chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom describes pt's lt arm as becoming twice the size as normal (swollen), & reddened w/white spots "almost to the elbow"; mom also described pt having a red rash to top of lt shoulder; MD stated pt had infection where shot was given;
This spontaneous report was received from a pharmacist and refers to a patient of unknown demographics. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 plaque-forming units (pfu), subcutaneously (lot # L032403 with expiry date of 26-NOV-2016, dose and site of administration were not reported). No adverse experience was reported. Additional information has been requested.
Pt experience pallor and complained of nausea and possible dizziness. He claimed that it was due to the fact that hadnot eaten anything prior to the vaccination. EMS was dispatched and all vitals were normal upon assessment.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Feb2021 as dose 2, single (Lot number: EL9292), in left arm, on 17Aug2021 as dose 3 (booster), single (Lot number: Fc3180), in left arm and on 02Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid nodule" (unspecified if ongoing); "osteopenia" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CELEBREX; SPIRONOLACTONE; TYLENOL; CALCIUM; VITAMIN D3; VITAMIN C [ASCORBIC ACID], start date: 27Jun2022; ZINC; COLACE. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient received anti-viral details: product: COVID 19 Treatment, Brand: Pfizer, from 27Jun2022 to 01Jul2022 as treatment of COVID-19. On 08Jul2022, at 12:00 PM, day 7 return of symptoms- sinus congestion, post nasal drip, no fever Positive test Follows negative test on day 6 with no symptoms. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (07Jul2022) Negative, notes: Follows negative test on day 6 with no symptoms; (08Jul2022) Positive, notes: Day 7 return of symptoms- sinus congestion, post nasal drip, no fever Positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19 from 27Jun2022 to 01Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The first dose my arm hurt my arm about a couple of days but it hurt badly the day after vaccine. I am concerned that I was given sterile water for the 2nd dose instead of the actual vaccine. The liquid when being injected in to me felt to thin, I am not sure if they let the 2nd dose get to warm or if I did not receive the vaccine. I only had a little bit of soreness the next day and it went away quickly. My arm feels tired now. It felt like it was watered down version of the shot, it felt thin, weak and watery.
ARM WEAKNESS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced arm weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm weakness was not reported. This report was non-serious.
Hives; This spontaneous case was received on 10-May-2021 from pharmacist via Communication (reference number: SEQW21-01301) and concerned 57-year-old, female patient.  The patient's medical history included menstrual cycle disorder. The patient's concomitant medications were not listed.   On 08-Nov-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location and route of administration: not reported) for prevention of influenza. The batch number was not reported.  On the same day, probably less than 30 minutes after receiving Flucelvax Quadrivalent, while driving home, the patient developed hives.   On unspecified date, the patient was recommended Benadryl (diphenhydramine) for treatment, but the reporter did not know if the patient actually took Benadryl.  On unspecified date in Nov-2020, the patient recovered from the event hives, reported as the symptoms lasted few days.   The reporter did not provide causality assessment.   The case was assessed as non-serious.   Company comment: The event of hives was considered as related to Flucelvax Quadrivalent.; Sender's Comments: The event of hives was considered as related to Flucelvax Quadrivalent.
Pt mentioned some flushing and slightly scratchy throat. Previous history of anaphylactic rxn to allergy shots
Initial unsolicited report received from a health care professional via other company (Pfizer) on 05 April 2016. Manufacturer Report Number: 2016180314. This case involves a female patient (age not reported) who was vaccinated with a dose of Influenza vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient developed allergy due to flu vaccine. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Headache, Myalgia, Arthralgia, Fever, Injection site pain, Chills, Fatigue
I received my first dose of moderna and was diagnosed with Covid the following week.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I received my first dose of moderna and was diagnosed with Covid the following week.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I received my first dose of moderna and was diagnosed with Covid the following week.). At the time of the report, COVID-19 (I received my first dose of moderna and was diagnosed with Covid the following week.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Diagnosed with Covid..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
T 97.2 - loss of appetite, fatigue, vague weakness of joints, anxiety.
A raised rash has appeared at injection site as well as small rashes around the site. Also will randomly break out in a rash on random parts of body with intense itching
Patient had fever and chills during the night after 2nd dose; Patient had fever and chills during the night after 2nd dose; This is a spontaneous report from a non-contactable consumer (Patient) via company representative. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of (BNT162B2) for via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. On an unspecified date, patient had fever and chills during the night after 2nd dose. Event took place after use of product. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Red raised lesions on near left shoulder area- some appeared to be filled with yellow clear fluid, Arm and shoulder stiffness and soreness. Dr. diagnosed patient with herpes zoster. Patient was prescribed Valacyclovir.
Full body hives treated with Benadryl and Hydrocortisone, persistently recurring for 2 weeks following vaccination
Brachioplexopathy of (R) arm (injected side) lasting >2 weeks. Pain in median, radial and ulnar nerves.
