chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Just kind of sore; Received booster dose; Had terrible stomach cramps; Throwing up; Headache; Diarrhea; Couldn't eat; her stomach is still making a lot of noise; felt like having the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 30Nov2021 10:45 (Lot number: FF2587) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, Lot Number: ER8132, Anatomical Location: Left arm), administration date: 29Mar2021, when the patient was 79 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Lot Number: EN6198, Anatomical Location: Left arm), for Covid-19 Immunization; Flu vaccine (50 some years ago, the first flu vaccine around 1961 or 1962; felt like had been in a fight after receiving), for Immunization, reaction(s): "felt like had been in a fight after receiving". The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Received booster dose"; ABDOMINAL PAIN UPPER (non-serious) with onset 30Nov2021, outcome "recovered with sequelae" (2021), described as "Had terrible stomach cramps"; PAIN (non-serious) with onset 02Dec2021, outcome "recovering", described as "Just kind of sore"; EATING DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Couldn't eat"; GASTROINTESTINAL SOUNDS ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "her stomach is still making a lot of noise"; INFLUENZA (non-serious) with onset 2021, outcome "unknown", described as "felt like having the flu"; VOMITING (non-serious) with onset 30Nov2021, outcome "unknown", described as "Throwing up"; HEADACHE (non-serious) with onset 30Nov2021, outcome "recovered" (02Dec2021), described as "Headache"; DIARRHOEA (non-serious) with onset 30Nov2021, outcome "recovered" (01Dec2021), described as "Diarrhea".  Additional information: Diarrhea: The patient had diarrhea all the next day, 01Dec2021. Just kind of sore: 02Dec2021 (Today), the patient was okay just kind of sore. Throwing up: The patient stated she just threw up one time. Stomach cramps: The stomach cramps went away, patient was unsure when stomach cramps went away, it was during the night. Her stomach was still making a lot of noise but not in any pain. Diarrhea: The diarrhea went away last night, 01Dec2021. The patient did not get up any during the night. Headache: The headache was gone and went away, 02Dec2021 (today) around noon. The patient thinks she recovered completely form the headache. Just kind of sore: The patient stated the soreness had improved, actually felt like having the flu. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. AE(s) did not require a visit to emergency room or physician office. Prior Vaccinations (within 4 weeks) were none.   No follow-up attempts are possible. No further information is expected.
Rheumatoid arthritis flare up; Pain in arm after both moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Pain in arm after both moderna vaccine). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved and VACCINATION SITE PAIN (Pain in arm after both moderna vaccine) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  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.  Company comment  This spontaneous case reported by a consumer, concerns a 47 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) in the same year, but unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series.  On an unknown date, the patient had received ADALIMUMAB for Rheumatoid Arthritis, which could be considered as a confounder. No further clinical information on comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event was reported as not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 47 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) in the same year, but unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series.  On an unknown date, the patient had received ADALIMUMAB for Rheumatoid Arthritis, which could be considered as a confounder. No further clinical information on comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event was reported as not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Headache fatigue, nausea, neck ache, sore arm, chills Narrative: employee states: She experienced extreme fatigue beginning around 6pm same day as injection with nausea, sore arm at injection site, and restless sleeping. Friday 3/26/21: zero energy, headache, neck aches, nausea, mild chills, and sore at injection site Saturday 3/27/21: low energy, nausea, injection site tender Symptoms subsided late Saturday afternoon/early evening.  Other Relevant History:
Was given FLUMIST on 11/14 afternoon then few hours later developed fever and vomiting then chest pain diagnosed with left lower lobe pneumonia. Admitted to hospital as out patient for IV fluids. Placed on two antibiotics and pain relievers.  12/5/08 Reviewed ER medical records of 11/17/2008. FINAL DX: vomiting & dehydration; pneumonia Records reveal patient experienced nausea, vomiting, dehydration, dry mouth, sunken eyes, veins flat.  IV had to be started w/difficulty by anesthesia.  Tx w/IVF, antipyretics. Follow-up: This is to update a VAERS report that we submitted for this patient. The VAERS ID # is 333037. Pt was seen in our office on 11/26 for follow up on her pneumonia. She had a repeat chest Xray done at that time that revealed her pneumonia was worse and had progressed into the left upper lung as well as lower. She was admitted into hospital. Cat scan was completed at hospital which revealed the left lung had collapsed and pleural effusion had worsened. Pt was placed on ICU status and on Friday 11/28 had surgery to place two chest tubes in left side and debridement of the pleural cavity. Patient remained in ICU for 5 days. Given IV Vancomycin and Cefotaxime while admitted. Was released home from hospital on 12/4 and continues IV Cefotaxime every 8 hours via home infusion for at least one more week. Will be reevaluated for further IV antibiotics by Dr. in one week. Thank you for your attention in this matter.
