chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am currently Breastfeeding; I am currently Breastfeeding; my left breast was very sore to the touch and hurt; I have significantly decreased my milk supply in my left breast only. I was producing 4-5 oz per breast, now my left breast is only producing less than 1 oz.; my left arm pit; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Sep2021 13:15 (Lot number: FD0809) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROZAC. Past drug history included: Known allergies: none. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 14Sep2021 17:00, outcome "unknown" and all described as "I am currently Breastfeeding"; BREAST PAIN (non-serious) with onset 14Sep2021 17:00, outcome "not recovered", described as "my left breast was very sore to the touch and hurt"; SUPPRESSED LACTATION (non-serious) with onset 14Sep2021 17:00, outcome "not recovered", described as "I have significantly decreased my milk supply in my left breast only. I was producing 4-5 oz per breast, now my left breast is only producing less than 1 oz."; PAIN IN EXTREMITY (non-serious) with onset 14Sep2021 17:00, outcome "not recovered", described as "my left arm pit". The events "i am currently breastfeeding", "i am currently breastfeeding", "my left breast was very sore to the touch and hurt", "i have significantly decreased my milk supply in my left breast only. i was producing 4-5 oz per breast, now my left breast is only producing less than 1 oz." and "my left arm pit" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of breast pain, suppressed lactation, pain in extremity.  Additional information: The patient had not received any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID 19. Since the vaccination the patient had not tested for COVID 19.  No follow-up attempts are possible. No further information is expected.  Follow-up (18Oct2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101243499 mother/baby case
Narrative:  Patient reported epigastric pain following administration of moderna covid-19 vaccine dose 1. Unclear how quickly the pain resolved. No treatment was initiated and no other work up was needed.
Seven days after receiving my first Moderna shot for Covid-19, I developed a large pink colored oval rash around the injection site on my left arm.  The rash also itched.   Doing some online research I believe I developed a case of "Covid-Arm".   I am treating the rash with a cortisone cream.   I have had the rash now for two days.  It is not getting worse but is still very prevalent.   My initial side effects from the injection consisted of a sore arm for two days and a mild, dull headache that responded to one dose of Tylenol.  Otherwise I had no initial side effects from the first dose.
Patient got a rash on her face and eyes.  No irritation at injection site.  She had also received a Pneumovax immunization at her dr's office before coming to the pharmacy.
On 9/14/00 at 09:00, the pt received her 1st "adult" IM dose of Engerix-B. Subsequently, on 9/14/00, she experienced generalized weakness, myalgia, headache, and fever. A doctor visit was required. The vaccinee took meperidine hydrochloride that she "had left over from an unknown date". Her elevated WBC was treated with doxycycline, amoxicillin trihydrate/clavulanic acid (Augmentin), and Cipro. The WBC reverted to "almost normal" with antibiotics and then climbed again. The reporter stated that these adverse events were ongoing, moderate in severity and could possibly be related to an animal bite, but that this was "not likely". Engerix-B was discontinued. The case is serious because the reporter stated that the adverse events were disabling/incapacitating.
1st day after flu shot - headache, chills, fever (101.3 F)...late in the 1st day fever broke and then 2nd day after flu shot wake up with no hearing in my right ear (sudden hearing loss).
9-year-old-patient came to the clinic to receive a booster dose. Patient accidentally given the Pfizer 12+ dose instead of Pfizer 5-11 years dose. The patient and parent waited for 15-minute observation. Patient did not show any adverse symptoms.
Fever; Body aches; Felt very flu like; Horrible shaking chills; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient suffered from  shingles two-three months prior to vaccination in his/her scalp.).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 10 hrs after receiving Shingles vaccine, the patient experienced chills (Verbatim: Horrible shaking chills), fever (Verbatim: Fever), general body pain (Verbatim: Body aches) and influenza-like symptoms (Verbatim: Felt very flu like). The outcome of the chills was resolved (duration 5 hrs) and the outcome of the fever and general body pain were not reported and the outcome of the influenza-like symptoms was resolved (duration 48 hrs).   It was unknown if the reporter considered the chills, fever, general body pain and influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the chills, fever, general body pain and influenza-like symptoms to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that after the first dose, within 10 hours he/she had horrible shaking chills, fever and body aches. The chills subsided 4 to 5 hours later but still felt very flu like for another 24-48 hours.  The patient also had shingles two-three months prior in scalp.  Fortunately, the patient caught shinles early and was better in a couple of weeks. The patient stated that he/she would rather have the side effects from the shingles vaccine than shingles again, which was told he/she couple get it again, that was why the patient's physician  recommended him/her to get the vaccine. The follow-up could not be possible as no contact details were available.
