chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 79 year old female patient reporting on herself. The patient's concurrent conditions and medical history were not provided. On an unknown date in 2015, the patient was vaccinated with a dose of PNEUMOVAX 23, (dose, route, lot number and expiration date were not provided). Concomitant therapies were not provided. The patient stated that on 18-NOV-2015 her upper arm "swelled and was red for a couple days" after receiving a dose of PNEUMOVAX 23. She also said "I had a low blood platelet count when I had my routine blood work during my doctor's visit". The patient sought medical attention by pharmacist visit and no treatment was received for the adverse events. The outcome of platelet count decreased, injection site swelling and injection site erythema was unknown. The relatedness between the events and suspect therapy was unknown. Additional information is not expected since no permission for further contact was given.
zoster like eruption beginning 31OCT thought to be dermatitis & treated w/Hydrocortisone-worsened & clinically dx'd zoster 2NOV
expired dose of Daptacel administered to patient; Initial information received on 05-Aug-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (Office Staff).  This case involves a five years old female patient who received expired 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5180BA and Exp. Date 06-Apr-2019) via intramuscular route in the upper left thigh, on 05-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), POLIO VACCINE INACT 3V (VERO) (IPOL) and HEPATITIS B VACCINE for Immunisation.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether the patients had any adverse reactions.  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.  List of documents held by sender: none.
Chills, vomiting, sharp stomach/abdomen pains, nausea, headache.
Very sore right shoulder, immediately began to feel sore in my lymph node under the armpit. Later, soreness in full right arm, upper back and neck. Fever over night, chills, body soreness all next day, brain fog, nausea
She got ?very sick? after her second injection.  She says the injection induced suicidal ideation.  She had thoughts to hang herself which she has not had previously.  She said, ?if I wasn?t in so much physical pain and couldn?t move I would have done it?my whole body was in pain?it is like I had COVID all over again except the breathing part?.I couldn?t move.?  She was ?curled up on the floor in the closet.?  The suicidal ideation resolved after 1.5 days at the same time as the body aches resolved.  She is not sure if the suicidal ideation was a side effect to the injection or triggered by the body aches from the vaccination.  She had not had any suicidal ideation in the timeframe prior to the vaccination.  Her last suicidal ideation prior to this event was about one year ago.  She has not had any suicidal ideation since the 1.5 days after the vaccination.  She was also having trouble recalling information during the 1.5 days after the injection  or ?form complete sentences?I would forget things mid-word.?   The cognitive effects lasted 1.5 days.  She did not have any adverse effects after 1.5 days.  She did not cut or have any urges to cut.  She last had urges to cut a couple of months ago.  She did not have any illicit drug or alcohol or marijuana use during that timeframe.  She thinks the body aches and suicidal ideation developed at the same time (as compared to one starting before the other).  She also had chills but did not check her temperature.  She did not take any NSAIDS or Tylenol.  She did not experience any other acute psychiatric symptoms during the 1.5 days.  She did not have psychosis, mania, depression, PTSD or OCD triggered.  She did not have any new medications during this timeframe.  Her COVID 19 infection was in March of 2020.  She thinks it is possible that the vaccination was a ?trigger? to suicidal ideation because during her COVID-19 infection she wondered if she was going to survive.  She did not have suicidal ideation back in March of 2020 during her COVID-19 infection.  She said her ?resolve? to kill herself was unique for the 1.5 days stating, ?the only reason I didn?t do it was I couldn?t get up.?  She did not go to the hospital ?because I had no way to get there.?  She realizes she should have called 911.  The experience was ?scary.?  She said she did not think about calling me adding, ?I didn?t know what to do?I couldn?t think straight...I couldn?t even remember my birthday but I do that a lot?my birthday was never celebrated.?  She had the Pfizer vaccination.  The only side effects after the first injection of the vaccine was congestion and a sore arm (both of which lasted three days).  She does not recall having congestion after the second injection.  She reports that she is fine now.   She thinks she had suicidal ideation triggered by a past psychiatric medication as well but she cannot recall which medication.
