chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bruising at the injection site; This spontaneous case was received on 27-Aug-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-01760) and concerned 41-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 26-Aug-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: intramuscular, dose: 0.5 ml and anatomical location: deltoid) for influenza prophylaxis. The batch number was not reported. It was administered by the site nurse in the on-site clinic.  On 27-Aug-2021 in the morning, one day after receiving Flucelvax Quadrivalent, while getting ready for work the patient realized there was bruising at the injection site. He was not experiencing any other issues.   At the time of initial reporting on 27-Aug-2021, the patient had not recovered from the event of 'vaccination site bruising'.  The reporter did not provide causality assessment.   The reporter assessed the case non-serious.  Company comment: A 41-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving the vaccine, the patient realized there was bruising at the injection site. Causal role of the suspect vaccine is assessed as possibly related due to biological and chronological plausibility.; Sender's Comments: A 41-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving the vaccine, the patient realized there was bruising at the injection site. Causal role of the suspect vaccine is assessed as possibly related due to biological and chronological plausibility.
Second adult dose of Hepatitis A vaccine was given 16 days too soon.  Rehab facility is in rural area, was unable to connect to internet or use cell phone to call my staff County Health and Human Services, Immunizations clinic to verify date of last dose. No adverse events reported.
Severe headache, dizziness, weakness, nausea started 8 minutes after shot, diagnosed with stroke with brain bleed in ER.
Redness and swelling to left upper arm at injection site. Pt complained of stinging/itching and tenderness to touch.
2 days post vax the pt experienced pain and redness at injection site. Pt was advised to treat with an ice pack and Tylenol. 5 days post vax the injection remains red but is no longer painful.
IPV was administered into area over right bicep muscle instead of subcutaneously. Arm became edematous and erythematous 24 to 48 hours after injection. Seen in ER and doctor's office. Treated with warm compresses.
This spontaneous report was received from a pharmacy technician and a registered pharmacist refers to a female patient (pharmacy technician) of unknown age with no pertinent medical history and no drug reactions/allergies. The pharmacy technician provided the information on vaccine and the events. On 19-JUN-2013 the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot # J000446, expiration date 11-APR-2014) subcutaneously. Within a day on 20-JUN-2013, the site of injection was red and raised. On 21-JUN-2013 (reported as today), the injection site was painful to touch and was about 6 inches long and 2 inches wide. It was puffy and itched and there was a raised rash (not like chicken pox). Treatment was not rendered for the adverse event. The patient did not recover from the events at the time of this report. Medical attention was not sought for the events. Causality was not reported. Additional information is not expected.
Information has been received from a physician concerning an "approximately 18-20 years old" female who on unspecified date was vaccinated with the first dose of GARDASIL. Immediately after receiving vaccination, the patient had a convulsive seizure for 2 seconds and then fainted. The patient has recovered but the physician does not plan to administer the second or third doses to the patient. The patient sought unspecified medical attention. Upon internal review, convulsive seizure was considered to be an other important event. Additional information has been requested.
Tired, muscle pain, a headache, shivering, fever, stomach pain, nausea, sore arm with mild pain
Left arm is in pain, unable to move left arm, large and red hot to the touch at the injection site... left side of neck is in pain,,, back pain... hurts taking in a deep breathe, Headache and very tired
Within 7-10 hours of receiving the vaccine I started feeling chills, fever and body aches. This resolved itself in about 24 hours. I also noticed that I had a swollen lymph node and my mentrual cycle has become irregular. After 6 months my cycle remains irregular.
injection area red, swollen, itchy & painful, for 3 days; sleepiness; achiness all over, no appetite
Side effects from second vaccination; A spontaneous report was received from a Consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and reported the events side effects from second vaccination(vaccine complication).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (unknown batch number) intramuscularly for prophylaxis of COVID-19 infection. No adverse events were reported to the first dose of vaccine.  On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (batch number provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient reported event side effects from second vaccination(vaccine complication)  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event side effects from second vaccination was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
12-24 hours post vaccine :Tongue Swelling and Tongue ulceration , no treatment, non-emergent.  Swelling resolved on 1/20/21.   12/21/21: Ulceration still present. No treatment.
