Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cough, Dyspnoea, Fatigue, Feeding disorder
Clinical narrative: clear liquid dripping out of her nose; sinuses where they felt like they were draining after the vaccine and this was different like a clear liquid coming out and was constantly going down her throat and nose and it was unreal; fatigue; she could not walk and she can barely move; her body ached / started feeling bad all over her body; could not eat and yesterday she was throwing out; could not eat and yesterday she was throwing out; brain fog/ started feeling bad all over her body; cough; she could not breathe/described the difficulty breathing as something stops in her chest making her not breathe; muscle pain/pain was in her muscles; light burning; swelling of her leg/swollen everywhere/ hand, arms, and fingers are swollen/her fingers and arms and both hands were so swollen with the fingers of both hands; hand, arms, and fingers are swollen/her fingers and arms and both hands were so swollen with the fingers of both hands being the worst and she could hardly move her fingers; developed headache which is more like migraine; severe headache; neck hurt so bad and she had severe pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EL9266) via an unspecified route of administration on 04Mar2021 at 14:00 pm as dose 1, single dose for covid-19 immunization (at the age of 64-years-old). Medical history included muscle damage (leg and knee damaged in a fall), surgery (before her pfizer covid vaccine, had last surgery where she gained 15 pounds and laid in bed and kind of gave up), gained 15 pounds, fall (leg and knee which were damaged in a fall prior to the pfizer covid vaccine), bulging discs (was disabled because of the bulging discs and muscles on her shoulders up to her neck), damaged neck and broke her femur from an unknown date and unknown if ongoing and urinary tract infection from an unknown date and ongoing sinus. Concomitant medication(s) included olopatadine hydrochloride (OLOPATADINE HYDROCHLORIDE, Nasal Solution and lot 140225 and expiry date Feb2022) taken for sinus disorder, start and stop date were not reported. It was reported that on 04Mar2021 at 14:00 pm the patient received the first dose of vaccine and stated that and in the evening of 4Mar2021 at 08:00PM she started to notice the swelling of her leg (it swelled especially on her leg which had a knee replacement year back). It was like water was pumped into her leg. She slept really late that night and when she woke up (she says she normally sleeps 4 hours at a time so it isn't necessarily the morning after), she developed headache which was more like migraine. She also noticed that her hand, arms, and fingers are swollen. It got better throughout the day and it got worse again in the evening. By that time, she also had clear liquid dripping out of her nose. She strongly suspects this reaction came from a drug. She also felt fatigue (feeling bad all over) and she does not want to describe it as something she experienced with the flu. She said that was hurts less than the flu but she couldn't walk and she can barely move. On Saturday 06Mar2021, she had muscle pain which started in her injured leg and she described the sensation as "light burning". She also felt like something was moving inside the muscle. On Sunday on 07Mar2021 at 03:00 am, she started to have deep cough. When she lay down at night, she could not breathe, and she had to stack 3 pillows just to breathe. She described the difficulty breathing as something stops in her chest making her not breathe. She was better yesterday on 16Mar2021 and had brain fog and she also could not eat and yesterday she was throwing out. Her main concern was the difficulty in breathing. She would consider her adverse events to be medium instead of severe. She would like to know if these are adverse events associated with the vaccine. She also would like guidance if she should take the second dose of the vaccine. Reporter stated that before her Pfizer COVID Vaccine, she had her last surgery where she gained 15 pounds and laid in bed and kind of gave up and her weight varies and she does not know what was going on with her because her weight depends upon her activity with her knee; states her weight average was 150 pounds and throughout she has gained about 10 pounds and last weighed 163 pounds and knows that was not right but the weight has been up and down and stated before she got on the scale and her weight would be less and she is trying to watch it and kind of gave up after breaking her leg and was stuck in bed last year but has pretty well recovered from breaking her leg; states she needs a knee replacement and it is hard to walk and she has to go today to get a shot; no further details provided by the reporter. Reporter stated that she has not had this type of reaction before and mentioned that got her first dose of the Pfizer COVID Vaccine on 04Mar2021 and the first day she got the shot at 2:00 pm that evening she went to her daughter and states she does stay laying down a lot due to her leg and knee which were damaged in a fall prior to the Pfizer COVID Vaccine, and she stays off her leg a lot. She mentioned that on 04Mar2021, she started to take her leggings off and looked at her legs and they were so swollen and were swollen everywhere which was not ongoing and only lasted about a day. Caller states within a few hours that night of receiving the vaccine she had a severe headache which was more like a migraine type and she knows this was a common side effect with this vaccine so she did not put much attention to the headache and in next morning her headache was worse and she got it under control because she usually uses vaporizers which are those things she puts on her table with water and lavender and peppermint and this got rid of the headache. She mentioned that the worst thing she had was that night of vaccination where her fingers and arms and both hands were so swollen with the fingers of both hands being the worst and she could hardly move her fingers and it was not normal swelling and stated that she knew what normal swelling looks like and this was fluid not just in her joints of the fingers hands and arms; states her hands were worse and lasted a day and this has completely resolved. She reported that that the swelling was the worst in the evening and her symptoms then started to change and she probably had swelling the whole day but getting up and moving helps and a little bit in the evening the swelling was worse. Reporter stated that she takes medications for her sinuses and her sinuses do not stop up but she had her sinuses where they felt like they were draining after the vaccine and this was different like a clear liquid coming out and was constantly going down her throat and nose and it was unreal and mentioned that she kept wiping it and draining and blowing her nose and it was not normal drainage; states the sinus drainage was not ongoing and lasted about a day. Caller stated that on the Friday evening after the Pfizer COVID Vaccine, she started feeling bad all over her body and that maybe a common symptom too but she felt really bad and her body ached and that did not start until the next day and she felt bad all over. She reported that she has been told that the aching is like the flu but this was not flu it was