chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BNT162B2 MRNA booster vaccine related pericarditis; This is a literature report.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PERICARDITIS (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "unknown", described as "BNT162B2 MRNA booster vaccine related pericarditis". The event "bnt162b2 mrna booster vaccine related pericarditis" required physician office visit.  CASE PRESENTATION: 72 year old female, previously well, who presented with a 3 day history of central, sticking chest pain associated with exertional dyspnea, cough, palpitations and malaise. She denied any coryzal symptoms. On presentation she was hemodynamically stable but hypoxic and tachycardic. Laboratory investigations revealed leucocytosis and troponinemia of 0.13ng/ml. ECG showed diffuse ST elevations. A transthoracic echo showed a small pericardial effusion with normal LV and RV function, EF 60-65% and a CT Pulmonary Angiogram revealed a small sub-segmental pulmonary embolism with atelectasis and trace effusions. On further questioning she revealed that the symptoms started 3 days after she received her 2nd booster dose of the Pfizer covid vaccine. She was started on colchicine and apixaban and was discharged home with follow- up. Two days after discharge the patient represented to the hospital with worsening chest pain. Investigations revealed worsening leucocytosis and increased inflammatory markers (CRP 303mg/L, ESR 62mm/h). A new finding of a small pericardial effusion and bilateral pleural effusions with consolidations were noted on a repeat CT scan. Decision was made to continue colchicine and commence prednisone. Other infectious and inflammatory causes of pericarditis were ruled out. The COVID spike IgG was negative and the NAAT Cov 2 IgG showed titres >250 (<50).  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the event of pericarditis and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Raised whelps on thighs where the shots were given and redness all over her body including arms, neck, face, legs, chest, and stomach. I immediately gave her 2.5 mL of liquid Benadryl and she was overly cranky and not feeling well for days and I told the doctor what happened and I also gave her Tylenol for her discomfort and she was not feeling well and I just kept a close contact on her and kept Benadryl in her system every 6 hours and cooled her body down as well with a cool bath and showed lots of love and holding. Shes still has yet to recover from the previous 1st shots she received on Feb. 15, 2016 when she was taken by ambulance to the ER and was in hospital for having a vaccine reaction where she was given Benadryl and steroids and was monitered for 6 hours. And also the ER gave her 2 junior Epi Pens for emergency to use as well. She has not full recovered for which she has extreme hyper sensitivity to light and some sound but can not be exposed to inside and outside light and it has to be dark or lights deemed in the house or I cover her up when taking her to the vehicle and I don't take her outside to play in grass at all or even to swim because she starts crying, agitated, cranky, not happy, screams, cries, and is very upset and uncontrolled.
Experienced loss of taste, smell and scratchy throat on 4/5 and developed metallic taste on 4/6.  The symptoms are unpleasant but I have not  contacted my physician or received any treatment.
Menstrual Cycle changes. More severe cramping and bloating. Much lighter and irregular cycle yet more painful. Almost zero blood.
Rash - face, neck, trunk, buttocks, groin, hands, and feet. Red raised with some blistering between fingers and toes.
breakthrough COVID infection; breakthrough COVID infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Batch/Lot number: unknown) as dose 2, single and administered in arm left, administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "parkinson's" (unspecified if ongoing). The patient's concomitant medications were not reported.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 COVID-19 vaccine.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Dec2021, outcome "recovering" and all described as "breakthrough COVID infection". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (15Dec2021) positive, notes: Nasal Swab. Clinical course: It was unknown, if patient had any known allergies.    The lot number for bnt162b2 was not provided and will be requested during follow up.
pt recv vax  15APR94 & 19APR94 devel pruritic rash on the upper portion of body; rash was mostly in the groin region & under arms & breast; 29APR94 pt presented to dermatologist; noted to have a sl fever of 99.2; dx hypersensitivity rxn;
SMALL PINPOINT HIVES WITH SEVERE ITCHING. EMPLOYEE STATES SHE DID NOT TREAT ITCHING OR HIVES. ITCHING RESOLVED IN ONE DAY. PINPOINT HIVES ARE STILL PRESENT.
My  right shoulder and upper arm  were tiff and painful to move upon awakening  3 days after receiving dose #2  Pfizer Covid vaccine.  I self treated with warm compress and ibuprofen for about 7 days.   These same symptoms re-occurred after doses # 3  (8/17/21) and  #4 (2/8/22), spreading further down my arm ,  feeling more intense, and lasting for months.  at this writing, I continue to experience intermittent episodes of upper Right arm pain that now radiates down my arm when bending at the elbow.
