chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dry mouth; tingling lips; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (dry mouth) and PARAESTHESIA ORAL (tingling lips) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (dry mouth) and PARAESTHESIA ORAL (tingling lips). At the time of the report, DRY MOUTH (dry mouth) and PARAESTHESIA ORAL (tingling lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history information was provided. No concomitant medications were reported No treatment details was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: No follow-up information provided
21 y/o F presented to Health Services on 7/5/22 for varicella vaccine, MCV4 (Menveo) vaccine and PPD placement. Pt returned on 7/7/22 for PPD reading (negative) and reported to nurse that there was redness at the injection site of her varicella vaccine. Pt reported that the area was also itchy and that the redness had spread a little bit each day since her vaccine. Pt denied fever and malaise. Area was assessed by nurse and nurse practitioner.  Area of 48 mm x 27 mm on posterior aspect of left upper arm was red, swollen and warm to the touch. Outline was drawn around area and pt was told to return the next day, 7/8/22, at 3 pm to have the area reassessed. Nurse practitioner recommended to the pt that she try taking an OTC antihistamine such as loratadine to see if this helps relieve the itchiness. Pt agreed to this plan. Pt called Health Services the next morning to cancel her appointment for 3 pm that day stating the area had improved. Nurse called the patient back to get more details.  Pt confirmed the area of redness was now smaller than the outline drawn around it the day before (7/7/22). Pt stated the redness and swelling had decreased and that it was no longer warm to the touch or itchy. Pt reported she took one tablet of loratadine the night before and stated the area has not been itchy since then. Pt denied fever and having redness/swelling/itchiness anywhere else on her body. Pt instructed to go to an Urgent Care if over the weekend the redness/swelling/itchiness returns/gets worse or spreads to other areas, and/or she develops a fever. Pt agreed to this plan.
pt recv TD instead of PPD vax & devel wide spread redness, itching & pain @ test site;disappeared in 48-72hr p/tx w/cold packs & in some cases topical hydrocortisone cream was applied;
bruise & red rash on rt arm silver dollar size; red circle silver dollar size on lt arm onset of silver dollar size areas 18APR94; will go to pvt MD;
It was suggested by a nurse to report this. I had vague achy feeling from the waste down the lasted a few hours on the same day 1st vaccine was received. Vague aches and pains where mostly in legs. Very slight. Lasted a few hours
I felt sick for the whole week  straight. Fatigue, ache, nausea. Now, the site of injection is swollen and itchy.
Patient developed a recurrence of cutaneous small vessel vasculitis affecting upper and lower extremities approximately 1-2 weeks after receiving COVID booster shot without other clear triggers. Of note, he has a history of known cryoglobulinemia secondary to prior hepatitis C infection with previous episode of cutaneous small vessel vasculitis (viral infection since treated and cleared but with persistent cryoglobulins.)
6/14/2022 sore throat. Tested with at home kit, negative. By the end of the day 6/15 I had headache, sore throat, nasal congestion, cough. 6/16 tested again, positive. Doctor determined that PAXLOVID not appropriate to use due to symptoms not being severe. Prescribed cough pills. I lost sense of smell and taste 6/17. On 6/20 sense of smell returned. 6/27 nurse practitioner advised that sense of taste could take up to 90 days to return. Still had sore throat which prompted to call. Throat has returned to normal. Everything is normal except taste has not returned as of 7/1.
Rash on bilateral legs. Not quite petechial but more like small bruises under the skin. Non-tender, no nodules, and the lesions are confined to the lower extremities.
Headache, Myalgia, Arthralgia, Fever, ErythemaMultiform, Diarrhea, NauseaVomiting, Fatigue, Pain, Chills Narrative:
Started itching at site-red, hot itchy- (ominates later, chest felt tight-used Albuterol inhaler (minimal relief)-took Benadryl 25mg-225pm. Still itchy all over, ears hot. Voice Hoarse. Benadryl 25 mg IM 3pm. BP-132/78 p-120. Also has
Initial information received on 04-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 month and 11 days old patient who received vaccine FLUZONE QUADRIVALENT lot number not reported via unknown route in unknown administration site at the end of December. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Inappropriate age at vaccine administration. The nurse practitioner is not sure if it was the FLUZONE QUADRIVALENT but she states that she knows it was a sanofi-pasteur vaccine and she is outside of her facility today. She states that it was given to a 4 month and 11 day child at the end of December. She states that they have gotten no calls from Mom with any issues or concerns. 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. Documents held by sender: none.
On the way home from receiving vaccine felt ill developed aches, chills, low grade fever and headache 2 hours after vaccine legs aches and back pain across the lower back,48 hours of headaches and fatigue, resolved by the next evening and well the 3rd day.
