chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suffered from more side effects with the booster than with the primary series; Experienced chills; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Suffered from more side effects with the booster than with the primary series) and CHILLS (Experienced chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Suffered from more side effects with the booster than with the primary series) and CHILLS (Experienced chills). At the time of the report, IMMUNISATION REACTION (Suffered from more side effects with the booster than with the primary series) and CHILLS (Experienced chills) outcome was unknown.            No concomitant medication was reported. No treatment medications was reported.   This case was linked to MOD-2022-560211 (Patient Link).   Reporter did not allow further contact
Initial misuse report received from a healthcare professional on 19 February 2013. A patient (no other information was provided regarding the patient) had inadvertently administered the ACT-HIB diluent on an unspecified date. No adverse event was reported. List of documents held by sender: none.
stabbing chest pains; chest pain; really bloated; blood pressure incresed; cannot eat very well; body aches; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANGINA PECTORIS (stabbing chest pains) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (stabbing chest pains) (seriousness criterion hospitalization), CHEST PAIN (chest pain), ABDOMINAL DISTENSION (really bloated), BLOOD PRESSURE INCREASED (blood pressure incresed), DECREASED APPETITE (cannot eat very well), MYALGIA (body aches) and PYREXIA (fever). The patient was hospitalized from 01-Apr-2021 to 03-Apr-2021 due to ANGINA PECTORIS. At the time of the report, ANGINA PECTORIS (stabbing chest pains), CHEST PAIN (chest pain), ABDOMINAL DISTENSION (really bloated) and DECREASED APPETITE (cannot eat very well) had not resolved and BLOOD PRESSURE INCREASED (blood pressure incresed), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) high.         No concomitant medications were reported. The reporter states that the patient was given metoprolol in the hospital which was discontinued by her primary care physician,lorazepam by one physician who suggested that she may be having anxiety and was prescribed omeprazole by a gastroenterologist. Action taken with mRNA-1273 in response to the event was not applicable.  This case concerns a 72-year-old male with a serious unexpected event of herpes zoster. Event onset 8 days after first dose mRNA-1273. Event resolved with dexpanthenol and chlorhexidine. 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.; Sender's Comments: This case concerns a 72-year-old male with a serious unexpected event of herpes zoster. Event onset 8 days after first dose mRNA-1273. Event resolved with dexpanthenol and chlorhexidine. 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.
have COVID; have COVID; bone-crushing-pain; fever; This is a spontaneous report from a contactable consumer reporting for a patient (nurse).  A 47-year-old female patient received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 20Dec2020 for immunization. The patient's medical history concomitant medications were not reported (unknown). Patient was an ER Nurse and took first dose of vaccine and then described mild/moderate symptoms on day one only. On 23Dec2020, patient posted they have COVID (positive COVID test). Contracted from spouse who got it from work. She further described it as "hit by a truck." On Day 4 she describes her COVID symptoms: bone-crushing-pain when fever rises. Symptoms were COVID symptoms, not directly related to vaccine. The events/symptoms started on 20Dec2020. Patient had no Covid prior vaccination. The patient was COVID tested post vaccination. The patient considered the events as non-serious. The outcome of events was not recovered.  Information on Lot/Batch number has been requested.
Woke at 11:30pm with chills and fever.  Kept me up the entire night with chills, headache, naurseaous.  Vomited next day around 5pm but felt fine with in 24 hours.  No other symptoms.
