chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 40-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EP6955), at the age of 40, via an unspecified route of administration, left arm, on Apr 13, 2021, at 09:15, single dose, for COVID-19 immunisation. Medical history included asthma. Concomitant medications included Albuterol (salbutamol) for unknown indication from unknown date and unknown if ongoing. The patient previously received Aspirin and Tussionex for unknown indications and experienced drug allergy. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 13, 2021, patient experienced arm soreness, brain fog, muscle aches and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures taken as a result of the arm soreness, brain fog, muscle aches and fatigue included treatment with Tylenol. The outcome of arm soreness, brain fog, muscle aches and fatigue: recovering (at the time of this report). No follow-up attempts needed. No further information expected.
Shortness of breath started on Wednesday afternoon.  Right deltoid slightly swollen, no rash present at that time.  Short of breath with no activity.  Muscle aches, fatigue, just felt off.  Then arm was very sore.  Sunday night my arm pit really started hurting.  Hurst over my shoulder, clavicle, and down into the lateral side of my breast.  Bothered enough in the night that I didn't sleep well.  This morning 1-5-21 I have a red rash over the injection site, arm is swollen over deltoid and hot.  Arm pit and down into breast is still hurting significantly.  I took Ibuprofen yesterday and helped some with pain in arm pit.  Off an on SOB and chest feels tight.  No cough
shoulder pain; swelling; REDNESS; Pt. jerked away and incomplete dose was injected.; This case was reported by a other health professional via sales rep and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced shoulder pain, swelling, erythema and accidental underdose. On an unknown date, the outcome of the shoulder pain, swelling, erythema and accidental underdose were unknown.   It was unknown if the reporter considered the shoulder pain, swelling and erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient jerked away and incomplete dose was injected, which led to accidental underdose
This spontaneous report was received from a licensed practical nurse reporting on herself a 62 year old female patient with previous case of shingles and drug reactions and allergies to TALWIN, BENTYL and Vancomycin. In approximately june 2016 ("reported as about 2 months ago" (prior to 5-AUG-2016)) the patient was vaccinated with ZOSTAVAX 19400 PFU(dose, lot number, expiration date not reported) subcutaneously. Patient'sconcomitant medications included Atenolol, LEXAPRO, zolpidem(manufacturer unknown), Lisinopril(manufacturer unknown) and BONIVA. Subsequently on unspecific date in June 2016(reported as "within 24 hours") after administration of ZOSTAVAX 19400 PFU she developed a red, raised area 3 inches in diameter around the injection site in her left arm which was warmth to the touch and "hurt like hell. The patient also developed a rash around the injection site. The patient sough medical attention by visiting the physician on unspecified date in 2016, but none labs diagnostic studies were performed nor treatment was given. It was reported that the red raised area, warmth and pain at the injection site resolved "after about a week" (recovered unspecified date in 2016). The rash persisted for "several weeks" until it began "fading" (recovered unspecified date in 2016). The patient also reported that the skin where the rash was, is now discolored, described as lavender in color and "very noticeable"(not recovered). The nurse did not think the discoloration was due to the scarring.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Dyspnoea" (unspecified if ongoing), notes: other medical history: shortness of breath. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine was received. Other medication in 2 weeks: Yes. No known allergies. Other medical history: shortness of breath  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I got my shot, sat down, and was reading through the information that the clinic provided me. A few minutes after, I noticed my right arm was getting warm, but I thought I was being paranoid (placebo effect). I began to feel nauseated. About another 5 minutes after feeling warm and nauseous, my ears began to ring and my vision went white. I was cold but sweating. I have passed out a handful of times before for various reasons, so I knew what was happening. I tried to signal to a volunteer from my seat that I needed help, but I ended up laying on the ground by my chair before someone came over. Once I laid down, the attention of the volunteers and nurses was on me. Three came over to assist me. They held my legs up,  kept a hand on my wrist for a pulse, and fetched water. I talked myself through the dizziness and ringing in my ears. They put a cold rag on my forehead and had smelling salts on hand. Once I began to feel better, they helped me slowly sit up, and eventually helped me stand up and get into a chair. They kept a close eye on me for the next 30 minutes to make sure I didn?t have any other reactions.
No adverse event; Patients had been administered with the Moderna vaccine which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine which were beyond the 30 day beyond use date).    No concomitant medication was reported. Patient received vaccine from lot 042J21A with a BUD of 17-Feb-2022. The time for expiry date was reported as 12 am. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live followup received contains updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Approximately 4 inch circular area of redness to left upper arm. Patient reports area feels warm. Afebrile.
