chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her arm completely swelled up; the swelling has gone down but the circle with the fine bump is still there; headache that won't go away; sensitive to the touch; formed another small swollen fine circle in that area; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (her arm completely swelled up), VACCINATION SITE INDURATION (the swelling has gone down but the circle with the fine bump is still there), HEADACHE (headache that won't go away), VACCINATION SITE PAIN (sensitive to the touch) and VACCINATION SITE SWELLING (formed another small swollen fine circle in that area) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced PERIPHERAL SWELLING (her arm completely swelled up), VACCINATION SITE INDURATION (the swelling has gone down but the circle with the fine bump is still there), HEADACHE (headache that won't go away), VACCINATION SITE PAIN (sensitive to the touch) and VACCINATION SITE SWELLING (formed another small swollen fine circle in that area). In November 2021, PERIPHERAL SWELLING (her arm completely swelled up) and VACCINATION SITE SWELLING (formed another small swollen fine circle in that area) had resolved. At the time of the report, VACCINATION SITE INDURATION (the swelling has gone down but the circle with the fine bump is still there) and HEADACHE (headache that won't go away) had not resolved and VACCINATION SITE PAIN (sensitive to the touch) outcome was unknown.            No concomitant drugs were reported. No treatment drugs were reported.
Red raised and hard and hot area around injection site, the area has grown larger and is currently  about 3 inches around. It does not hurt or bother me just a little itchiness now and then
Pain, swelling, stiffness, decreased range of motion, progressive weakness, pain shooting down arm (sometimes into hand), decrease of motor control. Symptoms continue after four months and physical therapy.
diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a contactable consumer reported for an unknown (patient). A 5-decade-old (mid 40 s) patient of an unspecified gender received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single and first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient underwent lab tests and procedures which included sars-cov-2 test resulted as positive on an unspecified date. The patient medical history and concomitant medications were not reported. Patient with no underlying health issues, fully vaccinated with the Pfizer product for over 2 months who had recently been diagnosed with COVID. This doc wants to know whether these patients might be eligible for a follow-on trial of some sort. Further, he was interested in whether there are trials ongoing for COVID long haulers. The clinical outcome of the events was unknown.  AE/PQC e-transmitted for lack of efficacy. Response: Proposed response: Please refer caller to Clinical Trials Contact Center at (withheld) per VR. Sent SR-Topic requires further discussion due to verbal only response. Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021869132 same drug/event/reporter, different patient
She states that she had her COVID-19 vaccine on 12/27.  On 1/1/2020 her husband noticed a rash on her arm. She states that over the weekend it has gotten larger and is estimating that it is 3.5"x2" in size this morning.  She feels like it is a bit warm to the touch, but is not painful and denies any pruritus. She does think that her arm is a "bit more swollen" then her other, but not significant.  Initially after the vaccine she did not have any other symptoms than a "typical" sore arm for 2 days. Instructed the employee to take a 2nd generation antihistamine, and to use NSAIDs and ICE to manage symptoms.
EPILEPSY, UNSPECIFIED 1/20/2022 DM 2 W CKD STAGE 3A (GFR 45-59) W HTN  ACUTE PULMONARY EMBOLISM 1/20/2022 DM 2 W CKD STAGE 3A (GFR 45-59) W HTN
Noticed redness, and heat to the touch at site after working all night.  Started with low grade temperature Saturday, he took Tylenol was gone Sunday.  He was nauseated off and on both Saturday and Sunday.  It stopped Sunday night.  Today, hand size redness and warm to the touch over site.  No complaint of pain except when palpating.  No other complaint at this time.
Initial report was received on 17 July 2012 from a consumer. A male patient (date of birth not reported) had received FLUZONE, lot number UH476AC (route and site of administration not reported) on 10 October 2011 (also reported as date of loss) and an unspecified amount of time later the patient presented a claim (adverse event NOS). No further information was provided at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported. Treatment information was not reported.  Reporter stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Flu Shot = Quad, not sure of manufacturer Adverse event currently diagnosed as pleurisy by ER.   Today I have appointment with Pneumologist.
