chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Throat itching after second fractional dose of 0.1 mL; regardless of their first dose vaccine, received the Pfizer mRNA COVID-19 vaccine in incremental doses at 30-minute intervals to a cumulative dose of 0.3 mL; This is a literature report for the following literature source(s):   A 68-year-old female patient 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); "Allergic rhinitis" (unspecified if ongoing); "shellfish" (unspecified if ongoing); "peanut allergy" (unspecified if ongoing); "anaphylactic reaction" (unspecified if ongoing), notes: Shrimp, peanut. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE), for COVID-19 immunisation, reaction(s): "Hypersensitivty reaction". The following information was reported: THROAT IRRITATION (medically significant), outcome "recovered", described as "Throat itching after second fractional dose of 0.1 mL"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown", described as "regardless of their first dose vaccine, received the Pfizer mRNA COVID-19 vaccine in incremental doses at 30-minute intervals to a cumulative dose of 0.3 mL". The patient underwent the following laboratory tests and procedures: Antibody test: Unknown result, notes: We compared COVID-19 spike antibody levels before and after administration of the vaccine using graded vaccine dosing; Vaccine excipient test: Negative, notes; SARS-CoV-2 antibody test: Unknown results, notes: measured at least 2 weeks after the procedure; notes: Unit: AU/mL; Negative, notes: less than 50 Unit: AU/mL; Tryptase: 6.4 ug/L. Therapeutic measures were taken as a result of throat irritation.  Additional information: Throat itching after second fractional dose of 0.1 mL. Resolved with diphenhydramine after which protocol was continued.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. 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-PV202200075520 Same article/drug/event and different patient;US-PFIZER INC-202201218786 Same article/event/ patient and different dose;
the patient was administered the first dose of VAQTA ten days before the patient turned one year old.; This spontaneous report as received from a physician concerning to a 11-month-old patient of unknown gender and ethnicity. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant medications were reported.  On 06-OCT-2011, ten days before the patient turned one year old, the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (VAQTA) with lot number reported as 1068AA which has been verified to be a valid lot number for hepatitis A vaccine, inactivated, and with an expiration date not reported, but upon internal validation established as 09-MAY-2014 (strength, dose, route of administration, and injection site were not provided) for prophylaxis (product administered to patient of inappropriate age). No product quality complaint was involved.
Came to the emergency room.  she woke up from the sleep, she was noticing increased secretions, she was short of breath and was wheezing.  She called EMS, when EMS came her pulse ox was 56%, she was placed on CPAP and oxygen, pulse ox went up to 82%.  Patient was placed on BiPAP in the emergency room  Severe mitral regurgitation, class IV CHF symptoms despite medical therapy for her volume overload.  Was transferred to larger hospital due to severity
Lose of appetite two weeks after first shot. Lost about 20 pounds of body weight in 3 days. Extreme pain in mid/lower back affecting basic functions like walking. Pain level was 9/10.  A week or two after the second shot, I had severe pain in my chest. The best way I could have described it at the time was it felt like my esophagus was swollen. I now know fully well it was my heart that was swollen.
chest pain, almost passed out on 8/11, abnormal EKG, nausea, headache. Ended up in ER 8/11
headache; fall; feeling shaky; dizziness; concussion; blurry vision; This case was reported by a consumer via call center representative and described the occurrence of fall in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included fall (history of falls) and stroke. Concurrent medical conditions included type i diabetes mellitus and peripheral vision defective (no peripheral vision as result of stroke in 2013).   On 26th September 2019, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 27th September 2019, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced fall, shaky feelings, dizziness, concussion and blurred vision. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the fall, shaky feelings, concussion and headache were not recovered/not resolved and the outcome of the dizziness and blurred vision were recovered/resolved.   The reporter considered the fall to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. It was unknown if the reporter considered the shaky feelings, dizziness, concussion, blurred vision and headache to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional information received were as follows: The reporter was the patient's wife. The patient received Shingrix and Flu vaccine on unknown arm. On Friday, in the morning, the patient fell and bumped his head. As a result of the fall, the patient developed blurry vision, dizziness, feeling shaky and a concussion. The caller stated that she took the patient to the emergency room. Less than a week after vaccination, the patient expereinced headache. The patient was still feeling a little shaky and had a dull headache. The caller stated that she believed he fell because he received both vaccines at the same time, the day before. The reporter consented to follow up.
