chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Now throat feels kind of enlarged; It is hard to talk; Started feeling that something was wrong with tongue/It was larger on one side than the other; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Started feeling that something was wrong with tongue/It was larger on one side than the other), PHARYNGEAL SWELLING (Now throat feels kind of enlarged) and SPEECH DISORDER (It is hard to talk) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0341-214) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced SWOLLEN TONGUE (Started feeling that something was wrong with tongue/It was larger on one side than the other). On 18-Nov-2021, the patient experienced PHARYNGEAL SWELLING (Now throat feels kind of enlarged) and SPEECH DISORDER (It is hard to talk). At the time of the report, SWOLLEN TONGUE (Started feeling that something was wrong with tongue/It was larger on one side than the other) was resolving and PHARYNGEAL SWELLING (Now throat feels kind of enlarged) and SPEECH DISORDER (It is hard to talk) outcome was unknown.            Relevant concomitant medications were not reported. Treatment information was not provided.  Company comments include This case concerns a 83-year-old female patient, with no relevant medical history, who experienced the non-serious, unexpected events swollen tongue,  pharyngeal swelling, and speech disorder. The events occurred  two days after third dose of mRNA 1273 vaccine. The patient felt her tongue was larger on one side, and throat was enlarged so patient had difficulty speaking. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 83-year-old female patient, with no relevant medical history, who experienced the non-serious, unexpected events swollen tongue,  pharyngeal swelling, and speech disorder. The events occurred  two days after third dose of mRNA 1273 vaccine. The patient felt her tongue was larger on one side, and throat was enlarged so patient had difficulty speaking. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
No adverse effects reported; a female patient was administered a M-M-R II vaccine by intramuscular rather than subcutaneous route; This spontaneous report was received from a registered pharmacist referring to a  28 years old female patient. No information was provided regarding patient's medical history, current conditions, drug reactions or allergies.  On 16-APR-2019,  the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) intramuscularly rather than the subcutaneous route (incorrect route of product administration) for prophylaxis (strength, dose, dose number and frequency was not reported). The suspect vaccine was reconstituted with a properly stored sterile diluent.   Lot No. R031681 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported as 01-APR-2020, but upon internal validation established as 01-NOV-2020.
A non-serious report of fever and sore throat has been received from a consumer concerning a 40 month old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 06-Oct-2009. The patient received a total of one dose before onset of the event given on 06-Oct-2009 at 5:00 pm. On 09-Oct-2009, in the morning, she experienced fever of 100.5 and a sore throat. The outcome of the events of fever and sore throat were unknown.
This spontaneous report was received from medical assistant refers to an unspecified patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 14-MAR-2016, patient was inadvertently administered with GARDASIL, that had been improperly stored, lot # K010215 (expiry date: 05-MAY-2017), orally (dosage not reported). The vaccine was stored at a temperature of 30.2F and time frame: cumulative time of 132 hours. No previous temperature excursion was reported. No adverse effects reported. No product quality complaint (PQC) involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a physician, via a sales representative, and described the occurrence of swelling injection site in a 22-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline).  On 20 August 2012 in the "pm", the subject received 3rd dose of CERVARIX .5 ml, unknown route, right arm). On 20 August 2012 in the "pm", less than one day after vaccination with CERVARIX, the subject experienced swelling injection site and injection site redness. The swelling at vaccination site was "the size of a golf ball". At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 18 September 2012 via healthcare professional who provided no additional information.
This case was reported by a physician and described the occurrence of swelling injection site in a 5-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included VARIVAX (Merck); unknown; unknown given on 21 April 2010. On 21 April 2010 at 11:30 the subject received 5th dose of KINRIX (.5 ml, unknown, right arm). On an unspecified date in April 2010, approximately 24 to 36 hours after vaccination with KINRIX, the subject experienced swelling injection site and injection site redness. After approximately 48 hours the events worsened and the subject also experienced "rubbery" at injection site (rubbery feeling in muscle). The physician reported a local reaction of swelling and redness that started approximately 24-36 hours following administration of KINRIX and became worse at 48 hours. At 48 hours the subject now had enlarged, swollen, rubbery but not indurated at the injection site. Varicella vaccine was administered at a different site and was not considered co-suspect. At the time of reporting the swelling injection site, injection site redness and rubbery at injection site were worse. Follow-up received from reporting physician on 10 May 2010: The events resolved on an unspecified date. The physician considered the events were non-serious.
