chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES; ALLERGIC REACTION; FEVER ON AND OFF; This spontaneous report received from a patient 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 not reported, batch number: Unk) 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 an unspecified date, the subject experienced body aches, allergic reaction, and fever on and off. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from allergic reaction, and the outcome of body aches and fever on and off was not reported. This report was non-serious.
Initial and follow up information has been received from a physician and a certified medical assistant concerning a 65 year old female patient who on 05-MAY-2008 at 10:30, was vaccinated intramuscularly into the left arm (previously reported as the right upper arm) with a dose of PNEUMOVAX (Lot# 657526/0555U).  There were no concomitant medications.  On 07-MAY-2008 the patient developed cellulitis.  The cellulitis became worse and the patient required an emergency room visit, with no hospital confinement.  The patient was also seen by a dermatologist and treated with antibiotics.  The patient is now fully recovered.  The physician reported that the cellulitis was a result of the patient's skin structure, and not associated with the vaccine.  No product quality complaint was involved.  The reporter considered cellulitis to be an other important medical event.  Additional information has been requested.
Patient stated she received Moderna as first dose of vaccine.  Vaccine card was not documented with brand of vaccine, only lot number. Patient stated she received her first dose at  Hospital on 12/20/2020, not our clinic, she also stated she was told she had received Moderna as first dose.  After receiving second dose of Moderna, it was seen in  patient received Pfizer as first dose. Patient was made aware and stated she "was fine with that".
pt exp swelling & erythema;pt exp chills, fever, runny nose & eyes;also fatigue;T101;exp myalgia, arthralgia, ulcer in mouth, h/a, coughing, sneezing;runny nose and eyes; exp 48 hr fatigue
Side effects started approximately 8 hours after receiving shot. First chills, then body aches, then headache and possibly joint pain in knees. 400 mg of Tylenol was taken approximately 15 hours (4:15am) after receiving the shot and symptoms diminished. The next morning I woke with a mild headache, body aches started to return around 10:30am as the Tylenol wore off. Additional 400 mg of Tylenol was taken. General fatigue was experienced the rest of the day. After the 2nd night of sleep I felt fine.
Started with tenderness and pain to the touch. After almost a month, tenderness and pain still there and causes a burning sensation with movement of the arm.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On unknown dates, the patients were administered improperly stored GARDASIL (Lot # K009482 with expiration date of 06-MAR-2017), (dose and route were not reported), which were stored at 1.8 C for 1 hour and 45 minutes. The vaccines did not have previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Some pain at the injection site on her right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was provided as follows: The patient felt some pain at the injection site on her right arm when she received the first dose in the end of October 2019. The pain lasted for a day or two. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020029108
shortness of breath; Tested positive; Tested positive; This is a spontaneous report from a contactable consumer. A 69-year-old female patient started to receive BNT162B2 (Pfizer product, lot number was EL3248, expiration date was unknown) via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. Patient was not pregnant. Patient had no COVID prior vaccination. The patient had COVID test post vaccination and tested positive on 26Jan2021. Patient developed shortness of breath oxygen levels keep dropping on 03Feb2021. The events resulted in Emergency room/department or urgent care and hospitalization. It was unknown if patient received treatment for events. The outcome of events was unknown.
My wife had tested positive for COVID-19, so I was testing every few days and I tested positive on 01/19/2023.  Around a day later, my symptoms began. I have allergies and wouldn't have noticed these symptoms had my wife not tested positive. I had congestion and coughing throughout. I spoke with my doctor and went through a drive through to pick up Paxlovid. Within a day after taking the Paxlovid, my cough improved. I still have congestion, but I assume that is more allergy related.
Case number PHEH2015US019301, is an initial spontaneous report from consumer (patient) received on 25 Sep 2015. This report refers to a 28 years old female pregnant patient. Medical history and concomitant medications were not reported. She was bitten by bat on 26 Jul 2015. She was vaccinated with first dose of post exposure of RABAVERT (batch number: not reported) on 28 Jul 2015. She did not know she was pregnant at the time of vaccination. She found out on 31 Jul 2015 and her health care professional advised her to continue remaining vaccines. She was vaccinated with second dose of RABAVERT (batch number: not reported) on 31 Jul 2015. On the same day (31 Jul 2015) she experienced bleeding and miscarried on 19 Aug 2015. Outcome of the event bleeding was reported as recovered on 19 Aug 2015 and outcome of other event was not reported. The reporter assessed the events serious (medically significant). Causality of the events was not reported. The case was lost to follow-up.
