chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Angioedema.  2 hours after immunization, patient noted erythema, edema and burning sensation in bilateral hands followed by lower back and buttocks.  Patient given diphenhydramine 12.5mg PO x2 by mother.  Edema and burning resolved, rash progressed to papular eruption.  Treated with topical diphenhydramine by mother.  Rash completely resolved after approximately two days.  No pruritus.  No urticaria. No facial or airway symptoms.  No GI symptoms.  No change in level of consciousness.
It was really bizarre, I remember feeling like all my senses were heightened , I got my period, it  didn't stop for 3 weeks. Called my OBGYN, they said let it run it's coarse and they had they had many similar phone calls. I take a Nuva ring for birth control, I was concerned about estrogen and the blood clots.  I did not feel well at all for about a week after my vaccine, everyday around 4pm I would get really bad headaches for about 3-4 weeks. I was nauseated and sweating.
Body aches, chills, headache the entire morning of 12/16/21 and blurry vision for about 30 minutes on 12/16/21. Vision returned to normal and ibuprofen was taken to relieve the other symptoms.
Swelling at injection site, redness at injection site; Amoxil 800mg given and Benadryl 18.5mg given.
I began menstruating on 4/16/21. I am nearly post-menopausal, with my last period beginning 8/19/2019.; This is a spontaneous report from a contactable consumer (patient) via Regulatory Authority. This non-pregnant 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 13:00 (at 53-years-old) as a single dose for COVID-9 immunisation. Medical history was not reported. Concomitant medications included metformin, lisinopril, simvastatin, fluoxetine, and losartan potassium (LO), all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number EN6207) in the left arm on 19Mar2021 at 13:15 (at 53-years-old) for COVID-19 immunisation. Prior to vaccination the patient had not been diagnosed with COVID-19, had not received any other vaccines in four weeks, and had no known allergies. On 16Apr2021 the patient began menstruating; she reported she was nearly post-menopausal, and her last period began on 19Aug2019. No treatment was received for the event. The clinical outcome of the event was not recovered.
No Adverse event; 1 ml dose received for dose 1; This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (1 ml dose received for dose 1) and NO ADVERSE EVENT (No Adverse event) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Chronic kidney disease since 22-Apr-2015, Hypertension, Pre-diabetic since 22-Apr-2015, High cholesterol, Pain and Diabetes mellitus. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, METFORMIN for Diabetes, ATORVASTATIN for High cholesterol, METOPROLOL SUCCINATE for Hypertension, IBUPROFEN for Pain.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 20-Jan-2021, the patient experienced OVERDOSE (1 ml dose received for dose 1). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, OVERDOSE (1 ml dose received for dose 1) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered OVERDOSE (1 ml dose received for dose 1) and NO ADVERSE EVENT (No Adverse event) to be not related.    Treatment information was not provided.   This case was linked to MOD-2022-630508, MOD-2022-628730 (Patient Link).
One minute post administration, patient experienced nausea, warmth, near vasovagal syncope. I applied ice pak, gave her bottled water, then a protein bar. She felt better by 11:16am. She  remained in observation for additional 15 minutes, then refused further care after thirty minutes.
pt recvd vax;immed p/vax,area around inject site became red,hot,hard & swollen;devel pruritus at inject site & felt n & dizzy;was tx w/ dph & ice pack to site;
Patient was given Varicella vaccine which was not ordered or indicated at time of appointment Nurse error.
Myalgia, NauseaVomiting, sore arm, fatigue, extreme chills Narrative:
Throat tightening and chest pain for a few seconds every 1/2 hour all night, decreased appetite and very tired. Resolved by morning.
pt recv vax 6JAN97 & exp bilat shoulder, arm, & hand & joint pains, weakness in hands, & insomnia;tx w/advil;events persisting;internist/infect disease specialist indicated pt sx are not r/t vax but to diabetic myopathy;
cramp; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE SPASMS (cramp) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR237B and AR237B) for COVID-19 prophylaxis.     Patient had never been tested positive or diagnosed with COVID-19. The patient had no chronic or long standing health conditions.    On 02-Aug-2022 at 11:12 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 31-Aug-2022 at 8:55 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 13-Jan-2023, the patient experienced MUSCLE SPASMS (cramp). At the time of the report, MUSCLE SPASMS (cramp) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2023-713292 (Patient Link).
