chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Low grade fever that finally broke 5/29/2021; Been very fatigued; This is a spontaneous report from a contactable consumer (patient herself). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Er8732) via an unspecified route of administration, administered in left arm on 30Mar2021 12:00 as single dose for COVID-19 immunization. Medical history included asthma, mild depression, aneurysm, food allergy (milk, eggs ragweed newly discovered), penicillin allergy. Patient was not pregnant at time of vaccination. No covid prior vaccination. Concomitant medications included montelukast, zingiber officinale (GINGER), diphenhydramine hydrochloride (BENADRYL) and trisleep. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: En6203) administered in left arm as single dose for COVID-19 immunization for which the patient had experienced events of anemia and monocytosis. It was reported that in Mar2021 the patient experienced low grade fever that finally broke 5/29/2021, been very fatigued. The patient had not tested positive prior to vaccination, later on since the vaccination, the patient underwent lab tests and procedures which included Nasal Swab test which was negative on an unspecified date. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of low-grade fever and fatigued as iron pills were taken by patient. The outcome of events was unknown  Follow-up attempts are needed. further information is expected.
Patient was inadvertently given Trumenba instead of Menatra at the 10 year old visit.; severe headache; fever; This is a spontaneous report from contactable physician via Pfizer Sales Representative.  A 10-year-old patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient was inadvertently given meningococcal group b rlp2086 instead of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA). The patient experienced severe headache and fever. The events were non serious with outcome of unknown.  The information on the batch/lot number has been requested.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (17 patients administered expired Moderna COVID-19 vaccine) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011L20A) for COVID-19 immunization. No medical history reported. On Aug 27, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 27, 2021, patient administered expired product (17 patients administered expired Moderna COVID-19 vaccine). At the time of the report, administered expired product (17 patients administered expired Moderna COVID-19 vaccine) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Profuse sweating on slight exertion, enough to wet hair and clothing, dripping onto the floor. This began on the date noted, and has continued through the present date.  The sweating is all over my body, such that even my phone in my pants pocket becomes wet, and sweat streams down my face and neck. It happens any time I am standing in one place, walking, cleaning, and even in cool weather, although hot weather makes it worse.
Immunization, received on 7/31/06. Pt present on 8/1/06 with increased swelling, erythema and induration of upper left arm measuring 10x25cm.
Patient experienced swelling, soreness, but the reason for report has a dime size sore on left arm that still present and sore.
Mobilliform rash started on the 10th day after receiving the vaccination and lasted 3 days. Had temp 101. resolved in three days.
Dose #2 pfizer; Pt reported onset of chest pain and SOB within 5 min of vaccine. Followed by nausea, vomiting, and feeling of swelling of lips, . Pt used her own albuterol, 2 puffs.  RRT called. BP 166/99, HR 90, pulse ox 100, airway intact, lungs clear, cardio tachy but regular, skin warm and dry with no diaphoresis.  Concern for anaphylaxis as pt symptoms continued and some increase in disorientation Epi Pen administered, O2 via NC.  IV access attempted but unable to obtain.  EMS called.  Pt monitored with resolution of CP, SOB, nausea, lips swelling and disorientation. Pt continued to have feelings of swelling of tongue and transported to ED
Pt had no reaction for 2 weeks. She then noticed demyeling without erythema or pain at site of injection. It has not progressed. She had generalized nausea, malaise and joint pain non specific. Screening labs at PCP - CBC and CMP - showed low sodium. Repeat lab is pending.
R29.810 - Facial droop EXTREMITY WEAKNESS CHEST PAIN R29.810 - Facial weakness
Headache; Sinus inflammed; Chills; Fatigue; Fever; Body ache; Nausea; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (received 1st dose on an unknown date and experienced soreness and arm discomfort, refer case id US2020002547).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, sinusitis, chills, fatigue, fever, general body pain and nausea. On an unknown date, the outcome of the headache, sinusitis, chills, fatigue, fever, general body pain and nausea were recovered/resolved.   It was unknown if the reporter considered the headache, sinusitis, chills, fatigue, fever, general body pain and nausea to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experienced headache, sinus inflammed, chills, fatigue, fever, body aches and nausea with the 2nd dose. This case has been linked to cases US2020002546, reported by the same reporter (reported for different patient).
