chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (little red splotchy spot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Medical history not 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 RASH MACULAR (little red splotchy spot). At the time of the report, RASH MACULAR (little red splotchy spot) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.  No relevant concomitant medications were reported.  Treatment details included not provided.
A consumer report has been received concerning a 13 year old male patient. The patient's concurrent disease included allergy to amoxicillin and patient history included reaction to sulfamethoxazole-trimethoprim -swelling of lips. Relevant history of patient included flu shot with no reaction. The patient received Nasal FLUMIST on 06-Dec-2012. On 06-Dec-2012 eight hours after FLUMIST the patient developed swelling of the lips. The patient recovered from the event of swelling of the lips on 07-Dec-2012. The report was considered to be non serious by reporter. Summary of follow-up information received by AstraZeneca/MedImmune on 29-Jan-2013 from consumer: outcome of the event added, event stop date added, narrative updated. Corrected report 04-Feb-2013: patient history corrected.
Fever. (L) deltoid with erythema (covering deltoid). Warmth, tenderness (injection site). 10/28/08-records received for DOS 10/17-10/19/08-DC DX: Cellulitis left deltoid, improved. Cough. Presented with fever and left arm pain, difficulty walking. At time of discharge gait normal.
Patient had swelling at injection site immediately after the injection. He was given 1 (one) tablet of Benadryl 25 mg and an ice pact to hold over injection site. He was observed for 25 minutes in store. No other symptoms. He was contacted again in 1 hour still no other symptoms. Swelling went down.
Problem with walking day of vaccine. Swelling and tenderness at site. Advised ice, Ibuprofen, call if worse.
headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (nausea) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Not Provided          No concomitant medication was reported.Treatment medication included Advil and Tylenol. Action taken with mRNA-1273 in response to the events was not applicable.
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a 0.5 ml single dose of PNEUMOVAX. Concomitant therapy included influenza virus vaccine (unspecified) received in the other arm. The nurse reported that "within 24 hours" the patient experienced quite a bit of cellulitis (red and hot) on her upper arm and that she recommended to the patient to go home, apply heat to the affected are and take some ADVIL for discomfort. The nurse also reported that there was no systemic reaction to the PNEUMOVAX vaccine, only localized reaction. At the time of the report the patient is recovering. This is one of two case from the same source. Additional information has been requested.
My husband had tested positive for COVID-19 on November 30th and I was having symptoms on the 4th. I was having a slightest sore and scratchy throat, but it was not enough to think I was sick. On the 5th my daughter and I went in and I also tested positive for COVID-19. From there the sore throat got worse, I had a dry cough, Wednesday I had a fever and chills and was out until about Friday the fever did not go away with medication either, I had body aches and chills that would not go away. I had a runny nose that turned into a sinus infection as well. I am still recovering in the mornings I have to clear my throat and its like I cant get it clear.
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 8:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 8:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 73.45.  Concomitant products were not reported.  On 17-Feb-2021 vials were moved to clinic. On 09-Feb-2021 the vaccines were moved to fridge. On 17-Feb-2021, the vial underwent the excursion on the following timings: at 08 AM temperature was 20. The vaccine beyond use date was reported as 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.
Brain tumor, admitted to hospital 12/10 Neurosurgery consulted and MRI ordered. Discharged, waiting for surgery. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
I was traveling on vacation I started having a throat irritation, nasal congestion and dry cough, minor headache, fatigue. I did a home COVID-19 test and it came back positive immediately. I went to a Urgent Care that was linked to a hospital PCR COVID-19 test that also came back positive. I was prescribed Paxlovid, that helped shorten the duration of my illness.
noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; This is a spontaneous report from a contactable consumer reported for self. This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EK9231) at single dose on left arm on 03Jan2021 at 0830AM for COVID-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Medical history was none. Family medical history was none. Relevant test was none. Prior Vaccinations (within 4 weeks) was none. There was no concomitant medication. Patient received 1st dose on 03Jan2021. Yesterday (18Jan2021), she noticed 3 lumps the size of finder tip on her shoulder that were red and itchy.  Across her cleavage, she noticed another 3-4 lumps. She noticed last night, 18Jan2021, three lumps on her shoulder that were really itchy and red and three or four across her cleavage area but not as large. She was just checking, she knew it said could have swollen lymph glands. Patient mentioned she tried to set the phone thing set up where they call you but she could not do it. The shoulder lumps were on her left side and about the size of tip of her little finger. She tried Witch Hazel; she rubbed it on and that soothed it a little at that time. she was scheduled for the second dose of the vaccine on the 25Jan2021.  Patient asked if  this was normal and what could the end result possibly be. The adverse events did not require a visit to physician or ER. The outcome of events was not resolved.
