chrisvoncsefalvay/vaers-outcomes huggingface dataset:
late second dose of Twinrix / due to the situation with the pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 61-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HAB (Twinrix).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, unknown after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter called asking for information on a late second dose of Twinrix because a patient already received the first dose and today wanted to receive the second dose but the immunization could not be given because due to the situation with the pandemic with the COVID, the CDC decided to suspend all the immunizations.  The reporter consented to follow up.
Myalgia & NauseaVomiting  Narrative: 5/8/2021 Myalgias, upset stomach and redness swelling at injection site.
Herpes zoster left periorbital region too late for culturing (7 days after onset, lesions crusted).  Follow up appointment in 1 week.
This case was reported by a healthcare professional, who is the subject, and described the occurrence of not responding to therapy in a female subject aged between 50 and 59 years old who was vaccinated with Hepatitis B vaccine, (manufacturer unspecified), Hepatitis A vaccine inactivated and TWINRIX. Previous and/or concurrent vaccination included PNEUMOVAX; non-GSK manufacturer given on 19 June 2007. On 19 June 2007, 19 July 2007 and 21 December 2007 the subject received 1st dose (left arm), 2nd dose (left arm) and 3rd dose of Hepatitis B vaccine (unknown, right arm) and had a negative titer (not responding to therapy). The subject also experienced drug dose administration interval too short between the 2nd and 3rd doses. On 21 June 2007 and 21 December 2007 the subject received unspecified dose of Hepatitis A vaccine (unknown) and had a negative titer (not responding to therapy). The Hepatitis A vaccine given on 21 December 2007 was given in a separate arm from the Hepatitis B vaccine given on that same day. The subject did not know which brand she received. On 25 August 2008 the subject received unspecified dose of TWINRIX (unknown) (extra dose administered). A titer was drawn on 17 December 2008 which was negative for Hepatitis A and Hepatitis B. On 9 January 2009 the subject received unspecified dose of TWINIRX (unknown) (extra dose administered). A titer was drawn on 25 February 2009 which was negative for Hepatitis A and Hepatitis B. Follow-up information was received from the subject on 13 April 2009. The subject reported that the events were unresolved. She considered the events were possibly related to TWINRIX. She considered that the events could have been associated with the following medical history/concurrent illnesses: Subject had a false positive HTLV-1 test in 1997, but cannot donate blood anymore, and on 22 March 2007, she was diagnosed with monoclonal gammopathy of uncertain significance, IgG kappa. Relevant laboratory results included: 08 May 2008: Hepatitis B Surface Antibody: less than 0.1 (reference range: 0.00-0.99): inconsistent with immunity. Hepatitis A Antibody, Total: Negative (reference range: negative); 17 December 2008: Hepatitis B Surface Antigen (HBsAg) Screen: Negative (reference range: negative). Hepatitis Be Antigen: Negative (reference range: negative). Hepatitis Be Antibody: Negative (reference range: negative). Hepatitis B Surface Antibody: 0.13 (reference range: 0.00-0.99): inconsistent with immunity; 25 February 2009: Hepatitis B Immunity Panel: Hepatitis B Core AB total: Non-reactive (reference range: non-reactive); Hepatitis B Surface Antibody QL: Non-reactive (reference range: non-reactive). Hepatitis A Antibody, Total: Non-reactive (reference range: non-reactive).
