chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the Pfizer Bivalent COVID-19 booster on 10/5/2022. On 12/23/2022, I began feeling achy and a little bit sick in the late afternoon. I took my temperature, and it was 99.7. On the morning of 12/24/2022, I felt even achier and weaker. I took my temperature, which was 100.7. I decided to take a home antigen test, which yielded a positive result. I went to an urgent care clinic. The doctor there recommended against my taking PAXLOVID, because it would cause even more damage to my remaining kidney. Since I wasn't congested, the doctor said that I should go home, rest, take it easy, and take TYLENOL as needed. I felt tired, weak, and shaky. I also had a headache, but it wasn't as bad as the body aches. On about 12/26/2022, I began to feel better. My temperature returned to normal. I felt confined, so I decided to go out and walk around my neighborhood a bit. I was physically tired afterwards, but I felt emotionally better. I continued to test myself regularly, and each time I got a positive result. I took a test earlier today, and I still got a positive result. I asked my doctor for some advice, and she told me that since I was now symptom-free and 10 days had passed, I could come out of isolation, go mask less in public, and return to my normal activities.
Mom states that injection site became swollen and had some itching. Mom called the ER and was told to give the child Benadryl. The swelling and itching decreased with the Benadryl.
I have been diagnosed with Shingles on 12/17/2019 after having the Shingle shot on 12/11/2019.
Patient received the high dose formulation but he is only 64, he did not have any adverse effects
teeth falling out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: TOOTH LOSS (non-serious), outcome "unknown", described as "teeth falling out".  Additional information: Reporter was concerned for her son who received the 2 dose vaccination. She asked to provide her information about side effects and any concerns with ingredients in it that would make teeth falling out. Regular dental care and now dentist is addressing to look into this vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning a 76 year old male who on 01-FEB-2007 was vaccinated with a dose of Zostavax. On 05-FEB-2007 the patient experienced a zoster outbreak on his face. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
tingling/itching on back and neck, shoulders arms; pt denies SOB, wheezing, rash, hives, nausea, states "it may be nerves"; recommended to take benadryl when getting home; info given
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
99.4 temp, pain in left side of body, arm leg, side, abd, vomiting 1x, irritable.
Toothache before 2nd dose/pretty bad tooth ache; This is a spontaneous report from a contactable consumer (patient reported himself) via Pfizer sponsored Program. A 67-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date in 2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, toothache before second dose on 11Feb2021. He wanted to take pain medications. Caller stated, "he already had the first dose of Pfizer-BioNTech COVID-19 Vaccine 11 days ago, he was not sure about the exact date. Next dose was coming this Thursday (11Feb2021)". Caller stated he did not have any side effects from the vaccine, when he offered the warm transfer to DSU. Caller wanted to know if he can take Tylenol or Advil for a "pretty bad tooth ache", but his next Dentist appointment was until 11Mar2021. Outcome of the event was unknown. No PQC present.  Information on the lot/batch number has been requested.
Blood glucose 158 mg/dL; Blood pressure 177/102 mmHg; Heart rate 92 bpm, Sp02 98%;  Per spouse her head, arms, and chest hurt; arms have itching and tingling. Client's spouse reports she had a similar reaction and it is "less than last time" and was recommended by her PCP to receive a dose of Janssen instead of a second dose of the Moderna (received 1st dose on 01/16/21 Moderna 013L20A).
Patient presented to facility with weakness, sore throat, congestions, yellow productive cough, chest tightness, fever, chills.
Within 24 hours of vaccination, developed arm, neck and shoulder pain.   Unable to move head side to side.  Neck limitations have subsided but arm/shoulder pain has continued.
Device malfunctioned. As I went to inject the vaccine into the patient, the vaccine leaked out of syringe. Repeated dose.
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from non-healthcare professional (office staff). This case is linked to case 2018SA256161 and 2018SA256154 (same reporter). This case involves 67-years old female patient who was vaccinated with a 0.5 ml expired dose of FLUZONE HIGH DOSE (Batch number: UI868AA, expiration date: 03-May-2018, dose in series, and site of administration were not reported) via intramuscular route on 04-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient was not pregnant. It was a case of actual medication error due to expired vaccine used. The patient had no adverse event following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
Reporting administration error as per immunization system. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates in the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from patientn at the time of the vaccination and no adverse reaction reported since given vaccine.
