chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a 71 year old female patient with no medical history and a penicillin allergy who on 18-OCT-2007, was vaccinated IM into the right shoulder with a first 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 658673/0990U). Concomitant therapy on that same day, included a dose of ZOSTAVAX given into the left arm. After receiving the pneumococcal 23v polysaccharide vaccine the patient developed an inflamed, reddened, and painful arm. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. It was reported that the rash resolved by the time the patient reported the adverse symptoms. No product complaint was involved. Additional information is not expected.
Tingling began on left side of face around 12:45 pm, 15 minutes after shot (in left arm). Tingling spread across forehead and down left side of cheek and jaw. Over the next 5 minutes tingling turned to burning sensation and left eye began to burn. Around 1:00 pm 3/4 of face and both eyes were burning but not painful and cheeks and forehead were slightly numb.  Approximately 45 minutes after injection my tongue began to tingle and burn. No swelling. Around 1:45 on my left upper thigh also began tingling and burning. By 3 pm all symptoms were gone.
tested positive a week after receiving the 1st dose of covid-19 vaccine last 02Feb2021; he missed the 2nd dose schedule which was 17Feb2021; The schedule is also less than 21 days; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored Program  A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 02Feb2021, as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, a week after the first dose of vaccine, the patient was tested positive for COVID-19. The patient missed the 2nd dose schedule which was 17Feb2021; and the schedule is also less than 21 days. The patient underwent lab test and procedure which included SARS-COV-2 test: positive, on an unspecified date. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The day after my injection (8/10/22) I woke up with a headache, severe body aches and a fever of 100.4,  Fever subsided with tylenol. today 8/11/22 fever went back up; and a RASH is developing on right arm (below injection site).   Important to note that i have had 3 Pfizer vaccines previously (3/22/21, 4/12/21, 11/18/21) - all three of these vaccine produced a huge rash (left arm).  vaccines also created red blotchy under skin (arms, chest, abdomen etc).  Blotchy skin still there. .  Clearly i am allergic to something in these vaccines!!!
Bloodshot eyes with some tears and pus; cough, chills, shaking. All symptoms began on 9/11/11 at approximately 9 P.M. BENADRYL was administered at E.R. only bloodshot eyes for 3 days, and other symptoms resolved within 1 day.
Pt states they received their Hep A/B vaccine on 3/7/2023 and that evening they developed a headache. Pt states that the headache is at his left temple and also affected his sleep.
1/23: swollen, painful, red lump about 1" below injection site on the left arm.  Lump was hot to the touch, about 2" around.  I took ibuprophen and applied ice packs throughout the day 1/24: lump is slightly less swollen and starts to itch mildly, continue with ibuprophen and applied ice packs  1/25-1/28: swelling, pain, and heat fade away slowly and slight itch continues, no treatment during this time 1/29-1/30: hours after rubbing the area, redness and swelling flare up again, but not as bad as original reaction 1/30: took Zyrtec and swelling/redness decreased 1/31-2/10: all symptoms subside except discoloration (red/purple hue) and slightly sensitive to the touch
positive for covid; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive for covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (positive for covid). At the time of the report, COVID-19 (positive for covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.    No treatment information was provided.
Patient reported small rash to pharmacy early evening of 10/8. Patient was advised to take benadryl. Patient's rash continued to spread and she began to have breathing difficulty. She reported to local hospital (Medical Center) where she was administered steroids and other injections (patient did not know names of medications). Patient's husband came to pharmacy next day and presented a Rx for Prednisone tablets which we filled for the patient
Information has been received from the registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 14-JAN-2013 (dose, route and lot number not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
vaccine side effect I've experienced; monthly cycle twice per month since recieving the vaccination , heavy menstruation; this is the first time I've had irregularies in menstruation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (vaccine side effect I've experienced), HEAVY MENSTRUAL BLEEDING (monthly cycle twice per month since recieving the vaccination , heavy menstruation) and MENSTRUATION IRREGULAR (this is the first time I've had irregularies in menstruation) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (monthly cycle twice per month since recieving the vaccination , heavy menstruation) and MENSTRUATION IRREGULAR (this is the first time I've had irregularies in menstruation). On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccine side effect I've experienced). At the time of the report, VACCINATION COMPLICATION (vaccine side effect I've experienced) outcome was unknown and HEAVY MENSTRUAL BLEEDING (monthly cycle twice per month since recieving the vaccination , heavy menstruation) and MENSTRUATION IRREGULAR (this is the first time I've had irregularies in menstruation) had not resolved.            Concomitant medications information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant Follow-up added to include phone number, height, weight,race,Adverse events
Information has been received from a health professional concerning a 12 year old female with a history of asthma who on 17-JAN-2008 was IM vaccinated with her first dose of GARDASIL (lot number reported as "2405AA").  Concomitant therapy included SINGULAIR, MENINGOCOCCAL POLYSACCHARIDE VACCINE GROUPS A AND C COMBINED and ASMANEX.  On 17-JAN-2008 the patient experienced numbness in lower extremities and myalgia in lower extremities.  Subsequently, the patient recovered from numbness in lower extremities and myalgia in lower extremities at an unspecified date.  The patient sought unspecified medical attention.  Additional information has been requested.