Very strong metallic taste in mouth that began on or about March 3, 2021 and is continuing
Patient developed pain in the evening of 5/19.  It became very bad after about 12 hours from vaccination, she reports that pain was from left elbow to left deltoid.  It was hard for her to sleep that night.  Following that, pain has subsided somewhat until when she reported to me, evening of 5/22.  It is now only the actual injection site where she has pain, and pain is less than before (and continues to improve daily).  She said she did not have any redness or swelling at any point, but she did have some warmth in the area.  She did not have this same reaction with the first dose of Shingrix.  I counseled her to continue monitoring and let us know if it DID NOT continue to improve, and to see her PCP if symptoms got any worse.  She did not experience any constitional symptoms such as fever, chills, headache.
C/O  dizziness & diaphoretic  Was given food and water, vital signs monitored
One-half hour after administration the patient presented with pruritic hives on stomach and armpits. Also c/o facial flushing. He was treated with 50mg Diphenhydramine IM with good symptom control/near resolution.
one hour after injection face was swollen with red blotches.  Subsided after several hours. two weeks after injection the injection site became red and itching.  Subsided after a week.
On 14th day got severe aches not in joints-No fever-c/o most pain is situated in arms below level of armpits.No lymph nodes noted-still having sx on & off for days @ a time-Feels good in am bad in pm.
Patient received Moderna on 1/11/2021 and developed a rash on 01/13/2021. According to the patient, the rash was about the size of an egg and hot to the touch. She had an appointment on 01/20/2021 with the APN for another medical matter and asked her to look at the rash around the injection site which according to the patient, was now a raised area about the size of her hand and still warm to the touch. The APN diagnosed the site as cellulitis and prescribed Keflex.
Chills; muscle pain; nausea; Head was about to explode/headache; A spontaneous report was received from a health care provider who received Moderna's COVID-19 vaccine (mRNA-1273) and had chills, muscle pain, nausea, and  headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 23 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection. On 23 Dec 2020, the patient experienced chills, muscle pain, nausea, and felt like her head was going to explode.  On 24 Dec 2020, the symptoms were not as bad, but on 25 Dec 2020, they became worse before ending that night.  On 26 Dec 2020, she only had a slight headache.    Treatment included a heating pad and Advil.  Action taken with mRNA-1273 in response to the event was not reported.  The events, chills, muscle pain, and nausea, were considered recovered/resolved on 25 Dec 2020.  The event, headache, was considered recovering/resolving.; Reporter's Comments: This case concerns female patient of unknown age, who experienced a non-serious expected events of chills, myalgia, nausea, and headache.  All events occurred at the same day of the first dose of mRNA-1273 vaccine. Treatment included a heating pad and Advil, and all events resolved two days later. The events were assessed as related to mRNA-1273 vaccine due to temporal association.
No symptoms reported.; adult patient inadvertently received a pediatric dose of VAQTA; This spontaneous report was received from a medical assistant referring to a adult patient of unknown gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions and allergies were not provided.  On 27-FEB-2020, the patient was inadvertently vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, once (strength, number of dose administered, vaccination scheme frequency was not reported; lot number S002505 has been verified to be a valid, expiration date reported and validated as 04-APR-2020) as prophylaxis. (incorrect dose administered). No product confusion was reported. No symptoms were reported for the patient.
HARD KNOT ON INJECTION SITE; NECK ACHE; JOINT  ACHES; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a 54 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced hard knot on injection site. On APR-2021, the subject experienced neck ache. On APR-2021, the subject experienced joint aches. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on APR-2021, and the outcome of hard knot on injection site, neck ache, joint aches and muscle aches was not reported. This report was non-serious.
Patient received Shingrix vaccine on 7/8 & husband informed us she has fever & seizure episodes + had to be admitted at Hospital on 7/9.
Vaccine Given to wrong pt. Brother was suppose to receive vaccine not patient. Mother was counseled by M.D. and was instructed that pt. should be okay.
