chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was stored in fridge post puncture; No adverse event; Receiven Moderna Covid 19 Bivalent after the vial had been punctured more than 12 Hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiven Moderna Covid 19 Bivalent after the vial had been punctured more than 12 Hours), PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiven Moderna Covid 19 Bivalent after the vial had been punctured more than 12 Hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiven Moderna Covid 19 Bivalent after the vial had been punctured more than 12 Hours), PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Receiven Moderna Covid 19 Bivalent after the vial had been punctured more than 12 Hours) and PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture).    No concomitant medications were reported. Individual vials were used. The vial was initially stored in the refrigerator on 22-Oct-2022. The vial was first punctured on 17-Nov-2022 at 8 AM. 2 Patient were given the vaccine on 18-Nov-2022 at 2:23 PM and 11:43 AM. The pre-drawn syringes were put back in the fridge post punctured. The vial did not undergo any temperature excursions. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-682303 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682303:Same reporter
Pt reported to EdDpresenting with N/V/D had dizziness and briefly became unconscious this has all occurred within 30min of vaccine administration.
R arm red, indurated, nontender-pt awoke w/pain in arm. Advised to use cool compresses.
No unusual adverse events noted.  Pt was vaccinated with Pfizer COVID-19 for first dose.  Pt was inadvertently administered Moderna COVID-19 vaccine for the 2nd dose.  Pt was called 09/02/2021 at 12:15 for update-states he felt fine when he woke up today but started feeling "clammy, hot, sweaty, and lethargic" at around 11:15 this am.  States he is still at work today.
Maternal report welt/hive (R) arm; that by time of exam, had improved and became less noticeable.
pt recv vax; exp n; f/u info: pt exp severe SOB p/ vax;
IM injection on 06/27/06 by evening pt was c/o stomach ache and ran low grade temp. By next morning 6/25/06 was listless, still with low grade temp and associated HA. No skin reaction at site of injection. By evening 6/28/06 no fever.
She was a little incoherent decreased activity loss of motivation overall very confused. I then contacted the doctor recommended a neurologist, but we haven't don't that yet and did a urine culture, but we don't have the results back just yet.  The doctor did give her antibiotics for I think a UTI, but I am not sure. We thought the UTI was causing the confusion. I did take her to the ER on 02/18 because I thought she had another UTI, but they said she didn't have a UTI. They said it was something in her blood culture and they gave antibiotics and retested three days later, and it was cleared up.
Left Popliteal DVT Edema, pain, increased warmth Starting Eliquis 10mg po bid x 7 days f/b 5mg bid x 6 months
I experienced an allergic reaction to peanut butter, I know have allergies to peanuts, beef, dark chocolate and raw carrots
Started noticing symptoms of neuropathy on both legs and feet and mildly in both arms shortly after receiving the first Pfizer vaccine. Condition has gotten worse with numbness and tingling in both legs.
Left shuolder frozen shoulder, throbbing when laying down at night.  Flu vaccination on Friday & Saturday evening shoulder became sore.
tongue started feeling itchy; asthma was triggered; This is a spontaneous report from a contactable nurse (patient).  A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number was not reported), dose 1 via an unspecified route of administration on 06Apr2021 at approximately 8:45am (at the age of 65-Year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included allergies to Penicillin and Shrimp. The patient's concomitant medications were not reported. The patient previously took avelox and lisinopril and experienced allergy. On 06Apr2021, patient reported that she didn't have a reaction until about 9:45 am but about an hour after her tongue started feeling itchy and asthma was triggered. She took 25mg Benadryl at 9:10, but when it started to wear off this afternoon, tongue started itching again, she took another Benadryl at 4:45pm. She further enquired can this be a reaction to the vaccine. If so, how long was it expected to last and how can she treat her reaction. Therapeutic measures were taken as a result of tongue started feeling itchy and asthma was triggered. At the time of this report, the outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Few days after vaccine had rash, itching, hives. Likely low grade allergic reaction. Now improving. Still some pain at injection site and pain in legs.
BAD COVID VACCINE REACTIONS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On 09-DEC-2021, the patient experienced bad covid vaccine reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad covid vaccine reactions was not reported. This report was non-serious. This case, from the same reporter is linked to 20220306273, 20210333455 and 20210308223.  Version created to amend previously reported information on 10-DEC-2021. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
From the elbow up to injection site feels warm; From the elbow up to injection site is red; From the elbow up to injection site is itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (From the elbow up to injection site feels warm), VACCINATION SITE ERYTHEMA (From the elbow up to injection site is red) and VACCINATION SITE PRURITUS (From the elbow up to injection site is itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (From the elbow up to injection site feels warm), VACCINATION SITE ERYTHEMA (From the elbow up to injection site is red) and VACCINATION SITE PRURITUS (From the elbow up to injection site is itchy). At the time of the report, VACCINATION SITE WARMTH (From the elbow up to injection site feels warm), VACCINATION SITE ERYTHEMA (From the elbow up to injection site is red) and VACCINATION SITE PRURITUS (From the elbow up to injection site is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Pain in neck and back, fever, cold sweats, upset stomach, chills, passed out three times
since 24SEP95 upper rt shoulder region, in the joint area has become a problem such as soreness (lots of discomfort) that its very hard to have the mobility shoulder once had;@ times this soreness runs down the length of my arm
Delayed injection site reaction. Swelling, redness, hot to touch. Onset exactly one week after dose was administered.