Pfizer (Orange Cap) for ages 5-11 was given to patient on 05/25/2004, who was 17 years old.
Patient reported itching on her arm, face, and neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Patient reported itching on her arm, face, and neck) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PRURITUS (Patient reported itching on her arm, face, and neck). At the time of the report, PRURITUS (Patient reported itching on her arm, face, and neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 Jul 2021, updated event outcome to recovered and the patient declined for a follow up.
Swelling of injection site, pruritus extending down the arm - patient returned after a week, was given diphendyramine (take two when she got home) and event cleared within 36 hours.
lung cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUNG NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "lung cancer". Therapeutic measures were taken as a result of lung neoplasm malignant. Clinical course: They removed something she thought.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250402 same reporter/product, different patient/AE;
Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the vaccines were stored in freezer and required vials were taken out to place in fridge as needed.  No treatment information was provided.
Initial site reaction was sore upper arm, no initial redness or other issues. General slight body aches and pains over the next 24 hours with no issues. No additional problems until on approximately Day 9 (Saturday after the immunization), the left arm became erythematous from approximately the vaccination site to almost the elbow.  This erythema was approximately three inches wide and the skin was raised slightly. Area was slightly itchy, not painful, and was warm to the touch. Erythema increased over the next 3 days and I sent a picture to my primary care physician. He advised a Medrol dose pack and Keflex. I requested that I be able to start the Keflex but hold off on the Medrol dose pack for a couple of days. He suggested Benadryl q 6 hours. I sent pictures each day. Two days later, there was some improvement but the provider did not feel there was enough improvement and he encouraged me to start the Medrol dose pack. I started the dose pack on Day 14 (Thursday) around 2 p.m. By 9:00 p.m. on the same day, there was considerable improvement in the look of the arm and the skin was only slightly raised. At the time of this report on Day 18, Monday 01/25/2021, I will finish the Medrol dose pack tomorrow. There is a shadow of where the erythema was and there is no raised skin.
Full body muscle aches began the day after the second dose. They continue to be more intense and widespread. Fatigue after 4 weeks.
Patient reported watching the Nurse swab his shoulder with alcohol ( here shoulder meets the arm). He noted that he feklt the injection going in and muscle felt tense. He waited 15 minutes prior to levaing the area. He reports leaving area on or about 1030hrs. He states he informed spouse his shoulder was little sore but he return to work around 1230hrs. Patient reports as time went on his left arm became more sore that he had started to use his right arm to move his left. Patient reports he left work around 1700hrs, went home then to bed. Discomfort was rated 3-4/10. On or about 2300-2330 pain increased to 7-8/10 and he could not get comfortable. After mid night he went to the Emergency Room. During the evaluation the pain increased to 8-9/10. He was diagnosed with post immunization arthropathy unspecified site and released to home with instructions to use ice. He then notes after returning home he still could not become comfortable (stood in hot shower, sat in hot tub of water).On or about 0330 he states pain increased to 9/10 and then he went to the Emergency Room. Patient was evaluated, MRI was conducted which reveal: Fluid in the subacromial-subdeltoid bursa suggesting a reactive bursitis. He was discharged to home with instructions to f/u with his Primary Care Physician. Patient was seen by his PCP on 20210210 on or about 1445 hrs for revealuaton and treatment. Evaluation revealed increased discomfort with moving of (L) arm. He was plaed in a shoulder sling, a shoulder immobilizer was subsequently ordered; he was placed on Lortab 10, given Diclofenac 75mg and placed on quarters.
While waiting for shot time to be up pt began feeling nauseous and "not feeling good".  Pt began feeling hot and diaphoretic with color to face and mouth white.  Pt was a/ox3.  Given water with gatorade packet placed in water. Pt tolerated fluids well.  Pt informed nurse that she felt that she had to vomit. No vomiting noted at this time.  V/S obtained with b/p 100/66 HR 73 and O2 98% on RA.  Pt started feeling better within 15 minutes of episode started.  Family was asked to come get pt d/t she lived over 30 minutes from site.  Family came to get pt. Pt verbalized that she felt better. V/s prior to departure 102/72 HR72 O2 99 on RA.