Onset of weakness approximately 4 hrs post vaccination.  Unable to stand.  Fell to the floor on 4 different occasion over 2 days time.  This required calling EMS and neighbors for assistance.  Weakness has continued through today.  Ordinarily this individual has no problems standing or walking.  To ER today for evaluation.
Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm; Scarring; This is a spontaneous report from a contactable nurse (patient herself). A 66-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EK4176), via an unspecified route of administration in the left arm on 19Jan2021 at 10:00 as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not have any other vaccine in four weeks, did not have other medications in two weeks, did not have COVID prior to vaccination, has no known allergies, and was not pregnant. There were no concomitant medications. On 24Jan2021 at 08:00, the patient experienced pink raised bumps with clear top filled with fluid that looked like tiny blisters with intense itching only on the vaccinated arm. Rash appeared on day 6 after injection and two new locations on same arm erupted after 4 more days. Scarring and itching up for two weeks. The patient was not tested for COVID after vaccination. As treatment, Permethrin cream was used to see if it was scabies to "no eff". The adverse events resulted in a doctor or other healthcare professional office/clinic visit and disability or permanent damage. Outcome of the events was recovering.; Sender's Comments: Based on temporal association  and/or known drug profile a contributory role of BNT162B2 to the reported events  cannot  be totally excluded.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
increased joint pain. Increased nerve pain in knees and behind eyes.Shooting nerve pain is sharpened. Extreme fatigue at times.
Initially pain all over and muscle and joint pain that started passing over first 3 days, on 4th day symptoms subsided but noticed charley horse in right leg, persisted for 4 days and started treating as if blood clot by drinking water, raising leg, taking Aleeve, and hot pad so symptoms subsided. Began having difficulty breathing even though symptoms passing so still concerned by the 10th day sought medical treatment and testing for clot. Diagnosis was dehydration likely caused by menstruating at same time as vaccination. Prescribed nsaid and muscle relaxer to reduce symptoms and action plan for increasing water and natural iron intake prior to next dose to prevent more dangerous complications. Had hospitalization for SARS in 2009 and also treated for dehydration, did not consider the vaccine might have a similar effect to the prior infection since I was coughing so hard I was vomiting up all water for 3 days, but my vaccine symptoms were VERY similar to the 2009 illness in slow mo without the coughing including the pain and nausea (hospital could only confirm it was an unknown coronavirus at the time my roommate brought from another county, he was a another race native and very ill but was not hospitalized and didn?t disclose he was sick so he wouldn?t miss the start of the semester in quarantine, flew anyway and didn?t tell us until I was hospitalized). Still dehydrated at 2 weeks after vaccine (today) but functionally symptom free at this time. Menstruation was normal, lighter flow than usual, and lasted 7 days which is normal for me post-IUD. Symptoms persisted after period stopped but progressively improved thereafter, unclear if because of home care for potential clot or because no longer menstruating so better able to retain water.
Left arm swelled; These pains moved to my legs/I have pains in both calves/leg,calf pains; Terrible pains in my body; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left arm swelled), PAIN IN EXTREMITY (These pains moved to my legs/I have pains in both calves/leg,calf pains) and MYALGIA (Terrible pains in my body) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia and Neuropathy.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (These pains moved to my legs/I have pains in both calves/leg,calf pains) and MYALGIA (Terrible pains in my body). On 22-Apr-2021, the patient experienced PERIPHERAL SWELLING (Left arm swelled). At the time of the report, PERIPHERAL SWELLING (Left arm swelled), PAIN IN EXTREMITY (These pains moved to my legs/I have pains in both calves/leg,calf pains) and MYALGIA (Terrible pains in my body) outcome was unknown.            No concomitant products were reported. No treatment drugs were reported.   This case was linked to MOD-2021-315529 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Significant Follow up, current condition updated.
Pt received PNEUMOVAX in clinic on 3/10/16 at 1100. Pt called clinic on 3/11/16 complaining of swollen deltoid and shoulder. arm red and warm to touch, painful and difficult to lift arm. Clinic recommended placing ice 15 minutes and 15 minutes off, and going to ED if symptoms worsen. Pt presented to ED 3/11/16 complaining of same symptoms, began 5 hrs post vaccine administration. In ED, given ketorolac 60mg IM, methylprednisolone NA succ 80 mg IM, diphenhydramine 50 mg PO. On discharge from ED, prescribed methylprednisolone 4mg dosepak, diphenhydramine OTC as needed, ice packs as needed, home med diclofenac as needed. Follow up call 3/14/16, pt tolerating medications and swelling in shoulder improved.