1 day after PNEUMONIA AND FLU vaccination in right deltoid, developed swollen, painful right elbow. Limited range of motion. Symptoms improving slowly at day 6.
To ED rom group home on due to altered mental status, lower extremity weakness and syncopal episode. Carotid Doppler could not fully done because the patient was not cooperative however 1 measurement did not show significant stenosis. Head CT scan was negative for any intracranial process. 2D echo was positive for severe concentric wall Thickness.  Telemetry was monitored by cardiology no significant events. Cardiac medication was optimized per cardiology -Due to questionable history of seizures patient initially was not started on any seizure medication however patient did have 1 episode of seizure ultimately patient was started on Keppra per neurology no other acute intervention was indicated... Patient found to have COVID-19 infection, however patient remain ed on good oxygen saturation on room air so no antimicrobial was indicated per ID. Patient was ultimately discharged in medical stable condition for subacute rehab.
Toes itchy for a week, finally slowed down, fingers in injection arm were numb.  extreme pain redness rash and very warn at injection site for 6 days.  Headaches have intensified and are pretty much non stop since the first vaccine.
Vaccine received 10AM 9/17/14 - pt started feeling sore/achy by 3PM. Achy legs and arms. Site near vaccination became red and swelled. Spread to inside of arm. Pt went to doctor on morning of 9/18/14. Running a fever. Dr. gave pt antibiotic but instructed her to wait until further notice to take.
tested positive for Covid 19; Unwell; Aches, pain; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid 19), MALAISE (Unwell) and MYALGIA (Aches, pain) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No medical history of patient was reported.  Concurrent medical conditions included Heart disorder.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid 19). On an unknown date, the patient experienced MALAISE (Unwell) and MYALGIA (Aches, pain). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid 19) had not resolved and MALAISE (Unwell) and MYALGIA (Aches, pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Heart medications. No laboratory data was provided.
Persistently high blood pressure. Unsure of start date. Discovered several weeks later. Have always had low blood pressure before vaccine.
On Feb. 15, noticed a red ring of about 1cm  circling a small mole near the injection site. Itchy, which was why I looked at it. Slightly painful. I rubbed it slightly. Next day, Feb . 16, gone. Day after that, Feb. 17, back again, slightly decreased in painfulness, itchiness, and redness.
Day 3 bilateral swollen glands with bilateral ear pain  Resolved by day 5  Day 9 Left arm redness (like 1st degree burn) swelling, pain/itching along whole upper arm and bicep area to the present.  Taking Zyrtec daily
This spontaneous report as received from a nurse refers to a 12 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 30-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
7-10 days after vaccines, pt developed a fever and had a seizure. Went to ER test run, then came to our office on 10/04/2005.
This initial spontaneous report was received from a nurse referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medications or drug allergies/drug reactions described. On unspecified dates, the patients were administered improperly stored doses of VAQTA injection (dose, route, anatomical location, lot # and expiration date were not reported). The nurse was not sure what specified vaccines were given, date of administration or to what patients. No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Tight Chest pains started to occur on the second dose on vaccine which was April 3, 2021. A week later the pain started to develop not being severe. As it was concerning no actions were taken it went away a couple days later. Months later on October, I was exposed to Covid. The chest pains were present even if I did not test positive this time it lasted about 5 days. On December 11, I received my third vaccine on Moderna. The last week of December, sudden sharp pain began once again. It started to get concerning when I felt pressure and shortness of breath. January 6, around 5am the feeling of laying down was uncomfortable feeling the pressure on my back and left arm. I tried to get up but the pressure got worst. I went to the ER, and I was told I had Acute Pericarditis. The only treatment to it was anti-inflammation pills. On January 11th, I went to a clinic as a check up as the anti inflammation pills do not help and the pressure in the chest continues.
