slight dizziness 145/84,84,97% RA. 12:43 141/82, 69,95%RA. Individual symptoms gradually resolved over 1 hour.  At 1:20 pm vitals were 136/84, 65, 95% RA. Individual was sent home with family at 12:54 pm.
Left arm (injection site) itching, with spread to right arm during observation.  Given oral Zyrtec 10mg
pt recvd vax 6MAR96 & devel fever, limpness & probable febrile seizure;adm to hosp short stay unit & observed for 24hrs;fever controlled;
Patient received vaccine on 12/17/2020 at approximately 12pm. At 10pm that day, patient developed chills and fatigue. At 6am on 12/18/2020, patient developed fever (temperature 100.2) and a very sore arm. Patient took acetaminophen (Tylenol) at 6:30am for the fever and pain. By 1pm on 12/18/2020, patient reports headache and dizziness. Patient took Rizatriptan (Maxalt) for the headache and dizzy, but it did not help. Patient took ibuprofen at approximately 4pm. Patient felt normal at 5:30pm on 12/18/2020.  Took Tylenol at 6:30 for the sore arm. Took Maxalt for the headache/dizziness (sometimes migraines make me dizzy, maxalt didn?t help). Took ibuprofen around 3-4ish? And felt fine by 5:30.
The Covid 6m-4yr vaccine was ordered for the patient. Patient was given a 0.3 ml dose WITHOUT the diluent added.  Provider was notified and they advised staff to contact and inform mom of event. Mom was informed and educated on signs/symptoms to look out for, if any arise to take patient to ER immediately. Mom verbalized understanding and had no other questions or concerns.  Patient has had no adverse reactions. Staff was reeducated on the use of diluent for the 6m-4yr Covid vaccine.
Received smallpox vaccine Aug 20 (part of basic training?); approx 10 days later developed vescicles at site of imm on L arm; in next few days got pustules on both distal lower extremities. All evolved into pustules and subsequent ulcerations...presented to Med Ctr ER on Sept 8 because leg ulcers not healing. Approx 10 1-3 mm ulcers on distal L lower leg with 15 mm surrounding erythema, about 5-10 on R LE. ER called Department of Community Health, call referred to me (MD)- pt discharged with instructions and antibiotics...needs to not use lotions/ointments, and not to allow drainage from sites to contact others; after discussion with DOD, likely auto-inoculation....as no new lesions in last week prior to arrival to ER.
Patient experienced a rash which spread down the arm that received the PNEUMOVAX 23 vial vaccine. Treatment included - MD visit - and 10 day course of antibiotics - Cephalexin 500 and BACTRIM DS.