chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in either June or July, refer linked case US2018GSK175505). On 4th September 2018, the patient received the 2nd dose of Shingrix. On 4th September 2018, immediately after receiving Shingrix, the patient experienced pain in arm, chills, churning of stomach, appetite absent, fluid intake reduced, decreased activity and somnolence. On 5th September 2018, the patient experienced feeling abnormal. In September 2018, the patient experienced weight loss, stomach pain and gastric disorder. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, churning of stomach, appetite absent, fluid intake reduced, decreased activity, somnolence, feeling abnormal, weight loss, stomach pain and gastric disorder were unknown and the outcome of the chills was recovered/resolved. It was unknown if the reporter considered the pain in arm, chills, churning of stomach, appetite absent, fluid intake reduced, decreased activity, somnolence, feeling abnormal, weight loss, stomach pain and gastric disorder to be related to Shingrix. Additional details were provided as follows: At 10 am, the patient received 2nd dose of Shingrix on left arm. The patient stated that with the second dose of the vaccine, when the injection was being given, it hurt. Later in the afternoon about 6:00 pm,8 hours after receiving Shingrix, the patient started having cold shakes that lasted for about three hours. Less than a day after receiving Shingrix , the patient's stomach felt like it was churning and was unable to eat or drink and just laid around all day. Several hours after receiving Shingrix, the patient tried to went to sleep that night and was able to sleep all night long which she said was not normal for her. One day after receiving Shingrix, the patient woke up the next morning and said that her body felt like it had been turned inside out. The patient could not think of any other way to describe what she was feeling but her stomach was still a problem. Most of the side effects had subsided but she still had stomach problems that lasted two weeks. The patient was able to eat and drink normally at the time of reporting. Less than 2 weeks after receiving Shingrix, the patient lost four pounds over three days after getting the second dose of the vaccine and she only weighed 100 pounds. The patient did not have a primary physician. She went to a clinic only when she needs to and at the time of reporting she was in good health.
chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: May2021, for COVID-19 immunization, reaction(s): "arm soreness". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever".  Additional information: Reporter received the Pfizer C19 vaccine in May and June of 2021: first dose, arm soreness for a couple hours; second dose, experienced a fever, chills 25-30 hours. Patient received other medication was unknown. Past medical history and family history was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
24 hrs post vaccination, the pt developed edema and redness at injection site. Was instructed to apply cool compresses and to call if redness or swelling increased. Did not require antibiotics.
Metallic taste in the mouth. Denies SOB, no treatment given except to continue monitor.
Patient came in 10/22/18 around 5:50pm for a PNEUMOVAX injection. She is a 60 year old smoker. She came in around 4:15 on 10/24/18 and stated she had a rash on her arm that started on 10/23/18. I looked at her arm and found the following: red rash around injection site, left underarm and left shoulder. She stated it was very painful and said she could feel a knot in her underarm area which I'm thinking could possibly be swollen lymph nodes. Patient was not sick at time of vaccination and only received PNEUMOVAX that day. I gave her the vaccination. She stated she felt fine other than the pain from the rash and she felt tired. I told her I didn't think it was severe enough to go to the emergency room. I recommended she either go to urgent care of call her PCP and see if they can see her tomorrow.
coughing; This is a spontaneous report from a contactable consumer (patient) from a sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 15Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced coughing (non-serious). The clinical course was reported as follows: The patient received the first dose on 15Jan2021, and the second dose was supposedly scheduled for 05Feb2021. The patient, however, missed receiving the second dose because the nurse on duty told her to go to her doctor as she was coughing at that time. The clinical outcome of the event was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Received DTaP and IPV R thigh swelling upper size. Ice packs, Motrin, Keflex 25mg TID x 7d.
Patient developed significant swelling, warmth, redness, and pain near injection site. Patient also reported shivering and diarrhea. Patient treated with cold compresses and acetaminophen.
Low grade fever immediately. Pain, irritability within one day. Within 2 days diarrhea. Within 3 days vomiting. Symptoms have yet to resolve 5 days later.
pelvic pain; This case was reported by a other health professional and described the occurrence of pelvic pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pelvic pain. On an unknown date, the outcome of the pelvic pain was unknown.   The reporter considered the pelvic pain to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. 14 days ago, the patient received booster vaccine. The patient experienced mysterious pelvic pain that believe might have come from the vaccine. The patient had been to the emergency room twice in the past week and they can't discover anything related to this pain. The patient was hoping you might have anyone come down with similar maladies. This case has been linked with case US2020AMR181685 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR181685:same reporter
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; OXYGEN SATURATION DECREASED; This spontaneous report received from a patient concerned a patient of unspecified age and sex and ethnicity. 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, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-DEC-2021, the patient experienced oxygen saturation decreased, suspected covid-19 infection and suspected clinical vaccination failure and was hospitalized (date unspecified). Laboratory data (dates unspecified) included: Oxygen saturation (not provided) 87. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure and oxygen saturation decreased was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint. This case, involving the same patient is linked to 20220161291.; Sender's Comments: V0:20220152367-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20220152367-COVID-19 VACCINE AD26.COV2.S-Suspected covid-19 infection, Oxygen saturation decreased This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Having menses when vaccinated for measles 29MAY90; Missed next period 26JUN90; Miscarried 16JUL90
Patient received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 81-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA520A, expiry date 30th April 2022) for prophylaxis.   On 4th May 2022, the patient received Menveo. On 4th May 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 04-MAY-2022 Reporters comment: A health care professional reported that, the patient received an expired dose of Menveo. The reporter consented to follow up. Additional supportive information: The patient received an expired dose of Menveo, which led to expired vaccine used.