This is a  49 Years  old  Female with asthma, discoid lupus and post-surgical hypothyroidism with Hurthle cell neoplasm of thyroid presenting with 1 weeks of moderate shortness of breath without cough, which began gradually.  Patient states that her symptoms first started after she received the first Moderna COVID-19 vaccine on 4/6/2021 and they lasted approximately 6 days.  Patient was doing well until she received the second dose of the vaccine on 5/4/2021.  Since then, she has been having shortness of breath, fatigue and headaches.  Patient also complains of chest pain that is worse with inspiration, and she denies any abdominal pain, no nausea, no vomiting, no swelling to the legs, and no leg pain. Symptoms are worse with exertion
Last night having chill and headache. This morning was better.  Went to work. But now around 5 pm started having chill and headache again.
5 minutes after vaccine administration, the patient felt light-headed, dizzy, nauseas, sweaty, and went pale.
As I was administering the last immunization of 4 immunizations, the client closed his eyes and lowered his head and slumped in the chair. His body stiffened and he straightened in the chair and started sliding to the floor. His mother and I helped him gently to the floor in a sitting postion holding him upright as he had lost consciousness. His mother and I told him to breathe deeply, and I was lightly tapping his cheeks to stimulate him to wake up. He started to regain consciousness and we helped him back into the chair. He started to breath deeply as instructed, and said he felt better and started to get up to walk away. He was told to sit in the chair and I got his blood pressure and checked his pulse. His pulse was weak and irreglar at 45. Skin was cold and clammy and his face lost color and was pale. His BP=85/45 at 09:45. I asked his mother if she would like me to call EMS and she said no she would take him to hiw own doctor to be checked. The client stated that he "lost it", "everything went black" and he didn't remember anything. At present he just felt nauseated. The client stated feeling bad when he got the third shot which was the polio shot. He said he felt allright until the 3rd shot. The client said it never happened to him before and his mother said he never had this reaction before. At 0950 his BP=89/75 and pulse=62. At 10:00 his BP=92/62 and pulse=62. He told me he was feeling much better. Client was answering questions appropriately and acting appropriately. He denied being nauseated. I encouraged fluids and asked the mother again if she would like me to call EMS and have him transported to the hospital. The mother told me she was going to take him to his doctor to have him checked out. He got up and was walking normally and color returned to his face and he left the clinic without any problems or complaints.
positive for the Virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Jan2022, outcome "unknown", described as "positive for the Virus". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Context: Reporter stated that her 7 year old son received his first dose of Pfizer BioNtech vaccine on 27Dec2021 and on first week of January he tested positive for the Virus. Reporter stated that her seven year old son missed his second dose of vaccine because he tested positive after getting the first dose. Is for the Pfizer Covid 19 vaccine. she wants to know when he can have the second dose of the vaccine. The case was reported as non serious.  Description of Product Complaint: Description of complaint: Pfizer Covid 19 vaccine: Clarified that her son had his first shot on 27Dec2021 and the first week January tested positive for the virus. Product strength and count size dispensed: Is a sample of the product available to be returned, if requested (Y/N): Packaging sealed and intact?   The lot number for bnt162b2 was not provided and will be requested during follow up.
Voice is completely gone; Throat was feeling like closed and stuff; Throat felt like closing, it completely actually closed because I am able to talk and breath and 'all the other stuff' but I lost my voice; Throat was feeling like closed and stuff; Throat felt like closing, it completely actually closed because I am able to talk and breath and 'all the other stuff' but I lost my voice; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 36-year-old on 11Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient said she was calling because she had her Pfizer first vaccine on sunday and then she started having like her symptoms which was like her throat was feeling like closed and stuff like that  in Apr2021. She received her Pfizer shot on Sunday morning and now today it's Tuesday (on 13Apr2021) and her voice was completely gone. The symptoms that she was having was that her throat felt like closing, it completely actually closed because she was able to talk and breath and 'all the other stuff' but she lost her voice and it wasn't one of the actual side effects that was listed on the paper that she receive, when she received the first dose of vaccine. When confirmed if it was the first shot or second, consumer stated, this was her first shot she got it, and she received it on Sunday, the Sunday which just passed. It was just Sunday, it was 11th. She received her shot on 11th which was Sunday. The patient stated, Yes, she just need to know if it was one of the actual side effect that they didn't put on the actual paper work, was this actual comment or actual side effect of her receiving her actual shot. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, chills Narrative: Headaches, myalgia, arthralgia, nausea, fever, chills; took Motrin.