I BEGAN HEARING LOW FREQUENCY NOISE AT VARIOUS TIMES OF THE DAY AND NIGHT. THE NOISE GOT PROGRESSIVELY WORSE, TO THE POINT IT WAS DIBILITATING. A FEW OTHERS  IN MY AREA REPORTED HEARING THE NOISE, BUT NOT TO THE SEVERITY i HEAR IT.
Bacterial Pneumonia  12/08/09 H&P records received for multiple clinic visits with the latest on DOS 07/15/09. DX: Bronchospasm. Pt seen on 06/05/09 DX: Diarrhea. Pt c/o fever for 3 days, vomiting, fluid, mucus, decreased appetite, slight nasal congestion, cough and wheezing. On examination: all systems wnl and breathing: unlabored. Pt to follow up if the condition worsens.
I received J&J vaccine on 31st March. I?m 32 years old woman.  I?m currently out of states, I came to another Country on 9th April. About 2days ago, I observed some tiny spots on my fingers (3 on middle finger, and 1 on ring finger - refer attached image). Also, at the same time I felt little disorientation where I was almost blank for just few seconds. I believe that might be due to empty stomach/low sugar. And then, I?m having a headache today.  After the vaccination, I had a fever of 102.7 degrees for about 2days.  I?m just concerned that this is nothing to worry about. And, if there are some blood tests or scans that I should get done just to be safe.
Injection site reaction starting about 8 hours after injection around the Proquad injection with warmth redness swelling and pain.
On February 14  I had a fever of 102.  I feel cold all night. I took Tylenol. I feel cold all the time. I really high fever. On the 16th I went got a COVID test which was negative. On the 16th my knee from a previous surgery got infected, it was swollen and painful. It was fine before the 16th. I had the surgery back in December. . I am now using crutches to walk. On the 17th my temperature was 104. I feel like numb like both of the arms and mouth and I couldn't breath. On the 17th my friend called EMS and they took me to the Hospital. They  didn't do nothing but check my oxygen and tell me these symptoms are normal for the vaccine. When I went to the ER I told them about my knee but they didn't look at it. I am still have a painful swollen knee and a fever. I have been taking ibuprofen for the fever.
Arthralgia, Fever, NauseaVomiting, fatigue, chills, severe arm pain Narrative:
Information has been received from a physician concerning a 10 year old male, with no pertinent medical history, drug reactions or allergies, who at 15 months of age, on 25-JUN-1998, was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # 625375/0065H). There was no concomitant medication. In approximately 2006, at nine years of age, the patient developed shingles. In 2007, at ten years of age, the patient developed a second episode of shingles. The shingles was treated with acyclovir. The duration of the episode was one week. The shingles rash was described as covering the shoulder and on the neck. At the time of reporting the patient was considered to be "recovering". Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Pt recv vax on 7/8/98; on same day pt exp fever (104.2) x 4 days, 102 fever x 2 days, sore/ red arm x 6 days
Faint; Had vertigo; decreased blood pressure; increased heart rate; A Spontaneous report was received from a consumer concerning, a 67 years-old,  female patient, who received Moderna COVID-19 vaccine (m-RNA-1273) and experienced vertigo and fainted/syncope.  The patient medical history was not provided. No relevant concomitant medications are provided.  On 11 Feb 2021, approximately 15 days prior to the onset of the events the patient received their first dose of mRNA1273(lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021,the patient experienced the events of vertigo, fainted, heart rate increased, and low blood pressure. The patient reported that she took blood pressure medicine and was normal now.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events,  faint, and vertigo, were unknown.; Reporter's Comments: This case concerns a 67-year-old female who experienced a serious unexpected event of syncope along with nonserious events of unexpected vertigo, decreased blood pressure and increased heart rate.  Event onset occurred 15 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
12:09pm: vaccine administered 12:15pm: patient complaint of sweating, jitteriness blood pressure taken (within normal limits) 12:20pm: tongue swelling (EpiPen administered) (911 called 12:25pm:  blood pressure taken (slightly elevated) 12:33pm: ambulance arrives
Administered pediatric dose (0.5ml) instead of adult dose (1ml). Patient will return for additional 0.5 dose today 4/8/22
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history and drug reactions and allergies were not provided. On 28-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis before telling the pharmacist that she had received another dose of ZOSTAVAX)in -2016 (reported as 1 year ago), so the patient had an extra dose administered (route, lot number and expiration date were not provided for any of the vaccines). Concomitant therapies included sterile diluent (STERILE DILUENT). No adverse events were reported.
