chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dr gave mmr intramusc instead of subcut.; This spontaneous report was received from a patient of unknown age and gender. Information of the patient's medical, concurrent condition and concomitant therapy was not reported.  On an unknown date, the patient was administrated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacture unknown) (strength, dose, frequency, lot #, and expiry date were not provided) intramuscularly for prophylaxis (incorrect route of product administration). The patient needed direction on what to do.
Patient reported sharp shooting pain from shoulder to her neck on day she received the shot. Patient felt lesser pain in her shoulder the day after her shot.  Momentarily tingling sensation in her hand even while standing up the day after she received her shot.
STROKE; This spontaneous report received from a consumer via a social media and by a company representative concerned a male of an unspecified age race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date following vaccination with covid-19 vaccine ad26.cov2.s (second shot), the patient experienced stroke (Dose number in series: 2). It was reported that "One of my brothers (I have 3) after he took the second COVID shot he had a stroke, he is doing better now, but not like he used. To be". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220939883-covid-19 vaccine ad26.cov2.s-Stroke. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
SWOLLEN GALNS IN THROAT SINCE DATE OF VACCINE 9/10/21 TONGUE HAS BEEN TINGLING, FEELS DRY LIKE (SAND PAPER)  AND I HAVE LOST TASTE SINCE VAXX DATE 09/10/21
SkinRash, Rash & UrticariaPruritus  Narrative:
I had a sinus infection in December of 2022. They prescribed antibiotics, nasal spray, and an inhaler. In January or February, I was still having trouble. I was treated with another antibiotic and nasal spray. I seemed to do better. I went downhill with fatigue, joint pain, sore throat, and weakness. I saw a doctor on April 7, 2023. The doctor prescribed another round of antibiotics. I've lost about 10 pounds in the last month. I'm going back April 27, 2023, for a follow-up appointment. I've had lots of joint pain. I haven't had a fever or cough, but my throat is very sore. I haven?t had much of an appetite either.
improperly stored ROTATEQ was administered; This spontaneous report as received from a nurse refers to a 2 month old patient. On 28-DEC-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1660991 exp date 27-APR-2021) orally. Data logger issue was reported. The temperature of excursion was 9°C (8.5 °C) for a time frame of 2 hours and above 9 °C (8.5 °C) for a time frame of 2 hours. There was no previous temperature excursion.
Rapid heart rate 12 hours after the shot, followed by seizure, body aches, and fever.
3 days of  "BITES" more each day. Friend with same. Venous papules, pustular lesions with Excuriations in various stages of healing.
Information has been received from a physician concerning a female who on 28-SEP-2009 at 11:30 was vaccinated with a first dose of GARDASIL in her left arm. The physician stated that the patient was lightheaded, had blurred vision, nausea and left arm pain that was radiating from shoulder down to her wrist. Neurological exam was normal, but the physician stated that mother of child does not think that she was her usual self. The patient was in the emergency room. The patient's outcome is unknown. Additional information has been requested.
I always was able to tolerate fire- ant bites, but this time I had two ant bites and my face was swollen and so was my neck. I had a full body reaction. My wife also had the same reaction( ants were by garbage can) we both are vaccinated and have no prior history of allergies. Both have received PFizer shot.
I lost my sense of taste; not smell but taste; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 93-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hearing problem" (unspecified if ongoing), notes: Hearing problem. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Primary immunization series complete, NDC number, UPC number, Expiry Date were Unknown), for COVID-19 immunization. The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "I lost my sense of taste; not smell but taste". The event "i lost my sense of taste; not smell but taste" required physician office visit.  Additional information: This was not anything serious. All the time, the patient had Moderna (Unspecified Shot) but the last one was Pfizer; the patient got the booster shot (Unspecified Booster shot) last month; the patient got from Pfizer. NDC number, UPC number, Expiry Date of Unspecified Booster Shot was Unknown. She (Doctor) thought that the patient had a mild reaction to it which left patient; they said the patient loose sense of taste not from the shot that the patient got a case of it which the patient never got sick, never had one symptom but in the past let's just said past 6, 8, 9, 10 months, the patient lost sense of taste. Okay, not smell but taste and when the patient went to the doctor, she said well the patient probably had a mild reaction and it did not leave any reaction. The patient does not have enough strength to talk on the phone as the patient was 93 years old; the patient had no strength anyway.  The patient queried if the people that have had the virus would left out with sense of their taste or smell.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received first dose of Moderna Covid Vaccine. Asked to wait 15 minutes before leaving store, patient left right away and fainted in store by front register. Patient was conscious, breathing normally, with a pulse. No EpiPen was administered since there was no allergic reaction.