01/13/22 presents to ED for "dehydration". PMHx of "UC, seizures, MPGN s/p renal transplant, HTN, HLD, Hypothyroidism, GERD, recent COVID infection 12/26"
pt was seen by an urgent care doctor in the patient's home and was dx with COVID and UTI; given doxycycline; no improvements; sx worsened; more weak and confused, fever, a lot of secretions in oropharynx; wife concerned and brought him to ED; was intubated due to excess secretions and concern of aspiration; started on remdesivir and dexamethasone; DNR; pt passed away in the hospital; death certificate and med records submitted to info@vaers.org
NauseaVomiting, fatigue Narrative: left work early after second dose due to nausea and fatigue
Experienced flu like symptoms; Warm touch at the injection site; Knot at the injection site; Sore at the injection site; Red Knot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Experienced flu like symptoms), VACCINATION SITE WARMTH (Warm touch at the injection site), VACCINATION SITE INDURATION (Knot at the injection site), VACCINATION SITE PAIN (Sore at the injection site) and VACCINATION SITE ERYTHEMA (Red Knot at the injection site) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Experienced flu like symptoms), VACCINATION SITE WARMTH (Warm touch at the injection site), VACCINATION SITE INDURATION (Knot at the injection site), VACCINATION SITE PAIN (Sore at the injection site) and VACCINATION SITE ERYTHEMA (Red Knot at the injection site). At the time of the report, INFLUENZA LIKE ILLNESS (Experienced flu like symptoms), VACCINATION SITE WARMTH (Warm touch at the injection site), VACCINATION SITE INDURATION (Knot at the injection site), VACCINATION SITE PAIN (Sore at the injection site) and VACCINATION SITE ERYTHEMA (Red Knot at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Tylenol and Benadryl as corrective treatment and mentioned that symptoms were ongoing.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: patient's first name corrected, email updated
I received the first dose on 12/30/20 and the 2nd dose on 1/20/21.  I started have an allergic reaction after eating walnuts on 1/30/21.  I have never had reactions to nuts before.  I had swelling, itching and rash on my face.  I took Benadryl and after 32 hours, my symptoms improved. I have since avoided tree nuts.  I have also been  having wrist and finger "tightness" in both hands since 2/10. and it seems to wax and wane.  Both hands feel stiff. Prior to the vaccinations, I have had no health conditions.   I have an appointment w/ my PCP later in the month.
Received PENTACEL on Thursday. Later that night patient started with a high pitched cry lasting 2 hours. Then Friday and Sat had a high pitched cry every time the patient cried. On Friday and Saturday had several episodes of vomiting.
Acute respiratory failure with hypoxia (H) This patient with no described history of prior lung disease, and no prior supplemental oxygen need, presented from her skilled nursing facility requiring oxygen at 3 L/min per nasal cannula for the treatment of hypoxemia.  Room air saturation is not recorded.  Etiology of hypoxemia is not certain.  She has tested positive for COVID-19 today, which is a possible etiology, though her lung exam is normal and her admission chest x-ray shows no acute infiltrate.  Initial D-dimer is minimally elevated at 0.56.  I think that we may be seen the patient earlier in her COVID-19 disease course, and that her pulmonary disease and chest x-ray may worsen over the next day or two.
H1N1 mist administered to child 11 mos 19 days. misadministration to wrong age
Patient experienced apparent drop of blood pressure within 10 minutes, fell from her chair, vomited after which she felt better
Information has been received from a registered nurse concerning a 30 year old female who had a negative varicella titer in 2004 (0.32) and no history of previous Varivax vaccinations who in 2004 was vaccinated with two doses of Varivax. On 18-OCT-2006, the patient tested negative for seroconversion (0.61). The patient had not contacted the disease and had not had any problems due to lack of seroconversion. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Patient fainted to the floor when rushed over patient was getting up in which he was assisted in a chair. He was sweating and dizzy. He injured his face when he fell since he was bleeding and vomited minutes after once he was seated in the chair. Ice pack was provided until paramedics arrived and took patient to emergency room.