16May2022 and on 18May2022, it started hitting again everyday, on and off and lasts long and it is very painful; It involves different fingers, initially it turns white then purple then the pain intensifies.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (16May2022 and on 18May2022, it started hitting again everyday, on and off and lasts long and it is very painful) and SKIN DISCOLOURATION (It involves different fingers, initially it turns white then purple then the pain intensifies.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 004M20A and 013A21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: FLU VACCINE VII in October 2021. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concurrent medical conditions included Lung disease, Hypertension, Drug allergy (steroid inhaler 10 years ago), Borderline diabetes, Cholesterol, Depression and Anxiety. Concomitant products included CLONAZEPAM for Anxiety, METFORMIN for Borderline diabetes, ATORVASTATIN for Cholesterol, SERTRALINE for Depression, ATENOLOL for Hypertension, THEOPHYLLINE for Lung disease, POTASSIUM, FUROSEMIDE (LASIX [FUROSEMIDE]) and BUDESONIDE (PULMICORT FLEXHALER) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022 at 10:20 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced SKIN DISCOLOURATION (It involves different fingers, initially it turns white then purple then the pain intensifies.). On 18-May-2022, the patient experienced PAIN IN EXTREMITY (16May2022 and on 18May2022, it started hitting again everyday, on and off and lasts long and it is very painful). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain in fingers, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (16May2022 and on 18May2022, it started hitting again everyday, on and off and lasts long and it is very painful) and SKIN DISCOLOURATION (It involves different fingers, initially it turns white then purple then the pain intensifies.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient never had COVID-19 positive test or diagnosis. It was previously reported by patient that an adverse event had occured after getting the 1st booster dose. He states that the pain on his finger tips had never completely disappeared and became less frequent.   This case was linked to MOD-2021-395679 (Patient Link).
Received vaccine in left arm the morning of 12/23/2020. Developed itchy palms and rash on torso the evening on 12/25/2020. Took Benadryl at onset. Did not seek medical attention. Reported incident on 01/06/2021. Rash almost gone, remaining only on left hand and very faded.
Patient fainted while sitting upright in chair approximately 2-3 minutes after receiving Moderna shot. He was unresponsive to touch or sensation for about 3 minutes but did stop breathing/circulation. He had some clamminess and low blood pressure/pulse during the event. However, he did not show symptoms of swelling, itching, or anaphylaxis. We applied a cool towel to his head and neck, and when he became conscious, gave him a bottle of water. Patient waited until EMS arrived where he was found to have had syncope/hypotension. Patient remained in pharmacy area another 15 minutes after being cleared by EMS before leaving. He did not require any further medications or treatment.
Pain at injection site into the chest. Extreme chills (shaking uncontrollably). I got extremely weak with body aches and a headache. I had a loss of appetite. I continue to have a softball sized knot at the injection site that is radiating heat. I laid down to sleep at 12:15 pm yesterday and slept until 9:30 this morning.   I am making an appointment with my doctor on Monday.
A non-serious spontaneous report of administered expired FLUMIST was received from a consumer concerning a female greater than five-years-old. No medical history was provided. The reporter indicated that the lot number and expiration date printed on the outside of the product package had a different lot number and an expiration date than the inside to the package. The outside of the package had an expiration date of Dec-2008 and the doses inside the package had an expiration date of Jan-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Had headache and a temperature of 102.1; Chills; Fever/ temperature of 102.1; Nausea; Reddening in the arm where the injection was administered and like a darkened area; Itching; This is a spontaneous report from a contactable consumer (Patient). A 81-year-old male patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: ER8737, Expiry Date: Unknown) via an unspecified route of administration on 07Apr2021 as DOSE 2, SINGLE for covid-19 immunization (at the age of 81 years).The patient medical history and concomitant were not reported. The patient previously took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 17Mar2021 as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date the patient had experienced headache, temperature of 102, chills, fever, nausea, reddening in the arm where the injection was administered and like a darkened area and Itching. The patient reported that, my first inoculation was on 17Mar2021, and I had absolutely no problems. My second dose on 07Apr2021 I had headache and a temperature of 102.1. I had chills, fever, and nausea. Which I understand those are the common side effects. Now, I also noticed the reddening in the arm where the injection was administered and like a darkened area. Now, is this common with the second injection because I had absolutely nothing with the first. My question is can I use Benadryl because it itches though. Reporter stated, In the evening would be better. Not right now. I just want to know what I can do with the itching problem. I just want to know if I can use some medication for stopping itching. That was the only concern that I had. A red area and it's like other area; it is itching; that area that got the injection site has like a bruise, it did look like a bruise (as said no like so did not capture separate event); it's red and flat. Patient further stated, I had several reactions the one I want to ask you about it's like a red area and it's like other area seems to be like, I don't know if it's from the injection site, it is itching, now would I be able to use Benadryl, for itching because I don't want to interfere with the COVID. Can I use the Benadryl for the itching? Pfizer number is ER8737. That is the one where I got all the reaction, I didn't have that with 1st shot but with second one I definitely did." Patient further stated, "I hear a lot of side effects with 2nd not with the first and that is where I don't know what to do. On an unspecified date the patient underwent lab tests and procedures which included body temperature and diagnosed with 102.1. It was reported that patient had a query he could take Benadryl or not, taken treatment is unknown. The outcome of all the events were unknown.  No follow-up attempts are possible. No further information is expected.
