chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in left shoulder and arm; Pain in left shoulder and arm; Can't raise his arm very good; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6201; expiration date: Jun2021), via an unspecified route of administration, administered in the left arm on 23Feb2021 09:30 (at the age of 73-years-old) as dose 1, single for COVID-19 immunization. Medical history included fever of 104.10, sick, severe pain in the shoulder, pain in arm on an unspecified date in 2020 (patient Went to the ER four months ago); calcium deposits in his shoulder, arm, and shoulder blades unspecified date in 2020, and overweight. The patient has no concomitant medications.  The patient previously took acetylsalicylic acid (BAYER ASPIRIN) for pain. The patient reported that he got the Pfizer COVID-19 vaccine on 23Feb2021, a Tuesday morning, for his vaccine first round. On 27Feb2021, the patient experienced pain in left shoulder and it was very painful ever since. The patient mentioned that he went to the ER 4 months prior to the report for severe pain to his shoulder and arm, a fever of 104.10. He went by ambulance because he was very sick. The patient said that it was the same left arm that was giving him problems that did back then. The patient said that he has had no problems since then after he was given antibiotics for the "virus thing", he had a 10-day antibiotic and he took one pill a day. The patient said that he has never had an allergy to medicine, and he doesn't think it was really that, he thinks it was the other problem, the same as he had before about 4 months ago. The patient said that he can't raise his arm very good, so he was planning on going to the emergency room at the time of the report since the ER takes good X-rays and can see if it was calcium deposits around where his shoulder blades are, he also needed them to give him a shot of cortisone to straighten this back up, and he needed to go to the emergency room because he needs stuff for the pain. The patient mentioned that he did not have any other recent vaccinations or started any new medications. The patient said that he doesn't think that it was the vaccine, he thinks it was the calcium deposits that must have been built up again. He said that he has a plan to got to the ER at the time of the report. The patient said that he doesn't think the cause was the vaccine solution since if it was that he would be aching in all of his other joints too, this was only just the shoulder where he had the problem four months ago. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of suspect vaccine BNT162B2 cannot be excluded for the reported events pain in left shoulder and arm, cant raise his arm very good.
Chills, sick, breathing issues for weeks. Hospitalized on ventilator on Nov. 17, 2021
This case was reported by a healthcare professional and described the occurrence of cough in a 4 year old male subject who was vaccinated with Havrix, Infanrix, Prevnar, Varivax, MMR, and IPOL for prophylaxis. The subject had no relevant medical history and no adverse events following receipt of previous immunizations. There were no concurrent medications. On 23 July 2007 at 2:45 p.m., the subject received unspecified dose of Havrix (.5 ml, unknown, left arm), 5th dose of Infanrix (.5 ml, intramuscular, left deltoid), 3rd dose of Prevnar (unknown), 2nd dose of Varivax (unknown), 2 dose of MMR II vaccine (unknown), and 4th dose of IPOL (unknown). On 23 July 2007 at 2:47 p.m., 2 minutes after vaccination with Havrix, IPOL, Infanrix, MMR II vaccine, Prevnar, and Varivax, the subject experienced coughing and crying while still in the physician's office. The mother of the subject just thought that her child was upset and took the child out to the car. The child then complained that the roof of his mouth was burning. The subject was taken back to the physician's office for examination. The physician heard wheezing upon examination. The subject also reported that he could not catch his breath. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with adrenaline (Epinephrine) injection and salbutamol sulphate (Albuterol) via nebulizer. On 23 July 2007, the events resolved "within one hour." The healthcare professional reported that the "doctor does not know which vaccines caused these events."
Multiple blisters; Injection site is itchy; slight fever at 100 deg F; Injection site is red; Injection site is swollen; Injection site is hard; horrible body ache; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE VESICLES (Multiple blisters), VACCINATION SITE PRURITUS (Injection site is itchy), PYREXIA (slight fever at 100 deg F), VACCINATION SITE ERYTHEMA (Injection site is red) and INJECTION SITE SWELLING (Injection site is swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE VESICLES (Multiple blisters), VACCINATION SITE PRURITUS (Injection site is itchy), PYREXIA (slight fever at 100 deg F), VACCINATION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE INDURATION (Injection site is hard) and MYALGIA (horrible body ache). At the time of the report, INJECTION SITE VESICLES (Multiple blisters), VACCINATION SITE PRURITUS (Injection site is itchy), PYREXIA (slight fever at 100 deg F), VACCINATION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE INDURATION (Injection site is hard) and MYALGIA (horrible body ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant informations were reported.  No treatment informations were reported.
Patient states pain in arm started after receiving shot and he can no longer lift right arm over parallel without extreme pain.