only sore arm 1st vaccine; This is a spontaneous report received from a contactable consumer. This consumer reported in response to consumer letter sent in the cross-referenced case.  A 71 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Feb2021 (Lot number: EN5318) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hormone therapy", start date: 2020 (unspecified if ongoing), notes: Hormon inhibitor; "Cancer", start date: 2020 (ongoing); "Blood pressure high", start date: 1990 (ongoing), notes: H BP; "Nerve pain", start date: 2019 (unspecified if ongoing), notes: Hip/Leg nerve pain; "Breast cancer", start date: Feb2019 (unspecified if ongoing), notes: Mar2019 Lumpectomy, Apr2019 Lumpectomy; "Lumpectomy", start date: Mar2019 (unspecified if ongoing), notes: Apr2021. Concomitant medication(s) included: LETROZOLE taken for hormone therapy, neoplasm malignant, start date: 2020 (ongoing); PLAVIX taken for hypertension, start date: Oct2020 (ongoing); LISINOPRIL taken for hypertension, start date: 1990 (ongoing); GABAPENTIN taken for neuralgia, start date: 2019 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "only sore arm 1st vaccine".  Additional Information: Patient medical history: Illness/AE: Breast cancer Onset date: Feb2019 Pertinent details: Mar2019 Lumpectomy Apr2019 Lumpectomy. Concomitant drugs: Drug name : Letrozole Reason for use: Harmon inhibitor, Cancer Route: Oral Start date: 2020 Ongoing: Yes. Drug name : Plavix Reason for use: H BP Route: Oral Start date: Oct2020 Ongoing: Yes. Drug name : Lisinopril Reason for use: H Bp Route: Oral Start date: 1990s Ongoing: Yes. Drug name : Gabapentin Reason for use: Hip/Leg nerve pain Route: Oral Start date: 2019 Ongoing: Yes. Vaccination facility type: Other. Vaccination facility address: Available. Relevant tests: None. Dose: 01, Date: 08Feb2021 Site and route of injection: Anatomical site if injection: Left arm Route of administration: Intramuscular Batch/Lot number: Lot# EN5318. Dose: 02 Date: 01Mar2021 Site and route of injection: Anatomical site if injection: Left arm Route of administration: Intramuscular Batch/Lot number: Lot# EN6198. Dose: 03 Date: 05Oct2021 Site and route of injection: Anatomical site if injection: Left arm Route of administration: Intramuscular Batch/Lot number: Lot# FF2587. Only sore arm 1st vaccine 2nd and booster same pain and discomfort (scary). Current or recent cancer (including blood cancers such as Hodgkin disease, leukemias, and myelomas. Specific relevant test for thromboembolic events with thrombocytopenia: None.  No follow-up attempts are possible. No further information is expected.
The patient received the flu shot on a Friday approximately 12/29/2000. Saturday morning the patient's arms and under arms broke out with red spots. In 3 days she was broke out all over her body. She went to the urgent care clinic the doctor said it was hives from the flu shot. She itched badly. She took medication 4 weeks then they were all gone.
Swelling and redness of the left inside arm below the injection site, patient took a couple Tylenol and by 5pm on the 9/3/15 the swelling was going down.  The patient was told to take some Benadryl and let us know if it worsened.
About 30 min after vaccine I developed tingling in my left arm down to my fingers. Around 6pm on 2/16, I developed a headache, stiff neck, and felt as if I was in a fog. I went to bed, woke up at 5:30 am for work. Increased pain to left deltoid, with numbness to left arm. Headache was intense, foggy brain feeling and continued neck stiffness. Motrin taken with little to no relief. Let work after 4 1/2 hour, slept for 3 hours at home. Awoke with increased headache, took Motrin again with fluids and slept until 2/18 am when I awoke with relief of HA. Foggy brain feeling throughout weekend, now with dizziness and continued stiff neck. I was unable to drive due to dizziness. Saturday 2/19, GI symptoms started with diarrhea after meals on 2/19 & 2/20. Monday 2/21, foggy brain and stiff neck remain.
headache, nausea, mild body aches 15 hours after administration; chills (without fever) and total body pain 18 hours after administration; fatigue
On 10/14/2019 after i received the vaccine , immediately once it was administered i could feel a lot of pain . Then that evening the right arm felt sore and although i slept throughout the night i knew there was something wrong as it was sore to lie onto the right arm. The next morning the swelling and redness began to above the elbow . That was 10/15 /2019 . The same day i reported it to the pharmacist on duty. Then on 10/16/2019 the soreness , swelling redness became more distinct and below the elbow. So i went to pharmacy and showed the right arm to the lady pharmacist who was standing in only. I started with Benadryl but stopped after 3 doses . On 10/17/2019 the redness and swelling spread to my hand tuimb and little finger , that night i visited Dr who appeared alarmed and gave me an anti biotic injection plus some antibiotic pills to take for some 10 days . On 10/18/2019 i again visited pharmacy to show the right arm yet again and ask for the information to report the event which was announced to me on the 10/15./2019 by pharmacist but no information was immediately given to me , only on  my asking on 10/18/2019 with the pharmacist. I also requested a copy of the RX of the vaccine which i got .My arm today 10/20/2019 is no longer swollen however ot still feels sore above and below the elbow as i place it to write this e mail on the desk and also when i am asleep i avoid to lie on the right side.
Skin rash on left arm, "Covid Arm."  Patient says that she noticed it the morning of 3/8/21, about 2 weeks after the vaccination was administered.  The rash is a few inches below the site where COVID-19 vaccine was administered.
tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FOSAMAX, start date: Feb2018, stop date: Feb2018; ZILEUTON, start date: Feb2014, stop date: Feb2014. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 22Jan2021, for COVID-19 immunization, reaction(s): "developed an escalation in the intensity of my (relatively minor) tinnitus". The following information was reported: TINNITUS (non-serious), outcome "not recovered". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: adverse event Approx three hours after receiving her first shot on 22Jan2021 she developed an escalation in the intensity of her (relatively minor) tinnitus. Noticed no difference after second Vax and first booster. But three hours after her second booster 08Apr2022 she experienced a very loud intensity of her tinnitus and it has not changed or subsided. This one was life altering. She do not plan to take any further covid treatments. Patient was received other medication in 2 weeks. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
16 x 18cm, red warm indented area (L) thigh at site of injection, stated on vertex soon TID 7 days
1st shot - 10/14/2021 Exposed to Covid - 10/18/21 Tested Postive - 10/22/21 Symptom - swollen and thicken skin on that arm where my shot & fever 103 - 104 on left arm where i had my 1st shot 10/22 - 10/23. Today 10/24 - swollen  is getting better and fever of my arm came down to 98.1 all day. I used cold wet cloth to bring the temperature down. Other than that I don't have any other symptom. Just wanted to know if I am ok! Thank you!!
Pt received first flu vaccine 11/11/16 then returned to clinic on 01/12/17 and received another flu vaccine. Pt notified by MD on 01/17/17 and stated she feels fine with no adverse reactions noted.
TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a pharmacist (PVX2019-290) on 31-Jan-2019. The report describes a female consumer who "took an unrefrigerated dose". The consumer was receiving oral Vivotif (one dose every other day) (lot number: 3003220 and expiry date: May 2019) for typhoid fever prophylaxis.  It was reported that the consumer took the first dose of Vivotif on Monday (28-Jan-2019). Then it was left unrefrigerated for about 45 hours and then she took the second dose on Wednesday (30-Jan-2019).  The action taken with Vivotif with respect to the event "took an unrefrigerated dose" was not applicable.  The clinical outcome of the event "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.
was vaccinated with  Moderna lot#025L20A. At 1355, shortly after arriving to observation area, he reported nausea, light headedness, and "feeling like he was going to pass out". First vitals were BP 91/53 (65), 36.7, 95% and HR-74 and noted to be pale. Denies allergies or past history of issues with vaccines however does report not liking needles. After laying down for 15mins he was noted to be less pale and better able to have conversations. Repeat vitals while siting up 123/80 (93), 97%, HR-85. Pt able to eat crackers and juice. Stayed in room until 1450 then walked around for 10mins and decided to leave. Last vitals 124/90 (102). Education given to call 911 if symptoms return or anything new happens. He was also educated to let staff know about this before getting second dose.
Presented with shortness of breath. She is vaccinated with Pfizer x2 but not boosted. She has had diarrhea for one week and then yesterday developed shortness of breath. She denies any change in smell or taste. In the ED she is sat 90 on room air and now 93% on 4 L NC.