This is a spontaneous report from a contactable other hcp. This other hcp (patient) reported that a 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 22-years, intramuscular, administered in right arm on 30Sep2021 at 14:30 (batch/lot number was not reported) as dose 1, single for COVID-19 immunisation, at workplace clinic. Medical history included asthma. The patient was not pregnant at time of vaccination. No other vaccine in four weeks, no COVID prior vaccination, no known allergies. Concomitant medications were not reported. On 30Sep2021, the patient experienced flush face, intense itching of the face and body, burning feeling of the face, dizzy and blisters on tongue. AE resulted in doctor or other healthcare professional office/clinic visit. Oral treatment for tongue and diphenhydramine hydrochloride (BENADRYL). Outcome of the events was recovered with lasting effects. No COVID tested post vaccination. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.
11cm x 8 cm area of erythema/induration to right upper arm after IPV, DTaP placed 2 days prior in this arm.
tinnitus; This case was reported by a physician via sales rep and described the occurrence of tinnitus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was not recovered/not resolved.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The physician reported to the sales representative the patient in the late 50s to early 60s developed tinnitus after receiving their 2nd dose of Shingrix. No additional information was available regarding the patients. The reporter was consented to follow up. This case has been linked with US2019157521, reported by same reporter.
30 seconds after giving the immunization patient said her head started to feel funny. She then put her head in her hands and closed her eyes. I asked if she was all right and if she wanted me to get her some water. She asked if she could just sit there for awhile.  I stayed with her for about 3-4 minutes all the time asking how she was doing/feeling.  I said maybe I should help her move out to the waiting area since the immunization rooms air conditioning was not working and the cooler air might help her.( As a side note, she came in very apprehensive about receiving the vaccine.) She then got up and started walking to the door where I opened it for her .  Then as she walked through door, and with my hand helping guide her, she took about two and a half steps and passed out suddenly - falling away from me. There were about 5 other people in the waiting area the witnessed the fall and we all heard how when she went down she hit her head pretty hard on the floor. I immediately went down to see how she was (ie. conscious, bleeding, any swelling at impact site). She was then conscious again but disoriented. She answered questions I put to her but wanted to stay lying on the floor. A lady that was waiting asked if she should call 911, which I responded YES, thank you. Her husband was also called and came in.  Paramedics showed up about 10 minutes later and began monitoring and eventually did transport her to the hospital via ambulance.
Cold sore; this breakout was bad; This is a spontaneous report received from a contactable consumer. A 55-Year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration, in arm left, on 25Mar2021 at 09:30 AM (at the age of 55 years, non-pregnant), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. There was no history of 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 did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Mar2021, the patient had experienced Cold sore (I am so curious if you have ever heard this, have not had one in years and this breakout was bad). The treatment received for the adverse event was reported as anti-viral. Outcome of the event was reported as recovering/resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Got Pfizer dose and then they tested positive; Dues for second dose but don't get it because they are positive; Got Pfizer dose and then they tested positive; Dues for second dose but don't get it because they are positive; This is a spontaneous report from a contactable Pharmacist. A patient of unspecified age and gender received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 28Dec2020 at SINGLE DOSE for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient got pfizer dose and then they tested positive; dues for second dose but don't get it because they are positive on 11Jan2021. Outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2  on 28Dec2020, and was diagnosed with COVID-19 on11Jan2021.  No complete effect could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  The positive COVID-19 is more likely pre-existing/intercurrent condition, and unrelated to BNT162B2.
REPORTED TO MEDICAL SUDDEN ONSET OF RIGHT ANTERIOR ARM PAIN, NUMBNESS, AND WEAKNESS APPROXIMATELY 7 DAYS AFTER RECEIVING HIS FIRST DOSE OF COVID 19 VACCINE.  DATE OF 1ST VACCINATION: 20 JAN 2021.  DATE OF 2ND VACCINATION: 17 FEB 2021.
