chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist, referring to a 45 year old female patient. The patient's medical history included treatment for pain management. The patient did not have any drug allergy. The patient's concomitant therapies included Sulindac. On 27-JAN-2018, the patient was vaccinated with the first dose of RECOMBIVAX HB intramuscularly, for prophylaxis (strength, dose, frequency, lot# and expiration date were not reported). On 28-FEB-2018, the patient received the second dose of RECOMBIVAX HB intramuscularly, lot# M039201, expiration date 14-NOV-2018, for prophylaxis (strength, dose and frequency were not reported) and PREVNAR 13 (strength, dose, route, frequency, lot#, expiration date and indication were not reported). On the same day, the patient started therapy with Sulindac. On 28-FEB-2018 on the evening, the patient experienced vomiting and diarrhea. The reporter stated that it was not sure if the gastrointestinal symptoms started before or after Sulindac. The patient stated drinking Gatorade and re-hydrates herself and felt better on 02-MAR-2018 (recovering). Diagnostic laboratories were not performed. The causality assessment between aforementioned events with RECOMBIVAX HB and PREVNAR 13 was not provided.
Reports after covid vaccination while she was driving home she experienced swelling of the tongue, dry mouth, legs twitching, and diarrhea. Went to ER for treatment.
no adverse event; Caller reported that PROQUAD that had undergone temperature excursion was administered to a patient.; This spontaneous report was received from a nurse referring to a 22-month-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 28-SEP-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot #W012743, expiration date: 16-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was undergone temperature excursion, with temperature was -11.8 Celsius (C) and time frame was 1 hour and 45 minutes. There was previous temperature excursion. No additional adverse event was reported (no adverse event).
Woke up achey and with a fever (100.3).  Chills  Fever was 103.2 on 11/10
This spontaneous report was received from a registered nurse via medical assistant and refers to a 12-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 16-OCT-2017, the patient was vaccinated with improperly stored M-M-R II (lot # M034387; expiry date: 19-JUL-2018) (dosing details were not provided) for prophylaxis (incorrect product storage). Temperature excursion details of the vaccine were not provided. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case : 1709USA008666 US-009507513-1710USA014650: Original Case : 1710USA014649 US-009507513-1710USA014651: Original Case : 1710USA014649 US-009507513-1710USA014649: Original Case : 1710USA014649.
Rash from hip down to knee on left leg. Rash included some bumps filled with pus. Extensive redness, warm to touch, hard mass.
High fever and headache which began within 10 mins of receiving Tdap. Change in mental status and inability to concentrate. By 1700 hr on 17Jan2007-felt terribly ill with chills, bodyache over entire body including soles of feet.  Lethargic. No appetite. Patient states that she felt very ill and was only willing to stay in bed and did not work on Jan 18 or 19, 2007. She did not go to the doctor or emergency room, but has scheduled an appt to go on 26 Jan as she is still not quite recuperated.  Left arm was noted to be warm and red. She states that she still has a headache. Rec'd Tdap on 16 Jan 2007.
Patient received the incorrect dose of 0.5mL versus the correct dose of 0.25mL.
Nausea, vomiting, diarrhea, and moderate-severe abdominal  pain for six hours, followed by  five days of loss of appetite, mild abdominal pain, and diminishing diarrhea. Self-treated  with Pepto-Bismol, famotidine,and  ginger tea.
This report described limb swelling in a four year old female who received DTaP. On an unspecified date, the vaccinee received the first 0.5 cc IM dose od DTaP, a right thigh dose of IVP and a left  deltoid dose of MMR. Subsequently, the vaccinee experienced "swollen limb". The vaccinees was examined by a health care professional for the reaction.  The swelling did not extend to the nearest joints. The area of swelling/induration was 4.7 x 4 cm. There was no fever. There was tenderness and erythema at the injection site. There was no fluctuance/crepitus or functional impairment. Cold packs and cefalexin monohydrate (Keflex) were prescribed. The reporter stated that these adverse events were of mild intensity. As of 07/30/01, the events had resolved.
This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. This nurse reported similar event for 3 patients. This is the second of three reports. A patient of an unspecified age, gender and ethnicity received PREVENAR 13, via an unspecified route of administration, on an unspecified date, single dose, for immunization. The patient medical history and the patient's concomitant medications were not reported. The patient experienced pain redness and swelling at the site of injection. The patient recovered from the events at time of this report. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017006187 Same reporter/drug/AE, different patients.;US-PFIZER INC-2017006206 Same reporter/drug/AE, different patients.
the first time she had that sensation when it was going in. It felt strange; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced FEELING ABNORMAL. At the time of the report, FEELING ABNORMAL outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-366094 (Patient Link).