fell asleep p/shots for 1 1/2 hrs; woke up & was shaking head & kicking feet; moving w/o any purpose; lasted for 2 hrs;
experienced a headache yesterday; 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. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. Relevant medical history included: "Headache" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "experienced a headache yesterday". Therapeutic measures were taken as a result of headache.  Additional information: Caller mentioned that he received the 1st dose of the Pfizer Covid19 vaccine and is due for his 2nd dose on Monday in the morning. He is asking if he can take pain medications, specifically Ibuprofen, as he gets headaches once or twice a month. He mentioned that it is unrelated to the vaccine, as it usually happens to him during his lifetime, but he experienced a headache yesterday. With Ibuprofen, the headaches would usually go away in 30 minutes to 1 hour and now wants to know if he can take Tylenol before getting the second dose. He is asking because he does not want to "mess up" his vaccination. Caller also taking cholesterol meds, Lipitor. Is it okay to take it? Would that affect the vaccine? Caller mentioned that he plans to stop it for a week as he did before while on vacation and nothing happened.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
22 month old female received DTaP on 12/12/2006 at the clinic. Mother noticed child developed a large erythematous and indurated area on the left thigh associated with slight reduction in appetite over the past 1-2 days.
Started with Allergies that developed into a sinus infection and bronchitis.  Was put on Amoxicillin and BEnzonatate for cough.  The sinus infection seems to have cleared up but still have an ongoing cough and congestion from Allergies.
Small blisters in mouth along with pain in jaw and severe headache on left side began approximately 1 hour after taking the vaccine.  Arm sore, headache and pain continues on left side of neck and jaw on the left side along with feeling fatigue.  Took ibuprofen 800 for pain and L-lysine for mouth sores.
COVID-19 vaccine breakthrough. Dose 1: 3/23/2021; 002B21A. Dose 2:  5/3/2021; 002C21A.
Started out with expected soreness.  3 weeks later I have limited movement and it hurts to put weight on that elbow.
(R) arm swelling and tenderness from mid upper arm to hand began 2 days after vaccine, no rash. Recommended ibuprofen, cold compress and update in AM.
Pt given HIB, PREVNAR, PEDIANX, ROTATEQ, influenza @ 13:35.  At 13:46 someone in waiting room said, "that baby's face doesn't look right."  Went to waiting room.  Mom holding infant, infant crying, hives noted on entire face and head.  Mom carried baby to exam room.  Trunks rash; hands, arms, legs, feet bilat right swollen.  Adv mom on potential  reaction.  Infant given 0.1cc BENADRY im @ 13:47.  LP-120 crying no wheezing.  13:53 R-45 hives on forehead only, blow by O2 admin. @ 13:49 P-148, hives on forehead, crying, no wheezing.  EMS arrival 13:52.  Pt to ER via EMS @ 13:55 with mom carrying infant.
Patient was double vaccinated, and triple boosted. She has no risk factors. 3-4 days after attending a class reunion, Patient contracted a moderate case of Covid infection. The symptoms include sudden moderate to severe fatigue and lack of appetite and thirst. She was positive via covid home test for 10 days. She still has significant fatigue. Pulse Ox was always good 95 to 100 and she had little or no fever.