28nov89 pt vax hepta B. pt ex pain at inject site.  28dec89 pt vax 2nd hepta B. pt ex prolonged pain and tenderness at inject site which lasted 2 days to 1 week. pt recovered
Pt had reaction to vaccine developed cellulitis had to have steroid and BENADRYL in the after hrs clinic and a KEFLEX abx.
4/2/16 Vomited after antibiotic dose given. Phone advice. 4/3/16 Eye discharge, fussy, Phone advice. 4/4/16 Eye discharge, office visit, tobramycin ophthalmic sol'n. 4/12/16 Viral exanthema on chest, urticaria, persistent ROM. Last dose amox. 4/11. Started cefdinir.
Prt received 2nd dose of Covid 2/4 and 2/5 was found to have significant short of breath with RR 40, temp 103 and 02 sat 80%. prt was sent to hospital where he was tested positive for Covid and started treatment with Decardron and Remedesivir  and on BIPAP mask to help with breathing and prt response to the treatment and able to discahrged after 3 days hospitalization  He was hospitalized from 2/5-2/08 and discharged
Extreme exhaustion (lasting 2 months, getting better over time) Cold ?brain freeze? headaches on left side of head, 2 months(again, lessening over time) Cold shocks in calves, lasted about 3 weeks Hot then cold in entire left side of body, started one hour after injection, lasted about an hour Sore left arm for about 24 hours Dizziness
diaphoresis, fevers, sinus congestion, body aches, headache, scratchy throat, cough, lack of energy
he didn't get it because he tested positive for Covid; he didn't get it because he tested positive for Covid; Tickle in his throat; This is a spontaneous report from contactable consumers (one was patient's wife) via medical information team and via a Pfizer-sponsored program. A 68-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809), via an unspecified route of administration, in the left arm on 05Feb2021 10:00 at a single dose for COVID-19 immunisation. Medical history included high blood pressure and thyroid. There were no concomitant medications. No additional vaccines were administered on the same date as the BNT162B2 vaccine. The patient had no prior vaccinations within 4 weeks. The patient got his first vaccine on 05Feb2021 and was supposed to get the second one last Friday (25Feb2021) but he didn't get it because he tested positive for Covid. The patient's wife wanted to know if he can still get his second dose; does the second dose have to be within 21 days; and do they have to make another appointment for the second dose or would they just walk in. They called the doctor on Thursday (Feb2021) because the patient was having a tickle in his throat (unspecified date in 2021) and the patient's wife did not like the way the patient was looking. The doctor advised him to go for the COVID-19 test because the patient was in direct contact with someone at work. The patient tested positive for COVID-19 virus (positive PCR and rapid COVID-19 test) on 26Feb2021 and was told not to get the second COVID-19 vaccine. It was clarified that the patient only has a tickle in his throat and no other symptoms. In addition, a lot of people at the patient's work have the virus, more than 50%. The outcome of the events was unknown.
All bones ached. Worst was both legs (2 days). Headache. (3 days); fatigue; no appetite.
Received COVID-19 vaccine on 12/18/2020 around 1225pm, ten minutes later while being monitored I started to feel hot flash, got dizzy like about to pass out, I asked to let me lay down, I felt the medication bitter taste in the back of my throat, I was clammy pale, I lay on a stretcher and put my feet up elevated, rapid response was called and BP was checked and Spo2, my hands were getting cold and tingling I was talking to RN, another RN, after laying down for ten minutes I sit up I was getting my BP back to normal, I sat down in the chair again for another 10 minutes, I was offered to go to the ER but I decline, I said I was getting better, after 15 minutes I left monitored by my supervisor I felt the medication in my stomach, after the tingling my fingers were numbed for the next days until present.
ErythemaMultiform Tingling right side of face lasted 1-2 hours; 1/13 - eythema at vaccine site x 4 iches Narrative:
A few hours after receiving my second Pfizer vaccination, I began experiencing bilateral Tinnitus.  It's been constant since the day of my second vaccination.  This is not a condition I had ever experienced prior to the vaccination.
woke up the next day and felt nauseated, could not stand up, my heart started racing, I had to lay down, felt cramping, extreme fatigue, felt overall sick, and the pain at the injection site. No fever. Just lasted that day. Feel better today.
Green watery stools, with bloody streaks. Grossly visible and verified with Hemocult testing.
multiple outbreaks of herpes zoster and postherpetic neuralgia; multiple outbreaks of herpes zoster and postherpetic neuralgia; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of the report was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of herpes zoster and post herpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).  The events of herpes zoster and post herpetic neuralgia were considered to be disabling.