Client reports that within 24 hrs. of receiving vaccines she developed a headache that lasted for 8 days and that the headache was not alleviated by TYLENOL or Ibuprofen. Reports went to PCP who encouraged her not to continue with VARIVAX series. No treatment recommended.
arm pain which lasted for 3 days; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 25th October 2020, 6 hrs after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's arm pain lasted for 3 days. The reporter consented to follow up.
Chills Achy Lack of energy Tired  Nausea No treatment just rest
Patient called and stated that she was having some dizziness, but only when she bent over.  She did not know if she was having any sinus or inner issues that might cause this.
Body aches and chills began morning after shot.  Temperature was taken around 2pm next day and was 101.5. treated with Tylenol. Slowly went down to 99.2 by end of day with aches still present. Arm was extremely sore / heavy an hour after injection and remained that way the entire day after. Effects began to clear up 36 hours later.   First pregnancy, 33weeks 5 days, due May 22.
Patient developed pain, erythema and tenderness of r arm at site of vaccine injection. Patient also reported cough, temp of 100 F and chills.
Symptom: Bright red blood in stool - size: about a quarter occurred twice in the evening on the day she received her 2 months vaccinations. I took her to Hospital ER. They tested her stool and it was positive for having blood in it. They diagnosed her with GI bleeding.
Appearance of small bumps; small red bumps on my hands/elbows/knees/feet; Small itchy bumps on my hands/ elbows/knees/feet; Bumps have a white head on them; Injection site was hot; Injection site was itchy; Injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Appearance of small bumps), RASH ERYTHEMATOUS (small red bumps on my hands/elbows/knees/feet), RASH PRURITIC (Small itchy bumps on my hands/ elbows/knees/feet), ACNE (Bumps have a white head on them) and VACCINATION SITE WARMTH (Injection site was hot) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced NODULE (Appearance of small bumps), RASH ERYTHEMATOUS (small red bumps on my hands/elbows/knees/feet), RASH PRURITIC (Small itchy bumps on my hands/ elbows/knees/feet), ACNE (Bumps have a white head on them), VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE PRURITUS (Injection site was itchy) and VACCINATION SITE ERYTHEMA (Injection site was red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, NODULE (Appearance of small bumps), RASH ERYTHEMATOUS (small red bumps on my hands/elbows/knees/feet), RASH PRURITIC (Small itchy bumps on my hands/ elbows/knees/feet), ACNE (Bumps have a white head on them), VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE PRURITUS (Injection site was itchy) and VACCINATION SITE ERYTHEMA (Injection site was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.
I initially developed 3 small red raised bumped on my R arm around Day 9 after the injection . One on forearm, one near antecubital, and one at inner upper arm. The bumps did not itch or have any drainage. The area increased in size, remained red, and had a central clearing, as if the skin came off the surface. The skin is now dry and cracked. I applied hydrocortisone 1% OTC on Day 7 and it caused a burning sensation to the area. The lesions are still, red, dry, no scabbing noted.
had given APAP dose appropriate for age p/inject & about 9PM fever was 105 R; no prolonged crying over 15 minutes; called MD but didn't take to MD;
This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (equilibrium was off), SOMNOLENCE (slept for 24hs), DECREASED APPETITE (did not have appetite), ARTHRALGIA (joint pain) and PYREXIA (fever of 100°F) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 17-Mar-2021.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced BALANCE DISORDER (equilibrium was off), SOMNOLENCE (slept for 24hs), DECREASED APPETITE (did not have appetite), ARTHRALGIA (joint pain), PYREXIA (fever of 100°F) and CHILLS (chills). On 31-Jan-2021, BALANCE DISORDER (equilibrium was off), SOMNOLENCE (slept for 24hs), DECREASED APPETITE (did not have appetite), ARTHRALGIA (joint pain), PYREXIA (fever of 100°F) and CHILLS (chills) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 100°f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was unknown by the reporter. Treatment medication included ibuprofen   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up information received on 05 May 2021n contain PCP removed as primary reporter.; Sender's Comments:  MOD-2021-019789:Same reporter/different patient (wife). PCP is not a valid reporter or husband.
