chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information as received from a certified medical assistant (CMA) refers to a 12-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot number K014191 and expiration date 10-MAY-2017) (dose and route not reported) which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
shingles; Information has been received regarding a case in litigation involving a male patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     On an unknown date in 2016, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot/batch # and expiration date were not reported).     Subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles.  As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX) use the pt suffered and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was not reported.  The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
10 DAYS AFTER PATIENT RECEIVED ROTA-TEQ VACCINE SHE BEGAN WITH MUCOUSY DIARRHEA.  MOTHER ALSO STATED A FEW DAYS AFTER THAT SHE SAW SPECKS OF RED IN STOOLS THOUGHT TO BE BLOOD.  STOOL CULTURE, O+P, WHITE CELLS WERE DONE, ALL WERE NEGATIVE.  NO TREATMENT WAS DONE, PATIENT WAS REFERRED TO PEDI-GI FOR EVALUATION.
Vax given 1/11 - 1/17 mild fever and cold. 1/20 to 1/22 inject site red. 1/26-1/27 starts stuttering while language precisely?? clear. 1/18 seen in office with pox over inject site and stuttering.
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 10-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006064: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474:
Seemed himself all day. Got home at 5:30 pm. Crying was different, shaking for probably 5 minutes. Seemed like he was in pain. Good eye contact. Fell asleep on car ride home, more snuggly tonight. Appetite good, no vomiting. Was given TYLENOL 0.8 ml at 1pm.
irritation an inch below the injection site. the size of a silver dollar. seems to be increasing size.
Headache started on April 28th in the morning.  Diarrhea, and sick to my stomach/throwing-up the afternoon of the 28th,. Woke up to a fever the 29th and muscles through out my body ache.  This continued on the next day which is now a week after I received the first shot.  Woke up Saturday morning with my entire right arm itchy.  Bright red started appearing where the injection happened only to move to a big red spot on my arm radiating heat.  Fever still ongoing Monday, May 2nd.
RIGHT DELTOID AREA BECAME VERY RED, INDURATED, AND PAINFUL. IT IS WARM TO TOUCH AND PT C/O PAIN EXTENDING TO HER RIGHT POSTERIOR SHOULDER AREA.
Fever 102.1, rash all over body (red & raised), body aches & headache. Gave pt an injection of KENALOG & pres. MEDROL Dose pack. See attached Progress Note.
Broke out in full body hives from the neck to her feet 16 hours after receiving the vaccination.  Her hands swelled for 4 days and palms wer red for one day.  Took benadryl around the clock for four days.
340 pm 16 1/2 mo old give DAPTACEL and flu #2. Previously child received PENTACEL (x3) and flu (x1) without reaction. Child developed rash on face, neck, shoulders, top of chest and back and hair. 911 called. Child assessed. 420 pm discharged and to f/u with pediatrician.
Arm has not stopped shaking since getting vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset Apr2021, outcome "unknown", described as "Arm has not stopped shaking since getting vaccine".  Additional information: It was unknown if reporter was a healthcare occupation/specialty professional (HCP). It was reported that . Just received vaccine 4 hours ago and arm has not stopped shaking since getting vaccine. Wants to know if this was a side effect or whats going on.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer 2/18 and 3/11. Positive on 9/28
The day after I received my vax, the injection site became very red, hot and tender to touch. Two days after vax, the injection site is swollen and extremely tender to touch. There is a large knot at injection site. 4 days after vax, injection site is still swollen, very sore and red.
The patient reported that beginning around 6 pm on the day of the vaccination (3/30/21) she began to feel achey, with body aches and headache that was a 4 on a 1-10 scale with chills, fever, and a temperature of 99.1.  She stated that at 8 pm her symptoms worsened and she took Ibuprofen 600 mg without effect.  She was able to sleep, however. This morning (3/31/21) @ approximately 8:30 AM she was standing in the bathroom and became lightheaded and thought she was going to pass out, sat down for a few minutes, felt better, began to walk into her bedroom holding onto the walls and then collapsed against the wall and "passed out".  She recoved later on her own and sought help.  She denied any head injury or tenderness of the scalp.  Upon arrival at the clinic her vital signs:  BP 80/46, P 88, R 16, O2sat 98%, T97.5 (she had just come in from outside where it was cold).  Her vitals signs after 10 min:  BP 80/50, P 104, R 16, O2sat 98%, T 99.1  She remained lightheaded for the remainder of her visit.  She was instructed she would need to be evaluated in the local ED where she was then sent.
Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm was red; arm was hurting; arm red with a red bump; diarrhea; she has arthritis and her pain has gotten worse; This is a spontaneous report from a Pfizer-sponsored program.  A nurse aide (consumer or other non hcp) reported for herself that the 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E13302), intramuscular injection in the left arm on 20Jan2021 at single dose for COVID-19 prophylaxis. Medical history included ongoing arthritis from an unknown date. Concomitant medication included duloxetine hydrochloride (CYMBALTA) and ibuprofen for arthritis. The patient got the vaccination on 20Jan2021 and experienced redness, pain and nausea on an unspecified date in Jan2021. She said that that night (on 20Jan2021) and the next morning her arm was hurting and it was red with a red bump. On Thursday (21Jan2021) and Friday (22Jan2021), she felt joint pain, no fever, and did not feel good. The patient experienced more tired and did not feel good on 21Jan2021. The patient experienced headache on 23Jan2021. Saturday (23Jan2021) she was more tired than usual and on Sunday (24Jan2021) she was home and felt completely tired and had stomach pain, joint pain, nausea, headache, but did not have a fever. She was feeling the same today (on 25Jan2021) and worse. The patient said that her arm was not red anymore, but it still had a small bump. Stomach pain comes and goes. She stated that she had some diarrhea, but not much in Jan2021. Her nausea comes and goes as well. She said that it was like you want to throw up, but she had not thrown up. She said that you just know that something was not right. She said that her headache was like a heaviness on top of her head and forehead. She said that it was bothering her but it was not terrible. Next dose is due on 10Feb2021. The patient said that she worked in a facility with elderly people. She said that she has arthritis and her pain has gotten worse in Jan2021. She said that even with the medication. She did not take her medication until Thursday evening to see if she had any effects from the vaccine. She took Ibuprofen 800mg and CYMBALTA for her arthritis. She said that her tiredness had nothing to do with her medications. She said that it was very rare that she even had a headache. The reason that she called was to see if she should she do anything, is it safe for her to go back to work. Event Joint pain, more tired and did not feel good were reported as worsened. The outcome of event arm was red was recovered on an unspecified date in Jan2021. The outcome of events arm was hurting, arm with a red bump, diarrhea was recovering. The outcome of events Joint pain, did not feel good, more tired than usual, Stomach pain, Nausea, headache was not recovered. The outcome of the other events was unknown.
It has been 2 weeks now and I have been nauseous everyday however I am also having diarrhea now and my injection site is sore again. In the beginning I couldn?t even lift my arm without wanting to throw up, had nausea and fatigue but most went away after 36 hours. I have not had a normal day since getting the vaccine.
- 36 hours after vaccine administration I start to experience loud ear ringing; - few hours later the ringing reduced in intensity and stays constant until now;  - it is a high frequency noise in both ears; - audiogram revealed high frequency hearing loss and ENT found the external ears to be normal; - I have received no treatment or any other type of care;
Patient with unprovoked PE on 4/2/22. Pfizer COVID booster given on 1/14/22 with SOB symptoms starting shortly after.
rash on entire back, which I noticed around 6 p.m the next day; Rash on upper left arm within two hours of vaccine; Slightly itchy but not too uncomfortable.; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 11May2021 at 12:00(at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 20Apr2021 at 11:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 11May2021 at 14:00, within two hours of vaccine, the patient experienced rash on upper left arm and on 12May2021 around 18:00, patient noticed rash on entire back. The rash was slightly itchy but not too uncomfortable. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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 event rash on upper left arm within two hours of vaccine and rash on entire back and slightly itchy but not too uncomfortable were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Between 6 to 8 days I started cramping and spotting. I shouldn't be because I have had hysterotomy 6 years ago. The first dose I spotted almost everyday up until I got my 2nd dose, and My and dose I bled heavy. I visited my doctor on July 23. And my gynecologists' couldn't find any masses or anything. The bleeding lasted about a week after my 2nd dose, I still have mild cramps. Heavy cramping stopped July 29.
