chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Today on 4/15/10 patient reports that day after Hepatitis B vaccine given on 1/5/10 (left Deltoid IM) he had swelling in upper arm that involved the shoulder down to his elbow.  Denies pain with swelling and states that he did not inform anyone of the swelling because it was not painful.  Patient states that the swelling lasted approximately 1 month.  He reports this to me today when he presents for his second Hep B vaccine.  Denies any other problems specifically SOB, hives, itching, etc.
I received my vaccine about 3pm Sat. April 3rd. About an hour or so later I started to feel ?run down? but nothing major. At 9pm I began getting chills but did not feel feverish. By 9:15 my body was aggressively trembling. Even my teeth were chattering. I could not control the shaking. I put many layers of blankets on me and turned my heat up to 80 in an effort to get warm. At some point I dozed off. I woke up at 12:30am and had a fever of a little over 101 degrees.  I fell asleep about 3am, still aggressively shaking.  I woke up at 9am (April 4th) and my head was throbbing. My fever was now 102.2. Also, every muscle in my back and shoulders ached. I sat up because I needed to get to the kitchen for some water. Once I stood up, my body felt like it was weighed down by heavy sandbags. I could barely walk to my kitchen and back. I went back to bed and covered up in massive blankets and tried to stay still. I did not take any pain reliever because I was too nervous to.  I never had any nausea but smells bothered me and I had no appetite. My fever stayed at 102.2 until I went to sleep (around 10pm).  Monday (April 5th) I still had chills but much milder. My temp was just over 101 all day. My head felt better but my muscles still hurt. By late evening (10pm) my fever was just over 99 degrees. I was feeling better and I no longer had chills.  Tuesday (April 6th) I woke up fever free. I felt mostly normal again except for my muscle aches.  Today is Friday (April 9th) and I continue to have muscle aches. The worst of it is in my lower back and it?s pretty severe. It feels like I lifted heavy weights with my lower back muscles. I have not been seen by a Doctor yet as I have no insurance. I?m not sure if I need to or not.   I wanted to contact you because I am a healthy person and what I experienced was BRUTAL. I have NO IDEA how a frail or vulnerable person could go through what I went through. Also, people need to know that they may have to take time off of work to deal with these side effects.
This case was reported by a consumer and described the occurrence of erythema urticarial in a 75-year-old patient who received SHINGRIX for prophylaxis. On 24th October 2018, the patient received the 2nd dose of SHINGRIX. On 27th October 2018, 3 days after receiving SHINGRIX, the patient experienced erythema urticarial and pruritus. On 28th October 2018, the patient experienced erythromacular rash. On an unknown date, the outcome of the erythema urticarial, pruritus and erythromacular rash were unknown. It was unknown if the reporter considered the erythema urticarial, pruritus and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The had large red welts on both sides of butt crack. They were large/raised and very red. The patient also had a couple of the same welts on the back of left leg. Both of the back of hands had red welts and were very itchy. Four days after receiving SHINGRIX, when patient got out of bed had red marks on both of sides under arms that were long and red, almost like scratches would look. The patient also had one spot in the same area that looked like the beginning of shingles. Lots of red spots in an area about the size of a baseball. The patient also has some red spots on face and head. This case has been linked to case US2018GSK196604.
No adverse event; patients were given monovalent vaccine instead of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patients were given monovalent vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, 0.3 ml) on 27-Jan-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2 and  0.3 ml) on 17-Feb-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.   On 26-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2023, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 03-Mar-2023, the patient experienced WRONG PRODUCT ADMINISTERED (patients were given monovalent vaccine instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patients were given monovalent vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patients were given monovalent vaccine instead of the bivalent booster).    The concomitant medication was not reported. The treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713899, US-MODERNATX, INC.-MOD-2023-713877 ( Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713899:Patient 1 case US-MODERNATX, INC.-MOD-2023-713877:Patient 3 case
Fever >102 R not responsive to APAP, trembling, rhonchi, cough; Proventil syrup, vaporizer, ATB, APAP;
Patient reported feeling muscle ticks and spasms starting the evening after receiving the second dose of Pfizer covid vaccine. Patient reports that the spasms in her legs happen on a daily basis but the spasms in her arms or other areas are not as predictable.