local rxn warm & hot to touch, throat scratchy, hollow-heeaded feeling w/in a few hr of vax;next day h/a;
This spontaneous report was received from a medical assistant and refers to a 19-year-old (at the time of events, currently, 23-year-old) female patient with medical history of chickenpox in 2013 and concurrent condition of recurrent unspecified infections. On 16-OCT-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 lot # J013555 with expiration date on 02-MAY-2015, intramuscularly in the left arm as a prophylaxis of recurrent infections. On the same day, the patient received a dose of AFLURIA (reported as "Novartis branded influenza MDV TIRV 2V3 vaccine") in her right arm and no adverse reaction was reported in the right arm. On an unknown date in October 2014, the patient started having a rash and an unspecified allergic reaction in her left arm. On 18-OCT-2014, the patient was examined by a physician and was prescribed prednisone (manufacturer unknown), 60 mg on day 1, 40 mg on days 2 and 3, and 20 mg on days 4 and 5 to treat the allergic reaction. On 24-OCT-2014, the patient stated to the medical assistant that her arm was still bothering her and she was unable to sleep on her left side on unspecified dates in October 2014. The patient recovered from the events on unspecified dates. The relatedness between the events and PNEUMOVAX 23 was not reported.
Complete body ache,  nauseous,  sweating,  fever.......I felt like someone beat me up with a baseball bat....couldn't even get out of bed  it started about 12:30 AM  and lasted about the rest of the following day...
Patient presents to urgent care with fatigue and muscle aches ~7 days after first covid vaccine. No other new symptoms. Also recently started on a statin. Held statin and referred patient to PCP for f/u.
Initial report received on 18 October 2006 from a health care professional.  A 54-year-old female patient, with no current illnesses, had received a right arm dose of FLUZONE SV '2006-'2007 USP, lot number U2197AA, on 16 October 2006.  The reporter was not sure if the injection was administered intra-muscular or subcutaneous.  Approximately one day later, the patient developed a reddened area at the injection site that was about two inches in diameter and tender.  The patient was treated by a physician and diagnosed with mild cellulitis.  Diagnostics and treatments received were not reported.  The patient's recovery status is unknown.
At about 6 pm, I was very tired and not hungry. I went to bed soon after. I slept fitfully because I had the chills. The next day (Sunday), I was achy, had a headache, felt nauseous, tired and virtually slept the day away (not eating). I started to perk up Monday and felt much better by supper time.
RHINORRHEA; PRODUCT AVAILABILITY ISSUE; This spontaneous report received from a health care professional concerned a 74 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced rhinorrhea, and product availability issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rhinorrhea and product availability issue was not reported. This report was non-serious.
Moderna Covid-19 Vaccine EUA 7 days after administration of the vaccine, itching and a red rash appeared at the injection site traveling up to the top of my shoulder and down to 2 inches above my  elbow. The rash was warm to touch and stiff and hard.  I contacted a doctor who diagnosed it as cellulitis and gave me a prescription of cephalexin for 5 days.
Within a few hours of vaccines, she was sick, lethargic, and had a high temp. 10 days later, she had a "fever seizure", according to hospital.
pt recvd vax 13OCT95 & same day pt exp discharge, eyes; the following day pt devel a fever w/maximum temp of 103;pt was treated w/acetaminophen & Ibuprofen & recovered 18OCT95
4/24/2006 Seen by Dr presented with rash on trunk, shoulders, upper arms. Diagnosed with chicken pox.
fever 102 oral; pneumonia dx on 1DEC93 took ATB & pred & now on 02 @ home;
My daughter had expected aches, fatigue, sore arm and headache for 2days. On the 3rd day she felt back to normal but that night she told me her heart was racing twice. She went on to have a panic attack which she has never had before.  The next night (4th night) she was abut hyper and happier but continues to say her heart is racing. She says she has never that before except for in an asthma attack.
Patient reports arm redness and swelling and warmth from injections site (deltoid) to elbow, wrapping around arm. No bumps or itching reported or observed. Symptoms first noticed the morning after vaccinations, on 9/27/23. When presented to pharmacy on 9/29/23, patient said symptoms were improving but were still present and observed. Instructed patient to report event to PCP. Patient declined recommendation to make an appointment with PCP or go to urgent care.
Following receiving second dose of COVID-19 vaccine, vaccinated individual had the following reactions 12 hours post-dose: chills, body aches, joint aches. The next morning upon waking to get ready for work, she had nausea and was very light-headed and pale, resulting in a missed day at work.