Patient given varicella vaccine 1/3/13. Left leg was red, swollen and warm for 1 week after injection. Child was fussy & irritable. Red area larger than a half dollar.
Shortness of breath, cough, fever, chills, headache, ringing ears, extreme exhaustion
injection site became red, warm, and itchy the day after the shot was received.  2 days after the shot, the patient had some malaise as well.
This spontaneous report as received from a female consumer of unknown age, who was reporting on herself. No demographic information was provided for the patient or physician. No concurrent condition, medical history and concomitant therapy was reported. On an unknown date, the patient was vaccinated with M-M-R II (batch #, lot#, expiration date, dose, route of administration and indication were not reported). On an unknown date, reported as "recently", the patient had blood work done to check her titers. The patient's rubella titer showed, that she had no immunity. The outcome of the vaccination failure was unknown. The relatedness between the event of vaccination failure and the M-M-R II was not reported. Additional information is not expected, because the reporter declined to participate in answering questions within this report.
Head pressure and fees winded denies shortness of breath Narrative: Health professional review employees current vital signs, noted to be stable
This spontaneous report was received from a female patient of unknown age, who was reporting on herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not reported), for prevention of shingles. On an unknown date, within 9 years, the patient was vaccinated with the second dose of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not reported), for prevention of shingles. The patient did not seek medical attention. Additional information has been requested.
48 Hours after the injection I woke up on 12/12/2021 early AM with pain soreness and redness in my left upper arm where I received the booster third shot of the COVID vaccine the swelling and redness was about the size of a quarter and as the day went on the swelling increased and redness to the area increased and the site became more painful the area had become the size of an orange and more painful and the area was hot to touch I made an appointment with the Dr  to show her my left arm and she prescribed Keflex after taking the Keflex for two days the swelling started to go down and I was on medication for 5 days and by the 5th day of medication the pain was relieved the area was hardly swelled and it wasn't hot to touch any more
upset stomach; chills; TIRED; headache.; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th December 2019, the patient received Shingrix. On 13th December 2019, less than a day after receiving Shingrix, the patient experienced tiredness and headache. On 15th December 2019, the patient experienced chills. On 17th December 2019, the patient experienced upset stomach. On an unknown date, the outcome of the tiredness, headache, chills and upset stomach were unknown.   It was unknown if the reporter considered the tiredness, headache, chills and upset stomach to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination wasn ot feeling well, the patient had minimal side effects tired and a headache. The patient also had the chills very badly and had an upset stomach. The patient asked is this coincidental or could there be a 2 day delay in the side effects. The patient was wondering because had to schedule next shot.
Noticed bump underneath armpit; A lot of pain under armpit; Booster; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Oct2021 as dose 3 (booster), single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single and via an unspecified route of administration on an unspecified date as dose 2, single both doses for COVID-19 immunization. It was reported that she received a booster dose of the Pfizer COVID vaccine on Wednesday 27Oct2021 and yesterday on 28Oct2021 noticed a bump under her armpit that she never had until she got the vaccine and a lot of pain in that area. She would like to know if this was a side effect from the vaccine and how long it might last. She stated to them that the top of her arm where the shot was given it hurts as well. She stated yesterday on 28Oct2021 it was a big bump under her armpit and she noticed that it was still but not as big as yesterday. She stated she just wanted to know if she should be alarmed or if it was normal and would go away as she has not had this before. She declined to provide age but was a female. She stated she had to leave to go to the dentist. Response received as Read from attached documents. According to Section 6 overall safety summary In a clinical study of participants 18 through 55 years of age, the most commonly reported adverse reactions (>10%) following administration of a booster dose were pain at the injection site. In clinical studies of participants 16 years of age and older, adverse reactions following administration of the primary series included pain at the injection site and lymphadenopathy. Informed caller no specific information in regarding how long a bump under arm may last. The outcome of the events was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further in-formation is expected.