The vaccine was administered to the patient. As she was seated in the observation area, she began to feel unwell and stood up to approach one of our clinic assistants to let them know. The assistant states the patient appeared flushed. The assistant then grabbed the patient's arm as she noticed the patient seemed faint. The patient then fainted and the assistant gently lowered the patient to the ground. Upon lying flat on the ground the patient immediately came to. The clinic called for assistance and the first set of vitals were taken. The patient's feet were elevated and a cool compress was placed on her forehead. Pt reported feeling better after a few minutes.  First set of vitals: HR 102 RR 16 BP 88/60 O2 99% Second set of vitals: HR 66 RR 14 BP 90/64 O2 99% Third set of vitals: HR 64 RR 14 BP 110/78 O2 99%
12-23-2020 Pain and swelling at the injection site and lymph nodes under her arm, HA, N&V, fever, bruising at the injection
blurred vision; dizziness; extreme pressure/pain to ears; numbness in hands/feet; tingling; Chest pain; bruised arm; This is a spontaneous report from a contactable other hcp (patient). A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in left arm on 28Jan2021 at 11:30 (at the age of 34-years-old) (Batch/Lot Number: EL9263) as dose 1, single for COVID-19 immunization. Concomitant medication(s) included spironolactone (SPIRONOLACTONE); sambucus nigra (ELDERBERRY EXTRACT) and daily vitamin. It was unknown if the patient had known allergies. On Jan2021, the patient experienced blurred vision, dizziness, extreme pressure/pain to ears, numbness in hands/feet, tingling, chest pain, bruised arm. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
back muscles frozen; This case was reported by a consumer via call center representative and described the occurrence of muscle stiffness in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced muscle stiffness. On an unknown date, the outcome of the muscle stiffness was unknown.   It was unknown if the reporter considered the muscle stiffness to be related to Shingrix.  Additional details were provided as follows: The patient had back muscles froze so long since few days when the patient received Shingrix. The patient asked how long it would last.
This spontaneous report was received from a back office lead and refers to a 43 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-JAN-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in the left deltoid, lot # L038499, expiration date 26-JUN-2017). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Suspected vaccination failure; shinles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient received shot for shingles and a year later, the patient experienced the shingles The case was considered, as suspected vaccination failure since the details regarding dose number and laboratory confirmation was not provided.
High fever (102 degrees); nausea; ringing in ears; severe dizziness; severe muscle pain at injection site;   These symptoms were so severe I missed an entire day of work and had to lay in bed. I took ibuprofen.  By the second day after the injection, I was much improved - the symptoms were mild (headache, slight dizziness, slight ringing in ears), and I was able to work that day.
On the day of receiving vax, pt's left arm was very swollen to the elbow and hard where he recvd his Hepatitis B shot. At 5 PM that day, pt started feeling very ill, flu-like, with fever, hurting all over and sick to stomach. The next day pt was unable to move and couldn't get out of bed. He was too sick to go to school. Pt stated he had a sore throat. Pt was treated at home with Motrin. On 9/26/01, pt's mother reported that pt's arm was looking better the night before. Upon awakening on 9/26/01, pt could not bend his knuckles and was hurting all over. He was pale and cold early in the AM of 9/26, but the swelling in his arm had improved. Pt reported pain in his teeth, testicles, joints and muscles. Pt seen by MD on 9/26/01, and MD felt pt had a strong, severe reaction to vaccine. On 9/26/01 pt reported feeling very tired. On 9/27/01 pt complained of a headache and stomach ache.