Flu shot was given Oct 2nd, 2013. Since the shot I was unable to lift my left arm above my waist. November 8, 2013 I was unable to move my left arm at all. I went to ER. The ER Dr. sent me to another hospital to an ortho who specializes in shoulders, who administered a steroid shot in my left shoulder. As of today Dec. 9th, 2013 I still do not have full use of my left arm.
No adverse event; During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm; During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm; This spontaneous case was reported by a patient and describes the occurrence of DEVICE CONNECTION ISSUE (During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm), UNDERDOSE (During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Patient had received 5 doses of the Pfizer COVID-19 vaccine previously.). Past adverse reactions to the above products included No adverse event with Pfizer.    On 22-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Sep-2023, the patient experienced DEVICE CONNECTION ISSUE (During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm) and UNDERDOSE (During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm) and UNDERDOSE (During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm) had not resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for DEVICE CONNECTION ISSUE (During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm) and UNDERDOSE (During his administration today part of the vaccine sprayed or leaked out of the syringe and onto his arm).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Felt fatigued; Nausea; Chills; Muscle ache; Really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt fatigued), NAUSEA (Nausea), CHILLS (Chills), MYALGIA (Muscle ache) and HEADACHE (Really bad headache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included GALCANEZUMAB GNLM (EMGALITY [GALCANEZUMAB GNLM]) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FATIGUE (Felt fatigued), NAUSEA (Nausea), CHILLS (Chills), MYALGIA (Muscle ache) and HEADACHE (Really bad headache). On 20-Jan-2021, FATIGUE (Felt fatigued), NAUSEA (Nausea), CHILLS (Chills), MYALGIA (Muscle ache) and HEADACHE (Really bad headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Systemic: Lymph Node Swelling-Mild, Additional Details: underarm lump for 7 days
A day later after the vaccine, pain started with the arm, neck and right shoulder. After three days after the vaccine severe pain in the ear, nostril, larynx and neck left side, including severe headache for the next 5 days. As the pain decreases, a notable type II degree II facial paralysis is generated on the left side. Two days after performing muscular facial and muscular exercises, a decrease begins to be noticed. To date the affected person also has pain in the neck, shoulder and arm
Patient received 5 covid shots: 2/25/21  Moderna  3/25/21 Moderna 7/31/21 Pfizer 11/26/21 Moderna Booster 12/2/21 Moderna Vaccine clinics patient presented to provided cash incentives. Patient reports no adverse events.
I went limp in my left arm and side of body. I was shot in right side of arm. I have been having numbness, pain, and soreness on that side. I also had my menastration come on after 12 years - 2 days later of taking the shot for 3 days.
This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial was removed from the freezer at 8AM on 11Oct2021.  Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-364617 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-364617:cross-linked to MOD21-157109 (MOD-2021-364617)
pt recv vax 24AUG94 & following vax devel a blotchy red rash on face & trunk; rash was raised & palpable; no wheezing or resp distress; given DPH & APAP; pt recovered;
swelling of muscle/tissue and joint pain distal to injection site. No cellulitis or s/s of infection noted. No systemic c/o's.  Tx with anti-inflammatory OTC's and ice.