pt recvd vax 6JUL92 @ 1620 pt noticed itching 1800; saw hives upper torso 2100 hands & wrists swollen; to ER @ 2200; given DPH; today all clear;
Tiredness, headache, muscle pain, chills, fever, stomach pain,  redness, pain and swelling  in area
arm was itchy at the site of injection and there was a big red circle around the injection site; arm was itchy at the site of injection and there was a big red circle around the injection site; rea was swollen like a lump; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (arm was itchy at the site of injection and there was a big red circle around the injection site), INJECTION SITE ERYTHEMA (arm was itchy at the site of injection and there was a big red circle around the injection site) and INJECTION SITE SWELLING (rea was swollen like a lump) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced INJECTION SITE PRURITUS (arm was itchy at the site of injection and there was a big red circle around the injection site), INJECTION SITE ERYTHEMA (arm was itchy at the site of injection and there was a big red circle around the injection site) and INJECTION SITE SWELLING (rea was swollen like a lump). At the time of the report, INJECTION SITE PRURITUS (arm was itchy at the site of injection and there was a big red circle around the injection site), INJECTION SITE ERYTHEMA (arm was itchy at the site of injection and there was a big red circle around the injection site) and INJECTION SITE SWELLING (rea was swollen like a lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Started experiencing pain, numbness, sensitivity in toes, began left foot first, then began in right toes.  Has occasional numbness right lateral calf. Symptoms worsened over 1 week's time. Developed sore throat and fever 1-2 days after receiving the flu vaccine. Was given antibiotic for strep.  Sore throat and fever resolved, but numbness and pain in toes have not.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot#L018501, exp. date 22-JUN-2017; Lot#L016427, exp. date 13-APR-2017; Lot#L004754, exp. date 10-NOV-2016) (Strength, dose, route and frequency were not provided). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from same source. Additional information has been requested.
After I got my second injection of the Pfizer vaccine, I twice got the shingles. This was despite the fact that I have never even had chicken pox. The dates of onset for both bouts are 01/10/2022 and 02/28/2022.
Started with severe headache, moved to base of skull and neck. Next day (Thurs. 3/18) extreme pain in neck, chest and shoulder area, headache, chills, fatigue, shortness of breath, heart palpitations, brain fog, malaise. I thought it would pass. Friday I felt no better - by evening I felt swelling in my neck and chest area. Noticeable swelling in clavicle area on both sides. Saturday & Sunday I rode it out until I could see my Dr. on Monday March 22. Dr. gave me a shot of steroids and a script for MethylPREDNISolone - 21 tablets. Today is Tuesday, March 23, 2021 and I feel much, much better. Dr. said to NOT get the 2nd shot and to report this reaction.
On about 7 occasions starting after the second vaccine dose, I have experienced sudden weakness in my legs. My legs feel heavy and unsteady and I have to  hang on to something such as a table or chair in order to move forward. It lasts for a few minutes and then I am able to resume my normal walking. This has never happened to me before and it is an entirely new symptom.
pt recvd vax;approx 10 mins later, felt dizzy for 1/2 hr; swelling at site; pain in upper shoulder & back; problems resolved 17nov94;
got her first shot of Shingrix over 3 years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 7TA92, expiry date 29-SEP-2025) for prophylaxis.   Previously administered products included Shingrix (first shot of Shingrix over 3 years ago).   On 07-NOV-2023, the patient received the 2nd dose of Shingrix. On 07-NOV-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: got her first shot of Shingrix over 3 years ago). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 07-NOV-2023 The patient that got her 1st shot of Shingrix over 3 years ago.   No further details available about patient restarting of the 2nd dose. Reporter stated the patient told her this happened at the time of the COVID-19 pandemic and when patient called the pharmacy where patient had received the first dose, they saying they did not have any Shingrix in stock eventually the patient stopped calling. The patient received the 2nd dose after the vaccination period, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Ongoing Dermatographia. Any scratch of the skin creates hives on body. Red, raised and itchy.
pain all the way down to the hip; myalgia; pain all the way down to the ankle; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (myalgia), ARTHRALGIA (pain all the way down to the ankle) and PAIN (pain all the way down to the hip) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MYALGIA (myalgia) and ARTHRALGIA (pain all the way down to the ankle). On 04-Mar-2021, the patient experienced PAIN (pain all the way down to the hip). On 04-Mar-2021, ARTHRALGIA (pain all the way down to the ankle) had resolved. At the time of the report, MYALGIA (myalgia) and PAIN (pain all the way down to the hip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Tylenol for unknown indication.  No relevant concomitant medications were reported.
Information has been received from a licensed practical nurse concerning a child between the age of 4-6 years who in first week of May 2007 was vaccinated SC with second dose of Proquad (Lot # 657262/0295U). It was reported that within 5 minutes to 12 hours after vaccination, the patient developed swelling, redness and warmth at injection site. The child was treated with cool compresses. At the time of report the patient recovering. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Puking, total muscle loss- soreness, headache, fatigue, sore throat, chills, been sick for over a week.
This is a report about me. I received my Covid vaccine on Sunday after my hospital shift (it was first dose of the Pfizer vaccine). Other than some muscle soreness, which I expected, I started experiencing numbness and tingling in the arm that received the shot (my left arm). It is now 4 days later, and the numbness/ tingling is not any better. I don't know if this is a frequent side effect that will go away in time, but it is very concerning to me.
