chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines were stored after beyond use date and CDC expiry date; Vaccine administered to patient past 30-day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past 30-day use by date.) and PRODUCT STORAGE ERROR (Vaccines were stored after beyond use date and CDC expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   The BUD date was reported as 02-Apr-2022. Date Stored in Standard Freezer for the lot 068H21A was 2 degrees F high, -1 degrees F low on 04-Jan-2022.   No treatment medication was reported.  This case contains information for the ninth of 45 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-571126 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-571126:Master case
This spontaneous report received from a patient via a company representative concerned a female of unspecified age. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine suspension for injection, route of admin not reported, batch number Unknown dose was not reported, administered on 26-AUG-2021 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 AUG-2021, the patient experienced body wobble. On AUG-2021, the patient experienced feel shook literally from the cells out. On AUG-2021, the patient experienced down hard with ache. On AUG-2021, the patient experienced sudden menstruation. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced odd headache. On 31-AUG-2021, the patient experienced heart palpitations. The action taken with covid-19 vaccine was not applicable. The patient recovered from fatigue on AUG-2021, and the outcome of down hard with ache, chills, odd headache, sudden menstruation, heart palpitations, body wobble, and feel shook literally from the cells out was not reported. This report was non-serious.
Temperature 102 degrees, localized soreness, headache, felt "weak" and "dizzy" the next morning. All symptoms improved with MOTRIN and local ice application.
noc sweats w/fever that was not measured;bitten by stray cat on 19SEP94 & recvd IV ATB, & Cephalexin for 10-14 days;
Patient came in 7 days post immunization to report  that she felt feverish, lethargic, and reported at first she was only had nausea to then stating she did vomit one time and by the end of taking her report had said she actually vomited 3 times.  All symptoms lasted for one day per patient.
About two days after the 3rd dose Swelling, redness, heat, itching and pain up and down my whole arm but I am not sure which arm. I do not recall also which arm I was given the dose I think it was my left arm, but I cannot guarantee. I think I did contact my PCP but I took Benadryl and put ice packs on it off and on. I also took ibuprofen. I did not need medical care. I did call the pharmacy to let them know. This lasted 4-5 days. I am assuming based of what news reported and the date of my third dose that I had a full dose of Moderna and not the half dose that was later recommended. I also had a breakthrough case of COVID on February 02,2022. I had to call my Oncologist because of the CLL and the Covid Diagnosis and he prescribed Paxlovid. I had headache, aches, congestion, flu like symptoms. Paxlovid worked very well for me, but my Blood Pressure did go up. I contacted my cardiologist office and they suggested I double up on my BP medication and I did and that help. I was able to discontinue the double dose two days after that.
client received of 1st dose Pfizer Covid Vaccine approximately 1400. Ancillary  signaled PHN client was not feeling good. Client sitting in chair, pale, stated feeling dizzy and seeing blurry. EMT  began taking vitals at 1405: blood pressure 142/110, pulse 75, oxygen 98%. Per client had just received vaccine. Client able to transfer self to anti-gravity chair at 1407. Client asked for water, PHN advised to take small sips. Vitals 1410: blood pressure 140/110, pulse 77, oxygen 99%. Per client vision slightly better, dizziness same, new onset of headache and nausea. PHN gave client emesis bag. Per client no pertinent medical history, no current medication and no history of allergies. Per client does not know if he has hypertension, does not regularly follow up with provider. No history of vision problems. Vitals at 1415: blood pressure 138/110, pulse 75, oxygen 98%. Client stated feeling the "room was spinning", nausea. Vitals at 1420: blood pressure 138/108, pulse 77, oxygen 97%. Per client dizziness, nausea same, vision improving slightly. PHN asked client if someone would be able to pick him up, per client no one, he would drive home. Vitals at 1425: blood pressure 140/106, pulse 74, oxygen 97%. Client stated headache to temporal and occipital area.  1430 client stated feeling eyesight heavy. Client alert and oriented. Vitals at 1431: blood pressure 134/108, pulse 75, oxygen 97%. Per client when he moves head quickly is when dizziness worsens. Client denied history of vertigo. 1434 PHN  offered client paramedics so client could be further evaluated, client denied. Vitals at 1435: blood pressure: 132/103, pulse 73, oxygen 97%. Per client blurry vision, nausea and dizziness same. Per client wanted to leave facility and go home. PHN advised client to stay longer in observation as symptoms had not resolved and he wanted to drive home. Client declined, stated he felt well enough to drive. PHN asked client to stand by chair to see check dizziness and if client could walk without complaints. Client was able to stand and take steps without assistance. PHN gave client ER precautions, asked client if he wanted to anyone else to pick him up and he declined. Client left facility with steady gait at 1441 against medical advise, symptoms had not resolved.
Patient seen in October for hypopigmentation consistent with vitiligo, starting a few months ago, possible reaction to the vaccine received in May
I am experiencing lymph node swelling in my armpits on both sides. But on the left side the swelling is pretty mad and causing a lot of discomfort throughout my arm, chest and upper back/neck on left side. I also had around 24 hours of pelvic cramping that occurred every 60 seconds but that has seem to subsided and not sure if that was related.