Evening of shot (Sept 29)? started feeling fatigued.  Pain, heat, swelling at injection site Sept 30 ? more fatigued.  Redness in 2 spots just below injection site (one was quarter size and other was half dollar size). More painful and swollen.  No fever. Oct 1 ? very fatigued.  Pain in leg and back muscles and joint pain.  Painful to walk.  Redness in left arm much larger area.  Swollen and painful and very itchy.  Had to stay in bed all day.  Took naps.  By nightfall, pain in muscles and joint substantially subsided.  Arm pain, swelling and itching continued. Oct 2 ? very little fatigue.  No more pain except for arm, where redness grew in size and swelling, pain and itching continued.  I took a photo. Oct 3 ? fatigue and muscle/joint pain gone.  Redness on arm even larger area and swelling, pain, and itching continued.  Took another photo. Oct 4 ? redness on arm about same, possibly a tiny bit lighter, still very sore and itchy.
felt bad; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose on an unknown date and had pain and burning sensation, refer case US2021AMR190657).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not reported. The patient received 2nd dose and felt bad for about 18 hours. The patient had no issue since, about 5 years. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR190657:same reporter
Menstrual cramps, crippling to the point of needing a heat pad followed by my period/bleeding all on March 31, 2021 after second vaccine. Last ending date of menstrual cycle was 3/10/2021
L posterior upper arm w/ moderate erythema 1.5cm x 1cm soft/warm to touch - pt seen in office 3/24/11 per provider use BENADRYL Q4-6 hrs - alternate warm and cool compresses.
Scaly patch and bumpy rash at site of injection on thigh. Was not noticeable at first, but very prominent now, has lasted for days.
she had 4 cycles in a month.; This is a spontaneous report from a contactable female consumer. This consumer is reporting for 5 Patients. These one of the 5 reports (Sister's friend).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date, the reporter stated that "Her sister's friend is a nurse and said she experienced the same after the 2nd dose: she had 4 cycles in a month". The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information was received from a health professional regarding a patient (demographics unknown), who on an unknown date, was vaccinated with VARIVAX (Merck) lot #J003221, expiration date 15-MAR-2015, that had been improperly stored. The outcome of improperly stored vaccination is unknown. This is a corrected report. On 23-SEP-2013, information received from a registered nurse stating that VARIVAX (Merck) was exposed to unknown temperatures for 5 hours during interoffice transport. No adverse symptoms reported. The patient was revaccinated. This is one of several reports received from the same source: 1311USA000056, 1310USA014891, 1310USA014881, 1310USA014883, 1310USA014888, 1310USA015417, 1311USA000071, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000021, 1311USA000020, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739, 1311USA000040, 1310USA015096, 1311USA000642, 1310USA014958, 1311USA000072, 1310USA015127, 1311USA000053, 1311USA000085, 1311USA000741, 1311USA000744, 1311USA000083, 1310USA015141, 1311USA000006, 1311USA000005, 1310USA014900, 1310USA015268, 1310USA015264, 1310USA014896, 1310USA014909, 1311USA000627, 1310USA015396, 1310USA015270, 1311USA000637, 1310USA014962, 1311USA000039, 1311USA000037, 1311USA000034, 1311USA000032, 1311USA000002, 1310USA014897 and 1309USA011086. Additional information is not expected.
2 x 2 cm raised, red, warmed, well defined area on left anterior thigh. No treatment.
ARM PAIN, REDNESS, SWELLING. ARM PAIN HAS PERSISTED X 6 MOS AFTER VACCINE.  PERSISTENT NASAL DRYNESS FOR 5 MONTHS AFTER RECEIPT OF VACCINE
Whole body convulsion or seizuring which lasted 4 hours.  Coma induced with phenobarbital for 3 days and 3 nights.
having headaches; still-- bundled in a blanket, feeling punky; feeling funny; Initial information received on 25-Oct-2022 regarding an unsolicited validnon-serious case from a consumer/non-hcp.  This case is linked to case 2022SA447771(CLUSTER).  This case involves a 70 years old male patient who experienced having headaches, still-- bundled in a blanket, feeling punky and feeling funny while receiving vaccine influenza vaccine (quadrivalent).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 11-Oct-2022, the patient received suspect influenza vaccine (quadrivalent) produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination(immunisation).  On an unknown date the patient developed a non-serious having headaches (headache), still-- bundled in a blanket, feeling punky (malaise), feeling funny (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE (QUADRIVALENT).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Not Recovered / Not Resolved for all the events.
