chrisvoncsefalvay/vaers-outcomes huggingface dataset:
malaise; chills; discomfort under armpit; laryngitis; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date in Feb2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was tested positive for COVID on 18Dec2020. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Patient reports after receiving 2nd vaccination on 1/19/2021, around 8-9pm that same night she began feeling very tired and fatigued. At 4am reports being very cold, chills, headache, body aches all over. "Feels like I have the flu, don't feel well at all."
Information has been received from a physician concerning an 11 year old female patient with asthma who on 25-NOV-2008 was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (Lot # 660016/0570X). Concomitant therapy included MSD, ALBUTEROL (unspecified) and influenza virus vaccine (unspecified). The patient developed a pruritic rash after administration of her first dose of GARDASIL. On 26-JAN-2009 the patient received her second dose GARDASIL (Lot # 661841/0653X). Concomitant therapy included MENACTRA. It was reported that the patient developed a pruritic rash and tingling in her tongue. She was treated with BENADRYL.  At the time of reporting the patient had not recovered. Additional information has been requested.
Redness extending from elbow to shoulder, swelling, pain developing within a few hours of vaccine. Treated with IM ROCEPHIN, and then admitted to hospital for IV antibiotics.
receiving expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. On 14-APR-2022, the patient received the second booster dose which got expired on 22-Jan-2022. No treatment information was provided by the reporter.
pt recv vax 9AUG95 & 8MAY96 pt devel chickenpox w/a rash w/less than 20 vesicles & a mild fever;pt recovered in approx 5 days;pt sibling also recv vax @ the same time & devel similar sx;
Large red circle, large knot, burning sensation began at injection site approximately day 8 and getting worse by day 10, area spreading had to seek medical attention
worst case of shingles; still suffering in pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles (Verbatim: worst case of shingles) and pain (Verbatim: still suffering in pain). The outcome of the shingles was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-Apr-2023 This case was reported by a patient's wife via interactive digital media. On the next day of vaccination, the patient woke with the worst case of shingles. It had been 17 months; umpteen treatments and he was still suffering in pain.  The pain was excruciating. The follow-up could not be possible as no contact details were available.
chest tightness/ chest tightness worsening slightly; lightheaded; vaccine-related axiety; chest pain; shortness of breath; nausea; vomiting; diarrhea; This is a spontaneous report from a non-contactable health care practitioner (other HCP). A 56-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Batch/Lot Number: EN6205; Expiry date was not reported) via an unspecified route of administration on an unspecified date (at the age of 56-years-old) at a single dose for covid-19 immunization. Medical history included chronic pain from an unknown date and ongoing. Concomitant medications included glipizide and lisinopril 10mg (taken at night) which were taken for an unspecified indication; and morphine taken two times a day for chronic pain. The start and stop dates of these medications were not reported. The patient previously took pioglitazone hydrochloride (ACTOS) and was taken off in the last couple of weeks and switched over to Glipizide. On an unspecified date during the patient's 15-minute waiting period after the vaccination, the patient began to experience chest tightness. The patient was transported to emergency department (ED). The patient also experienced lightheadedness and chest tightness worsening slightly while she was being monitored after the treatment was given. The events were reported as non-serious. Differential Diagnosis: Vaccine- Related Anxiety (include misc mental health, unspecified) and Red flag symptoms (CP (Chest pain), SOB (Shortness of breath), NVD (Nausea, vomiting, diarrhea), and unspecified Visual/Neuro concerns. Treatment included antihistamine, Cetirizine (Zyrtec), and water for the event chest tightness. The outcome of event chest tightness was not recovered (reported as worsening); while other events was unknown.  No follow-up attempts are possible. No further information is expected.
pt recvd vax 6AUG94 & later that evening exp cyanosis of the foot (immunized leg);pt had leg movement;parent treated event by warming,massaging & moving the pt's foot;cyanosis resolved w/in a few hrs;event reported to physician @12mo visit
Incorrect vaccine administered. Patient received Moderna for first dose and was given Pfizer-biontech vaccine for her second dose.
