chrisvoncsefalvay/vaers-outcomes huggingface dataset:
facial numbness and tingling; brain fog: my head was constantly heavy; felt lightheaded/dizzy; A spontaneous case was received from the consumer concerning female patient of 31 years who received Moderna's  COVID-19 vaccine and experienced  lightheaded and dizzy/Dizziness, brain fog: my head was constantly heavy/Head discomfort, facial numbness and tingling/Paraesthesia .  The patient's medical history was not provided. No relevant concomitant medications was reported.  On 29-Jan-2021 prior to the onset of the events, the patient received first of the two planned doses of mRNA-1273 (Lot Number:011520A) on the left arm for the prophylaxis of COVID-19 infection.  On 19-Jan-2021 the patient experienced anticipating a sore arm, but she felt lightheaded and dizzy, which lasted a day or two. On 01Jan2021, she had a brain fog; her head was constantly heavy. She can function cognitively, but it takes more to concentrate and accomplish things. She started developing facial numbness and tingling on 13Jan2021. She reports it happens every day most of the day.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, lightheaded and dizzy/Dizziness was resolved and brain fog: my head was constantly heavy/Head discomfort, facial numbness and tingling/Paraesthesia  was not provided.
Client c/o dryness of mouth, flushness to face, proceed by hyper salivation (spittle).  Client verbalized that she felt anxious and nervous about taking vaccine but started to feel decrease in sensation.   Client seen by EMS and vitals are BP-168/89, Heart Rate76, O2-97.  Client then cleared by EMS to go home.
patient received first dose on 25Jan2021 08:15 and second dose on 05Feb2021; patient received first dose on 25Jan2021 08:15 and second dose on 05Feb2021; Chills; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the right arm, on 05Feb2021 (at the age of 33-years-old) at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3248), in the right arm, on 25Jan2021 at 08:15 (at the age of 33-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced chills and headache on 05Feb2021 at 10:15, which were reported as non-serious. The patient received first dose on 25Jan2021 08:15 and second dose on 05Feb2021. The patient did not receive any treatment for the chills and headache. The clinical outcome of chills and headache was recovered on an unspecified date and of patient received first dose on 25Jan2021 08:15 and second dose on 05Feb2021 was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information expected.
on saturday, 2 days after vaccine was administered, patient noticed a red spot about 1 inch below injection site, as of today (sunday) red spot has grown and is roughly 2 inches x4 inches and is warm to the touch. patient states her arm is very sore and achey. Note : spot does not encompass the injection site, reaction top edge is about 1 inch below the injection site and continues down and forward on her left arm.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 03-MAR-2016, the patient was treated by a nurse practitioner for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
10/31/09 site of injection sore, painful to lift arm - No swelling , warmth or redness to site - Small bruise rt. arm at injection site. Advised warm compresses - NSAID - 11/1/09 Pt. reports muscle pain better today - 11/10/09 message left  and no response from message.
Janssen COVID-19 Vaccine EUA I got the vaccine the evening of 03/23/21. Overnight I noticed my body starting to hurt and felt chills. The morning  of 03/24/21 I woke up with full body aches, chills, and fever over 100 F. These symptoms lasted all day. Fever went up to 102 F.  Recently I have noticed a change in my menses since having the vaccine and I wonder if it is linked. I have been on birth control since last year to control heavy bleeding. It was helping very well. The period I had in April and May were like it was before I started the pill. It was heavy and I had numerous large clots. I will be scheduling an appt with my ob/gyn regarding this change.
10-15 minutes after the shots, left arm began to tingle. By the end of the day, both arms were tingling, right shoulder was sore and stiff, one finger on each hand was red and swollen.
Patient came in for catch up vaccines, at the age of 7 years old. Patient was given a Dtap, when this is only meant to be given through 6 years of age. Patient should have gotten a Tdap based on age.  No adverse reaction.
