chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(R) deltoid area swelling, (+) warm, red, mild tenderness. injection site blister 13 x 12 cm; induration 9 x 7 cm. T=98.7 F Benadryl 12.5mg/5ml 2tsp p.o q6-8hr prn, cool compress.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 08Feb2021 as dose 2, single (Lot number: EL3248), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 46 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jul2022, outcome "recovering" and all described as "Tested positive for COVID-19". The event "tested positive for covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as treatment.
pain in spine for 6 days;breathing became difficult;could not take deep breath, could not turn head from side side;sx started on evening of day of vax;breathing sx stopped p/2 days;
Information has been reported in a CDC slide titled as "Safety of PNEUMOVAX 23 in the Vaccine Adverse Reporting System (VAERS)". This spontaneous prospective pregnancy report as received from a registered nurse (RN) in Centers for Disease Control and Prevention (CDC) concerning a female patient of unknown age, 2 of the six patients who experienced cellulitis. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX 23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced cellulitis. The outcome of cellulitis was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX 23 administered during pregnancy) that received from the same source. Additional information has been requested.
Injection site pain in arm after COVID 19 vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a patient. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number and Expiration date was not reported), via an unspecified route of administration, on an unspecified date, as unknown single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date, the patient experienced injection site pain in arm after COVID-19 vaccine. The outcome of the event was unknown.
She started feeling dizzy and nauseous 2 to 3 minutes after receiving the vaccine. According to her mother, she is known to have hypoglycemia after any injections. She received a sip of coke and she started feeling better after 2 to 3 minutes. EMT checked on her and she refused to go to hospital to further getting checked up. She was able to walk with an assistance from one of the associates and go home with her mother.
Patients received 4 doses of expired Moderna Bivalent vaccine; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received 4 doses of expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received 4 doses of expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received 4 doses of expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patients received 4 doses of expired Moderna Bivalent vaccine).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided. The case contains information for patient 1 out of 4.   This case was linked to US-MODERNATX, INC.-MOD-2023-730170, US-MODERNATX, INC.-MOD-2023-730173, US-MODERNATX, INC.-MOD-2023-730178 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730178:Patient 4 Case US-MODERNATX, INC.-MOD-2023-730173:Patient 3 Case US-MODERNATX, INC.-MOD-2023-730170:Patient 2 Case
Patient's arm has significant swelling, itching, and redness all the way around the arm close to the site of injection.
1605 Administered Hep A and VZV to (L) arm at an IZ only visit. 1610 pt. left clinic. 1650 pt. returned to clinic with extensive urticaria on entire skin surface, agitated, alert and talkative. No SOB or wheezing. Examined by PA and pediatrician.  9/1/09  MR received from pcp including ER records from past immunization reaction.  Pt developed extensive urticaria on way home from PCP visit. Pt agitated but alert, with no respiratory problems.  Voice hoarse. Tachycardic at 109. DX:  anaphylactic Rxn to Immunizations. Tx: Benadryl, epi, steroids. Resolved by next day.
Red, firm splotch the size of a golf ball on my left arm at the injection site. Extremely itchy. This began the day after my vaccine (March 4) and disappeared by March 7. It returned again today (March 11)
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 30-NOV-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016, dose, route of administration and anatomical location were not reported). No adverse symptoms were reported. The temperature excursion was due to daily vaccine counts that caused the storage unit to have temperature fluctuations because of door opening. This is one of several reports from the same reporter. Additional information is not expected as no further follow-up is required.
Prior to this case, I was dealing with a flare up of my allergies that caused a sinus infection and was being treated for that. Prior to that treatment I was tested for COVID-19 and Flu but both were negative. Starting around 07/05/2022, I developed a sore throat. I still had a cough and it was worsening again so I saw the doctor in person. I started the 2nd round of antibiotics. On 07/06/2022, my husband was feeling worse and tested positive for COVID-19 so I decided to test myself and I was positive. We were both given Paxlovid and we started it that night. I continued to have the cough from previous respiratory issues, fever and the cough was 24/7. Within 30min to 1hour after taking the Paxlovid, I had the worst bitterness taste in my mouth. I took all the Paxlovid. I still had fevers spiking during that period and finally tested negative for COVID-19 on 07/16/2022. I still have a residual cough and my back is starting to slightly feel better (strained due to excessive coughing for over a month). I would remain tired for a total of 2 weeks (possibly due to COVID, allergies or the extreme heat).
Patient received first dose of SHINGRIX on 4/9/18. Came to pharmacy on 8/5/18 to report "improper injection in lower portion of arm" to pharmacist.
I am the epidemiologist reporting on behalf of 65 year-old male patient.  The patient received two doses of the Pfizer Vaccine: First: 3/17/2021 Second: 4/07/2021 The patient was found dead at home on 4/19/2021 (12 days post second dose). The immediate cause of death listed on the death certificate is ?coronary artery disease.? Other significant conditions contributing to death but not resulting in underlying cause are listed as ?hypertension COPD?. I do not have any additional information about other underlying conditions that may have contributed to this person?s death.