Vaccine was given around 1:30 pm on Friday. By 6 pm arm was starting to hurt. Woken at 2 am by nausea, arm pain and headache. The next 2 days had severe fatigue, headache, fever of 101, chills, nausea, body aches. Arm was hot and swollen but not red. Very painful to move, shooting, aching pain up into shoulder and neck, and all the way down to my hand. Took Tylenol - not sure if it helped. By Monday arm was still sore to the touch but most other symptoms (except fatigue) subsided. Tuesday the nausea, aches and headache returned and red, hot itchy blotches appeared on my arm. Weds went to doctor who prescribed prednisone 40 mg a day for 5 days. The blotches would go away a few hours after taking the prednisone , but come back by late afternoon. By Friday (7 days after vaccine) felt mostly better except for fatigue and itching arm. Itching completely gone 1 day after finishing prednisone.
had a swollen, red reaction at injection site; had a swollen, red reaction at injection site; This is a spontaneous report from a contactable Physician via Pfizer Sales Representative. This Physician reported similar events for 3 patients. This is 2nd of 3 reports.   An unknown age and gender patient received meningococcal group b rlp2086 (TRUMENBA) on an unspecific date at single dose for immunization. Medical history and concomitant drug were not reported. it was reported that patient experienced swollen, red reaction at injection site. Event took place after use of product. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020307227 Same reporter/drug, different patient;US-PFIZER INC-2020307304 Same reporter/drug, different patient
Vaccines were adminstered high in left shoulder. The second injection caused immediate significant pain.  Pain in arm continued with minimal improvement for ~ 10 days with difficulty fully moving shoulder despite regular ibuprofen use. Discussed with pediatrician around day 5 who recommended continuing ibuprofen. When pain continued we discussed again with pediatrician who prescribed decadron x 5 days. Pain improved by day 4. One ~ day 3 following decadron course, pain in left shoulder returned and worsened over next 3 days with limitation in movement. Seen by PCP office on 11/14 and shoulder MRI, ortho referral and repeat course of decadron for pain management were recommended.   Vaccines were covid spikevax moderna and fluzone quad -  I don't know which was administered 2nd - both were in a similar location.
The MA asked the questions about allergies and past vaccine reactions (I have never had a reaction to any vaccine, including past flu shots). The MA administered the injection and it felt strange. It didn't hurt, I felt a sensation that made me think that the fluid from the vaccine was pooling into my skin. When she pulled out the needle there was blood dripping down my arm (I have never bled from a vaccine before.) The MA apologized numerous times. In the next fifteen seconds the injection site swelled up into a lump that was at least 2 inches in height. The MA looked afraid, apologized more and said "I have never seen this before. I am going to get a nurse." The nurse came in and said she had never seen it before either so they got the doctor who said that she never has seen it before either. She asked me if I was having symptoms of anaphylaxis, which I was not. The MA explained ?I asked all the questions, I administered it like this, I pinched the skin like this?? and demonstrated to the doctor, who didn?t reply. The doctor said that she wanted me to sit for fifteen minutes to assure I am okay. The MA sat with me and apologized over and over again. The nurse got me an ice pack and the MA and nurse struggled to activate it by squeezing it, then handed it to me with a towel that made it so I couldn?t feel the cold. I took off the towel and put it on the lump. They didn?t bandage the injection site. I was in such a panic that I didn?t realize I was using an unsanitized ice pack on an open wound until I got home. The swelling had reached maximum at around 3 minutes after the injection, then started going down. After 15 minutes the swelling had reduced substantially, but was still swollen. They still looked panicked when I was leaving. I said that I?m going home to my mom who is an RN and that I have an epi pen which made their faces look relieved. I got home and my mom was horrified as she administers flu shots all the time with no reaction like that, ever. My mom thinks that MA didn?t administer it correctly, possibly it wasn?t given deep enough so it was into the subcutaneous fat or that it was in the wrong place on my arm which caused the bleeding. I feel like they were trying to hide that the MA made a mistake and it was not just a bad reaction to the vaccine. The MA apologized over and over again, probably ten times. The notes of my visit say that I had a reaction to the vaccine. I worry that it was administered incorrectly and they aren?t going to report the mistake, that?s why I feel it?s necessary for me to make the report. I still had noticeable swelling the next day, very sore arm and a bruise around the injection site. Three days after the injection there is less swelling around the injection site, but still can feel a slight bump and the bruise is beginning to fade.
