chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately upon the nurse inserting the needle into my arm, I felt pain in my upper arm.  The pain worsened and lasted for approximately 1 year, despite taking Celebrex and physical therapy.  I could not raise my arm above my head or open doors.  The pain was constant.
Initial information received on 03-Dec-2018 in the united states regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA333646 (same reporter). This case involves an adult female patient (age not reported) who was vaccinated with a pediatric dose of FLUZONE QUADRIVALENT (lot number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to vaccine underdose. It was not reported whether the patient experienced any adverse events 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. List of documents held by sender: none.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with because of a car accident. Vaccination took place 10.09.2008. According to the physician the relationship is None. We would be happy to fax you the Study SAE report.
Patient is 20-year-old female who received typhoid vaccination and influenza vaccine on the 14th of December 2004.   She reports doing well following the vaccination without any unusual reactions.  She reports going to work and doing typical paper work with no unusual exposures.  She reports getting the vaccine at approximately 1500 and then she went to work for the night.  She noticed at the end of her shift that her fingers were swollen and that her feet were swollen.  She had a rash in the folds of her arms that she described as lines.  She had a rash on her feet.  The soles felt tingling and her toes were sensitivity.  The tops of her feet were red.  No hives.  The rash was very sensitive but not really pruritic.  The rash was present for approximately 24 hours.  No other symptoms:  no shortness of breath or difficulty breathing.  No dizziness or lightheadedness.   She reports possible fever and chills when sleep because she woke up in a sweat.  She reports occasional cough.  No other recent illness and denies sore throat.  No sick contacts.   No history of food allergies as a child.  No problems with eggs and she can eat eggs on a regular basis.  She went to the emergency room yesterday and was treated with ibuprofen and kenalog cream.  The symptoms seem to have improved.  No joint aches or knee or back pain.
Skin itchiness w/o rash within 1 hr of receiving the vaccine.  Unknown duration. Pt denies swelling, SOB at that time.  Reported by pt when arrived for second dose on 6/19.  Pt was pre-medicated with Benadryl for second dose and asked to stay for 30 mins observation.  No reaction to second dose noted at the time of discharge.  Second dose was same Pfizer EW0173 IM Left Deltoid.
Pt returned to pharmacy saying she was dizzy and vision impaired and couldn't catch her breath. We called 911, sat her down. She said she hadn't eaten in that day. We gave her a Pepsi. She felt better. EMS personnel checked her out. Blood glucose level was 72 after soda. Stayed 5 min longer and went home.
Patient was diagnosed with Covid post immunization and required hospitalization.  SOB/Cough; COVID PNA. Decadron.
Patient given high dose influenza vaccine and did not meet the 65 year requirement. This was missed during screening process at mass vaccination clinic. No adverse reactions occurred, but wrong dose was given.
Chills beginning at 11:30 PM night of injection. Fever of 99.0-101 the following day along with headache, nausea, and body ache. Injection site pain radiating down right arm and into right side of neck
fever started later that day 100-100.9;hive-like rash travels, comes & goes, arm, abd, foot, hand, back;
Awoke at 9:00 AM the day after vaccination feeling fatigue, body aches, and general malaise. I went back to sleep and woke at 11:00 AM feeling the same way.  Attempted to get work done (I have a marketing job and work from home) but ?brain fog? meaning difficulty concentrating on tasks and feeling forgetful of things I intended to do was a prominent part of the experience, making my tasks take longer. There was also muscle pain in my left arm near the injection site that I felt whenever I moved my arm. All symptoms besides arm pain began to lessen between 4 and 5 PM, and I felt mostly improved until about 10 PM, when the fatigue and body aches returned along with chills. I took 400mg ibuprofen and this helped; symptoms abated about 2 hours later.  I feel mostly recovered now at 2:00 AM 12/17/21, with only a mildly sore arm still.
It was reported pt had temp on 102F(ear x 2 days). 20-30 papules, pustules on torso, 1 on thigh - on palm/soles. Runny nose x 5 days. Sore throat x 1 day. decreased appetite.
It has an oval area extremely warm and hot to the touch; It has an oval area and it itches; Injection site was becoming swollen; Injection site was becoming red and it has an oval area extremely red; Injection site was hard to the touch and has little pimples, 2 inches high about 2 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It has an oval area extremely warm and hot to the touch), VACCINATION SITE INDURATION (Injection site was hard to the touch and has little pimples, 2 inches high about 2 inches wide), VACCINATION SITE PRURITUS (It has an oval area and it itches), VACCINATION SITE SWELLING (Injection site was becoming swollen) and VACCINATION SITE ERYTHEMA (Injection site was becoming red and it has an oval area extremely red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included HYDROXYCHLOROQUINE, FOLIC ACID, PANTOPRAZOLE, FEBUXOSTAT, METOPROLOL, SERTRALINE and TRAMADOL for an unknown indication.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Injection site was hard to the touch and has little pimples, 2 inches high about 2 inches wide) and VACCINATION SITE ERYTHEMA (Injection site was becoming red and it has an oval area extremely red). On an unknown date, the patient experienced VACCINATION SITE WARMTH (It has an oval area extremely warm and hot to the touch), VACCINATION SITE PRURITUS (It has an oval area and it itches) and VACCINATION SITE SWELLING (Injection site was becoming swollen). At the time of the report, VACCINATION SITE WARMTH (It has an oval area extremely warm and hot to the touch), VACCINATION SITE INDURATION (Injection site was hard to the touch and has little pimples, 2 inches high about 2 inches wide), VACCINATION SITE PRURITUS (It has an oval area and it itches), VACCINATION SITE SWELLING (Injection site was becoming swollen) and VACCINATION SITE ERYTHEMA (Injection site was becoming red and it has an oval area extremely red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information were reported.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Injection site redness, Injection site induration, injection site pruritus and injection site swelling are consistent with the known safety profile of mRNA-1273 vaccine.