For the 3 months prior to this shot I felt great- almost better than I ever have. The shot hurt a lot going in which I commented on at the time.  He asked if it felt cold.  I said no it just hurts A LOT!  It felt like he had injected a gallon of fluid into my arm. Then in the 15 minute wait there was pain at the injection site which moved up my neck and then down my arm and then under my right collarbone.  After the 15 minutes I walked around the store for a while with my friend to make sure I was alright.  He had no reaction to the shot- good for him.  On the drive home, the pain spread down to the area of my right ovary....very odd.  By the time we got home my left hip ached.  Once home I could not stay awake and just went to sleep.  I got up for a little while in the evening and then back to sleep. For the next 4 days anytime that I would eat, I could not stay awake.  When I took the bandage off there was a dark purple welt. The pain was the worst on day 2 and 3. Eventually I treated my shoulder with Arnica, microcurrent, and acupuncture ( I am an acupuncturist).  On day 3 I started to get a headache so I did some acupuncture and stopped it.  I rarely get headaches. A few days after the shot I started getting pains in my legs so I started taking cayenne pepper and vitamin C.   Then I started getting nerve-type pains in my legs and feet mostly, some in arms/wrists. These largely went away after a week.  I felt well enough at the one-week mark to go for a ride on my motorcycle but I didn't last long as the shoulder pain really flared up.  By the 2 week mark I was feeling ok....but not great as I had been feeling.  In fact I haven't felt that great since.  I feel like it stimulated my period to start back up too.  :-(  I have an ongoing issue with the energy since the shot.  I get waves of tiredness periodically and late afternoon tiredness or after eating tiredness. I feel like I am running at 80%.   While the initial sciatica-type nerve pains went away early on, later I developed random infrequent but sharp painful tingling in my feet and ankles.   Some pains in my chest which seem to be gone now.  About a month after the vaccine I developed my first and only eye floater which drives me crazy- it is like a skeeter running around.  I need to go see someone about that.  And hiking this summer, I had altitude issues at only 4,000 feet.   I mention these because they might be related. I plan to see a doctor in early September.
felt like had the flu; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, less than a day after receiving Shingrix, the patient experienced influenza like illness. On an unknown date, the outcome of the influenza like illness was recovered/resolved.   It was unknown if the reporter considered the influenza like illness to be related to Shingrix.  Additional details were provided as follows: The patient reported that, after vaccination she felt like flu. Next day after vaccination, the influenza like illness was resolved. The reporter did not consent to follow up.
This is a spontaneous report from a contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR13, via an unspecified route of administration, on an unspecified date, as a single dose. Medical history and concomitant medications were not reported. On an unknown date, the patient stated that, after she ate sugar free candy, her lips went numb. The clinical outcome of the event, after she ate sugar free candy her lips went numb, was unknown. She wondered if this was a side effect of the vaccine. Follow-up (26JAN2015): New information reported from the same contactable consumer includes: patient information (patient date of birth). Follow up (12MAR2015): Follow-up attempts completed. No further information expected.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 27-JAN-2017, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # L000454, expiration date: 06-JAN-2017, as prophylaxis (Strength, dose and route of administration were not reported). No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
I was catching my breath; Fever; Chills; after second shot, sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I was catching my breath), PAIN IN EXTREMITY (after second shot, sore arm), PYREXIA (Fever) and CHILLS (Chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032b21A and 038A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (after second shot, sore arm). On 10-Apr-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 12-Apr-2021, the patient experienced DYSPNOEA (I was catching my breath). On 17-Apr-2021, DYSPNOEA (I was catching my breath) had resolved. At the time of the report, PAIN IN EXTREMITY (after second shot, sore arm), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Heart rate: 95-45 (abnormal) Heart rate was fluctuating as monitored by watch..         Concomitant product use was not provided.   Treatment information was not provided.   This case was linked to MOD-2021-163379 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow-up received and included updated event terms and lab data. On 25-Jul-2021: Follow up received and contains No new information.
She got her vaccine, she did not have any immediate reaction, had fever and chills by the end of the day which lasted a couple of days.  On Monday she noticed that her chest was very red, looked like it was sunburned.  She felt that was strange and where did it come from.  on her hands and wrist she had some very red, itchy and skin colored rash that was starting.  Every 4-5 hours it seemed to be getting worse, the chest rash started to separate and had white spots.  On Tuesday noticed that it was getting worse and let it go and by Wednesday is was pretty bad, but she felt fine.  She then noticed it was spreading down her stomach and going up to her neck.  On Thursday she went to the UC and they told her that she should have gone to the ER but was stubborn as she felt fine.  She was treated with Benadryl and Pepcid.  She chest area is still a little red, but has spread all over her body and has blisters popping up, some on her face and one on her big toe.  The rash is better, but still has a stinging itching feeling, but has red welts all over.  Some have areas that cluster together and other areas are just blistered.