After injection extreme shoulder/rotator cuff pain. Pain radiates down arm. 14 days of steroids and prescription Tylenol have not helped ease pain. Another appt to get a steroid shot today.
Information has been received from a registered nurse concerning a 20 week old (breast-fed) female with gastroesophageal reflux disease (GERD) and potential milk protein allergy (milk intolerance while breast feeding) and a history of umbilical hernia, gas and irritability who on 11-JAN-2008 and 14-MAR-2008 (also reported as 21-MAR-2008) was vaccinated PO with her first and second doses of Rotateq (lot# 657667/1392U, 656841/1319U).  Concomitant vaccinations administered on 14-MAR-2008 included a dose of PEDIARIX, a dose of Pneumovax 23 (manufacturer unknown) and a dose of ACTHIB.  On 15-MAR-2008 (also reported as 22-MAR-2008) the day after vaccination, the patient experienced bloody stools which resolved without intervention.  No other symptoms were noted.  The patient sought unspecified medical attention (method unknown).  No labs or diagnostic studies were performed.  The patient was not hospitalized.  On 23-MAR-2008 the patient recovered.  There was no product quality complaint.  Upon internal review, bloody stool was determined to be an other important medical event.  Additional information has been requested.
Pfizer BioNTech covid 19 Bivalent administered as primary dose. No adverse signs or symptoms.
This spontaneous report was received from a consumer referring to an "over 70 year old" female patient. There was no information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, lot#, dose and route unspecified) for prophylaxis. The consumer reported that, the patient couldn't breathe on an unspecified date, after receiving the "pneumonia shot". It was reported that the reporter could not confirm or deny that the "pneumonia shot" that was given to the patient was a Merck product. The outcome of the event dyspnoea was unknown at the time of this report. No product quality complaint was involved. Causality assessment was not provided. No further information was reported.
A couple minutes after the patient received the vaccine, she reported that she "didn't feel well" and that she "could not see". Pt laid down on the exam table and feet were elevated. Patient became pale and clammy. Vitals were taken and patient was monitored. After about 10 minutes, patient reported she felt better. Color returned to her skin and she returned to normal.
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 13:30 (Lot number: EL9266) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing). Concomitant medication(s) included: PROBIOTICS. Past drug history included: Morphine, reaction(s): "allergies"; Clarithromycin, reaction(s): "allergies". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Mar2021, outcome "recovered" (2021), described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received within 2 weeks of vaccination: OTC allergy medicine and vitamins. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021500137 same patient and reporter, different dose and event
Pt received shot at 1222. At 1241, pt reported symptoms of feeling like he was ?at high altitude, where it?s just a little bit harder to breathe.? Pt reports that he just got back from a ski trip and likens the sensation he?s feeling now to being at high altitude. BP 160/82, P52, O2 98%RA, Temp 98.9F Pt reports hx Afib. Lung sounds clear bilaterally. EMS on site and assessment was offered. Pt declined EMS assessment at this time. Pt was offered benadryl by staff and pt was advised that this might make him sleepy. Staff offered to call a friend/relative to drive him home. Pt told staff that benadryl does not make him sleepy and he took this at 1255. Pt advised to wait 30 minutes to see if symptoms resolve. At 1313, pt reported that symptoms have improved and he asked to leave. Recheck bp 160/78, O2 98%RA, Pulse 47 (pt states low pulse is normal for him). Pt advised to follow up with PCP prior to 2nd dose. Pt states that his wife is a nurse and she will be home to take care of him. Pt left vaccination site with no signs of distress noted. Calm, cooperative, A&Ox4, and fully conscious.
On 12/28, reported that on 12/25 she had swollen lymph glands in her clavical and neck areas.   Also, reported extreme fatigue (slept 16 hours following vaccine on 12/24) and significant arm soreness.  Is seeking medical attention.