Ongoing hospitalization, transitioned to hospice, BiPAP dependent, cannot come off, desats to 40s even with Vapotherm 100%, viral PNA, acute hypoxic respiratory failure.
Patient reported fever of about 101 and general malaise plus soreness in injected arm on 3/23, then on 3/24 came to pharmacy and showed pharmacist a swollen, red area on the underside of the right arm (the arm in which he received injection). A physician at the emergency room diagnosed the area as possible cellulitis and prescribed clindamycin 300mg three times daily for 7 days.
Maroon top Pfizer for ages 6 months through 4-year-old reconstituted incorrectly. It was reconstituted with 1.3mL versus the recommended reconstitution of 2.2mL on 07/12/2022. No adverse reaction reported.
vomiting; chills; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have coronary artery disease." (unspecified if ongoing), notes: I have coronary artery disease. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "vomiting up a storm"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization.  The following information was reported: VOMITING (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown". Additional information: Caller stated that she was violently sick throwing up. She was up all night and vomiting with the vaccine, every time I take it, this is what happens. I am a HCP myself. Caller stated, "I took the second booster, wasn't expecting a reaction, but I always get, vomiting. Why is this happening? My husband had the vaccines and was fine. It's just me". Caller stated, the "First time I didn't vomit, the second dose I was vomiting up a storm, the first and second booster I was vomiting and chills". Caller just received the last booster yesterday, "I was okay in the beginning and started vomiting about. I received the vaccine at 1:30pm and started vomiting at 11PM and it lasted all night until about 8 or 9AM, I was up every hour on the hour vomiting.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
So, I woke up on 5/2/22 with a stuffy nose and a scratchy throat and I thought there has been a lot of pollen is it allergies, cold or is it "IT". The cold like symptoms got worse and I was tired but not like tired, tired just tired and Thursday night I had a headache it was not a migraine but a different kind of headache that was a weird sensation and I knew this was different and took a home COVID-19 test and it was positive. I went to see my doctor and took a PCR test, and it was positive.
This spontaneous report was received from a register nurse concerning who stated a product confusion due to similar packing of PROQUAD (Merck) (lot number H020850, expiration date 26-MAY-2013) and M-M-R. The nurse stated that the PROQUAD (Merck) and M-M-R packing looked similar that the staff inadvertently stored the of PROQUAD (Merck) in the refrigerator. The improperly stored of PROQUAD (Merck) was not administered to any patients. No adverse events were reported. Additional information is not expected.
06dec89 pt vax hepta B. during night pt ex sweating. sx resolved.  pt received 2nd hepta B w/o adverse effect.
Arm hard and swollen around injection site  and itchy in the area , has been almost 2 weeks arm still itchy and large red area around where the shot was given and starting to look bruised
I had the newest shingles 2 injection series vaccine. I had the 2nd injection 6-30-18 after having the first injection 9 weeks prior. Had a fairly mild reaction to first injection: injection site on left arm hurt, red, large (3-4 inches hard, raised bump), 2 day headache (Didn't take anything. I try not to take analgesics because they are hard on my stomach, aches and lethargy for 2 1/2 to 3 days. Reported reaction to pharmacist. She recommended ADVIL, ice on injection site and using injected arm as much as possible that afternoon. Second injection in right arm. Ice helped the hard, raised, red injection site some. Extremely lethargic. I am a very active person. Severe headache for 4 days, somewhat relieved by Ibuprofen. Third day I broke out in hives which passed over a period of 4 days. I had the vaccine b/c I had chicken pox as a child and b/c I watched my brother-in-law suffer through a severe case of shingles for about a year.
Redness and minor swelling at site. Not hot to the touch and no streaking.   Watched patient for extra amount of time about 30 mins after reaction. Swelling and redness had started to decrease, no trouble breathing noted. Reviewed with mom what to watch for and what steps to take for reaction- mom stated understanding.
