chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lymph node on the top of his collarbone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Nov2021 (Lot number: 330268D) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single location: Left arm, Lot: FF2593), administration date: 22Oct2021, when the patient was 32 years old, for Covid-19 immunization, reaction(s): "blurred vision in one eye", "lymph node on the top of his collarbone". The following information was reported: LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "unknown", described as "lymph node on the top of his collarbone". The event "lymph node on the top of his collarbone" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the letters written on the patient card but thinks they are 330268D for the lot number; states his patient card had no expiry date or NDC written on it. It was reported that the patient had no prior vaccinations (within 4 weeks) and no relevant family medical history. No Relevant test done. The reported event does not require to visit Physician Office. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. It was reported that, most people and everyone in his family was pretty much healthy; states he was not on any new medications, and he does not have any medical issues.  Follow up attempts are completed. No further information expected.
Runny nose; Throat irritation; Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), THROAT IRRITATION (Throat irritation) and COUGH (Dry cough) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) 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 26-Mar-2021, the patient experienced RHINORRHOEA (Runny nose), THROAT IRRITATION (Throat irritation) and COUGH (Dry cough). At the time of the report, RHINORRHOEA (Runny nose), THROAT IRRITATION (Throat irritation) and COUGH (Dry cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided. No Concomitant medication information provided.
Mother and child presented today for vaccinations. Mother said, "no Rotavirus, she had a reaction to it and the Dr. said not to give it to her again." Reports on April 19th or 20th the child would not eat, if you touched her belly she would cry. Called ambulance, paramedics said she was awake, alert give her PEDIALYTE and see Dr tomorrow. Saw ARNP - x-ray was negative, said Rotavirus vaccine caused it and not to give it again.
she was breastfeeding; she was breastfeeding; The second shot it was just like just at the injection site; 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 patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 20Aug2021 (Lot number: FC3182) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Batch/lot number: EW0181, The first one was on my left shoulder), administration date: 30Jul2021, when the patient was 38 years old, for Covid-19 immunization, reaction(s): "Soreness towards her arm and shoulder"; Bnt162b2 (Dose: 1st, Batch/lot number: EW0181, The first one was on my left shoulder), for Covid-19 immunization, reaction(s): "I couldn't move my arm; It was from the shoulder all the way down to the wrist". The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 2021, outcome "unknown" and all described as "she was breastfeeding"; VACCINATION SITE DISCOMFORT (non-serious) with onset 2021, outcome "recovered" (2021), described as "The second shot it was just like just at the injection site". Therapeutic measures were not taken as a result of injection site discomfort.  Additional Information: No other prior vaccinations within 4 weeks. Consumer denied taking the number and stated, No its okay. Its all cleared up. The woman I spoke to before had read through the disclaimer with me and was able to make it clear that there were 2 separate lists, that the breastfeeding and pregnant women were not under the list of not to get the vaccine, it was just the location of it, it was just right under it and I just was kind of nervous reading it, so kind of like, I kind of read it like, my eyes kind of played a trick on me there. But yes, I don't really have any other questions. I was just asking her the 2 vaccines because there are  2 different type of vaccines. I was wondering if they were same or if they were different in any other way but she was just explaining that they are exactly the same. So, I really don't have any other question.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101192776 EDP (baby's 2nd dose);US-PFIZER INC-202101192586 EDP (baby's 1st dose)
This spontaneous report as received from a physician via a company representative refers to a 14 year old male patient. No information about concurrent conditions, medical history or concomitant therapy was provided. On an unknown date the patient started therapy with GARDASIL (route, dose, frequency and lot # not reported). It was reported that the patient was scheduled to receive his second dose of GARDASIL on 07-NOV-2014. On 07-NOV-2014, during the office visit the patient was vaccinated with the second dose of GARDASIL (route, dose, frequency and lot # not reported). Other suspect therapies included influenza virus vaccine (unspecified) (also reported as FLU) given on 07-NOV-2014 (also reported as on the same day). On 13-NOV-2014 the patient had a stroke. The outcome of stroke and relatedness between stroke and GARDASIL were not reported. Upon internal review stroke was determined to be medically significant. Additional information has been requested.