About 6 hours after injection, I felt incredibly exhausted. After 12 hours, nausea and headache set in. 13-14 hours, a terrible stomachache and diarrhea. My skin felt so sensitive that it hurt to touch. Zofran treated the nausea. The day after the injection I was exhausted, was nauseous and had a headache. 48 hours after injection I woke up with a strange headache. I could look to the right pain free, but if I looked to the left or left/up, I had a piercing pain near my right eye. Excedrin/Tylenol did not relieve this headache. On Hour 72, the headache is still present, though to a lesser degree.
Patient is fully vaccinated and boosted.  COVID positive 5/10/2022 on admission to the hospital. 77 year old male with history of BPH, depression presenting to medical facility 5/10/22 with a complaint of fatigue. Patient reports that he has been unable to walk due to bilateral leg weakness, with new onset cough. Patient states his inability to ambulate has progressed over the past 6 weeks. . His previous functional status was adequate, with independence in all activities. No mental status changes. SpO2 90%. CXR: There is no acute process. Remdesivir given for 3 days. Discharged home.
Narrative: Patient contacted telephone triage nurse today requesting appt with provider for c/o what he believes is vertigo. Patient states for the past 3 days, he is noticing dizziness "only when I move my head too fast, stand up too fast, or walk too fast, etc. - with movement." States a few times it was so bad he had to  hold onto the wall while he was walking, but dizziness dissipates as soon as he sits down or holds still. + Mild sinus headache, "post nasal drip right now", no ear pain. State overall symptoms have gotten slightly better today, "but would still like to get checked out." No vomiting. No ear pain.
The vaccinator used a booster calendar to verify patient was within the timeframe to receive the Pfizer booster shoot. Because the patient received the second dose on 09/29/2021, the system  would not let the vaccinator proceed with the shot. The booster calendar stated the patient could receive the shot on 02/28/2022, so I move the 2nd date of the Pfizer vaccine to 09/28/2021 thinking I would be able to go back afterwards and correct the date. I was unable to correct my error. I noted the account of the actual Pfizer 2nd dose date of 09/29/2021.
10/15/21 pt admitted to hospital with bacterial pneumonia; had a positive COVID test on 10/12/21 at SNF (name of facility not in medical records); given ABX; mentation improved; became hypotensive and ran fever; had UTI and aspiration pneumonia; pt's condition worsened and he was transitioned to comfort care and passed away in the hospital
patient experienced signs and sxs of allergic rxn. redness at injection site. trouble breathing went to emergency room after consulting the pharmacy rxn happened within 2 hours of injection patient was treated in ER with IV fluids and prescribed prednisone and hydroxyzine once discharged
Reaction began Fri 9 March, redness & warmth at the site & increased over the weekend, painful to touch or move. Treated with BENADRYL & observed closely & continued to enlarge. Initiated antibiotics KEFLEX 250 mg/5ml to give 8.5 ml twice daily x 10 days.
On 11/01/1999 pt experienced a fever. On 11/03/1999 pt was diagnosed with chickenpox. Pt experienced a papular rash with approximately 100 lesions, a fever of 102.3F and itching. The pt was treated with Benadryl. the pt also experienced a fine strep rash and was treated with PCN. On 11/05 the pt was seen in the office and the lesions were dry and crusting at the time. The pts sibling had a similar experience.
On 9/1/2021 I received my first Moderna vaccine, and on the morning of 9/10/2021 noticed a fist-sized rash at the injection site. Rash does not itch, but I do feel a burning sensation coming from it.
Started as a sore arm in early evening. By midnight was in severe pain & unable to move arm. Put off going to doctor, but did not improve. Went to PCP on 11/11/11 and put on steroids & 1 week later given another Rx for another week of steroids.