Started with right arm tingling/slight numbness feeling down to my fingertips. Two days my left arm felt the same with slight improvement in my right arm. Later that day, I felt tingling in my left leg down to my toes. I have felt these symptoms every day since, but they have improved in severity, moving from one side to the other at times. This has not affected my activities of daily living, nor my work as a RN.
Pt reports hot and cold flashes, dizziness, vision,nausea, headache,arthralgia. Developed chest pain and dyspnea. Seen in ER given fluids IV and IV anti emetics.
Pt called on 4/7/10 to report he went to ER on 4/6/10 (evening) stating his arms was red, sore and swollen. He had limited ROM. Seen in ER and given prednisone and BENADRYL in ER. Given prednisone to take as an outpatient and advised to return for f/u.
SEVERE NEUROPATHY IN ALL HER LIMBS / VERY DIFFICULT MOBILITY; This spontaneous report received from a patient via a company representative via concerned a 40 year old female of unspecified race and ethnic origin. 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 administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date- and end date were not reported. Frequency time of 01 total was administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced severe neuropathy in all her limbs and very difficult mobility after injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe neuropathy in all her limbs/ very difficult mobility was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211143298-COVID-19 VACCINE AD26.COV2.S-Severe neuropathy in all her limbs/ very difficult mobility. 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).
I had heart palpations, I was actually at an appointment with my rheumatoid arthritis specialist. My blood pressure would not come down during the whole appointment. She advised me to see my primary care physician as soon as possible, she actually made the appointment for me before I left her office. The next day I say my primary care physician, my blood pressure was not as high as the prior day but still high. I was prescribed a medication for my blood pressure although I have only been on it for two days I am starting to feel better.
Two weeks after the flu vaccination was administered, there suddenly developed a "hot spot" at the injection site, with localized heat and swelling to about the size of a ping-pong ball.
Severe headache starting at bedtime on day 1 of shot.  Lasted all day the next day.  The headache was pounding and a 7/10.  That Monday it was less severe and had changed to constant head pain. The pain was 3/10, Fatigue for 2 days (Day 1 and 2, more energy on day 3.) We tested for covid just in case and that was negative. The head pain lasted the entire week.  Contacted dr for a virtual visit on  1/24/22, recommended taking motrin 3x a day. The pain stayed at 3/10  On 1/26 the pain got worse, 6/10. Saw dr in person on 1/28, told us to stop taking the motrin.  Referred us to a neurologist. 1/28 Patient left school with major stomach pain and his headache got worse.  He laid around for the next day or two. The headache has stayed between a 5-8/10  for the remaining weeks along with the stomach pain.  He is not really eating because he does not feel like it because his head hurts. At this date, 2/9/22 he has had the headache for 3 weeks and 4 days and the belly pain for 1 week 5 days.
Cellulitis; whole arm swollen; Redness in the Injection site; Swelling in the Injection site; This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA201A, expiry date 30th October 2020), (batch number AMVA206A, expiry date 13th November 2020) and (batch number AMVA323A, expiry date 31st March 2020) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Menveo. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On 10th August 2020, less than a day after receiving Menveo, the patient experienced cellulitis (serious criteria GSK medically significant), extensive swelling of vaccinated limb, injection site erythema and injection site swelling. On an unknown date, the outcome of the cellulitis, extensive swelling of vaccinated limb, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the cellulitis, extensive swelling of vaccinated limb, injection site erythema and injection site swelling to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Several patients experienced redness and swelling in the injection site, whole arm swolling and cellulitis after receiving a dose of Menveo. The symptoms started within hours.  The reporter reported 3 different lot numbers and expiration dates for the vaccines administered to different patients.  The reporter did not know how many patients experienced the symptoms but agreed to follow up and look up the information.  The reporter consented to follow up.  This case is one of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159654:same reporter US-GLAXOSMITHKLINE-US2020159650:same reporter
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 28-NOV-2015 at time- 18:39, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.3 and 1.8 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
12/5/21 71 yr/o year old male presenting for URI symptoms that are worsening over days     Symptoms include congestion, sinus pressure, post nasal drip and non-productive cough. Denies fever, chills, wheezing, shortness of breath, anosmia and dysgeusia. Sick contacts: sick family member. SARS-CoV-2 immunity status: fully vaccinated. Patient reports history of: seasonal or environmental allergies. Patient has taken decongestants and cough suppressants for symptoms with partial effect. Appearance: He is well-developed. HENT:Head: Normocephalic and atraumatic.  Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. No rhinorrhea.