Within two hours of receiving the shot, I went to bed with fatigue and by the end of the day I was suicidal. I had been experiencing a moderate depressive episode (which started due to some emotional blows) but I was able to function and to work. Within hours after the vaccine my depression became catastrophic and life-threatening. I could barely get out of bed for three weeks and all I could think about was ending the pain. I was not able to work. Since then, I've gotten a tiny bit better each day. I know that some women are experiencing hormonal side effects from the COVID-19 vaccination; my best guess is that since I am post-menopausal, the hormonal side effect I am experiencing is suicidal depression. Today is Day 56 since I received the vaccination. After 3 weeks at about 2%, my energy level is back to about 80% of what it was before the vaccination; on a scale of 1-100 for mental health, I'm at around 5%; suicide is always on my mind but I'm not actively planning my exit at this moment. I want to know how to get this hormonal effect out of my body. Or to get any ideas about how long it will take to go away. If anyone reading this has any other possibilities, please let me know. I just want to feel the way I felt before I got the shot. For me the Johnson & Johnson COVID-19 vaccination has pretty much been a suicide pill and I'm hanging on by a thread. I would like people taking the vaccine to be informed of possible hormonal side effects. If I had known, I would not have gotten the vaccine since I have a history of hormonal dysfunction.
Malaise, lymphadenitis, restricted duty for three days  RX: Motrin, ice pack
A red, rash and lump started just below injection site ( Friday evening3/19) Saturday ( 3/20) the rash spread down arm a bit more, but not until Saturday evening I had a slight fever 100.6. Sunday morning red, hot slightly bumpy rash was all over my upper left arm...it was ,hot and sometimes part of my arm felt like a tight mound. Went to Urgent Care Center.  Saw Dr Diagnosed as severe infection from the Covid vaccine.  Prescribed Clindamycin300 mg & Cephalexin 500 mg cost $ 175 !!!! Wednesday went to Primary Care Dr, who confirmed it was a very bad reaction and red rash had migrated further down my arm and around to my inner arm and moving towards my elbow
Optical migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Medical Information Team. The reporter is the patient.  A 67 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in right arm, administration date 04Mar2021 at 01:00 (Lot number: EN6205) at the age of 67 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Raynaud's phenomenon" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM+D; FLAXSEED OIL NATURE MADE; MAGNESIUM. Vaccination history included: Bnt162b2 (first dose (lot number: EN6201, administration time: 12:45 PM, & vaccine location: left arm)), administration date: 11Feb2021, when the patient was 67 years old, for COVID-19 immunisation.  The following information was reported: OPHTHALMIC MIGRAINE (non-serious) with onset 04Mar2021 02:00, outcome "recovered" (04Mar2021 02:20), described as "Optical migraine". The event "optical migraine" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of ophthalmic migraine. Additional information: The patient received the second dose of the Pfizer COVID vaccine on 04Mar2021 and 1 hour after receiving the vaccine she started to experienced vision changes that lasted about 20 minutes. By the time she gets to the urgent care to have it evaluated, the vision changes had subsided. The patient was concerned and wanted to know if this has happened to anyone else. The patient went to an ophthalmologist and it was determined unrelated to the vaccine and it was optical migraine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccine, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Infant received vaccines below and began breaking out with a rash within 5 minutes of receiving vaccines. Rash was on face, lower arms, hands, legs and feet. Benadryl was given and rash subsided after 20 minutes. 1st set of immunizations.
No additional Adverse Events (AEs); VARIVAX and MMR II that underwent multiple temperature excursions and were administered; This spontaneous report was received from a medical assistant referring to a 1-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or past medical history provided.  On 06-MAY-2021, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # T020652, expiration date: 16-JUN-2022 (dose, route of administration and anatomical location were not reported), and of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA (recombinant human albumin)) (M-M-R II) injection lot # S035352, expiration date: 05-NOV-2021 (dose, route of administration and anatomical location were not reported). Both vaccines were administered as prophylaxis. Both vaccines underwent multiple temperature excursions: -14.03 Celsius degree (C) for 1 hour 15 minutes 0 seconds; -14.9 C for 0 hours 9 minutes 0 seconds; -10.3 C for 1 hour 0 minutes 0 seconds; -6.3 C for 2 hours 0 minutes 0 seconds. Previous temperature excursion was reported as -14.03 C for 1 hour 15 minutes 0 seconds; -14.9 C for 0 hours 9 minutes 0 seconds. Data logger was used to capture the temperature excursion. No additional adverse events were reported.
