chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom called the following day to report vomiting, fever, lack of air, body pain and headache. Mom gave her acetaminophen and the girl improved.
Spoke to patient on 3/25/2013.  She stated that on 11/16/12 she was riding bus home from school and fainted and had a seizure.  Taken to hospital for 3 days of tests which were all normal.  States since 11/12 she has been having silent seizures daily and "mini" mild seizures weekly.  Is non-compliant with medications she was prescribed, but states the seizures are "lighter" with medication.  Also complains of sometimes having blurred vision, bilateral edema and numbness and tingling in arms.
Hospitalization 12/28/21 2nd Pfizer covid shot 3/5/21, EN6205, IM/RD 3rd Pfizer covid shot 9/9/21, FE3592, IM/LD
Tested positive for COVID-19, 3 months after vaccine. Saw doctor and was given codeine cough syrup and ondansetron HCL; benzonatate.
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with GARDASIL 9 (route of administration, lot number and expiry date were not reported). No concomitant therapy was reported. On an unknown date, after receiving Gardasil 9 (confirmed that not GARDASIL), the patients experienced syncope, dizziness, chest pain and/or tachycardia. At the time of the report, the outcome of syncope, tachycardia, dizziness and chest pain was not reported. Relatedness between syncope, tachycardia, dizziness, chest pain and the vaccination with GARDASIL 9 was not reported. Additional information has been requested.
Titers had fallen below protective levels in 7 serotypes; This is a spontaneous report from a contactable physician. This report was received from a Pfizer sales representative via Medical Information Team. A 5-year-old patient of an unspecified gender received the first, second, third and fourth doses of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), all via unspecified routes of administration on unspecified dates of therapy at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The physician stated that the 5-year-old patient had to receive a follow-up dose of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) because after seeing allergy and immunology specialist, was informed by immunologist that titers had fallen below protective levels in 7 serotypes. The outcome of the event was unknown. The information on the batch number has been requested.
Pt with redness, swelling and mild induration extending from upper shoulder to elbow region. Onset of swelling 9/16 in the evening. injection occurred 9/15. Left arm.
Day after injections, tenderness and erythema developed just inferior to injection site; fever of 102F.  Next day developed rigors and presented to ER; redness spreading.  HR 134.  Hospitalist admitted patient to hospital with diagnosis of cellulitis with sepsis for IV Vanco.
Blood pressure spiked; I flush every day; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 60-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), via an unspecified route of administration on 16Mar2021 (at the age of 60-years-old) as dose number unknown, single for covid-19 immunisation. The patient's medical history included rheumatoid arthritis. The patient's concomitant medication(s) included etanercept (ENBREL) and unspecified vitamin supplement. The patient stated on the 16Mar2021 of this month, he got his shot and 2 days after on 18Mar2021 10:00 he got it his blood pressure spiked to 168/105 and he got real flushed and since then his blood pressure has hung in there in the 140's 150's over 80's over 90's. He flush every day and he want to know if there was, he had read out and he cannot see anywhere where it says blood pressure. It could be a side effect. He was kind of concerned with this. Laboratory work: he stated, "Yes, he actually did, just like a month because he goes like every 6 months to go and check his liver function and while on the Enbrel he has to take. He has to do it twice a year, but he did it like a month ago." He stated event started two days later so, it was like 48 hours later almost exact because he had my appointment at 10 and he woke up and he felt flushed and took his blood pressure it was like 160/105. Treatment: he stated, "No, he had called his doctor and they have told me to call you guys to see if there have been any side effects. Really, he has done nothing. He eat clean. He was a vegetarian. So, his blood pressure has always been right around 120's/70's." The patient required physician office visit. The patient not received treatment for the event. The outcome of the events was unknown.   No follow-up attempts are possible; no further information expected.
Starting on 04/17/2022, I developed a severe sore throat to the point I couldn't swallow, eat or talk. I had severe exhaustion and upper respiratory symptoms that were severe. I started running a fever on 04/20/2022 of around 102, and that same day I tested myself at home for COVID and it was positive. I treated the fever with Tylenol. I called the doctor about the sore throat since it was not going away even after 9 days and they told me to wait it out, and to take Advil instead of Tylenol for pain/fever. Developed loss of appetite and nausea later during the episode.
Flu like symptoms, intestinal distress, feeling of light headed, dizziness, cold sweat, weakness.
Hives, itching and SOB started within half an hour and progressed.  Pt was sent to ED.