arm still hurts on the same arm of injection; Lightheadedness, Dizziness; Little nausea; Body ache/muscle ache; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm still hurts on the same arm of injection), DIZZINESS (Lightheadedness, Dizziness), NAUSEA (Little nausea), MYALGIA (Body ache/muscle ache) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm still hurts on the same arm of injection), DIZZINESS (Lightheadedness, Dizziness), NAUSEA (Little nausea), MYALGIA (Body ache/muscle ache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form once a day. At the time of the report, PAIN IN EXTREMITY (arm still hurts on the same arm of injection) had not resolved and DIZZINESS (Lightheadedness, Dizziness), NAUSEA (Little nausea), MYALGIA (Body ache/muscle ache) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-103303 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103303:Boyfriend's case
7 days after injection, I have a red welt about 2" x 4" at the injection site. It is warm to the touch and itchy. As of today, the size has grown outside of the initial area that we marked on my arm with a pen by about 1/4".
Pt recvd 2 Engerix-B vax 30APR91 recvd 1st dose 1MAY91 & exp intestinal discomfort/intestinal agony, gall baldder disease;21 hrs p/GI pain hives occurred; t101, tightness in chest, bronchial bark; Pt exp same events w/2nd dose 1JUN91;
Pt called said she has a golf ball sized lump in her arm at injection site with pain in entire arm down to finger.
pt recv vax;2 wk later, devel swollen lymph nodes & conjunctivitis;swollen lymph nodes lasted for 2 wk;
Information has been received from a female consumer with unspecified allergies and hypercholesterolemia who on 12/1/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included levothyroxine Na, metoprolol succinate, clopidogrel bisulphate and fluvastatin sodium. On 12/2/04, the patient developed swelling in her arm, lymph nodes and chest. On 12/3/04, the patient was administered a steroid shot and an antibiotic. No diagnostic studies were performed. On 12/10/04 the patient recovered. No product quality complaint was involved. The reporter indicated that swelling of arm, lymph nodes, and chest were considered to be other important medical events (OMIC). Additional information has been requested.
Hospitalization for COVID-19 Reported per Moderna COVID-19 Vaccine EUA
Headache, Arthralgia, Fever, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE, JOINT PAINS Narrative:
Patient received the monovalent vaccines as a booster dose. No adverse reaction noted. Patient notified.
This spontaneous report as received from a Licensed Practical Nurse and Office Manager refers to a female patient of unknown age. On 21-APR-2013 the patient was vaccinated with ZOSTAVAX lot # J000444, in deltoid area (dose and route was not reported). On an unknown date in 2013, after vaccination, the patient experienced reaction at the injection site (deltoid area), which was red, with swelling and heat. The patient was diagnosed with cellulitis and was treated with MEDROL patch. The outcome of events was reported as recovered. The relatedness between event and ZOSTAVAX was not reported. The Licensed Practical Nurse stated that pharmacy had quarantined the ZOSTAVAX vaccine with the Lot number J000444. This is one of several reports from the same source. Additional information has been requested.
Slight swelling with an open ulcer, with slight drainage since 01/04/2018.
Fever- started at 99.4 (5:00 a.m.) increased to 100.8 within an hour.  Roughly about 2 hr increments the fever started to reduce 100.6, 99.6, 99.0, 98.7 to normal with no fever reducer medication.  Body aches- started when temp got to 100.8 and lasted about 12 hrs.  Tired- started after temp was reduced to normal and gradually got more tired as the day went on.  Woke the next day with no symptoms
prolonged febrile sz w/in 12hrs of receiving vax;2nd sz in the hosp; recvd Ativan & phenobarb to control szs; t105
Information has been received from a 61 year old female with allergy to DEMEROL and influenza vaccine who on 10-JUL-2008 (also reported 11-JUL-2008) was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included MAXALT. On 22-JUL-2008, the patient developed a swollen, red and warm area about the size of a baseball on her left arm at the site of injection. The area burned and itched. The patient visited a pharmacist. No laboratory diagnostics studies were performed. At the time of report, the events persisted. Additional information has been requested.
Chest pain, left sided.  Patient went to the ED, two times, 9/22 and 9/25.