This spontaneous report as received from a medical assistance refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with VARIVAX, lot # M010482, expiration date 01-MAR-2018 and lot # M017290, expiration date 07-APR-2018 and PROQUAD, lot # M001152, expiration date 05-JUL-2017 and lot # M017335, expiration date 05-OCT-2017. The medical assistant reported that an unspecified number of patient have received improperly stored VARIVAX lot # M010482, expiration date 01-MAR-2018 and lot # M017290, expiration date 07-APR-2018 and PROQUAD, lot # M001152, expiration date 05-JUL-2017 and lot # M017335, expiration date 05-OCT-2017 on unspecified dates since AUG-2016. No symptoms were reported. The outcome of incorrect product storage and no adverse event is unknown. Previous temperature excursion: PROQUAD, lot # M001152, expiration date 05-JUL-2017 (had a previous excursion of 15.8F for 40 minutes) and lot # M017335, expiration date 05-OCT-2017 (had a previous excursion). VARIVAX lot # M010482, expiration date 01-MAR-2018 (had a previous excursion of 15.8F for 40 minutes) and lot # M017290, expiration date 07-APR-2018 (had a previous excursion of 15.8F for 40 minutes). Temperature: 16.1F. Time frame: 2 hours. Data logger: yes. Additional information has been requested.
I had Cervical spine surgery on 11-9-22 and was being released to go home when I went into A-Fib and was rushed from Hospital to Medical center.  After x-ray, blood test, ct scan, echocardiogram I was admitted for heart failure.  Cardio Dr. Said he could not find anything wrong with my heart but wants to see me to put a monitor on and see what my heart is doing.  He is an Electro cardio Dr. And My PCP wants me to see a Cardiologist which I can?t get into until February.  My PCP is having to work with me as the hospital took me off the Blood pressure medication I was on, and after being released on 11-13-22 and I came home, my blood pressure was at a very high number.  He now has me back on the Losartan and the new heart pill Metoprolol 50 mg, twice a day.
Pain at injection site, chills and fever tmax 103.8 next day, headache. Went to ER on 7/29/2015 at 4:00 PM. Dx with cellulitis and admitted. Still in hospital.
administered from the punctured Moderna vial that had been stored at room temperature > 24 hours.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (administered from the punctured Moderna vial that had been stored at room temperature > 24 hours.) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PRODUCT STORAGE ERROR (administered from the punctured Moderna vial that had been stored at room temperature > 24 hours.). At the time of the report, PRODUCT STORAGE ERROR (administered from the punctured Moderna vial that had been stored at room temperature > 24 hours.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-106726, US-MODERNATX, INC.-MOD-2021-106777, US-MODERNATX, INC.-MOD-2021-106844, US-MODERNATX, INC.-MOD-2021-106726, US-MODERNATX, INC.-MOD-2021-106777 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106726:crosslinked US-MODERNATX, INC.-MOD-2021-106777:crosslinked US-MODERNATX, INC.-MOD-2021-106844:crosslinked US-MODERNATX, INC.-MOD-2021-106777:crosslinked US-MODERNATX, INC.-MOD-2021-106726:crosslinked
Angioedema, throat swelling, respiratory distress not resolved with benadryl and 2 epipens requiring ER visit
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.
The patient is a 60 year old female who presents for redness swelling and pain involving the left upper arm at site of Pneumovax pt received yesterday.  It has been persistent and present for 1 day.  Additional Comments: pt has fever to 101. Pt also started Augmentin last night for treatment of persistent sinusitis. Despite being on Augmentin she still developed fever, redness swelling, chills. Patient states that when she was sleeping last night her arm was  painful and woke her up from sleep.  When she woke up this morning the arm was swollen but not red. Since then redness has developed and has been extending out  from the site of the Pneumovax injection.  She feels ill and she is having chills.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Painful Injection Site), VACCINATION SITE ERYTHEMA, VACCINATION SITE INDURATION, VACCINATION SITE PRURITUS, and VACCINATION SITE SWELLING in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLONASE ALLERGY for Allergy, BYSTOLIC for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN. On 23-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA, VACCINATION SITE INDURATION, and VACCINATION SITE SWELLING. On 31-Mar-2021, the patient experienced FEELING HOT, INJECTION SITE WARMTH, and INJECTION SITE SWELLING. On an unknown date, the patient experienced VACCINATION SITE PRURITUS, and VACCINATION SITE RASH. The patient was treated with CEPHALEXIN (oral) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA, VACCINATION SITE INDURATION, VACCINATION SITE PRURITUS, VACCINATION SITE SWELLING, VACCINATION SITE RASH, FEELING HOT, INJECTION SITE WARMTH, and INJECTION SITE SWELLING outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: No specific follow-up information recorded.
Chill, muscle numbness, tremors, joint pain, pain in glands of the head, severe headache, excessive cold
Urinated far more than usual during the night.  Went 5 times during the night, then again when I woke up at 9am.  Shivering began at 1am and lasted until 6am.  Upon getting up I got real dizzy after urinating, decided to go back to bed, but could not figure out how to get back in, so I stood beside my bed until the dizziness went away.  At some point I must of figured I was ok as the next thing I know I'm on the landing of the steps upstairs, which is 6 steps, and my son is saying to my wife "I'm calling an ambulance".  Upon arrival at Hospital. I heard them say he's severely dehydrated and his blood pressure is extremely low.  I also had a fractured right clavicle.  I was kept in the Hospital for 3 days.
Chills, Fever (101 degrees). Treated with rest and hydration and cold compresses at home. Patient was fine by next morning.