chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial wasfirst punctured on 25-Oct-2021 and the dose was administered on 31-Jan-2022; received Moderna COVID-19 vaccine after the manufacturers expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Moderna COVID-19 vaccine after the manufacturers expiration date) and PRODUCT STORAGE ERROR (The vial wasfirst punctured on 25-Oct-2021 and the dose was administered on 31-Jan-2022) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 026D21A and 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Jan-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (received Moderna COVID-19 vaccine after the manufacturers expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial wasfirst punctured on 25-Oct-2021 and the dose was administered on 31-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received Moderna COVID-19 vaccine after the manufacturers expiration date) and PRODUCT STORAGE ERROR (The vial wasfirst punctured on 25-Oct-2021 and the dose was administered on 31-Jan-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  It was not known on which arm the patient received her first and second dose.  The vial was punctured on 25-Oct-2021 and 31-Jan-2022. The vaccine provider was not aware that a punctured vial was only good for 12 hours and expired vaccine was administered to the patient. The vial did not undergo any temperature excursions.  No adverse reactions or side effects were reported after both the doses.  No treatment information was provided by the reporter.
chest pain; left arm went numb; GERD; light headed/dizzy; increased in smell; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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 provided).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (light headed/dizzy) and PAROSMIA (increased in smell). On 10-Apr-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged), HYPOAESTHESIA (left arm went numb) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD). On 28-Mar-2021, PAROSMIA (increased in smell) had resolved. On 12-Apr-2021, CHEST PAIN (chest pain), DIZZINESS (light headed/dizzy), HYPOAESTHESIA (left arm went numb) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       They did a EKG and chemical test, everything normal. More tests were run and everything came back normal. Patient spent two nights in the hospital.  Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
A day after the first shot, I was incredibly weak and got a headache and lightheaded halfway through the day.  For two days after the second shot, I was lightheaded and very nauseous.
Redness and injection at and around injection site the day following the injection and does not show sign of worsening or healing.
shakes/ got the shakes; fast heartbeat; hot; blood pressure a little low; chills; my son ended up with 100.4 temp for a day and half but recovered afterwards; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes/ got the shakes), HEART RATE INCREASED (fast heartbeat), FEELING HOT (hot), HYPOTENSION (blood pressure a little low) and CHILLS (chills) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 929929) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Nov-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced TREMOR (shakes/ got the shakes), HEART RATE INCREASED (fast heartbeat), FEELING HOT (hot), HYPOTENSION (blood pressure a little low), CHILLS (chills) and PYREXIA (my son ended up with 100.4 temp for a day and half but recovered afterwards). At the time of the report, TREMOR (shakes/ got the shakes), HEART RATE INCREASED (fast heartbeat), FEELING HOT (hot), HYPOTENSION (blood pressure a little low) and CHILLS (chills) outcome was unknown and PYREXIA (my son ended up with 100.4 temp for a day and half but recovered afterwards) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) Low. On an unknown date, Body temperature: 100.4 (High) 100.4. On an unknown date, Heart rate: fast (High) Fast.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had experienced very bad reaction after Moderna second dose No concomitant and treatment information were reported by the reporter Reporter stated that her son ended up with 100.4 temp for a day and half but recovered afterwards. Heard appt of people having this with second dose.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: FollowUp received on 22-Nov-2021.New Event Fever occur and resolved updated and in lab data also updated.
it can make you sicker than hell; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 03-Dec-2020.  This case involves unknown demographic patient who reported it can make the patient sicker than hell (illness), while she received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, unspecified time after receiving the vaccine, it was stated that it could made sicker than hell (illness). Been there. And had never taken another one.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
When I caught COVID-19 I was congested and coughing. I had post nasal drip and an irritated throat. My symptoms went away with Nyquil. On June 29th, I was coughing bad. I called the doctor and I was prescribed Paxlovid. I don't have a fever. It didn't feel like the COVID-19 got into my lungs. I started Paxlovid in the afternoon of June 30th. I took it for 5 days. I would cough during the day. I did Nyquil at night. I had no problem sleeping and I also use a CPAP machine. Since testing negative for COVID-19 I had a a cough off and on.
Extreme Pounding / intense pain in left upper arm muscular area where injection was given has not decreased  in 5 days and  increases with arm movements .