None. Client 18y 9m 11 d was given adult dose of Hep A. Should have been pediatric.
Mild heart palpitations that come and go. It's not been consistent and I haven't looked into treatment.
This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. It was reported that she received her first dose of the Pfizer BioNTech COVID-19 vaccine and on an unspecified date, the patient was sick for 4 days after where she could not get out of bed and could not even get up to eat. She stated that with the second dose of the vaccine, she was sick for 5 days after. The outcome of the events was unknown. Additionally patient states that she was calling to report side effects that her 84 year old mother is experiencing after taking Olmesartan (did verify that spelling with the caller). She states that her mother has been experiencing dizziness, headaches, "always sneezing", "always cleaning her eyes and especially her nose", vomiting, and "terrible" diarrhea. patient reported that this has been going on for "many, many long years." Caller only wanted to call in to report this but did ask how long it has been since Pfizer discontinued making this product. Response: Reviewed the attached VR but let caller know that I was unable to find the discontinuation date for this product as it was not listed. Let caller know that I am only trained to speak on the Pfizer BioNTech COVID-19 vaccine and we can only speak about Pfizer produced products here at Pfizer. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I did get Covid; I did get Covid; headache; fever; nausea; aches; sore throat; hacking cough. I am left with the cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "I did get Covid"; PAIN (non-serious) with onset Sep2022, outcome "unknown", described as "aches"; PYREXIA (non-serious) with onset Sep2022, outcome "unknown", described as "fever"; COUGH (non-serious) with onset Sep2022, outcome "not recovered", described as "hacking cough. I am left with the cough"; HEADACHE (non-serious) with onset Sep2022, outcome "unknown"; NAUSEA (non-serious) with onset Sep2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset Sep2022, outcome "unknown", described as "sore throat ".  Clinical course: The patient have had all but the latest Pfizer vaccines for Covid. The patient  tried to get the latest one, however, the drugstores did not have it. For some reason, they were  only using Moderna boosters. The patient asked to provide the  places that carry Pfizer booster. The patient did get Covid Sep2022. It hit with headache, fever, nausea, aches, sore throat and a hacking cough. The patient was left with the cough and reported it was not good.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jan2021 as dose 1, single, in left arm, on 24Jan2021 as dose 2, single, in left arm and on 01Oct2021 as dose 3 (booster), single at the age of 34 years for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 27Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MIRENA. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes"; COVID-19 (medically significant) with onset 2022, outcome "unknown", described as "Rebound Covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer 3 rd dose: 01Oct2021/Moderna dose 4: 27Sep2022". Therapeutic measures were taken as a result of vaccination failure, covid-19, interchange of vaccine products.  Clinical course: No treatment  Patient received treatment with paxlovid from 18Dec2022 to 23Dec2022 for treatment of Covid-19.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
SEVERE SHIVERING FOR HOURS THAT BOTHERED OVERNIGHT, SHE ALSO MENTIONED FLU LIKE SYMPTOMS. SHE TOOK IBUPROFEN AROUND 3 AM THAT HELPED ALOT
Patient had syncope episode 2 minutes after Hep A and MCV4 vaccines.  Regained consciousness.  BP 80/44.  Monitored for 15 minutes.  BP at 122/70.
This case was reported by a other health professional via call center representative and described the occurrence of tiredness in a 60-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2019) for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 5th March 2019, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In March 2019, the patient experienced tiredness and influenza-like symptoms. On an unknown date, the outcome of the tiredness, influenza-like symptoms, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the tiredness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. After vaccination with SHINGRIX, the patient felt very tired, like she was going to have the flu. The patient received only the adjuvant part of SHINGRIX, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated the administration of just the adjuvant was already been reported. GlaxoSmithKline was previously contacted and they were instructed to wait 4 weeks before giving the patient the full vaccine. Till the time of reporting, the patient was not revaccinated yet.
Systemic: Seizure-Mild, Additional Details: Within 10 seconds of giving Pfizer vaccine, patient began to pass out then had a seizure. Called 911. Experienced bradycardia and was taken to hospital.
