chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Emphysema; His arm "turned black and blue six inches around"; I couldn't sleep; I couldn't eat; headache; fever of 99; threw up a couple times; couldn't stop coughing and was producing phlegm; 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 male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pravastatin (PRAVASTATIN), (Batch/Lot number: unknown) for blood cholesterol. The patient's relevant medical history included: "Cholesterol" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for Immunization, reaction(s): "never reacted to flu vaccines". The following information was reported: EMPHYSEMA (non-serious), outcome "unknown"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "His arm "turned black and blue six inches around""; INSOMNIA (non-serious), outcome "unknown", described as "I couldn't sleep"; DECREASED APPETITE (non-serious), outcome "unknown", described as "I couldn't eat"; HEADACHE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever of 99"; VOMITING (non-serious), outcome "unknown", described as "threw up a couple times"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "couldn't stop coughing and was producing phlegm". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for pravastatin was unknown. Therapeutic measures were taken as a result of emphysema.  Additional information: The patient was not allergic to anything. The patient mentioned that he had a bad reaction to the medication Prevnar 20 and was asking if he could take a blood test to see how much of the vaccine he received. He's pretty sure the nurse gave him "too much of it since it comes in a vial right". "I had every side effect". It was bad for like two weeks. The patient had emphysema and used an inhaler. "Do you think it mixed with that inhaler I'm taking? Atmosphere HFA Aerosole inhaler." He also wondered if his reaction was from the pravastatin he took for cholesterol.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Rash, blotchy skin.  Appeared first on legs, extended to neck, chest area.  Rapid heart beat started 4/20/2021, headaches
Information has been received from a pharmacist concerning a female (age unknown) who was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed high blood pressure 7 to 10 days after receiving vaccination.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint.  Additional information has been requested.
Patient called and reported swelling and oozing at injection site and tongue and throat swelling 24 hours after vaccine. She called PCP and was told to take Zertec, Benadryl and a script for Keflex was given.
Headache, NauseaVomiting, H/A nausea chills Narrative:
Pt was given 5-11 yr covid vaccine instead of 12 and up covid vaccine
Irritability x 2 weeks doesn't sleep for any length of time. Very restless and fussy". He doesn't act like himself". Rash-individual red spots on buttocks and upper thigh and abdomen. Like chicken pox but are not fluid filled. Had vaccines 6/4. Rash began 6/8. Still visible on 6/21.
The left side of her jaw, lip, shoulder where she got the shot, and tip of tongue went numb; The left side of her jaw, lip, shoulder where she got the shot, and tip of tongue went numb; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced left side of her jaw, lip, shoulder where she got the shot, and tip of tongue went numb. Patient stated that after receiving the first dose, her tongue became a little tight underneath and then the tip of her tongue went numb like somebody gave her Novocain, going into her jaw and into the side of her jaw. Patient also reported that this numbness went a little bit down into the same arm that she received her injection. Patient stated that this lasted strongly for about an hour or 45 minutes and then reports still having some numbness in the jaw. She stated took Benadryl and went to bed. Patient stated that on 05Mar2021 the feeling was just in one little spot on her jaw, not the whole jaw, and states it feels like when the Novocain was going out of your mouth. Patient would like to know if it was safe for her to receive the second dose of the vaccine. Patient stated that she has already spoken to her nurse practitioner about this but states that he/she does not actually believe in getting the vaccine and recommended the patient not take it. Patient also reports that in the past she received injections of a prednisone or cortisone type material in her neck and lower back and with one of those injections experienced throat swelling, couldn't hardly talk, retaining fluids really badly and had to go to the emergency room. Patient would like to know if any of these injections contain the same ingredients as the Pfizer BioNTech COVID-19 vaccine, specifically polyethylene glycol. Patient was concerned that she may need allergy testing done before the administration of her second dose of the vaccine. She has a question. She got her first Pfizer COVID immunization. The left side of her jaw, lip, shoulder where she got the shot, and tip of tongue went numb. Has Pfizer seen others have this. It was like the tongue got tight underneath then it felt like the tip of her tongue was numb. Then it was the bottom lip, chin, jaw, and into the shoulder where the vaccine was given. She reported it online through V-safe already. Reference Number: She just got an email from all true and it asked if she had any symptoms. She put that down, but otherwise she felt good. It started 14 minutes after the shot. She had since left and drove home. The patient was treated for the events with Benadryl. The events were considered as non-serious by the reporter. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Dizzy; Unsteady on her feet; Chills/ Chilling badly; Had temperature of 102.2 degree Fahrenheit; Cold; Could not wake up/ Wanted to sleep all day; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, NASOPHARYNGITIS, HYPERSOMNIA, GAIT DISTURBANCE, and CHILLS in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Breast cancer (left breast). Concomitant products included TAMOXIFEN for Cancer, METFORMIN for Diabetes, METOPROLOL for Tachycardia, SIMVASTATIN for an unknown indication.    On 12-Aug-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced NASOPHARYNGITIS, HYPERSOMNIA, and CHILLS. 13-Aug-2021, the patient experienced PYREXIA. On an unknown date, the patient experienced DIZZINESS and GAIT DISTURBANCE. At the time of the report, DIZZINESS, NASOPHARYNGITIS, HYPERSOMNIA, GAIT DISTURBANCE, CHILLS, and PYREXIA outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, Body temperature: high 102.2 degree F in the evening and later decreased to 101.2 degree F. On 15-Aug-2021, Body temperature: (normal) 97.4 degree F. On 16-Aug-2021, Body temperature: (normal) 99.1 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No treatment medication information was provided. Concomitant medication included diuretic every few days. Historical vaccine included shingles vaccine.
Fatigue, muscle and back ache, some what swollen glands.  Slight temperature.  This went on thru the course of the day.  I took ibuprofen that night and woke up feeling fine.
Patient received HPV #3 on 07/13/09. No immediate adverse events noted. Patient presented to ER on 08/01/09 with syncope and again on 08/24/09 with possible seizures.   9/3/09-records received for follow-up visit 3/23/09-school physical-no complaints-Rash on face. Seb. Dermatitis. ED visit 8/1/09-and 8/24/09 for syncopal episode after getting out of hottub, flushing, lightheadedness and palpitations. Admitted for 3 days and to follow up with neurologist. Family HX of seizure disorder.   10/5/09 Hospital records and DC summary received, service dates 8/1/09 to 8/4/09. Assessment: Status post fall with questionable loss on consciousness.  Patient found by family face down after falling in bathtub with almost 1 foot of water. Some amnesia and questionable loss of consciousness.. No apparent injuries or acute injuries. No deformities of extremities.
Pt recvd vax & devel HIB infect; exp felt to be life threatening; addtl details are being requested;
Took the 1st shot Thurs. Feb 25, no effects, 21 days later took 2nd shot on Thursday 3/18/21. That night my arm was sore, came down with aches, headache, tiredness, then chills, fever, weakness, dry heaves, light headedness but did not passout.  Stayed in bed for two days, Friday n Saturday. Got up Sunday layed around all day. Got up Monday, Tuesday and today, Wednesday the 24th with headache and feelilng blah, no energy. Vaccine site still slightly sore and itches too. still not feeling myself, today is Wed. Mar 24.  May not have any bearing on vaccine but too much of a coincidence.
This is a spontaneous report received 03-MAY-2017 from a nurse who reported on a 13-year-old male who received his first dose of GARDASIL 9 on 29-JUL-2015 (lot and expiration unknown). The reporter stated that the patient received a second dose of  GARDASIL 9 (lot M009378, exp. 23-APR-2018) on 04-AUG-2016. No side effects were reported. No treatment was given. Outcome and causality were not reported. Additional information has been requested.
physicians ordered fluzone high dose QIV for both patients and the nurse accidentally pulled and administered vaxelis with no reported adverse event; Initial information was received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 76 years old male patient who was reported with physicians ordered influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] for both patients and the nurse accidentally pulled and administered vaxelis with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Nov-2022, the patient received suspect influenza quadrival a-b high dose hv vaccine lot number not reported via unknown route in unknown administration site (strength, form, dosage, frequency, expiry date: unknown) for Immunization.  On 07-Nov-2022 the patient reported a non-serious event of physicians ordered influenza quadrival a-b high dose hv vaccine for both patients and the nurse accidentally pulled and administered vaxelis with no reported adverse event (wrong product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Swelling in left thigh over 2 day period. Warm, pain and tenderness. 5 - 6cm swelling.
I had my vaccination on 09/10/2022. On 12/13/2022 I woke up feeling congested and I had sinus drainage to back of my throat. A couple days later I developed a cough. I went to the doctors who stated nothing was wrong and sent me home.
This spontaneous report as received from a health worker (medical assistant) refers to an 11 weeks old female patient with no drug allergy. The patient has had a swallowing problem since the patient was born at 34 weeks and had a G tube prior to the first dose of ROTATEQ. The patient also had a diagnosis of failure to thrive. On 28-JUN-2012, the patient was vaccinated with the first dose of 2 ml ROTATEQ (lot# reported as 1692AA, exp 06/27/2013) orally and was choking. No other co-suspects were reported. There were no concomitant medications. The patient's mother had to suction for treatment. The ROTATEQ was discontinued. The patient had sought medical attention as she was in the office. No laboratory information performed. The outcome was reported as recovered on 28-JUN-2012. Choking was considered as life threatening by the reporting medical assistant. Additional information has been requested.
flu like symptoms / and mild ones; feeling sick / symptoms were so bad / almost goes to an emergency room; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms and feeling unwell were unknown.   It was unknown if the reporter considered the influenza-like symptoms and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported the paient had sever flu like symptoms for a few days and mild ones for another few days. The patient stated that she woke up in the middle of the night felt sick for a few days and the symptoms were so bad she almost goes to an emergency room.   The reporter was not sure when the patient received the vaccine or when the symptoms started and could not find the details for the adverse event report.      The reporter consented to follow up.
Initial report was received from a healthcare professional on 29 October 2012. An 81-year-old female patient had received an intramuscular injection in the right deltoid of FLUZONE, lot number UH729AB, on 23 October 2012 and the same day experienced erythema, pain, blistering, and warmth at the injection site. The patient was evaluated on 23 October 2012 and 24 October 2012 and prescribed BACTRIM DS and prednisone for possible cellulitis. No culture performed to determine bacterial cause of possible cellulitis. The patient had an allergy to amoxicillin and a history of atrial fibrillation and breast cancer in 1997 with lymph node removal and right side lumpectomy. The patient was no acutely ill at the time of vaccination. The patient's outcome was not reported. Documents held by sender: None.
Caller stated that 12/15/20 had pain in the vaccination area , headache and exhaustion that  lasted about 24hours
When reconstituting the Pfizer COVID19 vaccine, an erro was made but not discovered until 3 doses (0.3ml ea) had been give.  There were only 3+ doses in the vial. Upon review it appears that only 1ml NaCl solution had been used to dilute.
Patient reported severe weakness in both arms and both legs for 3 days following the influenza vaccine. He stated he required help from family members to stand up and was unable to stand or walk for as long a period as normal.
Nauseous; This is a spontaneous report from a contactable consumer (reported for herself).   A female patient of an unspecified age received first dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of administration on 24Jul2021, as DOSE 1, SINGLE for Covid-19 immunization. Medical history and concomitant medications were not provided. It was stated that had she received first shot a day prior to this report (reported as yesterday), her first vaccine and then she fell asleep and she woke up and she was hungry and tried to eat something. She felt nauseous, it made her nauseous and, what else. That's it, now she wanted to know if this was, because that's one of the symptoms that's on the papers that they gave. The patient stated, "was there something for her to worry about". The outcome of the event was unknown.   The lot number for the vaccine was not provided and would be requested during follow up.
Immediate vomiting after dose was given, intermittent vomiting for 24 hours after dose given.
No further AE; Temperature: 70F; This spontaneous report was received from a pharmacist and a nurse, referred to a 5-year-old patient of unknown gender. Information about the patient's pertinent medical history, concomitant medications and drug reactions/allergies was not provided.  On 02-MAR-2023, doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot# W025273, expiration date: 10-AUG-2024) experienced a temperature excursion of 70 Fahrenheit (F) for 9 minutes with no previous temperature excursion. It was not known if digital data logger was involved. On 06-JUN-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml/once, administered for prophylaxis (lot# W025273, expiration date: 10-AUG-2024; strength, anatomical location, and route of administration were not provided) (Product storage error). No symptoms reported. No further adverse event (AE) details and no product quality complaints (PQCs) were reported.  This case is one of multiple reports from the same reporter.
Erythema and warmth 2-3cm distal to site of injection noticed 1 day after injection. Area of erythema and warmth spread around arm by day#2. No systemic signs/symptoms. Site is painful to touch.  Site is indurated and warm but not fluctuant.
TEMPORARY REACTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested. No concomitant medications were reported. On an unspecified date, the subject experienced temporary reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temporary reaction. This report was non-serious.
fatigue/tired; weakness; numbness/feels numbness in her arms, in her shoulders even while sitting, sleeping, even when she wakes up; shortness of breath; low fevers; miserable condition; permanent headaches; pain; This is a spontaneous report from a contactable consumer (patient husband). A consumer (patient husband) reported for patient (wife) that: A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration, administered in Arm Left on 07Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administered in Arm Left on 20May2021 as single dose for covid-19 immunisation and experienced the events Headache, fever, shortness of breath, pain in the arms and shoulder, numbness and weakness. Reporter stated, we both had our both doses, my wife took her second dose was on 07Jun2021 and on 10Jun2021 both of us especially my wife has been going through a lot of fatigue, weakness, numbness, I mean shortness of breath, everything that is possible is going on with her, I mean heart beat and I mean she feels numbness in her arms, in her shoulders even while sitting, sleeping, even when she wakes up she is tired, going to bed she is tired, during the day especially after, in the afternoon. As far as I remember almost every day, we have been getting temperatures. We have like low fevers and especially her she is in kind of miserable condition because of shortness of breath. We take some stairs up to our apartment and she has to sit down for like 5 minutes to catch up her breath and pain, she has permanent headaches almost for the past two weeks. Specially After the second dose she is experiencing a very bad kind of reactions. Reporter stated his wife especially after second dose it has been since 10Jun2021 and ever since that day. I mean her condition is, and she is experiencing the same kind of symptoms every day. Therapeutic measures were taken as a result of the events with Ibuprofen. The outcome of the events was reported as not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Fever, 99.8-101.5. Starting 06/07/2014: rash covering body.
Information has been received from a consumer concerning her 19 month old son who on 01-DEC-2009 was vaccinated with his first dose of oral ROTATEQ (lot # not given) despite being past the indicated age.  Follow up information received from physician indicating that the patient had no adverse effect.  No further information is available.
tight leg cramps - both right and left thighs. started day 3 of treatment. has occurred 3 times. takes about 20 minutes to walk it off.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (tight leg cramps - both right and left thighs. started day 3 of treatment. has occurred 3 times. takes about 20 minutes to walk it off.) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 treatment.    The patient's past medical history included Cardiac arrhythmia. Concomitant products included ATENOLOL from 01-May-2022 to 23-May-2022 for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 22-May-2022 at 9:15 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCLE SPASMS (tight leg cramps - both right and left thighs. started day 3 of treatment. has occurred 3 times. takes about 20 minutes to walk it off.). At the time of the report, MUSCLE SPASMS (tight leg cramps - both right and left thighs. started day 3 of treatment. has occurred 3 times. takes about 20 minutes to walk it off.) outcome was unknown.            The patient had no known allergies.  The patient experienced tight leg cramps in both right and left thighs. It started day 3 of treatment and had occurred 3 times. It took about 20 minutes to walk it off.  The device date was reported as 23-May-2022.