Approximately 12 hours of nausea, vomiting, lower back pain, headache, and cold sweats.  Rest, fluids, and advil took care of symptoms.
pain under right armpit; swelling under right armpit; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 07Apr2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included unspecified birth control, unspecified allergy medications; all for unknown indication from unknown start date. The patient had no allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 02:00, the patient woke up with pain and swelling under right armpit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event pain under right armpit and swelling under right armpit was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
first rash, then large hardened red area with a lesion-looking red mark, all in all approximately 5" diameter
Patient was given the first dose of Moderna Covid 19 vaccine which is indicated for persons 18 and older. Patient and their guardian was notified and understood. Patient did not experience any side effects or symptoms after the vaccine. They were monitored for 15 minutes at the pharmacy and followed up with over phone.
3 days, post vax, had 5cm x 8cm indurated area at site of injection. Complained of arthralgias x one week.
Patient received the Pfitzer BioNTech Covid-19 vaccine EUA at 1:00 pm. At approximately 1:05 , the patient had a syncopal episode and fell face forward from his chair hitting his face on the floor. The patient regained consciousness immediately and was assessed for injury and other reactions. Instructed patient to lay on back and elevate feet on chair. Patient was pale and diaphoretic  and reported feeling light headed. Vitals at 1:10pm B/P 143/92 HR 74, o2 % 96, Resp: 20 , Temp 98.6. At this time, patient reported feeling better. Instructed patient to remain lying down. Nurse continued to monitor vitals. 1:15 pm vitals : B/P 125/90, HR 81, o2% 99, resp: 20. Patient change to a sitting position upright position.
Received injection (Flucelvax Quadrivalent) at 6:30PM.  1 hour after injection. arm was tender and itchy.  90 min after injection heart began racing , 114bpm (heart rate remained rapid for several hours, @ 10:30PM 107bpm).  2 hours after injection throat began to feel thick and eyes and lips were slightly itchy, breathing was a bit labored. Went to bed around 10:30PM sitting upright. Continued to monitor heart rate. Did not have any increase in symptoms  of throat thickening, or increase of itchy eyes and lips.  8 hours after injection (at 2:40AM) heart rate began to slow down (85-69bpm).  13.5 hours after injetion (at 8:12AM )heart rate was 60bpm. I did not feel back to myself for a couple of days.
Daughter was given 12+ Pfizer Bivalent Shot (gray cap) when it was supposed to be pediatrics dose (orange cap)
PT SYMPTOMATIC AND TESTED POSITIVE FOR COVID19 05/13 VIA RAPID ANTIGEN.
patient was given booster dose from a Moderna 6 months through 5 years vial presentation; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT USE ISSUE (patient was given booster dose from a Moderna 6 months through 5 years vial presentation) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Second primary dose) and Pfizer (First primary dose). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    In July 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 25 microgram. In July 2022, the patient experienced PRODUCT USE ISSUE (patient was given booster dose from a Moderna 6 months through 5 years vial presentation). At the time of the report, PRODUCT USE ISSUE (patient was given booster dose from a Moderna 6 months through 5 years vial presentation) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient was given booster dose from a Moderna 6 months through 5 years vial presentation. The patient was not immunocompromised.
fainted w/short gran mal sz to follow lasting approx 30 sec; resp nl; pt states felt faint, freight train-like noise followed by trouble getting breath;
Pt recvd measles vax on 21AUG91 & 3 days later pt devel vomiting & h/a which persisted x 3 days; no further details provided;
Approximately 12 hours after vaccine, developed stiff neck.  Following day: achy all over.  Within 48 hours, headache which has persisted through 07/19/2005.  No fever, no rash.  Positive for aseptic meningitis currently in community; illness consistent with those symptoms.
On 03/01/2001 the patient presented with a papulovesicular rash on his chest and trunk. The patient did not have a fever. On 03/05/2001 the patient had recovered.
A non-serious spontaneous report of "FluMist got in the corner of a two year old's eyes" was received from a licensed practical nurse concerning a 24-month-old male. The patient's medical history and concomitant medications were not reported. On 20-Oct-2009, the patient was administered FluMist. The patient was already screaming, and his eyes were shut when the nurse went to administer FluMist to the second nostril. Then the patient moved his head and some of the vaccine went to the corner of his eye. There was no adverse event associated with this vaccination error; therefore, treatment and submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 month of age for FluMist.
Felt extreme tiredness about 5:00 p.m.  By 5:30 chills began and lasted approximately 1 hour 30 minutes.  No fever, no other symptoms.  Once chills ended, normal energy level returned quickly.