About a day after receiving the shot I started to experience what I thought was a severe UTI. I had extreme pain in my bladder and the urge to urinate frequently. No burning sensation with intubation as is typical with a UTI. Test result may yielded no growth for bacteria. No antibiotics cleared the symptoms. A urologist tested for painful bladder syndrome , cancer and a slew of other possibilities. The source is still a mystery. I?ve never had this issue before the shot and ever since the shot I?ve had extreme bladder pain off and on.
A report has been received from a Health Professional concerning a 13 years old, female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient received FLUMIST Quadrivalent during Oct-2014. The patient experienced nose bleed one day after receiving FLUMIST Quadrivalent which started on 09-OCT-2014. The patient recovered from the event of nose bleed one day after receiving FLUMIST Quadrivalent on 09-OCT-2014. The reporter considered the event to be non-serious.
Pt reported extended nose bleed for 5 days following the vaccine. Enough to soak piles of tissues and was constant.
Intense itching through out body starting day after 1 st injection worsening after 2 md injection then progressively worsening. I continue sx dx idopathic urticaria using several meds to control somewhat currently
Developed hives a few hours after shot, with swollen lips that progressed into the evening on the 30th.  Worse on the 31st, went to urgent care given IV cortisone and pepcid symptoms resolved, discharged in the early afternoon, 2 hours after dc symptoms returned to cover face with lump in throat.  911 contact and taken by ambulance to Medical Center ER, admitted over night and discharged on 11/1 to home still with full body hives.  11/2 had consults with primary MD and allergist MD, given regimen of predisone taper 60 mg over 10 days along with pepcid, zyrtec .  Full body hives began to resolve of 11/3, returned to work on 11/4, intermittant hives persisted on/off for 4 weeks, currently still taking pepcid and zyrtec.
Information has been received from a pharmacy student concerning a patient who was vaccinated with a dose of Pneumovax 23. Subsequently the patient experienced a fever and cellulitis at the injection site. It was reported that because of the patient's condition it was not sure if this AE could be related to the vaccine. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Information has been received from a physician concerning a 22 year old female who on 23-APR-2009 was vaccinated with the first dose of 0.5ml GARDASIL (Lot # 663454/0672Y), on 23-JUL-2009 with the second dose of 0.5ml GARDASIL (Lot # 663454/0672Y), and on 05-JAN-2010 with the third dose of 0.5ml GARDASIL (Lot # 663454/0672Y). On 06-JAN-2010 the patient's arm was sore at the injection site, and there were some swelling and redness. There were no labs or diagnostic tests performed. The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
History of Present Illness: Today patient is sent to ED as SNF staff found him to be unresponsive after norco given for pain. EMS was called. fsbs checked by EMS and 121. CT head neg here. Now patient is awake alert and oriented. He needs a translator which was used by me at the bedside for hx. Patient reports he could not communicate with anyone at his SNF. And there was confusion thus he came to ED. Missed HD. Feels some shortness of breath, a little more than usual. Placed on 02 in the ED. No fever, chills, rigors. Antibiotics are new as he is hpylori +. He feels weak, tired, some mental fog, nausea with poor appetite. No other complaints at this time.    #Acute PE on AC -> po eliquis. Patient taking BID. Last dose 0900 2/13. Start heparin gtt- no bolus. Hold eliquis. High high suspicion for malignancy as patient has acute PE already on anticoagulation.  Continue with oncology consult in the a.m.
Pfizer-BioNTech COVID-19 Vaccine EUA Monday February 1, 2021        Injection in left shoulder was at 1 PM Monday.        First noted slight pain at injection site about 12 hours after injection. Tuesday February 2, 2021        Shoulder pain at injection site increased to moderate level, slightly more than fall flu shot .        Noted some body and joint aches. Wednesday February 3, 2021       First noted left lymph node under left arm (armpit area) was swollen approximately 43 hours after injection of vaccine after waking up on Wednesday morning.       Shoulder pain at injection site is still considered to be moderate.