Next morning after shot. Red, hot to touch, arm soreness, fatigue. Next morning arm burning, swollen, itchy. Temp 99.8.
Parents of patient reported there was an 8-10cm swelling at the site of injection. This was noted "soon after" the injection was given. The parents deny noting fevers or other symptoms. The patient was not seen by any providers for this reaction.
Redness, swelling and itching of injection site, left deltoid. Recommended icing and starting benadryl as needed for itching, if symptoms worsen parents and child instructed to schedule an appointment with PCP. Followed up with telephone call on 6/13/22, dad stated redness is improving and no longer itchy.
Information has been received from a physician concerning a 70-80 year old female who on approx 20Dec04 last week was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included warfarin sodium (Coumadin). On approx 21Dec04, the day after vaccination, the pt experienced redness from her elbow to her shoulder. On approx 22Dec04 two days after vaccination, the pt had a little bruising on her arm. Unspecified medical attention was sought. She was treated with cephalexin (Keflex). The pt's outcome was unk. No product quality complaint was involved. It was also reported that two other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and had adverse events (WAES0412USA01731 and 0501USA01732). Additional information has been requested.
arm was sore; hasn't been able to get the second dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the husband for her wife. The patient received 1st dose of Shingrix on left arm. The reporter stated that after vaccination with 1st dose, the patient experienced sore arm for couple of days. The reporter stated that, the patient had not yet received dose 2 of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This was 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020147944:same reporter
Pain and swelling in (R) arm, treated with TORADOL injection for pain and Rx for NAPROXEN.
The few days leading up to the getting the 2nd dose of the Covid vaccine I had tweaked my neck and had some pain. I took ibuprofen, which helped it; however, the day of the vaccine I did not take it because I had heard that it was probably a good idea to not take ibuprofen with the vaccine. I received the vaccine at 11AM on March 24, 2021  and later that day my neck pain started to get worse (maybe around 2 or 3 I started feeling it worsen). I tried to stretch it out and relieve it without medication. But that night the pain progressively got worse. I couldn't sleep. Pain was radiating in my neck and down my back. I felt chills and body aches (I did not have a fever though). It was a constant pain. When describing it to people I recall saying it was similar to labor pains, but without the relief a break between contractions (I've delivered three babies without any pain medication or epidural). I was literally crying and screaming in pain. My husband was trying to help, and thought he might have to take me to the emergency room. I did take ibuprofen to try and help relieve the pain and it did not work. I had one dose of flexeril at my house from a previous issue a couple years back, so I took that to try and help. I also took tylenol to try and help relieve it. After a few hours of the extreme pain I was able to fall asleep (still very uncomfortable) and in the morning I went to the urgent care (which is the care provider I listed as the best medical professional to speak to about this. This is a different place than where I received my vaccine). My husband (a nurse), my sister (a physical therapist) and the NP at the urgent care all told me they thought my pain was worsened and that the episode in the night was due to the vaccine. After the urgent care visit I was prescribed a Medrol pack and was told to alternate ibuprofen and tylenol and to ice the area and perform stretches. That all helped and I never experienced the wild pain again. I have been fine since then.
pt recv vax 13FEB96 & 26FEB96 pt devel a chicken pox rash w/one pock @ inj site & 2 on the abd;also exp malaise & a faintness feeling on first day;no further details were provided;
pt recvd vax; approx 4 to 4 1/2 hrs p/ vax,pt began screaming,lasted about 4 hrs;apap given at proper dose & intervals & did not have a fever; inject site swollen & warm but no inflammation;
Patient was given the wrong vaccine. She was given the dose for 12 and older. She is only 11 but the size of an adult. She has no symptom to report. She felt fine as I called the Mother the next day.