On evening of 4/26/21 patient developed sore, hot, swelling arm all the way down to wrist.   Patient could barely move arm.  By Thursday (4/29) patient could move arm, and swelling and hot-to-touch had resolved but still a little sore.
Waves of quite severe malaise, abnormal neurological sensations  in limbs,  flushing, with start of rash versus hives, all starting 15minutes post infection.  Relieved by Benadryl 50mg, which I brought with me.  Took one hour to clear the initial wave of moderately severe malaise.   Starting three hours later, extremely tired. Temperature 99 .5 my temperature runs low, went to bed.  Next morning, temperature 100.5, didn?t feel well.  Temperature rose to 102.5 in the afternoon.  Regular Extra strength Tylenol brought it below 101.    Extreme headache! interfered with function, lasted 3 days,  severe day 1&2, milder day 3.  Queasy with No appetite x 2 days.  Day two after vaccine fever peaked at 101.5.  Day three after vaccine, temperature peaked at 99.4 Day four very tired Day five entirely normal.
DTaP+IPV combo administered 2-10-09. Within 24 hrs developed swollen, red, painful arm at site - 2-11-09 broke out in oral blisters on tongue, anterior mouth lasted 2 days - 2-13-09: (R) eye red and couldn't close it - 2-14-09: facial drooping - 2-16-09: Dxd with Bell's Palsy probably due to herpes gingivostomatitis - 2-18-09: Seen by NP; now with increased sleepiness and ataxia
Mom had a stroke less than a month after receiving this vaccine. She was hospitalized and then subsequently died  in the nursing home.
CAUGHT COVID; This spontaneous report received from a patient via Social media via a company representative concerned a patient of unspecified age, sex, unknown race and ethnicity. 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) (suspension for injection, route of admin, and batch number were not reported expiry: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. It was unknown if the patient had any adverse events with covid-19 vaccine ad26. cov2. s (dose number series1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient caught covid. The patient stated that "Took J and J shot and booster and still caught Covid, All I can say is just be careful" (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of caught covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000212957. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria because there is no report of symptoms or statement indicating the vaccine did not work) based on the PQC evaluation/investigation performed.  Version created to amend previously reported information on 19-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Positive warm and indurated (R) worse than (L) no fever or pus. Not particularly painful No difficulty breathing or swallowing using arms normally.
Weakness, body aches, feverish, headache, chills, bronchial cough, severe sore throat, short breath, severe congestion. Treatment: OTC Mucinex, vicks vapor rub, lozenges, antibiotics, steroids, inhaler. Also taking home remedy: ginger, garlic, cayenne pepper, turmeric, thyme, honey, lemon concoction. Symptoms timeline:  12/17: too tired, 12/18: just off, 12/19: headache, 12/20: mild cold symptoms, 12/21-22-23: body ache, feverish, chills, 12/24-28: severe sore throat, congestion, cough. Rx meds started 12/28
7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.  Date the vial was initially stored in the refrigerator on 01 Dec 2021. The use by date was 30 Dec 2021. The vial did not undergone any temperature excursions.
Pt was one day history of macular rash over torso. It began in P.M.
pt says she has blue circle around the injection area that it is lumpy and has been there about 5 days.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 14-year-old male patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain (serious criteria disability). On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be possibly related to BEXSERO. Additional details were provided as follows: This case was reported by an office manager who was married to a physician and was reporting this case as a patient's parent. The age at vaccination was not reported. The limited information was provided by the sales representative from the office manager.
This case was reported by a other health professional via call center representative and described the occurrence of cancer in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. In September 2018, unknown after receiving SHINGRIX, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was unknown. It was unknown if the reporter considered the cancer to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable. The reporter stated via online chat that the patient was diagnosed with cancer in September 2018. The patient had already received one dose of SHINGRIX, but the timing was unknown. No other information was provided. The chatter stated that question was urgent and that the patient was waiting at the time of reporting. The reporter stated that the timing was unknown, but if the patient was diagnosed in September it was likely that the patient received the first dose before being diagnosed.