I have developed a large reddened area at the site of injection. It is warm to the touch and extremely itchy. The pruritis is extreme. It has tripled in size and hardness in 24hrs
Patient fainted for less than a minute, about 7-8 mins after receiving the vaccine. Patient was conscious right after and said she was fine, except felt dizzy. Paramedics evaluated patient and found vitals to be normal but blood glucose low.
Approximately 3 hours after recieving second dose, patient was brought to infirmary with complaints of headache, syncope, sore throat, and body aches. Patient was reffered to provider and symptom management was provided (tylenol).
This is in follow-up to report(s) previously submitted on 10/10/2006. Information has been received from a certified medical assistant (CMA) concerning a 6-month-old male patient who on 28 August 2006 was vaccinated PO with the first 2.0 mL dose of ROTATEQ (Lot #654664/0726F).  It was unknown if medical attention was sought an no adverse event was reported.  The patient did not have any symptoms.  Additional information has been requested.
Oval shaped rash with itching and a knot at the injection site.  Showed while in office but did not say it bothered her.  Did not mention any treatment just wanted to let us know.  Rash was still present and pt did not seek care for this.  She had a lab appointment and wanted to let us know.
swollen armpit; armpit was swollen; had swelling under his arm; felt soreness in his injection arm; had a cold sore on his lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Aug2021 16:30 (Lot number: FD8448) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "Covid-19", start date: May2021, stop date: May2021, notes: Patient reports he did get COVID about three months ago so he was told he had to wait, so that is the reason he waited to get the shot. Concomitant medication(s) included: CANDESARTAN HCT taken for hypertension (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Aug2021, outcome "unknown", described as "felt soreness in his injection arm"; SWELLING (non-serious) with onset 24Aug2021, outcome "recovered" (31Aug2021), described as "swollen armpit"; LYMPHADENOPATHY (non-serious) with onset 24Aug2021, outcome "recovered" (31Aug2021), described as "armpit was swollen"; PERIPHERAL SWELLING (non-serious) with onset 24Aug2021, outcome "recovered" (31Aug2021), described as "had swelling under his arm"; CHEILITIS (non-serious) with onset 22Aug2021, outcome "recovering", described as "had a cold sore on his lip". The events "swollen armpit", "armpit was swollen" and "had swelling under his arm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of swelling, lymphadenopathy, peripheral swelling, cheilitis.  Additional information included: Caller was calling on behalf of her father who received his first Comirnaty vaccine dose on Sunday, 22Aug2021. The following day on Monday he felt soreness in his injection arm and the day after on Tuesday he experienced a swollen armpit. The swelling resolved after 1 week. The arm in which he received the vaccine he had swelling under his arm; in the armpit area so that he couldn't put his arm down and he had a cold sore on his lip in the week of vaccination. Caller stated he bought some Abreva to put on his cold sore and it has improved. His arm was back to normal now and the cold sore was almost gone. He went to his PCP who recommended he call Pfizer. He wanted to know if it was safe to get his second dose of the vaccine after having this adverse reaction.   No follow-up attempts are possible. No further information is expected.
Radiating soreness/numbness (whole left arm/injection arm), neck/spine pain (similar to arm soreness) but 'pricklier',  traveling pain/soreness (effected right arm), night sweats, dry throat, 'frog' in throat, sneezing, runny nose, stomach discomfort
2-3 min p/vax pt became very gray & limp; Began breathing p/pt was laid down on back; sent to ER for 02 & work up-subsequently adm for observation; dx hyporesponsive, vasoresponse w/cyanosis & pale color;
significant supraclavicular adenopathy on left/virchow's nodes became very inflammed/nodes were very large, tender and multiple in nature; This is a spontaneous report from a contactable physician. A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL3249, intramuscular at left arm on 19Jan2021 17:00 at a single dose for COVID-19 immunization. Medical history included asthma and allergies with sulfa. Concomitant medication included levothyroxine. Historical vaccine included BNT162B2 on 30Dec2020 for COVID-19 immunization. The patient is not pregnant. On 20Jan2021, the patient experienced significant supraclavicular adenopathy on left (virchow's nodes became very inflamed). The patient was undergoing testing which included blood work, CT of neck, thorax and abdomen to rule out lymphoma, cancer, but nodes were very large, tender and multiple in nature. Nodes are decreasing in size 6 days out. The outcome of the event was recovering.