FLUZONE HIGH DOSE QUADRIVALENT was administered to a patient instead of FLUBLOK QUADRIVALENT; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00816793) and transmitted to Sanofi on 18-Oct-2021.  This case involves a 62-year-old female patient who received a 0.5 mL (once) dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ747AB and expiry date 30-Jun-2022) via intramuscular route in the left deltoid on 01-Oct-2021 for prophylactic vaccination instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (wrong product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to wrong vaccine administered (latency was on same day).  At the time of report, no adverse event reported.  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.
30 yrs old and her HCP prescribed shingrix; This case was reported by a consumer via call center representative and described the occurrence of product prescribing error in a 30-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in the past (inappropriate age)). Concurrent medical conditions included clinical depression.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product prescribing error. On an unknown date, the outcome of the product prescribing error was unknown.  Additional details were provided as follows: Age at vaccination was not applicable for this report. This case was reported by the patient herself. The patient reported that, she was 30 years old and her HCP (health care professional) wrote her a prescription to get shingrix due to the fact that she has had shingles in the past (inappropriate age), which led to product prescribing error. The patient had not yet received the vaccine. The patient spoke per PI about dosing guidelines, approved in adults aged 18 years and older who were or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy. The reporter did not consent to follow up.
10:30am swelling & redness of injection site. Temporally 97.6 degrees F. Also nausea. Area of redness 1 1/2" x 1 1/2". Painful applied cold compress x 10" no relief 12 noon parent called PCP. Warm moist heat applied x 10". Remained at school. Parent present.
When I arrived at facility, I asked what vaccine they were giving, they said Pfister.  I asked if I could get Moderna and the said yes.  I was lead into a room that was divided by Pfister and Moderna.  I was seated in the middle of the Moderna section.  I was given my shot and noticed that my return date for my second shot says 5/13.  Moderna second vaccine is 28 days after the first vaccine and Pfister is 21 days after. I had spoke with my diabetes PA that day for a routine call and I asked her about the wrong date being put on my card.  She looked into my medical record and it shows that I was given Pistzer.  How am I suppose to know what I really received?? What about the other elderly that were in my row that are going to go and get their second shot on 5/13 only to have their vaccines mixed.  This is extremely scary and very unprofessional by the facility.
Terrible joint pain. 1 month later still have terrible knee pain; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Ew0158), dose 1 via an unspecified route of administration, administered in left arm on 14Apr2021 as single dose for COVID-19 immunisation. Medical history included hiatal hernia and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID. Concomitant medication included pantoprazole (PANTOPRAZOL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Er8729), via an unspecified route of administration administered in right arm on an unknown date as second dose, single dose for COVID-19 immunisation. Post vaccination, the patient had not been tested for COVID-19. On 06May2021, the patient experienced terrible joint pain and in 1 month later still had terrible knee pain (at the time of report). The patient did not receive treatment in response to the event. Outcome of the event was not recovered.  Follow up needed, further information was requested.
On 4/13/21 patient developed difficulty walking and fell on 4/15/21. Also on 4/13/21 swelling and edema on both legs noted. Pt was admitted to hospital on 4/15/21 and found to have extensive DBT from lower IVC, Bilateral ileofemoral and both lower extremities. D-dimer was markedly elevated. Pt currently on anticoagulant Apixaban.
Information has been received from a nurse concerning a 16 year old female who on 24-AUG-2007 was vaccinated with first dose of Gardasil.  Within 5 minutes after receiving the injection, the patient felt light headed, pale, nauseated and looked slightly green.  The patient recovered and walked out of the office.  Additional information has been requested.
Paxlovid indication=Treatment of COVID-19; Paxlovid indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "anemia" (unspecified if ongoing). 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 "Paxlovid indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I experience chronic grand mal seizures where my lungs collapse and I need intubated in order to breath and also sedated in order for the seizure to stop. They do not stop in seconds or moments or when the ambulance arrives.
my period was due to start the same day, it is now June 3rd and I still have not started my period; vaccine has now cause a fertility problem; This is a spontaneous report from a contactable physician (patient). A non-pregnant female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 18May2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the covid 1st dose vaccine on 18May2021, her period was due to start the same day, it is now 03Jun2021 and still had not started her period. Nor she was pregnant. This vaccine had now caused a fertility problem. Her OB has advised against the second dose. The patient stated that for the company to say it does not cause infertility problems is a lie because there are hundreds of women going through this same exact issue. It does not involve a report of exposure during pregnancy. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.