Strange taste in mouth, sweetish at first,  several weeks later metallic.  Now (4-7-2021) it's sweet again.
feeling unwell; nausea; redness; injection site swelling; little fever; joint pain; chills; muscle ache; headache; body ache; tiredness; couldn't hardly stand; This is a spontaneous report from a contactable consumer or other non hcp.  A 55-years-old male patient received bnt162b2 (BNT162B2solution for injection), dose 2 via an unspecified route of administration on 19Apr2021 12:40 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included blood pressure measurement and concomitant medications were not reported. On Tuesday,feeling unwell, nausea, redness, injection site swelling right where they gave me the shot, a little fever, joint pain, chills, muscle ache, headache, body ache, tiredness and rated his pain as 10/10. The patient had taken Acetaminophen, drank sprite, ate crackers, and laid down for about 2 hours. He also reported that back pain is still existent a couple of inches above his waist line and on one side, all the way across. Caller states he rates his back pain as a 4 or 3/10, is nauseous rating it 2/10, has pressure in his hands and swelling in his fingers. He was taking Acetaminophen for every 6 hours. The outcome of the vents was unknown.   No follow up attempts required as no further information is expected.
After 2 day arm soreness  about a week later got a rash with redness and itchy about an inch down from injection site. Dermatologist said an allergic reaction to put muciprine ? On it. It feels a little better after  2 applications
Rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication provided. No concomitant medication provided.
I've been sick for 2 weeks; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves an unknown age and unknown gender patient who reported i've been sick for 2 weeks after receiving Influenza Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown strength, expiry date, formulation, lot number) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient reported i've been sick for 2 weeks (illness) (unknown latency).  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  It was reported, : I got my flu shot and I've been sick for 2 weeks.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events
Headache, body aches, nausea, diarrhea, cough, runny nose, extreme fatigue, swollen/sore throat, tightness in chest.  Began 3/20/21 PM and progressively got worse. Doctor e-visit 3/23/21.
Mensuration symptoms increased greatly since May of 2021. Cramping and bleeding more prevalent than ever before and frequent cramping and bleeding outside of mensuration period.  Bleeding lasts for as long as period would, 3-4 days and happens about once a month, alongside period. Cycle has also become irregular, unpredictable, and now unable to track.
Blister formation on R toe (5th) w/in 2 hours after vaccine administration.
Patient came in to show her right arm had a red rash going down to her elbow and there was a little swelling. She went in to her Dr. this morning ( did not know the Doctor's name) and she was given a steroid shot and will be on oral prednisone for the next few days. She is feel very tired and lethargic and has been having chills and a loss of appetite since the shot was given on 10/22/19. At the time of the shot, she was also given Pneumovax  in the same arm and Fluad in the other arm. Could have potentially caused more of a reaction as well.  The doctor she saw this morning said it was most likely due to the Shingrix.
p/vax pt devel an inj rxn characterized by swelling, redness, pain 7 weakness which extended to the elbow;tx w/ice & anti-inflammatory med;redness & swelling resolved w/in several weeks;pain & weakness cont as of 6/25/99;
Respiratory distress; Anxiety; Fever; Passed away; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever, respiratory distress, anxiety and passed away.  The patient's medical history was not provided. Concomitant product use was not provided.   On an unknown date, 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 an unknown date, within 24 hours of receiving the vaccine, the patient developed a fever, respiratory distress and anxiety. Treatment for the events included oxygen, morphine, and lorazepam.    On the evening of 26 Dec 2020, the patient passed away.  Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 26 Dec 2020. The cause of death was not reported. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted events of death (unknown cause)  and respiratory distress, the non-serious listed event of fever, and the non-serious unlisted event of anxiety.  The events of respiratory distress, fever, and anxiety occurred within 24 hours of vaccination, while the event of death (unknown cause) occurred an unknown amount of time after vaccination.  Very limited information has been provided regarding the circumstances leading to death and additional information has been requested.  Based on the current available information and temporal association between the use of the product and the onset of events after vaccination, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death
Approximately 20 days after first dose I started to experience daily headaches. I have no prior history of daily headaches. I have had a mild headache every day for the last 14 days. I am not sure sure that it was from the vaccine but I have no previous history of daily headaches prior to the vaccine.
Painful to touch; Itch; Arm pain with a red apple sized area on her arm; Body pain; Fever; Arm pain with a red apple sized area on her arm; Chills; Exhaustion; Arm pain with a red apple sized area on her arm; "Too sick to get up"; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("Too sick to get up"), PAIN (Painful to touch), PRURITUS (Itch), PERIPHERAL SWELLING (Arm pain with a red apple sized area on her arm) and MYALGIA (Body pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced ILLNESS ("Too sick to get up"), PERIPHERAL SWELLING (Arm pain with a red apple sized area on her arm), MYALGIA (Body pain), PYREXIA (Fever), VACCINATION SITE PAIN (Arm pain with a red apple sized area on her arm), CHILLS (Chills), FATIGUE (Exhaustion) and VACCINATION SITE ERYTHEMA (Arm pain with a red apple sized area on her arm). On an unknown date, the patient experienced PAIN (Painful to touch) and PRURITUS (Itch). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 17-Mar-2021, ILLNESS ("Too sick to get up"), MYALGIA (Body pain), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Exhaustion) had resolved. On 19-Mar-2021, PERIPHERAL SWELLING (Arm pain with a red apple sized area on her arm), VACCINATION SITE PAIN (Arm pain with a red apple sized area on her arm) and VACCINATION SITE ERYTHEMA (Arm pain with a red apple sized area on her arm) had resolved. At the time of the report, PAIN (Painful to touch) and PRURITUS (Itch) outcome was unknown.            Treatment for the event included Anti-itch cream.   This case was linked to MOD-2021-049619 (Patient Link).
