chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the second dose, I experienced a high fever and body aches in the evening which lasted 3 days. I later in the month had a period; I do not have my menstruation with the medication I am on and have not for 6 years.
Ringing in ears, tinnitus.  Went to get ears tested and tech performing test stated I was the 3rd person she had tested that day with Tinnitus starting after receiving the vaccine
Pt called to report that she went to her PMD to check her injection site from Flu vaccine given intramuscularly on 11/31/07 that it was red and inflamed. RN did not witnessed the site. Per pt her PMD said no signs of abscess on site, no drainage noted but was given Amoxicillin 500mg TID X 10 days. Had taken 1st dose today and was feeling much better. Per pt, no pain on site and less redness noted. Informed Dr of incident. Pt was given flu vaccine on 10/31/07 IM on R deltoid muscle, not breaking any aseptic technique. Hand washing properly observed and site properly prepped and applied band aid on site of injection.
welts, hard, on face and neck; welts, hard, on face and neck; ear is very itchy; pain in the right arm; very large red mark on right arm; wants to scratch her ear off because it is so very itchy.; This case was reported by a consumer via call center representative and described the occurrence of welts in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Gel shots (received gel shot's in knee few weeks ago).   On 5th May 2022, the patient received Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced welts, induration, ear pruritus, pain in arm, erythema of extremities and scratch. On an unknown date, the outcome of the welts, induration, ear pruritus and scratch were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved and the outcome of the erythema of extremities was recovering/resolving.   It was unknown if the reporter considered the welts, induration, ear pruritus and scratch to be related to Shingrix. The reporter considered the pain in arm and erythema of extremities to be related to Shingrix.     Additional Information: GSK receipt date: 11-May-2022 Reporter's comment: The patient self reported this case. The patient received a dose of Shingrix in right arm on Thursday and she developed 3 welts.  The patient stated that they were hard and about the size of a large mosquito bite. One in on her face, on her cheek near the jaw bone and she had 2 on her neck, also her ear was very itchy.  She said that she wanted to scratch her ear off because it was so very itchy.  She did had pain in the right arm (which had been resolved) and she did had a very large red mark on the right arm but that was going away now.  She was calling GlaxoSmithKline on the day of reporting to see if she was experiencing a reaction from the Shingrix. She said that she reported her face/neck symptoms to her pharmacist and her pharmacist did not thought it was due to Shingrix. She said the only other thing she had was in the last few weeks she got gel shots in her knee.  She did not specified if it was shot 1 or shot 2 of the series. She did not want to provide her email address.  She did not had the lot number/expiration date of the Shingrix because she stated she did not receive any paperwork from the pharmacy, but she provided the pharmacy's phone number who should had that information on file.  No further questions were asked, reporter did not want to answer further questions. Did not consent to follow-up.
Client received an inactivated polio vaccine from a multi-dose vial that had been subjected to temperature greater than 46 deg F.  Temperature excursion occurred on 4/1/2019.  Vaccinating nurse was unaware of the excursion at the time of administration on 4/02/2019.
Information has been received from a physician concerning a 15 month old female patient with allergies to amoxicillin (AMOXIL) and cefprozil (CEFZIL) who on 09/18/2002 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  There was no concomitant medication.  On 09/25/2002 the patient became limp following a "staring spell", which lasted one minute.  The physician does not know whether the event was associated with the vaccine, or whether the event was a seizure of syncope.  It was reported that no further episodes of the same occurred.  Unspecified medical attention was sought.  Additional information has been requested.
Received approval from cardiologist's office to receive TL at local health fair. 15 minutes after immunization, felt ill, heart accelerated. Client's mother was with her and took her to emergency dept in hospital where she was monitored for 4 hours and discharged when her pulse decreased to 100 beats/min. Continues to have tiredness w/exertion
Patient received the PNEUMOVAX from physician and then came to the pharmacy to receive the PNEUMOVAX, having forgotten she had received it earlier that day. After administration, the duplication was discovered and the physician was contacted. No adverse events have been reported at this time.
Patient administered Pfizer 12 &up MRNA verses Pfizer 12&UP Bivalent, no reaction.
at second appt, pt reported having had to go to dr for x-rays and treatment following 1st injection on 2/16.  dr said shot was given too high and too close to the bone, resulting in a bone injury.  Pt reports that the severe pain lasted for 3 weeks, but is now much less.  she was anxious about the placement of the shot, so I reassured her that it would be given in the appropriate location.
redness, swelling, pain in (L) arm ?from flu shot on 10/30/07-rec. Zinacef 750mg IM 11/1/07 then started on Keflex 250 mg one tsp po tid x 10d- (see picture)
*administration route note: was admin IM per lab tech personnel, according to pt specialist advised from ultrasound result that vaccine was actually subcutaneous with incorrect admin Pt had onset of localized pain, swelling, tenderness 16 days after vaccine was administered, worsened x3 days and then improving, last followup was minimal discomfort/tenderness, no swelling/rash at that time was 5 weeks since immunization
9Concomitant medications were reported as yes. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FN6205) via an unspecified route of administration in right arm on 03March2021 at 12:45 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. The patient had reported no allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since having the vaccine. On 25Mar2021 at 07:30, the patient experienced nausea and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcomes for the events nausea and joint pain were recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Childs mother described that initially the child complained of itching internally. As the itching continued the child began to experience some rash activity after the child would itch.
The day after receiving his 2nd vaccine the patient began to experience slight itching on the palms of hands. 36 Hours after receiving the vaccine patient noted itching had spread to forearms and was also itching on his lower extremities. At this time there were no noticeable hives. Patient contacted pharmacy 48 hours after receiving vaccination and stated that he now had several hives on his abdomen. Patient was advised to take Benadryl, not to scratch the area, and to keep skin from drying out. Patient was told that if symptoms worsen or if his mouth or throat begin to itch or swell he should call 911 and go to the emergency room.
2 days after Pneumonia injection, inflammation noted, burning sensation 4 inches below site. No redness at injection site.
fatigue the day after the shot; This is a spontaneous report from a contactable consumer reported for herself. A 47-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EL3247; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 09Feb2021 14:30 (at the age of 47-years-old) as DOSE 2, SINGLE for covid-19 immunisation at the clinic. Patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (Lot number: EL3247) via an unspecified route of administration, administered in right arm on 19Jan2021 (at the age of 47-years-old) as dose 1, single for covid-19 immunisation. The patient previously took codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue the day after the shot on 10Feb2021. No treatment received for the event. Seriousness criteria included none and the event was not serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Clinical outcome of events was recovered on unspecified date.   Follow-up attempts are completed. No further information is expected.
After 15 minutes of observation, patient complained of localized chest pain, described as pressure, pain level at 8/10.
W/in 36 hrs of vax pt devel h/a, meningismus, photophobia, D, severe vomiting, & fever 100.5 to 101F.  Sx persisted for 24 hrs.
Hospitalization: 8/18/2022 admitted; 8/24/2022 discharged. Presentation to the ED: shortness of breath, chronic back pain, cough, worsening shortness of breath, productive cough, chest pain.  COVID-19 + date: 8/18/2022 Treatment: IV antibiotics. No COVID prophalyxis. Supplemental O2 as needed.  Discharge to: Home Health Care
Pfizer vaccine was administered outside of office - reported by patient- ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------- G47.33 ADULT OBSTRUCTIVE SLEEP APNEA 12/14/2021 CANCER METASTATIC TO UNSPECIFIED LUNG I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 12/14/2021 CANCER METASTATIC TO UNSPECIFIED LUNG J96.00 ACUTE RESPIRATORY FAILURE 12/14/2021 CANCER METASTATIC TO UNSPECIFIED LUNG J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/15/2021 CANCER METASTATIC TO UNSPECIFIED LUNG G47.33 ADULT OBSTRUCTIVE SLEEP APNEA 12/14/2021 CANCER METASTATIC TO UNSPECIFIED LUNG I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 12/14/2021 CANCER METASTATIC TO UNSPECIFIED LUNG J96.00 ACUTE RESPIRATORY FAILURE 12/14/2021 CANCER METASTATIC TO UNSPECIFIED LUNG J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/15/2021 CANCER METASTATIC TO UNSPECIFIED LUNG
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 65-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date January 2019). On 30th January 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: It was reported that the patient received SHINGRIX and it bothered her. The reporter thought it was maybe soreness but was uncertain. The reporter stated that the patient's tenseness might had contributed to adverse event. The case was linked with the case US2018019800, reported by the same reporter for spouse.
Numb/Tingle sensation on left side of face & down arm of left/injection side of body, nausea/vomit, fatigue, headache, body aches, diareha
Pt reported to Mother she was itching and hurting. Mother observed a rash under left breast radiating to left side and back.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "Heart murmur" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: After taking the medication Patient experienced an extremely bitter taste in my mouth that does not go away after eating or brushing your teeth. The taste caused me to feel nauseous and Patient had difficulty sleeping. Patient also noticed that Patient was having pain in my gums and teeth after one 2 doses of the medicine. Patient decided after the fourth dose to discontinue the use as the adverse effects outweighed the Covid effects.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
She developed left shoulder joint pain extending into her deltoid and acromioclavicular space after her flu injection administered at site which continued 3 weeks after the injection. She presented to the location for initial evaluation 10/05/2018. Rated left shoulder pain 7/10 stabbing and aching in nature. She states she had decreased ROM in the left shoulder joint. BP 119/77, pulse 61, temp oral 97.7. No visible edema, erythema, ecchymosis, streaking or wound. No neurovascular deficits. No epitrochlear nodes. Full ROM left shoulder joint. Hand grasps equal.
pt recvd flu vax 930AM; face became fiery red 24 hrs later;
3 days after MMR right upper quadrant pain, no other symptoms, Pt convinced related to vaccine resolved.
It was reported that an 18 y.o. female PT received a Menomune A/C/Y/W-135 vax, administered SC on 9/16/02 at 9:33 a.m. Between 1 and 1:30 p.m. that same day the PT was treated at an MD's office for swelling of arm, pain in shoulder/back, swelling of face and difficulty breathing. The PT never had a reaction to a vaccine in the past. No hives. 2 epi sq 50 mg/IM Benadryl.
7/28/21 h/o BPH, DM, CAD s/p PCI, HTN, glaucoma, and HLP who presents with 2 day history of generalized weakness and URI symptoms
About 4 weeks from vaccination I started having increased muscle and joint stiffness and soreness.  Symptoms have not abated as of this report.
Death within 24 hours. (According to death certificate, undetermined cause and manner of death). Autopsy states cause of death as undetermined. Infant was found in bassinet in prone position.
Redness, swelling, hot to touch extending 2 inches down from injection site. Pain on touch and consistent pain. Stiffness extending down left arm. Received both doses in left arm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive, notes: Now on Day 9, the patient was having symptoms again and tested positive; (May2022) Negative, notes: On day 8 of having COVID, the patient tested negative on a rapid antigen test. Therapeutic measures were taken as a result of covid-19.  Clinical information: Patient received other medication in 2 weeks. COVID 19 treatment with Pfizer product start date reported as 26Apr2022 and stop date was reported as 30Apr2022. The clinical course was reported as: on day 8 of having COVID and after complexing paxlovid, the patient tested negative on a rapid antigen test. Now on Day 9, the patient was having symptoms again and tested positive and reported viral rebound.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12/18/21 presents to EC ED for "RLE swelling". PMHx of "stage 4 metastatic melanoma of the RLE s/p immunotherapy and RT, immune mediated colitis c/w perforated viscus s/p total colectomy with ileostomy creation (10/25/2021), radiation dermatitis, HTN, HLD, hypothyroidism"
Covid arm started 12 hours after the shot; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (Covid arm started 12 hours after the shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 012MZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (Covid arm started 12 hours after the shot). At the time of the report, VACCINATION SITE REACTION (Covid arm started 12 hours after the shot) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant treatment was provided. No treatment medication was provided. Patient had experienced Covid arm in 12 hours after taking 3rd dose.   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up received on 08-OCT- 2021.it includes Patient date of birth, first, second and third doses start date with batch numbers.
9 days after receiving my booster and with no major prior health concerns became sick on Nov 27th with what I thought was good poisoning and had symptoms (abdom pain only)  in my home from 2pm until next morning about 6am. I had not slept all night and was in extreme pain.  On morning of Nov 28 I went to the ER and was diagnosed with Acute Appendicitis and had surgery the same day to remove the appendix with no complications.
Employee received first dose of vaccine and states she became nauseous.  Reassurance given declined crackers, did eat hard candy and small sips of water, spoke with her mom and requested to be evaluated in the Emergency Department.  Once arrived in the Emergency Department employee stated she felt like her chest was going to explode.  B/p 119/70, P 82, R 16, Temp 96.9.
eczema; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included dupilumab (DUPIXENT) taken for eczema, start and stop date were not reported. The patient experienced eczema on an unspecified date. It was reported that for a patient who got the COVID 19 vaccine on Monday. The patient's mom was called that the patient was on Dupixent for eczema, an injection every 14 days. She wanted to know if it was ok to get the injections tomorrow since having the vaccine on Monday. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot obtained. No further information is excepted.
Sharp pain at site of injection, beginning immediately at time of injection; patient reports no swelling, redness, fevers/chills/sweats or other signs of infection; patient says area is constantly tender to palpation and painful, regardless of movement of arm.
I tested positive for COVID.; I tested positive for COVID.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 23-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Feb2021 (Lot number: EL9264) at the age of 23 years as dose 2, single and administered in arm right, administration date 23Jan2021 (Lot number: EL3249) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Nov2021, outcome "recovering" and all described as "I tested positive for COVID.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) positive, notes: Nasal Swab (PCR test). Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: The patient had no known allergies. The patient had no vaccine in four weeks and had none other medications in 2 weeks. The patient was tested for covid post vaccination and resulted positive.
pt rcvd vax; pt devel diffused generalized urticaria; pt seen twice in emergency ER due to urticaria; pt treated w/ diphenhydramine HC1 & epinephrine;