28 year old pregnant female , EDC 06/20/2022 in for 3rd dose of Pfizer covid vaccine as recommended by her Ob-Gyn.  Vaccine given and patient was instructed to remain in lobby for observation for 15 minutes.  Summoned to lobby by clerk about 5 min after vaccine. Patient reports feeling dizzy and having lower abdominal cramps.  Was able to ambulate with assistance back to vaccine room and helped onto exam table. Vital signs monitored- WNL. skin warm, dry. Color pink, non-splotchy.  Alert, responsive to person, place, time and situation. Uncle, is in clinic.  Patient verbalized concern that she  will not be able to go to work today and is requesting an excuse.  911 alerted to sent ambulance, patient agreed with decision. Explained that she will be sent to hospital for further evaluation. Ambulance personnel transported her to Medical Center.
Patient states she had vaccine on 5/11/2021 and on 05/15/2021 she broke out with hives on both arms on inside, and on back of neck and a few on her chest. The arms lasted about 1.5 weeks before fading. She used Zyrtec and steroid cream.  She did visit her PCP.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 14-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (10PK-0.5ml SD-PFS LLokw Tip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion four times.  The total cumulative excursion time of the first time was 256 hours with the highest recorded temperature of 47 Fahrenheit degree. The total cumulative excursion time of the second time was 80 hours with the lowest recorded temperature of 30 Fahrenheit degree. The total cumulative excursion time of the third time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The total cumulative excursion time of the fourth time was 1172 hours with the lowest recorded temperature of -3 Celsius degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Headache, fatigue, low grade fever, arm soreness, nausea, light headedness
ear ache; inflammatory response; This is a spontaneous report from contactable pharmacist. A 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 01Jul2021 as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (she also revealed that, prior to taking the 1st dose of the Pfizer covid vaccine, she was diagnosed with Covid-19, date is unknown). The patient's concomitant medications were not reported.  The patient experienced earache and inflammatory response in 2021 and caller wants to know if this might be related to her body's immune response, because of the high antibodies. Caller stated patient returned last week for the second and revealed that she had an antibody test that resulted in a high titer results, she also revealed that, prior to taking the 1st dose of the Pfizer covid vaccine, she was diagnosed with Covid-19, date is unknown. Caller inquired should the patient receive the second dose of the Pfizer Covid vaccine since her antibodies came back high. Antibody testing was not currently recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination because the clinical utility of post-vaccination testing has not been established. Antibody tests currently authorized under an EUA icon have variable sensitivity, specificity, as well as positive and negative predictive values, and were not authorized for the assessment of immune response in vaccinated people. Furthermore, the serologic correlates of protection have not been established, and antibody testing does not evaluate the cellular immune response, which might also play a role in vaccine-mediated protection. Finally, antibody testing against nucleocapsid would not detect immune responses resulting from vaccination, but patients might not always know what type of antibody test was used. If antibody testing was performed following vaccination, additional doses of the same or different COVID-19 vaccines were not recommended based on antibody test results at this time. If antibody testing was done after the first dose of an mRNA vaccine, the vaccination series should be completed regardless of the antibody test result. She does not have number for her titers. She was having earache and inflammatory response after the first dose and went to her PCP and he consulted back to them. They cannot figure out what is causing earache and inflammation. The other pharmacist got all the information yesterday and did not have time to contact Pfizer and only contacted VAER's last night. The patient underwent lab tests and procedures which included antibody test: high titer in 2021. The outcome of events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
PATIENT WAS GIVEN A BOOSTER DOSE 5 WEEKS AFTER THEIR SECOND DOSE, COMPLAINING OF HEART PROBLEMS AND IRREGULAR BEATING
stomach pain; whole body ache; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), MYALGIA (whole body ache) and CHILLS (chills) in a 50-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jun-2021, the patient experienced MYALGIA (whole body ache) and CHILLS (chills). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) outcome was unknown and MYALGIA (whole body ache) and CHILLS (chills) had not resolved.            No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Event start date updated. On 28-Jun-2021: New event added: stomach ache
eosinophilia; diarrhea; extreme fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of EOSINOPHILIA, DIARRHOEA, and FATIGUE in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DIARRHOEA and FATIGUE. On 26-Apr-2021, the patient experienced EOSINOPHILIA. At the time of the report, EOSINOPHILIA, DIARRHOEA, and FATIGUE  outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Eosinophil count: 18.5 (High).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EOSINOPHILIA to be related. No further causality assessments were provided for DIARRHOEA and FATIGUE.    Concomitant medication included ACE Inhibitors.  No treatment information provided.  Action taken with mRNA-1273 in response to the events was not Applicable.