Information has been received from a 26 year old female consumer with no pertinent medical history or allergies/drug reactions, for GARDASIL, a Pregnancy Registry product, concerning herself who on 03-MAY-2010 and on 06-JUL-2010 was vaccinated with a first and second dose respectively of GARDASIL (Lot # not provided). There was no concomitant therapy. On 08-JUL-2010 she was expecting to have her period and it never started. There was no relevant laboratory data. As of 11-JUL-2010 it was unknown if she was planning on having her third injection of GARDASIL and she still has not had her monthly period. The patient had asked if she was pregnant what would happen. It was unknown if the patient sought medical attention. Additional information has been requested.
called one patient for a shot and another patient came when the first patient was called.  there was a strong language barrier and second patient got a flu shot when she was wanting the covid shot.
received a second dose in error; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Kinrix (received 1st dose of Kinrix on 12th October 2021 from batch number 29MZ2 with expiry date unknown).   On 14th April 2022, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 14th April 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-APR-2022 Reporter's comment: The practice director reported that a patient received second dose of Kinrix in error. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose on 14th April 2022, which led to extra dose administered.
Incredible pain; could hardly walk; sore throat; hands really hurt; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Incredible pain), GAIT DISTURBANCE (could hardly walk), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (hands really hurt) and ARTHRALGIA (joint pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN (Incredible pain), GAIT DISTURBANCE (could hardly walk), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (hands really hurt), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). At the time of the report, PAIN (Incredible pain), GAIT DISTURBANCE (could hardly walk), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (hands really hurt), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Information has been received from a physician concerning a 65 year old female with no known allergies and no pertinent medical history who on 26-JUL-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included amlodipine besylate (+) atorovastatin calcium (Caduet).  The physician reported that the patient developed four small vesicular lesions at the injection site, and on her left leg.  No symptoms were noted.  Additional information has been requested.
but he developed a cold this week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 70 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "but he developed a cold this week".  Additional information: She said that her father is scheduled to get the 2nd dose on Saturday, but he developed a cold this week. She would like to know if they can reschedule him in getting the 2nd dose. When asked for the date of the 1st dose she said she can't remember the exact date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age or gender. On an unknown date the patient was vaccinated with VAQTA, (0.5 ml, intramuscular, dose number and lot number unknown). The healthcare worker reported that a dose of VAQTA that underwent a temperature excursion was administered to one unspecified patient. No adverse effect reported. Additional information has been requested.
Numb left arm, intense headaches, inability to coordinate a fraise, pinches on the brain, blurred vision, problems to be focus. (attention problem)
Androgenetic Alopecia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 at 09:15 as dose 2, single (Lot number: ER8737) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Disease" (unspecified if ongoing), notes: Hashimoto's Disease; "Bi-Polar II" (unspecified if ongoing), notes: Bi-Polar II; "Migraine Headaches" (unspecified if ongoing), notes: Migraine Headaches. The patient took concomitant medications. Past drug history included: Doxycycline, reaction(s): "allergies:Doxycycline", notes: known allergies Doxycycline. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 16Mar2021, when the patient was 36-year-old, for Covid-19 immunization. The following information was reported: ANDROGENETIC ALOPECIA (non-serious) with onset 01Sep2021, outcome "not recovered". The event "androgenetic alopecia" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of androgenetic alopecia.  Additional Information: No other vaccine in four weeks. Other medications in two weeks: Yes (Not enough space in this field to list). Ae treatment: Spironolactone, Minoxidil, Ketoconazole. No covid prior vaccination. If covid tested post vaccination: Yes.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2014US024342, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to a 69-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 06 Nov 2014. The nurse reported that FLUVIRIN prefilled syringe stored at 49 F for 1 hour and 15 minutes was administered to the patient. No adverse event reported following this medication error. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
According to database the patient received their first dose of COVID-19 vaccine on 6/26/21 and received a Pfizer brand vaccine. She then received 2 more doses spaced 4 weeks apart of Moderna.
Client presented to ER at 21:19 on 1/29/01 with a headache, nausea and vomiting (with bloody emesis), sweats and chills. Received extensive work-up and all was essentially negative except that she was found to be very early in pregnancy, with miscarriage later. Received Compazine/Benadryl and RX for Vicodan/Phenergan suppositories. Continued to vomit, was treated again and discharged on 1/30/01 at 00:25 AM. Returned to ER on 2/1/01 with headache and nausea and vomiting, no rash or meningeal symptoms. Temperature was 99F. Rx'd with IV 2 liters NS. Phenergan, Benadryl and 10 mgm Morphine given IV. Observed and discharged ambulatory. Impression: Headache and adverse reaction to immunizations. Per chart at hospital.