Low back pain; HANDS SWOLLEN; Injection site burning; LEFT HIP PAIN; 2nd dose of moderna vaccine taken on 01 Feb 2021; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Low back pain), PERIPHERAL SWELLING (HANDS SWOLLEN), VACCINATION SITE PAIN (Injection site burning), ARTHRALGIA (LEFT HIP PAIN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of moderna vaccine taken on 01 Feb 2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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 started ADALIMUMAB (HUMIRA) (unknown route) UNK, CF. On 01-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of moderna vaccine taken on 01 Feb 2021). On an unknown date, the patient experienced BACK PAIN (Low back pain), PERIPHERAL SWELLING (HANDS SWOLLEN), VACCINATION SITE PAIN (Injection site burning) and ARTHRALGIA (LEFT HIP PAIN). At the time of the report, BACK PAIN (Low back pain), PERIPHERAL SWELLING (HANDS SWOLLEN), VACCINATION SITE PAIN (Injection site burning), ARTHRALGIA (LEFT HIP PAIN) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of moderna vaccine taken on 01 Feb 2021) outcome was unknown.            No concomitant or treatment medication provided There was no reason possibility of events with HUMIRA This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
The hours directly after receiving the shot were uneventful. I ate a normal dinner and went to bed around 9:00p. Around 11:30p I woke with a stomach ache, shivering from fever and a severe headache. I had been told by the Pharmasist that I might experience adverse symptoms and was given a sheet with them described. And, because I was not experiencing breathing problems, I took an aspirin and attempted to go back to sleep. The shivering lasted until approximately 4:00a. I did sleep intermittently. In the morning, I was exhausted, weak, headache, no appetite and a bit dizzy. Again, since I had been warned that there would be side effects, I was not too alarmed. I ate lightly that day and the next. I was tired and went to bed early on the day after the shot. I slept fitfully and woke early. I ate normally on this 2nd day after the shot. I was still a bit weak and had now develped hives. Hives were located; around my neck, under my breasts, in the crook of my arms (side of arms opposite of elbows) and on my shoulders. As this is a common side effect whenever I have had a fever, I was not too alarmed. Today is the 3rd day after the shot. The hives are more pronounced.
improperly stored vaccine involved in a temperature excursion was administered to a patient; No additional AE reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On an unspecified date, the patient was administered an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, route of administration, and anatomical site of vaccination were not reported; lot number W006595 has been verified to be valid, expiration date reported and established as 10-OCT-2024) for prophylaxis.   It was reported that the vaccine was exposed to a temperature excursion of 57.49 degrees Fahrenheit for 1 hour and 45 minutes (product storage error). No additional adverse events were reported (no adverse event).
After taking my Pfizer booster, I noticed around 8pm that night, that I had severe pain at the injection site and I put some alcohol on the band aid. It was throbbing with terrible pain the next morning  when I woke up. Took off the band aid and there was a big red blister and it hurt so bad. I immediately called the pharmacist and they said that I should take Benadryl for 5 days, 2 to 3 times a day and to let her know if it didn't get better. After the 2nd day it got better. Blister was gone, there was less pain but the pain lasted for about 4 more days. Itching every now and then, recently being about 4 days ago where it started to itch again. Put some alcohol on it. itching is still on and off, blister and pain has subsided.
Pt came in on 6-12-12 had itchy rash total body ached soon after inj.
Patient contacted office to inform us that when she received her first dose of Pfizer she bled for a couple weeks (like a menstrual cycle) and she received her 2nd dose on Saturday April 17th and started bleeding today April 22nd.
Sore left arm, as expected, but then awoke every 3 hrs during then night following the injection with strong pain in the wrist/hand affected by the carpal tunnel, had to go get a cold pack from the freezer, then could sleep another 3 hrs before the pain woke me up again.  (Recommend that carpal tunnel pts get the shot in the opposite arm!)  Improved during the day, a little pain the next night, pain recurred the 3rd night and had to get a cold pack again, then OK.
Flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu-like symptoms".   Additional information: Reported she had 4 more friends with flu like symptoms. She clarified every women she talked to about the COVID-19 Vaccine, all had the same type of symptoms after the first COVID-19 Vaccine dose. She said she didn't remember the rest of the women, or have any information on what COVID-19 Vaccine they had.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021522956 same reporter/SD/AE, different patient.