LEFT EYE DISCOMFORT; RED VEIN ON EYES; TIREDNESS; SENSE OF SMELL WENT AWAY; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported.  The patient's past medical history included cocaine use, marijuana use, abstains from alcohol, and smoker, and concurrent conditions included sleep disorder, high blood pressure, fast heartbeat, problem with urination, and allergy, and other pre-existing medical conditions included unspecified allergy medication a little white pill. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced sense of smell went away. On 29-MAR-2021, the subject experienced tiredness. On 31-MAR-2021, the subject experienced left eye discomfort. On 31-MAR-2021, the subject experienced red vein on eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sense of smell went away, left eye discomfort, tiredness and red vein on eyes was not reported. This report was non-serious.
Charley horse to right leg and right calf and under left armpit,  severe headache, fever, intense shivering, muscle pain, arm pain to whole arm that was injected, sore throat, blurry vision, cold sweats, dizziness
I received my vaccine at Pharmacy, not my doctors office. As expected, my arm was sore so my husband said I needed to massage it. As soon as I did, I felt a flush down my left arm to my fingertips, then down the left side of my body. Within less then an hour I had what felt like a swollen ball of fire in my descending colon which required using a heat pad on my abdomen. This continued for the rest of the day/ evening until I finally justwent to bed. As soon as I laid down, I experienced what felt like a burning raise up through my colon and intestines and up into my stomach until it reached my  diaphragm.   Also down to my rectum. It felt like I was going to explode on both ends at once (meaning vomit and have explosive  diarrhea , then suddenly I started having sharp pains to my heart. It felt like shocks.   This continued until I finally fell asleep. Over the next few days my arm was sore as expected but nothing else until the morning of the 26th when I woke to feeling extreme itching sensation under my skin at the site of my vaccine. My skin didn?t itch, it was inside my arm. I told my husband it felt like something was eating my arm from the inside out.  This has continued to today with a large red area on my upper arm along with a hard welt and the area is hot. This evening I started breaking out in a rash on the other arm near my armpit and trunk junction which is spreading up over my shoulder.
with extreme itching; red ring band around the arm; painful; was stiff; swelled; This non-serious case was reported by a physician via sales rep and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-JUN-2023, the patient received the 1st dose of Shingrix (left arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced pruritus (Verbatim: with extreme itching), erythema of extremities (Verbatim: red ring band around the arm), pain (Verbatim: painful), stiffness (Verbatim: was stiff) and swelling (Verbatim: swelled). The outcome of the pruritus was resolved and the outcome of the erythema of extremities was resolving and the outcome of the pain, stiffness and swelling were unknown.   It was unknown if the reporter considered the pruritus, erythema of extremities, pain, stiffness and swelling to be related to Shingrix.     It was unknown if the company considered the pruritus, erythema of extremities, pain, stiffness and swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-JUN-2023 The reporter stated patient administered first dose of Shingrix in left arm. She experienced swelling, stiffness, painful with extreme itching and red ring band form around the arm. On 12th June 2023 the extreme itching lasted and the redness started to dissipate. No further information was known. The reporter consented to follow up.
Patient got all over body rash 2 weeks after vaccine, requiring multiple courses of steroids.
03/04/2021- Difficulty breathing and chest tightness, off and on throughout day.  03/05/2021- Face swelling on the left side and also swollen lymph nodes, symptoms  still continue 03/11/2021.
A minute or so after the shot had mild headache and difficulty breathing for 20-30 seconds.; A minute or so after the shot had mild headache and difficulty breathing for 20-30 seconds.; This is a spontaneous report from a contactable consumer (patient). A 20-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in arm left on 18Apr2021 10:15 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history were none. No known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient experienced a minute or so after the shot had mild headache and difficulty breathing for 20-30 seconds on 18Apr2021 10:15 with outcome of recovered on 18Apr2021. No treatment received. Seriousness criteria of difficulty breathing was medically significant.  Follow-up needed. Information about batch/lot number has been requested.