ADMITTED TO HOSPITAL 7/3/2022 older woman was admitted with altered level of consciousness and slurred speech.  She was seen by neurology who did not feel that she had any acute cva.  She has improved.    She did test positive for covid and did receive remdesivir
Patient reports that she developed tenderness and warmth and mild swelling at the site of injection. Patient denied any other symptoms and was advised to monitor for worsening symptoms and seek medical assistance if symptoms did not improved or worsened. Patient called in at the end of the day when the clinic was closing and she was not seen in the clinic.
Dizziness; Fever; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Dizziness) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Feb-2021, DIZZINESS (Dizziness) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  second dose was given to the deltoid muscle (unknown arm)
little pain on her arm; sneezing; runny nose; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had her 1st dose on 07Mar2021, after the 1st dose she experienced little pain on her arm, sneezing and runny nose on an unspecified date in Mar2021. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 09-JUN-2014 the patient was vaccinated with a properly stored, expired dose of VAQTA, 0.5 ml, intramuscular injection (lot# 671235/0984AA, expiration date: 10-MAY-2014). Concomitant medications and other relevant history were not reported. No adverse effects were reported. Additional information has been requested.
Tdap and Hep A given in error. Prevnar #3 given today. Will return 9/6/07 to receive (DTaP/IPV/Hep B) Pediarix and HIB #3. Last IZ given 7/6/07 - Pediarix, HIB and Prevnar. No adverse symptoms. 8/20/07 or 8/21/07.
MEDICATION MIXTURE ERROR SALINE WITH PRE-DILUTED MODERNA ADMINISTERD TO PATIENT PAITENT EXPERIENCED NO OBVIOUS REACTION AFTER RECEIVING DILUTED MODERNA PATIENT SELF AMUBULATED FROM SITE
Patient received Moderna COVID vaccine on 3/27/21, 4/23/21, 11/13/21, and 6/6/22. On 3/3/23, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia, community acquired and COVID-19 pneumonia. Patient discharged home on 3/7/23.
Left arm started to heat up like fire up hot sunburn hot to neck and right arm; Panic attack; Arm a bit sore; This is a spontaneous report received from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route administration in the left arm on 24Mar2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included leukaemia (childhood in remission). The patient had no known allergies. Concomitant mediation included norethindrone; ethinyl estradiol (MICROGESTIN), esomeprazole (MANUFACTURER UNKNOWN), omega3 (MANUFACTURER UNKNOWN) and turmeric all drugs started on an unknown date for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 24Mar2021 at 12:00 (minutes after the injection), the patient's whole left arm started to heat up like fire up hot, sunburn hot. No spots no rashes were present, it continued to travel over neck to right arm which was not as severe, but also not amazing. After about 10 minutes and a panic attack later it was gone. The patient felt completely fine but reported to have had a sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events experienced. The clinical outcome of the events left arm started to heat up like fire up hot sunburn hot to neck and right arm and panic attack was resolved on 24Mar2021. The clinical outcome of the event arm a bit sore was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fatigue  Swollen/painful site - continuing 8 days later Swollen lymph-nodes on injection side 5-9 days  Cough - 7 days later
Tongue started swelling; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 19Apr2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified blood pressure meds (MANUFACTURE UNKNOWN) for unspecified indications, from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 19Apr2021, the patient experienced tongue started swelling and white welms occurred 2 hours after vaccine was administered. Since the vaccination, it was unknown if the patient was tested for COVID-19. Therapeutic measures were taken as a result of event tongue started swelling and white welms which included diphenhydramine hydrochloride (BENADRYL) from on unknown date. The clinical outcome of the events Tongue started swelling and white welms were recovering at the time of report.   No follow-up attempts are possible. No further information is expected.
Date and time adverse event started: Tuesday 3-16-21, unknown time. fatigue and then diarrhea 3/20-contacted the patient , patient  says that he is feeling much better , fatigue is gone and diarrhea are gone .
Insomnia, couldn't fall asleep until 4am that night.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 11:15 (Lot number: En5318) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Known allergies: Yes; "GERD" (unspecified if ongoing), notes: GERD; "HTN" (unspecified if ongoing), notes: HTN. The patient took concomitant medications. The following information was reported: INSOMNIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Insomnia, couldn't fall asleep until 4am that night.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of insomnia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Dry mouth; Rash along arm; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth) and RASH (Rash along arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced RASH (Rash along arm). On 21-May-2021, the patient experienced DRY MOUTH (Dry mouth). At the time of the report, DRY MOUTH (Dry mouth) and RASH (Rash along arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.