Headache, Myalgia, Fever, NauseaVomiting, Chills, soreness L arm Narrative:  Tmax 101 F
Patient informed me via Instant Message that she had a reaction to her 2nd dose of PFE vaccine...it exacerbated her asthma.  She saw her PCP March 25, 2021 who sent her on to the ER where they ga; Patient informed me via Instant Message that she had a reaction to her 2nd dose of PFE vaccine...it exacerbated her asthma.  She saw her PCP March 25, 2021 who sent her on to the ER where they ga; This is a spontaneous report from a contactable consumer. This consumer reported for patient that. An unspecified age female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP7534), via an unspecified route of administration on 19Mar2021 as Dose 2, SINGLE for covid-19 immunization. The patient medical included asthma from an unknown date. The patient concomitant drugs include Prednisone 60 mg start date and stop dates were unknown. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: ENG202) on 26Feb2021 for covid-19 immunisation. On 20MAR2021 the patient experienced Coughing and asthma. She used an inhaler for 5 days but it wasn't working that well. When she called her doctor, they suggested that she go to the ER. She has a past medical history of asthma but has not had an episode this bad since she was a child. At the ER on 25Mar2021 she was tested for Covid and resulted negative, Flu, and X-ray they were all in normal range. She received 60mg of prednisone in the hospital and was released on a 5-day Prednisone starting with 50mg and then going down. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
pt recvd vax 9AM 15SEP93 & mom states pt became extremly irritable, crying (uncontrolably); pt taken to MD 415PM by this time pt was beginning to settle; remained @ MD office for observation 5PM fretful;
soreness at the injection site; This is a spontaneous report from a contactable consumer or other non hcp. A adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 26Feb2021 as dose 1, single for covid-19 immunisation. Medical history included cystic fibrosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was unknown that the patient receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. On 26Feb2021 the patient experienced soreness at the injection site. The patient did not received treatment for the adverse reaction. It was unknown if patient had been tested for COVID-19 since the vaccination. Outcome of the event was recovering.  No follow up attempts are needed. No further information is expected.
This spontaneous report as received from a regulatory authority refers to a 14 year old female patient. The patient had no medical history and current illnesses. The patient's other medications and prior vaccinations were not reported. On 09-MAY-2016, the patient was vaccinated with third dose of GARDASIL 9, route of administration: through needle and syringe (not specified), in the right arm (dose, frequency, lot number and lot expiration date were not reported) for prophylaxis. On 10-MAY-2016, the patient experienced severe pain throughout back. The outcome of back pain was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown ages and gender. On an unknown date, the unspecified number of patients received an improperly stored dose of PNEUMOVAX 23 (dose, lot #, expiration date and route were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
A 17yo was scheduled for vaccination via invite link shared with his parent's dental office. His parents signed consent for him to receive the vaccine and the patient was able to slip in through the system unnoticed. Pt has not reported any side effects or adverse outcomes to us.
lump under her chin; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (lump under her chin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (lump under her chin). At the time of the report, SKIN MASS (lump under her chin) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported . No treatment medication was reported .   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: followup received on 25-may-2021 No new information was reported .
This spontaneous report was received from a female patient of unknown age, reporting on herself. Information regarding her medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with GARDASIL. Patient reported that recently on an unknown date, she was diagnosed with human papillomavirus (HPV). Thus, she inquired why Merck does not manufactures a vaccine to protect against all strains of HPV. Outcome of the event was unknown. Causality assessment was not provided. Additional information is not expected as the reporter did not wish further contact.
redness extending up arm into neck/face; Swelling  extending up arm into neck/face; A spontaneous report was received from a physician for a patient of an unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and had experienced erythema (redness extending up arm into neck/face) and swelling (swelling extending up arm into neck/face).  The patient's medical history was not provided. No concomitant product use was reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient had experienced redness and swelling that extended up arm into neck/face.  Treatment information was unknown.  Action taken with mRNA-1273 was unknown.  The outcome of the event, vaccine was administered to a 16 year old, was unknown.
No Covid-19 symptoms. Patient presented with a UTI. Tested positive for Covid-19 on 7-31-2021 with an Antigen test. PCR tests for Covid-19 were negative on 7-27-21, 8-5-21, 8-21-21, 9-7-21. Patient was hospitalized at Hospital from 7-27-21 through 7-31-21; was discharged to Skilled Nursing and Rehabilitation Care.
Patient had rash down left arm. Treated with IM dexamethasone at urgent care facility. Patient speaks little English and would not wait for translation, could not verify any other information.