10 patients administered vaccine past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided by the reporter.  Date the vial was initially stored in the refrigerator: 26-Oct-2021 The Pharmacist administered some vaccinations from a Moderna Covid-19 vial that had been punctured on 04-NOV-2021 and was past the 12 hour beyond use date. 10 patients received vaccine from that vial.
She could barelypick her arm up and only 90 degrees; Huge red circle around the vaccine site; Arm was stiff; This spontaneous case was received on 20-Apr-2022 from a other non-health professional (consumerr) via Agency (reference number: SEQW22-01266) and concerned a 74-year-old female patient.  The patient's concurrent conditions included scoliosis. The patient's past medical history included a rotator cuff tear after a car accident in 2012, and no surgery was done. The patient's concomitant medication included an unspecified statin, supplements and Norco (fentanyl citrate), all used for an unreported indication.  On 18-Jan-2018, the patient was vaccinated with Fluad TIV (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; anatomical location: arm; dose and route of administration: not reported) for influenza prophylaxis. The batch number reported was 179603 and expiration date was reported as 30-Jun-2018.  On 19-Jan-2018, one day after receiving Fluad TIV, the patient experienced a huge red circle around the vaccine site and her arm was stiff.  On 20-Jan-2018, two days after receiving Fluad TIV, the patient could barely pick her arm up and only 90 degrees.  On an unspecified date, the patient saw an orthopedic physician. The patient tried physical therapy for six months but it did not help.  On an unspecified date, the patient underwent debridement and arthroscopy procedures.  On an unspeciified date, reported as after abot four years, the patient recovered from the events.  The reporter did not provide a causality assessment.  The events of 'stiffness' and 'mobility decreased' were considered to be medically significant by Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 74-year-old patient developed a huge red circle around the vaccine site, arm stiffness, and decreased mobility (reportedly, the patient could barelypick arm up and only 90 degrees) within two days after receiving the suspect product Fluad TIV. Underlying medical history of rotator cuff tear contributed to the development of the events arm stiffness and decreased mobility. Nevertheless, causal role of the suspect vaccine is assessed as possibly related for all events, due to chronological plausibility.; Sender's Comments: A 74-year-old patient developed a huge red circle around the vaccine site, arm stiffness, and decreased mobility (reportedly, the patient could barelypick arm up and only 90 degrees) within two days after receiving the suspect product Fluad TIV. Underlying medical history of rotator cuff tear contributed to the development of the events arm stiffness and decreased mobility. Nevertheless, causal role of the suspect vaccine is assessed as possibly related for all events, due to chronological plausibility.
Patient received 1st dose of Moderna COVID vaccine on 03/23/2021. When she woke up the next morning her lymph nodes were swollen and within 3 days she was in the Emergency Room . They did a CT with contrast from the neck up and sent her home with antibiotics. Her lymph nodes and tongue were still swollen so she went back to the ER where they did a CT with contrast from the neck down. Based on their findings they sent her via ambulance to the hospital in  where she was admitted for 6 days and received IV antibiotics. She was released on 4/11/2021 and sent home with Augmentin and a Medrol Dosepak. Patient reported this adverse reaction to the pharmacy on the morning of 4/19/2021.
A nurse reported that on 7/14/00 the patient developed an injection site reaction characterized by redness, swelling, and warmth at the site of Acel-Imune administration. She was seen by the physician and recovered. This is 1 of 3 patients from this facility who experienced this event following receipt of Acel-Imune lot 472-251. The reporter indicated that 7 to 8 patients experienced this event; however, only 3 are presently identifiable.
Information has been received from a registered nurse concerning a 1.2 year old male who on 03/21/1996 was vaccinated with a dose of varicella virus vaccine live. On 02/26/2002, the pt developed chicken pox. On 02/27/2002, the pt was seen in the office. It was reported that the pt had vesicular lesions all over, about 20-30 on trunk and face, that started the day before. Therapy with oral Benadryl was started. It was also noted that the pt received a current vaccination of hep B vaccine recombinant. Additional info has been requested.