Gardasil #3 given on 5/9/12 in right deltoid. Mother called 5/11/12 stating patients right deltoid was red, swollen, painful and hot to touch. Client states CC was pruritus. Mother gave Ibuprofen, ice pack and Benadryl cream. Advised to seek medical attention if worsens.
Central induration 5 cm x 4 cm. Peripheral erythema 12 cm x 7 cm. Pain & itching.
Delayed onset altered mental status, Bradycardia followed by shock/hypoxia. Successfully tx with Epi/Diphenhydramine/Methylprednisolone/IVF/O2.
I've had high pulse and blood pressure. Went into hospital and they had 90 pulse and highish bp. Its hard to see my doctor because she is quitting. I also self tested at numbers grocery stores and it just stays high. If you know if I can get a booster with this condition please call. I prefer to stay safe but concerned the high BP will persist if I get a booster.
Breakthrough case admission after 4 vaccines Moderna 2/3/21 Lot# 026L20A;  Moderna 3/3/21 Lot# 030L20A;  Moderna 10/27/21 Lot# 939906;  MOderna 4/21/22 Lot# 057M21A
I started with congestion and post nasal drip. I also had a cough and fatigue. It got worse on Friday, My husband had COVID-19 already so I tested 3 times on Monday June 20th and the 21st and both were negative. On that Wednesday we went to a walk in Clinic and had a PCR on June 22nd which was negative. I took another test on Friday the 24th which also was negative. On the 25th in the morning, I took another test and it was positive. By Saturday I felt really lousy and had a fever of 99. I took Tylenol, Cough medicine and an inhaler that I had been prescribed from a previous illness. I still have nasal congestion but the cough is very sporadic and I no longer have fever. The fatigue has lessened but I am still recovering.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a adult female patient who received SHINGRIX for prophylaxis. On 27th February 2019, the patient received SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced muscle pain, headache and tiredness. On an unknown date, the outcome of the muscle pain, headache and tiredness were unknown. It was unknown if the reporter considered the muscle pain, headache and tiredness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experiencing muscle aches, headache, and tiredness. The reporter consented to follow up. The caller hung up on me after answering the PI question. No details to adverse drug event.
Pulmonary embolism dx 1 week after 2nd shot-Symptoms started soon after 2nd shot
patient received the vaccine around 10:45AM and  initially experienced soreness at the injection site and general malaise throughout the day.  At 2 AM woke with reports of shortness of breath and that she felt lightheaded.  She then had a syncopal event that was about 30 seconds long- had possible seizure like activity and was taken to the emergency room.  At that time had swelling at the injection site as well as continued soreness.
pt recv vax 26FEB98 & 3MAR exp h/a, n/v, diarrhea, lethargy, fatigue;also xp sore throat, cough, upset stomach;abd pain;T101-102;dxgastroenteritis;pt lost energy & very weak;convuls;sl tender lymph node;heart murmur;
This is a spontaneous report from a contactable pharmacist.  A female patient of an unspecified age and ethnicity received PREVNAR 13 on an unspecified date at single dose for immunisation.  Medical history included egg allergy. The patient's concomitant medications were not reported. On an unspecified date the patient experienced a rash on her right arm, it was about the size of a hand which was red and hot to the touch. The rash hurt and the patient had aches and itches. Events outcome was unknown. The reporter considered there was a reasonable possibility that the events were related to the suspect vaccine.
pt recvd vax & exp positive anti-HBs & pos surface antigen; No further details were provided;
Pt recv vax on 12/28/98; on 1/1/99 pt exp upper respiratory infection, seizure-jerking, eyes rolled back,slept afterwards, fever
Information has been received on 15-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 06-JUN-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a hospital as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster the very virus the ZOSTAVAX is intended to prevent. On or about 27-JUN-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Patient experienced syncope with jerky movements of arms and eye rolling reported by mother. Patient appeared pale and diaphoretic. Vital signs normal; heart rate slightly low, but returned to normal.