Chest pain; Fast fluttering Heartbeat; I also have shortness of breath because I have Asthma; Asthma; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 21-year-old male patient received bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: FC3182 and expiration date was not reported) via an unspecified route of administration, administered in arm left on 25Aug2021 (age at vaccination 21-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number and Expiration Date: not reported) via an unspecified route of administration on an unspecified date in Aug2021 as dose 1, single for COVID-19 immunization and had no events reported. No prior vaccination within 4 weeks. On an unspecified date in Aug2021, the patient experienced chest pain, asthma, fast fluttering heartbeat, I also have shortness of breath because I have asthma. When probed for the concern, consumer stated, he was taking about the second dose, he had second dose and he was experiencing chest pain and he was having like fast fluttering heartbeat that was all today he thought 24 hours and he also had shortness of breath because he had asthma (event conservatively captured). When paraphrased the concern, consumer stated, he concerned was that everyone was telling him to go to the ER (Emergency Room) near Hospital. He was asking whether he needed to go. But he did not have money for that, did Pfizer pay for that. Consumer stated, he did take both the shots (1st and 2nd dose), that's what he meant to say 2 vaccines (both doses) in a month. When probed if having any prior medical history, consumer stated, he did not put on hold. As consumer abruptly hung up the call. Product details (Expiration date, NDC and UPC), Pharmacy details and treatment could not be probed over the call. Limited information available over the call and appropriate response could not be provided. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
pt recv vax 10NOV97 & 13NOV97 pt exp a prodromal phase w/body aches;22NOV97 pt devel a gen rash;
sweats, coughing, aching weekend following flu shot vs MD 21OCT94 dx acute bronchitis on Biaxin called back today 25OCT94;
Got the first one and I now have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient him/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received the 1st dose of Shingles vaccine and he/she now had shingles. The patient stated that if you got the 1st vaccine out, you should get the newer one. The patient's physician said that he/she needed to get the newer vaccine.
INJECTION WAS ADMINISTERED IN THE CLAVICULAR SECTION OF THE L DELTOID: TINGLING AND HEAVINESS AT SITE RADIATING DOWN THE ARM TO HAND AND INTO THE L SHOULDER (I BELIEVE IT WAS GIVEN TOO CLOSE TO THE NERVE: THIS RXN R/T VACCINE DELIVERY TECHNIQUE;   RXN TO VACCINE ITSELF:  32 HOURS AFTER ADMIN, CHILLS, SEVERE ARTHRALGIAS THAT LASTED 12 HOURS AS WELL AS SUSTAINED HEADACHE AND SACRUM ACHE FOR 4 DAYS
Patient was given Moderna vaccine on 10/06/2021 that expired on 10/02/2021. Two providers at our clinic were contacted by Manager about this event. Both doctors state this should be considered a true dose since it is only 4 days past expiration. A local public health authority provider was also contacted and confirmed that this should be considered a true dose. Patient was notified of incident and that he would not need to get an additional vaccine at this time. Patient indicated that he was not worried about it and was only receiving the vaccine due to the mandate. Our contact information was provided to the patient should he have any questions or concerns.
Vaccine administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient age was reported as 20 years 1 months.  No concomitant medications were reported. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Vaccine Ndc Code was reported as 80777-0273-99. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. No treatment information was reported.
fever since last PM 101-102, sleepy, eating OK; supple neck, chest clear;
pt exp hives & asthma six to eight (6-8) hrs p/receiving flu vax;
On 4/6/21 evening of the shot, I had a fever 100.5 and chills all night. Felt better the next day. On 4/12, 13, and14 , I started having lower abdominal pain off and on for 3 days, and started running a fever again for those days, 99.5 to 100.5.  The 15th no pain or fever, so far.,
The nerves in my left arm are causing a great deal of pain. I work out every day and have had to back off and miss quite a few days because my shoulders and left are can not take the pain. In fact the pain was so great one night when I was drinking hot chocolate when I put the cup up to my mouth, the pain was so great that the muscle in my arm quit and I poured hot chocolate all over myself.
Very cold chills, fever, fatigue,  weak,  this started in the early morning the next day.
About 4-5 days after 1st shot started back of neck pain and gradually both inner thighs knees upper back mid back both and upper arms. They would not go away. And also have fever.
Sore and achy arm after injection; A spontaneous report was received from a consumer concerning a 69 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore and achy arm after injection (Arthralgia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  Prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Jan 2021, case received by safety. Patient experienced the event(s) sore and achy arm after injection (Arthralgia).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore and achy arm after injection (Arthralgia), was unknown.
Information regarding PREVNAR was received from a physician regarding a patient who received a dose on an unspecified date and experienced hardening under the skin, fever and redness under the skin.  Relevant medical history was not provided.  Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day.  Concomitant medications were not reported.  On an unspecified date, the patient experienced fever, hardening under the skin and redness under the skin that was "shaped like a pencil, perpendicular to the muscle fiber."  It was unknown if the patient recovered from the events.  No additional information was available at the time of this report.
This spontaneous report as received from a pharmacist refers to a 2 month old patient of unknown gender. Medical history and concurrent conditions were not reported. On 25-JUL-2014, the patient was vaccinated with an expired ROTATEQ, oral, lot#J003465, expiration date 08-JUL-2014. Dose were not reported. No co-suspect and concomitant therapies were reported. No adverse affects reported. Additional information is not expected (no allowed to contact physician).
Received immunization on 04/04/2003. Developed rash on 04/05/2003
02/10/22 presents to Triage for "Fetal Tachycardia in the setting of a known COVID-19 infection" "38w2d". "No past medical history on file"
On  May 17, 2021, I tested positive for COVID-19 despite being fully vaccinated back in February.  It started with a runny/stuffy nose, tiredness, sore throat on May 13 and I lost my taste on May 17.