Pain at injection site, redness and swelling to injection site, fever 102, headache, swelling at injection site.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 3:42 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 3:42 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 42.30 for dose administered on 24-May-2021 at 15:42.  No concomitant medications were reported.  Batch number 026C21A underwent temperature excursion on 24-May-2021 with temperature 35 degrees Fahrenheit between 8AM-9AM. 3 vials of same batch number were moved to fridge on 18-May-2021, moved to clinic on 24-May-2021 and beyond use date for these 3 vials were reported as 17-Jun-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a physician concerning an 18 year old female who on 23-JUN-2008 was vaccinated IM in the arm with the first dose of GARDASIL  vaccine (yeast). On 23-JUN-2008 the patient fainted and fell to ground. On 23-JUN-2008 the patient recovered from fainting. Unknown medical attention was sought. Additional information has been requested.
I experienced extreme chills, body aches, nausea and headache.  The severity resolved  in 48 hours but throughout the week I still felt "off".  My headache persisted for 7 days though.   I treated it with Excedrin migraine and Ibuprofen.
CHIEF COMPLAINT:   90 y/o female presents to ED via EMS s/p fall 30 min PTA c/o left hip pain and right forearm lac. Left hip is externally rotated with shortening. Lac is approx 2 in. Bleeding controlled. Denies LOC. Pt is unsure of why she fell. Denies anticoags.   HISTORY OF PRESENT ILLNESS:     90 years old female brought in for evaluation of a fall and right forearm laceration.  Patient presently not communicating.  But does state does not know why she fell.  As per EMS she was going from bathroom to bed.  No history of loss of consciousness.  Also as per EMS has a skin tear on the right forearm.  No other specific information at this point of time.
Pain in left deltoid muscle. Difficulty lifting with left arm, especially movements that include the deltoid muscle
Patient receive their vaccine on 4/21 at 4:00pm.  The patient was instructed to stay for 30 minutes due to a history of a severe allergic reaction. Around 4:20 the patient started complaining of feeling ?funny and off.?  He was moved from the chair to the floor and his feet were elevated.  Help was requested from providers and MD and NP reported to help.  Patient?s blood pressure and blood sugar were taken and he was given oxygen.  Pt had facial swelling that seemingly got better and then worse.  At that time epinephrine was administered and EMS was called.  Pt was taken to ER for further evaluation.
got COVID; got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunization; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart attack" (unspecified if ongoing), notes: Heart attack; "Congestive heart failure" (unspecified if ongoing), notes: Congestive heart failure; "problems with my bronchial tubes" (unspecified if ongoing); "Diarrhea " (unspecified if ongoing), notes: this medicine they give me diarrhea . The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I got COVID and I get check and they give me the Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient stated, I got the pack yesterday. I got COVID and I get check and they give me the Paxlovid and I took Wednesday, I took it morning and night and today I took it this morning but twice today now the pain in my leg is so bad, I have legs not on the floor, I mean it is killer pain. It is the whole thing from the thigh down to the ankle, it is just I mean it is actual joint pain and it is kind of scares me and I do not know, is that normal. I tell you I have had, a Pfizer is the way I go. I have had Pfizer, all the COVID shot and the booster shot from Pfizer (further clarification unknown hence captured as Unspecified shots). I am on other medication and I have had a heart attack and I have got congestive heart failure and I am having problems with my bronchial tubes. I haven't got bronchitis. I got a disease in the bronchial tubes. And I do have that, this medicine they give me diarrhea but you know what, that does not bother me too much because diarrhea I call mother natures cleanse and I can deal with that. I do not know if it made my blood pressure go up or down, do not know about that.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Received Moderna booster shot and began having pain in right shoulder.  Shoulder pain continued the next two days.  Ran a 10K two days after the booster and noticed slowness in time.  On Monday of the third day, presented at the Emergency Room from pain in right shoulder and difficulty breathing.  Was diagnosed with Pulminory Embolism with pneumonia.
This spontaneous report was received from a healthcare professional referring to an approximately 6 months old patient of unknown gender. Information about the patient's medical history or concurrent conditions were not reported. On 04-AUG-2015, the patient was vaccinated with Hepatitis B vaccine (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided). Other suspect therapies included pneumococcal vaccine (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided); rotavirus vaccine, oral, (manufacturer unknown), (dose, lot # and expiration date were not provided); and DTaP (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided), all vaccinations on the same date. Concomitant medication was not reported. On an unknown date, in 2015, the patient experienced an adverse event, described as "vaccine adverse experience". At the time of reporting, the outcome of vaccine adverse experience was unknown. The causal relationship between the adverse event and the suspect therapies was not reported. Additional information has been requested.
No adverse event; Caller stated an expired vaccine was given.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-APR-2022, the patient was vaccinated with measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5 milliliter (valid lot #T034827, expiration date: 11-APR-2022) (expired product administered) (strength, route of administration, and anatomical location were not provided) as prophylaxis. No adverse event was reported.
Pt received the Menactra vaccine ~ 945am and approx. 2hrs later began complaining of soarness in both arms, legs, abdomen and back. She finds it uncomfortable to move these body parts. No fever, but Dr. said to give Advil 400mg. Pt felt a little better, but not much. She was seen at 330pm the same day for evaluation.