she noticed a "bright red blotchy spot" where she received the vaccine; she noticed a "bright red blotchy spot" where she received the vaccine; her arm got a big red spot/blotch; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN0167, Expiration date: Unknown), via an unspecified route of administration in the left arm, on 04Jun2021 at 14:30 (at the age of 50-year-old) as 2 ND DOSE, SINGLE DOSE for COVID-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8730, Expiration date: Unknown), via an unspecified route of administration in the left arm, on 12May2021 (at the age of 50-year-old) as 1 ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was unknown.  Additional vaccines administered on same date of the pfizer suspect was none. Prior vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. The patient started that she got the vaccine, both of them, and nothing happened for the first couple days. On 06Jun2021, the patient experienced bright red blotchy spot and the area where it was red and blotchy had some warmth to it. The patient stated that she did not have this type of side effect when she received her first dose. She also reported that when the pharmacist gave her second dose of injection, he squeezed her arm and she was not sure if this was what could have caused her arm to get red at the injection site or if the redness was a possible side effect from the vaccine. She stated that she got the second vaccine on friday at walgreens and the location she received the vaccination was fine, until a day later. She stated that she thinks on Sunday her arm got a big red spot and she does not know if it was from him holding/squeezing her arm and then giving the shot and releasing her arm. She stated that there is one big red blotch on her arm now and she is trying to see if that is normal. The caller states that there is nothing else is going on with her but she wants to make sure that nothing happens as a result of this. She also stated that she did not felt sick or anything and she had no side effects with her first shot so she just wanted to know if this could be a side effect or not. The patient stated that there was nothing else was going on with her but she wanted to make sure that nothing happens as a result of this. The patient treatment was not provided. The outcome of the events injection site erythema and injection site blisters was unknown. The outcome of the event macular rash was not recovered.  Information about lot/batch number is available. Follow-up attempts are needed
I had muscle soreness and a lot of joint pain. I also had a rash on my left arm. I had trouble breathing 8 hours after the vaccine. I feel like I'm breathing out of straws. It varies in intensity. I'll wake up and not be able to breathe well. I've been on 2 different antibiotics. Once in March and one recently. The antibiotics helped to get rid of the infection. I also have black and blue marks all over my legs that are unaccounted for. I did a ropes course and did not experience any trauma, but I have at least 40 black and blue marks all over my legs, hips, arms but not my trunk which is where I would've expected it. I thought my breathing was due to allergies, but I do not experience runny nose, itchy eyes or anything common with allergies. I am using arnica for the bruises. They seem to be healing faster than a normal bruise. I use a nebulizer when I can't breathe. This just eases the coughing symptoms. The nebulizer just puts of the infection. I am not coughing up mucus or anything, but my breathing is just constricted. It takes effort for me to breathe.
woke up day p/vax lt upper arm swollen & red to back & shoulder;APAP given & DPH recommended;
I had severe pain with my first shot and the pain never left. My husband was having serious medical issues so I ignored it thinking it would eventually go away. The pain is worse now.  Can?t really use my left arm. Believe I was injected in my Bursa rather than muscle.
Fatal heart attack, passed away.; Nausea followed by heart attack; vomiting all night; This case was reported by a consumer and described the occurrence of heart attack in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced nausea and vomiting. On 28th July 2020 06:00, the patient experienced heart attack (serious criteria death, GSK medically significant and clinically significant/intervention required). On an unknown date, the outcome of the heart attack was fatal and the outcome of the nausea and vomiting were unknown. The patient died on 28th July 2020. The reported cause of death was heart attack.   It was unknown if the reporter considered the heart attack, nausea and vomiting to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's Comment: The case was reported by patient's husband. The patient received Shingrix and experienced nausea and vomiting all night and the patient suffered a heart attack and passed away.  The patient suffered a fatal heart attack within 18 hours of a Shingrix vaccine injection and nausea followed by heart attack. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023029284:FU1 same reporter; Reported Cause(s) of Death: Heart attack
Aches; Fever; Chills; Expired vaccine beyond 12 hours after first puncture was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond 12 hours after first puncture was administered), PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Sep-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond 12 hours after first puncture was administered). On an unknown date, the patient experienced PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills). On 18-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond 12 hours after first puncture was administered) had resolved. At the time of the report, PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The reporter was calling to report that on 17-Sep-2021, at 3:50 PM, a vial of Moderna vaccine was used to prefill syringes for future administration and the syringes were labelled and placed in the vaccine fridge immediately. On 18-Sep-2021 one of the syringes was used to administer a Moderna vaccine dose to a patient. The expired vaccine was administered to the patient.  On 20-Sep-2021, the error was realized. On a follow-up with the patient the patient reported that thy experienced usual fever, chills, and aches similar to patient first dose experience but had done well otherwise.   This case was linked to MOD-2021-353631 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Additional information was received on 14-OCT-2021 and contains significant information such as patient identifiers and demographics, suspect product information including lot number, dose number, additional events experienced, and description of the events.
This case was reported by a nurse via call center representative and described the occurrence of helicobacter pylori infection in a female patient who received SHINGRIX for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX. In December 2018, less than a year after receiving SHINGRIX, the patient experienced helicobacter pylori infection (serious criteria GSK medically significant). The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the helicobacter pylori infection was unknown. It was unknown if the reporter considered the helicobacter pylori infection to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who was a retired nurse. The age at vaccination was not reported. The patient paid for the 2nd dose of SHINGRIX at the time of receiving the 1st dose. The patient was diagnosed with H Pylori (helicobacter pylori infection) and already took the first round of antibiotics. The patient just took a breath test to see if she was over the H Pylori. The patient read that, it was mildly radioactive and did not want it to compromise with the SHINGRIX. The patient wanted to know if one would play against the other, because she wanted the SHINGRIX to work perfectly. It was lemon flavored medicine in water to drink. The patient did not called about H Pylori in relation to receiving SHINGRIX, but she mentioned the H Pylori started in December 2018, adverse event filed conservatively. Lab Comments: On an unknown date, the patient just took a breath test to see if she was over the H Pylori. She read that it is mildy radioactive and does not want it to compromise with the SHINGRIX.