I exp shortness of breath and sore arm (right). The shortness of breath lasted couple hours and soreness of right arm few days.
shortness of breath; Chest pain; Weakness; fatigue; This non-serious case was reported by a nurse via sales rep and described the occurrence of shortness of breath in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included emphysema and chronic obstructive pulmonary disease.   On 25-AUG-2023, the patient received Arexvy (unknown arm). In AUG-2023, 24 hrs after receiving Arexvy, the patient experienced shortness of breath (Verbatim: shortness of breath), chest pain (Verbatim: Chest pain), weakness (Verbatim: Weakness) and fatigue (Verbatim: fatigue).  The outcome of the shortness of breath, chest pain, weakness and fatigue were not reported.   It was unknown if the reporter considered the shortness of breath, chest pain, weakness and fatigue to be related to Arexvy.     It was unknown if the company considered the shortness of breath, chest pain, weakness and fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-AUG-2023 It was reported that 24 hours after vaccine in arm at pharmacy, patient reported shortness of breath, chest pain, weakness and fatigue.
6/26 32y.o. female with history of asthma, hypertension, fatty liver disease, came to the hospital with complaints of nausea vomiting diarrhea and fatigue.
PATIENT HAD DEVELOPED SWELLING AND REDNESS BELOW INJECTION SITE WHICH MOVED FURTHER DOWN ARM TO REGION OF ELBOW
9/3/21- Patient presented with 2 to3 day history of nausea, vomiting and abdominal pain worsening previous night.  Described pain as 9/10.  CT showed inflammatory changes of appendix  with extraluminal air consistent with perforated appendix.  No abscessed identified.   Appendectomy performed the day of presentation confirmed perforated appendicitis.  remained in hospital for 4 days receiving IV antibiotics, blood cultures on day 1 showing gram negative rods.  Discharged 9/7 on oral antibiotics.
sx devel 1SEP93 redness, swollen, pruritus, painful, (5" x 2 1/2 swollen), inc fever 101; sx lasted 5 days (fever gone by 3SEP93); used APAP, DPH elix;
pt recvd vax & nursing on bottle & began coughing clear sputum; became cyanotic, eyes rolled back; lasting < 1 min; post ictal period for 15 min;
Weakness after exercising 5 hours after vaccination. Chills while sleeping Saturday evening. Sore arm, head ache in early hour of Sunday. Lost sense of smell and taste while eating breakfast on Sunday morning ( 8:00 AM) Mild headache for the remaining of the day, no taste or smell during lunch (2:00 PM).  Before going to bed (10:00PM) regain faint sense of smell, took 2 Tylenol. Woke up fine on Monday morning, smell and taste is back to normal.
Blurred vision; mussel weakness (unable to walk); problems breathing, swallowing, talking.
extreme toothache; jaw pressure; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (extreme toothache) and JAW DISORDER (jaw pressure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (extreme toothache) and JAW DISORDER (jaw pressure). At the time of the report, TOOTHACHE (extreme toothache) and JAW DISORDER (jaw pressure) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.  No relevant Lab Data was provided.  No relevant medical history was provided.   This case was linked to MOD-2021-240150.
2 days after injection of VARIVAX arm red and swollen size of tennis ball painful to touch per mom.
Numbness to feet that traveled to arms nausea weakness back pain  hospitalization with diagnosis of Guillain Barre syndrome.
Pt c/o rash x 2 days on both arms and shoulders. Other s/s include sore throat, cough, headaches and itching. Rx given Oraped 15mg/5ml 4 tsp daily #100 ml and Benadryl Allergy Childrens 12.5 mg chew 1 every 6 hrs. prn for itching.
vaccine administration error. 2nd dose of Moderna vaccine was administered before the recommended 24 days from 1st dose. 2nd dose was administered 21 days after 1st dose.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EK4176), in left arm, on 12Feb2021 as dose 2, single (Lot number: EM9809), in left arm, on 27Sep2021 at 15:45 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 11Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Aug2022) Positive, notes: first testing positive on anti-gen test 28Aug2022; (03Sep2022) Negative, notes: after testing negative starting 03Sep2022; (07Sep2022) Positive, notes: Tested positive again or Covid-19 via antigen test on 07Sep2022; (unspecified date) Positive, notes: COVID 19 Treatment.  Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: Paxlovid rebound. Headache, Blocked and runny nose, sneezing, coughing with mild phlegm. No fever yet. Tested positive again for Covid-19 via antigen test on 07Sep2022 after testing negative starting 03Sep2022 following completion Paxlovid course after first testing positive on anti-gen test 28Aug2022.  No Follow-up attempts are possible No further information is expected.
9 mo infant immunized 16JAN91; 24 hrs later fever to 105. Approx 36-48 hrs later appeared hypotonic w/difficulty urinating. Hospitalized; infant was floppy, dx as transverse myelitis C2-T1 area. Tx Steroids & antibiotics. Doing better.
Moderna vaccine was expiring at 4:22AM on 5/19/21 (but it was till in the refrigerator), on the same day at about 10:45AM the pharmacist inject patient with the expired vaccine. Attention was brought to patient the following day, no adverse side effect per patient. A pharmacist spoke with a representative at Moderna (case #MOD21-091951), we were advised against revaccination. We will follow up with patient in the next week.