an ache and was different than when you have the flu and she felt really drained and had heavy fatigue mixed in with that; states it was just like she was really sick and got an infection but she did not have an infection and had just gone to see her HCP the day before and the HCP did a test that he ran and she had no infection in her bladder. Reporter stated that she does have bladder problems but had no symptoms the day before and went in to the HCP as this was a different matter but her bladder was clear of infection and she had a urinary tract infection the month before and went in to the HCP to make sure the urinary tract infection was completely gone and she had no infection. She stated that the Saturday after 04Mar2021, the pain got worse and she probably noticed the pain was in her muscles; states she had muscle pain off and on before the vaccine because she has a fused back and other things that did not affect her back but when she fell she had muscles and her leg that was damaged and after 04Mar2021, she hurt all over in her muscles and it was more severe and was weird and a burning muscle pain she could feel moving and it was light burning; states in her muscles that were damaged when she fell previously, they had to cut through the bottom muscle so she has muscle damage from that and when she fell she had an MRI. Caller stated that the muscle pain she has had after the vaccine was something different in her leg; states before the vaccine she had tearing below her knee from the fall and it kind of hurts when she walks. It seems the pain hit her muscles and affected her muscles that were damaged in her body where she felt the pain and felt the pain go in when she hurt, and the pain moved up when she felt it like something traveling through her leg. On Sunday, the pain lasted all day and this was a bad day or two where her muscles probably still hurts and she did not feel any better and then the day before yesterday actually felt like a fog in her head and felt sick the whole week; states her headache was really bad and was back and she started getting a cough and by Sunday at 3:00 am, she could not breathe and started having trouble laying down and still cannot lay but uses high propped pillows and felt like there was something on her chest and she could not breathe and she still cannot breathe. She stated that she has a pain pump that controls her pain; clarifies to state she was a 13 year pain patient and the pain pump does not control her pain much anymore but it does control the pain in her neck; states this was her 2nd pump that was implanted on 27Aug2018 and has serial number NGP615696H and model number 8637/20 but her HCP changed that and she has no information on her 1st pump and states she has no medication name, lot, expiry date or NDC to provide for this 2nd pump. Caller stated for the Pfizer COVID Vaccine, she has her patient card with lot number and the date she got the first dose on 04Mar2021 and the date for her 2nd dose was scheduled for 26Mar2021 at 1:00 pm. Caller stated with her 1st dose she had these pretty bad reactions. She mentioned that Caller states she was disabled because of pain and the worst reaction to the vaccine she has had was when pain hit her muscles. Caller stated prior to the Pfizer COVID Vaccine, she had muscles that were damaged when she slipped in water at a medical clinic and should have gone to the emergency room at that time and her HCP thought her muscles were affected because she broke her femur at that time and has been through hell before with her knee. Caller stated that she left the HCP office and had a urine test and asked about the Pfizer COVID Vaccine and she does not know if the HCP knows she had the vaccine and stated that the HCP said they are giving out the vaccine and sent her over there to get it and she did not think to ask questions before the HCP sent her. States she also goes to another HCP; no further information provided. She stated that she does not know if she would call her reactions not mild but does not know if they tell her not to take the 2nd dose if she was not covered at all for the covid virus or if she stops now and does not have the 2nd dose is it like having zero coverage. Caller stated she takes a medication for her sinuses that dries her sinuses up and does not have sinus issues where it hurts and has no drainage much at night but had a really bad sinus issue due to the area she lives in and the solution she uses was Olopatadine Hydrochloride. Caller states that she has only called Medtronic before about her pain pump for questions and dealt with that company and stayed away from calling about her reaction because when she called Medtronic, they took one reaction she reported to them and made it sound like a horrible reaction and it was not even a reaction but they made it sound like something was wrong with the pump and she thought that was crazy; no further details provided by the caller and caller previously stated she has no lot numbers or information to provide for her 1st pain pump and provided the information of the second pump previously stated in this report. Description of Product Complaint included: "States she does not know if she would call her reactions to the Pfizer COVID Vaccine are not mild but does not know if they tell her not to take the 2nd dose if she is not covered at all for the covid virus or if she stops now and does not have the 2nd dose is it like having zero coverage. Caller states she takes medications for her sinuses and her sinuses do not stop up but she had her sinuses where they felt like they were draining after the vaccine and this was different like a clear liquid coming out and was constantly going down her throat and nose and it was unreal; states she kept wiping it and draining and blowing her nose and it was not normal drainage; states the sinus drainage is not ongoing and lasted about a day. Caller states she takes a medication for her sinuses that dries her sinuses up and does not have sinus issues where it hurts and has no drainage much at night but had a really bad sinus issue due to the area she lives in and the solution she uses is Olopatadine Hydrochloride Nasal Solution and has lot 140225 with expiry date Feb2022. State she is a 13 year pain patient and the pain pump does not control her pain much anymore but it does control the pain in her neck; states this is her 2nd pump that is implanted on 27Aug2018 and has serial number NGP615696H and model number 8637/20 but her HCP changed that and she has no information on her 1st pump and states she has no medication name, lot, expiry date or NDC to provide for this 2nd pump. States she does not know if she would call her reactions not mild but does not know if they tell her not to take the 2nd dose if she is not covered at all for the covid virus or if she stops now and does not have the 2nd dose is it like having zero coverage. States her daughter hears a lot of things and states she heard the Pfizer COVID Vaccine only covers you for three months; caller has no further information to provide". Patient was recovered from the events of peripheral swelling, movement disorder in Mar2021 and from events rhinorrhoea and nasal sinus discharge on an unspecified date and outcome was unknown for rest of the other events.  No follow-up attempts are possible. No further information is expected.