Neck mass; A spontaneous report was received from a health care professional concerning a 76-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced neck mass.   The patient's medical history was not provided by the reporter. No concomitant medications were reported.   On 12 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On the 19 Jan 2021, prior to receiving mRNA-1273, the patient experienced neck mass. Patient was hospitalized from 19 Jan 2021 to 25 Jan 2021.  No treatment details were provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, neck mass, is 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 event, a causal relationship cannot be excluded.
soreness, swelling in the same arm right below the injection site; soreness, swelling in the same arm right below the injection site; He reported having chills; 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 58-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 3, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "soreness, swelling in the same arm right below the injection site"; CHILLS (non-serious), outcome "unknown", described as "He reported having chills".  Additional information: Consumer stated, "I got a question about the Pfizer booster shot (clarified as Pfizer Covid-19 vaccine) number 2. I took the booster shot number 2 which would be my 4th vaccination, I took it at Saturday which would have been the 9th this year.IHe reported having chills, soreness at injection site and swelling underneath the left armpit right below where the hair is in the underarm. He mentioned he read a possible side effect is swelling at the injection site, and wants to know if swelling under the armpit in the same arm the injection was administered has been reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (12Apr2022): This is a Follow-up spontaneous report from a Contactable consumer. Updated information included: New reporter info added, New events added. Patient's age was captured.
02/25/22 presents to ED for "recurring falls". PMHx of "CAD s//p recent stent, dyslipidemia, cardiomyopathy, HTN, CVA, seizure disorder"
The patient did not have any adverse reactions to the vaccine, all that was done was the patient was given 0.3 ml of the covid boost instead of 0.2 ml. Patient did wait the recommended time of 15 minutes in the room with his mother. Patient's mother was notified of this and verbalized understanding and thanked Dr. for letting her know.
12 hours after: high fever (103-104), sweats, sore eyes, fatigue. High fever (over 102-104) lasted for >24h. 3 days after vaccine, I still have a fever (100) and still have a headache
tongue swelled up; severe sore throat; pimples on my tongue; (pimples on my tongue) were painful; pimples on my lips; bone pain; didn't have strength to get up; could not reach for air; don't taste very good the food; little dizzy; forget a few things; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (tongue swelled up), OROPHARYNGEAL PAIN (severe sore throat), TONGUE DISORDER (pimples on my tongue), GLOSSODYNIA ((pimples on my tongue) were painful) and ACNE (pimples on my lips) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, ATORVASTATIN and LISINOPRIL for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (tongue swelled up), OROPHARYNGEAL PAIN (severe sore throat), TONGUE DISORDER (pimples on my tongue), GLOSSODYNIA ((pimples on my tongue) were painful), ACNE (pimples on my lips), BONE PAIN (bone pain), ASTHENIA (didn't have strength to get up), DYSPNOEA (could not reach for air), TASTE DISORDER (don't taste very good the food), DIZZINESS (little dizzy), MEMORY IMPAIRMENT (forget a few things), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (tongue swelled up), OROPHARYNGEAL PAIN (severe sore throat), TONGUE DISORDER (pimples on my tongue), GLOSSODYNIA ((pimples on my tongue) were painful), ACNE (pimples on my lips), BONE PAIN (bone pain), ASTHENIA (didn't have strength to get up), DYSPNOEA (could not reach for air), TASTE DISORDER (don't taste very good the food), DIZZINESS (little dizzy), MEMORY IMPAIRMENT (forget a few things), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medication was provided.
Drug ineffective; She experienced COVID vaccine also states she had a virus with diarrhea, stomach ache, swollen glands, headache, stuffy/runny nose; This is a spontaneous report from a contactable nurse (patient herself). A 71-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown single (at the age of 71-years-old) for COVID-19 immunization. Patient medical history were not reported. The concomitant medications included filgrastim sndz (ZARXIO). Patient reported that she experienced COVID vaccine also states she had a virus with diarrhea, stomach ache, swollen glands, headache, stuffy/runny nose, was off IBRN for one week. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.
uncontrollable shaking brain fog  tremors  Diarrhea bad stomach pain   focal aware seizure
Patient   received the  second booster, but she claimed she hasn't received the first booster. She did not fill out the consent form truthfully.  So she received the fourth dose which she was not suppose to .When processing the form, the error was found.
This is a spontaneous report received from contactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced pain in extremity (arm was super sore), and felt abnormal (fingers felt weird), with outcome of unknown. Additional information: Event took place after vaccination. No follow-up attempts possible. No further information expected.
This spontaneous report was received from registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 07-MAR-2014, the patient was vaccinated with a dose of PEDVAXHIB, 0.5 ml intramuscularly, (lot number and expiration date were not provided), which was exposed to a temperature of 47F for 10 minutes. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.