This case was reported by a pharmacist via sales rep and described the occurrence of cold symptoms in a 60-year-old female patient who received SHINGRIX. On 3rd February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cold symptoms and muscle pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the cold symptoms and muscle pain were recovered/resolved. The reporter considered the cold symptoms and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in an unknown deltoid. The patient experienced cold like symptoms and muscle aches. The symptoms lasted for approximately about 2 weeks. All questions were asked but the reporter provided limited information. For tolerability after 2nd dose of SHINGRIX, refer case US2018GSK080935.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Flu Seasonal QIV Dresden. Previously administered products included Flu vaccine with an associated reaction of injection site pain (patient had gotten the flu vaccine every year for the past nine years). On an unknown date, the patient received Influenza quadrivalent vaccine unspecified 2013-2014 season. On an unknown date, less than a year after receiving Influenza quadrivalent vaccine unspecified 2013-2014 season, the patient experienced injection site pain. Rechallenge with Influenza quadrivalent vaccine unspecified 2013-2014 season was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza quadrivalent vaccine unspecified 2013-2014 season. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported that she has gotten the flu vaccine every year for the past nine years and it usually hurts a little at the injection site, but resolved after a couple days. This was 5 of the 9 cases reported by the same reporter for the same patient.
Enlarged lymph nodes in armpit on right side. Enlarged and painful lymph nodes above collar bone and neck. Swelling and pain to right arm to shoulder blade area.
hallucination; restlessness; sleepiness during the day; trembling; mumbling words in his sleep; weak; tiredness; chills; A spontaneous report was received from a male patient (unspecified age) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hallucination, tiredness, restlessness, chills, not feeling good, sleepiness in the morning, trembling, mumbling words in his sleep and weak.  The patient's medical history included drug allergy to versed anesthesia during cataract surgery. No relevant concomitant medications were reported.  On 26 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On 23 Feb 2021, prior to the onset of the events the patient received the second of two planned doses of mRNA-1273 (lot/batch: 022M20A) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, after receiving the second dose the patient experienced restlessness, chills, tiredness, hallucination, not feeling good, sleepiness during the day, trembling, mumbling words in his sleep and weak. The patient had been to the emergency room and they could not find anything wrong. The patient reported that he thought as he was allergic to Versed (midazolam) anesthesia which he took some years back during cataract surgery similarly now he had reaction to vaccine.  Treatment information was not reported.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, hallucination, tiredness, restlessness, chills, not feeling good, sleepiness in the morning, trembling, mumbling words in his sleep and weak was unknown.; 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.
Rapid heart beat, shortness of breath and breathlessness. Reported feeling like he had run over the stairs but had been in bed for 45 mins and was lying down at the time. Lasted several hours.  Had one episode of rapid heart beat again early the next morning but nothing after that.  Was 5 hours after his second dose of Pfizer vaccine. (His first dose was 5 weeks prior)
Nausea, cramping, soreness all over my body, headache, chills and fever.  These have lasted so far for 10 hours.
injection site, the area is still swollen; injection site, the area is still swollen and there is a knot around 2-3 inches; chills; fever; sore muscles; lack of energy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-024493 (Moderna).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Covid 19" (unspecified if ongoing), notes: had prior to getting the 1st dose and stayed at home, mild symptoms. Concomitant medication(s) included: AMLODIPINE taken for coronary artery disease; ATORVASTATIN taken for blood cholesterol; BABY ASPIRIN; MAGNESIUM; ZINC; VIT D [COLECALCIFEROL]. Vaccination history included: moderna (DOSE 1), administration date: 20Feb2021, for COVID-19 Immunization, reaction(s): "chills", "fever", "sore muscle", "lack of energy"; coviD-19 vaccine (DOSE 2), administration date: 20Mar2021, for COVID-19 Immunization, reaction(s): "chills", "fever", "sore muscle", "lack of energy". The following information was reported: CHILLS (non-serious) with onset 02Sep2021, outcome "recovered" (05Sep2021); PYREXIA (non-serious) with onset 02Sep2021, outcome "recovered" (05Sep2021), described as "fever"; ASTHENIA (non-serious) with onset 02Sep2021, outcome "recovered" (05Sep2021), described as "lack of energy"; MYALGIA (non-serious) with onset 02Sep2021, outcome "recovered" (05Sep2021), described as "sore muscles"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "injection site, the area is still swollen"; VACCINATION SITE MASS (non-serious), outcome "unknown", described as "injection site, the area is still swollen and there is a knot around 2-3 inches". The events "chills", "fever", "sore muscles", "lack of energy", "injection site, the area is still swollen" and "injection site, the area is still swollen and there is a knot around 2-3 inches" required physician office visit.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
tested positive; tested positive; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse reported similar events for 3 patients. This is the second of 3 reports.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not provided) via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had tested positive on an unspecified date in Jan2021, after the first dose of the vaccine was given. The second dose was set up and the patient would be off of the 14-day quarantine by then, but the reporter was not sure if the people was eligible to get the second dose. The outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021058398 same reporter/vaccine/AE and different patients.;US-PFIZER INC-2021058679 same reporter/vaccine/AE and different patients.