I had COVID. My symptoms were severe headaches, sore throat, body aches and extreme fatigue.
Received vaccines around 12:10pm, cried a lot therefore eyes and ears red when leaving. In car while driving home itchy eyes and saw rash on arm. When returned to our office approx 12:55 pm (+) pinkish macular rash on chest, (L) volar surface of lower arm, ears red and splotchy. Children's Benadryl Ttsp PO taken without difficulty with cup of H20. Playful and rash decreased after 25 minutes.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age. On an unknown date of unspecified number of patients might have received a dose of PNEUMOVAX23 (Lot#, dose and route not reported). PNEUMOVAX23 was reported to have a temperature excursion on 06-SEP-2013 by the pharmacist and the excursion was not supported. The pharmacist was calling in for recommendations for revaccination for patients who might have been administered the unsupported product. Follow-up information was received from the pharmacist to approximately 7 adult patients of unknown age. The pharmacist stated approximately 7 adult patients were vaccinated improperly stored PNEUMOVAX23. It was unspecified if the patients had sought medical attention. Additional information has been requested.
COVID symptoms began Jan 4, 2023 with mild fever, cough, sore throat, and tiredness. On Jan 5 I tested positive for COVID, with moderate symptoms. I also contacted Hospital Clinic for consultation, and they prescribed Paxlovid. However, I did not read the instructions carefully and was only taking 3 pills a day instead of 6.  Symptoms were treated with rest and cough/cold medicines (Dayquil, NyQuil).  By Jan 8 my symptoms were much improved and I stopped taking Paxlovid. I had no further COVID symptoms by Jan 10.
This consumer report (initial receipt 08-Jun-2012) concerns a female patient, who had a medical history of drug reaction/allergy to penicillin, mushrooms and chocolate. 2 years ago in 2010 the patient received flu vaccine (manufacturer and batch no. was not provided) and ZOSTAVAX. 2 days after receiving the vaccinations the patient developed what looked like rosacea across her face which was painful, burning, had broken vessels and red skin. The patient sought medical attention. She tried all sorts of treatment including antibiotics, antivirals and prednisone but nothing worked. All lab diagnostic studies and all kind of lab work were performed. The patient said she then developed a complex.
Information has been received from a 29 year old female Pharmacy Technician for ZOSTAVAX (Merck), a Pregnancy Registry product, with drug reaction/allergy to MACROBID and a history of urinary tract infection, chickenpox when she was 1 or 2 years of age. The patient had been nursing her baby since August 2008 and was still nursing at the time of the report. It was reported that the Pharmacy Technician was mixing up a lot of doses of ZOSTAVAX (Merck) for the pharmacists to administered in January 2009 while she was pregnant. Concomitant therapy included unspecified prenatal vitamin. The Pharmacy Technician stated that approximately around 29-JAN-2009 she experienced a fever, aches, flu like symptoms, itchy back, and rash and blisters appeared. The Pharmacy Technician saw her physician on 29-JAN-2010 and he prescribed VALTREX. The patient stated that she did not take the VALTREX because she was pregnant at that time and did not feel comfortable taking VALTREX. The Pharmacy Technician stated that it took about 5 weeks approximately around the beginning of March 2009 before all those symptoms resolved. The Pharmacy Technician stated that she had not mixed up any ZOSTAVAX (Merck) since this had occurred in 2009. The Pharmacy Technician reported that last Monday 22-MAR-2010 she started feeling itchy on the collarbone and neck and by Saturday 27-MAR-2010 she developed shingles type rash. The Pharmacy Technician requested information on how her physician could culture the blister, rash to determine whether the rash was wild type shingles or shingles from exposure to ZOSTAVAX (Merck) since when she experienced the blisters and rash in January 2009 no one had sent it out for analysis to determine the exact cause of the blisters and rash. At the time of the report the patient had not recovered. The patient was scheduled to see the physician on 29-MAR-2010. Fever, aches, flu like symptoms, itchy back, rash and blisters were determined to be an other important medical events for the reporter due to VALTREX prescribed. Additional information has been requested.