I experienced with my first vaccine, no symptoms.   I experienced on 01-01-2021, started to developed skin lesions on my legs, very itchy. This became so big and scary that I called a dermatologist and I was diagnosed with eczema. I also had headaches, felt like I had the flu but no fever.  I received my second vaccine at Hospital.   To this day I still have the lesions, using a topical cream and it spreads to my back and my arms as time goes on I have 6-7 skin lesions I am still treating.   I had eczema when I was eight years old but it seems the Pfizer vaccine triggered it.
12/03/2021 On the night of my booster vaccine I began to have symptoms of body chills, I just could not get warm and was shivering uncontrollably, and a fever. I also had really bad muscle and joint aches. I also had extreme fatigue come on and these all lasted three days. On the evening of the third day post vaccination, I was feeling completely fine and 100%.
Patient was given DTaP, IPV and MMR in clinic and had no immediate reaction. In waiting room , 10-15 min later he apparently fainted. He was returned to exam room and appeared clammy and somewhat unresponsive. Pulse ranged from 90-120, respirations 16-30/min and BP was 80/60 and faint. 911 was called due to lack of responsiveness. Child was stabilized and taken to hospital. Vagal response: child okay.
Shaking chills, muscle aches, fever 100.2 approximately 8 hrs duration, took Extra Strength TYLENOL.
After receiving the first shot on Jan 19 I had a nosebleed.  It was mild and happened about an hour after the shot.  When I received the 2nd shot on Feb 9 I had a very severe nosebleed about 24 hours after the shot.  It took about 45 minutes to stop and I passed several clots.  It was very frightening.
Information has been received from a licensed practical nurse concerning a female patient who was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. Subsequently the patient became dizzy and passed out. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax 4OCT & reported to medicl dept on 23OCT swelling & warmth of lt deltoid several days p/shot;lump @ site of shot;persisted to present; pain in muscles of rt arm on 19OCT;upset stomach, diarrhea;no fever; several hive-like lesion
Can't really taste anything; Feel really bad; Sick all days; My throat is like swollen; Lymph nodes is swollen like right now it's difficult for me to swallow; Headache; I do not feel well; I am tired, all I wanna do is sleep; Fever; Chills; My throat, lymph node they are swollen like it is making it difficult for me to swallow; looks like diarrheal/Little diarrhea; I am very weak; I am not able to do hardly anything like I have been taking medication all day for soothing my throat so that I am able to talk; This is a spontaneous report from a contactable consumer (patient). This 34-years-Adult-female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EW0169),via an unspecified route of administration on 11Jun2021 at 09:30(at the age of 34-years) as Dose 1,Single for COVID-19 immunization. The patient's medical history included hypertension. Concomitant medications included MULTIVITAMINS, I was taking, but since I have not been feeling well, I have not been taking it. No other vaccine taken previously, this is 1st one. On 12Jun2021 the patient experienced headache, do not feel well, am tired, all wanna do is sleep, fever, chills, my throat, lymph node they are swollen like it is making it difficult for me to swallow, looks like diarrheal/little diarrhea, very weak, not able to do hardly anything, like have been taking medication all day for soothing my throat so that able to talk, can't really taste anything, feel really bad, sick all days, my throat is like swollen, lymph nodes is swollen like right now it's difficult for me to swallow. Therapeutic measures were taken as a result of, sick all days (illness), Since I have been sick, I was taking Tylenol and I have been taking Brilaroxazine, with my food and honey. When probed for having any medical enquiry Consumer stated, "I was told if I had this to report it, there was somebody would check upon me. Yes, I am calling to report so that they would know what is going on. I need to know how long this is going to last because I have got this vaccine since Friday and here is Monday and I am not able to do hardly anything like I have been taking medication all day for soothing my throat so that I am able to talk." Scheduled date for second shot on 09Jul2021. The outcome for all event was unknown.  Further probing could not be done as the consumer was unwilling to share any further information. Hence limited information available over the call.
Extreme headaches every other day for approx. 1 minute then goes away since late 2003. Loss of hair (began losing hair approx. 3 months after receiving those vaccines). Evacuate blood from time to time. I currently have Anthrax 1, 2 and 3 not because I wanted but because was "a must" to have them.
This case was reported by a nurse via call center representative and described the occurrence of vomiting in a 4-month-old female patient who received ROTARIX. On 28th December 2016, the patient received the 2nd dose of ROTARIX. On 28th December 2016, several minutes after receiving ROTARIX, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional details were provided as follows: It was reported that the patient threw up, minutes after receiving a dose of ROTARIX.
6 out of 10 got COVID; 6 out of 10 got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "6 out of 10 got COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
A few hours after the 1st dose, the injection site was very sore.  It hurt to raise my arms up.  Then I felt feverish - was running a slight temperature of 99.2 - 99.4 F.  This lasted for 36 - 48 hours.   A week later (2/20/21) - the injection site started to itch.  I have a huge, raised welt.  It feels hot to the touch and is sore.  I also ran a slight fever of 99.6 F.
Pain everywhere for 24 hours (all joints and muscles, including cheeks, muscles in feet, forearms, pretty much everywhere), headache, nausea. Pain started in about 12 hours after shot and continued for 24 hours. Gastrointestinal upset lasted for about a week.