I had an asthma attack at work. I felt nausea.  I checked into a Medical Center ER  when I was having the attack and I couldn't control my breathing body aches  - and they gave me anti-nausea medicine. A few days after that I was non stop throwing up -  I couldn't get out of bed. I was still having intermittent vomiting - about once a week - and I'd have to take off work. This kept happening up until about a month ago (with the vomiting).  It was horrible. I had headaches, too - they weren't major but were bothersome - I had them for about three weeks and then they went away.  A couple of weeks later - I was still throwing up and I went to ER - but I don't remember the date of second visit - they gave me IV and Zofran. I had stomach pain from the vomiting.  I was admitted into hospital last week - the 18th and was discharged the next evening. I was using inhaler every day for two times a day. They dosed me with a lot of antibiotics  - IV antibiotics and also Steroids - Zumatrol and they sent me home with doxycycline HIC 100 mg and those were for 10 days; twice a day; and I haven't been needing my inhaler since last Friday.
Starting 5 minutes after the patient stood up to leave, she reports ears ringing loudly, feeling warm all over, and being very sensitive to light. Symptoms resolved after less than 5 minutes.
On Dec 21st 2021, I started coughing but I did have family members that had been sick with cough and cold. But it got worse the cough as the days went on I started getting laryngitis, runny nose. On Christmas, I went to the hospital, I had a fever and they tested me for covid. The test was negative for Covid, the Flu, Sars. They told me to get over the counter medications that people with high blood pressure could drink. They let me go in the evening. Driving home I started throwing up. I went home and fell asleep all night, was drained and exhausted. The next day I got the medication they told me and made an appointment with my doctor. A week later I went to the Doctor who told me to get over the counter allergy medication and prescribed a nasal spray. The symptoms got better in January but I still had the laryngitis which lasted to the end of January.
Immediately after getting the vaccine, slight soreness in arm, slight increase in fatigue, slight increase in body aches  About 10 hours later, huge increase in body aches/pains. Inability to sleep. Felt suicidal due to pain. Considered going to ER, decided against.  Following day, Horrible stomach pains and nonsolid poops. Period began 1.5 weeks early. Very heavy, bad cramps, worst I've had in adult life, lasted 2 days longer than usual (7 days total). Using the bathroom miserable experience. Lymph nodes swollen, pain (minimal) and swelling at injection site. Body aches reduce to 'mostly bearable, able to sleep.   1 week later, Lymph nodes reduce in size, injection site pain/swelling resolved  To current day, 1 month later: existing pain, fatigue, and brain fog worse than pre-shot. 10% of poops are solid. Stomach pain comes and goes.  I don't know what is wrong with me but whatever it is has has gotten worse since the shot.  I have very little healthcare access.
Rapid heart rate of 160 while resting, tachycardia, myocarditis symptoms, fever, fatigue, brain fog, insomnia
Big red round rash; As if coming down with flu; Very tired; Sore muscles; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Big red round rash), INFLUENZA LIKE ILLNESS (As if coming down with flu), MYALGIA (Sore muscles) and FATIGUE (Very tired) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced MYALGIA (Sore muscles). On 14-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (As if coming down with flu) and FATIGUE (Very tired). On 19-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Big red round rash). On 15-Feb-2021, INFLUENZA LIKE ILLNESS (As if coming down with flu) and FATIGUE (Very tired) had resolved. At the time of the report, RASH ERYTHEMATOUS (Big red round rash) and MYALGIA (Sore muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.