Nasuea, vomiting, weakness, chills, body aches, chest pain, headache, sore throat, numbness in arms 1 week-3 months post vaccination.
This spontaneous report as received from an unspecifed reporter and the a male patient of unknown age. In August 2017, reported as this week,  the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous for prophylaxis. On 15-AUG-2017, the patient experienced red bumps on his legs (rash erythematous).The outcome of rash erythematous was unknown.
The next day my arm was red and had a large lump about 3 inches in diameter. It was also so painful that even my shirt resting on my arm was painful.  It took several days before my arm wasn't terribly sore,  about 2 weeks before the lump wasn't visable, and even now, 3 weeks later, there's still redness, a slight lump and a bit of pain deep in my arm when I press on it.
Felt dizzy and lightheaded for a few hours Felt very tired, headache, muscle aches - so far a day and a half and still going on Fever of 100 degrees
patient given 0.2ml of pfizer covid-19 bivalent booster instead of 0.3 ml -   patient had  no reaction or adverse event. No other immunization were given at time of this injection
General body pain; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General body pain), CHILLS (Chills) and PYREXIA (Fever) in a 59-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.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jul-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced PAIN (General body pain), CHILLS (Chills) and PYREXIA (Fever). On 05-Dec-2021, PAIN (General body pain), CHILLS (Chills) and PYREXIA (Fever) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  Primary reporter did not have the lot number information, because the packaging was discarded. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   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.
Sore arm with one shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm with one shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029120A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm with one shot). At the time of the report, PAIN IN EXTREMITY (Sore arm with one shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was provided by the reporter No treatment information was provided by the reporter This case concerns a 71-year-old female patient with no relevant medical history, who experienced the unexpected event of Pain in Extremity. The event occurred on an unknown date after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-381260, MOD-2021-381265 (Patient Link).; Sender's Comments: This case concerns a 71-year-old female patient with no relevant medical history, who experienced the unexpected event of Pain in Extremity. The event occurred on an unknown date after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
On 1/26/2023, I was having lunch with friends. I wasn't feeling well, though. I had a headache and sore throat. I thought that maybe I was getting a cold. My throat was so sore that it was hard to swallow. On 1/27/2023, I went to the doctor. I was told that I had a skin infection on my face, because I had little blisters extending from the bottom lip to the left side of the face and the bottom of the eye and into the ear. It turns out that I was misdiagnosed, though. The following week, I wasn't doing any better, so I returned to the doctor's office. It was then that I was informed that I had shingles. I was prescribed VALTREX. I was also told to use eye drops for dry eye and ear drops. Whenever I spoke, I looked like I had had a stroke, because my lips were twisting. Because of this, I underwent a CT scan to rule out a stroke; fortunately, it turns out that I hadn't had a stroke. The doctor was really concerned, because the sores extended into my left eye and left ear. For that reason, I had to also see an ophthalmologist and an ENT. The ENT took samples of the scabs in my ear and gave me ofloxacin ear drops. The ophthalmologist advised me to use both OTC gel eye drops and eye drops for dry eye. He also told me that I didn't have an infection in the eye, though it was very irritated. It took about three months to recover, for the most part. Even now, I still have lingering pain in the left ear and on the left side of my face, because the nerve has not completely healed.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 18-SEP-2014 the patient was vaccinated with expired second dose of RECOMBIVAX HB, injection 5/0.5 mcrg/ml, lot # 0293AE, expired date 01-SEP-2014 (dose, frequency and route unknown). The RECOMBIVAX HB did not have any previous temperature excursions. No adverse symptoms reported. RECOMBIVAX HB was supported with post-expiry data. Additional information has been requested.
Radial nerve symptoms, suspect mod weakness of wrist extensor. Radial nerve edema.
-Dibilitating headache came on slowly starting around 4pm day of vaccine (roughly 60-90 minutes following) Built in intensity and the following morning throughout the day after vaccine was causing dizziness to the point of motionsickness and vomiting when moved too much. headache hit peak at 24 hrs post vaccination and slowly decreased in intensity until about 48 hrs post vaccination. Took advil throughout. -Full body shivers despite warm or hot environment and comfort level Beginning about 30 hrs post vaccination vaccination and lasting about 6 hrs.  -Large bump at vaccination point started developing 72 hrs post vaccination. By 5 days post it was the diameter of roughly a baseball but only slightly raised, hot to the touch, very painful, restricted arm function and itched. That evening before bed (5 days post) self treated with 20 minute ice pack,  hydrocortizone cream and performing deep massage moving outward from vaccination point as long as could tolerate pain. Noticed extreme improvement the next morning: area had cooled to regular body temperature marked improvement in pain, size and fuctionality. Repeated "treatment" that evening (6 days post) and today (a few hours shy of 7 days post) area is still itchy, knot has decreased to the size of a bean, pain gone except when poked like a bruise. I will likely repeat self prescribed treatment more time.