chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3rd day my joints, neck and back hurt for the next 3 days; 3rd day my joints, neck and back hurt for the next 3 days; 3rd day my joints, neck and back hurt for the next 3 days; feeling like I was going to get fever; cheeks and ears turned red and hot; This is a spontaneous report from a contactable consumer (patient, self-reported). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3249 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 28Jan2021 at 12:00 PM (age at vaccination: 45 years), as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included Hashimoto's, lichen planopilaris, stroke, brain aneurysm, degenerate disc disease, and adhesive, dust, mold, mildew allergy. The past drug included Morphine and Darvocet which had allergies. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on first night she started feeling like she was going to get a fever, cheeks and ears turned red and hot. Took temp but not out of ordinary. Second night she was fine. On 3rd day her joints, neck and back hurt for the next 3 days on 28Jan2021 at 06:00 PM. The patient did not receive any treatment for the events. The outcome of the events was recovered with lasting effects or sequel on an unspecified date.  Follow-up attempts completed. No further information expected.
Shortly after shot, tip of tongue then sides started to tingle. This was about 10-15 minutes after. Then the back of my throat also was tingling. I remained at the clinic for one full hour on my own. This subsided over the next couple days. The tongue tingling has happened with each vaccine from Pfizer (1st, second and now this last booster)
I got my period. I'm on a continuous birth control prescription and have been for 10 years. My last period was 2011. No break through spotting. My initial vaccine series were Pfizer COVID vaccines, and this was a Moderna booster 6 months later. With the initial series, minimal effects occurred - localized soreness, no fatigue, no menstruation. With the booster, I experienced fatigue starting approximately 60 hours post-vaccine, and I menstruated for approximately 72 hours.
small red patch on Right flank/side; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin red in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-APR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 06-APR-2023, 1 days after receiving Shingrix, the patient experienced skin red (Verbatim: small red patch on Right flank/side). The outcome of the skin red was not reported.   It was unknown if the reporter considered the skin red to be related to Shingrix.     It was unknown if the company considered the skin red to be related to Shingrix.   Additional Information: GSK receipt date: 07-APR-2023 The reporter was Consumer. The reporter reported that she received first dose of SHINGRIX on 5 April 2023 in left arm  and experienced a small red patch on the right side, flank area. The reporter consented to follow up.
pt recv vax 8NOV97 & exp discomfort noting that w/in 3hr of shot arm became more tender & later that noc the site got very tender & swollen;9NOV97 below the inj site was @ least 1cm larger than the other arm;
Approx 15mm red area, swells periodically, "hive like", noticed approx 2 wks post vax;
Second dose: fatigue; Episode of cold chills; Muscle ache; Rash on neck and chest; Inflamed with redness; Itchy; This is a spontaneous report from a contactable other HCP(Patient).   A 35-year-old non-pregnant female received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number was EL9264) via an unspecified route of administration, in left arm on 09Feb2021 (age at the time of vaccination was 35-year-old) as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included Vit C/D for birth control. The patient had no known allergies. Previously the patient received first dose of bnt162b2 (COMITNATY, Solution for injection, Batch/Lot number was EL3249) via intramuscular route in left arm on 19Jan2021 11:30 (age at the time of vaccination was 35-year-old) as single dose for COVID-19 immunization. First dose: headache and fatigue for 3 days.The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. On 12Feb2021, the patient experienced Fatigue, episode of cold chills and muscle ache for 1.5 days. 72 hours post- experience rash on neck and chest (inflamed with redness and itchy. Patient received treatment as topical steroid. Outcome of all the events was unknown.   Follow-up (12May2021):.Follow-up attempts completed. No further information expected.
chills, sweating, aching muscles and joints...took ibuprofen to help with symptoms.  Symptoms lasted about 24 hours.
Patient felt nauseated and hot.  Laid down and given water.   About 10 minutes later, patient had clear emesis (small amount).  Patient sat up and cool cloth applied to face and neck.  Felt cooler and said she has a hx of cyclic nausea/vomiting.    She was resting and cool cloth applied again to face.  Sipped some water.  After total of 40  minutes of observation, patient felt better and declined further evaluation in the ED.