Mild headache that lasted about 8 hours; This is a spontaneous report from a non-health care professional. A male patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the right arm on 27Mar2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration on 06Mar2021, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021, the patient experienced mild headache that lasted about 8 hours. The event 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 event.  The clinical outcome of the event mild headache that lasted about 8 hours was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a 65 year old female who was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently, seven days after receiving the vaccination, the patient developed a rash all over her body that looked more like chicken pox than shingles.  The physician wasn't the one that gave the vaccine, it was given at the patient's "army base".  The patient did have a titer drawn prior to getting the vaccine and there was an indication that the patient already had chicken pox.  The physician prescribed "antivirals".  Unspecified medical attention was sought.  No product quality complaint.  Additional information has been requested.
Could not get up from bed; Fatigue; body aches; Fever; Arm pain; Could not get up from bed; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), the first episode of ASTHENIA (Could not get up from bed), the second episode of ASTHENIA (Could not get up from bed), MYALGIA (body aches) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia. Concomitant products included HYDROXYZINE HCL, GABAPENTIN, VITAMIN D [VITAMIN D NOS], TRAZODONE, CYCLOBENZAPRINE and IBUPROFEN (EXCEDRIN IB) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), the first episode of ASTHENIA (Could not get up from bed), MYALGIA (body aches) and PYREXIA (Fever). On 08-Apr-2021, the patient experienced the second episode of ASTHENIA (Could not get up from bed) and FATIGUE (Fatigue). On 28-Mar-2021, PAIN IN EXTREMITY (Arm pain), MYALGIA (body aches) and PYREXIA (Fever) had resolved. On 09-Apr-2021, last episode of ASTHENIA (Could not get up from bed) and FATIGUE (Fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No treatment was provided for the symptoms.
Stiff and numbness on facial area, mostly nose, above upper lip and between eyebrows. Blurred vision, headache, jittery, low grade fever.; Stiff and numbness on facial area, mostly nose, above upper lip and between eyebrows; Blurred vision; Headache; Jittery; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 17Apr2021 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression and allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included piroxicam (PAXIL) from unknown date for unspecified indication and unknown if ongoing. On 17Apr2021, the patient experienced stiff and numbness on facial area, mostly nose, above upper lip and between eyebrow, blurred vision, headache, jittery and low grade fever. 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 events, stiff and numbness on facial area, mostly nose, above upper lip and between eyebrows, blurred vision, headache, jittery and low grade fever was resolved on an unknown date on Apr2021.   No follow-up attempts are needed. No further information is expected.
On 4/11/2016, child received two vaccinations that were expired (Hep B, expired 11/1/2015 and Hib expired 10/28/2015)
Headache; Hives; This is a spontaneous report from a contactable healthcare professional, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0173) via an unspecified route of administration in the left arm on 13May2021 at 17:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient previously received azithromycin (MANUFACTURER UNKNOWN) and codeine (MANUFACTURER UNKNOWN) for unknown indication from unknown date and experienced drug allergy. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 18:15, the patient experienced headache and hives. No therapeutic measures were received for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events headache and hives was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Received 1st vaccine 1/28/21.  No adverse effects. On approximately 2/14/21 I  started feeling cold/flu like symptoms & had a slight headache for 3 days.  Symptoms not severe just cold like & lasted a week. received 2nd vaccine 2/21/2021. My husband had both his vaccinations by 2/15/2021, On 2/21/2021 He hade severe cold & flu symptoms. Took him to urgent care where we both tested positive for Covid/19 & my husband also tested positive for the flu. Just don?t understand how we both tested positive for covid after receiving both vaccnations, We re tested 3/5/3021 & still tested positive. How much longer do we need to wait to be retested?
Pt was treated at a walk-in-clinic on 5/11 for a local cellulitis of left gluteus where vaccine was given (with Keflex and IM steroid). She developed malaise, chills, paresthesias of hands and later body, nausea, lethargy and myalgias that started the day after her vaccine . She also developed a raised, erythematous area at her injection site that was warm & tender.
1.  large red rash on upper right arm. 2.  blood pressure started to rise.  3.  Bell's Palsey symptoms started to occur.  4.  PVC's detected in heart beat.  5.  Feelings of uneasiness and anxiety.  Blood pressure kept increasing.
Pain @ injection site; muscle pain, shortness of breath, fast heart beat, difficulty breathing, vomiting at 4:45 am and at 5:40 am on 1/16/21.
This spontaneous report as received from a physician refers to herself: an approximately 33 year old female patient. Medical history was not provided. In the summer of 1986, the patient was vaccinated with hepatitis B vaccine (V232) dose 3. After about one month (unspecified date in 1986) the patient experienced sub-acute allergic reaction (medically significant). The patient received the hepatitis B vaccine (V232) that was released on 01-JUN-1982, the other one was only released on 01-MAY-1986. The sub-acute allergic reaction lasted 9 months. The worst of it had stopped in the Spring of 1987; however patient had still some "auto immune reaction" (dates not provided). The outcome of sub-acute allergic reaction was reported as recovered. Sub-acute allergic reaction was determined medically significant upon internal review. Additional information has been requested.