This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received through the manufacturer  pregnancy registry from a 21 year old female with no pertinent medical history who on 11AUG2003 was vaccinated SC with a dose of varicella virus vaccine live while unknowingly pregnant. There was no concomitant medication. The vaccine was vaccine administered on 11AUG2003 and the pt discovered that she was pregnant on 22AUG2003. The pt reported that she has suffered no personal side effects. She indicated that she intends to reschedule a revisit with her physician. No other information was provided. Unspecified medical attention was sought. There were no product quality complaint. Follow up information received from a consumer indicated that there was no local reaction at the vaccination site, no varicella symptoms post vaccination, and no herpes zoster symptoms post vaccination. On 24SEP2003 and 07NOV2003, routine ultrasounds were within normal limits. A follow up 20 week scan was ordered. On 28OCT2003, the routine MSAFP was negative. The pt has a history of 3 previous pregnancies. No birth defects occurred in any previous pregnancy. A still birth or miscarriage occurred in a previous pregnancy at 8 weeks (spontaneous abortion on 12JUL1996). It was unknown if the products of conception were examined. The fetus was normal. There were no complications during pregnancy, no infections or illnesses during pregnancy, and no concurrent medical conditions. Additional follow up information received on 23-May-2004 from a physician indicated that the patient presented in labor on 13-Apri-2004 at about 12:30 AM at 38 weeks with no rupture of membranes. She delivered a female infant, vaginally at 3:00 pm on 13-Apr-2004. The patient developed a hematoma on her left labia. The baby had a normal studies, no abnormalities, had routine newborn care and was completely normal. Mother and baby were discharged home in 2 days. The physician saw the patient on 05-May-2004 to check the hematoma. The hematoma had completely resolved. Additional information has been requested.
DIZZINESS; FELL DOWN; EXHAUSTION; HEADACHE; BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on right arm on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On 22-MAR-2021, the subject experienced dizziness. On 22-MAR-2021, the subject experienced fell down. On 22-MAR-2021, the subject experienced exhaustion. On 22-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from exhaustion, dizziness, and headache, and the outcome of body aches and fell down was not reported. This report was non-serious.
Information was received from a medical assistant and an office manager, referring to an unspecified number of patients of unknown age and gender. The patients' current condition, concomitant medication and medical history were not provided. On unspecified dates between 23-JAN-2017 and 21-FEB-2017, the patients received unspecified doses of improperly stored PROQUAD (concentration, frequency and route were unknown; lot # M023931 with expiration date 09-NOV-2017, lot# M038861 with expiration date 13-MAR-2018 and lot# M035690 with expiration date 06-FEB-2018, respectively) for prophylaxis. No adverse effects were reported. PROQUAD was stored between 5 Fahrenheit degree (F) and 14 F for 18 hour 40 minutes, and between 14 F and 46 F for 4 hour 30 minutes. There was no previous temperature excursion, and the data logger was involved. Lot number lot# M038861 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live. Additional information has been requested. Sender's Comments: US-009507513-1703USA006076.
Pt came into pharmacy. Complaint about  severe bruising and swelling on injection site persisting 1 week after immunization. Right arm was large area of  bruising and yellowish color. Injection site may have been too low (under deltoid for IM). Suggested patient check with MD if bruising persists.