Started having headaches, congestion and a sore throat. Took a Home COVID-19 Test and was positive. Contacted doctor and was prescribed Paxlovid. Still currently sick.
I had  the vaccine on 2/2/21 the next day a little soar around the area of the injection and by Friday 2/5/21 my left arm was still soar and redness around the injection area.   A week later 2/9/21,  itching, redness, swallowing and soar.
This spontaneous report was received from a licensed practical nurse, referring to an 11 months old male patient. No medical history or concurrent conditions were reported. On 06-JAN-2016, "7 days before his 1st birthday", the patient was vaccinated with VAQTA (dose, route and lot number were not provided). Concomitant medication was not reported. No adverse effects were reported and there was not product quality complaint involved. Additional information has been requested.
On 2/18/00, the pt developed "chicken Pox - like lesions" on her arm and face. She sought unspecified medical attention. No further information is available.
Pfizer-BioNTech COVID-19 Vaccine EUA swollen node under the skin by left collarbone and swollen area around it, sore to touch, sore if left arm lifted towards right this began the day following the 2nd dose of vaccine and continues (today is 4th day after vaccine)
Approx 2 days after injection pt complained of fever, chills, nausea and vomiting. Over weeks pt developed severe myalgias, chest discomfort and generalized muscle weakness was unable to get out of bed. Chest discomfort and muscle weakness improved but still there. Numbness/tingling in left arm/hand still present but not as severe as initially. Pt visited doctor twice, had a bladder infection and reaction was initially thought to be due to antibiotics. Initial antibiotics was Cipro, later on changed to Levaquin and then to Doxycycline. Then reaction thought to be due to TD. Pt was admitted to a hospital overnight for a neurological evaluation. MRI, nerve conduction studies and carotid dopplers. All test were normal. No treatment given for reaction symptoms. TD was given as a routine booster, no other vaccines given at the same time. Pt did not recall any adverse reactions to prior TD injections and in general did not recall getting any earlier TD boosters. Reaction was reported by the pts doctor to VEARS on either 10/24/06 or 10/25/06.
swelling of L 2nd adn 3rd MCP joints one week after immunization received.
Emergency Room Doctor from hospital called that patient had a febrile seizure. His temperature at the hospital was 100.7. No tests run.  1/16/09-records received for DOS 11/5/08-presented to ED with C/O single seizure just prior to arrival. Lost consciousness and was unresponsive, generalized motor activity observed. Fever 101.3. Tachycardic. Impression: Febrile seizure.
Probable cellultiis L arm. Attending MD checked pt and referred to ER for further possible treatment.
24OCT92 temp elevated to 103; 25OCT92 had convuls; MD felt not related to flu vax but unsure of cause;
9/11/10 - AM - onset of joint pain, fever and sore throat 9/13/10 - Seen by PMD; was given injection for inflammation; started feeling better after injection. 9/15/10 - went back to work 9/17/10 - called MD due to increased fever, max is 101 degrees F, was given Rx of ZITHROMAX. Allergic PCN.
2nd dose in two weeks; don't feel well; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included SHINGLES VACCINE (NOS) (SHINGLES VACCINE).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On 24th May 2022, unknown after receiving Shingles vaccine, the patient experienced unwell. On an unknown date, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the unwell and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient went to two different pharmacist and the pharmacist told to get the 2nd one in two weeks so the patient did. On the date of reporting, the patient did not feel well and was reading information that not to get the next one until 2 to 4 months. Since the patient received the shot too quick next. Additional Supportive Information: The patient received 2nd dose of Shingrix earlier than recommended time frame, which led to shortening of interval between vaccine doses.
extremely red; injection site welt; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (injection site welt), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE ERYTHEMA (extremely red) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced INJECTION SITE INDURATION (injection site welt) and INJECTION SITE PRURITUS (itching at the injection site). On 23-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (extremely red). At the time of the report, INJECTION SITE INDURATION (injection site welt), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE ERYTHEMA (extremely red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Tinnitus, plugged ears, vertigo almost immediately after receiving the shot. No known ear issues before vaccine.
Flu like symptoms; Full body rash with itching; Full body rash with itching; localized arm pain with ancillary edema x 5 days; localized arm pain with ancillary edema x 5 days; This is a spontaneous report from a contactable nurse (patient). The nurse reported 2 reports for same patient, same product. This is the second report. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ3246), intramuscular in the right arm on 12Jan2021 08:30 AM at single dose for covid-19 immunisation. Known allergies included Tramadol and Lexapro. No other medical history. Concomitant medication (Other medications in two weeks) included VITAMIN B complex (B COMPLEX), collagen marine, methylsulfonylmethane (MARINE COLLAGEN PEPTIDES WITH MSM), saw palmetto [serenoa repens] and zinc. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685, administrator route=Intramuscular, vaccine location=Left arm) on 22Dec2020 at age of 39-year-old for covid-19 immunisation and experienced general malaise with nausea and diarrhea, localized pain 3-4/10 after first dose x 5 days. The patient experienced full body rash with itching, localized arm pain with ancillary edema x 5 days. Flu like symptoms. After second dose in 2021. Treatment for events included Antihistamine. No Covid prior vaccination. The outcome of events was recovering. Unknown if Covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021123153 same patient, same product (first dose), different events.