105 temp and respiratory illness (croup) followed by prolonged gastro intestinal issues.  Treating with probiotics seems to helping but not as well as one would hope.
she was exhausted for an entire week/She generally felt fatigued; She felt very weak/ She had no energy; She was not feeling great for about 7-10 days; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EU6199, Expiry date: not reported), via an unspecified route of administration on 06Mar2021 (age at the time of vaccination was 58-year-old) as single dose for COVID-19 immunisation. The patient's medical history included seasonal allergy from an unknown date and unknown if ongoing , sinus disorder from an unknown date and unknown if ongoing , hay fever, pet dander and pollen allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not administer any other vaccines on same date of Pfizer vaccine and did not receive any other vaccinations within 4 weeks of Pfizer vaccination. On an unknown date in Mar2021, after the first vaccination the patient was exhausted for an entire week. The patient felt very weak, had no energy, and generally felt fatigued and was not feeling great for about 7-10 days. The patient recuperated from her first COVID-19 Vaccine dose. The patient received a corrective therapy for all the events. The patient visited emergency room/ physician office visit due to the events. The patient underwent lab tests and procedures which included chest x-ray and result was normal on an unknown date Jan2020, oxygen saturation: always in the 90s on an unknown date in 2021. The outcome of all events was recovered on an unknown date in 2021.
Syncope at 2-3 minutes after immunization. HPV #1, MCV (MENACTRA), ADACEL were the vaccines given. No hx of previous reaction to any vaccine.
Chills, body aches, terrible headache, nausea, tired for approximately 24 hours upon onset of symptoms Left axillary lymphadenopathy for approximately 3 days
Within days of getting the second dose of the vaccine, I started to have problems with my left shoulder. I got the injection in my left arm and it felt like a sore muscle. The pain started at the injection site and then it spread to the top of my shoulder. It kept getting worse and the pain My doctor thought I had damaged my Bicep muscle. It is very sore to touch and I can't raise my arm or lift things. It is hard to reach for anything and I can't turn my arm. It even hurts to drive.  It is the top of my shoulder at the head of the Bicep. It has been nine months and my left shoulder has improved a little but it is still painful and does not function correctly. I tried Physical Therapy and it did not help. I got the third dose in the other arm and I experienced the same pain in my right arm. That is when I realized that the problems with my left shoulder might be related to my vaccine.
arm soreness; arm swollen; rash; This is a spontaneous report from a Pfizer sponsored program 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 and expiration date was not reported) via an unspecified route of administration on 09Mar2021 as dose number unknown, single for COVID-19 immunization. Medical history included diabetes mellitus and she had broken blood vessels in her eye on the side that she got the vaccine. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) taken for she had broken blood vessels in her eye on the side that she got the vaccine. The patient had arm soreness and arm swollen and rash lasted few days on an unspecified date in Mar 2021. The event outcome for soreness in arm, arm swollen, and rash was reported as recovered on unspecified date of 2021.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Pt states at about 5-6PM on 12/17/03, she got hives on the top and back of both arms, states her throat was hoarse.  States shortness of breath, declining tired and heart palpitations.  States she took 2 Benadryl with some relief.  States she called ER and MD with both stating she should wait and see if it goes away and to call if symptoms worsening.  States taking Benadryl about every 4 hours for 3 days with symptoms improving.  States on 01/13/04 her heartrate is a 32 for 44 BPM at times and that she is still tired and hoarse.  Plans to see MD on 01/15/04 for these symptoms.
enlarged lymph node on his left collarbone; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (enlarged lymph node on his left collarbone) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia and war syndrome.    On 29-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced LYMPHADENOPATHY (enlarged lymph node on his left collarbone). At the time of the report, LYMPHADENOPATHY (enlarged lymph node on his left collarbone) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2022-458224 (Patient Link).
30 minutes after injection, had sore arm, "hurting" while breathing, increased heart rate, increased blood pressure; after arriving at ER, more than 1 hour after injection, had vomiting x 3, hives/welts on chest and arms, fever and chills
Woke up next am after vaccination with complaints of facial swelling. Went to ER and was released then had to return to ER again the next day and was once again released. Went to different ER and was hospitalized. Facial swelling worsened and began having difficulty breathing and as of today 01/11/2010 pt is intubated.
High fevers that persisted despite use of medication for 3 days, lethargic, rash.
On the same day after the 2nd dose, I had the arm pain with body aches and headaches. The second dose was not as bad.
Pain in arm Pain in shoulders and neck Very bad nausea  Vomited once Fatigue
Pericarditis causing sinus tachycardia since onset of symptoms 12/24/21 and continuing.
Sensory polyneuropathy; right arm weakness - worsening with time. Currently under investigation with EMG and MRI
W/in a few hrs p/receiving the inject pt developed n,d; Sx resolved later that day;