Within a minute -face,ears,neck turned bright red.  Paramedics took EKG and BP was 211/110. That morning ( I check it regularly due to salt sensitivity) it was 123/69  (Normally 120-140/ 60-76.
Starting 3.30.21 10pm, fever 101.2, chills, body aches, headache, fatigue, sweats, anorexia. Took 1 tylenol and 1 ASA
2 month old was administered Act-HIB and Pentacel/no AE; Initial information was received on 28-Apr-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office manager).  This case involves a 2 month-old female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB] (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) for prophylactic vaccination.  On 28-Apr-2021, the patient received first dose 0.5 mL(once) of suspect HIB (PRP/T) VACCINE (lot UJ399AA and expiry date 02-OCT-2021) via an intramuscular route at the right thigh for prophylactic vaccination and a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for Pentacel
Information has been received from a female consumer referring to herself (age unspecified). No current condition and medical history was reported. On an unknown date in 2015, "last week", the patient was vaccinated with ZOSTAVAX (dose, strength, lot number and expired date not reported) subcutaneous. On an unknown date in 2015, "last week", the patient experienced numbness, swelling, a lump, itching and redness at injection site. And the patient also experienced itching around eyes, ears, scalp and neck. The patient did not seek medical attention (also reported as "did seek medical attention"). No lab diagnostics studies were performed. BENADRYL cream (manufacturer unknown) and ice was given at injection site by herself. The outcome of all the adverse events was reported as recovering. Additional information is not expected because the reporter refused additional contact.
Generalized headache, onset about 20 hours after vaccination.  Fatigue.  Symptoms persist despite acetaminophen.  This is day one.  Duration of symptoms cannot be predicted.
Red dots all over the body including face, arms, neck, legs. Also a big rash at the place of injection
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/7/22 at approximately 08:50am. When error discovered facility contacted for course of action. At direction of the, patient contacted regarding occurrence to offer re-vaccination of dose. Patient accepted revaccination on 1/27/2022. No adverse side effects or event as result of dose.
Pt vaccinated with HIB/MMR developed febrile seizures - hospitalized 13OCT90 x 3 days for observation.
A non-serious spontaneous report of abrasion and nose bleed has been received from a registered nurse concerning a 46-month old female patient subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No relevant medical and drug history were reported for this patient. The patient received FLUMIST via nasal route on 03-Oct-2008. The patient developed nose bleed after FLUMIST administration. The patient received the initial dose without any problem. The patient was reportedly moving after FLUMIST administration into the other nostril. According to the reporter, there was a possibility of an abrasion inside the second nostril from the FLUMIST syringe tip resulting in nose bleed. The outcome of the adverse events was not reported.
Patient received the vaccine from a vial punctured on 20 April 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from a vial punctured on 20 April 2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021 at 1:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from a vial punctured on 20 April 2021). On 21-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from a vial punctured on 20 April 2021) had resolved. Not Provided      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.   The vial was punctured on 20 April 2021 at 5 PM. The punctured vial was kept in the refrigerator at 42 °F all of the time.  No concomitant medications information was reported. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: patient identifier added. batch/lot number added. vial storage conditions mentioned.
Developed hives, SOB & closing of throat, angioedema taken to ER tx Adrenalin & DPH;
Patient reported appearance of blisters on administration site on 08/23/15 and was prescribed Acyclovir 300mg on 08/25/15.
Vax - 3rd dose Rabavert at 12:45 p.m. March 3. Chills, sweats, muscle pain, dizziness reported approx 5:00 p.m. on 3/3/03. Went to ER midnight. MD told PT believed PT experiencing side effects - nothing to do but wait for Sx to abate. Gave him Vicodin. Reported talked with PT at 5 p.m. on 3/4/03. Reports feeling much better.
The cases were received 21 March 2014 at GPV. Initial misuse report received from a healthcare professional on 20 September 2013. A 04-month-old patient had received FLUZONE. It's an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none
The following morning when I woke up on Tues 2/16 around 08:00AM, I noticed slight swelling of hands, feet and tongue. I don't know when they began but I did not notice them the day of vaccine. I took a Zyrtec around 09:15AM and swelling remained the same for the remainder of the day and was subsided by following day 2/17.
Bell's Palsy, right side. Onset 3/10/21. Facial palsy impairing eating/drinking/speaking/blinking/eye closure unable/facial expression droop/unilateral lack of facial movement or facial expression. Reduced salivation.
Deep Venous Thrombosis: DVT extending from the right common femoral to the popliteal vein. Swelling of entire Rt Leg and Numbness