This case was reported by a pharmacist and described a 53 year old male patient who did not respond to the Hep-B vaccines.    The patient's medical history included childhood asthma, depression, and seasonal allergies.  Concurrent medications were not reported.    On an unspecified date, the patient received the third dose of Energix-B.  Approximately two months after the third dose, on an unspecified date, a hep-B surface antibody titer indicated that the patient was "non-immune".  The reporting pharmacist considered the event to probably be related to vaccinations with Energix-B.  The pharmacist reported that the patient has begun the second series of Energix-B.
patient should have received a pediatric dose of the covid-19 vaccine. a vial of the adult vaccine was used by mistake, mixed and administered using the instructions for the pediatric dose. (1.3ml diluent and 0.2ml dose administered). mom reports no unexpected side-effects at this time- just a sore arm right now.
2nd Pyzer Shot 2/8/2021 2:54 PM I believe I had an allergic reaction the first night: Arm twitched several times approx.  6-7pm,Light headache approx. 8pm Anxiety increased between 8pm-2am,Woke 3:49 am with bad headache in rear of head, went to bathroom and turned over.   Woke up with bad headache a little while later, Several times woke up  struggling to swallow.  Last time I woke up with Difficulty breathing and pressure on chest  Decided I needed to wake my husband, but that is my last thought or action until I woke up 9AM.  I take a generic Zyrtec at supper time each night.  I think had I not had Zyrtec these symptoms could have been serious.  Was OK until 3  11pm 3/9/2021 Slight headache & Shortness of breath.
Pt was triaged on 11/20/17 by Clinic RN. Note at the time of triage is as follows: On 11/17/17,  pt noticed that her arm was sore and that she was beginning to develop hives from her deltoid to her arm pit. She states that there was heat present and that the hives were raised and painful. She reports that she applied an ice pack with some relief. She reports that evening she had some SOB that was relieved by her albuterol inhaler. She states that on Saturday she did not have any SOB, the hives subsided, but she still has pain present that had improved. She states that today she still has pain present to her left arm. She states there is some redness present, she states there is still swelling present near the injection site. She is unsure if she has had a fever, she states that she has felt warm. She denies discharge from the wound, but it is painful to the touch. She denies SOB at this time.
I just became dehydration overnight.  When I stood up, I passed out. I went the ER via ambulance. They did an EKG of my heart. They did bloodwork. Was not diagnosed with anything but the dehydration.
Case number PHEH2011US02925 is an initial spontaneous report received from a health care professional on 30 Aug 2011 with the follow up information received on 20 Sep 2011: This report refers to a male child. His medical history included of allergies. He was given only the MenA lyophilized powder component of MENVEO (batch number: M10053) reconstituted with the sterile diluent from VARIVAX (manufacturer and batch number: unknown) intramuscularly on 26 Aug 2011. No other adverse reaction was reported. Follow up information received from the health care professional on 20 Sep 2011: Updated medical history.
I started with a 190 heart beat, I went to the doctor, and she put me right in the hospital. With that I was in the ER and they decided to do a catscan, and that's when they found something wrong with my renal, and they admitted me, and not only did they do test on my heart, they did a test on my kidneys - a renal biopsy. And that is where they found I had Vasculitis, and that is when they put me on Dialysis. I lost my muscle tone, and now I have to have a live in aid, and physical therapy. Before, I was walking 3.5 miles. If this is from the injection, I do not want this to happen to someone else.   2 mths in With hospital and at Rehab
This spontaneous report as received from a certified medical assistant refers to a 4 year old patient of an unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX unknown route and strength (lot # K015970 with expiration date 23-SEP-2016 or lot # K021847 with expiration date 03-NOV-2016 or lot # L001335 with expiration date of 13-JAN-2017) which were exposed to temperatures outside of the recommended range. There was no adverse event reported. The reporter could not break out which specific lot number of vaccine was administered to the patient. This is one of several reports received from the same reporter. Additional information has been requested.