Seizure 2 weeks later with overnight hospitalization after not having seizure since 10/2016
SYMPOTMS SUCH AS STUFF NOSE THAT PROGRESSED TO LOSS OF TASTE AND SMELL; CHILLS; ACHEY ALL OVER BODY; FEVER; NAUSEA; REALLY TIRED; SWELLING OF LYMPHOCYTES; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dry cough, and other pre-existing medical conditions included has a dry cough from taking lisinopril, starting medication about a week before getting the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) 1 total, administered on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril. On 25-MAR-2021, the subject experienced swelling of lymphocytes. On 25-MAR-2021 16:00, the subject experienced really tired. On 25-MAR-2021 22:00, the subject experienced achey all over body. On 25-MAR-2021 22:00, the subject experienced chills. On 25-MAR-2021 22:00, the subject experienced fever. On 25-MAR-2021 22:00, the subject experienced nausea. On 26-MAR-2021, the subject experienced symptoms such as stuff nose that progressed to loss of taste and smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from really tired, fever, chills, and swelling of lymphocytes, and the outcome of nausea, sympotms such as stuff nose that progressed to loss of taste and smell and achey all over body was not reported. This report was non-serious.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 02-MAR-2012, the patient was inoculated with ZOSTAVAX for routine adult health maintenance and for the prevention of shingles (dose, lot #, and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-DEC-2015, he was treated by a physician for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number unknown, expiration date unknown), via an unspecified route of administration, on an unspecified date in 2021 at single dose for covid-19 immunization. Medical history included allergies from 2021 and ongoing. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for allergies from 2021 to an unspecified stop date. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date for covid-19 immunization. As per the description, the caller stated that she took an allegra for her allergies the morning she received the second dose of the Pfizer-BioNTech COVID-19 vaccine. She explained she didn't experience any side effects from the vaccine besides a sore arm. She mentioned she has been taking this pill for a month for her allergies and asked if it could have blended the inflammation response of the vaccine. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I had all the general side effects listed. I had everything and Fatigue chills headache muscle pain, joint pain nausea and vomiting and fever, and  diarrhea . I took Advil 12 hrs later
SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19  VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 32 year old, female. The patient's height, and weight were not reported. The patient's concurrent conditions included: nasal allergies, and vocal cord dysfunction and the patient was not pregnant at time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 11-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 30 years old. Concomitant medications included bupropion, Zyrtec (cetirizine hydrochloride), Vit d3 (colecalciferol), Sprintec (ethinylestradiol/norgestimate), Lamictal (lamotrigine), and Singulair (montelukast sodium). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received non-company suspect vaccine Pfizer (tozinameran) (dose number in series 2) (form of admin and route of admin were not reported, batch number: 33036BD, expiry date: UNKNOWN) dose and frequency were not reported, administered on 27-DEC-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with Pfizer (tozinameran) (dose number in series 2). The patient additionally received non-company suspect vaccine Moderna (elasomeran) (dose number in series 3) (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported, administered in left arm on 09-SEP-2022 for covid-19 prophylaxis. The patient was revaccinated with different covid-19 vaccine (dose number in series 3).  On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 3). The patient received non-company suspect drug included: Paxlovid (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered from 16-NOV-2022 to 21-NOV-2022 for treatment of Covid-19.  On 23-NOV-2022, the patient experienced rebound covid-19 infection after taking Paxlovid, symptoms started 2 days after last dose of Paxlovid (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and elasomeran was not applicable and with Paxlovid was drug discontinued. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
This 9 month old infant had a 2 1/2 by 3 1/4 cm erythematous circular area surrounding the injection site with a firm indurated area. The site was warm to touch, the reaction began 48 hours after the injection. The infant was started on Augmentin for cellulitis.
Not sure at the time of the call /  if the diluent vials were administered to patients; Not sure at the time of the call /  if the diluent vials were administered to patients; package doses unit missing; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in in an unspecified number of patients who received Herpes zoster (Shingrix) (batch number 7Y359, expiry date 15th November 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist had a Shingrix box which was only with 3 lyophilized vials and no diluent vials. The reporter was not sure at the time of the call if the box came that way or if the diluent vials were administered to patients, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No further information was provided at the time of the call. The reporter consented to follow up by telephone.
Patient felt weak and nauseous after receiving vaccine dose.  She states she has had vasovagal reactions in the past after giving blood and that she did not eat much today, so low blood sugar may be involved.  Pharmacist took patient's blood pressure and pulse, which were both normal, and observed patient seated for 30 minutes.  Patient applied ice pack to forehead and neck and drank some juice her mother bought and started to feel better.  She was able to walk out on her own after sitting and never actually passed out.