pain @ injection site , 2-4 days more than normal. 4 days later burning & itching . 6 days ver red and hot -  2/3rd upper arm inflammed -  Intermittent headache , No blisters, or exudate Today - day 8, has redness of face
Client received Pfizer-BioNTech COVID-19 Vaccine with lot number ER8731 EXP. 7/2021 at 1632 on 04/09/2021. Client reported to EMT complaints of dizziness, dry tongue, and tachycardia. EMT noted heart rate to be accelerated on initial assessment. Medical history was reviewed and client disclosed history of hypotension. Client was unable to move from seat/seated position in observation area to zero-gravity chair. While remaining seated and upright, client was given water, Gatorade and ice pack for chest; client was alert and oriented to person, place, time and situation. Vital signs at 1705 were blood pressure of 140/98 and heart rate of 64. Client disclosed that had not taken hypotension medication today. Vital signs at 1713 were blood pressure of 128/82, pulse of 64, and client then noted that symptoms had resolved. Vital signs at 1738 were blood pressure of 130/86 and pulse of 64. Client then contacted husband to pick client up. Client denied EMS offer, staff educated to follow-up with health care provider regarding if should receive second Pfizer dose and about further medical care if symptoms returned or escalated. No medications or other interventions were indicated. Client then stood up and ambulated independently out of site, stating client was feeling fine and would like to wait for husband in her car.
This spontaneous report as received from a registered nurse refers to a patient of unknown age, unknown gender. On 07-JUN-2013 the patient was vaccinated with an expired VARIVAX (Merck) (lot # 670700/0817AA, expiry date 02-JUN-2013, strength, dose, frequency, route and site unspecified). No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Moderna on 2/26 and 3/26. Positive on 11/26
Patient described normal soreness and slight rash of left arm starting day after injection that is still present a month later.  Patient is also experiencing pain the injection location a month later.
Ankylosing spondylitis relapse; Wearing off effect; This spontaneous case was reported by a physician and describes the occurrence of ANKYLOSING SPONDYLITIS (Ankylosing spondylitis relapse) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Ankylosing spondylitis relapse) (seriousness criterion medically significant) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). At the time of the report, ANKYLOSING SPONDYLITIS (Ankylosing spondylitis relapse) had not resolved and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANKYLOSING SPONDYLITIS (Ankylosing spondylitis relapse) to be possibly related. No further causality assessment was provided for THERAPEUTIC RESPONSE SHORTENED (Wearing off effect).    Concomitant medications were not provided.  Treatment information was unknown.  The event Therapeutic response shortened " was reported for the co-suspect drug humira.  Company comment: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Sender's Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.
stomach ache; diarrhea; nausea; feel extremly tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (diarrhea), NAUSEA (nausea), FATIGUE (feel extremly tired) and HEADACHE (headache) in a  patient of an unknown age and gender 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, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (diarrhea), NAUSEA (nausea), FATIGUE (feel extremly tired) and HEADACHE (headache). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (diarrhea), NAUSEA (nausea), FATIGUE (feel extremly tired) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided. Treatment information was not provided.
Inflammation localised/inflammation in hands; Ache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation localised/inflammation in hands), PAIN (Ache) and FATIGUE (Tiredness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. In September 2021, the patient experienced PAIN (Ache) and FATIGUE (Tiredness). On an unknown date, the patient experienced INFLAMMATION (Inflammation localised/inflammation in hands). At the time of the report, INFLAMMATION (Inflammation localised/inflammation in hands) was resolving and PAIN (Ache) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Fine.         No concomitant medications were reported.   On an unknown date, the patient experienced inflammation in hands. In September 2021, the patient experienced felt tired and achy after third covid vaccine booster. Moderna was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Fatigue, anorexia, fever up to 104.6 for 3-4 days then low grade fever for a few more days as energy slowly came back.
This is a spontaneous report from a contactable nurse. The nurse reported for a 2 months old female patient who received PREVNAR 13 on 16Jan2012 at 0.5 ml single as immunization for the prevention of invasive disease. The patient had no relevant medical history and relevant concomitant medications. It was reported that the patient had a large red bump since 16Jan2012 after she was administered PREVNAR 13 as it was further elaborated that the bump was big and round which grew bigger, was hard and was like a red purplish knot after couple of months. It was further elaborated that when the patient came for her fourth month immunization the bump was very red and was hard like a keloid so she was administered with her second dose of PREVNAR 13 on an unknown date in 2012 on the other leg, after which the patient had similar large red bump on her leg and there was yellow greenish drainage from the previous bump. No relevant laboratory data was reported. The status of PREVNAR 13 therapy was unknown at the time of report. Therapeutic measures taken included unspecified antibiotic ointment. The clinical outcome of the reported events was unknown at the time of report.