SKIN REACTION Delayed reaction rash that is still coming and going after receiving the 1st dose on 21January2021; itcht rash in axillary region after the 2nd dose; Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (SKIN REACTION Delayed reaction rash that is still coming and going after receiving the 1st dose on 21January2021), PRURITUS (itcht rash in axillary region after the 2nd dose) and RASH (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (SKIN REACTION Delayed reaction rash that is still coming and going after receiving the 1st dose on 21January2021), PRURITUS (itcht rash in axillary region after the 2nd dose) and RASH (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021). At the time of the report, SKIN REACTION (SKIN REACTION Delayed reaction rash that is still coming and going after receiving the 1st dose on 21January2021), PRURITUS (itcht rash in axillary region after the 2nd dose) and RASH (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021) outcome was unknown.            Treatment information were not provided.  No concomitant medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-098115 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Email attached on 29-MAY-2021contains significant information. One event updated. On 31-May-2021: Follow up received on 31-MAY-2021 contains Non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098115:1st dose
PATIENT DEVELOPED ACUTE DYSPNEA, WITHIN FEW HOURS AFTER TAKING BOOSTER SHOT, WHICH GRADUALLY PROGRESSED AND CULMINATED IN HOSPITALIZATION WITH ACUTE HYPOXIC RESPIRATORY FAILURE.
pt recvd vax 15NOV93 & 17NOV93 about 1 hr p/receiving TB skin test; sx started w/severe back pain, generalized aching, h/a, nausea; lasted 4 days;
Left brachial plexopathy with weakness of left arm (Parsonage Turner Syndrome)
Her temp got up to, she think it was to '38.7'; Muscle ache but at the injection site for sure; Neck pain; Chills; headache; This is a spontaneous report from a contactable nurse (patient).  This 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK4176), via an unspecified route of administration, on 02Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 63-years-old. Medical history was none. Concomitant medications were unknown. Nurse stated she got her shot yesterday in the morning on 02Jan2021. So, she had had just muscle ache but at the injection site for sure and headache, neck pain and then last night starting around 6 O'clock fever and chills. Her temp got up to, she think it was to 38.7 (not clarified further) was when she finally tried to get out of bed to take it. So, she is taking Tylenol a 1000 mg around the clock every 6 hours. The patient is feeling much better but she doesn't want to go through another night like that. Outcome was unknown.   For the reporting nurse fever and chills were related to the vaccine.
12/29/2020 hives hand, legs, glutes --  Benadryl in PM. 12/30/2020 hives have coursed to entire back area and some on scalp -- Zyrtec and Prednisone  40mg medication. Symptoms have not resolved
Nausea beginning 11/13/21, 7:30 am Vomiting beginning 11/13/21, 7:30 am Fever beginning 11/13/21, 11:00 am  Tylenol administered
Blisters in mouth. Flu-like symptoms (severe) x 2 wks. 101 degrees temperature.
Approximately 25 minutes after vaccine administration, client reported left-sided chest pressure, non-radiating and no pain. Client hypertensive (164/84) and other vitals within normal limits. Emergency medical services were alerted and assumed care of client. Client refused transport to hospital and was escorted off premises and walked unassisted with steady gait. Client was educated on vaccine side-effects, advised to seek follow-up with primary care provider, and provided information on VSAFE.
Initially back of left arm injection site was sore; redness started on Wednesday 3/27; by Friday 3/29, larger welt developed.  Now hot to touch, sore, itchy, approximately 2 inches in diameter.
Fever, chills, nausea, headache, fatigue lasted 3 days. Redness and swelling on most of upper arm, soreness from shoulder halfway down upper arm lasted 5  days.