1-18-08 Left arm min. redness, warmth; sl. induration, nontender
red rash; itchiness; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), RASH ERYTHEMATOUS (red rash) and PRURITUS (itchiness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). On 01-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash) and PRURITUS (itchiness). On 01-Mar-2021, PAIN IN EXTREMITY (soreness in arm) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash) and PRURITUS (itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Benadryl. Concomitant medication details were not provided.
pneumonia; bruises on the chest, back, then all over the body; itchy; burning; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K206A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced CONTUSION (bruises on the chest, back, then all over the body), PRURITUS (itchy) and BURNING SENSATION (burning). In October 2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia), CONTUSION (bruises on the chest, back, then all over the body), PRURITUS (itchy) and BURNING SENSATION (burning) outcome was unknown.            No concomitant medications were reported. Patient has been treated with steroid shots, oral steroids, & steroid cream. The patient also got pneumonia last week.  Company Comment: This case concerns a 69-year-old male patient with no medical history reported, who experienced the unexpected serious event of pneumonia. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event occured after the second dose and no additional dosing will be given. The benefit-risk relationship of the vaccine in not affected by this report.; Sender's Comments: This case concerns a 69-year-old male patient with no medical history reported, who experienced the unexpected serious event of pneumonia. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event occured after the second dose and no additional dosing will be given. The benefit-risk relationship of the vaccine in not affected by this report.
pt recv vax;T 106,crying;leg,muscle,back hurting;would not move arm for 1 wk;rash on stomach,lasted 3 days;fever for 2 days;
Itching mild to acute over 12-14 hours persisting for 5 days.  Redness starting after about 12 hours & persisting for 5 days.  Swelling by 32 hours and persisting for 4 days - now reducing.    Pain by 32 hours for 2days.  Starting area about size of quarter to max size of 3 1/2 inches - now reducing.
Site Reaction to Left Thigh- painful to touch - Prolonged crying - approx. 12 hours
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional 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: Unknown ,expiry: unknown) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
(10/29) S: received yellow fever L post. tricep on 10/21. Next day noticed more redness 6 in from inj site. site warm. On 10/22 area increased in size and began to feel painful. No N/V, slight itchiness, no rash. (10/24) - present to clinic with of pain (3-4/10), red, warm area. O: 4x8cm erythmic, high temp plague (L) bicep ending 2-3 on above antecubital. No tx wanted to phone call to client. Arm all clear be seen by PCP.
After immunization, swelling/heat/redness @ injection site which went away after 3 weeks. Pain remains at injection site from 9/11/18 to 7/5/19. Referred to PCP.
Given TDAP on 2-16-11, didn't feel well on 2-17-11 - had headache and fever 102 degrees on 2-18-11. Body aches, swollen glands in neck fever and headache went to ER.
Pt states hx of anxiety and was throwing up with abdominal painprior to arrival as well. Given 4 mg SL zofran with mild relief of nausea, abdominal pain persisted: Pt presents with nausea/vomiting which she attributes to anxiety. States she has had severe anxiety about getting vaccine and has been vomiting with abdominal pian throughout the day. She is noted to be extremely hypertensive today, denies hx of hypertension. She was given 4 mg SL zofran with resolution of nausea however abdominal pain and hypertension did not resolve. Of note, pt has a hx of Whipple procedure Nov 2019 and reports she has had intermittent abdominal pain since that time. Report called and pt escorted via wheelchair to the ER
Patient complained of dizziness, headache, blurred vision, and body feeling warm 5 min after administering vaccines. BP taken - WNL. Patient sat down and drank a glass of water for 15 min. She then stated she was feeling a lot better and all symptoms were gone.
Never received the second Shingrix vaccine; Swelling face reappeared, not yet resolved. Shingles was never diagnosed; Itchy face reappeared, not yet resolved. Shingles was never diagnosed; Headache since the current symptoms started; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In June 2022, between 1 and 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced facial swelling, pruritus facial and headache. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with ophthalmologicals (nos) (Eye Drop (Nos)). On an unknown date, the outcome of the facial swelling, pruritus facial and headache were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the facial swelling, pruritus facial and headache to be possibly related to Shingrix.     Linked case(s) involving the same patient:  US2021AMR077318, US2022094114   Additional Information: GSK Receipt Date: 15-June-2022 Reporter's Comment: The patient reports this case for herself for the 2nd episodes of adverse events. The patient received 1st dose of Shingrix on an unknown arm, about 18 months ago. On an unknown date, two weeks ago, the patient experinced same symptoms (swelling/itchy face) reappeared near the left eye. A new eye doctor started her on another eye drop but the swelling and itching has yet to resolve. The patient was also reporting a headache since the current symptoms started. This eye doctor told the patient that it could be a reoccurrence from the Shingrix vaccine 18 months ago. The reporter consented to follow up. Additional supportive information: The patient reports that she never received the second Shingrix vaccine. which led to incomplete course of vaccination. This case has been linked with case US2021AMR077318 reported by same reporter for 1st episodes of adverse events. Note: From the narrative it was not clear if the patient did not received 2nd dose due to medical reason hence incomplete course of vaccination was coded as event.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022094114:Same reporter. Case deleted - FU1 of US2021AMR077318 US-GLAXOSMITHKLINE-US2021AMR077318:Same reporter. 1st episode of AEs.
vaccine given 6/6/22, beyond use date 6/7/22, expiration date 5/31/22