a couple that die from COVID and left 5 kids behind; This is a spontaneous report from a Pfizer-sponsored program Pfizer.com - General Company Information via a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at an unknown dose via an unknown route on an unknown date for COVID-19 immunization. The patient medical history and concomitant medications were not reported. A couple died from COVID and left 5 kids behind. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101212055 same reporter, same event, drug/ different patient; Reported Cause(s) of Death: a couple that die from COVID and left 5 kids behind
cardiac arrest (V fib) treated: with amiodarone, magnesium, 6 doses of epi, calcium, bicarb. Achieved ROSC. outcome: withdrawal of care
Vasovagal syncope in parking lot outside of medical clinic ~15 minutes after vaccine given. No head injury or other injury. Full recovery within 15-30 minutes.  Brought back into clinic and recovery occurred in exam room.
Alot of hard Swelling, about the size of a large baseball at the injection site and moving upwards towards my left shoulder, alot of soreness at injection site and surrounding swollen area. Heat radiating from skin. Very painful to move my left arm.
transient pallor, weakness, coo, clammy skin;onset of gen urticaria about 6-8hr p/vax;
Red, swollen, tender from shoulder to elbow, no fever less than 24 hrs.
Pfizer 11/15/21, Moderna 2/23/21, 3/26/21. Pfizer 4/19/22. Positive on 10/9/22
Shingles; information had been received on from a lawyer and the patient (pt), regarding a case in litigation referring a female pt of unknown age.  In 2016, the pt was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (route anatomical location, lot number and expiration date were not provided) for Long term prevention of shingles and/or zoster-related conditions.  Subsequent to pt´s Zoster Vaccine Live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result Zoster Vaccine Live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Redness, painful hard lump with Pneumovax. Slowly improving over 1 wk.
Received Tdap (deltoid) on 1/14/13. Presented to me on 1/30/13 with complaint of pain on right neck after the injection on 01/14/13 with some associated facial itches. Pain progressively worse 42 cm x 3 cm area of cellulitis at angle of jaw and adjust (R) neck on 1/30/13 c/w cellulitis.
Pt. got vaccine 11-13. On 11-14, she noticed shoulder above vaccine site, neck, and back of ear really hurt/couldn't lift arm. On 11-15 and 11-16, it was very painful. Today 11/17, she said she can lift arm a little bit/still not normal. No rash.
Pt describes onset of abdominal cramping, diarrhea, and headache approx. 24 hours after 2nd pfizer vaccine. Has tried taking 1 ibuprofen for the headache; however, states it did not really help and she did not want to suppress her immune system.   I recommend that she try taking immodium and tylenol; however, pt reports "tylenol doesn't work for me". Discussed that if she was going to take ibuprofen, 400 mg would be more of a therapeutic dose. Recommend she call the clinic on 5/15/21 if her symptoms do not seem to be improving.
I have had discomfort and pain in my left arm. The pain at times throb/burns at times and its painful when i move my arm certain ways. I can feel were i got my shot 2 months ago.
deep vein thrombosis, swelling, pain in both legs and lower abdomen.  warm and red skin.  red swollen veins.
Received 15 mos vaccines at 18 mos visit; had recent folliculitis/abscesses perineum. Left leg developed fever, cellulitis and abscess; needed IV antibiotic and hospital stay x1 night.
chills; temperature of up to 99.0 degrees / fever; joint aching/Had aches in my joints; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 02Mar2021, as dose 1, single, for COVID-19 immunisation. Medical history included COVID-19 from 22Dec2020 which was really bad for about a week and a half and she was not sure if that made her side effects worse or not. The patient's concomitant medications were not reported. The patient experienced a small reaction which includes chills, a temperature of up to 99.0 degrees and joint aching. The patient wants to know if she should receive the second dose of the Pfizer COVID-19 vaccine since she had this reaction after the first dose and if she experiences a similar reaction, if it was okay to take Tylenol for these symptoms. She denied any signs of a serious allergic reaction. The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.