Chronic hives over entire body, swelling of face, constant, every day for at least 2 months
I had numbness in both legs. It started from my left thigh and it's now radiating to the right side.; body aches; dizziness; joint pain; cough; My skin blotches; Eyesight are weak; This is a spontaneous reported from a contactable consumer (patient). An 86-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 17Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date in Jan21 for COVID-19 immunization. In Feb2021, the patient had numbness in both legs. It started from left thigh and it's now radiating to the right side, body aches, dizziness, joint pain, cough, my skin blotches, eyesight are weak. He took Tylenol maximum strength. He stopped because on the label it's said not to take it for extended time. His doctor recommended Aleve. After taking it for few days he was saw no change at all. He was took Tylenol again. He been taking Tylenol for 2 weeks. He was noticed a change and improvement. The need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. The outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax 29DEC97 & 30DEC97 pt exp vomiting for 3 days;4JAN98 pt reported a temp of 101, nausea, diarrhea which lasted 2 to 3 days;pt recovered;
Rash on both arms, both legs from knees down, and also small patch on upper chest.
I have had no adverse reactions to the injection until this morning, day 8 after the injection. Awoke this morning with itchy, red rash on upper left arm about 3-4 inches in length and 1 1/2 inches wide..Area is also warm to the touch with some swelling. It is not at injection site, but on front of upper arm. I have no fever. Initially I thought perhaps I had a bug bite, but on doing some searching on the internet found a reported phenomenon of "Covid Vaccine Arm" that occurs about 7-8 days after injection. I think that this may be what is occurring with me. I have cleansed the area and have been applying cortisone cream to relieve the itching.  I have had no other symptoms today.  Please note that I am registered with v-safe and have completed the daily check-ins through yesterday 2/3/2021. I did not receive a text check in today and am assuming I am now on the weekly check in schedule.
11 cm x 7 cm area of erythema and induration area (L) deltoid
Patient started to experience adverese reactions of burning and stinging in her face, eyes, and scalp at 8:30am. Patient's vitals were stable at 8:37am and 8:47am. Patient started to fade in and out of consciousness. Ambulance was called and patient was trasferred to healthcare facility.
Approximately 1.5 hours after influenza vaccine was administered Pt inquired about the adverse reactions of the flu vaccine and said she felt dizzy and her left arm was numb and tingling. Arm without redness or swelling upon assessment. Pt alert, no signs of distress. BP was 110/70. Instructed patient that if she was feeling dizzy she needed to call someone to pick her up and drive her to her MD because dizziness was the only symptom that could remotely be associated with adverse reaction to the influenza vaccine and that something else could be going on with her that needed medical attention. She also had her 15 month old daughter with her.  After this was suggested she stated she would sit for awhile and see if she got better. RN asked her again to contact someone to come drive her home even if she felt better.  Pt then started crying, hyperventilating and saying she felt funny.  BP 122/80, pulse 72 and regular. Continued to cry and hyperventilate and would not calm down. Client was texting on her phone repeatedly to a family member to come and get her.  EMS activated due to pts increased aggitation and inability to calm down.  Pt transported to local ER by EMS.
Between 6-7PM on 9MAR92 started w/diarrhea & t101 R followed by vomiting; rx Lytren 11MAR92 t104; 11MAR92 dx w/OM on ATB;
Improper dose of vaccine given, a dose of peds Pfizer was given to a 12 year old Pt. (Covid Vaccine)
pt recv vax 7MAY97 & 13MAY97 pt devel chickenpox;
Rash up the arm into the neck. Itching throughout the body. No previous history of reaction to ZOSTAVAX. Patient called doctor and he said it might be an allergic reaction to the shot.
a patient received a expired Quadracel vaccine on 21Jun2019/No AE; Initial information received on 24-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four years old female patient who received a fifth dose of expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] vaccine on 21-Jun-2019 which was already expired on 20-Jun-2019 lot C5222AA via intramuscular route in the right deltoid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD).  It was an actual medication error due to expired vaccine used.  There were not side effects.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  The outcome was reported as unknown.  List of documents held by sender: none.
Right upper arm swelling, redness, "itchy", slightly warm. No induration or pain. Advised cold compress and Benadryl Children's Liquid 1 tsp for itching.
Symptoms: Nausea, Sharp Headache (Right Side), Body Ache, Fatigue. / Time: Bed Rest (two days), hospital visit on the third day. / Treatment: Bed Rest and Antibiotics.
Child was anxious & giggly before injections. Apx 5-10 afterward, became light headed, hot, sl nausea, gave sucker. Stood up to ambulate after walking forward got weak, sat down then fainted. Was slow for weakness to resolve, gave 5 cc BENADRYL. (8/16 - child doing fine per grandparent).
Nauseous after 30 minutes Severe diarrhea after 40 minutes Vomiting after 2 hours Symptoms lasted 12 hours
Pharmacist inadvertently administered a  0.5ml dose of the Shingrix diluent only. No adverse reaction reported to date. No reported visit required to healthcare professional
59 y.o. female with history of hypertension, hyperlipidemia who presents with abnormal speech.  Patient ports that on 12/9 she had her second dose of Shingrix.  Next day she did notice symptoms of arm soreness and general fatigue.  Starting on 12/11 she began noticing symptoms that her "tongue was twisted" with resulting abnormal speech.  Patient denies any facial numbness.  Denies any extremity weakness or numbness/tingling.  Symptoms have been persistent since then so patient came to emergency room for further evaluation.  Otherwise denies headache, fevers, nausea, chest pain, palpitations, shortness of breath, abdominal pain, dysuria, diarrhea.  Denies any family history of strokes or other neurologic processes.
This spontaneous case reported by a consumer, describes the occurrence of injection site warmth (left arm site of injection hot), influenza-like illness (feels like flu symptoms), dizziness (dizzy), pyrexia (fever) and headache in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine), for COVID-19 immunization. Concomitant products included multivitamin & mineral for an unknown indication. On Jan 19, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine, batch# 010M20A), intramuscular; 1 dosage form. On Feb 16, 2021, patient experienced injection site warmth (left arm site of injection hot), pyrexia (fever) and headache. On Feb 17, 2021, patient experienced influenza-like illness (feels like the flu symptoms) and dizziness (dizzy). At the time of the report, injection site warmth (left arm site of injection hot), influenza-like illness (feels like the flu symptoms), dizziness (dizzy), pyrexia (fever) and headache outcome: unknown.
Left upper arm pain that came on gradually and is now severe with any movement of the arm.  Patient presented the following day with pain. No bony tenderness.
The patient was contacted the next day on 5/11 and he said ge did not experience any strong side effects.  Only felt soreness in the arm.  Spoke to patient again on 5/13, patient feels fine and zero side effects.
face and lips swelled; face and lips swelled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 8-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious), LIP SWELLING (non-serious), outcome "unknown" and all described as "face and lips swelled".  Additional information: The reporter was patient's grandmother. Stated that her granddaughter had a reaction, her face swelled up and her lips swelled up and luckily her throat did not close. Wanted to know if a patient had a reaction to the first dose of the vaccine that they should not get the second one.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I was coughing and had fever, fatigue and runny nose. It was in the middle of the day and took 3 test that were positive. I went to the ER the next morning. I had to call an ambulance I was disoriented, light head and extremely week. At the ER received iv fluid for low blood pressure. I just finished a prescription of Paxlovid on 06/27/2022. I now still have fatigue and coughing still, but definitely improved.
Patient states that she had severe cramping and a severe episode of diarrhea on the evening of 1/16/16 that was only relieved by taking Immodium. She states that she has no other symptoms of illness and still feels "off" but has not had any diarrhea as of noon on 1/17/16. She believes it may have been related to the Prevnar vaccine she received on 1/13/16 since that was the only thing she has changed in her lifestyle recently.
pt recvd vax 10OCT94 evening of 10OCT94 pt devel erythema, swelling & raised pruritic annular eruption which progressed to generalized erythematous maculopapular eruption involving chest, abdo, back & proximal extrem;
The patient was sitting on his mother's lap awaiting vaccination. At the time of the injection, he moved and got pricked by the needle on the lower left-side of his right deltoid muscle. There was a small puncture and very little bleeding. The mother declined another bandage for the wound, stating she has supplies at home if needed.