Angioedema; chest tightness; SOB; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar events for different doses. This is the second of two reports. A 56-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8734) administered in right arm on 07Apr2021 at 18:00 (at the age of 56-years-old) at single dose for COVID-19 immunisation. Medical history included prior history of idiopathic angioedema, several other antibiotics allergies - rash, hornet and wasp sting allergies; no chronic health conditions. Patient was not pregnant. No COVID prior vaccination; no COVID tested post vaccination. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken at 50 mg for 3 for 12 hours pre-dose; no other vaccine received in four weeks. The patient previously took ZITHROMAX and experienced allergies - anaphylactic; the patient received the first dose of BNT162b2 (lot number: EP7534) on 17Mar2021 at 06:00 pm (at the age of 56-years-old) administered in the right arm for COVID-19 immunisation and experienced angioedema. The patient experienced angioedema, chest tightness, shortness of breath (SOB); initial reactions started around 12:00 noon on 08Apr2021, slowly continued to get worse throughout the day. Had to go to emergency room (ER) that evening. Angioedema reoccurred the following night and again on 10Apr2021. Another trip to ER on 10Apr2021 due to angioedema, chest tightness and SOB. The events were treatment with BENADRYL, SOLUMEDROL IV, PEPCID IV, nebulizer. The patient had recovered from the events in Apr2021.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Angioedema, Chest Tightness and shortness of Breath. Consider also possible contributory effects from patient's medical history 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. ,Linked Report(s) : US-PFIZER INC-2021330573 same patient, vaccine different dose
48 hours after vaccine,  area became red, hard, painful, warm and swollen.  Area was mapped at that time, measured 7x7 cm. Reddened area became bigger next day and more painful, measured 9x9 cm. Employee health called  72 hrs after vaccine who directed me to call  PCP. On call provider directed me to take antihistamine, apply ice and OTC steroid cream. I took loratadine and diphenhydramine and used ice. Next days swelling and pain better. One week later, there is some remaining itchiness but no redness, pain or swelling.
Shortness of breath, congestion/cough, low grade temp, chills, headache, joint/muscle aches, fatigue, arm pain/swelling/bruising/redness.
I was woken up middle of the night with unbearable pain in my lower back on Sunday morning, 1am. There was no activity that cause the flair, and the pressure in my lower spine (just above tailbone)  felt like my lower back would burst. The shock to my spinal system each time my back seized,  caused the pain to shoot from a steady 2 straight to a 10 on the pain scale, and I was losing complete motor function temporarily. I was treated by Dr. on 5/29. I was given some pain medication and steroid injection cocktail, and a Rx  of Methylprednisolone and Cyclobenzaprine. This is helping considerably. I can function almost normally now, but even while taking the medication, I can still feel a lot of pressure. I believe I am recovering, but until I am off the medication, I will not know for certain. Please ask me for a follow-up in a month or so.
Mom called up on 3/6/03 and stated her child broke out with generalized chickenpox.
approx 830PM on 5DEC95 pt began intermittent jerks mom later reported limbs stiffening than relax x 4-5mins;afterwards pt went into a deep sleep;referred to local hosp;nl exam;active & playful
Diagnosed as Angioedema; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EL9265) via an unspecified route of administration on 28Jan2021 10:00 into left arm at a single dose for COVID-19 immunisation. The patient medical history included Hypersensitivity Pneumonitis (PF-ILD) Interstitial Lung Disease and the patient allergies to Lisinopril, meclizine, and Bactrim. There is no other vaccine was administered in four weeks. There is no COVID prior to vaccination. Concomitant medications within two weeks included nintedanib, atorvasatin, Vitamin D3, cyanocobalamin (VITAMIN B12) and acetylsalicylic acid (ASPRIN). The patient diagnosed as angioedema on 30Jan2021 and result in emergent room/department or urgent care. The patient awoke on 31Jan2021 with facial swelling, lip swollen right side of face. No swelling of throat. The patient received methylprednisolone (Solu-MEDROL) injection 125mg, tranexamic acid (CYKLOKAPRON) 1 g in sodium chloride 0.9% 100 ml IVPB (mini-bag plus) as treatment. The patient did not test COVID post vaccination. The outcome of the event was recovering.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.