On Mar 19, 2015, at 8:43 AM, patient wrote: I just wanted to inform you of an adverse reaction I had that began the evening after I received the flu vaccine. My lips began swelling and got progressively worse over the next few days. I took BENADRYL every 8 hours in the hopes of decreasing the reaction but by day 2, other parts of my face began swelling, lip swelling increased and I broke out with cold sores all over my lips. I went to see Dr. on Friday and he began me on VALTREX for the cold sores. By Friday night it was much worse and today is the first time I have been able to come back to work.
Pt developed erythema and swelling at site of injection.  Treated with Keflex.
INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) once a total dose was not reported, administered on 11-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 16-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210349960.
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 35-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.       No concomitant medications were reported.  The pharmacist reported that, temperature excursion occurred several days ago in the freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer, and they just found out about the excursion in an audit.   No adverse event reported for the patient.  No treatment medications were reported.
Child received his 4th DTaP vaccination on 5/17/2004 around 2:00pm. Extensive Swelling Reaction was noted the next morning around the area of injection in the left thigh. Child had no fever, normal activity level but redness and swelling were noted and increasing over time.  Due to in the increase of swelling and redness, this prompted a visit to the medical center for evaluation.
one hour after shot left arm went numb for twelve hours, and sixteen hours after shot ran a low grade fever for 24 hours, on 03/20/2021 a week after, both of my ears starting ring and have not stopped , and a pain above my right kidney started and has not went away
5-10 seconds of stiffening of arms and legs. No obvious clonic/tonic movements. This was with extreme crying after the last shot (MMR). No LOC. observed. No treatment necessary. Went home after 15 minutes of observation.
"just doesn't feel good, feels kind of weak, chest hurts" has asthma- no treatment observation - no breathing difficulty no local reaction. Fa - notified and is picking him up. Instructed fa on s/s to watch for to report to MD or EMS. Fa picked up @ 11;20 a.m.
Trouble breathing approx 6 hrs after injection. Eyes swelled shut. Used inhaler & took BENADRYL. Third time this has happened when taking flu shot.
myalgias,h/a,fever,vaccinia-type eruption w/redness&swelling,deltoid;
Mother called agency on 7/15/2005 that child received vaccine on 7/11/2005. States whole leg swelled down to ankle and took to ER at local hospital. Was treated with Benadryl and an ointment that began with an "H". Mother did not report exact date of emergency room visit.
04/29/21 in ED "with PMHx most significant for CHF, COPD on 4L, GERD, HTN, HLD,, IDDM presenting for dyspnea"; discharged home on 05/06/21.
painful axillary lymph node swelling started overnight on 10/20/2021. Then on evening of 10/22 patient noted diffuse ecchymosis/purple bruising extending from axilla down the inner aspect of the arm to the wrist.
Received vaccine at 10 AM on 9/20/18. Began to experience itching at site at 1:30 PM and by 2:00 PM injection site was swollen, red and warm. Sent to the ED for further evaluation and treatment.
Patient reports a mild headache that begun at 5pm on the day of vaccination. It has subsided. She currently has a fever of 101 degrees F,  and mild upper back pain. She contacted her primary care physician, and made an appointment with urgent care for this afternoon (04/14/2021).  She also reports general tiredness.
Patient experience mild fever and fatigue after the 2nd dose of pfizer vaccine. However, about 10 days later, he woke up with some hive like bumps spreading from his left arm to his face. Mom has noticed some on his left fingers too.  They are not really itchy but painful. Advised mom to take him to his primary care.
Caller said she took 1st dose on month 0, then took second dose at month 1 and then the 3rd dose at month 3; No other AE; This spontaneous report was received from a consumer and refers to a female patient of unknown age. No information on patient's medical history, current conditions and concomitant medications was provided.     On an unknown dates (reported as 1st dose on month 0, then took second dose at month 1 and then the 3rd dose at month 3) the patient was vaccinated with all three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration and no adverse event). The company unidentified HPV vaccine administered (name and lot number not provided).
swollen arm with heat , for 2 days ,nausea 5 days, fever to 100.1 1 day broke with med-advil muscle aches from neck down 5 days, fatigue 5 days, severe abdominal pain stabbing for 5 days went to ED and IBS flare up also