On 9/3/01, PM, pt had cloudy vision on the left and sharp left frontal headache X 2 for 20 seconds while shopping at the mall. No associated dizziness, nausea or other symptoms. No stress, trauma, toilet straining or toxins. On 9/4/01, seen by ophthalmologist. On 9/5/01, had transient loss of some vision for about 1 hour in the right eye and ++ tender right calf for about 1 hour. Pulses and color normal. Sensory (fifth) left loss for +24 hours. Fields by confrontation and pin confirmed. On 9/6/01, seen by Retinologist and floursecein angiography was ok. Neurologist fifth confirmed. MRI was read as normal by neuro-radiologist. On 9/7/01, Neuro-retinologist was seen. On 9/10/01, conferred with immunologist, rheumatologist. On 9/14/01, had mammogram. Took aspirin (just because) without symptoms. On 9/17/01, had good neuro exam by chiropractic neurologist. No Dx or RX. On 9/18/01, was given Diamox 500 SR bid for 1 day and then Diamox qd since light-headed. On 9/24/01, had Retinologist follow-up. On 9/26, LP was normal. Also had special tests. Field defect and subjective complaints which vary slightly. For instance, defect became worse after she sneezed and vision maybe "slightly better after chiropractic visit". Thus far, all studies of blood, MRI, optic nerve conduction, flourescein angiography has been normal. Audiogram and acoustic reflex (unilateral only) was normal. No associated symptoms at all. No internist has ever seen her. No complete physical has ever done. No spinal tap, ultrasound of vessels or other studies have been done. ASA discontinued on 9/18/01. Note: Severe 1st time allergic reaction to shitoke mushrooms, 6 weeks ago. No cross reaginicity or long term problems found in literature search. Hep-B #1 injection +3 weeks ago, without local reaction. Reports of association with optic neuropathy, etc, denied by immunologist. Uneventful trip to Canada (Lyme) 5 weeks ago and Cedar City about 3 weeks ago. Blood test negative. No clinical history. Dx: blind in left eye (quadrant defect) and bilateral optic nerve neuropathy; no etiology. Follow up information received 10/18/02 stated, "blindness Partial, Cognitive Problems"
Pt recv vax 08May96. Within 24-48 hr, pt exp numbness of face & hands lasting several days. Also exp muscle spasms, shortness of breath, "black outs & minor strokes".
Unspecified date the vaccinee received the first dose, subsequently the vaccinee experienced myalgia.
After the first dose of the vaccine, she had mild flu-like symptoms, headache and swelling; After the first dose of the vaccine, she had mild flu-like symptoms, headache and swelling; Swelling at injection site; This is a spontaneous report from a contactable Nurse (patient) communicated to a Pfizer sales representative. This 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as first with unknown single dose for covid-19 immunisation. Medical history included patient was being treated for hypertension (ongoing) and hyperlipidemia (ongoing). Patient had COVID-19 in June (unspecified year) and still has ongoing lost sense of taste and smell with fatigue and headaches lingering. The patient's concomitant medications were not reported. After the first dose of the vaccine, she had mild flu-like symptoms, headache and swelling at injection site. Symptoms lasted 2-3 days. Event took place after use of product. Outcome of the events was recovering.  No follow-up attempts are possible; Information about Lot/batch number cannot be obtained.
Patient received Varicella and Hep A (Havrix) at 12:45 PM. He started having puffy eyes, coughing, difficulty breathing and wheezing at 2pm. He was brought back to my office at 3:20pm.
Symptoms: chest pain.  Hospitalized 5/13/21 - 5/15/21. Diagnosis: myocarditis. Treatment: observation, limitation of physical activity.
COLD CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced cold chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold chills. This report was non-serious.
Extreme sore throat, constant coughing. Nothing relieves either. I was put on an antibiotic and cough medicine with codine
Mother reported that after a day "on the golf course" she fainted and had "seizure like activity" - was not hospitalized, but advised by MD to report to VAERS - (High temperatures & humidity locally).
5 days of Diarrhea  4 days of left ear pain 4 days of constant headache 5 days of lethargy 2 days of cough 4 days of hip joint pain 4 days of muscle pain TXT: Extra Strength Tylenol & 800 ibuprofen
Runny nose, difficulty breathing, slight swelling in throat, burning, tingling in lips and gums, achy muscles.
Tremors in right hand at rest and with activities. worse with fingers flexed and forearm internally rotated