Patient came to report that her arm was itchy today after receiving the Shingrix shot last Saturday. I told her that is an uncommon side effect. It became red and swollen Sunday but the itching didn't start until Tuesday. The itchiness is only on the area the shot was given, it did not spread to other parts. The patient did not report any other symptoms. I told the patient to take Benadryl, and if the itchiness did spread, to let the Dr know. Any signs of anaphylaxis reaction to go to ER.
10 Min after vaccination pressure felt in head and headache 3hrs after itchy throat, uncontrolled coughing, runny nose got worse but also stuffy slight muscle aching  5 hrs after vaccination muscle pain worsens voice becomes hoarse and cough worse, body become hot but started having chills, lips felt tight, headache  worsened, shortness of breath and wheezing. All around general sick feeling.
Severe abdominal pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) in the arm left on 23Mar2021(at the age of 23-years-old) at 16.00 as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient's past drug history was reported as avocado. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) in the left arm on 02Mar2021 at 11.00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 17:00, the patient experienced headache and severe abdominal pain 25 hours after receiving second dose. The patient underwent lab tests and procedures which included nasal swab for COVID-19 on 02Apr2021 and tested negative. The clinical outcome of the events headache and severe abdominal pain was recovered on an unknown date on unknown date of 2021.   No follow-up attempts are needed. No further information is expected.
Pt began feeling lip tingling and dizziness approximately 20 minutes following the injection. About 5 mins later she reported throat tightness, stating that her symptoms felt similar to early symptoms during previous episodes of anaphylaxis. Vital were obtained and pt was stable c an HR of 65, O2 of 98 on room air,. BP was elevated at 180/102, which pt reported was usually around 130/85. EMS was notified and pt was administered a single .15mg auto injector dose of epinephrine. She remained stable and conscious over the next 5 minutes until EMS arrived, Pt intake was given to EMS and pt was transported to the ER within 15 minutes of first notifying staff of symptoms.
Left Deltoid area where injection site developed welt 2.5x2.5cm red area raised area 0.3 cm,  Hydrocortisone 2.5 to be applied topically 2-4 times a day.
non-serious COVID-19; non-serious COVID-19; Aches/ Pain; FACILITATED COLLECT  This is a Solicited report based on the information received by Pfizer. (manufacturer control number: 21K-163-4126510-00) from a contactable female consumer reporting for herself.  An adult female subject received two doses of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 on 01May2021 and dose 1 on 01Apr2021, both intramuscular (Batch/Lot number was not reported) (at the age of 21-year-old) as single dose for COVID-19 immunisation and adalimumab (HUMIRA), via an unspecified route of administration from an unspecified date to an unspecified date (Batch/Lot number was not reported), at unspecified dose and frequency for an unspecified indication.  The subject medical history included corrective surgery in 2018. Concomitant medications were not reported.  The subject experienced non-serious COVID-19 in 2021 with outcome of unknown, aches/pain in 2021 with outcome of unknown.  The subject underwent lab tests and procedures which included COVID-19 test: positive in 2021.  The action taken in response to the events for adalimumab was unknown. The reporter's causality for the event non-serious COVID-19, aches/pain after Pfizer/BioNTech Covid Vaccine was not provided. Company's opinion for the events non-serious COVID-19, aches/pain with adalimumab (HUMIRA) was no reasonable possibility.  The reporter's assessment of the causal relationship of the event with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events and pain.
Her arm was a little sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 14:00 (Lot number: EW0158) at the age of 70 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Apr2021, outcome "recovered" (09Apr2021), described as "Her arm was a little sore".  Additional Information: Reporter states after the first one, her arm was a little sore.   No follow-up attempts are possible. No further information is expected.