Patient experienced a Vasovagal responsive after the admin of Tdap and Menactra respectively. Patient lost consciousness and needed to be placed on the floor. O2 by face mask, vitals 9 10 min. Patient stabilized after 15 min. Continued observation for another 30 min due to stated buzzing in ears and drowsiness.
This spontaneous report was received from an office manager, referring to a 5 years old patient of unknown gender. It was reported none concomitant medications, none medical history and none drug reactions or allergies. On an unspecified date in 2018 (reported as "in the last 3 weeks"), the patient was vaccinated with (wistar ra 27-3) M-M-R II and Oka/Merck VARIVAX both subcutaneously in the same leg (strength, doses, dose numbers, lot numbers and expiration date were not reported), for prophylaxis. Other suspect therapies included a DILUENT MRK INJ (lot number and expiration date were not reported). In 2018, the patient reported tenderness, warmth, swelling and a lump at injection site. It was reported that treatment was not given for the adverse events; however, it was also stated that the treatment given was ice to the injection site for the patient. Lab diagnostics or studies were not performed and the patient sought medical attention by contacting the office. The outcome of injection site mass, injection site swelling, injection site pain and injection site warmth was unknown. The causality assessment between (wistar ra 27-3) M-M-R II, Oka/Merck VARIVAX, the DILUENT MRK INJ and the aforementioned events was not provided. This is one of two reports received from the same reporter. As of 28-JUN-2018, all telephone attempts to obtain follow-up information have been unsuccessful. Sender's Comments: US-009507513-1804USA007907.
Fatigued and slept for 3hrs. in the middle of the day. Muscle pain and stomach cramps, Back cramps. Light Nausea. Numbness on right side of face.
Severe aches and soreness. Nearly debilitating. A full day of immobility due to muscle and joint pain. First dose was the same. Assumed second wouldn't be as bad.
Bad soreness in the right arm after injection that lasted for about 2 days; the soreness after 24 hours was really bad in particular, I could barely lift my arm (the best way to describe it is as if someone took a brick and punched me with it). Arm soreness is a common side effect though after this shot, but I thought I would still mention it.  On Nov. 3rd, 2021, one week after the first shot, for no longer than up to 2 hours in the evening starting at about 6:15 pm and lasting until approximately 8pm, I felt a slight tinge of a fever. Warm forehead and cheeks. It was very, very mild. No other symptoms were present.   Treatment: Rest and Sleep; Arm soreness eventually went away on its own Outcome: No further complications
day of vax lt arm became very tender;on following day exp chills, h/a & severe pain & erythema in lt upper arm;
This spontaneous report was received from a registered nurse regarding a 12 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 18-AUG-2014, the patient was vaccinated with a dose of GARDASIL (dose and route were not reported, lot # K005083, expiration date 04-NOV-2016). On 27-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose and route were not reported, lot # K026247). There was no adverse experience reported. Additional information has been requested.
6 other people who have the same exact symptoms as hers; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of ADVERSE EVENT (6 other people who have the same exact symptoms as hers) 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 ADVERSE EVENT (6 other people who have the same exact symptoms as hers). At the time of the report, ADVERSE EVENT (6 other people who have the same exact symptoms as hers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication provided. No concomitant medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: follow-up email added and No new information is provided
UrticariaPruritus Narrative: employee states: 7 days after injection, she noticed on the injected  deltoid area, redness/congestion and itchiness around one scar from former vaccine received as a child. Applied steroid cream locally to control itchiness. on 1/20/21, both scars from childhood vaccines in the same arm were swollen and  itchy, again used steroid cream and oral Unisom for symptoms. The childhood vaccine scars were form Cowpox or BCG, possibly related to the immune responses from the COVID vaccine.
Information has been received from a licensed practical nurse concerning a patient who in approximately August 2007, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot#658000/0845U). On 15-AUG-2007 the patient developed injection site pain and swelling. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Itching both arms, abdomen, some on legs, earache, watery eyes, runny nose. Chills started in the evening. Used Benadryl at HS. Itching increased 4-22-2015, to include chest and head, continued earache, irritated throat, irritated- watery eyes, headache and chills.
The vaccine was maintained at proper refrigeration temperatures, but for longer than 31 days.  7/29/21 was day 31 at refrigeration temps and vaccine was given on 8/12/21.  No adverse events have been reported by patient.  Error discovered on 8/16/21
the injections hurt intensely and my muscles twitched and throbbed when injected into both arms. had a second shot for pneumonia too
Administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046821A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Itching on chest and arms; Beginning of rash; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (Itching on chest and arms) and RASH (Beginning of rash) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concurrent medical conditions included Allergy (sulfa allergy).    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Feb-2021, the patient experienced PRURITUS (Itching on chest and arms) and RASH (Beginning of rash). At the time of the report, PRURITUS (Itching on chest and arms) and RASH (Beginning of rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
EXTREMELY IRRITABLE; LITTLE THINGS SET ME OFF; ANGER ISSUES; REALLY SUFFERING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced extremely irritable, little things set me off, anger issues, and really suffering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extremely irritable, little things set me off, anger issues, and really suffering. This report was non-serious.