No problems on vaccination date or several days after, but now says can't move or twist vaccinated arm without being in severe pain.  No visible redness or swelling, she just says it hurts and can't lift or move correctly and it is affecting daily life.  Trying to find a physician to see for further tests.  OTC analgesics and creams not effective so far
Dizzy, dyspnea, stomach, freeze, shaking and high blood pressure in ten minutes. Two nurses and one doctor put the patient on one medical bed to save her, giving her a blue bag on her mouth. It lasted about 20 minutes. After getting home, her arm hurt, vomit, headache, neck hurt and high blood pressure.
missed the 1 month seocnd dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jul-2021 and was forwarded to Moderna on 27-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the 1 month seocnd dose) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the 1 month seocnd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the 1 month seocnd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
9/13/16 muscle aches; joint aches, fatigue, malaise, fever. Took acetaminophen 500mg two tabs at 1600, 1900 and on 9/14/16 0600. 9/14/16 muscle and joint aches minimized no fever, fatigue. Injection site warm and swollen. Seen by Dr, no restrictions. Release. Dx: Immunization reaction.
Pt presented to the pharmacy to get her second SHINGRIX vaccine on 12/7/2018. After the patient filled out the patient quetionnaire, it was observed that she checked yes for question 4 and circled the word "fainted" for having a reaction after having a vaccine. Consultation with patient revealed that she fainted after receiving the first SHINGRIX vaccine (on 9/19/2018). The patient received the first SHINGRIX vaccine along with her annual flu vaccine (FLUARIX QUAD) on the same date and time. The patient was counseled to stay in the store for 15 to 20 min but the patient left store and went to the bank after getting both vaccines. While in line at the bank, the patient fainted and had to go to the ER. The patient had a bleeding injury to her head after fainting and was completely recovered at the time she presented to the pharmacy for her second dose of SHINGRIX. The pharmacy was not notified about the fainting episode until the patient presented to the pharmacy for her second dose of SHINGRIX (12/7/18). The patient received the second dose and this time stayed in the pharmacy area for 20 minutes sitting down. There was no reaction (fainting or otherwise) after the second dose.
Received PPSV23 right deltoid 3-28-2011, c/o pain right deltoid that evening with stiffness and difficulty moving right arm at midnight.  3-30-2011 at midnight c/o pain distal to injection site.  Saw a provider the afternoon of 3-30-11 with c/o pain approximately 70 mm distal to the injection site.  At this time the patient had an approximate 70 x 80 mm area of erythema along the inner aspect of the right arm, +/- 70 mm below the injection site.  The injection site was clean.  Area of erythema was warm to touch and painful.  The patient was able to move her arm with c/o pain.  Was diagnosed with cellulitis and Keflex 500mg, 2 po bid, for 10 days and Naprosyn 500mg, 1 po bid prn pain/ fever ordered.  The patient's temp was 97.3 at the OV on the 30th.  There was mild induration at the area of erythema, no LAD in axilla or epitrochlear involvement.
Member received first COVID Pfizer vaccine on 18 Nov 2021, and came in for the 2nd dose on 03 Dec 2021 and got the vaccine. This was given 2 days prior to the 4 day grace period as outlined by the CDC there fore invalidating the members first vaccination on 18 Nov.
Starting 05/12/2022, I had a mild post nasal drip. On 05/13/2022 I tested positive for COVID (faint line) and that evening I had a very mild low grade fever. I called my doctor on Friday and got an rx for Paxlovid. The next day, on Saturday, I started the Paxlovid and I had a mild fever of 99.0-99.5. This same day I tested for COVID again and it was a bright line this time. Sunday my temp lowered to the range of 98-99. I had a mild cough but nothing bad and a slight runny nose. Yesterday the cough was better and I had a mild runny nose. Today I am feeling I'm almost completely better, no fever and rare cough and runny nose. Per my smart watch, my SpO2 was normal the entire episode and my HR may have gone up slightly but I am sure its due to being dehydrated.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: patient stated he is experiencing severe arm pain from the moment he received the vaccine til now. recieved on 05/03/21. stated he has limited arm movement but has not been seen by a doctor. Recommdened on the call today to go follow up with md and see if its nerve pain/damage. I stated to patient it could also be a clot that is causing pain so need to follow up with MD. Pt acknowledged and and will make an appt asap. I told patient I am starting a safety report and we will followup soon.
Rash red, swollen area at the injection site- Left upper arm approx a 50cent piece in size  Narrative:
I did not get the adverse reaction until day eight. Then at the injection site I had  approximately a 3 inch welt. It was hot and red and itched tremendously. It remained for approximately two days, and then it subsided. It itches so much that I now have some tiny sores waiting to heal.  I also find the my arm ?cracks? when I raise it.... sort of like a torn rotator cuff.....  this arm had surgery about 5 years ago to repair the rotator cuff.  I did not seek medical attention.
ADMINISTRATION OF EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patient experienced administration of expired vaccine. On 23-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949990.