Headache, Myalgia, Arthralgia. Fever. chills Narrative
moderate fatigue/tiredness; some difficulty concentrating; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL 3247, expiry date unknown) in the workplace clinic, via an unspecified route of administration on 26Jan2021 at 13:45 at a single dose on the left arm for COVID-19 immunization. The patient had no medical history and no known allergies. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that on 27Jan2021 at 06:45, the morning after the patient was vaccinated, he had moderate fatigue/tiredness with some difficulty concentrating. The patient stated that it felt similar to getting 2-3 hour sleep, but he had no issue sleeping last night. The patient did not receive treatment for the event. The patient was recovering from the events.  The events were reported as non-serious.
Fever 101.6 and chills started first night, headache, sever body and joint pain, diarrhea,  exhaustion started on day 2 and are continuing, day 3 a rash has started on the arm of injection and is warm to the touch.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 69 year old female with unspecified race. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: 1808020, expiry: unknown) dose was not reported, 01 total, dose series 1, administered to right arm on 10-MAR-2021 for prophylactic vaccination.  In AUG-2021, following vaccination with covid-19 vaccine ad26.cov2.s, patient had done SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibody test which was found negative (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. On 25-OCT-2021, the patient received additional company suspect vaccine covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, 01 total, dose series 2, administered on right arm for prophylactic vaccination. No concomitant medications were reported.  On 22-NOV-2021, patient had done SARS-CoV-2 antibody test which was found negative (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. This case, involving the same patient is linked to 20211149833.; Sender's Comments: V0:20211150258-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Right-sided parotitis; referred to ENT for further evaluation and management on 2/12/2013.
painful swelling of the lymph nodes in arm pit area of injected arm; painful swelling of the lymph nodes in arm pit area of injected arm; red rash around the injection site area; red rash around the injection site area; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (painful swelling of the lymph nodes in arm pit area of injected arm), VACCINATION SITE LYMPHADENOPATHY (painful swelling of the lymph nodes in arm pit area of injected arm), VACCINATION SITE RASH (red rash around the injection site area) and VACCINATION SITE ERYTHEMA (red rash around the injection site area) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPH NODE PAIN (painful swelling of the lymph nodes in arm pit area of injected arm), VACCINATION SITE LYMPHADENOPATHY (painful swelling of the lymph nodes in arm pit area of injected arm), VACCINATION SITE RASH (red rash around the injection site area) and VACCINATION SITE ERYTHEMA (red rash around the injection site area). At the time of the report, LYMPH NODE PAIN (painful swelling of the lymph nodes in arm pit area of injected arm), VACCINATION SITE LYMPHADENOPATHY (painful swelling of the lymph nodes in arm pit area of injected arm), VACCINATION SITE RASH (red rash around the injection site area) and VACCINATION SITE ERYTHEMA (red rash around the injection site area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication were provided
Pain at injection site Day 2, which resolved. On 1/13/21, 10 days after injection, large welt at site, approximately 9 x 19 cm. With severe itching, pain and swelling. Redness continued to enlarge for days expanding all around upper RT arm. Required medical attention, IM abx of Rocephin, po antibiotics of Bactrim, Keflex. Prednisone 60 mg taper. Also had headache, fatigue for week after.
Presented with anemia (hemoglobin 7.2), thrombocytopenia (platelets 9) on 4/29/21, antiplatelet antibody positive, consistent with ITP, perhaps exacerbated by mRNA COVID vaccine. Platelets are stable after transfusion and improving with steroids.
Left arm very swollen and tender to touch, red rash and numbness in the arm and fingers.
This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, over last 3.5 years, the patients were vaccinated with PROQUAD (Merck) that had been improperly stored (most current lot information included: lot # K019102 and expiry: 15-APR-2016; dose and route not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling of armpit and/or swelling of lymph nodes in armpit. Iced once a day for three days and disappeared.