After 30 minutes waiting, I had hives on face and on way home tongue felt prickly.  I was instruct by pharmacist to take Benadryl once got home.   Exactly a week later 7/28/21, I started itching uncontrollably on arm at site of injection.  Next morning, 7/29/21 it was a red circle on my arm and it was hot to touch and itched.  Went to work and 8.5 hours later, entire arm and shoulder was hurting and achy.  Today, 7/30/21, arm, shoulder pain with itch.   Still warm to touch from red area / raised.
Case developed extreme fatigue and disorientation resulting in a fall. Case was taken by ambulance to Hospital. Case suffered a stroke, admitted to hospital 06/02, then into ICU 06/07/2021.
bloated stomach; A spontaneous report was received from a consumer (reporting on self) concerning a male patient of unspecified age, who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced bloated stomach/PT: abdominal distension.    The patient's medical history was not provided.    Concomitant product use was not provided by the reporter.    On 07 Jan 2021, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number not provided) in left arm  for prophylaxis of COVID-19 infection.    On 08 Jan 2021, in the morning the patient woke up with a bloated stomach. The patient had treated the event with two GAS-X tablets and the symptoms were ongoing.    Action taken with mRNA-1273 in response to the event was not reported.  Outcome of the event of bloated stomach was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
broke out in rash 22AUG92-under area-spread to arms, hands, neck, stomach, legs & feet; started as small blister type rash; MD told mom pt probably scratched self-rash spread -no fever;
I had chills, fever, vomiting, breathing issues, and all over body aches. I tested positive for COVID-19 at work. My doctor did not prescribe me any medications because it was too late. They told me to take Tylenol and other over the counter medications. I am still struggling with my blood pressure. My blood pressure was not going down with the lisinopril and I had to double my medication.
Mild sore throat; General achiness all over; the injection site, Puffy, tight skin feeling; Mild headache; Really red; Hot to the touch; The injection site started itching; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Mild sore throat), MYALGIA (General achiness all over), VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE PRURITUS (The injection site started itching) and VACCINATION SITE INDURATION (the injection site, Puffy, tight skin feeling) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (The injection site started itching). On 25-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch) and VACCINATION SITE ERYTHEMA (Really red). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Mild sore throat), MYALGIA (General achiness all over), VACCINATION SITE INDURATION (the injection site, Puffy, tight skin feeling) and HEADACHE (Mild headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, OROPHARYNGEAL PAIN (Mild sore throat), MYALGIA (General achiness all over), VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE PRURITUS (The injection site started itching), VACCINATION SITE INDURATION (the injection site, Puffy, tight skin feeling), VACCINATION SITE ERYTHEMA (Really red) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: NNI FU.
Today, 03/17/2021, at 530 pm: light-headed, dizzy, nausea - so dizzy I can not walk. I have eaten and am  hydrated. And the symptoms persist. I have felt bouts of light-headedness, dizzyness, and tinges of nausea that are mild since I got the 1st shot, but not prior to that. Six hours after the first shot, i felt dizzy, nauseous =and it dissipated by an hour and disappeared entirely by late the next morning (1/22/2021). After the second shot, I had no side effects. However, as i described above, I have felt slight nausea and lightheadedness during the past month or so. But this is very serious. And I am scared to walk.
This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a adult female patient who received SHINGRIX. Concomitant products included atenolol, MUCINEX, naproxen, Omega 3, PEPCID, PERCOCET, SYNTHROID, ZOLOFT and Coq10. On 28th January 2018, the patient received SHINGRIX. On 29th January 2018, 1 days after receiving SHINGRIX, the patient experienced swelling arm and influenza-like symptoms. On an unknown date, the outcome of the swelling arm was not recovered/not resolved and the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the swelling arm and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a lot of swelling on her arm and the swelling had gotten bigger at approximately 4 inches in diameter.
Transverse Myelitis; had no feeling in his feet or left leg; Severe back pain; This is a spontaneous report from contactable consumers. A 33-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously healthy and athletic. Three days after receiving the vaccine the patient reported severe back pain, and 2 days after the back pain started he had no feeling in his feet or left leg. The staff at the hospital believe his condition is transverse myelitis, and told the family there are no reported cases of this being caused by the Pfizer covid vaccine, but the family would like more information from Pfizer. The patient was hospitalized for the event transverse myelitis on unspecified date. The outcome of the events was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
The patient reported feeling somewhat dizzy at the time of injection, this resolved within minutes.  At around 45 minutes after administration, the patient reported what he described as mild pain in the right upper and lower quadrants of his abdomen.  He was referred to a medical facility for further evaluation.