Parkinson's disease symptoms; could barely walk; shaking; arms and legs flailing; couldn't coordinate arms or hands; jerky; mild nausea; small fever; shivering; wiped out; headache; This spontaneous case was reported by a consumer and describes the occurrence of PARKINSON'S DISEASE (Parkinson's disease symptoms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iodine allergy (iodine contrast), Drug allergy (erythromycin), Shellfish allergy (shellfish (mussels) severe) and Grass allergy (all grasses). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (headache). On 17-Mar-2021, the patient experienced PARKINSON'S DISEASE (Parkinson's disease symptoms) (seriousness criterion medically significant), GAIT DISTURBANCE (could barely walk), TREMOR (shaking), LIMB DISCOMFORT (arms and legs flailing), COORDINATION ABNORMAL (couldn't coordinate arms or hands), DYSKINESIA (jerky), NAUSEA (mild nausea), PYREXIA (small fever), CHILLS (shivering) and FATIGUE (wiped out). On 18-Mar-2021, PARKINSON'S DISEASE (Parkinson's disease symptoms), GAIT DISTURBANCE (could barely walk), TREMOR (shaking), LIMB DISCOMFORT (arms and legs flailing), COORDINATION ABNORMAL (couldn't coordinate arms or hands) and DYSKINESIA (jerky) had resolved. On 19-Mar-2021, HEADACHE (headache), NAUSEA (mild nausea), PYREXIA (small fever), CHILLS (shivering) and FATIGUE (wiped out) had resolved.            She received low dose aspirin for headache and fever.; Sender's Comments: This case concerns a 72-year-old female with a serious unexpected event of "Parkinson's disease symptoms," and nonserious unexpected dyskinesia, gait disturbance, tremor, coordination abnormal, limb discomfort, and expected pyrexia, chills, headache, fatigue, nausea. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 20-JUL-2011, the patient was vaccinated with first dose of GARDASIL (lot number, expiration date and dose were unknown). On 25-JUL-2012 the patient was vaccinated with second dose of GARDASIL (lot number, expiration date and dose were unknown). Then on 10-JUL-2013, the patient was vaccinated with third dose of GARDASIL (lot number, expiration date and dose were unknown) (inappropriate schedule of vaccine administered). Due to the lapse between doses, the patient was administered an additional dose of either GARDASIL or GARDASIL 9 (lot number, expiration date and dose were unknown) on 25-NOV-2015 (extra dose administered). No adverse effects were reported. Additional information has been requested.
Chills, Headache, Brain Fog, Heart rate between 105-110, Fever of 99.6., Pain in left side of chest. Same side as injection site. Waiting to see if symptoms resolve in the next 24 hours.
I had burning at the injection site immediately after receiving the vaccine. As I was leaving after 15 minutes I mentioned it to the person checking me out. At this time we noticed redness and hives starting at the injection site. I was told to sit for another 15 minutes but as soon as I sat down again the hives spread rapidly and I began to have dizziness and confusion. At this point I was taken to the ER and on the way I started having nausea and my throat started burning and felt tight. In the ER I was given IV Benadryl, Pepcid, and solumedrol and IM epinephrine. Since discharge I had one instance of hive and facial swelling and continued to take Benadryl for two days. I am now having episodes of shortness of breath and tachycardia.
(No reaction from 1st Moderna) Received 2nd Moderna  vaccine 5-5-21 Got hives 5-27-21 -bad for 2 days & mild for 6 more days. Since it was so long after thought maybe it was from something else until got it again after booster.  Received 3rd booster Moderna vaccine 12-15-21.  On 12-17-21 a large red circle appeared where I received the shot.  On 12-28-21 broke out again in hives. Bad for few days, now milder.
Pt experienced an inject site rxn, approx 5 days p/immun. Swelling (size of baseball), redness & hot to touch. Pt due to be examined 9MAR90. It is unknown if the rxn is cellulitis or an inject site rxn.
After administering Tdap vaccine, noted to have erythema and hardness below site of administration. Pain in raising arm.