UTI; Is okay to Cipro at this time; This is a spontaneous report from a contactable consumer (patient) via medical information team. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8733), dose 1 via an unspecified route of administration on 07Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got her first dose of the Pfizer BioNTech COVID-19 vaccine on 07Apr2021 and reports that her second doe was coming up. However, her doctor has put her on Cipro 250mg to take twice a day for 7 days for a UTI in 2021, and caller would like to know if it was okay to take this at this time in 2021. She was worried about the medication affecting the effectiveness of the vaccine. The outcome for the events were unknown.  No follow-up attempts are needed. No further information is expected.
2/2 severe headache, left hand cramped/closed, body pain, severe fatigue,, severe right arm pain, unable to move..Tues, no cramping or body pain but started with .right side head pain (above my ear at temple level) 4 days straight without any relief, no sleep. Fevers started 2/3, everyday at the same time, between 4-5pm, I get a wave of nausea and sweaty, 99.6,99.8, 99.9. Today 2/6 10am 99.6, 99.8 by noon 100.1...again at 5pm fever 110.1 wave of nausea and sweaty. Head pain has lessened and I have stopped taking OTC meds because NOTHING made a difference
Patient received first dose Moderna, second dose Pfizer 5/29/2021. Troubleshooting: Scribe and vaccinator did not look at card to see what was given prior. Counseled by staff that she had received two doses of mRNA vaccine and there was no need for a third dose. Possible language barrier, but pt checked Moderna in the computer.
Vaccine touched the pharmacist skin; Vaccine touched the pharmacist skin; This case was reported by a pharmacist via call center representative and described the occurrence of exposure via skin contact in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2022, the patient received Shingrix. On 4th November 2022, unknown after receiving Shingrix, the patient experienced exposure via skin contact and occupational exposure while administering product. On an unknown date, the outcome of the exposure via skin contact and occupational exposure while administering product were unknown.   Additional Information: GSK receipt date: 04 Nov 2022 Reporter comment: This case was reported by pharmacist. The pharmacist reported that today (on the day of reporting) while she was administering a Shingrix vaccine to a patient, 4 to 5 droplets of the vaccine came out around the base of the needle where it attaches to the syringe while the syringe with the reconstituted vaccine was in the patient's arm.  The pharmacist reported that 4 to 5 droplets of the reconstituted Shingrix vaccine touched the skin when it came out of the syringe.  Reporter did not consent to follow up. Additional supportive information: 4 to 5 droplets of the reconstituted Shingrix vaccine touched the skin when it came out of the syringe, which led to exposure via skin contact and  occupational exposure while administering product. This case is linked with US2022161291 reported by the same reporter.; Sender's Comments:  US-GSK-US2022161291:Same Reporter
Extreme pain in my back and right hipp,fatigue ,fever,swelling at injection and muscle pain. I also got a rash on my shoulders , arms and chest. I was very weak and hurting pretty much every where. It started to be better two days later, but than I had some nausea.
Initial information received on 20-Jul-2018 regarding an unsolicited valid non-serious case received from consumer. This case involves a 68 years old male patient who was administered of DAPTACEL instead of ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jul-2018, the patient received 0.5 ml once dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in deltoid instead of ADACEL. It was a case of actual medication error due to wrong vaccine administered. It was unknown if any adverse event occurred. 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 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 SON WAS AND STILL COMPLAINS OF SEVERE HEADACHES AND STOMACH PAIN. HE IS OFTEN IN THE NURSE OFFICE OR HAVING TO COME HOME FROM SCHOOL BECAUSE OF THIS. IT'S OFTEN AND THROUGHOUT THE DAY BOTH MORNING AND NIGHT.
Abnormal bruising at the injection site.  Fever of 102.2 (my baseline is 97.7).  Horrible headache lasting for 11 days, resolving on the 12th day.  I have experienced tinnitus ever since my injection.  I have been hoping it would go away, but the tinnitus persists to this day.
Info has been received from a pharmacist concerning an 11 year old male with many food allergies and a possible yeast allergy who in 8/01 was vaccinated with a 1st dose and in 2/02 was vaccinated with a 2nd dose of Hep-B. The pharmacist reported that approx. 1 to 2 days after each dose, the pt developed a non-specific rash, swollen glands, a low-grade fever and congestion. All symptoms seemed to resolve approx. 1 week after onset. Additional info has been requested.