Shortness of breath, numb face , tingling arms and legs, tinnitus in both ears, heart palpitations, blurry vision. Still have tinnitus, hearing sensitivity, vison problems and chest pai.
This spontaneous report was received from license vocational nurse (L.V.N), concerning to a patient of unknown age and gender. It was reported that on an unknown date, the patient was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported) and the second dose was received on an unspecified date 2 years after receiving the first dose in the vaccination series. Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
received second anthrax shot sub q .5cc in posterior right arm.  approx two weeks later small blisters (looks similar to small pox blisters) appeared on lateral aspect of right arm. pt stated that they did itch on occasion and denies any contact with anyone who received the small pox vaccine.  treatment includes benedryl and hydracortisone cream.
This is a Spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (Case Number: 00377203) from a non-contactable female consumer reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date a year before this report for immunization. Since being vaccinated, she has experienced pain in her chest area. She developed bronchitis on an unknown date and she has had surgery on an unknown date on her nose to remove nasal polyps. She also had chronic asthma. The outcome of the events was unknown. Therapeutic measures were taken as a result of she has had surgery on an unknown date on her nose to remove nasal polyps. Merck & Co., Inc. for additional information. Any follow-up information received by Merck & Co., Inc. regarding this case will be forwarded to you upon receipt. Please note that this information has not been reported to the FDA.
Onset of crying @ 3PM woke from nap "screaming nonstop x 3 hrs; Inconsolable crying-responded to APAP & DPH-resolved in 24hrs;
Patient began to experience syncope within a few minutes after receiving the vaccine. This quickly progressed to unconsciousness and the patient was unresponsive for about a minute. The patient experienced a short tonic-clonic episode before regaining consciousness. After the patient was responsive she expressed difficulty breathing at which time a dose of epinephrine was administered. Medical services responded and monitored the patient for that time forward.
9JUL97 mom states left clinic & on way home pt had fever, mom states did not give APAP;approx 7:30 pt had shaking possible sz;went to ER, t105 pt had lt OM;LP negative;pt adm over noc & sent home on antibiotics;doing fine on 10JUL97;
Reports that she has not started her menstrual cycle since receiving her 2nd Pfizer vaccination on 4/20/21.  She reports her LMP was 4/8/2021 and that she has always been "regular".  If she has ever been late, it has only been a couple of days. Patient reports that she has a history of a bilateral tubal ligation almost 3 years ago, and that she had a negative home pregnancy test a couple of days ago. She is unsure the Pfizer vaccine has caused her to not have a menstrual cycle, but reports that there have been no other changes.
started with a red rash and then kind of itchy warmness in my back lasted about two days and then today my left arm looks like covid arm and red circle with a spot that looks like raw skin and a blisters next to it
Fever; Chills; Headache; Muscle aches; Injection site burning and soreness for 36 hours; This is a spontaneous report from a contactable healthcare professional (the patient).  A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL9262), intramuscular in the left arm on 20Jan2021 10:30 (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, and the patient was diagnosed with COVID-19 prior to vaccination. The patient did not have any allergies to medications, food, or other products. The patient did not have any concomitant medications. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021, the patient experienced fever, chills, headache, muscle aches, injection site burning and soreness for 36 hours (as reported). The patient did not receive treatment for these events. The clinical outcome of fever, chills, headache, muscle aches, injection site burning and soreness was recovering (as reported). It was also reported that since the vaccination, the patient had not been tested for COVID-19.     No follow-up attempts are possible. No further information is expected
Moderna vaccine given when it was expired on 05OCT2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given when it was expired on 05OCT2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given when it was expired on 05OCT2021). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given when it was expired on 05OCT2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment was reported by the reporter.  Patient has not reported any side effects following the vaccination.
Case number PHEH2013US023743 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 71-years-old  male patient. His medical history and concomitant medications were not reported. He was vaccinated with an expired dose of FLUVIRIN 2012/2013 (batch number: 123303, expiry date: Jun 2013) at a dose of 0.5 ml intramuscularly on 18 OCT 2013. No adverse event was reported following the maladministration.
hives after first shot; This is a spontaneous report from a non-contactable healthcare professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, via an unspecified route of administration, the first dose on 15Dec2020 (lot number: EH9899) at a single dose, then the second dose on 08Jan2021 (lot number: EK9231) at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. The patient experienced hives after first shot on 15Dec2020. No treatment received. Outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Right arm burning sensation as injection was started. Right arm soreness at injection site immediately. About 45 minutes after vaccine, new onset of facial numbness and tingling (in cheeks and forehead). Symptoms went away after about 10 minutes. Facial numbness/tingling returned 3 hours post injection for >30 minutes. Woke up the next day and facial numbness/tingling was still present and also included both sides of face. This resolved around 1:00pm. Headache and significant right arm pain continued. Took 600mg of ibuprofen which reduced pain. Saturday (today) mild right arm soreness.
Redness near injection site.  Severe headache, fever 101.3, upset stomach,