Patient experienced a seizure episode immediately after I administered his COVID-19 vaccine. I administered the vaccine at 10:22 AM and a few seconds later Patient started to shake and toss his head back. I immediately called 911/paramedics after his wife and I helped him to lay to his side. His seizure episode lasted about 2 or 3 minutes. He quickly regained consciousness and became fully responsive before the paramedics arrived.
macular papular rash face & trunk w/irritability;afeb (not when was brought in had lt OM also);blotchy rash for 3 days, irritable, ear infection also
10/7 severe chills and fever F 100.3 at 7:00 pm - took 2 ADVIL rechecked temperature 11 pm - down to 99.6 very tired and restless nights sleep. Awoke feeling malaise and fatigue entire day of 10/8/15 sleep well that night. Awoke on 10/9/15 feeling back to normal.
Thirsty; Fever; Tired; Chills; This is a spontaneous report from a contactable healthcare professional, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the left arm on 22Mar2021 at 13:00 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not test for COVID-19. On 23Mar2021 at 07:00, the patient experienced fever, chills, tiredness and thirsty. There were not therapeutic measures taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fever, chills, tiredness and thirsty was resolving at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
awful cramps and bleeding; awful cramps and bleeding; period was delayed; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 41 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Apr2021 (Lot number: EW0193) at the age of 41 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Known allergy: Gadolinium contrast" (unspecified if ongoing). Concomitant medication(s) included: CLONAZEPAM; PAROXETINE; ROSUVASTATIN. The following information was reported: MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious) all with onset 01May2021, outcome "recovering" and all described as "awful cramps and bleeding"; MENSTRUATION DELAYED (non-serious) with onset 01May2021, outcome "recovering", described as "period was delayed". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, dysmenorrhea and menstruation delayed. Additional information: the patient had not received other vaccine in four weeks. The patient stated, "my period was delayed and had awful cramps and bleeding. I have had awful periods since". The patient had no COVID prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Chills, followed by shaking chills, myalgias, vomiting (x1), headache, lethargy.  Chills, myalgias, headache and lethargy lasted all night then took Naproxen in the AM and was able to go to work. Stayed on Naproxen all day and all the next night with no additional symptoms (other than extreme tiredness) throughout the day until night two had drenching night sweats throughout the entire night (changed drenched t-shirt 5 times, soaked sheets and pillow case, until up to go to work at 6:00 AM.  Since morning no additional symptoms including no tiredness/lethargy.  I currently feel completely normal.  Last dose of naproxen was at 6:00 AM and no symptoms since.  Currently 1:45 PM.
PATIENT TESTED POSITIVE FOR COVI 19 ON 04/24/2021
Both inner thighs have been itching since about a week after first shot.  6 days after the second shot both inside thighs have softball size red, swollen patches that itcha and burn.
This report describes the occurrence of mercury poisoning in a male child of unspecified age who was vaccinated with Hep B vaccine recombinant (Engerix B) for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. The subject's medical history concurrent conditions, and concurrent medications were not reported. The subject received injections of hepatitis b vaccine on 09 Jan 1995, 24 March 1995, and 23 Aug 1995. He also received diphtheria and tetanus toxoids and pertussis vaccine 09 Jan 1995, 24 March 1995, and 16 May 1995). diptheria and tetanus toxoids and acellular pertussis vaccine (Acel Immune 15 July 1996), Haemophilus influenza type B conjugate vaccine 09 Jan 1995, 24 March 1995, and 16 May 1995, and Hib Titier 05 April 1996), oral poliomyelitis virus vaccine (Orimune 09 Jan 1995, 24 March 1995, 15 July 1996), MMRII 26 Dec 1995), and varicella virus vaccine (Varivax 11 Jan 1995). He also received a tuberculin skin test 23 Dec 1995). The subject's attorney alleged that, as a result of the vaccines administered, the subject suffers from the effects of mercury poisoning. The mercury poisoning in this report is considered medically serious.
MMR vaccine was given on 11/19/01 and on 11/26/01, the pt developed a fever. On 11/29/01, the pt had a measles rash.