Information has been received from a 68 year old female medical receptionist (180 pounds, 62 inches) who on 20-JUL-2007 at 10:00 AM was vaccinated in her left upper arm with Zostavax (Oka/Merck) (lot # 656607/0163U).  She had no illness at the time of her vaccination.  On 21-JUL-2007 the patient developed a red bump, approximately 2 inches across which was warm and painful the first day.  It spread to 5 inches the second day, then it was 2 inches, still warm and a little painful when touched.  The patient considered the events to be non serious.  The patient's outcome was not reported.  Additional information is not expected.
developed / swelling / at injection site; developed / pain / at injection site; developed / warmness (AE) at injection site; developed redness / at injection site; allergic reaction; given / bysubcutaneous route / instead of intramuscular route; This case was reported by a pharmacist via and described the occurrence of injection site swelling in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 4Y2P4, expiry date 23rd January 2023) for prophylaxis.   Co-suspect products included cefalexin (Cephalexine) for injection site swelling, injection site pain, injection site warmth and injection site erythema.   On 27th April 2021, the patient received the 1st dose of Shingrix (subcutaneous). In May 2021, the patient started Cephalexine at an unknown dose and frequency. On 27th April 2021, unknown after receiving Shingrix and an unknown time after starting Cephalexine, the patient experienced intramuscular formulation administered by other route. In May 2021, the patient experienced allergic reaction. On an unknown date, the patient experienced injection site swelling, injection site pain, injection site warmth and injection site erythema. Cephalexine was discontinued. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site warmth, injection site erythema and allergic reaction were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.  It was unknown if the reporter considered the injection site swelling, injection site pain, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. After vaccination with Shingrix, the patient experienced injection site swelling, injection site pain, injection site warmth, injection site erythema and on 1st May 2021, the patient went to the emergency room. The patient received Shingrix by subcutaneous instead of intramuscular route, which led to  intramuscular formulation administered by other route. The patient was prescribed Cephalexin and discontinued Cephalexin because of an allergic reaction. The patient was prescribed Bactrim DS. The patient had not started the medication Bactrim yet. The health care professional stated that, symptoms had not resolved by 1st May 2021. The reporter consented to follow up.
Half sweating to death; sick; Fever; Chills; Extremely ill; A spontaneous report from United States was received from a Consumer concerning a  Years-old male  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extremely ill, chills, fever, half sweating to death, sick.    The patient's medical history was not provided.  No relevant concomitant medications were reported.    On22-01-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly  for prophylaxis of COVID-19 infection.  On 22-01-2021, The patient experienced extremely ill and chills.  On an unknown date , the patient experienced fever, half sweating to death, sick.  Laboratory details was not provided.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events was unknown.
Patient described having extreme hair loss. Her hair came out in clumps. She already talk to her Rheumatologist about it and he said to talk to her pharmacist.
This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced chills, felt sick, high fever, weak, and fatigued. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, felt sick, high fever, weak, and fatigued. This report was non-serious.
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient experienced a sore arm for 3 days but no other reactions. The patient still intended to receive the 2nd dose. The reporter denied for follow up. This case has been linked with case US2018GSK160166, reported by same reporter.
I received the injection at 1:30 p.m. on July 2, 2018; by 6:30 p.m. the arm was hurting a lot. I put ice on it and it helped some. On the morning of July 3, 2018 I started experiencing headache and felt extremely tired and sleepy. This lasted until July 4, in the morning.
Body aches; Chills; Headache; Nausea and vomiting; FEver; Nausea and vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea and vomiting) and PYREXIA (FEver) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (Body aches), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea and vomiting), PYREXIA (FEver) and VOMITING (Nausea and vomiting). At the time of the report, PAIN (Body aches), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea and vomiting), PYREXIA (FEver) and VOMITING (Nausea and vomiting) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.
Covid breakthrough. First Vaccine Pfizer 09//05/2021.  Patient is a 74 yo F who denies PMH states no home meds, noted previous hospitalizations for HTN, presenting with exertional dyspnea, + covid-19 multi-focal pneumonia.
Patient was tested at the local pharmacy on 12/19 with positive results.  Admitted to hospital on 12/26/2021 with a second positive testing: RNA.  No symptoms or underlying health conditions charted in system.  Number of days in hospital unknown.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 19Nov2014, stop date: 22May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: covid free for 4-5 days, then covid again; Negative, notes: then paxlovid, tested negative; positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient received other medication in 2 weeks, CRESTOR. After having covid, then PAXLOVID, tested negative after several days, was then covid free for 4-5 days, then covid again. Patient stated that, "So mad I ever took the PAXLOVID". Patient was treated for COVID with PAXLOVID, treatment start date on 23May2022 and treatment stop date on 27May2022. Adverse event start date was on 01Jun2022 and adverse event start time was at 10:00 PM (as reported).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
KNOT FORMED AROUND THE AREA OF INJECTION, FILLED WITH BLOOD; NICKED A SMALL BLOOD VESSEL; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Janssen dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total, administered on 09-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-DEC-2021, after being vaccinated, patient had a knot formed around the area of injection and appeared to be filled with blood. She thinks she nicked a small blood vessel (dose number in series 2 adverse events). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of knot formed around the area of injection, filled with blood and nicked a small blood vessel was not reported. This report was non-serious.