Aches, chills, fever-like symptoms. No fever. Felt completely fine after 24 hours.
patient recived vaccine expired on 26-Aug-2020/no AE; Initial information was received on 20-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 12-year-old female patient who received a forth dose of 0.5 ml of IPV (VERO) [IPOL] vaccine which was expired 26-Aug-2020 [lot number: R1D972M] via an intramuscular route in the left deltoid on 07-Jan-2020 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  It was an actual medication error due to expired vaccine used. (latency: at the time of vaccination)  At the time of report, no adverse event was reported.  It was reported that, normally they(reporter) would not have kept this vaccine for more than 28 days and they do not have an explanation on how this happened.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
stomach problems and feeling bad; feel sick; arm little sore; Nauseous, very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach problems and feeling bad), ILLNESS (feel sick), PAIN IN EXTREMITY (arm little sore) and NAUSEA (Nauseous, very uncomfortable) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 043L20A) for COVID-19 vaccination.     Concomitant products included ONDANSETRON for Product used for unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach problems and feeling bad), ILLNESS (feel sick), PAIN IN EXTREMITY (arm little sore) and NAUSEA (Nauseous, very uncomfortable). At the time of the report, ABDOMINAL DISCOMFORT (stomach problems and feeling bad), ILLNESS (feel sick), PAIN IN EXTREMITY (arm little sore) and NAUSEA (Nauseous, very uncomfortable) outcome was unknown.            Reporter did not allow further contact
School nurse called on patient's behalf to notify us that patient ended up with a 2 inch circular area around injection site. Followed up with physician and treated for cellulitis.
I felt the typical symptoms after dose #2 the following day (Saturday, April 3rd, 2021) These symptoms included fever, feeling weak and having chills at night. However, those symptoms subsided by Sunday, April 4th, 2021. Instead, I began to have very odd chest pains that I have never had before. I went to the ER and they believed it was due to me taking too much ibuprofen for my fever symptoms which would give me heart burn and said it could be a symptom from the vaccine. The night thereafter I woke up due to an earthquake and felt the chest pain only much worse. I immediately went to the ER again.
missed the window for dose 2 of the vaccine/one week past the 42 day; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the window for dose 2 of the vaccine/one week past the 42 day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the window for dose 2 of the vaccine/one week past the 42 day). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the window for dose 2 of the vaccine/one week past the 42 day) had resolved.        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 concomitant medications were reported.  No information regarding corrective treatment was reported by the patient.
Patient was given Pfizer vaccine at 4:13pm. 2 minutes after given the vaccine, patient eyes rolled back to head and started shaking and passed out on the chair. I ran to the e-kit and was about inject her with an Epipen but didn't since the patient gained consciousness.  Her father wanted to sit and monitor her. She complained of a stomach cramp and went to the bathroom and proceeded to throw up. I had her keep the door unlocked and was checking in on her during this. I took her vitals at 4:25pm  86/54 and then again at 4:30pm 89/67. I  advised the patient to sit and relax while we got her water, orange juice and bread since she said she didn't eat anything today. We told the father we are going to call 911 since she didn't seem to get better. I checked her O2: 98 and HR: 61 at 4:46pm. The paramedic checked her vital and it was within normal range. The paramedic gave her the option to either they take her to hospital or she can go on her own. She chose to leave by herself without going to a hospital
expired dose of acthib administered with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old male patient to whom experienced expired dose of HIB (PRP/T) VACCINE [ACT-HIB] administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 03-Sep-2022, the patient received a 0.5 ml total, 4th dose of suspect HIB (PRP/T) VACCINE, unknown formulation, (lot UJ661AA, exp date: 06-May-2022) via intramuscular route in the left thigh as Immunization.  On 03-Sep-2022 the patient got expired dose of acthib administered with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
My Dysmenorrhea was a huge issue for me until I started taking Norethindrone, which fixed the issue.  However when I got the Covid vaccine my Dysmenorrhea returned. I vomited and had severe cramping. My cramping used to be two days. On Norethindrone I had no cramps or vomiting, I didn't even have a flow during my menstrual cycle anymore. After the vaccine, I vomited, had cramps for 4 or 5 days, (so worse than before). I have continued to have spotty breakthrough  bleeding on and off for three weeks, which is much longer than it has ever been.  I'm concerned about what will happen with the second dose of the vaccine.
I experienced sever pain to my left arm with swelling. The pain radiated from, my left arm to my neck, head and all the way down to my fingertips. I also had numbness sensation. I tool Tylenol for pain and an anti-inflammatory medication. I did continue to have unexplained muscle spasm and fatigue.  I went to see my PCP to evaluate my fatigue and muscle spasm that has not resolved.
Patient experienced usual arm soreness from the shot, but as the days wore on, the soreness progressed into pain. Within a few days, patient realized the pain was more than a usual vaccination soreness. Within 7 days, Patient's shoulder was making loud popping sounds, and he kept feeling like it was falling out of socket. Basic movements like combing hair, teeth brushing, driving, and typing were painful and difficult with his left arm. Patient visited a physical therapist, and he said it isn't rotator cuff, but it could be a laberal tear. An MRI would better diagnose the issue. The physical therapist recommended 6 weeks of immobility on his shoulder. Patient purchased a brace and is wearing that to prevent mobility. Patient had not done anything else to injure his shoulder and was perfectly healthy when he presented himself to be vaccinated.