I had a sudden onset of general irritation leading to pain, itching, burning, feeling of my eyes ballooning and significant loss of vision to both of my eyes.  I do not wear glasses and have no other eye conditions. I made an urgent appointment and went to the eye doctor on 9/16/21.  He prescribed me Predisolone eye drops to be used every 2 hours. The Dr was a Optometrist and made me an appointment with an Opthalmologist for the next day 9/17/21. Dr diagnosed me with significant loss of vision, scar tissue in my right eye and acute uveitis of both eyes, prescribed dialating eye drops, continue prednisolone eye drops cyclopentolate and made me an an urgent appointment with Glaucoma Specialist. She has referred me to a retina specialist with my appointment 10/14/21.
Patient developed fever, weight loss and chest pain following COVID vaccination. Patient initially did not think symptoms were related to the vaccine however when they persisted he presented for care once in  primary care and then ED. Labs and chest x-ray were negative. He was then referred to ID clinic where chest CT was requested. CT revealed evidence of pericarditis.
Nausea, Fever, Body aches, Chills, Headache, and Diarrhea lasting 2 days.
numbness; Pain in the arm; Bloating; This is a spontaneous report from a contactable consumer (patient) received via Pfizer sponsored program. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unspecified) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that she took her first shot of the vaccine and experienced a lot of side effects such as pain in the arm, numbness, and bloating on an unspecified date. The clinical outcome for the events was unknown.  Information on lot/batch number has been requested.
mom reported 7DEC92 temp did not exceed 101 evening of 7DEC; vomited APAP & then was given APAP suppository; 8DEc92 8PM started to cry & fussy until 10PM; slept about 45 mins woke up crying for about 2 hrs; slept 7 hrs & cont crying; sz
Information has been received from a Registered Nurse (R.N) concerning a patient who approximately 31 day old on an unknown date, was vaccinated with ROTATEQ and PNEUMOVAX at one month of age at another physician's office. Concomitant therapy included DTP. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
After receiving his vaccines patient stood up to leave office, but then stated he felt dizzy and light headed. Pt was brought back into his patient room to be monitored. Pt stated he was seeing black and face became pale. Gave patient two gatorades and some cookies, and monitored BP. Within 5 minutes patient was back to baseline.
Redness, swelling, warmth at injection site starting the day after administration. Observed on Monday 3/15/21 to be about 2.5 inches in diameter, red, and warm to the touch.
This spontaneous report as received from a consumer (the patient's grandmother) refers to a 9 year old male patient. The patient had none pertinent medical history and none drug reactions or allergies. On 29-AUG-2014, the patient was administered with (Oka/Merck) VARIVAX (dose, route of administration, lot number and expiration date were not provided). The patient did not take any concomitant medications. The grandmother stated that, on 07-SEP-2014 (reported as 9 days later), the patient become ill. The patient's body became swollen, itching and broke out into hives. This adverse reaction has been ongoing for the past 9 weeks. The patient sought medical attention, he had been tot he doctor and the Emergency Room twice. An unspecified blood test was performed (results were no provided). The patient received ALLEGRA, ZYRTEC and BENADRYL as a treatment for adverse events. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and the vaccination with (Oka/Merck) VARIVAX was not provided. Additional information has been requested.
Rigors, fever , body pain, chills, diaphoresis, fatigue, weakness .lymphadenopathy left axilla
Very painful at injection site. Chills and fever. Malaise. Weepiness.
Extreme lethargy; Less pain than first dose; Every muscle and bone felt achy; Extreme headache; couldnt even get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Extreme lethargy), PAIN (Less pain than first dose), MYALGIA (Every muscle and bone felt achy), HEADACHE (Extreme headache) and MALAISE (couldnt even get out of bed) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and VITAMINS NOS for an unknown indication.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced LETHARGY (Extreme lethargy), PAIN (Less pain than first dose), MYALGIA (Every muscle and bone felt achy), HEADACHE (Extreme headache) and MALAISE (couldnt even get out of bed). On 04-Mar-2021, LETHARGY (Extreme lethargy), PAIN (Less pain than first dose), MYALGIA (Every muscle and bone felt achy), HEADACHE (Extreme headache) and MALAISE (couldnt even get out of bed) had resolved.            No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-038188 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-038188:Crosslinked husbands case
Patient received vaccine and when she stood up she grabbed the door frame of the consultation room to steady herself. Her daughter was in the room also. Patient did not move and said she felt nauseous. I, as the pharmacist, got a chair and helped the patient to a sitting position. I brought a waste basket over in case of vomit.  Her right hand was shaking and she said she felt nauseous. Her daughter brought her a Sprite and she proceeded to take some small sips. Her hand stopped shaking and she said she was feeling better. She remained seated but after a few minutes said her right arm was going numb and her face was feeling hot. Her daughter was alarmed and called emergency for the emergency squad to come and assess her. Once they arrived they took her blood pressure and proceeded to place her on a stretcher and left for the hospital.
Headache, Myalgia, NauseaVomiting, chills and heavy persperation Narrative:  Other Relevant History:
Nausea; lightheadedness; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient experienced nausea and lightheadedness on an unspecified date at the time of first vaccination. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained