chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body pain/aches; Muscle stiffness; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Aug2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome, asthma, celiac disease and allergies to red food coloring and gluten. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN), nebivolol hydrochloride (BYSTOLIC) and omeprazole (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 13Aug2021, the patient experienced body pain, muscle stiffness and aches. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body pain/aches and muscle stiffness was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tremendous increase in aggression; This spontaneous case was reported by a consumer and describes the occurrence of AGGRESSION (Tremendous increase in aggression) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products RISPERIDONE tablet for Irritability, Aggression and Autism and RISPERIDONE tablet for Irritability, Aggression and Autism.    Concurrent medical conditions included Autism, Intellectual disability, Irritability and Aggression. Concomitant products included CLONAZEPAM for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, RISPERIDONE (Oral) 2 milligram once a day and RISPERIDONE (Oral) .5 milligram once a day. In 2021, the patient experienced AGGRESSION (Tremendous increase in aggression). At the time of the report, AGGRESSION (Tremendous increase in aggression) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that on an unknown date ("for ages"), the patient started treatment with risperidone 2mg and 0.5mg for irritability and aggression related to autism.  On an unknown date, the patient received the COVID-19 vaccine (Moderna).  On an unknown date in 2021, during his last 90-day supply of risperidone, the patient experienced a tremendous increase in aggression, which had increased gradually over time, while taking that specific 90-day supply of risperidone. He reportedly broke furniture and attacked his mother in the car. The patient's mother originally thought the aggression was related to receiving the Moderna COVID-19 vaccine, but eventually she realized it was not likely related. On an unspecified date in 2021, the patient got a new bottle of risperidone 2mg, and within a couple days of taking the new bottle, the patient was back to normal. His mother attributed the increase in aggression specifically to the risperidone 2mg tablets and thought maybe they did not have enough of the active ingredient in them. She spoke with the patient's psychiatrist, but no changes in therapy were made. As of 27-Aug-2021, treatment with risperidone 2mg and 0.5mg was ongoing.
Patient woke up on 11/25/2021 at 5 am to use the bathroom, started feeling numbness in the legs once walking down the stairs and then felt total paralysis which led her to fall down the stairs. She stated that she was shaking and her tongue swelled. This lasted until 12pm that day so 7 hours total and then the feelings subsided and now the patient is feeling perfectly fine with resolution of all symptoms. She has not seen MD yet but will be notifying the MD at her appointment.
This spontaneous report as received from a healthcare worker refers to a 2 year old male patient. On 16-MAY-2014 the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX, lot # unknown, 0.5 ml, subcutaneous. On 28-MAY-2014, the patient was seen in the emergency room (ER) at hospital for a fever of 105F and rash. In the ER the patient was administered ibuprofen, TYLENOL and acyclovir. The outcome of the events was reported as recovered on an unspecified date in 2014. The causality of the events and therapy with (Oka/Merck) VARIVAX was unknown. Additional information has been requested.
Weakness 2 weeks after the 1st dose; Fever 2 weeks after the 1st dose; Nausea 2 weeks after the 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of ASTHENIA (Weakness 2 weeks after the 1st dose), PYREXIA (Fever 2 weeks after the 1st dose) and NAUSEA (Nausea 2 weeks after the 1st dose) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness 2 weeks after the 1st dose), PYREXIA (Fever 2 weeks after the 1st dose) and NAUSEA (Nausea 2 weeks after the 1st dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness 2 weeks after the 1st dose), PYREXIA (Fever 2 weeks after the 1st dose) and NAUSEA (Nausea 2 weeks after the 1st dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Concomitant Medication was added.Event outcome was updated.
how much time he needs to wait to take the 2nd Pfizer COVID 19 booster shot after taking Paxlovid.; how much time he needs to wait to take the 2nd Pfizer COVID 19 booster shot after taking Paxlovid.; 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 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; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "how much time he needs to wait to take the 2nd Pfizer COVID 19 booster shot after taking Paxlovid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Caller would like to know how much time he needs to wait to take the 2nd Pfizer COVID 19 booster shot after taking Paxlovid. consent for report. Caller states he's out of time and out of breath. Wants to know if Pfizer recommends 3 months or 4 months to wait for the COVID-19 Vaccine second booster. Patient states he just wants an answer to his question. there a product complaint to report is Yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
noted to be talking very slow, slurring speech at times; half of her hair was gone and it had become curly when it was always straight; sore shoulder; I had fever of four degrees higher than normally I am. I am lower than normal.; chills; body aches; soreness of the arm; a red bump at the site of injection; This is a spontaneous report from a contactable consumer or other non-HCP. A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ZP7533), intramuscular, administered in Deltoid Right on 29Jun2021 11:30 as DOSE 2, SINGLE (at the age of: 45-year-old) for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE , Solution injection, Lot number/Expiration date: Unknown) for covid-19 immunization and experienced reaction to the first shot: shoulder pain and couldn't sleep on my right side, mouth lost its sense of taste and chest got warm. Medical history included asthma, sleep disorder, gastrointestinal disorder, stress Yes, I have lot of the stress but I have had stress prior to this vaccine.(further not clarified) and I am trying to figure out if anyone has reported hair loss with this vaccine.". Concomitant medication(s) included salbutamol (VENTOLIN [SALBUTAMOL]) taken for asthma, ; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for asthma, ; diazepam (DIAZEPAM) taken for sleep disorder, ; ondansetron (ZOFRAN [ONDANSETRON]) taken for gastrointestinal disorder, ; omeprazole (OMEPRAZOLE) taken for gastrointestinal disorder ; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for asthma. On an unspecified date the patient experienced noted to be talking very slow, slurring speech at times, half of her hair was gone and it had become curly when it was always straight, sore shoulder, she had fever of four degrees higher than normally she is. She is lower than normal, chills, body aches, soreness of the arm, a red bump at the site of injection. The patient underwent lab tests and procedures which included blood test: very high iron level on Jul2021 , body temperature: fever of four degrees higher than normally i am on Jul2021 I am lower than normal. Therapeutic measures were taken as a result, she had fever of four degrees higher than normally she is. The outcome of all events was unknown.
Chills, shaking, chest felt like someone stepping on it, stuffy nose, headache, felt like I was beat up the next morning, fatigue, low grade fever 100F, headache. Very hard to move arm above head the night of vaccine and next day.
Sore Injection Site; Swollen Lymph Node (Left Armpit); Chills; Fever 99F; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore Injection Site), LYMPHADENOPATHY (Swollen Lymph Node (Left Armpit)), CHILLS (Chills), PYREXIA (Fever 99F) and FATIGUE (Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced INJECTION SITE PAIN (Sore Injection Site), LYMPHADENOPATHY (Swollen Lymph Node (Left Armpit)), CHILLS (Chills), PYREXIA (Fever 99F), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Sore Injection Site), LYMPHADENOPATHY (Swollen Lymph Node (Left Armpit)), CHILLS (Chills), PYREXIA (Fever 99F), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter.
Arm:  rash warm to touch, itchy, and sore that has been slowly spreading around my arm and down towards my hand (currently at my elbow) as of 4/10/2021.  Rash appeared on 4/5/2021 with vaccination date of 3/27/2021.
2 inch warm red rash at injection site. Itching, no fever, was sore day of and day after injection and then resolved. On 4/14 itching started and swelling. On 4/15 noticed the warm red raised bump. Dense to the touch.
3-11-21 9AM HAD 'CHEST PAIN, SOB, SORE ARM, MUSCLE ACHES AND FEVER'.  'LUNGS ALSO HURT/PAINFUL TO BREATHE IN'.   3-15-21 11:20AM PT STATES 'FEELS BETTER NOW'. ADVISED TO CALL HEART DR R/T DOSE#2.
Experiencing a worst reaction in my arm; Pain at the injection site, redness and swelling; my arm pain seems to be getting progressively worse; Pain at the injection site, redness and swelling; Pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Aug2021 (Lot number: EW0172) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Experiencing a worst reaction in my arm"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "Pain at the injection site, redness and swelling"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "my arm pain seems to be getting progressively worse"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain at the injection site".  Additional information: It was reported that, the patient had the vaccine on Monday, the first one and it seemed like today, stated that the patient was experiencing a worst reaction in arm and having pain at the injection site, redness and swelling, the size of a cellphone case and there was, it was like painful. Enquired that, was the patient supposed to expect this on the second vaccine. Should the patient not get the second vaccine. Covid-19 Vaccine (manufacturer not clarified, hence is this a Pfizer product tab left unchecked). Stated that, the consumer was informed about Pfizer Medical Information department and further stated, what exactly did their department do. Consumer was informed about the role of Pfizer Drug Safety. Further stated that, was there anything that could be done for the pain or they did not know that either. Consumer was informed that Pfizer medical information was the concerned department for all queries. When probed whether consumer was healthcare professional (Reporter type): Stated as no and the patient work in the medical profession in the business office (not clarified further, hence reporter type captured as Consumer or other non-health professional). Stated that, the consumer didn't know LOT whether the consumer could read her writing. It looks like it was EW0172, that was what it looks like. Stated that, they could calculate age, the consumer just gave birth date. Stated that, the patient had other symptoms but those went away but this was probably the worst and arm pain seemed to be getting progressively worse. Stated that, no treatment because the patient didn't know what to do that was why the patient called this number. Enquired that, are there any other vaccine within 2 weeks prior to the first COVID-19 vaccine, the consumer stated as no, had not. The consumer was provided with the number of Pfizer Medical Information.  Follow-up attempts are completed. No further information is expected.
Pain at vaccination site. BPs 91/59 (pulse 75); final BP 83/52 (pulse 59).
Received second Moderna vaccine on 4-14-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second Moderna vaccine on 4-14-2021) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01a21a) for COVID-19 vaccination.     The patient's past medical history included Cancer.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second Moderna vaccine on 4-14-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second Moderna vaccine on 4-14-2021) had resolved. Not Provided          no concomitant medicines and treatment information  were provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-076164 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076164:For First dose
p/vax pt exp sore rt arm down to elbow, 3-4 days
This case was reported by a physician via call center representative and described the occurrence of shingles in a adult male patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient developed Shingles 1 week after receiving the 1st dose of SHINGRIX. The health care professional did not have access to further information.
High fever up to 106.2 degrees rectally that occurred Saturday night, 04/07/2007,(about 2.5 days after vaccinations). Vomitted 1 time during 1st night after receiving vaccinations.  Took to ER on Saturday night when fever got so high.  ER docs did thorough exam, including chest film and U/A and found nothing wrong.  Sent home with instructions to give alternating Tylenol and Motrin.  Fever finally got down to 101 rectally after this regimen begun.  Fever did not completely go away until Monday morning at about 3:00.  No residual problems after this.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were not reported. The nurse reported that on 23-OCT-2017 the patient was vaccinated with expired dose of RECOMBIVAX HB (lot # M007763, Expiry date: 15-SEP-2017) for prophylaxis. There was no adverse event reported. There was no product quality compliant involved.
Patient developed a rash on the skin over her entire upper body 2 days after receiving the second dosage of the SHINGRIX vaccine. Patient was recommended an BENADRYL and topical anti-itch medication as needed. Patient was also advised to follow up with primary care provider.
Numbness in left hand, first dosage never had any numbness. 2nd dosage on 3/14/21 @10:35 when my left hand went numb. Had a few of the gentlemen ask if i had any swelling or any other symptoms. If did monitor for 30min to an hour and if any more symptoms popped up or worsen call 911 or go to prompt care or see primarycare doctor
Patient presented to Hospital with an anterior wall myocardial infarction 5 days after second Pfizer COVID19 vaccine. She was fully anticoagulated with Warfarin at the time of presentation. No prior cardiac history. She was treated with primary PCI of the LAD.
Pt reports swelling, achiness, and low grade fever that went away after taking Tylenol.
Got a lump; Turned hot; Really itchy; A spontaneous report was received from a consumer concerning a 35-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a lump/mas, turned hot/skin warm, and really itchy/pruritus.   The patient's medical history was not provided by the reporter. No concomitant medications were reported.  On 04 Jan 2021, prior to the onset of the event, the patient received their doses of mRNA-1273 (Lot number: unknown ) in an unknown route for prophylaxis of COVID-19 infection.   On an unknown date, the patient got a lump, turned hot, really itchy for 3 days.  Treatment for the events included none. No consultation with Healthcare professional done.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events got a lump, turned hot, really itchy were reported to be resolved on an unknown date.; Sender'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.
Eyelid swelling &  LID -petechiae   Diffuse SubeonjuNCTIVAL  HEMORRHAGE   Diffuse FACiAL PLETRORA & SWELLING
Note: Above 2 boxes are estimates.  All I know at the moment is it was August 2008. I can look up date later.  SYMPTOMS: Couldn't move arm for a while.  Entire body (esp left arm, but also the rest of my body) has been experiencing: muscle coordination issues, great muscle fatigue, muscle weakness (including weak grip) persistent trembling, numbness, tingling, and stiffness. Also seem to take longer to recover from minor strains and sprains. Can't work out, can't carry things, can't hold a cup of coffee without spilling, having trouble typing because fine motor activities are too exhausing, can't do a jigsaw puzzle, can't hold hands steady, get tired easily.  Had 3 MRIs, 2 EMGs, 1 SSEP, 1 spinal tap, 1 schimic skin test, 1 chest x-ray, a lot of blood work, been on various meds, seen 2 neurologists (and about to see a 3rd), a rhematologist, physical therapist, acupuncturist, and my primary care doctor.
swelling in (R) deltoid with reddness & heat to the touch. No treatment needed Started Thursday morning, mother states  already looks better today.
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The office manager reported that the patients received unspecified doses of RECOMBIVAX HB (lot # reported as L042470 with expiration date: 15-SEP-2017, lot# L048236 with expiration date: 13-MAR-2018 and lot# reported as M027339 with expiration date: 31-MAY-2018) that were improperly stored (freezer: temperature of 31F for 5 hours; refrigerator: temperature of 54F for 7 hours; there was a data logger in combination with manual monitoring system). Route of administration was not reported. Vaccinations occurred between 15-SEP-2016 and 16-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Client received 1st dose Pfizer at 1142. Around 1152, she stated her heart rate was increasing and she was dizzy. @ 1147, O2-99, HR -148, BP-137/103. Client stated she had not eaten yet. @ 1220, HR-74, BP 109/81. Client was released @ 1223.
red, circular welt. warm to the touch, and hard under skin surface. painful and itchy