This spontaneous report as received from a certified medical assistant (CMA) concerning an unspecified number of patients (gender and age unspecified) which reported that the patients received improperly doses of M-M-R II (dose, route and lot # unspecified) between 16-JUN-2014 and 13-JUL-2014. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Severe arm pain at point of injection which was administered too high on the arm possibly into shoulder joint.
pt recv vax & on 11JAN94 exp localized itching @ inj site; No further details were provided;
On the night of the 23rd, I was having severe  cramping that I assumed was Braxton Hicks contractions. I called early morning on the 24th.  I was instructed to go in to labor and delivery immediately. I had a scheduled c section on 5-5-21. So we were only 37 weeks. I had uncontrollable shaking which my doctor thought was due to a panic attack because I have past anxiety and depression. They tried to check my cervix and my back was uncontrollably straightening out and I had no control over my body. My doctor was about to send me home but decided it would be best to do a c section. They waited until another c section was finished. I had no bleeding, I was just in pain. When they did the c section, the found that I had a concealed abruption and was internally bleeding. I lost a lot of blood. My doctor told me this is rare and normally happens with drug addicts, not healthy women in pregnancy. My baby almost died. She had to be resuscitated because all the blood that was in her lungs due to my placenta tear from the uterine wall.  This is my third baby and I?ve never had any issues or health problems while pregnant. I did not have gestational diabetes. Even at birthweight at 37 weeks premature, she was born at 8 pounds 4 ounces. No one knows what happened.
Severe redness/swelling/discomfort at injection site measuring > 4 cm at time of office visit 5 days later.
Four weeks later and arm still hurts and is increasingly hurting worse.  Wakes me up in my sleep and if I am not using it the ache increases. Whole arm and hand has swelled.  Makes me cry it hurts so bad in the morning. Went to my Dr. who could still feel where the injection sites are.
Bone aches from the waist down; Bad chills; Sore left arm; This spontaneous case was reported by a pharmacist and describes the occurrence of BONE PAIN (Bone aches from the waist down), CHILLS (Bad chills) and VACCINATION SITE PAIN (Sore left arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced BONE PAIN (Bone aches from the waist down), CHILLS (Bad chills) and VACCINATION SITE PAIN (Sore left arm). At the time of the report, BONE PAIN (Bone aches from the waist down), CHILLS (Bad chills) and VACCINATION SITE PAIN (Sore left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, Antibody test: 800 antibody level returned at 800 5 months after his first booster dose. In May 2022, Antibody test: 800 800 ELU/ml.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  In March of 2021 after his Primary Series the patient had an antibody dose of 1800 ELU/ml.  The patient reported that after his third booster dose his antibody level returned at 800 5 months after his first booster dose.  The patient had a sore left arm, bone aches from the waist down, and bad chills after his first Moderna Covid-19 vaccine booster dose on 12-NOV-2021.   This case was linked to MOD-2022-630007 (Patient Link).
Initial report received 25 June 2009 from another manufacturer (document number 45220198), who received the report from a consumer, who is the patient. A female patient (age not reported) who had a history of unspecified reactions to many unspecified narcotics, reported that she was allergic to a flu vaccine (manufacturer, lot number and date of administration not reported) and immediately after receiving the vaccine, she came down with an extreme case of the flu. The patient also reported becoming "sick" after receiving polio vaccine (manufacturer, lot number and date of administration not reported) many years ago. The patient sought medical attention at a doctor's office and subsequently recovered (dates of recovery not reported). Documents held by sender: None.
My son was giving multiple vaccines at one time including, 2 vaccines that are in combination. To come home with a fever and reaction on his leg, then was running into walls.
She developed redness on the injection site on her Left thigh on 7/21/19.  Started Tylenol yesterday. The redness is not going away.  No fever.  She is acting fine.   She had MMRV on the left thigh given on 7/15/19/ They are leaving  tomorrow. I reassured the mother that patient has a local reaction to the MMR. Give her Benadryl 2.5 ml q 6hrs x 2-3 days. - diphenhydrAMINE (BENADRYL 2.5 MG/ML) 12.5 MG/5ML Syrup; Take 2.5 mL by mouth four times daily as needed for swelling/pruritis for up to 3 days.
Patient began to feel ill with palpatations, dizziness, fatigue, shortness of breath, exercise/activity intolerance, diarrhea, and diaphoresis on 2/10/22. Patient presented to primary care physician 2/15/22 due to symptoms. Patient was found to be in Afib with RVR, elevated proBNP, hypotensive and had hyponatremia. Patient was admitted to Hospital 2/15/22 through 2/17/22.